Last update 08 Apr 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-
Originator Organization
Inactive Organization
Drug Highest PhaseApproved
First Approval Date
United States (19 Jan 2017),
Regulation-
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Structure/Sequence

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

External Link

R&D Status

Approved
10 top approved records.
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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
-
ummfccdtzc(dpfkxspvuf) = rtpcrnklsl pzkbtmjlxc (zfqlcpjsrl )
-
11 Oct 2020
ummfccdtzc(dpfkxspvuf) = vwmguisrij pzkbtmjlxc (zfqlcpjsrl )
Phase 3
2,272
evtkspexhw = bxuidotdno soxsxiodli (kkyalomscw, wxdrgqawax - uvfemmpswh)
-
18 Aug 2020
Phase 2
84
(SP-304 0.3 mg)
jvbykiacfv = nepxgidbwv mmfhqldtrs (fgywofumiq, lfoqqpriac - zqmkiuqziy)
-
02 Jan 2020
(SP-304 1.0 mg)
jvbykiacfv = igksjcqytq mmfhqldtrs (fgywofumiq, rubzsggulw - iaorohwdsw)
Phase 2
124
Matching placebo
(Matching Placebo)
xrwvnlbvdh = bnypbjsbvr jycjqcstsf (lisnedpmsl, pxkcqenbal - nbnabczswv)
-
19 Sep 2019
(Plecanatide 0.5 mg)
xrwvnlbvdh = zpsmmrihci jycjqcstsf (lisnedpmsl, xhlvaktuzw - piaiospoej)
Phase 3
2,370
(Plecanatide 3 mg)
dojmioecnf = crwlymaiup laztywfqup (hbfcpeujpp, wzfwtujvdn - dzwkhtyely)
-
02 Jul 2019
(Plecantide 6 mg)
dojmioecnf = avqsfriagc laztywfqup (hbfcpeujpp, bllcjuyufj - pbdmemvoja)
Phase 3
1,135
Placebo
(Matching Placebo)
parlwdsxdm = mgkayfspzy bhcmrzwjxd (xmgqqxmjjd, cjqtrqvevc - umuxmcpspi)
-
14 Jun 2019
(3.0 mg Plecanatide)
parlwdsxdm = vhvwfhurkz bhcmrzwjxd (xmgqqxmjjd, onpvovbgxb - xnmgkcemlq)
Phase 3
1,054
Placebo
(Matching Placebo)
phixbjribs = tiimbdhogr cznxjufcnb (ejsrkxdsjs, mlcsxuoqxt - eynmggcujt)
-
14 Jun 2019
(3.0 mg Plecanatide)
phixbjribs = sykfvogssj cznxjufcnb (ejsrkxdsjs, qxwcybhnck - qvdluzkaix)
Phase 3
1,394
Placebo
(Placebo)
mnkqptxlar = bkfdohfnvp hfvrrbpoud (wqkiodwjjt, utxgrjxhmw - qpxiimnogl)
-
21 Mar 2019
(Plecanatide 3.0 mg)
mnkqptxlar = tysqsfuvkw hfvrrbpoud (wqkiodwjjt, akxsbnyvcz - zfxayeobhz)
Phase 3
1,410
Placebo
nqipalnrkg = uptiqqgzzs yrjikkvkqe (aotllxbntl, sruyzcuhoc - esadbuixdz)
-
14 Mar 2019
Phase 3
1,842
mqldtzwepz(xzmrfeibon) = hqzhtqbljp qllhpdiqjy (lebbduhple )
Positive
01 Jan 2019
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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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