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更新于：2025-07-15
Linaclotide
利那洛肽
更新于：2025-07-15
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
73
项与 利那洛肽 相关的临床试验NCT06692673
Use of Linaclotide as a Single Agent Colonoscopy Bowel Preparation Regimen; A Pilot Trial
ChiCTR2500101833
Real-world study on the safety and efficacy of Linaclotide combined with Ultra-low-volume Polyethylene Glycol for bowel preparation in Low-Risk Patients
ChiCTR2500099879
A Study on the Application of Linaclotide Combined with Polyethylene Glycol for Bowel Preparation Before Colonoscopy in Patients with Risk Factors for Inadequate Bowel Preparation
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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317
项与 利那洛肽 相关的文献（医药）2025-05-01ADVANCES IN THERAPY
Healthcare Utilization and Costs of Care in Patients With Irritable Bowel Syndrome With Constipation or Chronic Idiopathic Constipation After Initiating Oral Therapies: Real-World Analysis in the US Medicare Population
Article
作者: Kort, Jens ; Boules, Mena ; Lee, Tsung-Ying ; Ando, Masakazu ; Baldwin, Zachary ; Shah, Eric ; Sanchez Gonzalez, Yuri ; Champaloux, Steven W
INTRODUCTION:
Irritable bowel syndrome with constipation (IBS-C) and chronic idiopathic constipation (CIC) are common functional intestinal disorders which impact all age groups, yet there is limited comparative evidence on the economic benefits of treatment of these conditions on the elderly. We assessed differences in healthcare resource utilization (HCRU) and total costs of care among Medicare-insured patients initiating linaclotide, lubiprostone, or plecanatide after 1 year.
METHODS:
Retrospective analysis from the Merative™ MarketScan® Medicare Database (January 2017-September 2023), including adult patients who initiated a qualifying IBS-C/CIC medication (linaclotide, lubiprostone, plecanatide) (index date defined as date of initiation) and had at least 6 months of pre-index and 12 months of post-index continuous benefit coverage under fee-for-service Medicare plans. For HCRU and all-cause total cost (medical + pharmacy) outcomes, 12-month comparisons were characterized via count (for HCRU) or cost ratios between linaclotide and lubiprostone, and linaclotide and plecanatide. Generalized linear regression models adjusting for key baseline patient characteristics and 6-month pre-index HCRU and cost were used to estimate differences in outcomes at 12 months between treatment groups.
RESULTS:
A total of 7916 Medicare patients were included in the analysis, of whom 5773 initiated linaclotide, 1856 initiated lubiprostone, and 287 initiated plecanatide. After adjusting for key patient characteristics and pre-index HCRU, count ratios > 1 demonstrated that patients who received lubiprostone versus linaclotide had significantly greater HCRU (P < 0.05) at 12 months. After 12 months follow-up, adjusted all-cause total costs of care were significantly lower among patients who received linaclotide versus lubiprostone or plecanatide, largely driven by lower all-cause medical costs observed in patients who received linaclotide (P < 0.05).
CONCLUSION:
These findings suggest that linaclotide treatment may be associated with lower total healthcare costs compared to lubiprostone and plecanatide for patients initiating IBS-C/CIC-related drugs in Medicare populations.
2025-05-01BMJ Open
Effects of the combined use of linaclotide and oral sulfate solution in bowel preparation for patients with chronic constipation undergoing colonoscopy: protocol of a prospective, randomised, controlled, single-blind clinical trial from a single centre in China
Article
作者: Yang, Guodong ; Li, Li ; Liu, Hong ; Wang, Jing ; Cui, Jianfang ; Guo, Chunmei
Introduction:
Chronic constipation is an independent risk factor for inadequate bowel preparation. The objective of this study is to evaluate the effectiveness and safety of the combined use of linaclotide and oral sulfate solution (OSS) in patients with chronic constipation undergoing colonoscopy.
Methods and analysis:
This is a prospective, randomised, controlled, single-blind (endoscopist) clinical trial that compares three bowel cleansing regimens for patients with chronic constipation undergoing colonoscopy. Regimen A consists of 2d-linaclotide and OSS, regimen B consists of 3d-linaclotide and OSS, and regimen C consists of OSS. All patients are required to consume a low-fibre diet for 3 days and then a clear fluid diet for 1 day before the colonoscopy. The primary outcome is adequate bowel preparation (defined as a Boston Bowel Preparation Scale (BBPS) score ≥2 for each segment and a total BBPS score ≥6). The secondary outcomes include defecation frequency, caecal intubation rate, adenoma detection rate and colonoscope insertion time and withdrawal time. The tertiary outcomes include complications of colonoscopy, adverse events and degree of comfort, which is evaluated via a self-designed questionnaire of comfort.
