A Phase 3, Long-Term Extension Study to Evaluate the Safety and Efficacy of Imsidolimab (ANB019) in the Treatment of Adult Subjects With Generalized Pustular Psoriasis

This is a Phase 3, long term extension study to evaluate the safety and efficacy of imsidolimab compared with placebo in adult subjects with generalized pustular psoriasis (GPP).

开始日期2022-04-21

申办/合作机构

Vanda Pharmaceuticals, Inc.

NCT05352893

/ Completed临床3期

A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Imsidolimab (ANB019) in the Treatment of Adult Subjects With Generalized Pustular Psoriasis

This is a Phase 3, multicenter, randomized, double-blind, placebo-controlled study to evaluate the efficacy and safety of imsidolimab compared with placebo in adult subjects with generalized pustular psoriasis (GPP).

开始日期2022-04-14

申办/合作机构

Vanda Pharmaceuticals, Inc.

NCT04856930

/ Completed临床2期

A Phase 2, Randomized, Double-Blind, Placebo Controlled Study to Evaluate the Efficacy and Safety of Imsidolimab (ANB019) in the Treatment of Subjects With Hidradenitis Suppurativa

Efficacy and safety of imsidolimab (ANB019) in participants with Hidradenitis Suppurativa

开始日期2021-07-07

申办/合作机构

Vanda Pharmaceuticals, Inc.

100 项与 Imsidolimab 相关的临床结果

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100 项与 Imsidolimab 相关的转化医学

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100 项与 Imsidolimab 相关的专利（医药）

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项与 Imsidolimab 相关的文献（医药）

2026-04-28·NEJM evidence

Efficacy and Safety of Imsidolimab for Generalized Pustular Psoriasis

Article

作者: Randazzo, Bruce ; Dahl, Martin ; Parmley, Stephen ; Johnson, Caroline ; Lizzul, Paul ; Birznieks, Gunther ; Brzezynski, Jennifer ; Tyner, Christina ; Bachelez, Hervé ; Polymeropoulos, Christos ; Bushman, Margaret ; Xiao, Changfu ; Polymeropoulos, Mihael ; Saikali, Khalil ; Gudjonsson, Johann E. ; Severtson, Anne ; Yap, Evelyn Wen Yee ; Denguezli, Mohamed ; Borlu, Murat ; Przychodzen, Bartlomiej ; Smieszek, Sandra ; Reich, Adam ; Chaowattanapanit, Suteeraporn ; Raina, Priya

BACKGROUND:

Generalized pustular psoriasis (GPP) is a rare, life-threatening disease attributed to aberrant interleukin-36 (IL-36) activity, often due to variants in the IL-36 receptor antagonist gene. Imsidolimab is a novel, humanized, affinity-matured immunoglobulin G4 monoclonal antibody that binds the IL-36 receptor and antagonizes IL-36 signaling.

METHODS:

Two phase 3 trials were conducted at 26 clinical sites within 11 countries investigating imsidolimab treatment for GPP. GEMINI-1 was a double-blind, placebo-controlled trial that randomly assigned 45 patients (18-80 years of age) with a GPP flare to receive either a single intravenous dose of 300 mg of imsidolimab, 750 mg of imsidolimab, or placebo. The primary endpoint was GPP Physician Global Assessment (GPPPGA) scores of clear (0) or almost clear (1) at week 4 (range: 0 [clear] to 4 [severe]; minimally clinically important difference, 1.4). GEMINI-2 was a follow-on relapse prevention trial with a primary objective of evaluating the safety of imsidolimab up to 104 weeks. Patients who improved with treatment in GEMINI-1 were randomly assigned to receive either 200 mg of subcutaneous imsidolimab or placebo monthly, whereas partial responders received open-label 200 mg of subcutaneous imsidolimab monthly.

RESULTS:

In GEMINI-1, 53% of patients in the groups that received either 300 mg (n=8/15) or 750 mg (n=8/15) of imsidolimab had GPPPGA scores of 0 or 1 at week 4, compared to 13% in the placebo group (n=2/15) (P=0.023 for both the 300 mg vs. placebo comparison and 750 mg vs. placebo comparison). In GEMINI-2, no serious adverse events led to imsidolimab discontinuation.

CONCLUSIONS:

Compared with placebo, a significantly higher proportion of patients with GPP randomly assigned to receive a single intravenous dose of imsidolimab were clear or almost clear of the disease after 4 weeks based on the GPPPGA. There were no serious adverse events that led to treatment discontinuation with imsidolimab up to 104 weeks of treatment. (Funded by AnaptysBio; ClinicalTrials.gov number, NCT05352893 for GEMINI-1 and NCT05366855 for GEMINI-2.).

