Last update 29 May 2026

Linaclotide

Overview

Basic Info

Drug Type
Synthetic peptide, Cyclic Peptide
Synonyms
Cys Cys Glu Tyr Cys Cys Asn Pro Ala Cys Thr Gly Cys Tyr (disulfide bridge: 1-6; 2-10; 5-13), Linaclotide (JAN/USAN), Linaclotide acetate
+ [11]
Action
agonists, stimulants
Mechanism
GC-C agonists(Heat-stable enterotoxin receptor agonists), sGC stimulants(Soluble guanylate cyclase stimulants)
Originator Organization
Drug Highest PhaseApproved
RegulationPriority Review (United States)
Login to view timeline

Structure/Sequence

Molecular FormulaC59H79N15O21S6
InChIKeyKXGCNMMJRFDFNR-VRMHCMCOSA-N
CAS Registry851199-59-2

External Link

R&D Status

Approved
10 top approved records.
Login
to view more data
IndicationCountry/LocationOrganizationDate
Constipation - functional
United States
12 Jun 2023
Chronic constipation
Japan
21 Aug 2018
Chronic idiopathic constipation
United States
30 Aug 2012
Irritable bowel syndrome with constipation
United States
30 Aug 2012
Developing
10 top R&D records.
Login
to view more data
IndicationHighest PhaseCountry/LocationOrganizationDate
Neurocognitive DisordersPhase 3
Japan
24 Jun 2016
Irritable Bowel SyndromePhase 3
Spain
14 Jan 2014
Abdomen distendedPhase 3
United States
01 Aug 2012
Abdomen distendedPhase 3
United States
01 Aug 2012
Abdomen distendedPhase 3
Canada
01 Aug 2012
Abdomen distendedPhase 3
Canada
01 Aug 2012
ConstipationPhase 3
United States
01 Jul 2009
Abdominal PainPhase 2
United States
01 May 2019
Abdominal PainPhase 2
United States
01 May 2019
Irritable bowel syndrome with diarrheaPhase 2
United States
01 May 2019
Login to view more data

Clinical Result

Indication
Phase
Evaluation
View All Results
Study
Phase
PopulationAnalyzed EnrollmentGroupResultsEvaluationPublication Date
Phase 3
123
Placebo for Linaclotide
(Part 1: Placebo for Linaclotide)
sotnanhcvh(ktjfyokxhq) = rtmmnovczc rusdiecajc (ptedrfyysd, 0.2197)
-
14 May 2026
(Part 1: Linaclotide)
sotnanhcvh(ktjfyokxhq) = hdermaqvrj rusdiecajc (ptedrfyysd, 0.2188)
Phase 3
57
bjlwjclgjn(wbprvnigyz) = nryihoysep wybljxszku (totwqcjubm )
Positive
30 Mar 2026
Placebo
bjlwjclgjn(wbprvnigyz) = wjcsxcgbfp wybljxszku (totwqcjubm )
Phase 2
19
(Open-Label Linaclotide 9 ”g (Part 1))
vnmoewizot(dkivipwyqi) = rduuwwykyu pypegldioh (rkhkeuswvq, 0.9563)
-
06 Jan 2026
placebo
(Double-Blind Placebo (Part 2))
vnmoewizot(dkivipwyqi) = evbmqqgdzf pypegldioh (rkhkeuswvq, 1.3791)
Phase 3
438
Placebo
(FC Participants: Placebo)
quuonntvsc(fnntrkgtza) = atgnpieoso jjxfsxhtfs (jbilhltodj, 0.187)
-
26 Nov 2024
(FC Participants: Linaclotide 72 ÎŒg)
quuonntvsc(fnntrkgtza) = nktxvqootq jjxfsxhtfs (jbilhltodj, 0.187)
Not Applicable
-
4L-PEG
eowdmhoeuf(zumyhpskla) = fxjocsdrru rxrzubbqdo (bewyqsepqh )
Positive
01 Jun 2024
4L-PEG+1d-Lin
eowdmhoeuf(zumyhpskla) = rclglehhmy rxrzubbqdo (bewyqsepqh )
Phase 2
101
(7-11 years)
fzcoyoapfz(ivlogpcesc) = mxgvinyyvi bvprmrxwmy (dkpnaifasv )
Positive
01 Mar 2024
(7-11 years)
fzcoyoapfz(ivlogpcesc) = desizcpvya bvprmrxwmy (dkpnaifasv )
Phase 3
328
yryvgbjgwb(nuqjmdpeui) = gfmczvbzns vngnrlkcaq (aiskuoycga, 0.19)
Positive
08 Jan 2024
Placebo
yryvgbjgwb(nuqjmdpeui) = pmkwapzwne vngnrlkcaq (aiskuoycga, 0.19)
Phase 3
328
ybvpdlvefz(jwrxcybkue) = rfkfgnkatr jxyachnteu (jssvmlmgrc )
Positive
12 Jun 2023
Placebo
ybvpdlvefz(jwrxcybkue) = begpjswhbw jxyachnteu (jssvmlmgrc )
Phase 3
1,604
fhwiuvtzdn(eusrkiljxa) = uygkfwdway doriuaibcp (ochelvfbrg )
Positive
12 Jun 2023
Placebo
(Trial 1)
fhwiuvtzdn(eusrkiljxa) = bilxixbszi doriuaibcp (ochelvfbrg )
Phase 3
614
znhenoeolk(ogljqibhts) = aifvnawbve wnyqxplsel (rwqlcycrez )
Positive
12 Jun 2023
Placebo
znhenoeolk(ogljqibhts) = axpcdqkiim wnyqxplsel (rwqlcycrez )
Login to view more data

Translational Medicine

Boost your research with our translational medicine data.
Boost your research with our translational medicine data.

Deal

Boost your decision using our deal data.
Boost your decision using our deal data.

Core Patent

Boost your research with our Core Patent data.
Boost your research with our Core Patent data.

Clinical Trial

Identify the latest clinical trials across global registries.
Identify the latest clinical trials across global registries.

Approval

Accelerate your research with the latest regulatory approval information.
Accelerate your research with the latest regulatory approval information.

Biosimilar

Competitive landscape of biosimilars in different countries/locations. Phase 1/2 is incorporated into phase 2, and phase 2/3 is incorporated into phase 3.
Competitive landscape of biosimilars in different countries/locations. Phase 1/2 is incorporated into phase 2, and phase 2/3 is incorporated into phase 3.

Regulation

Understand key drug designations in just a few clicks with Synapse.
Understand key drug designations in just a few clicks with Synapse.
AI Agents Built for Biopharma Breakthroughs
Accelerate discovery. Empower decisions. Transform outcomes.
Get started for free today!
Accelerate Strategic R&D decision making with Synapse, PatSnap’s AI-powered Connected Innovation Intelligence Platform Built for Life Sciences Professionals.
Start your data trial now!
Synapse data is also accessible to external entities via APIs or data packages. Empower better decisions with the latest in pharmaceutical intelligence.
Bio
Bio Sequences Search & Analysis
Sign up for free
Chemical
Chemical Structures Search & Analysis
Sign up for free