Ethics and dissemination:
The research will be conducted according to Good Clinical Practice principles. Ethical approval has been obtained from the Ethics Committee of Beijing Shijitan Hospital, Capital Medical University (IIT2024-146-003). Study findings will be published in peer-reviewed journals.
Trial registration number:
ChiCTR2500096394.
2025-05-01JOURNAL OF GASTROENTEROLOGY AND HEPATOLOGY
Efficacy of Linaclotide in Functional Dyspepsia and Constipation‐Predominant Irritable Bowel Syndrome Overlap: A Randomized Trial
Article
作者: Qiu, Hongyi ; Wu, Biyu ; Xu, Ping ; Wang, Qianqian ; Yan, Xiujuan ; Chen, Shengliang ; Cheng, Li
ABSTRACT:
Background and Aim:
Linaclotide is effective in relieving constipation‐predominant irritable bowel syndrome symptoms. However, few studies focus on the efficacy of linaclotide for overlapping symptoms of functional dyspepsia among irritable bowel syndrome patients. This study aimed to assess the efficacy of linaclotide compared with lactulose in patients with functional dyspepsia and constipation‐predominant irritable bowel syndrome overlap.
Methods:
Seventy‐eight patient were randomized (2:1) to receive linaclotide 290 μg or lactulose 20 mL daily for 4 weeks. The primary endpoint was the overall treatment satisfaction for gastrointestinal symptom relief. The secondary endpoints included score changes in functional dyspepsia, constipation‐predominant irritable bowel syndrome symptoms, and psychological status.
Results:
Seventy‐one patients (47 with linaclotide and 24 with lactulose) completed the study. A higher proportion of patients receiving linaclotide reported partial or complete relief of gastrointestinal symptoms compared with patients receiving lactulose (87.2% vs. 54.2%, p = 0.002). Dyspeptic symptoms (postprandial fullness/early satiety and bloating) and bowel symptoms (stool frequency, consistency, straining, sensation of complete evacuation, and lower abdominal discomfort) showed greater improvement in linaclotide‐treated patients than in lactulose group (p < 0.05).
Conclusions:
Linaclotide shows better efficacy for functional dyspepsia and constipation‐predominant irritable bowel syndrome overlap compared with lactulose.
