A Phase 3, Multicenter, Double-blind, Randomized, Placebo-controlled, Parallel-group Trial to Assess the Efficacy, Safety and Tolerability of Cenerimod in Adult Patients With Systemic Lupus Erythematosus and Active Lupus Nephritis in Combination With Background Therapy

The goal of this clinical trial is to learn if cenerimod, on top of regular treatment, works to treat active lupus nephritis in adults with systemic lupus erythematosus and active lupus nephritis. It will also learn about the safety of cenerimod. The main questions it aims to answer are:
* Does cenerimod improve kidney function in participants?
* What medical problems do participants have when taking cenerimod?
Researchers will compare cenerimod to a placebo (a look-alike substance that contains no drug) to see how well cenerimod works when it is added to regular treatment.
Participants will:
* Take cenerimod or a placebo every day for 76 weeks (approximately 1.5 years), on top of regular treatment.
* Visit the clinic every 1 to 3 months for checkups and tests.

开始日期2026-02-09

申办/合作机构

Viatris, Inc.

NCT07266090

/ Active, not recruiting临床2期

A Multicenter,Open-label,Single Arm,Multiple-dose Study to Evaluate the Safety,Tolerability,Pharmacokinetics and Pharmacodynamics of Cenerimod in Adult Chinese Participants With Moderate-to-severe Systemic Lupus Erythematosus (SLE) on Top of Background Therapy

The goal of this clinical trial is to learn about the safety, how the body processes the drug, and its effects of a drug called cenerimod in adult Chinese participants (aged 18-75) with moderate to severe Systemic Lupus Erythematosus (SLE) who are already receiving standard background therapy.
The main questions it aims to answer are:
* What is the safety and tolerability of a daily 4 mg dose of cenerimod in Chinese participants with SLE?
* How is cenerimod processed by the body (pharmacokinetics) in this population?
* What is the effect of cenerimod on the level of lymphocytes in the blood (pharmacodynamics)? This is a single-arm study without a comparison group.
Participants will:
* Take one 4 mg cenerimod tablet by mouth once daily for up to 12 months.
* Continue their stable, pre-existing background SLE medications throughout the study.
* Attend regular clinic visits over a period of up to 22 months for tests and check-ups, including blood draws, heart monitoring (12-lead electrocardiogram), vital signs(blood pressure),and physical examinations.
* Undergo a final safety follow-up 6 months after their last dose of the study drug.

开始日期2026-01-14

申办/合作机构

晖致医药有限公司

NCT07301723

/ Completed临床1期

A Single-center, Open-label Trial to Determine the Absolute Bioavailability of Cenerimod Using an Intravenous 14C-radiolabeled Cenerimod Microtracer in Healthy Male Participants

The goal of this clinical trial is to learn about the absolute bioavailability of cenerimod in healthy participants. It will also provide information about the safety of cenerimod.
Participants will receive one tablet with cenerimod, followed by an intravenous (i.v.) infusion with a 14C-radiolabeled cenerimod microtracer (cenerimod with a very low dose of radioactivity) 6 hours later.
Participants will stay at the clinic for a total of 4 days, and will return to the clinic for further tests over the course of approximately 3 months.

开始日期2025-12-11

申办/合作机构

Viatris, Inc.

100 项与 Cenerimod 相关的临床结果

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100 项与 Cenerimod 相关的转化医学

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100 项与 Cenerimod 相关的专利（医药）

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项与 Cenerimod 相关的文献（医药）

2025-02-01·ANNALS OF THE RHEUMATIC DISEASES

Pharmacodynamics of the S1P₁ receptor modulator cenerimod in a phase 2b randomised clinical trial in patients with moderate to severe SLE.

Article

作者: Murphy, Mark Joseph ; Suffiotti, Madeleine ; Keller, Marcel Peter ; Seifer, Gustavo ; Strasser, Daniel Stefan ; Berkani, Ouali ; Cornelisse, Peter ; Brazauskas, Pijus

BACKGROUND:

Systemic lupus erythematosus (SLE) is a complex autoimmune disease characterised by autoreactive T and B lymphocytes. Sphingosine-1- phosphate (S1P) is involved in lymphocyte egress from peripheral lymphoid organs into the circulation. In phase 2a clinical trial, the potent, selective S1P₁ receptor modulator cenerimod reduced circulating antibody-secreting cells and interferon (IFN)-associated biomarkers.

OBJECTIVES:

Pharmacodynamic effects of 2 and 4 mg cenerimod were evaluated in the phase 2b clinical trial (CARE) in moderate to severe patients with SLE (NCT03742037).

METHODS:

Blood samples were collected at baseline and after 6 months of treatment with cenerimod or placebo from CARE. The gene expression signatures for type 1 interferon (IFN-1), IFN-γ and plasma cells were used to assess dose-dependent pharmacodynamic effects of cenerimod. Cell-type deconvolution was performed to estimate cell abundance.

RESULTS:

Cenerimod 4 mg reduced IFN-associated protein and gene signature biomarkers after 6 months compared with placebo. A larger decrease of IFN proteins was evident in IFN-1 high patients compared with IFN-1 low patients. The median IFN-1 score in the IFN-1 high patients was reduced after 6 months of cenerimod 4 mg and the transition from IFN-1 low to high status compared with placebo was prevented. Cenerimod 4 mg exhibited a larger effect size on the pharmacodynamic biomarkers IFN-1, IFN-γ and plasma cells compared with cenerimod 2 mg.

CONCLUSIONS:

This study further characterised the mechanism of action of cenerimod in patients with SLE and substantiated the scientific rationale for cenerimod 4 mg in the phase 3 clinical trials in moderate to severe SLE (OPUS-1/-2).

2025-01-01·Lancet Rheumatology

Cenerimod, a sphingosine-1-phosphate receptor modulator, versus placebo in patients with moderate-to-severe systemic lupus erythematosus (CARE): an international, double-blind, randomised, placebo-controlled, phase 2 trial

Article

作者: Trokan, Luba ; Cahuzac, Clélia ; Merrill, Joan T ; Murphy, Mark J ; Kalunian, Kenneth ; Berkani, Ouali ; Askanase, Anca D ; Navarra, Sandra V ; D'Cruz, David ; Cornelisse, Peter ; Strasser, Daniel S

BACKGROUND:

Sphingosine-1-phosphate (S1P) is a signalling molecule that has an inhibitory role in atherosclerosis, inflammation, cell proliferation, and immunity. Cenerimod is a selective S1P₁ receptor modulator under investigation for the treatment of systemic lupus erythematosus (SLE). We aimed to determine the efficacy, safety, and tolerability of four doses of cenerimod in adults with moderate-to-severe SLE receiving standard of care background therapy.

METHODS:

CARE was a double-blind, randomised, placebo-controlled, phase 2 trial, in adults (aged 18-75 years) with moderate-to-severe SLE (a score of at least 6 out of 105 on the SLE disease activity index-2000, modified to exclude leukopenia [mSLEDAI-2K] score). Participants were recruited from 189 hospitals, specialist centres, and outpatient clinics in 22 countries in Asia Pacific, Latin America, Europe, and the USA. Participants were randomly assigned (1:1:1:1:1), using an interactive response technology via balanced block randomisation (block size of 5) and stratified by oral glucocorticoid dose at randomisation and disease activity at screening, to once-daily oral cenerimod at 0·5 mg, 1·0 mg, 2·0 mg, or 4·0 mg or placebo, in addition to stable background SLE therapy, and followed up for 12 months. After 6 months, participants assigned to cenerimod 4·0 mg were randomly assigned again (1:1) to either cenerimod 2.0 mg or placebo for a further 6 months. The primary endpoint was change from baseline to month 6 in mSLEDAI-2K score, assessed in all participants randomly assigned to treatment (full analysis set). To meet the primary endpoint, the doses had to show a significant improvement over placebo, when adjusting for multiplicity, considering the hierarchical testing strategy, per a prespecified plan. Safety analyses included all participants who received at least one dose of study treatment. This study is registered with ClinicalTrials.gov, NCT03742037, and is complete.

FINDINGS:

Between Dec 21, 2018, and Aug 25, 2022, 810 patients were screened and 427 were randomly assigned to 0·5 mg (n=85), 1·0 mg (n=85), 2·0 mg (n=86), and 4·0 mg (n=85) cenerimod or placebo (n=86). Median age was 42 years (IQR 33-51), 406 (95%) of 427 participants were women, 21 (5%) were men, and 337 (79%) were White. At month 6, the least squares mean change from baseline in mSLEDAI-2K score was -2·85 (95% CI -3·60 to -2·10) for the placebo group and -3·24 (-3·98 to -2·49; difference vs placebo -0·39 [95% CI -1·45 to 0·68]; p=0·47) for the cenerimod 0·5 mg group, -3·41 (-4·16 to -2·67; difference vs placebo -0·57 [-1·62 to 0·49]; p=0·29) for the 1·0 mg group, -2·84 (-3·58 to -2·09; difference vs placebo 0·01 [-1·05 to 1·08]; p=0·98) for the 2·0 mg group, and -4·04 (-4·79 to -3·28; difference vs placebo -1·19 [-2·25 to -0·12]; p=0·029) for the 4·0 mg group; hence, the primary endpoint was not met. Treatment-emergent adverse events up to 12 months had no clear treatment-related or dose-related pattern across the groups. At month 6, treatment-emergent lymphopenia was reported in one (1%) of 85 patients who received cenerimod 0·5 mg, five (6%) of 85 patients who received 1·0 mg, nine (10%) of 86 patients who received 2·0 mg, 12 (14%) of 84 patients who received 4·0 mg, and no patients who received placebo. Two deaths due to adverse events occurred (both in the cenerimod 1·0 mg group; one due to acute coronary syndrome and the other due to upper gastrointestinal haemorrhage), and were determined to be unrelated to study treatment.

