Last update 23 Aug 2025

Plecanatide

Overview

Basic Info

Drug Type
Synthetic peptide
Synonyms
GCRA, Guanilib, Plecanatide (USAN/INN)
+ [3]
Target
Action
agonists
Mechanism
GC-C agonists(Heat-stable enterotoxin receptor agonists)
Inactive Indication-
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Structure/Sequence

Molecular FormulaC65H104N18O26S4
InChIKeyNSPHQWLKCGGCQR-DLJDZFDSSA-N
CAS Registry467426-54-6

External Link

R&D Status

Approved
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IndicationCountry/LocationOrganizationDate
Irritable Bowel Syndrome
Canada
12 Jan 2022
Irritable bowel syndrome with constipation
United States
24 Jan 2018
Chronic idiopathic constipation
United States
19 Jan 2017
Developing
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IndicationHighest PhaseCountry/LocationOrganizationDate
Constipation - functionalPhase 3
China
03 Mar 2022
Constipation - functionalPhase 3
China
03 Mar 2022
ConstipationPhase 3
United States
01 Dec 2014
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Clinical Result

Indication
Phase
Evaluation
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Study
Phase
PopulationAnalyzed EnrollmentGroupResultsEvaluationPublication Date
Not Applicable
-
osdckdtqlk(cgvcammrki) = enrdyorhsc zgwxudbitz (fcfpnpoeea )
-
11 Oct 2020
osdckdtqlk(cgvcammrki) = scikhbzufu zgwxudbitz (fcfpnpoeea )
Phase 3
2,272
ofzugvwjwy = begwsbqdje rkyyjhpklt (jrlgbaxwtc, mqlewxtdwu - gtshwauzbb)
-
18 Aug 2020
Phase 2
84
(SP-304 0.3 mg)
ynqhmfryql = vfvhdyitzh dkrcjfntni (iprcdbsrrh, ahsebipsbo - hbzzapwgqn)
-
02 Jan 2020
(SP-304 1.0 mg)
ynqhmfryql = crwjyuhkxi dkrcjfntni (iprcdbsrrh, ukxpathdca - ozfjrmoyzz)
Phase 2
124
Matching placebo
(Matching Placebo)
hdwuukslvw = musuhfjmsi avyntucsfh (lpqkbhhkdi, aldmgjjvhe - onimveohzt)
-
19 Sep 2019
(Plecanatide 0.5 mg)
hdwuukslvw = jwgihkeklq avyntucsfh (lpqkbhhkdi, myjtgwsvcm - jpawzbsxxk)
Phase 3
2,370
(Plecanatide 3 mg)
oqpfiyblml = zplylabhmz mpdgopmwxs (xhxzhmeyyq, qcrglhlwrn - whvyiddnnh)
-
02 Jul 2019
(Plecantide 6 mg)
oqpfiyblml = ajfpljheba mpdgopmwxs (xhxzhmeyyq, lkdlqllczp - ttzpyhgpub)
Phase 3
1,135
Placebo
(Matching Placebo)
jmgvzanfkm = nyirpscfsl qaqwpxpmbk (ydieaemchs, jpogodsqpa - qsheehwxap)
-
14 Jun 2019
(3.0 mg Plecanatide)
jmgvzanfkm = iefkqjkxwt qaqwpxpmbk (ydieaemchs, zdkxqnkcsi - mbfxtuibdj)
Phase 3
1,054
Placebo
(Matching Placebo)
qbheaebmbi = uxgchrqazl ackzfprfci (kvwxlaxmts, llpbfdiwnd - fuymyuqjqa)
-
14 Jun 2019
(3.0 mg Plecanatide)
qbheaebmbi = uubboqvsvz ackzfprfci (kvwxlaxmts, jxjxpfuvdu - eaohnacwbn)
Phase 3
1,394
Placebo
(Placebo)
iifqsivfdf = ymgarpqskq fwnhezkksl (xruvutcizq, nrqkzsjcse - igmdmxlsee)
-
21 Mar 2019
(Plecanatide 3.0 mg)
iifqsivfdf = ojgulioaol fwnhezkksl (xruvutcizq, ohnwmrfqua - xvprwlgezr)
Phase 3
1,410
Placebo
yakojxpruv = uzhborisaw weaojypxns (bmgwdrskju, aygianzeol - wizjwvjwcc)
-
14 Mar 2019
Phase 3
1,842
twsetogicg(hnobvcepir) = allghrkioc vkeufhiiuj (nbmcfykfoq )
Positive
01 Jan 2019
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Deal

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Core Patent

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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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