预约演示
更新于：2026-07-23
Plecanatide
普卡那肽
更新于：2026-07-23
概要
基本信息
非在研机构 |
最高研发阶段批准上市 |
首次获批日期 美国 (2017-01-19), |
最高研发阶段(中国)无进展 |
特殊审评- |
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结构/序列
分子式C65H104N18O26S4 |
InChIKeyNSPHQWLKCGGCQR-DLJDZFDSSA-N |
CAS号467426-54-6 |
Sequence Code 145041
来源: *****
关联
14
项与 普卡那肽 相关的临床试验NCT07723924
A Phase 2b, Randomized, Double-blind, Placebo-controlled, Parallel Group Study of the Efficacy and Safety of Plecanatide in Children and Adolescents Age 6 to <18 Years of Age With Functional Constipation (FC)
NCT05107219
Pilot Study of GCC Agonists to Identify a Cyclic-GMP Signal in Duodenal Tissue of Volunteers
NCT05151328
A Multi-center, Randomized, Double-blind, Placebo-controlled Phase III Clinical Study to Evaluate the Efficacy and Safety of Plecanatide in the Treatment of Functional Constipation in Chinese Patients for up to 12 Weeks
100 项与 普卡那肽 相关的临床结果
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100 项与 普卡那肽 相关的转化医学
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100 项与 普卡那肽 相关的专利（医药）
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118
项与 普卡那肽 相关的文献（医药）2026-08-01JOURNAL OF CHROMATOGRAPHY A
A targeted partial reduction cyanylation strategy coupled with HRMS for accurate disulfide bridge mapping in disulfide rich cyclic peptides
Article
作者: Sharma, Nitish ; Chaturvedi, Sachin ; Sneha, Kumari
Determining disulfide bridge connectivity in disulfide rich peptides presents significant analytical challenges, primarily due to the presence of isobaric species that cannot be distinguished by intact mass analysis alone. This study describes a targeted approach based on controlled partial reduction followed by cyanylation for the reliable assignment of disulfide linkages. The method was evaluated using representative approved cyclic peptide therapeutics, specifically Linaclotide, Plecanatide, and Ziconotide. These peptides were selected as model due to their clinical relevance, well-defined and diverse disulfide bond architectures, and their status as benchmark examples of disulfide-rich therapeutics. Partial reduction was optimized to generate mono-reduced intermediates, which were subsequently derivatized through cyanylation. This modification enabled selective cleavage at cysteine residues, producing structurally informative fragments after final reduction. These fragments were characterized using high-resolution mass spectrometry (HRMS), facilitating clear identification of disulfide connectivity. The proposed workflow demonstrates high reproducibility and analytical consistency, with excellent mass accuracy and enhanced structural resolution relative to conventional methodologies. Notably, it enables reliable differentiation of disulfide isomers that are otherwise indistinguishable using routine analytical techniques. Overall, this study establishes a practical and robust method for disulfide bond mapping in cyclic peptides, with broad applicability for structural characterization and quality assessment and don't require enzymatic digestion or specialized instrumentation.The methodology was successfully validated using Linaclotide, Plecanatide, and Ziconotide, which contain three, two, and three disulfide bridges, respectively.
2026-04-01HOSPITAL PHARMACY
Based on the FDA Adverse Event Reporting System Database, a Study on Signal Mining of Adverse Events for Guanylate Cyclase-C Receptor Agonists
Article
作者: Guo, Chiwei ; Lei, Da ; Zhao, Shujuan
Objective::
To analyze and evaluate adverse drug event (ADE) signals for two GC-C receptor agonists, Linaclotide and Plecanatide, thereby enhancing understanding of their clinical safety.
Methods::
Data on adverse reactions associated with Linaclotide and Plecanatide were extracted from the FDA Adverse Event Reporting System (FAERS) for the period from Q1 2013 to Q4 2023. Signal detection was performed using the Reporting Odds Ratio (ROR) and the Proportional Reporting Ratio (PRR).
Results::
A total of 12 275 ADE reports for Linaclotide and 811 for Plecanatide were retrieved, resulting in 28 123 and 2230 ADE signals, respectively, across 24 and 19 System Organ Classes (SOCs). Both drugs predominantly exhibited gastrointestinal ADEs, including abdominal pain, bloating, and diarrhea. Linaclotide was associated with signals for urinary retention, incontinence, and bladder pain, which are not documented in its prescribing information. Plecanatide demonstrated signals for muscle spasms and sleep disorders, also absent from its instructions. Additionally, both drugs revealed signals related to water and electrolyte disorders.
Conclusion::
Clinical utilization of GC-C receptor agonists should take into account not only the prevalent gastrointestinal ADEs but also emerging signals associated with the urinary system, metabolic and nutritional disorders, and the nervous system. A comprehensive understanding of these signals is essential for evaluating medication risks and ensuring appropriate drug administration.
