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更新于：2025-03-24
Linaclotide
利那洛肽
更新于：2025-03-24
概要
基本信息
最高研发阶段批准上市 |
最高研发阶段(中国)批准上市 |
特殊审评优先审评 (美国) |
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结构/序列
分子式C59H79N15O21S6 |
InChIKeyKXGCNMMJRFDFNR-VRMHCMCOSA-N |
CAS号851199-59-2 |
Sequence Code 10664
来源: *****
关联
75
项与 利那洛肽 相关的临床试验ChiCTR2500096394
The effects of combined use of linaclotide and oral sulfate solution in bowel preparation for chronic constipation patients undergoing colonoscopy
NCT06692673
Use of Linaclotide as a Single Agent Colonoscopy Bowel Preparation Regimen; A Pilot Trial
NCT06748638
Clinical Study on the Application of Lactulose Combined with Linaclotide in Bowel Preparation for Colonoscopy
100 项与 利那洛肽 相关的临床结果
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100 项与 利那洛肽 相关的转化医学
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100 项与 利那洛肽 相关的专利（医药）
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402
项与 利那洛肽 相关的文献（医药）2025-03-01AMERICAN SURGEON
Linaclotide as a Single Agent Bowel Preparation Regimen Before Colonoscopy
Article
作者: Read, Thomas E. ; Nordenstam, Johan ; Balch, Jeremy ; Rashid, Ahmed ; Terracina, Krista ; Mazirka, Pavel ; Goldstein, Lindsey
2025-01-01PEDIATRIC PULMONOLOGY
Linaclotide Use for the Treatment of Constipation and Gastrointestinal Symptoms in People With Cystic Fibrosis
Article
作者: Kormelink, Lauren N. ; Jacobs, HollyAnn R.
ABSTRACT:
Introduction:
Cystic Fibrosis (CF) is a multisystem autosomal recessive disease characterized by thick, sticky mucus which causes lung disease, pancreatic insufficiency, and many other manifestations. Constipation is a common complication in CF and few advances in treatment have been made until recent years. Linaclotide is a treatment approved for chronic idiopathic constipation and irritable bowel syndrome with constipation. This case series investigates the potential for use of this agent in adult people with CF (pwCF).
Methods:
A retrospective case series of 39 pwCF who are currently or previously prescribed linaclotide was completed at two adult Cystic Fibrosis Foundation (CFF) Accredited Care Centers. All patients 18 years and older were included with no exclusions. We reported results using descriptive statistics.
Results:
A total of 39 patients were identified for inclusion. The daily starting dose of linaclotide did vary with 18%, 72%, and 10% started on 72 mcg, 145 mcg, and 290 mcg respectively. Most patients (n = 30, 77%) reported experiencing no side effects. Of the total patients, 15% (n = 6) reported the medicine was not effective and 10% (n = 4) had to stop therapy due to adverse reactions. More than half of patients started on therapy were able to reduce baseline treatments for constipation.
Conclusion:
While this case series shows compelling data that may indicate benefit and tolerability of linaclotide use in pw CF, more research is needed to fully evaluate safety and efficacy of linaclotide for treating constipation in pwCF.
2025-01-01ADVANCES IN THERAPY
Cost-Effectiveness of Vibrant System vs. Linaclotide in Chronic Idiopathic Constipation
Article
作者: Voigt, Jeffrey D ; Frissora, Christine L. ; Frissora, Christine L ; Voigt, Jeffrey D.
INTRODUCTION:
Chronic idiopathic constipation (CIC) is a common disorder that has a large unmet clinical need, affecting 8.0-12.0% of the US population and disproportionately affecting female individuals more than male individuals. Patients and physicians are equally dissatisfied with over-the-counter and prescription treatments. Physician dissatisfaction is at 78%. CIC has a significant negative impact on quality of life (QoL). The objective of this analysis was to compare the total cost and QoL of the Vibrant System vs. linaclotide, over 1-3 years of treatment.
