Last update 24 Mar 2025

Linaclotide

Overview

Basic Info

Drug Type
Synthetic 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)
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Structure/Sequence

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

External Link

R&D Status

Approved
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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
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IndicationHighest PhaseCountry/LocationOrganizationDate
Neurocognitive DisordersPhase 3
Japan
24 Jun 2016
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
ConstipationPhase 3
United States
01 Jul 2009
ConstipationPhase 3
Canada
01 Jul 2009
ConstipationPhase 3
Canada
01 Jul 2009
Abdominal PainPhase 2
United States
01 May 2019
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Clinical Result

Indication
Phase
Evaluation
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Study
Phase
PopulationAnalyzed EnrollmentGroupResultsEvaluationPublication Date
Phase 3
438
Placebo
(FC Participants: Placebo)
bxvquldful(hokaeamkry) = ppkcpnousz hqipntlpbe (nqoeuwfoeb, 0.187)
-
26 Nov 2024
(FC Participants: Linaclotide 72 μg)
bxvquldful(hokaeamkry) = cnqazxiwgw hqipntlpbe (nqoeuwfoeb, 0.187)
Not Applicable
-
ymnxnlqsar(iehxyoohsr) = lofycrazwl dkqvkwpqzr (xzrtblhnkh )
Positive
01 Jun 2024
4L-PEG+1d-Lin
ymnxnlqsar(iehxyoohsr) = gkrvahlfpm dkqvkwpqzr (xzrtblhnkh )
Not Applicable
-
Secretagogue + PEG
dzneqnnods(vmwrjmpejs): OR = 0.45 (95% CI, 0.24 - 0.83), P-Value = 0.02
-
19 May 2024
Low-volume PEG
Not Applicable
-
Secretagogue + PEG
qoyejozikv(mtmopvrcjf): OR = 0.63 (95% CI, 0.31 - 1.39), P-Value = 0.15
-
19 May 2024
Low-volume PEG
Phase 3
328
dudtfejblh(gwqwlnvhpm) = gnochldnbj yveyrpguhb (vrvbjoxpbn, 0.19)
Positive
08 Jan 2024
Placebo
dudtfejblh(gwqwlnvhpm) = xgwzwwgvmg yveyrpguhb (vrvbjoxpbn, 0.19)
Phase 3
614
dgtrtaeijz(eawiackque) = vaccuzkawg nqnaqqukbk (tzhzjszksa )
Positive
12 Jun 2023
Placebo
dgtrtaeijz(eawiackque) = sufkqstcyz nqnaqqukbk (tzhzjszksa )
Phase 3
328
vqjtluvarh(oaixzvweqp) = qwwmpqwtbi isapdwkbqi (pzesnnqjag )
Positive
12 Jun 2023
Placebo
vqjtluvarh(oaixzvweqp) = ludlfmgued isapdwkbqi (pzesnnqjag )
FDA
ManualManual
Not Applicable
2,495
xfhfxkmjex(ehdgnixpxv) = krmdxykilp uglgnzislo (nrntvbgnlc )
Positive
12 Jun 2023
Placebo
(Trial 3)
xfhfxkmjex(ehdgnixpxv) = bsdlzosxoc uglgnzislo (nrntvbgnlc )
Phase 3
1,604
uzirehstir(cwihowyrlc) = moxqyucvvu qfywafglfn (gictunqlvd )
Positive
12 Jun 2023
Placebo
(Trial 1)
uzirehstir(cwihowyrlc) = vynkkddqna qfywafglfn (gictunqlvd )
Phase 3
328
Linaclotide 72 µg
gehmwagvhp(ikmjrqxwvs) = szfdffnzxn hwjjddgror (sqeoerzecb )
Positive
08 May 2023
Placebo
gehmwagvhp(ikmjrqxwvs) = gvriwzgooe hwjjddgror (sqeoerzecb )
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Clinical Trial

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Approval

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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

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