2024-05-01·American journal of clinical dermatology

Small-Molecule Inhibitors and Biologics for Palmoplantar Psoriasis and Palmoplantar Pustulosis: A Systematic Review and Network Meta-Analysis

Review

作者: Wu, Po-Chien ; Huang, Yu-Huei ; Huang, I-Hsin ; Chiu, Hsien-Yi

BACKGROUND:

The comparative efficacy of biologics and small-molecule inhibitors in treating palmoplantar psoriasis (PP) and palmoplantar pustulosis (PPP) remains uncertain.

OBJECTIVE:

The aim was to perform a systematic review and network meta-analysis (NMA) to compare the efficacy of biologics and small-molecule inhibitors for the treatment of PP and PPP.

METHODS:

MEDLINE, Embase, and Cochrane Central Register of Controlled Trials were searched for eligible studies from inception to May 13, 2023. This NMA was conducted and reported following the Preferred Reporting Items for Systematic Reviews and Meta-Analyses Extension Statement for Network Meta-Analyses guidelines. Frequentist random-effects models NMA was performed with the surface under the cumulative ranking curve calculated for ranking. Our primary outcome was the proportion of patients achieving a clear/minimal Palmoplantar Psoriasis/Pustulosis Physician Global Assessment score (PPPGA 0/1 or PPPPGA 0/1) response at 12-16 weeks. Secondary outcomes consisted of the percentage of overall improvement in palmoplantar score and of improvement ≥ 75%, at 12-16 weeks.

RESULTS:

The study comprised a total of 29 randomized controlled trials (RCTs), involving 4798 psoriasis patients with palmoplantar diseases. For PP, 16 RCTs with nine different treatments, including adalimumab, apremilast, bimekizumab, etanercept, guselkumab, infliximab, ixekizumab, secukinumab, and ustekinumab were included for the analysis. In the NMA of PP, secukinumab 300 mg ranked highest (odds ratio [OR] 33.50, 95% confidence interval [CI] 4.37-256.86) in achieving PPPGA 0/1, followed by guselkumab 100 mg (OR 18.68, 95% CI 10.07-34.65). In the case of PPP, seven RCTs with six treatments, including apremilast, etanercept, guselkumab, imsidolimab, spesolimab, and ustekinumab, were included for the analysis. In the NMA of PPP, although no treatment demonstrated a significant difference compared to placebo in achieving PPPPGA 0/1, guselkumab 100 mg showed the greatest statistically significant improvement in the palmoplantar score (weighted mean difference 31.73, 95% CI 19.89-43.57) as a secondary outcome.

CONCLUSION:

Among all available biologics and small-molecule inhibitors, secukinumab 300 mg and guselkumab 100 mg had the most favorable efficacy in treating PP and PPP, respectively.

2024-04-01·Journal of the American Academy of Dermatology

The expanding horizon of anti-IL-36 therapy

作者: Heymann, Warren R

A review.The IL-36 signaling pathway dermatol. revolution is underway.This pathway is key in the pathogenesis of generalized pustular psoriasis (GPP).The IL-36 receptor (IL-36R) antagonist spesolimab effectively manages GPP, rapidly controlling GPP flares and preventing their recurrence.A phase II trial of imsidolimab, a humanized IgG4 monoclonal antibody specifically binding IL-36R, demonstrated a rapid resolution of pustular eruptions in GPP patients.In this issue of the Journal of the American Academy of Dermatol. , the National Psoriasis Foundation asserts that 'GPP is a life-threatening disease that needs to be treated as quickly as possible'.A controversial point regarding spesolimab focuses on (whether) screening for tuberculosis should be performed when the drug has been prescribed.Ahmad et al state that 'IL-36 comprises 4 isoforms: the proinflammatory IL-36α, IL-36β, and IL-36γ, and the anti-inflammatory IL-36R antagonist.An imbalance between proinflammatory and anti-inflammatory IL-36 isoforms can contribute to the inflammatory fate of cells and tissues.Cutaneous IL-36 signaling is crucial for the immunopathol. outcome of various skin diseases.Consequently, the IL-36/IL-36R axis has recently been recognized as a promising drug target for the treatment of inflammatory disorders beyond psoriasis.A safe prediction is that IL-36 antagonists will be broadly used in medical dermatol. beyond the realm of GPP.