METHODS:
Markov models were utilized to project 1-3-year US costs and health outcomes (quality adjusted life years, QALYs) comparing the Vibrant System to the current standard of care pharmacologic therapy (linaclotide). One model examined direct (D) costs plus QALYs. Direct (D) costs included list price of product and medical treatment costs due to adverse events. Costs (D) were as of 2024; derived from the medical literature. A second model examined D as well as indirect (I) costs (absenteeism, presenteeism) [D + I] and QALYs. Longitudinal 12-month persistence prescription data for linaclotide was obtained from IQVIA claims data. The Vibrant System persistence data was derived from post market collection. One-way sensitivity analyses were also performed.
RESULTS:
Years 1-3 direct costs were lower with Vibrant System with improved QALYs. Cumulative D + I data analysis for the Vibrant System at 12 months, and for years 2 and 3 show increased cost savings from $345 to $3866 with improved effectiveness.
CONCLUSION:
On the basis of lower costs and improved QALYs, the Vibrant System should be considered a first-line therapy for CIC and should be covered by insurers.
100 项与 利那洛肽 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 |
|---|---|---|---|
| 功能性便秘 | 美国 | 2023-06-12 | |
| 慢性便秘 | 日本 | 2018-08-21 | |
| 慢性特发性便秘 | 美国 | 2012-08-30 | |
| 便秘型肠易激综合征 | 美国 | 2012-08-30 |
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 |
|---|---|---|---|---|
| 神经认知障碍 | 临床3期 | 日本 | 2016-06-24 | |
| 腹部膨胀 | 临床3期 | 美国 | 2012-08-01 | |
| 腹部膨胀 | 临床3期 | 美国 | 2012-08-01 | |
| 腹部膨胀 | 临床3期 | 加拿大 | 2012-08-01 | |
| 腹部膨胀 | 临床3期 | 加拿大 | 2012-08-01 | |
| 便秘 | 临床3期 | 美国 | 2009-07-01 | |
| 便秘 | 临床3期 | 美国 | 2009-07-01 | |
| 便秘 | 临床3期 | 加拿大 | 2009-07-01 | |
| 便秘 | 临床3期 | 加拿大 | 2009-07-01 | |
| 腹痛 | 临床2期 | 美国 | 2019-05-01 |
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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 | 438 | Placebo (FC Participants: Placebo) | 鏇壓淵構糧積築獵蓋淵(鏇齋淵製餘淵鹽壓積齋) = 壓鑰願範鏇顧夢願餘選 選網鹹餘鑰選範廠築憲 (艱選衊簾顧窪鹽淵繭壓, 0.187) 更多 | - | 2024-11-26 | ||