INTERPRETATION:

The primary endpoint was not met. Cenerimod was well tolerated over 12 months. Cenerimod 4·0 mg is being investigated for the treatment of SLE in two ongoing phase 3 trials (NCT05648500, NCT05672576).

FUNDING:

Idorsia Pharmaceuticals.

2024-12-03·Cureus Journal of Medical Science

Evolving Treatment Strategies for Systemic Lupus Erythematosus in Clinical Practice: A Narrative Review

Review

作者: Upshaw, William C ; Varrassi, Giustino ; Burroughs, Caroline R ; Mosieri, Chizoba N ; Tassin, Joseph P ; Patel, Chandni R ; Shekoohi, Sahar ; Bembenick, Kristin Nicole ; Kaye, Alan D ; Kaye, Adam M ; Ahmadzadeh, Shahab ; Hawkins, Alison M

Systemic lupus erythematosus (SLE) is an autoimmune disease that more commonly affects African American people, although it is seen in people of all racial backgrounds. This condition is characterized by a dysregulated immune response resulting in widespread inflammation. Clinical manifestations caused by this inflammation include arthritis, anemia, cutaneous rashes, pleuritis, and nephritis. Treatment for SLE aims to reduce disease activity and maintain a state of low inflammation. In this regard, numerous treatments are used, such as hydroxychloroquine, glucocorticoids, and non-glucocorticoid immunosuppressants such as methotrexate. Related to these drugs resulting in significant adverse effects and being ineffective in controlling SLE symptoms in some patients, new biologic agents have been created in hopes of better treating SLE. This includes belimumab and anifrolumab, monoclonal antibodies directed against the cytokine, and type 1 interferon receptor, respectively. These agents are indicated in patients with SLE whose symptoms are inadequately controlled by standard therapy alone. Clinical trials have shown that these agents effectively reduce SLE symptoms as judged using standardized metrics of disease activity. These biological agents have also been shown to have generally mild side effects when taken by patients with SLE, making them safe for use. In addition to the above medications, new treatments are being developed for SLE patients, such as cenerimod, litifilimab, chimeric antigen receptor T cells, and DS-7011a (anti-toll-like receptor 7 monoclonal antibody). These new treatments have shown promise in clinical trials. However, more information regarding their safety and efficacy is needed before they are available for the treatment of SLE.

项与 Cenerimod 相关的新闻（医药）

2026-07-09

·动脉网

系统性红斑狼疮市场迎来转折点，6种后期新兴疗法即将重塑治疗格局 DelveInsightSystemic Lupus Erythematosus Market at a Turning Point as 6 Late-Stage Emerging Therapies Set to Redefine Treatment Landscape