134

项与 Imsidolimab 相关的新闻（医药）

2026-07-29

·丁香园 Insight 数据库

刚刚！华海药业首个创新药获批上市

7 月 29 日，NMPA 官网显示，华海药业子公司华奥泰生物抗 IL-36R 单抗「瑞西奇拜单抗」通过优先审评审批程序在国内获批上市，用于治疗成人(体重≥40kg)泛发性脓疱型银屑病发作。截图来自：NMPA 官网瑞西奇拜单抗（HB0034）为华奥泰自主研发的 IgG1 型靶向 IL-36R 的人源化单克隆抗体，对 IL-36R 具有高亲和力，能特异性结合 IL-36R，竞争性阻断受体激动剂 (IL36α，β 和 γ) 与 IL-36R 的结合。目前已有众多研究表明，IL-36 是导致炎症循环、皮肤炎症、脓疱形成和异常组织重构的主要细胞因子，IL-36 信号通路与包括 GPP 在内的多种自身炎症性疾病的发病机制密切相关。因此阻断 IL-36 炎症通路信号，可以减少炎性疾病中驱动致病的细胞炎症因子的释放，从而达到治疗疾病的目的。 Insight 数据库显示，该药推进速度较快，2021 年 10 月首次公示临床，而后在 2025 年完成关键 II 期研究，随即在同年申报上市。今日获批，距该药启动临床不超过 5 年。研发关键节点截图来自：Insight 数据库瑞西奇拜单抗的关键性 II 期研究由北京大学人民医院张建中教授牵头（登记号：NCT06231381/CTR20240444）。这是一项评价瑞西奇拜单抗在中重度泛发性脓疱型银屑病急性发作患者中疗效和安全性的多中心、双盲、随机、安慰剂平行对照试验。2025 年 3 月，华海药业宣布该项研究已经达到主要疗效终点和所有关键次要疗效终点。根据研究分析结果显示，相比于安慰剂，瑞西奇拜单抗单次静脉给药后的第 1 周 GPP 发作患者的皮肤脓疱得到明显清除，达到方案预设的主要研究终点，安全性方面表现良好，未发现新的安全性信号。具体临床数据目前暂未披露。关键临床登记截图来自：Insight 数据库网页版结语泛发性脓疱型银屑病 (GPP) 是一种罕见、可危及生命的、系统性中性粒细胞性皮肤病，发作时主要表现为全身红斑和脓疱并伴随全身系统性炎症症状，如发热、关节痛、肌痛、C 反应蛋白升高、白细胞增多等。GPP 的急性发作与死亡直接相关，若不及时控制可能会导致败血症和多系统器官衰竭，危及生命。在中国，大约每 100 万人中有 14 人患有 GPP，患者数量约为 2 万名。2023 年度，泛发性脓疱型银屑病已被纳入中国《第二批罕见病目录》。在美国，瑞西奇拜单抗也已获得 FDA 的孤儿药资格认定。值得一提的是，此次获批之后，瑞西奇拜单抗成为了继勃林格殷格翰「司柏索利单抗」之后国内第 2 款、国产首款 IL36R 单抗，为国内 GPP 患者带来了新的治疗新选择。 Insight 数据库显示，IL36R 单抗赛道还属于蓝海赛道，哪怕在全球范围内也仅有 6 款进入临床研发。国内竞争者更少，除 AnaptysBio 的 Imsidolimab 处于 III 期临床外，仅正大天晴的同机制新药 TQH2929 于去年 12 月刚刚启动 II 期临床，其余项目均在临床前。这意味着瑞西奇拜单抗获批之后，有望在较长一段时间内成为相应患者群体唯一的国产药选择。尽管勃林格殷格翰的司柏索利单抗自 2022 年获批之后已经通过谈判进入医保，瑞西奇拜单抗作为国产药的供应和销售优势仍然不可小觑。同时，瑞西奇拜单抗也是华海药业首个获批上市的自研创新药，是这家老牌药企创新转型之路上的重要一步。华海药业现已搭建覆盖 18 条临床阶段项目的创新药管线，以自免和肿瘤两大领域为主攻方向：自免无疑将成为最先开花结果的领域，瑞西奇拜单抗率先获批，IL17A 单抗 HB0017 也已在 2026 年 6 月申报上市，继续接棒；早期管线还开发有一款潜在全球 FIC 药物 HB1734，这是一款 IL17A/IL36R 双抗。在肿瘤领域，PD-L1/VEGF 双特异性抗体融合蛋白 HB0025 也已经处于 III 期临床阶段。编辑：ccai 封面来源：企业 Logo 免责声明：本文仅作消息分享，并不构成投资建议，也不代表 Insight 数据库的立场，文章观点仅供分享行业见解，请广大投资者谨慎。