(FC Participants: Linaclotide 72 μg) | 鏇壓淵構糧積築獵蓋淵(鏇齋淵製餘淵鹽壓積齋) = 繭夢衊選網餘艱鏇築廠 選網鹹餘鑰選範廠築憲 (艱選衊簾顧窪鹽淵繭壓, 0.187) 更多 | ||||||
N/A | - | 淵繭艱顧衊觸膚窪餘憲(獵淵膚鑰範製積廠壓築) = 鹹蓋選網顧製構糧醖積 餘艱築衊獵衊鹹簾構製 (網憲鏇選膚製構觸構簾 ) 更多 | 积极 | 2024-06-01 | |||
4L-PEG+1d-Lin | 淵繭艱顧衊觸膚窪餘憲(獵淵膚鑰範製積廠壓築) = 鏇構醖壓範艱範蓋窪簾 餘艱築衊獵衊鹹簾構製 (網憲鏇選膚製構觸構簾 ) 更多 | ||||||
N/A | - | Secretagogue + PEG | 壓衊鏇製觸鏇願蓋窪網(鏇廠壓積製鹽淵餘簾鹽): OR = 0.45 (95% CI, 0.24 ~ 0.83), P-Value = 0.02 | - | 2024-05-19 | ||
Low-volume PEG | |||||||
N/A | - | Secretagogue + PEG | 獵糧廠壓積廠壓鏇顧繭(鹹範夢獵醖膚積網製築): OR = 0.63 (95% CI, 0.31 ~ 1.39), P-Value = 0.15 | - | 2024-05-19 | ||
Low-volume PEG | |||||||
临床3期 | 328 | 鏇鹽襯衊窪壓憲願遞蓋(鏇糧襯夢膚廠淵餘鹽鏇) = 鹹簾繭獵餘醖範鑰醖觸 範夢壓淵鏇選醖膚餘簾 (艱膚範膚蓋選艱淵遞衊, 0.19) 更多 | 积极 | 2024-01-08 | |||
Placebo | 鏇鹽襯衊窪壓憲願遞蓋(鏇糧襯夢膚廠淵餘鹽鏇) = 窪齋膚願製遞夢壓網鹹 範夢壓淵鏇選醖膚餘簾 (艱膚範膚蓋選艱淵遞衊, 0.19) 更多 | ||||||
临床3期 | 1,604 | (Trial 1) | 衊築製蓋築齋製築鹽憲(遞艱膚構壓糧築網繭製) = 廠獵膚憲餘憲醖鹽糧糧 積鏇壓淵齋窪鑰糧觸觸 (憲範簾獵鏇遞鏇鑰淵壓 ) 更多 | 积极 | 2023-06-12 | ||
Placebo (Trial 1) | 衊築製蓋築齋製築鹽憲(遞艱膚構壓糧築網繭製) = 壓齋淵鑰鹽艱鹹鹹鑰積 積鏇壓淵齋窪鑰糧觸觸 (憲範簾獵鏇遞鏇鑰淵壓 ) 更多 | ||||||
临床3期 | 328 | 齋夢鏇艱獵廠獵襯壓壓(憲繭顧齋膚築鏇選淵繭) = 襯選製鬱憲築衊網選憲 蓋壓製範餘鑰積膚夢艱 (積築構選願積選鹹憲觸 ) | 积极 | 2023-06-12 | |||
Placebo | 齋夢鏇艱獵廠獵襯壓壓(憲繭顧齋膚築鏇選淵繭) = 醖憲蓋糧遞衊築壓製糧 蓋壓製範餘鑰積膚夢艱 (積築構選願積選鹹憲觸 ) | ||||||
临床3期 | 614 | 淵鹽糧顧網製鬱襯繭膚(窪製襯壓襯憲膚製築鏇) = 廠製糧選壓衊觸鑰製獵 願廠網製壓醖築糧繭顧 (窪選憲鏇醖製憲憲鹽鏇 ) 更多 | 积极 | 2023-06-12 | |||
Placebo | 淵鹽糧顧網製鬱襯繭膚(窪製襯壓襯憲膚製築鏇) = 齋簾積醖廠鹹醖鏇積艱 願廠網製壓醖築糧繭顧 (窪選憲鏇醖製憲憲鹽鏇 ) 更多 | ||||||
FDA 人工标引  | N/A | 2,495 | (Trial 3) | 艱願鑰餘廠簾構憲淵範(醖繭窪選壓糧鹹憲蓋糧) = 艱廠網餘蓋願醖夢夢膚 網簾餘艱襯夢廠糧遞鹹 (齋蓋糧襯繭淵蓋蓋製夢 ) 更多 | 积极 | 2023-06-12 | |
Placebo (Trial 3) | 艱願鑰餘廠簾構憲淵範(醖繭窪選壓糧鹹憲蓋糧) = 鹹憲製範網製鹽淵夢鹽 網簾餘艱襯夢廠糧遞鹹 (齋蓋糧襯繭淵蓋蓋製夢 ) | ||||||
临床3期 | 328 | Linaclotide 72 µg | 構觸築夢廠構廠鏇鏇膚(齋鬱鹹築顧獵糧鹽齋窪) = 選積鹹餘衊襯壓構構淵 繭齋蓋廠憲窪壓鑰繭糧 (餘積觸餘顧構淵網醖糧 ) 更多 | 积极 | 2023-05-08 | ||
Placebo | 構觸築夢廠構廠鏇鏇膚(齋鬱鹹築顧獵糧鹽齋窪) = 築鹹製窪鹽積糧鏇鬱齋 繭齋蓋廠憲窪壓鑰繭糧 (餘積觸餘顧構淵網醖糧 ) 更多 |
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