Companies like Biogen and Royalty Pharma (Litifilimab), Biogen and UCB 渤健和Royalty Pharma（Litifilimab）、渤健和优时比(Dapirolizumab pegol), Idorsia Pharmaceuticals and Viatris (Cenerimod), Novartis (Ianalumab, YTB3231), Kyowa Kirin (KK-4277), and others are advancing late, mid, and early-stage drugs, showing promise in the systemic lupus erythematosus treatment market. Dapirolizumab pegol、Idorsia Pharmaceuticals 和 Viatris（Cenerimod）、Novartis（Ianalumab、YTB3231）、Kyowa Kirin（KK-4277）以及其他公司正在推进处于后期、中期和早期阶段的药物，在系统性红斑狼疮治疗市场中展现出前景。LAS VEGAS 拉斯维加斯, ，July 9, 2026 2026年7月9日/PRNewswire/ --Systemic lupuserythematosus (SLE) is a chronic, complex autoimmune disease that can affect multiple organ systems, with disease severity and clinical manifestations varying considerably among patients. Despite significant advances in understanding its pathophysiology, SLE remains incurable, and current treatment strategies primarily focus on controlling disease activity, achieving remission or low disease activity, preventing irreversible organ damage, minimizing flares, and improving patients' long-term quality of life.. /美通社/ -- 系统性红斑狼疮（SLE）是一种慢性、复杂的自身免疫性疾病，可累及多个器官系统，其疾病严重程度和临床表现因患者而异。尽管在理解其病理生理学方面已取得显著进展，但系统性红斑狼疮仍无法治愈，目前的治疗策略主要集中在控制疾病活动度、实现缓解或低疾病活动度、预防不可逆的器官损伤、减少复发以及改善患者的长期生活质量。The therapeutic landscape for SLE remains limited, with only two therapies currently approved by the US FDA specifically for the disease: 系统性红斑狼疮（SLE）的治疗选择仍然有限，目前美国食品药品监督管理局（FDA）仅批准了两种专门针对该疾病的疗法：BENLYSTA 贝利尤单抗(belimumab) from （贝利尤单抗）来自GlaxoSmithKline 葛兰素史克and 和SAPHNELO SAPHNELO(anifrolumab) from （阿尼鲁单抗）来自AstraZeneca 阿斯利康. Conventional treatment continues to rely on nonsteroidal anti-inflammatory drugs (NSAIDs), antimalarial agents, glucocorticoids, immunosuppressants, and other supportive therapies. 常规治疗继续依赖非甾体抗炎药（NSAIDs）、抗疟药、糖皮质激素、免疫抑制剂以及其他支持性疗法。While glucocorticoids remain a cornerstone of disease management, their well-documented long-term toxicities have intensified efforts to reduce steroid exposure through treat-to-target strategies. The persistent need for multiple lines of therapy and the limitations associated with existing treatments highlight the substantial unmet need for safer and more effective disease-modifying options.. 尽管糖皮质激素仍是疾病管理的基石，但其长期毒性已有充分记录，这促使人们通过“达标治疗”策略加大努力，以减少类固醇暴露。对多线治疗的持续需求以及现有疗法的局限性，凸显出对更安全、更有效的疾病修饰治疗选项的巨大未满足需求。Discover what is the future of the systemic lupus erythematosus (SLE) drugs market @ 探索系统性红斑狼疮（SLE）药物市场的未来 @https://www.delveinsight.com/report-store/systemic-lupus-erythematosus-market https://www.delveinsight.com/report-store/systemic-lupus-erythematosus-marketThe SLE pipeline is robust and increasingly diverse, with several late-stage and emerging therapies targeting novel immune pathways. Prominent investigational candidates include 系统性红斑狼疮（SLE）研发管线稳健且日益多元化，多种处于后期阶段及新兴的疗法正针对 novel 免疫通路。主要的在研候选药物包括obinutuzumab 奥比努珠单抗(Roche), （罗氏）ianalumab 伊那利珠单抗(Novartis), （诺华）dapirolizumab pegol 达匹罗珠单抗聚乙二醇(Biogen/UCB), （渤健/优时比）upadacitinib 乌帕替尼(AbbVie), （艾伯维）deucravacitinib 德乌克拉维替尼(Bristol Myers Squibb), （百时美施贵宝）litifilimab 利替非利单抗(Biogen and Royalty Pharma), and other innovative agents that have the potential to improve disease control while reducing treatment-related toxicity. （渤健和Royalty Pharma），以及其他有潜力在降低治疗相关毒性的同时改善疾病控制的创新药物。Aparna Thakur, Project Manager of Forecasting at DelveInsight, said that Oral small molecules such as cenerimod (S1P1 modulator), deucravacitinib (TYK2 inhibitor), and upadacitinib (JAK1 inhibitor) target multiple immune pathways in SLE, reflecting a shift toward oral multi-pathway immune modulation in treatment.. DelveInsight 预测项目经理 Aparna Thakur 表示，诸如 cenerimod（S1P1 调节剂）、deucravacitinib（TYK2 抑制剂）和 upadacitinib（JAK1 抑制剂）等口服小分子药物针对系统性红斑狼疮（SLE）中的多种免疫通路，反映出治疗策略正转向口服多通路免疫调节。In parallel, CAR T-cell therapies are emerging as a potentially transformative approach for patients with refractory SLE by enabling targeted B-cell depletion and immune system reprogramming that could deliver durable, treatment-free remission. Leading programs in this space include 与此同时，CAR T细胞疗法正成为一种可能具有变革性的方法，用于治疗难治性系统性红斑狼疮（SLE）患者，通过实现靶向B细胞清除和免疫系统重编程，有望带来持久且无需持续治疗的缓解。该领域的领先项目包括rapcabtagene autoleucel (YTB-323), zolacabtagene autoleucel, resecabtagene autoleucel (CABA-201), and obecabtagene autoleucel (obe-cel, AUCATZYL) 拉普卡贝基因自体细胞（YTB-323）、佐拉卡贝基因自体细胞、雷塞卡贝基因自体细胞（CABA-201）以及奥贝卡贝基因自体细胞（obe-cel，AUCATZYL）, signaling a potential shift from lifelong immunosuppression toward one-time disease-modifying interventions. ，标志着可能从终身免疫抑制转向一次性疾病修饰干预。As per Thakur, CD19-directed CAR-T therapies, including rapcabtagene autoleucel, zolacabtagene autoleucel, and resecabtagene autoleucel, show strong potential in SLE by inducing deep B-cell depletion and durable remission, though safety risks such as CRS and ICANS require intensive monitoring. 据Thakur所述，包括rapcabtagene autoleucel、zolacabtagene autoleucel和resecabtagene autoleucel在内的CD19靶向CAR-T疗法，通过诱导深度B细胞清除和持久缓解，在系统性红斑狼疮（SLE）治疗中展现出强劲潜力，但细胞因子释放综合征（CRS）和免疫效应细胞相关神经毒性综合征（ICANS）等安全风险需要密切监测。Reflecting the growing innovation and expanding therapeutic opportunities in this space, DelveInsight estimates that the SLE market across the leading markets, including the United States, the EU4 (Germany, France, Italy, and Spain), the United Kingdom, and Japan, was valued at approximately 反映了该领域日益增长的创新和不断扩大的治疗机会，DelveInsight估计，包括美国、欧盟四国（德国、法国、意大利和西班牙）、英国和日本在内的主要市场的系统性红斑狼疮（SLE）市场价值约为USD 3 billion 30亿美元in 2025 and is projected to grow at a 在2025年，并预计将以CAGR of 10.4% 10.4% 的复合年增长率through 2036. 至2036年。Below, we highlight 6 emerging late-stage therapies poised to reshape the future of the systemic lupus erythematosus treatment market. 下文重点介绍6种有望重塑系统性红斑狼疮治疗市场未来的新兴后期疗法。Biogen and Royalty Pharma's Litifilimab 渤健与Royalty Pharma的LitifilimabCLEC4C protein inhibitors CLEC4C蛋白抑制剂Litifilimab (BIIB059) is a humanized IgG1 monoclonal antibody designed to target Litifilimab（BIIB059）是一种人源化IgG1单克隆抗体，旨在靶向BDCA2 (Blood Dendritic Cell Antigen 2) BDCA2（血液树突状细胞抗原2）and is being developed as a potential therapy for systemic lupus erythematosus (SLE). BDCA2 is a receptor primarily found on plasmacytoid dendritic cells (pDCs), a specialized immune cell population involved in the production of inflammatory mediators. By binding to BDCA2, litifilimab suppresses pDC activation, thereby reducing the release of type I interferons (IFN-I) along with other proinflammatory cytokines and chemokines implicated in SLE pathogenesis.. 并正在被开发为系统性红斑狼疮（SLE）的潜在疗法。BDCA2是一种主要存在于浆细胞样树突状细胞（pDCs）上的受体，而pDCs是一类参与炎症介质产生的特化免疫细胞群。通过结合BDCA2，litifilimab抑制pDC的活化，从而减少I型干扰素（IFN-I）以及其他与SLE发病机制相关的促炎细胞因子和趋化因子的释放。Biogen is currently evaluating litifilimab in two global Phase III clinical studies, 渤健目前正在两项全球III期临床研究中评估litifilimab，TOPAZ-1 (NCT04895241) and TOPAZ-2 (NCT04961567) TOPAZ-1（NCT04895241）和 TOPAZ-2（NCT04961567）, for patients with SLE, with topline results anticipated by the end of 2026. In October 2025, the company announced that patient enrollment had been completed for both Phase III trials and that the expected data readout timeline had been accelerated to the second half of 2026. Earlier, in February 2025, Biogen entered into a funding agreement with . ，针对系统性红斑狼疮（SLE）患者，预计将于2026年底公布主要结果。