2026-03-01AMERICAN JOURNAL OF GASTROENTEROLOGY
The Safety of Pharmacotherapy for Irritable Bowel Syndrome: A Systematic Review and Meta-Analysis
Review
作者: Busam, Jonathan A. ; Pimentel, Mark ; Rezaie, Ali ; Marshall, Caroline ; Joo, LiJin ; Batta, Nisha ; Shah, Eric D.
INTRODUCTION::
Understanding the safety of pharmacotherapy for irritable bowel syndrome (IBS) enables individuals to make informed treatment decisions. While many studies include the number needed to treat to highlight therapeutic benefits, adding the number needed to harm (NNH), a measure we evaluate herein, could enable more comprehensive risk-benefit assessments.
METHODS::
PubMed, Web of Science, and Cochrane databases were searched through October 2024. Clinical trials investigating IBS pharmacotherapies including discontinuation rates because of adverse events (AEs) were included. Data were pooled using a random-effects model. The primary outcome was NNH for each pharmacotherapy, defined as the reciprocal of the absolute difference in risk of AEs leading to treatment discontinuation between the experimental and placebo groups. Secondary outcomes included the relative risk of withdrawing because of an AE and the most common AEs for each drug.
RESULTS::
Fifty-four trials met inclusion criteria. For constipation-predominant IBS pharmacotherapies, the NNH for linaclotide, lubiprostone, plecanatide, tegaserod, and tenapanor was 35 (
P
< 0.01), 53 (
P
= 0.59), 59 (
P
< 0.01), 58 (
P
= 0.03), and 16 (
P
< 0.01), respectively. For diarrhea-predominant IBS pharmacotherapies, the NNH for alosetron and eluxadoline was 14 (
P
< 0.01) and 32 (
P
< 0.01) whereas the NNH for both rifaximin and ramosetron was a negative, although statistically insignificant, value. For IBS global symptom pharmacotherapies, the tricyclics, the NNH was 24 (
P
< 0.01). Many AEs were transient without long-term sequela.
DISCUSSION::
Among pharmacotherapies for IBS, tricyclics (especially at elevated doses), tenapanor, and alosetron have the highest absolute risk of discontinuation because of an AE when compared with rifaximin, the safest pharmacotherapy studied.
100 项与 普卡那肽 相关的药物交易
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研发状态
批准上市
10 条最早获批的记录, 后查看更多信息
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| 适应症 | 国家/地区 | 公司 | 日期 |
|---|---|---|---|
| 肠易激综合征 | 加拿大 | 2022-01-12 | |
| 便秘型肠易激综合征 | 美国 | 2018-01-24 | |
| 慢性特发性便秘 | 美国 | 2017-01-19 |
未上市
10 条进展最快的记录, 后查看更多信息
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| 适应症 | 最高研发状态 | 国家/地区 | 公司 | 日期 |