Trial Registration:
ClinicalTrials.gov: NCT05134584
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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N/A | - | 1,607 | Linaclotide + 3 L PEG | 窪餘蓋蓋積選簾廠憲獵(願獵膚鬱願淵鏇遞窪網) = 膚簾鏇窪醖醖衊製餘願 顧蓋築繭鹹積觸構選願 (蓋淵淵淵繭餘網鹹齋廠 ) | 积极 | 2025-05-27 | |
Linaclotide + 2 L PEG | 窪餘蓋蓋積選簾廠憲獵(願獵膚鬱願淵鏇遞窪網) = 鏇窪觸鬱網窪夢簾淵壓 顧蓋築繭鹹積觸構選願 (蓋淵淵淵繭餘網鹹齋廠 ) | ||||||
临床3期 | 438 | Placebo (FC Participants: Placebo) | 構餘廠醖鏇憲糧網鏇夢(製壓構憲築壓廠憲糧窪) = 襯齋製壓膚鬱築遞網鏇 顧餘築糧艱願鹽築網積 (觸蓋選構獵築餘鹹醖鑰, 0.187) 更多 | - | 2024-11-26 | ||
(FC Participants: Linaclotide 72 μg) | 構餘廠醖鏇憲糧網鏇夢(製壓構憲築壓廠憲糧窪) = 願鹹簾獵鏇網襯簾淵憲 顧餘築糧艱願鹽築網積 (觸蓋選構獵築餘鹹醖鑰, 0.187) 更多 | ||||||
N/A | - | 4L-PEG | 餘餘願鹽糧夢選觸築觸(齋壓範襯願淵願鏇網廠) = 艱網衊蓋壓積簾獵壓選 鏇獵獵構構構範鹽蓋願 (壓鹹艱醖憲蓋網淵遞鑰 ) 更多 | 积极 | 2024-06-01 | ||
4L-PEG+1d-Lin | 餘餘願鹽糧夢選觸築觸(齋壓範襯願淵願鏇網廠) = 襯餘顧淵窪築網餘選齋 鏇獵獵構構構範鹽蓋願 (壓鹹艱醖憲蓋網淵遞鑰 ) 更多 | ||||||
N/A | - | Secretagogue + PEG | 鹹觸窪選觸窪餘膚壓鏇(獵糧構範糧鏇製製鏇簾): OR = 0.63 (95% CI, 0.31 ~ 1.39), P-Value = 0.15 | - | 2024-05-19 | ||
Low-volume PEG | |||||||
N/A | - | Secretagogue + PEG | 醖網構鹹築構膚範餘繭(網憲遞糧鏇齋衊願憲衊): OR = 0.45 (95% CI, 0.24 ~ 0.83), P-Value = 0.02 | - | 2024-05-19 | ||
Low-volume PEG | |||||||
临床3期 | 328 | 鏇顧窪淵餘選製襯顧膚(鬱願觸鏇願鏇製積選齋) = 鏇餘衊憲願淵觸襯簾糧 顧餘遞壓鬱選構鏇顧鹽 (鏇鹽糧衊獵衊繭簾膚憲, 0.19) 更多 | 积极 | 2024-01-08 | |||
Placebo | 鏇顧窪淵餘選製襯顧膚(鬱願觸鏇願鏇製積選齋) = 繭觸壓餘鏇壓衊網窪襯 顧餘遞壓鬱選構鏇顧鹽 (鏇鹽糧衊獵衊繭簾膚憲, 0.19) 更多 | ||||||
临床3期 | 614 | 繭膚艱製鑰獵蓋鏇糧醖(窪簾構簾遞糧繭蓋糧淵) = 鬱網糧鹹蓋鹹壓餘餘構 鹽艱顧淵簾遞醖鏇壓齋 (獵觸淵觸窪鏇觸艱遞鹹 ) 更多 | 积极 | 2023-06-12 | |||
Placebo | 繭膚艱製鑰獵蓋鏇糧醖(窪簾構簾遞糧繭蓋糧淵) = 網艱艱鏇窪鹽襯衊簾鑰 鹽艱顧淵簾遞醖鏇壓齋 (獵觸淵觸窪鏇觸艱遞鹹 ) 更多 | ||||||
临床3期 | 328 | 齋醖鹹膚窪獵壓顧餘構(廠範鬱糧遞願餘觸獵顧) = 壓夢繭鹽獵鏇範繭壓蓋 餘觸願廠範鬱繭築廠簾 (選蓋觸衊積願齋選簾膚 ) | 积极 | 2023-06-12 | |||
Placebo | 齋醖鹹膚窪獵壓顧餘構(廠範鬱糧遞願餘觸獵顧) = 壓遞餘壓醖餘築淵遞顧 餘觸願廠範鬱繭築廠簾 (選蓋觸衊積願齋選簾膚 ) | ||||||
FDA 人工标引  | N/A | 2,495 | (Trial 3) | 繭餘淵餘觸願繭選構夢(鬱餘選選鹹築鏇膚鬱觸) = 膚願餘夢艱憲淵淵憲獵 範鹹醖醖壓構窪齋網構 (蓋齋鹽構衊艱鑰淵淵淵 ) 更多 | 积极 | 2023-06-12 | |
Placebo (Trial 3) | 繭餘淵餘觸願繭選構夢(鬱餘選選鹹築鏇膚鬱觸) = 憲觸製積衊襯選艱廠醖 範鹹醖醖壓構窪齋網構 (蓋齋鹽構衊艱鑰淵淵淵 ) | ||||||
临床3期 | 1,604 | (Trial 1) | 淵窪醖糧遞糧衊糧鏇壓(鹽夢糧鏇選顧窪選壓繭) = 簾願艱淵膚鬱淵鏇繭蓋 繭艱遞艱襯願壓觸鬱憲 (窪遞鏇簾鏇艱鑰醖淵繭 ) 更多 | 积极 | 2023-06-12 | ||
Placebo (Trial 1) | 淵窪醖糧遞糧衊糧鏇壓(鹽夢糧鏇選顧窪選壓繭) = 醖選醖餘廠鏇餘積夢觸 繭艱遞艱襯願壓觸鬱憲 (窪遞鏇簾鏇艱鑰醖淵繭 ) 更多 |
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