2025年10月，公司宣布两项III期临床试验的患者入组工作均已完成，且预期数据读出时间表已提前至2026年下半年。此前，于2025年2月，Biogen与达成了资助协议。Royalty Pharma 罗伊蒂制药, under which it is eligible to receive up to ，根据该规定，其有资格获得最高达USD 200 million 2亿美元in 2025 and an additional 在2025年以及额外的USD 50 million 5000万美元in 2026 to help support the ongoing development of the litifilimab program. 在2026年，以支持litifilimab项目的持续开发。Roche's Obinutuzumab (GAZYVA/GAZYVARO) 罗氏的奥比努珠单抗（GAZYVA/GAZYVARO）TSLP inhibitor TSLP抑制剂Obinutuzumab is a glycoengineered monoclonal antibody designed to target the 奥比努珠单抗是一种糖工程化单克隆抗体，旨在靶向CD20 protein CD20蛋白expressed on the surface of lymphoma and leukemia cells. As a type II anti-CD20 antibody, it exhibits greater antibody-dependent cellular cytotoxicity and stronger direct cell-killing activity compared with conventional CD20 antibodies. After binding to CD20, obinutuzumab promotes B-cell destruction by engaging immune effector cells, directly triggering intracellular death-signaling pathways, and activating the complement cascade. 表达于淋巴瘤和白血病细胞表面。作为一种II型抗CD20抗体，与传统的CD20抗体相比，它具有更强的抗体依赖性细胞介导的细胞毒性（ADCC）和更直接的细胞杀伤活性。奥比努珠单抗在与CD20结合后，通过招募免疫效应细胞、直接触发细胞内死亡信号通路以及激活补体级联反应，促进B细胞的破坏。In Europe, the therapy is marketed under the name GAZYVARO.. 在欧洲，该疗法以商品名GAZYVARO销售。In February 2026, Roche submitted regulatory applications in the United States and Europe seeking approval of obinutuzumab for the treatment of Systemic Lupus Erythematosus. Subsequently, in April 2026, Roche announced that the FDA had accepted its 2026年2月，罗氏向美国和欧洲的监管机构提交了申请，寻求批准奥比努珠单抗用于治疗系统性红斑狼疮。随后，在2026年4月，罗氏宣布美国食品药品监督管理局（FDA）已受理其supplemental Biologics License Application (sBLA) 补充生物制品许可申请（sBLA）for obinutuzumab in SLE. The filing is based on positive results from the 用于系统性红斑狼疮（SLE）的奥比努珠单抗。该申报基于来自以下的阳性结果Phase III ALLEGORY study III期ALLEGORY研究, which showed a statistically significant and clinically meaningful improvement in the primary endpoint. The FDA is expected to issue a decision on the application by ，该结果显示主要终点指标取得了具有统计学显著性和临床意义的改善。预计美国食品药品监督管理局（FDA）将在之前对该申请作出决定December 2026 2026年12月. 。Discover more about which pipeline drugs could transform systemic lupus erythematosus treatment @ 了解更多关于哪些在研药物可能变革系统性红斑狼疮的治疗 @Systemic Lupus Erythematosus Market Size 系统性红斑狼疮市场规模Novartis' Ianalumab 诺华公司的伊那利珠单抗BAFF-R inhibitor, ADCC-mediated B-cell depletor BAFF-R抑制剂，ADCC介导的B细胞清除剂Ianalumab, a novel monoclonal antibody developed by Novartis, targets the 伊那鲁单抗是一种由诺华公司开发的新型单克隆抗体，靶向B-cell Activating Factor Receptor (BAFF-R) B细胞激活因子受体（BAFF-R）. It is designed to inhibit BAFF-R signaling while simultaneously promoting B-cell depletion through antibody-dependent cellular cytotoxicity (ADCC). The therapy is currently being evaluated in two Phase III clinical studies for systemic lupus erythematosus (SLE): 它旨在抑制BAFF-R信号传导，同时通过抗体依赖性细胞介导的细胞毒性（ADCC）促进B细胞清除。该疗法目前正在两项针对系统性红斑狼疮（SLE）的III期临床研究中进行评估：NCT05639114 (SIRIUS-SLE 1) and NCT05624749 (SIRIUS-SLE 2) NCT05639114（SIRIUS-SLE 1）和 NCT05624749（SIRIUS-SLE 2）. 。According to Novartis' 2026 interim financial report, topline results from the Phase III SIRIUS-SLE 1 and SIRIUS-SLE 2 trials are expected in 根据诺华2026年中期财务报告，SIRIUS-SLE 1和SIRIUS-SLE 2两项III期临床试验的顶线结果预计将于2027 2027. Pending positive outcomes, the company plans to submit Ianalumab for regulatory approval in SLE in . 待取得积极结果后，公司计划提交伊那利珠单抗（Ianalumab）用于系统性红斑狼疮（SLE）的监管审批申请2028 2028. 。Johnson & Johnson's Nipocalimab (IMAAVY) 强生公司的Nipocalimab（IMAAVY）FcRn blockade FcRn阻断Nipocalimab is an investigational immunoselective therapy engineered to selectively bind with high affinity to the 尼泊卡利单抗是一种研究中的免疫选择性疗法，经工程化设计以高亲和力选择性结合neonatal Fc receptor (FcRn) 新生儿Fc受体（FcRn）, blocking its activity and lowering circulating pathogenic IgG antibodies while maintaining essential immune functions. The therapy is being evaluated across three major autoantibody-driven disease areas: rheumatologic disorders, rare autoantibody-mediated conditions, and maternal-fetal diseases, where inhibiting IgG interaction with FcRn in the placenta is expected to reduce the transfer of harmful maternal alloantibodies to the fetus. ，阻断其活性并降低循环中的致病性IgG抗体，同时维持必要的免疫功能。该疗法正在三大自身抗体驱动的疾病领域中进行评估：风湿性疾病、罕见的自身抗体介导疾病以及母胎疾病。在母胎疾病中，抑制IgG与胎盘FcRn的相互作用有望减少有害的母体同种抗体向胎儿的转移。In March 2026, Johnson & Johnson announced that the U.S. Food and Drug Administration granted . 2026年3月，强生公司宣布美国食品药品监督管理局批准了。Fast Track Designation (FTD) 快速通道认定（FTD）to nipocalimab for the treatment of Systemic Lupus Erythematosus. 用于尼泊卡利单抗治疗系统性红斑狼疮。Explore systemic lupus erythematosus competitors Johnson & Johnson marketed products @ 探索系统性红斑狼疮竞争对手强生公司上市产品 @Systemic Lupus Erythematosus Marketed Drugs 系统性红斑狼疮上市药物Idorsia Pharmaceuticals and Viatris' Cenerimod Idorsia制药公司和Viatris的CenerimodSphingosine 1-phosphate receptor modulators 鞘氨醇-1-磷酸受体调节剂Cenerimod is a highly selective Cenerimod 是一种高度选择性的Sphingosine-1-Phosphate Receptor 1 (S1P1) modulator 鞘氨醇-1-磷酸受体1（S1P1）调节剂administered as a once-daily oral tablet. Although the exact cause of systemic lupus erythematosus remains unclear, dysregulated T and B lymphocytes are recognized as central drivers of disease pathogenesis. By selectively targeting the S1P1 receptor, cenerimod is designed to modulate lymphocyte trafficking and reduce immune-mediated inflammation. 每日一次口服给药。尽管系统性红斑狼疮的确切病因尚不明确，但T淋巴细胞和B淋巴细胞的失调被认为是疾病发病机制的核心驱动因素。通过选择性靶向S1P1受体，cenerimod旨在调节淋巴细胞的迁移并减少免疫介导的炎症。The therapy is currently being evaluated in two . 该疗法目前正在两个中心进行评估。Phase III clinical trials, OPUS-1 (NCT05648500) and OPUS-2 (NCT05672576) III期临床试验，OPUS-1（NCT05648500）和OPUS-2（NCT05672576）, for the treatment of SLE. The US FDA has also granted ，用于治疗系统性红斑狼疮（SLE）。美国食品药品监督管理局也已批准Fast Track Designation (FTD) 快速通道资格认定（FTD）to cenerimod, underscoring its potential to address an unmet medical need in SLE. 至cenerimod，强调其在解决系统性红斑狼疮（SLE）未满足医疗需求方面的潜力。In February 2025, Idorsia Pharmaceuticals amended its collaboration agreement with 2025年2月，Idorsia Pharmaceuticals修订了其与Viatris 晖致for the development of cenerimod. Under the revised terms, Idorsia's contribution toward the drug's 2025 development costs was reduced by 用于cenerimod的开发。根据修订后的条款，Idorsia对该药物2025年开发成本的贡献减少了USD 100 million 1亿美元. In exchange, the company agreed to a 。作为交换，公司同意了USD 250 million 2.5亿美元reduction in future regulatory and commercial milestone payments while granting Viatris expanded territorial commercialization rights for cenerimod. 减少未来的监管和商业里程碑付款，同时授予Viatris更广泛的地区商业化权利以推广cenerimod。AbbVie's RINVOQ (upadacitinib) 艾伯维的RINVOQ（乌帕替尼）JAK 1 inhibitor JAK1抑制剂Upadacitinib (ABT-494) is a selective inhibitor of 乌帕替尼（ABT-494）是一种选择性抑制剂Janus kinase 1 (JAK1) Janus激酶1（JAK1）that is approved for the treatment of several immune-mediated inflammatory diseases, including ankylosing spondylitis, atopic dermatitis, axial spondyloarthritis, Crohn's disease, giant cell arteritis, psoriatic arthritis, rheumatoid arthritis, and ulcerative colitis. In addition to its approved indications, the therapy is currently under clinical investigation for potential use in alopecia areata, hidradenitis suppurativa (HS), systemic lupus erythematosus (SLE), Takayasu arteritis, and vitiligo.. 