孤儿药上市批准优先审批临床2期

2026-07-23

·科佰生物

IL36及相关细胞模型

背景白细胞介素（IL）-36是一组包含三种受体激动剂IL-36α、IL-36β、IL-36γ和一种拮抗剂IL-36受体α（IL-36Ra）的细胞因子。IL-36基因位于人类基因组2号染色体Q14区域，于1999年通过全基因组筛查首次被发现。由于其保守序列与预测结构与IL-1的相似性，该基因被认为属于IL-1细胞因子家族的同源物。因此，IL-36细胞因子家族最初被命名为IL-1F6（IL36α）、IL-1F8（IL36β）、IL-1F9（IL36γ）和IL-1F5（IL36Rα），后于2011年正式统一命名。 IL-36α、IL-36β和IL-36γ是IL-36R的激动性配体，而IL-36Ra则为抑制性配体。所有这些配体均需经蛋白酶剪切后方可活化。IL-36 细胞因子在先天免疫调节中起重要作用。IL-36α、β、γ 三种具有促炎功能的激动剂的过度表达和激活导致致病性炎症。IL-36 亚家族成员均具有相同的受体复合物 — IL-36 受体 (IL-36R)。 IL36及其可能的信号通路白细胞介素-36（IL-36）是白细胞介素-1（IL-1）超家族中的新型细胞因子亚家族。根据基因序列和结合受体，该家族还包括IL-1、IL-18和IL-33，并在免疫和炎症调节中发挥重要作用。由于其与IL-1基因组的紧密邻近性和保守序列相似性，IL-36在多种免疫性疾病和炎症性疾病中得到了广泛研究。IL-36存在于多种人体组织中，如皮肤、肺、肠道和滑膜，并可由多种细胞表达，包括角质形成细胞、支气管上皮细胞和肠道上皮细胞等上皮细胞，以及中性粒细胞、单核巨噬细胞和T细胞等免疫细胞。白细胞介素-36细胞因子必须在中性粒细胞衍生的蛋白酶作用下加工后才能被激活。通过不同酶切去N端后，IL-36配体与IL-36受体的亲和力可增强数百倍。组织蛋白酶G和弹性蛋白酶能激活IL-36α，而IL-36β和IL-36γ则分别由组织蛋白酶G和弹性蛋白酶激活。 IL-36细胞因子（IL-36α、β和γ）与IL-36受体（IL1Rrp2）结合，并招募辅助蛋白IL-1RAcP。进而会激活MyD88、MAPK、STAT3、IRAKs以及NF-κB信号通路，从而调节下游免疫与炎症反应。而IL-36Ra与IL-36受体（IL1Rrp2）的结合则可阻止辅助蛋白IL-1RAcP的招募及其后续的信号级联反应，导致促炎介质无法产生。 IL36相关的细胞模型 IL-36/IL-36R轴在多种炎症性疾病中的关键作用，被认为是一个有前景的药物靶点，适应症主要是治疗包括银屑病在内的炎症性疾病为主。Spesolimab是首个FDA批准的靶向IL36R的人源化单克隆抗体，以高亲和力特异性结合 IL-36R，从而防止配体激活下游炎症通路。由勃林格殷格翰公司开发，用于治疗脓疱型银屑病，全身性脓疱性银屑病（GPP），坏疽性脓皮病，掌跖脓疱病(PPP)，化脓性汗腺炎（HS）等。 Imsidolimab单抗是一种IgG4抗体，可抑制IL-36R的功能，由AnaptysBio开发，它对全身性脓疱性银屑病患者的治疗、维持疗效和预防复发有效且耐受性良好。其他正在开发中的IL-36R 单克隆抗体，HB0034（Huaota）最近完成了 Ia 期随机双盲安慰剂对照试验（NCT05064345），Ib 期试验（NCT05512598）和 Ic 期试验（NCT05460455）的招募工作正在进行中。IMG008（Inmagene Bio）预计将在不久的将来进行临床试验。国内外还有一些处在临床前研究阶段针对IL36/IL36R的药物未列出。为了助力IL36相关靶点药物的研发，科佰生物开发了多款细胞模型，用于候选药物早期机理研究。部分结果如下： IL36 Effector Reporter Cell(Adherent) CBP74511 Figure 3. Inhibition of hIL36α Induced Reporter Activity By Blocking Abs in IL36 Effector Reporter Cell(Adherent, C12). IL36 Effector Reporter Cell(Suspension) CBP74119 Figure 4. Inhibition of hIL36-induced Reporter Activity by Blocking Ab in IL36 Effector Reporter Cell(Suspension, C6). 药物靶点模型报告基因细胞模型可以很好的反映分子作用机制，同时具备更小的变异性和更好的可操作性，已被中检院及药企广泛应用于抗体药物生物活性的检定，对于药物研发、质量控制、批次放行都有重要意义。科佰生物公司十分重视研发创新，凭借细胞功能改造技术、高精度和灵活的基因编辑工具平台，提供包括激酶，GPCR，免疫治疗，耐药等多类疾病靶点的药物检测细胞模型。目前已覆盖1500多株现货细胞模型，同时提供高质量的Cell-base生物测活服务。免疫治疗靶点细胞模型 ● T Cells Activation Assays (NFAT, IL2, NFκB….) ● Fc Effectors Activity Assays ( ADCC, ADCPs…) ● Immune Checkpoint Bioassays: Co-Inhibitory Targets (PD-1/PD-L1&2, TIGIT/CD155, CTLA4, LAG3, LILRB4/APOE, CD112R/CD112, SIRPα/CD47, TIM-3, BTLA/HVEM, CD161/CLEC2D, TIGIT&PD-1, LAG3&PD-1, CTLA4&PD-1 Combi…) ● Immune Checkpoint Bioassays: Co-Stimulatory Targets (OX40, 4-1BB, GITR, CD27, HVEM/LIGHT, CD28, BTLA…) ● Cytokines and Growth Factor Assays ( BCMA, TGFβ, EGF, CSF1R, IL2, IL15, IL4&13, IL6, IL10, IL11, IL12, IL18, IL23, IL31, IL36, IFNs, OSMR, RANKL, TPO, TIE2, Wnt, EPO, VEGF, TSLP, NGF…) ● Others (TLR family members, STING，A2A family members, SARS Cov2…) -科佰生物产品- 免疫治疗细胞库点击查看 BaF3激酶靶点细胞株点击查看 GPCR细胞库点击查看耐药细胞点击查看 << 滑动查看下一张图片 >> 部分文字，图片来源网络，如涉及侵权，请联系告知。 ● CaSR：钙稳态 “哨兵”，代谢与肾病核心 GPCR 靶点 ● PAC1R：神经调控、疼痛与神经保护的核心GPCR靶点 ● IL33 相关细胞模型关注科佰生物了解更多资讯热线电话：4008-750-250 药靶模型联系方式: 华东销售经理(上海）： 18240630236/18114809104 华东销售经理(江苏、安徽）：15715191010 华北销售经理：18628311252 华南销售经理：13823536064 华中&华西销售经理：18071545918 全国销售经理：13816461235 邮箱：sales@cobioer.com 网站：www.cobioer.com