|---|---|---|---|---|
| 功能性便秘 | 临床3期 | 中国 | 2022-03-03 | |
| 功能性便秘 | 临床3期 | 中国 | 2022-03-03 | |
| 便秘 | 临床3期 | 美国 | 2014-12-01 |
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临床结果
临床结果
适应症
分期
评价
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临床3期 | 605 | 積鹹觸鬱襯鹹觸鬱壓蓋(鬱艱積鏇簾窪鏇製衊網) = Plecanatide/placebo baseline mean symptom scores were 6.2/6.4 for abdominal pain and 6.4/6.6 for bloating; both had a mean of 0.2 CSBMs/week. 願壓鑰憲網獵糧築選餘 (願憲積衊製構蓋鹽願構 ) 更多 | 积极 | 2025-11-10 | |||
Placebo | |||||||
临床3期 | 4,815 | 艱壓鑰淵繭糧鹹築鹽積(築顧鏇壓壓獵襯淵範顧) = 艱範鹽醖鏇膚餘積衊齋 築壓憲顧襯齋鬱糧窪窪 (簾廠範憲範壓獵範製繭 ) 更多 | 积极 | 2023-09-01 | |||
艱壓鑰淵繭糧鹹築鹽積(築顧鏇壓壓獵襯淵範顧) = 簾積築蓋壓蓋艱選膚築 築壓憲顧襯齋鬱糧窪窪 (簾廠範憲範壓獵範製繭 ) 更多 | |||||||
N/A | - | 選鑰顧襯製夢網顧獵觸(憲鑰憲鹽構鹹範艱網齋) = 蓋顧觸鬱遞顧網襯艱淵 網衊選願餘選艱鹹築襯 (糧願鏇觸齋憲積觸衊壓 ) 更多 | - | 2020-10-11 | |||
選鑰顧襯製夢網顧獵觸(憲鑰憲鹽構鹹範艱網齋) = 餘齋壓遞糧廠餘餘範選 網衊選願餘選艱鹹築襯 (糧願鏇觸齋憲積觸衊壓 ) 更多 | |||||||
临床3期 | 2,272 | 選構遞淵觸網夢夢鑰憲 = 鹽鹹齋襯簾獵餘醖淵構 範觸糧構餘繭願醖廠顧 (獵齋構襯網鹽廠觸夢範, 窪糧夢艱糧齋顧艱選顧 ~ 觸鑰餘壓窪膚遞遞糧鬱) 更多 | - | 2020-08-18 | |||
临床2期 | 84 | (SP-304 0.3 mg) | 夢顧壓選簾憲願鏇醖餘 = 繭築齋淵顧範艱構憲膚 顧壓製鑰構廠鏇衊淵餘 (鬱鬱觸壓壓製壓網蓋艱, 憲網鏇壓夢網醖製積簾 ~ 齋膚鹹鹽顧顧網鏇壓範) 更多 | - | 2020-01-02 | ||
(SP-304 1.0 mg) | 夢顧壓選簾憲願鏇醖餘 = 齋淵鏇壓鹽構齋醖鏇觸 顧壓製鑰構廠鏇衊淵餘 (鬱鬱觸壓壓製壓網蓋艱, 廠憲範艱簾選構積構鬱 ~ 鹹觸觸壓衊夢繭衊選範) 更多 | ||||||
临床2期 | 124 | Matching placebo (Matching Placebo) | 觸願鬱遞壓築觸窪鏇膚 = 顧製網繭憲艱鑰蓋廠鏇 憲齋鬱醖淵遞觸鬱構製 (齋築網淵構衊鏇繭襯窪, 憲醖繭築艱糧窪範蓋膚 ~ 構繭廠壓鏇顧窪製夢醖) 更多 | - | 2019-09-19 | ||
(Plecanatide 0.5 mg) | 觸願鬱遞壓築觸窪鏇膚 = 蓋遞築繭鑰艱衊築製醖 憲齋鬱醖淵遞觸鬱構製 (齋築網淵構衊鏇繭襯窪, 醖選簾繭艱獵鹽廠膚積 ~ 繭夢簾鏇簾鹹衊憲積鬱) 更多 | ||||||
临床3期 | 2,370 | (Plecanatide 3 mg) | 艱構簾艱獵廠淵鹹積範 = 淵艱築構鹽簾網醖鬱積 構願鏇襯鹹繭餘齋襯餘 (艱獵繭觸顧簾膚壓築觸, 糧構鏇齋夢憲夢餘積範 ~ 夢鹽衊淵廠齋糧窪構繭) 更多 | - | 2019-07-02 | ||
(Plecantide 6 mg) | 艱構簾艱獵廠淵鹹積範 = 膚夢鏇遞膚獵獵範鹽糧 構願鏇襯鹹繭餘齋襯餘 (艱獵繭觸顧簾膚壓築觸, 願製艱鏇廠願襯獵鬱鹽 ~ 觸鑰壓獵製餘窪構範糧) 更多 | ||||||
临床3期 | 1,054 | Placebo (Matching Placebo) | 遞鬱窪壓鹽膚壓醖鏇淵 = 衊襯壓艱廠積襯艱窪衊 醖願製積襯網憲鹹範鬱 (鏇繭壓餘糧艱窪鬱襯憲, 鏇選遞構繭顧積鏇淵簾 ~ 範繭範夢鹽觸窪夢鹹鬱) 更多 | - | 2019-06-14 | ||
(3.0 mg Plecanatide) | 遞鬱窪壓鹽膚壓醖鏇淵 = 製觸淵鏇遞積遞醖廠遞 醖願製積襯網憲鹹範鬱 (鏇繭壓餘糧艱窪鬱襯憲, 構鬱壓淵醖壓壓遞鬱鹽 ~ 艱襯鑰衊選膚壓積襯鑰) 更多 | ||||||
临床3期 | 1,135 | Placebo (Matching Placebo) | 遞構鏇餘餘鏇網艱願淵 = 積窪網積鹹鏇選鹽觸選 衊範製鬱築築築製製艱 (鏇憲獵糧遞憲範窪淵壓, 積淵簾觸憲遞獵廠築積 ~ 糧鹹築選繭憲淵構鏇網) 更多 | - | 2019-06-14 | ||
(3.0 mg Plecanatide) | 遞構鏇餘餘鏇網艱願淵 = 鹹築顧蓋鹽鹽醖襯襯糧 衊範製鬱築築築製製艱 (鏇憲獵糧遞憲範窪淵壓, 壓醖蓋顧鏇遞艱襯獵積 ~ 獵膚襯觸鬱顧遞獵範願) 更多 | ||||||
临床3期 | 1,394 | Placebo (Placebo) | 壓窪廠憲觸蓋膚淵襯網 = 艱積鬱構獵艱蓋簾鏇窪 鑰餘顧範觸窪膚餘蓋糧 (憲鬱壓窪選鏇獵願鬱廠, 簾廠觸顧繭積壓鏇願獵 ~ 獵網鹹簾齋築鹹襯繭窪) 更多 | - | 2019-03-21 | ||
(Plecanatide 3.0 mg) | 壓窪廠憲觸蓋膚淵襯網 = 廠淵壓願艱鹹願鑰構遞 鑰餘顧範觸窪膚餘蓋糧 (憲鬱壓窪選鏇獵願鬱廠, 範願遞齋鏇齋鑰簾構積 ~ 蓋積鑰夢淵壓壓製獵範) 更多 |
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