该药物已获批用于治疗多种免疫介导的炎症性疾病，包括强直性脊柱炎、特应性皮炎、中轴型脊柱关节炎、克罗恩病、巨细胞动脉炎、银屑病关节炎、类风湿性关节炎和溃疡性结肠炎。除了已批准的适应症外，该疗法目前正在进行临床研究，以评估其在斑秃、化脓性汗腺炎（HS）、系统性红斑狼疮（SLE）、大动脉炎和白癜风中的潜在应用。AbbVie's RINVOQ (upadacitinib) continues to be an interesting lupus asset after its 艾伯维的RINVOQ（乌帕替尼）在其后继续成为一种有趣的狼疮资产Phase 2 SLEek study 二期 SLEek 研究showed meaningful activity in moderate to severe systemic lupus erythematosus, with the 30 mg monotherapy arm meeting the primary endpoint and achieving steroid-sparing benefit versus placebo. Updated data presented in 2023 also showed durability through 48 weeks, with fewer flares, longer time to first flare, and sustained improvements in disease-activity measures such as SRI-4, BICLA, and LLDAS, while no new safety signals were reported.. 在中重度系统性红斑狼疮中显示出有意义的活性，其中30 mg单药治疗组达到主要终点，并与安慰剂相比实现减少激素用量的获益。2023年公布的更新数据还显示，疗效持续至48周，复发次数更少，首次复发时间延长，SRI-4、BICLA和LLDAS等疾病活动度指标持续改善，且未报告新的安全性信号。The key development story is that AbbVie advanced RINVOQ into Phase 3 lupus testing after the positive Phase 2 readout, but it did not move forward with the ABBV-599 combination because elsubrutinib did not add enough efficacy to justify development. 关键进展是，在二期临床试验结果积极后，艾伯维将RINVOQ推进至系统性红斑狼疮的三期临床试验，但并未继续开发ABBV-599联合疗法，因为elsubrutinib未能提供足够的疗效以证明其开发价值。Find out more about top SLE CAR-T pipeline assets @ 了解更多关于顶级系统性红斑狼疮（SLE）CAR-T 管线资产的信息 @Systemic Lupus Erythematosus Clinical Trials 系统性红斑狼疮临床试验Source: 来源：Systemic Lupus Erythematosus Market Report 系统性红斑狼疮市场报告Systemic Lupus Erythematosus Market Insights, Epidemiology, and Market Forecast – 2036 系统性红斑狼疮市场洞察、流行病学及市场预测——2036年report delivers an in-depth understanding of the disease, historical and forecasted epidemiology, as well as the market trends, market drivers, market barriers, and key SLE companies, including 本报告深入解析了该疾病、历史及预测流行病学，以及市场趋势、市场驱动因素、市场壁垒和关键系统性红斑狼疮（SLE）企业，包括GlaxoSmithKline, AstraZeneca, Genentech (Roche), AbbVie, Bristol Myers Squibb, Novartis, MorphoSys, UCB Pharma, Biogen, Juno Therapeutics, Johnson & Johnson Innovative Medicine, Idorsia Pharmaceuticals, Viatris, Merck 葛兰素史克、阿斯利康、基因泰克（罗氏）、艾伯维、百时美施贵宝、诺华、MorphoSys、优时比制药、渤健、Juno Therapeutics、强生创新制药、Idorsia Pharmaceuticals、晖致、默克, and others. ，以及其他。Related Reports 相关报告Systemic Lupus Erythematosus Clinical Trial Analysis 系统性红斑狼疮临床试验分析Complement 3 Glomerulopathy Pipeline Insight 补体3肾小球病研发管线洞察– –2026 2026report provides comprehensive insights about the pipeline landscape, pipeline drug profiles, including clinical and non-clinical stage products, and the key SLE companies, including 报告提供了关于管线格局、管线药物概况（包括临床和非临床阶段产品）以及关键系统性红斑狼疮（SLE）企业的全面洞察，包括Yake Biotechnology, UCB, Sorrento Therapeutics, SinoMab Bioscience Ltd, Shanghai Junshi Biosciences, Sareum, Sanofi, Roche, Rheos Medicine, Resolve, Provention Bio, Pfizer, Novartis, Neovacs, Merck, Medsenic, Landos Biopharma, Kezar Life Sciences, Kangpu Biopharmaceuticals, Janssen Research & Development, Janssen, InnoCare, ImmuPharma, I-MAB Biopharma, ILTOO, Idorsia Pharmaceuticals, Horizon Therapeutics, Genovax, Exinda Therapeutics, Equillium, Eli Lilly and Company, Eisai, Daiichi Sankyo Company, Corestem, Corbus Pharmaceuticals, Citryll BV, Chipscreen Biosciences, Carna Bioscience, Bristol-Myers Squibb, Brickell Biotech, Boston Pharmaceuticals, Biogen, Athos Therapeutics, Asahi Kasei Pharma, Aria Pharmaceuticals, Antengene Therapeutics, Amgen, Alpine Immune Sciences, Akeso Biopharma, AbbVie, . 雅科生物、优时比（UCB）、索伦托治疗公司、三叶草生物制药、上海君实生物、Sareum、赛诺菲、罗氏、Rheos Medicine、Resolve Therapeutics、Provention Bio、辉瑞、诺华、Neovacs、默克、Medsenic、兰多斯生物制药、Kezar Life Sciences、康普生物制药、强生研发、杨森、和誉医药、ImmuPharma、天境生物、ILTOO、Idorsia Pharmaceuticals、Horizon Therapeutics、Genovax、Exinda Therapeutics、Equillium、礼来公司、卫材、第一三共株式会社、Corestem、Corbus Pharmaceuticals、Citryll BV、微芯生物、Carna Bioscience、百时美施贵宝、Brickell Biotech、Boston Pharmaceuticals、渤健、Athos Therapeutics、旭化成制药、Aria Pharmaceuticals、安腾基因治疗、安进、Alpine Immune Sciences、康方生物、艾伯维and others. 以及其他。JAK Inhibitors Market JAK抑制剂市场JAK Inhibitors Market Size, Target Population, Competitive Landscape & Market Forecast JAK抑制剂市场规模、目标人群、竞争格局与市场预测– –2036 2036report deliver an in-depth understanding of the disease, historical and forecasted epidemiology, as well as the market trends, market drivers, market barriers, and key JAK inhibitors companies, including 本报告提供对疾病的深入理解、历史及预测流行病学数据，以及市场趋势、市场驱动因素、市场壁垒和关键JAK抑制剂公司，包括Incyte Corporation, Aclaris Therapeutics, Sareum, Takeda, AstraZeneca, Ajax Therapeutics, Pfizer, GSK, Dizal Pharmaceutical, Confluence Life Sciences, Celon Pharma, Arcutis Biotherapeutics, Reistone Biopharma Incyte公司、Aclaris Therapeutics公司、Sareum公司、武田制药、阿斯利康、Ajax Therapeutics公司、辉瑞公司、葛兰素史克、迪哲医药、Confluence Life Sciences公司、Celon Pharma公司、Arcutis Biotherapeutics公司、雷石生物制药, and others. ，以及其他。FcRn Inhibitors Market FcRn抑制剂市场FcRn Inhibitors Market Size, Target Population, Competitive Landscape & Market Forecast FcRn抑制剂市场规模、目标人群、竞争格局及市场预测– –2036 2036report deliver an in-depth understanding of the disease, historical and forecasted epidemiology, as well as the market trends, market drivers, market barriers, and key FcRn inhibitors companies, including 报告提供对疾病的深入理解、历史和预测的流行病学数据，以及市场趋势、市场驱动因素、市场壁垒和主要的FcRn抑制剂公司，包括Immunovant, Viridian Therapeutics, argenx Immunovant，Viridian Therapeutics，argenx, and others. 以及其他。TSLP Inhibitors Market TSLP抑制剂市场TSLP Inhibitors Market Size, Target Population, Competitive Landscape & Market Forecast TSLP抑制剂市场规模、目标人群、竞争格局与市场预测– –2036 2036report deliver an in-depth understanding of the disease, historical and forecasted epidemiology, as well as the market trends, market drivers, market barriers, and key TSLP inhibitors companies, including 报告提供对疾病的深入理解、历史及预测流行病学，以及市场趋势、市场驱动因素、市场壁垒和关键TSLP抑制剂公司，包括Sanofi, Uniquity Bio, Upstream Bio, Keymed Biosciences, Belenos Bioscience, Biosion, Pfizer 赛诺菲、Uniquity Bio、Upstream Bio、康诺思腾生物、贝洛诺斯生物科学、Biosion、辉瑞, and others. ，以及其他。About 关于DelveInsight DelveInsightDelveInsight is a leading Business Consultant and Market Research firm focused exclusively on life sciences. It supports pharma companies by providing comprehensive end-to-end solutions to improve their performance.Get hassle-free access to all the healthcare and pharma market research reports through our subscription-based platformPharmDelve. DelveInsight 是一家领先的商业咨询和市场研究公司，专注于生命科学领域。它通过提供全面的端到端解决方案来帮助制药公司提升业绩。通过我们基于订阅的平台 PharmDelve，您可以轻松获取所有医疗保健和制药市场研究报告。. 。Contact Us 联系我们Shruti Thakur 什鲁蒂·塔库尔[emailprotected] [email protected]+14699457679 +14699457679www.delveinsight.com www.delveinsight.comSOURCE DelveInsight Business Research, LLP 来源：DelveInsight Business Research, LLP21 二十一% %more press release views with 更多新闻稿浏览量，通过Request a Demo 申请演示