2026-07-16

·PRNewswire

Vanda Pharmaceuticals Announces EMA Positive Opinion for Orphan Drug Designation of Imsidolimab for Generalized Pustular Psoriasis - A Milestone Recognition of GPP as a Distinct Rare Disease in Europe

WASHINGTON, July 16, 2026 /PRNewswire/ -- Vanda Pharmaceuticals Inc. (Vanda) (Nasdaq: VNDA) today announced that the Committee for Orphan Medicinal Products at the European Medicines Agency (EMA) has adopted a positive opinion recommending orphan drug designation for imsidolimab, the company's investigational medicinal product, a high-affinity humanized immunoglobulin G4 (IgG4) monoclonal antibody, for the treatment of generalized pustular psoriasis (GPP). This marks the first time the EMA has granted orphan drug designation recognition for a drug to treat GPP in the European Union (EU). GPP is a severe, chronic, and potentially life-threatening inflammatory skin disease, genetically and clinically distinct from plaque psoriasis, driven by dysregulation in the interleukin-36 (IL-36) signaling pathway.1 It is characterized by widespread pustular eruptions, systemic inflammation, and serious complications that can lead to increased mortality.234 Imsidolimab inhibits IL-36 receptor signaling, addressing the deficiency in the endogenous IL-36 receptor antagonist commonly observed in patients with GPP. The EMA's orphan drug designation is granted to medicines intended for the treatment of life-threatening or chronically debilitating rare conditions affecting fewer than 5 in 10,000 people in the EU. Benefits include protocol assistance, reduced regulatory fees, and market exclusivity provisions in the EU following approval. "The EMA's positive opinion is a significant milestone that reinforces the highly encouraging clinical data supporting the imsidolimab program and formally recognizes GPP as an orphan disease in the EU for the first time," said Dr. Mihael H. Polymeropoulos, "This designation highlights the urgent unmet medical need in GPP and brings us one step closer to delivering a meaningful new therapy to patients in the EU." This designation follows similar regulatory recognitions in the United States and Japan. Additionally, the imsidolimab Biologics License Application (BLA) for GPP is currently under review by the FDA with a target action date of December 12, 2026. References Smieszek, S. et al. Efficacy and Safety of Imsidolimab for Generalized Pustular Psoriasis. NEJM Evidence 5, (2026). Ministry of Health Labour and Welfare (MHLW), "Pustular psoriasis (generalized type) (Designated Intractable Disease 37)," Japan Intractable Diseases Information Center. Accessed: Mar. 10, 2026. [Online]. Available: H. Fujita, R. Iwasaki, S. Tsuboi, Y. Murashiuma, and M. Akiyama, "Regional differences in the prevalence of generalized pustular psoriasis in Japan," J. Dermatol., vol. 51, no. 3, pp. 380–390, Mar. 2024, doi: 10.1111/1346-8138.17089. H. Miyachi et al., "Treatments and outcomes of generalized pustular psoriasis: A cohort of 1516 patients in a nationwide inpatient database in Japan," J. Am. Acad. Dermatol., vol. 86, no. 6, pp. 1266–1274, Jun. 2022, doi: 10.1016/j.jaad.2021.06.008. About Vanda Pharmaceuticals Inc. Vanda is a leading global biopharmaceutical company focused on the development and commercialization of innovative therapies to address high unmet medical needs and improve the lives of patients. For more on Vanda Pharmaceuticals Inc., please visit and follow us on X @vandapharma. CAUTIONARY NOTE REGARDING FORWARD-LOOKING STATEMENTS Various statements in this press release, including but not limited to statements regarding the potential benefits associated with EMA approval of an orphan drug, the therapeutic potential of imsidolimab for patients with GPP in the EU, and the anticipated timing of the completion of the FDA's review of the imsidolimab BLA are "forward-looking statements" under the securities laws. All statements other than statements of historical fact are statements that could be deemed forward-looking statements. Forward-looking statements are based upon current expectations and assumptions that involve risks, changes in circumstances and uncertainties. Important factors that could cause actual results to differ materially from those reflected in Vanda's forward-looking statements include, among others, Vanda's ability to obtain approval of, and to successfully commercialize, imsidolimab in the EU for the treatment of patients with GPP, Vanda's ability to satisfy the conditions necessary to receive the benefits associated with EMA approval of an orphan drug, and the FDA's ability to complete its review of, and reach a decision with respect to, the imsidolimab BLA by December 12, 2026. Therefore, no assurance can be given that the results or developments anticipated by Vanda will be realized or, even if substantially realized, that they will have the expected consequences to, or effects on, Vanda. Forward-looking statements in this press release should be evaluated together with the various risks and uncertainties that affect Vanda's business and market, particularly those identified in the "Cautionary Note Regarding Forward-Looking Statements", "Risk Factors" and "Management's Discussion and Analysis of Financial Condition and Results of Operations" sections of Vanda's most recent Annual Report on Form 10-K, as updated by Vanda's subsequent Quarterly Reports on Form 10-Q, Current Reports on Form 8-K and other filings with the U.S. Securities and Exchange Commission, which are available at . All written and verbal forward-looking statements attributable to Vanda or any person acting on its behalf are expressly qualified in their entirety by the cautionary statements contained or referred to herein. Vanda cautions investors not to rely too heavily on the forward-looking statements Vanda makes or that are made on its behalf. The information in this press release is provided only as of the date of this press release, and Vanda undertakes no obligation, and specifically declines any obligation, to update or revise publicly any forward-looking statements, whether as a result of new information, future events or otherwise, except as required by law. Corporate Contact: Kevin Moran Senior Vice President, Chief Financial Officer and Treasurer Vanda Pharmaceuticals Inc. 202-734-3400 [email protected] Jim Golden / Jack Kelleher / Dan Moore Collected Strategies [email protected] Follow us on X @vandapharma SOURCE Vanda Pharmaceuticals Inc. 21% more press release views with Request a Demo

