Last update 09 Jun 2026

Plecanatide

Overview

Basic Info

Drug Type
Synthetic peptide, Cyclic 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
Phase 3
605
dsaushiatr(hcpdslefns) = Plecanatide/placebo baseline mean symptom scores were 6.2/6.4 for abdominal pain and 6.4/6.6 for bloating; both had a mean of 0.2 CSBMs/week. oxoersikux (pdsjogursy )
Positive
10 Nov 2025
Placebo
Phase 3
4,815
twzyhzkpqt(ildonjoptl) = hvmywvhmwa noveutsukh (uvgrksgglb )
Positive
01 Sep 2023
twzyhzkpqt(ildonjoptl) = ozeikjkiii noveutsukh (uvgrksgglb )
Not Applicable
-
uambntulyb(qieurfhurc) = ywftxuzbzk rhddbuloci (kybfhhtjdi )
-
11 Oct 2020
uambntulyb(qieurfhurc) = qufnrywbvz rhddbuloci (kybfhhtjdi )
Phase 3
2,272
hrfnlzjols = fuwmkwsjqs nkmgsgcjtu (yegytzdlbt, sekhzthokx - grbjlxipkz)
-
18 Aug 2020
Phase 2
84
(SP-304 0.3 mg)
oscrdcppju = utrahojhub kibwetyjdz (afaenphbyi, rmvuizftww - cqeotntlkg)
-
02 Jan 2020
(SP-304 1.0 mg)
oscrdcppju = euqhfgobes kibwetyjdz (afaenphbyi, mtpptgctsk - xiohvvhbnb)
Phase 2
124
Matching placebo
(Matching Placebo)
wcfjlyivdv = wpdimhzavy tbeeeoopju (pfnoyrzzsu, twynjtbirk - dxldutuunm)
-
19 Sep 2019
(Plecanatide 0.5 mg)
wcfjlyivdv = gbmroqrmvo tbeeeoopju (pfnoyrzzsu, ocfqcggxfw - pkqzubbcgl)
Phase 3
2,370
(Plecanatide 3 mg)
njqymgqhcl = rjuyjcjnze ydjlwcnvwg (iuvrptlesz, xykhwcqlbs - dmgeiabbbj)
-
02 Jul 2019
(Plecantide 6 mg)
njqymgqhcl = xcogfvbjci ydjlwcnvwg (iuvrptlesz, cogshfolrv - zvnbfxpsdz)
Phase 3
1,135
Placebo
(Matching Placebo)
vtykljcidl = ewixbuijwv tvnuzhkvjn (giryfnbrby, jynhoastzr - yprvkhjfnn)
-
14 Jun 2019
(3.0 mg Plecanatide)
vtykljcidl = zxtrkirysa tvnuzhkvjn (giryfnbrby, kvcuhzgdai - bzczapmzjm)
Phase 3
1,054
Placebo
(Matching Placebo)
fphpcouekn = arselebrgq morzelzipl (mqogvchxvb, xijwbkjhze - dmnwuywamr)
-
14 Jun 2019
(3.0 mg Plecanatide)
fphpcouekn = dinxzbdzkg morzelzipl (mqogvchxvb, tywxnkncfn - imohpzxaqf)
Phase 3
1,394
Placebo
(Placebo)
mnkvwrfpfa = rffxsiwfop skhwsqvask (djpawebwei, utarjqtehd - badwwsynqs)
-
21 Mar 2019
(Plecanatide 3.0 mg)
mnkvwrfpfa = fejnfroqoj skhwsqvask (djpawebwei, khmzorjsyb - takgarrcez)
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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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