2026-07-09

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Systemic Lupus Erythematosus Market at a Turning Point as 6 Late-Stage Emerging Therapies Set to Redefine Treatment Landscape | DelveInsight

Companies like Biogen and Royalty Pharma (Litifilimab), Biogen and UCB (Dapirolizumab pegol), Idorsia Pharmaceuticals and Viatris (Cenerimod), Novartis (Ianalumab, YTB3231), Kyowa Kirin (KK-4277), and others are advancing late, mid, and early-stage drugs, showing promise in the systemic lupus erythematosus treatment market. LAS VEGAS, July 9, 2026 /PRNewswire/ -- Systemic lupus erythematosus (SLE) is a chronic, complex autoimmune disease that can affect multiple organ systems, with disease severity and clinical manifestations varying considerably among patients. Despite significant advances in understanding its pathophysiology, SLE remains incurable, and current treatment strategies primarily focus on controlling disease activity, achieving remission or low disease activity, preventing irreversible organ damage, minimizing flares, and improving patients' long-term quality of life. The therapeutic landscape for SLE remains limited, with only two therapies currently approved by the US FDA specifically for the disease: BENLYSTA (belimumab) from GlaxoSmithKline and SAPHNELO (anifrolumab) from AstraZeneca. Conventional treatment continues to rely on nonsteroidal anti-inflammatory drugs (NSAIDs), antimalarial agents, glucocorticoids, immunosuppressants, and other supportive therapies. While glucocorticoids remain a cornerstone of disease management, their well-documented long-term toxicities have intensified efforts to reduce steroid exposure through treat-to-target strategies. The persistent need for multiple lines of therapy and the limitations associated with existing treatments highlight the substantial unmet need for safer and more effective disease-modifying options. Discover what is the future of the systemic lupus erythematosus (SLE) drugs market @ The SLE pipeline is robust and increasingly diverse, with several late-stage and emerging therapies targeting novel immune pathways. Prominent investigational candidates include obinutuzumab (Roche), ianalumab (Novartis), dapirolizumab pegol (Biogen/UCB), upadacitinib (AbbVie), deucravacitinib (Bristol Myers Squibb), litifilimab (Biogen and Royalty Pharma), and other innovative agents that have the potential to improve disease control while reducing treatment-related toxicity. Aparna Thakur, Project Manager of Forecasting at DelveInsight, said that Oral small molecules such as cenerimod (S1P1 modulator), deucravacitinib (TYK2 inhibitor), and upadacitinib (JAK1 inhibitor) target multiple immune pathways in SLE, reflecting a shift toward oral multi-pathway immune modulation in treatment. In parallel, CAR T-cell therapies are emerging as a potentially transformative approach for patients with refractory SLE by enabling targeted B-cell depletion and immune system reprogramming that could deliver durable, treatment-free remission. Leading programs in this space include rapcabtagene autoleucel (YTB-323), zolacabtagene autoleucel, resecabtagene autoleucel (CABA-201), and obecabtagene autoleucel (obe-cel, AUCATZYL), signaling a potential shift from lifelong immunosuppression toward one-time disease-modifying interventions. As per Thakur, CD19-directed CAR-T therapies, including rapcabtagene autoleucel, zolacabtagene autoleucel, and resecabtagene autoleucel, show strong potential in SLE by inducing deep B-cell depletion and durable remission, though safety risks such as CRS and ICANS require intensive monitoring. Reflecting the growing innovation and expanding therapeutic opportunities in this space, DelveInsight estimates that the SLE market across the leading markets, including the United States, the EU4 (Germany, France, Italy, and Spain), the United Kingdom, and Japan, was valued at approximately USD 3 billion in 2025 and is projected to grow at a CAGR of 10.4% through 2036. Below, we highlight 6 emerging late-stage therapies poised to reshape the future of the systemic lupus erythematosus treatment market. Biogen and Royalty Pharma's Litifilimab CLEC4C protein inhibitors Litifilimab (BIIB059) is a humanized IgG1 monoclonal antibody designed to target BDCA2 (Blood Dendritic Cell Antigen 2) and is being developed as a potential therapy for systemic lupus erythematosus (SLE). BDCA2 is a receptor primarily found on plasmacytoid dendritic cells (pDCs), a specialized immune cell population involved in the production of inflammatory mediators. By binding to BDCA2, litifilimab suppresses pDC activation, thereby reducing the release of type I interferons (IFN-I) along with other proinflammatory cytokines and chemokines implicated in SLE pathogenesis. Biogen is currently evaluating litifilimab in two global Phase III clinical studies, TOPAZ-1 (NCT04895241) and TOPAZ-2 (NCT04961567), for patients with SLE, with topline results anticipated by the end of 2026. In October 2025, the company announced that patient enrollment had been completed for both Phase III trials and that the expected data readout timeline had been accelerated to the second half of 2026. Earlier, in February 2025, Biogen entered into a funding agreement with Royalty Pharma, under which it is eligible to receive up to USD 200 million in 2025 and an additional USD 50 million in 2026 to help support the ongoing development of the litifilimab program. Roche's Obinutuzumab (GAZYVA/GAZYVARO) TSLP inhibitor Obinutuzumab is a glycoengineered monoclonal antibody designed to target the CD20 protein expressed on the surface of lymphoma and leukemia cells. As a type II anti-CD20 antibody, it exhibits greater antibody-dependent cellular cytotoxicity and stronger direct cell-killing activity compared with conventional CD20 antibodies. After binding to CD20, obinutuzumab promotes B-cell destruction by engaging immune effector cells, directly triggering intracellular death-signaling pathways, and activating the complement cascade. In Europe, the therapy is marketed under the name GAZYVARO. In February 2026, Roche submitted regulatory applications in the United States and Europe seeking approval of obinutuzumab for the treatment of Systemic Lupus Erythematosus. Subsequently, in April 2026, Roche announced that the FDA had accepted its supplemental Biologics License Application (sBLA) for obinutuzumab in SLE. The filing is based on positive results from the Phase III ALLEGORY study, which showed a statistically significant and clinically meaningful improvement in the primary endpoint. The FDA is expected to issue a decision on the application by December 2026. Discover more about which pipeline drugs could transform systemic lupus erythematosus treatment @ Systemic Lupus Erythematosus Market Size Novartis' Ianalumab BAFF-R inhibitor, ADCC-mediated B-cell depletor Ianalumab, a novel monoclonal antibody developed by Novartis, targets the B-cell Activating Factor Receptor (BAFF-R). It is designed to inhibit BAFF-R signaling while simultaneously promoting B-cell depletion through antibody-dependent cellular cytotoxicity (ADCC). The therapy is currently being evaluated in two Phase III clinical studies for systemic lupus erythematosus (SLE): NCT05639114 (SIRIUS-SLE 1) and NCT05624749 (SIRIUS-SLE 2). According to Novartis' 2026 interim financial report, topline results from the Phase III SIRIUS-SLE 1 and SIRIUS-SLE 2 trials are expected in 2027. Pending positive outcomes, the company plans to submit Ianalumab for regulatory approval in SLE in 2028. Johnson & Johnson's Nipocalimab (IMAAVY) FcRn blockade Nipocalimab is an investigational immunoselective therapy engineered to selectively bind with high affinity to the neonatal Fc receptor (FcRn), blocking its activity and lowering circulating pathogenic IgG antibodies while maintaining essential immune functions. The therapy is being evaluated across three major autoantibody-driven disease areas: rheumatologic disorders, rare autoantibody-mediated conditions, and maternal-fetal diseases, where inhibiting IgG interaction with FcRn in the placenta is expected to reduce the transfer of harmful maternal alloantibodies to the fetus. In March 2026, Johnson & Johnson announced that the U.S. Food and Drug Administration granted Fast Track Designation (FTD) to nipocalimab for the treatment of Systemic Lupus Erythematosus. Explore systemic lupus erythematosus competitors Johnson & Johnson marketed products @ Systemic Lupus Erythematosus Marketed Drugs Idorsia Pharmaceuticals and Viatris' Cenerimod Sphingosine 1-phosphate receptor modulators Cenerimod is a highly selective Sphingosine-1-Phosphate Receptor 1 (S1P1) modulator administered as a once-daily oral tablet. Although the exact cause of systemic lupus erythematosus remains unclear, dysregulated T and B lymphocytes are recognized as central drivers of disease pathogenesis. By selectively targeting the S1P1 receptor, cenerimod is designed to modulate lymphocyte trafficking and reduce immune-mediated inflammation. The therapy is currently being evaluated in two Phase III clinical trials, OPUS-1 (NCT05648500) and OPUS-2 (NCT05672576), for the treatment of SLE. The US FDA has also granted Fast Track Designation (FTD) to cenerimod, underscoring its potential to address an unmet medical need in SLE. In February 2025, Idorsia Pharmaceuticals amended its collaboration agreement with Viatris for the development of cenerimod. Under the revised terms, Idorsia's contribution toward the drug's 2025 development costs was reduced by USD 100 million. In exchange, the company agreed to a USD 250 million reduction in future regulatory and commercial milestone payments while granting Viatris expanded territorial commercialization rights for cenerimod. AbbVie's RINVOQ (upadacitinib) JAK 1 inhibitor Upadacitinib (ABT-494) is a selective inhibitor of Janus kinase 1 (JAK1) that is approved for the treatment of several immune-mediated inflammatory diseases, including ankylosing spondylitis, atopic dermatitis, axial spondyloarthritis, Crohn's disease, giant cell arteritis, psoriatic arthritis, rheumatoid arthritis, and ulcerative colitis. In addition to its approved indications, the therapy is currently under clinical investigation for potential use in alopecia areata, hidradenitis suppurativa (HS), systemic lupus erythematosus (SLE), Takayasu arteritis, and vitiligo. AbbVie's RINVOQ (upadacitinib) continues to be an interesting lupus asset after its Phase 2 SLEek study showed meaningful activity in moderate to severe systemic lupus erythematosus, with the 30 mg monotherapy arm meeting the primary endpoint and achieving steroid-sparing benefit versus placebo. Updated data presented in 2023 also showed durability through 48 weeks, with fewer flares, longer time to first flare, and sustained improvements in disease-activity measures such as SRI-4, BICLA, and LLDAS, while no new safety signals were reported. The key development story is that AbbVie advanced RINVOQ into Phase 3 lupus testing after the positive Phase 2 readout, but it did not move forward with the ABBV-599 combination because elsubrutinib did not add enough efficacy to justify development. Find out more about top SLE CAR-T pipeline assets @ Systemic Lupus Erythematosus Clinical Trials Source: Systemic Lupus Erythematosus Market Report Systemic Lupus Erythematosus Market Insights, Epidemiology, and Market Forecast – 2036 report delivers an in-depth understanding of the disease, historical and forecasted epidemiology, as well as the market trends, market drivers, market barriers, and key SLE companies, including GlaxoSmithKline, AstraZeneca, Genentech (Roche), AbbVie, Bristol Myers Squibb, Novartis, MorphoSys, UCB Pharma, Biogen, Juno Therapeutics, Johnson & Johnson Innovative Medicine, Idorsia Pharmaceuticals, Viatris, Merck, and others. Related Reports Systemic Lupus Erythematosus Clinical Trial Analysis Complement 3 Glomerulopathy Pipeline Insight – 2026 report provides comprehensive insights about the pipeline landscape, pipeline drug profiles, including clinical and non-clinical stage products, and the key SLE companies, including Yake Biotechnology, UCB, Sorrento Therapeutics, SinoMab Bioscience Ltd, Shanghai Junshi Biosciences, Sareum, Sanofi, Roche, Rheos Medicine, Resolve, Provention Bio, Pfizer, Novartis, Neovacs, Merck, Medsenic, Landos Biopharma, Kezar Life Sciences, Kangpu Biopharmaceuticals, Janssen Research & Development, Janssen, InnoCare, ImmuPharma, I-MAB Biopharma, ILTOO, Idorsia Pharmaceuticals, Horizon Therapeutics, Genovax, Exinda Therapeutics, Equillium, Eli Lilly and Company, Eisai, Daiichi Sankyo Company, Corestem, Corbus Pharmaceuticals, Citryll BV, Chipscreen Biosciences, Carna Bioscience, Bristol-Myers Squibb, Brickell Biotech, Boston Pharmaceuticals, Biogen, Athos Therapeutics, Asahi Kasei Pharma, Aria Pharmaceuticals, Antengene Therapeutics, Amgen, Alpine Immune Sciences, Akeso Biopharma, AbbVie, and others. JAK Inhibitors Market JAK Inhibitors Market Size, Target Population, Competitive Landscape & Market Forecast – 2036 report deliver an in-depth understanding of the disease, historical and forecasted epidemiology, as well as the market trends, market drivers, market barriers, and key JAK inhibitors companies, including Incyte Corporation, Aclaris Therapeutics, Sareum, Takeda, AstraZeneca, Ajax Therapeutics, Pfizer, GSK, Dizal Pharmaceutical, Confluence Life Sciences, Celon Pharma, Arcutis Biotherapeutics, Reistone Biopharma, and others. FcRn Inhibitors Market FcRn Inhibitors Market Size, Target Population, Competitive Landscape & Market Forecast – 2036 report deliver an in-depth understanding of the disease, historical and forecasted epidemiology, as well as the market trends, market drivers, market barriers, and key FcRn inhibitors companies, including Immunovant, Viridian Therapeutics, argenx, and others. TSLP Inhibitors Market TSLP Inhibitors Market Size, Target Population, Competitive Landscape & Market Forecast – 2036 report deliver an in-depth understanding of the disease, historical and forecasted epidemiology, as well as the market trends, market drivers, market barriers, and key TSLP inhibitors companies, including Sanofi, Uniquity Bio, Upstream Bio, Keymed Biosciences, Belenos Bioscience, Biosion, Pfizer, and others. About DelveInsight DelveInsight is a leading Business Consultant and Market Research firm focused exclusively on life sciences. It supports pharma companies by providing comprehensive end-to-end solutions to improve their performance. Get hassle-free access to all the healthcare and pharma market research reports through our subscription-based platform PharmDelve . Contact Us Shruti Thakur [email protected] +14699457679 SOURCE DelveInsight Business Research, LLP 21% more press release views with Request a Demo