100 项与 Imsidolimab 相关的药物交易

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外链

KEGG	Wiki	ATC	Drug Bank
D11892	-	-	-

研发状态

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适应症	最高研发状态	国家/地区	公司	日期
泛发性脓疱型银屑病	申请上市	美国	Vanda Pharmaceuticals, Inc.	2025-12-17
化脓性汗腺炎	临床2期	美国	AnaptysBio, Inc.	2021-07-07
化脓性汗腺炎	临床2期	美国	Vanda Pharmaceuticals, Inc.	2021-07-07
化脓性汗腺炎	临床2期	加拿大	Vanda Pharmaceuticals, Inc.	2021-07-07
化脓性汗腺炎	临床2期	加拿大	AnaptysBio, Inc.	2021-07-07
化脓性汗腺炎	临床2期	格鲁吉亚	AnaptysBio, Inc.	2021-07-07
化脓性汗腺炎	临床2期	波兰	AnaptysBio, Inc.	2021-07-07
化脓性汗腺炎	临床2期	波兰	Vanda Pharmaceuticals, Inc.	2021-07-07
寻常痤疮	临床2期	美国	Vanda Pharmaceuticals, Inc.	2021-05-15
寻常痤疮	临床2期	加拿大	Vanda Pharmaceuticals, Inc.	2021-05-15

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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