临床3期临床2期临床结果免疫疗法快速通道

2026-04-05

·信狐药迅

佛山瑞迪奥RDC及其冷药盒、珠海润都去甲乌药碱获批上市| 新获批(3.30-4.5）

每周药品注册获批数据，分门别类呈现，一目了然。(3.30-4.5）新药上市申请药品名称企业注册分类受理号锝[99mTc]肼基烟酰胺聚乙二醇双环RGD肽注射液佛山瑞迪奥医药有限公司 1 CXHS2500065 注射用甲苯磺酸钠烟酰胺腙聚乙二醇双环RGD肽佛山瑞迪奥医药有限公司 1 CXHS2500064 盐酸去甲乌药碱注射液珠海润都制药股份有限公司 1 CXHS2400019 注射用重组巴曲酶上海腾瑞制药股份有限公司 1 CXSS2500050 注射用重组人透明质酸酶上海宝济药业股份有限公司 2.4 CXSS2400095 新药临床申请药品名称企业注册分类受理号 YKYY018雾化吸入剂北京悦康科创医药科技股份有限公司 1 CXHL2600254 YKYY018雾化吸入剂北京悦康科创医药科技股份有限公司 1 CXHL2600252 ICP-054片北京诺诚健华医药科技有限公司 1 CXHL2600251 ICP-054片北京诺诚健华医药科技有限公司 1 CXHL2600250 ICP-054片北京诺诚健华医药科技有限公司 1 CXHL2600249 AHB-171注射液杭州浩博医药有限公司 1 CXHL2600240 ACC085注射液江苏艾迪药业集团股份有限公司 1 CXHL2600114 D-2570片益方生物科技(上海)股份有限公司 1 CXHL2600111 KBD104409片康百达(四川)生物医药科技有限公司 1 CXHL2600093 KBD104409片康百达(四川)生物医药科技有限公司 1 CXHL2600092 RFUS-1646片宜昌人福药业有限责任公司 1 CXHL2600097 RFUS-1646片宜昌人福药业有限责任公司 1 CXHL2600096 ABA001注射液北京阳光诺和药物研究股份有限公司 1 CXHL2600091 LY4268989片礼来苏州制药有限公司 1 CXHL2600088 LY4268989片礼来苏州制药有限公司 1 CXHL2600087 BSA204注射液倍臻生物技术(苏州)有限公司 1 CXHL2600071 盐酸左沙丁胺醇异丙托溴铵吸入溶液济南景笙科技有限公司 2.1 CXHL2600094 布南色林口崩片力品药业(厦门)股份有限公司 2.2 CXHL2600086 ZYG24004 江苏知原药业股份有限公司 2.2;2.4 CXHL2600085 ZYG24004 江苏知原药业股份有限公司 2.2;2.4 CXHL2600084 泽布替尼胶囊百济神州(苏州)生物科技有限公司 2.4 CXHL2600102 MI226注射液南京迈诺威医药科技有限公司 2.4 CXHL2600077 MI226注射液南京迈诺威医药科技有限公司 2.4 CXHL2600076 MI226注射液南京迈诺威医药科技有限公司 2.4 CXHL2600075 注射用RC288 荣昌生物制药(烟台)股份有限公司 1 CXSL2600288 注射用BG-C0979 广州百济神州生物制药有限公司 1 CXSL2600291 GenSci161注射液长春金赛药业有限责任公司 1 CXSL2600283 GenSci161注射液长春金赛药业有限责任公司 1 CXSL2600282 CRPA1A2注射液北京可瑞生物科技有限公司 1 CXSL2600286 INB301注射液云南白药集团股份有限公司 1 CXSL2600238 注射用BAT8008 百奥泰生物制药股份有限公司 1 CXSL2600116 注射用SSGJ-612 沈阳三生制药有限责任公司 1 CXSL2600105 LPJT-026 注射液乐普健糖药业(重庆)有限公司 1 CXSL2600110 LPJT-026 注射液乐普健糖药业(重庆)有限公司 1 CXSL2600109 TST001注射液苏州创胜医药集团有限公司 1 CXSL2600103 SCTB41注射液神州细胞工程有限公司 1 CXSL2600099 注射用BR113 杭州博之锐生物制药有限公司 1 CXSL2600108 SHR-2173注射液广东恒瑞医药有限公司 1 CXSL2600098 HLXTE-HAase02重组人透明质酸酶注射液复星汉霖(成都)生物技术有限公司 1 CXSL2600095 注射用QLS5132 齐鲁制药有限公司 1 CXSL2600093 注射用BL-B01D1 成都百利多特生物药业有限责任公司 1 CXSL2600091 注射用RGL-236 上海瑞宏迪医药有限公司 1 CXSL2600012 DSL201注射液苏州星核迪赛生物技术有限公司 1 CXSL2501184 人脐带间充质基质细胞注射液京东方再生医学科技有限公司 1 CXSL2501180 SND002细胞注射液贵州生诺生物科技有限公司 1 CXSL2501177 KN5501细胞注射液深圳恩瑞恺诺生物技术有限公司 1 CXSL2501183 KN5501细胞注射液深圳恩瑞恺诺生物技术有限公司 1 CXSL2501181 KN5501细胞注射液深圳恩瑞恺诺生物技术有限公司 1 CXSL2501182 帕博利珠单抗注射液百奥泰生物制药股份有限公司 2.2 CXSL2600114 恩朗苏拜单抗注射液石药集团巨石生物制药有限公司 2.2 CXSL2600097 QL2107注射液齐鲁制药有限公司 2.2 CXSL2600092 仿制药申请药品名称企业注册分类受理号舒林酸片福安药业集团庆余堂制药有限公司 3 CYHS2404001 舒林酸片福安药业集团庆余堂制药有限公司 3 CYHS2404000 盐酸溴己新口服溶液江苏开元药业有限公司 3 CYHS2403730 氯化钾口服溶液江西博泰药业有限公司 3 CYHS2403332 盐酸氯普鲁卡因注射液成都欣捷高新技术开发股份有限公司 3 CYHS2403257 盐酸氯普鲁卡因注射液成都欣捷高新技术开发股份有限公司 3 CYHS2403256 枸橼酸芬太尼口腔贴片宜昌人福药业有限责任公司 3 CYHS2403172 枸橼酸芬太尼口腔贴片宜昌人福药业有限责任公司 3 CYHS2403171 枸橼酸芬太尼口腔贴片宜昌人福药业有限责任公司 3 CYHS2403170 枸橼酸芬太尼口腔贴片宜昌人福药业有限责任公司 3 CYHS2403169 枸橼酸芬太尼口腔贴片宜昌人福药业有限责任公司 3 CYHS2403168 枸橼酸芬太尼口腔贴片宜昌人福药业有限责任公司 3 CYHS2403167 注射用硫酸多黏菌素B 齐鲁制药(海南)有限公司 3 CYHS2403113 盐酸左沙丁胺醇雾化吸入溶液江苏万高药业股份有限公司 3 CYHS2403064 硫代硫酸钠注射液海南倍康医药科技有限公司 3 CYHS2403037 舒林酸片成都通德药业有限公司 3 CYHS2402986 卡络磺钠片仁合益康集团有限公司 3 CYHS2402929 卡络磺钠片仁合益康集团有限公司 3 CYHS2402928 氯化钾注射液绪必迪药业(河北)有限公司 3 CYHS2402622 对乙酰氨基酚片江苏贝佳制药有限公司 3 CYHS2402290 舒必利注射液华夏生生药业(北京)有限公司 3 CYHS2401964 吡格列酮二甲双胍片浙江易泽达医药科技有限公司 3 CYHS2401882 钠钾镁钙注射用浓溶液北京民康百草医药科技有限公司 3 CYHS2401763 注射用吲哚菁绿海南紫程众投生物科技有限公司 3 CYHS2401375 盐酸甲氧氯普胺注射液北京柏雅联合药物研究所有限公司 3 CYHS2401169 米诺地尔搽剂乐信乐美(海南)生物科技有限公司 3 CYHS2302972 氧(液态) 玉得气体有限责任公司 4 CYHS2501861 硫酸氨基葡萄糖胶囊西洲医药科技(浙江)有限公司 4 CYHS2404645 吸入用乙酰半胱氨酸溶液山西普恒制药有限公司 4 CYHS2404284 达格列净二甲双胍缓释片(I) 江苏德源药业股份有限公司 4 CYHS2404249 他达拉非片四川新斯顿制药股份有限公司 4 CYHS2404199 他达拉非片四川新斯顿制药股份有限公司 4 CYHS2404198 硫酸氨基葡萄糖胶囊海南海力制药有限公司 4 CYHS2404102 硫酸镁钠钾口服用浓溶液江西博泰药业有限公司 4 CYHS2404063 氨甲环酸片石家庄四药有限公司 4 CYHS2404049 马来酸氟伏沙明片安徽正善生物药业有限公司 4 CYHS2403968 培哚普利氨氯地平片(III) 海南皇隆制药股份有限公司 4 CYHS2403963 硫酸氨基葡萄糖胶囊浙江领创优品药业有限公司 4 CYHS2403946 乙酰半胱氨酸颗粒海南广升誉制药有限公司 4 CYHS2403913 乙酰半胱氨酸颗粒海南广升誉制药有限公司 4 CYHS2403912 硫酸特布他林雾化吸入用溶液湖南醇健制药科技有限公司 4 CYHS2403895 比索洛尔氨氯地平片宁波科尔康美诺华药业有限公司 4 CYHS2403884 盐酸莫西沙星片辰欣药业股份有限公司 4 CYHS2403827 非奈利酮片山东朗诺制药有限公司 4 CYHS2403673 非奈利酮片山东朗诺制药有限公司 4 CYHS2403672 盐酸特比萘芬喷雾剂辽宁新高制药有限公司 4 CYHS2403640 艾拉莫德片北京福元医药股份有限公司 4 CYHS2403598 吸入用乙酰半胱氨酸溶液四川美大康华康药业有限公司 4 CYHS2403564 苯磺酸阿曲库铵注射液华夏生生药业(北京)有限公司 4 CYHS2403552 缬沙坦氢氯噻嗪片深圳奥萨制药有限公司 4 CYHS2403509 注射用伏立康唑悦康药业集团股份有限公司 4 CYHS2403514 结构脂肪乳注射液(C6-24) 广东嘉博制药有限公司 4 CYHS2403472 盐酸奥洛他定滴眼液长春迪瑞制药有限公司 4 CYHS2403439 盐酸奥洛他定滴眼液长春迪瑞制药有限公司 4 CYHS2403438 硫酸镁钠钾口服用浓溶液天津恒翊药业有限公司 4 CYHS2403422 西格列汀二甲双胍片(Ⅱ) 甘李药业山东有限公司 4 CYHS2403373 聚乙烯醇滴眼液海南斯达制药有限公司 4 CYHS2403312 注射用醋酸西曲瑞克武汉人福利康药业有限公司 4 CYHS2403238 替米沙坦氨氯地平片(II) 杭州康恩贝制药有限公司 4 CYHS2403197 依达拉奉氯化钠注射液安徽誉恒生物科技有限公司 4 CYHS2403195 他克莫司软膏浙江众延医药科技有限公司 4 CYHS2403207 他克莫司软膏浙江众延医药科技有限公司 4 CYHS2403206 帕拉米韦氯化钠注射液南京恒道医药科技股份有限公司 4 CYHS2403038 乳果糖口服溶液西洲医药科技(浙江)有限公司 4 CYHS2402971 盐酸尼卡地平注射液扬州中宝药业股份有限公司 4 CYHS2402947 他达拉非片贵州瑞和制药有限公司 4 CYHS2402924 他达拉非片贵州瑞和制药有限公司 4 CYHS2402923 布洛芬混悬液石家庄凯达生物工程有限公司 4 CYHS2402917 盐酸奥洛他定滴眼液呋欧医药科技(湖州)有限公司 4 CYHS2402800 二十碳五烯酸乙酯软胶囊江苏万高药业股份有限公司 4 CYHS2402773 注射用头孢哌酮钠舒巴坦钠海南全星制药有限公司 4 CYHS2402471 丁二磺酸腺苷蛋氨酸肠溶片北京福元医药股份有限公司 4 CYHS2402422 酒石酸溴莫尼定滴眼液沈阳兴齐眼药股份有限公司 4 CYHS2402421 左卡尼汀注射液国药一心制药有限公司 4 CYHS2402333 左卡尼汀注射液国药一心制药有限公司 4 CYHS2402332 酒石酸西尼必利片浙江远力健药业有限责任公司 4 CYHS2402264 他达拉非片迪沙药业集团有限公司 4 CYHS2401871 他达拉非片迪沙药业集团有限公司 4 CYHS2401870 美沙拉秦肠溶片浙江华海药业股份有限公司 4 CYHS2400127 马昔腾坦片山东华铂凯盛生物科技有限公司 4 CYHS2303558 米拉贝隆缓释片广东东阳光药业股份有限公司 4 CYHS2200741国;CYHS2200741 米拉贝隆缓释片广东东阳光药业股份有限公司 4 CYHS2200740国;CYHS2200740 吸附破伤风疫苗北京民海生物科技有限公司 3.3 CXSS2500049 注射用乳糖酸克拉霉素上海博志研新药物研究有限公司 3 CYHL2600012 阿普昔腾坦片石药集团中诺药业(石家庄)有限公司 3 CYHL2600013 抗D人免疫球蛋白新疆德源生物工程有限公司 3.2 CXSL2600013 帕妥珠曲妥珠单抗注射液(皮下注射) 复星汉霖(成都)生物技术有限公司 3.3 CXSL2600101 帕妥珠曲妥珠单抗注射液(皮下注射) 复星汉霖(成都)生物技术有限公司 3.3 CXSL2600100 进口申请药品名称企业注册分类受理号德莫奇单抗注射液 GlaxoSmithKline Trading Services Limited 1 JXSS2500002 德莫奇单抗注射液 GlaxoSmithKline Trading Services Limited 1 JXSS2500001 洛匹那韦利托那韦片 Hetero Labs limited 5.2 JYHS2300031 洛匹那韦利托那韦片 Hetero Labs limited 5.2 JYHS2300030 BMS-986458片 Bristol-Myers Squibb Company 1 JXHL2600077 BMS-986458片 Bristol-Myers Squibb Company 1 JXHL2600076 HTT227片 Novartis Pharma AG 1 JXHL2600027 AZD3470薄膜衣片 Astrazeneca AB 1 JXHL2600023 AZD3470薄膜衣片 Astrazeneca AB 1 JXHL2600022 AZD3470薄膜衣片 Astrazeneca AB 1 JXHL2600021 AZD3470薄膜衣片 Astrazeneca AB 1 JXHL2600020 Cenerimod片 Viatris Innovation GmbH 1 JXHL2600024 Enpatoran Merck Healthcare KGaA 1 JXHL2600015 RO7771950肠溶片 F. Hoffmann-La Roche Ltd. 1 JXHL2600014 RO7771950片 F. Hoffmann-La Roche Ltd. 1 JXHL2600013 BI764198 片 Boehringer Ingelheim International GmbH 1 JXHL2600016 JNJ-88549968注射液 Janssen Research & Development, LLC 1 JXSL2600059 Cevostamab F.Hoffmann-La Roche Ltd. 1 JXSL2600022 Cevostamab F.Hoffmann-La Roche Ltd. 1 JXSL2600021 PF-08634404 Pfizer Inc. 1 JXSL2600019 PF-08634404 Pfizer Inc. 1 JXSL2600018 NNC0487-0111注射液 Novo Nordisk A/S 1 JXSL2600017 NNC0487-0111注射液 Novo Nordisk A/S 1 JXSL2600016 NNC0487-0111注射液 Novo Nordisk A/S 1 JXSL2600015 NNC0487-0111注射液 Novo Nordisk A/S 1 JXSL2600014 NNC0487-0111注射液 Novo Nordisk A/S 1 JXSL2600013 NNC0487-0111注射液 Novo Nordisk A/S 1 JXSL2600012 NNC0487-0111注射液 Novo Nordisk A/S 1 JXSL2600011 NNC0487-0111注射液 Novo Nordisk A/S 1 JXSL2600010 NNC0487-0111注射液 Novo Nordisk A/S 1 JXSL2600009 NNC0487-0111注射液 Novo Nordisk A/S 1 JXSL2600008 NNC0487-0111注射液 Novo Nordisk A/S 1 JXSL2600007 NNC0487-0111注射液 Novo Nordisk A/S 1 JXSL2600006 IMGN151注射液 AbbVie Inc. 1 JXSL2600020 FXB0871 Fosun Industrial Co., Limited 1 JXSL2600005 Budoprutug注射液 Climb Bio, Inc. 1 JXSL2600004 中药相关申请药品名称企业注册分类受理号丹元糖痹软膏杏林中医药科技(广州)有限公司 1.1 CXZL2600012 十味安神颗粒河北平安健康集团股份有限公司 1.1 CXZL2600011 固表通窍颗粒九华华源药业股份有限公司 1.1 CXZL2600004 注：橙色字体部分结论为不批准或收到通知件；