NCT05352893 \| NCT05366855 (GEMINI-2, Pubmed \| NEJM Evid)	临床3期	泛发性脓疱型银屑病	45	Imsidolimab 300 mg	蓋願顧鬱艱獵網衊憲積(觸淵構襯簾積鑰淵膚醖) = 網衊糧鹽選衊夢網廠醖憲鑰選鹽網醖製鬱鏇簾 (醖構鑰憲夢淵淵鏇選膚 )	积极	2026-04-28
				Imsidolimab 750 mg	蓋願顧鬱艱獵網衊憲積(觸淵構襯簾積鑰淵膚醖) = 鑰網淵蓋衊醖壓繭選顧憲鑰選鹽網醖製鬱鏇簾 (醖構鑰憲夢淵淵鏇選膚 )
NCT05366855 (GEMINI-2, CTgov)	临床3期	泛发性脓疱型银屑病	42	imsidol (ANB019-301 Imsidolimab Responder + ANB019-302 Imsidolimab 200 mg SC)	衊築壓夢襯顧簾蓋憲鏇 = 鹹憲蓋壓蓋衊願範選鹹襯積積遞襯鬱選齋積製 (醖築繭廠獵製艱鹹鹽範, 顧鬱醖壓艱選鹹蓋淵觸 ~ 觸簾鹹繭遞鏇膚簾觸繭) 更多	-	2026-03-27
				Placebo (ANB019-301 Imsidolimab Responder + ANB019-302 Placebo SC)	衊築壓夢襯顧簾蓋憲鏇 = 鬱繭鹽鹽願遞膚窪鑰鏇襯積積遞襯鬱選齋積製 (醖築繭廠獵製艱鹹鹽範, 淵鑰製艱憲憲鑰鹹積膚 ~ 窪醖衊糧繭願鏇簾遞廠) 更多
NCT05352893 (GEMINI1 \| GEMINI-1, CTgov)	临床3期	泛发性脓疱型银屑病	45	Placebo	願醖夢糧窪膚壓鬱艱窪 = 壓衊鹽築繭選衊鏇鹽遞簾顧鬱淵艱廠憲願壓網 (壓艱齋範簾顧製範願積, 餘壓醖夢鑰遞醖襯遞觸 ~ 醖襯製淵遞範齋餘繭衊) 更多	-	2026-03-17
NCT04856930 (CTgov)	临床2期	化脓性汗腺炎	149	Imsidolimab (Placebo-Controlled Period: Imsidolimab 400/200 mg)	壓鑰鬱遞醖獵築範餘壓(齋艱構鹽網糧壓選襯窪) = 遞繭廠壓襯網醖齋簾遞醖壓網蓋製範襯遞獵齋 (廠艱壓製觸廠廠齋選築, 6.05) 更多	-	2025-09-22
				Imsidolimab (Placebo-Controlled Period: Imsidolimab 200/100 mg)	壓鑰鬱遞醖獵築範餘壓(齋艱構鹽網糧壓選襯窪) = 醖繭積鹹製觸窪艱衊憲醖壓網蓋製範襯遞獵齋 (廠艱壓製觸廠廠齋選築, 4.63) 更多
NCT05366855 (GEMINI-2, GlobeNewswire) 人工标引	临床3期	泛发性脓疱型银屑病维持	16	imsidolimab (GEMINI-2 + GPPPGA 0/1 responder patients from GEMINI-1)	獵醖獵構蓋範範膚範餘(窪艱廠築構網憲壓膚憲) = 鹽糧衊鏇積壓窪鑰遞顧範鑰製網齋願餘顧憲糧 (淵繭廠醖製醖壓網餘觸 )	积极	2024-05-09
NCT05352893 (GEMINI1, GlobeNewswire) 人工标引	临床3期	泛发性脓疱型银屑病	45	Imsidolimab 750mg (GEMINI-1)	壓蓋壓鏇衊夢壓餘淵艱(積衊廠繭鏇簾淵蓋齋網) = 鏇餘鹽製範鬱鑰齋積鏇鹹鏇積遞繭鏇積簾襯簾 (壓壓願襯築範衊衊鑰觸 )	积极	2024-05-09
				Imsidolimab 300mg (GEMINI-1)	壓蓋壓鏇衊夢壓餘淵艱(積衊廠繭鏇簾淵蓋齋網) = 觸壓淵鹹選願衊選願鏇鹹鏇積遞繭鏇積簾襯簾 (壓壓願襯築範衊衊鑰觸 )
NCT05352893 (GEMINI1, Corporate Publications) 人工标引	临床3期	泛发性脓疱型银屑病	45	Imsidolimab	餘壓築範觸鏇積壓構淵(窪選築壓膚廠鹽顧淵膚) = 簾衊願築餘簾鑰壓觸簾窪壓觸壓夢構艱選選願 (築觸醖積衊網艱獵衊衊 ) 达到更多	积极	2023-10-09
				Placebo	餘壓築範觸鏇積壓構淵(窪選築壓膚廠鹽顧淵膚) = 顧範蓋襯鹹廠繭壓夢艱窪壓觸壓夢構艱選選願 (築觸醖積衊網艱獵衊衊 ) 达到
NCT04856917 (CTgov)	临床2期	寻常痤疮	123	Imsidolimab (Imsidolimab 400/200 mg)	醖衊觸廠襯顧選獵製願(糧齋築衊夢醖壓網選蓋) = 衊窪窪鏇願襯餘蓋衊艱糧衊齋網艱網構衊遞餘 (衊構鹹網積餘廠糧淵範, 13.63) 更多	-	2023-06-15
				Imsidolimab (Imsidolimab 200/100 mg)	醖衊觸廠襯顧選獵製願(糧齋築衊夢醖壓網選蓋) = 繭夢觸願壓積壓製選憲糧衊齋網艱網構衊遞餘 (衊構鹹網積餘廠糧淵範, 16.38) 更多
NCT04697056 (CTgov)	临床2期	鱼鳞病	5	Imsidolimab (Imsidolimab)	鑰製選廠憲遞艱艱願繭 = 窪艱膚憲範範觸網觸餘鹹獵糧淵鏇憲鹽鹹選窪 (餘簾網繭鏇鹽選範齋鏇, 繭構醖齋繭繭鬱觸鏇製 ~ 膚鏇壓構壓齋範顧壓鏇) 更多	-	2023-03-02
				placebo (Placebo)	鑰製選廠憲遞艱艱願繭 = 夢製顧製構選糧鬱顧範鹹獵糧淵鏇憲鹽鹹選窪 (餘簾網繭鏇鹽選範齋鏇, 餘獵願願製顧選壓窪憲 ~ 築襯築繭鏇艱鏇遞廠艱) 更多
NCT03633396 (POPLAR, CTgov)	临床2期	手掌和足底脓疱病	59	Placebo (Placebo)	鏇繭選廠繭廠鬱網襯憲(顧襯衊製鹹願夢鏇鹹齋) = 糧繭積艱醖衊艱廠願遞襯範構廠鹽艱鏇鑰淵顧 (網蓋糧壓壓顧鏇築簾繭, 1.48) 更多	-	2022-05-31
				Imsidolimab (Imsidolimab)	鏇繭選廠繭廠鬱網襯憲(顧襯衊製鹹願夢鏇鹹齋) = 遞網衊蓋網壓膚製觸願襯範構廠鹽艱鏇鑰淵顧 (網蓋糧壓壓顧鏇築簾繭, 1.46) 更多