上市批准临床申请

100 项与 Cenerimod 相关的药物交易

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外链

KEGG	Wiki	ATC	Drug Bank
D11283	-	-	DB12705

研发状态

10 条进展最快的记录,

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适应症	最高研发状态	国家/地区	公司	日期
狼疮性肾炎	临床3期	中国	Corden Pharma GmbH	2026-01-16
狼疮性肾炎	临床3期	中国	爱多希（北京）医药有限公司	2026-01-16
狼疮性肾炎	临床3期	中国	Viatris, Inc.	2026-01-16
系统性红斑狼疮	临床3期	日本	Viatris, Inc.	2022-12-13
系统性红斑狼疮	临床3期	阿根廷	Viatris, Inc.	2022-12-13
系统性红斑狼疮	临床3期	巴西	Viatris, Inc.	2022-12-13
系统性红斑狼疮	临床3期	保加利亚	Viatris, Inc.	2022-12-13
系统性红斑狼疮	临床3期	哥伦比亚	Viatris, Inc.	2022-12-13
系统性红斑狼疮	临床3期	法国	Viatris, Inc.	2022-12-13
系统性红斑狼疮	临床3期	希腊	Viatris, Inc.	2022-12-13

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临床结果

适应症

分期

评价

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研究	分期	人群特征	评价人数	分组	结果	评价	发布日期


NCT03742037 (CARE, ACR2025)	临床2期	系统性红斑狼疮	427	Cenerimod 4 mg	願膚鏇網膚築觸願夢鬱(鏇鑰醖簾齋蓋窪築構獵) = 廠窪齋淵鑰夢淵範夢鹽夢鏇鬱構醖願廠構觸蓋 (憲餘範窪遞醖壓膚獵築 ) 更多	积极	2025-10-24
				Placebo	願膚鏇網膚築觸願夢鬱(鏇鑰醖簾齋蓋窪築構獵) = 鹹簾醖鹹憲積築餘壓鹹夢鏇鬱構醖願廠構觸蓋 (憲餘範窪遞醖壓膚獵築 ) 更多
NCT03742037 (CARE, EULAR2025)	临床2期	系统性红斑狼疮	427	Cenerimod 0.5 mg	鑰艱願膚膚鬱範顧窪願(廠鑰夢襯選廠鑰艱鹹衊) = 構網積鹽築醖顧壓壓糧淵鑰範憲襯糧顧鏇顧簾 (膚醖鹹窪糧範鏇構鏇醖 )	积极	2025-06-11
				Placebo	鑰艱願膚膚鬱範顧窪願(廠鑰夢襯選廠鑰艱鹹衊) = 鑰襯製簾鑰範淵夢鹽齋淵鑰範憲襯糧顧鏇顧簾 (膚醖鹹窪糧範鏇構鏇醖 )
NCT03742037 (CARE, EULAR2023)	临床2期	IFN-1 gene expression signature \| anti-dsDNA antibody levels	427	Cenerimod 4 mg	醖廠獵糧膚遞簾餘願憲(齋鑰廠網壓膚鏇網蓋壓) = 壓繭繭繭繭膚淵構夢膚壓網憲鏇築獵選簾淵艱 (鬱繭積繭鹹蓋艱願齋糧 ) 更多	积极	2023-05-31
				Placebo	醖廠獵糧膚遞簾餘願憲(齋鑰廠網壓膚鏇網蓋壓) = 簾製糧餘鏇繭膚膚鬱淵壓網憲鏇築獵選簾淵艱 (鬱繭積繭鹹蓋艱願齋糧 ) 更多
NCT03742037 (ACR2022) 人工标引	临床2期	系统性红斑狼疮	427	Cenerimod	餘齋觸廠壓構遞蓋鏇鹽(獵衊蓋範觸蓋齋鏇齋鹹) = AEs were similar across treatment groups. The % of reported hypertension AEs was higher in the cenerimod 1 and 4 mg groups vs PBO 遞齋衊築醖糧積醖範壓 (鬱遞積衊憲築繭範窪顧 )	-	2022-09-12
NCT02472795 (CTgov)	临床1/2期	系统性红斑狼疮	105	Cenerimod (Cenerimod 0.5 mg (Part A))	積艱糧築餘遞鹽遞遞醖(壓選鑰網簾襯觸蓋鑰鹹) = 壓蓋憲築齋鏇艱夢積壓憲齋鏇糧鏇齋夢鑰鹽夢 (願鏇築選網網餘壓窪構, 0.48) 更多	-	2020-02-26
				Cenerimod (Cenerimod 1 mg (Part A))	積艱糧築餘遞鹽遞遞醖(壓選鑰網簾襯觸蓋鑰鹹) = 築遞選襯膚齋簾積網餘憲齋鏇糧鏇齋夢鑰鹽夢 (願鏇築選網網餘壓窪構, 0.68) 更多
NCT02472795 (Pubmed \| Lupus Sci Med)	临床1/2期	系统性红斑狼疮	105	Cenerimod 0.5 mg	鬱夢壓鹹窪製壓鑰糧製(網餘獵鹹淵顧衊願願網) = 範顧憲艱鏇憲艱鹹壓鬱製鹽廠獵夢齋獵艱齋製 (艱構夢憲願觸鏇壓襯製 )	积极	2019-01-01
				Cenerimod 1 mg	鬱夢壓鹹窪製壓鑰糧製(網餘獵鹹淵顧衊願願網) = 廠簾簾遞願鑰淵廠鹹範製鹽廠獵夢齋獵艱齋製 (艱構夢憲願觸鏇壓襯製 )