guanylate cyclase-C agonist

Plecanatide

US: FDA-approvedEU: Not on the registerUK: Not on the registerCA: AuthorisedAU: Status unknownCH: Not on the registerBR: Not on the registerRS: Not on the registerSG: Not on the registerTR: Not on the register

Answer

Plecanatide is authorised or registered in the US and Canada: 2 of the 10 registers read. No trial states a phase. It has 15 registered trials, 1 of them running. Brand names on the FDA label register: Trulance Immediate Release.

RegulatorTrial register10 regulators' registers, read 2026-08-31 to 2026-10-03 · ClinicalTrials.gov, read 2026-10-03

Not medical, legal or regulatory advice.

Registered trials15Trial register ClinicalTrials.gov
Running now1Trial register recruiting, active or enrolling
Results posted10Trial register with results on the register
Stopped early0%Trial register all peptides: 10%

15 trials by status

Trial register
Running 1Completed 14

ClinicalTrials.gov · read 2026-10-03 · 10 trials have posted results

Trials first submitted per year

Trial register

ClinicalTrials.gov first-submitted date, last 10 years · read 2026-10-03. 2026 is not complete. 1 trial carries no first-submitted date (EU CTIS publishes none, or the year is outside this range).

Status by jurisdiction

World map
Authorised or registeredNot on the register, or withdrawnNot read yet, or status unknown
WhereStatusRegisterRead
United StatesFDA-approvedFDA, openfda2026-10-03
European UnionNot on the registerEMA, ema2026-08-31
United KingdomNot on the registerMHRA, uk-mhra2026-09-03
CanadaAuthorisedHealth Canada, ca-dpd2026-10-03
AustraliaStatus unknownTGA, au-artgnot read
SwitzerlandNot on the registerSwissmedic, ch-swissmedic2026-09-03
BrazilNot on the registerANVISA, br-anvisa2026-09-03
SerbiaNot on the registerALIMS, rs-alims2026-09-03
SingaporeNot on the registerHSA, sg-hsa2026-09-03
TurkeyNot on the registerTITCK, tr-titck2026-09-03

An EU decision applies in the 30 territories the EU register covers: its member states, and Iceland, Liechtenstein and Norway. A dashed tile has no register read for this peptide.

Side effects

Trial register
8 placebo-controlled trials · 4,622 people on Plecanatide · grey is placebo
Diarrhoea5.8% 1.2%
Headache2.3% 1.6%
ClinicalTrials.gov posted results · read 2026-10-03All side effects

CHANGE ALERTS

Get an email when this changes

One email when the status of Plecanatide changes on the register. You confirm your address first.

REGISTERED TRIALS

Newest 10 of 15 trials

All 15 trials
NCT07723924
This is a Randomized, Double-blind, Placebo-controlled, Multicenter, Parallel-group Study of the Efficacy and Safety of 2 Weight-b
currently recruiting participants · register updated 2026-10-02
NCT05107219
GCC Agonist Signal in the Small Intestine
completed · register updated 2026-04-07
NCT03596905
Efficacy and Safety of Plecanatide in Children 6 to <18 Years With Irritable Bowel Syndrome With Constipation (IBS-C)
completed · register updated 2025-12-31
NCT05151328
Efficacy and Safety of Plecanatide Comparing With Placebo in the Treatment of Functional Constipation
completed · register updated 2024-07-11
NCT02706483
Long Term Safety Study of Plecanatide
completed · register updated 2020-08-18
NCT01053962
SP-304 Dose Ranging Study in Patients With Chronic Idiopathic Constipation
completed · register updated 2020-01-02
NCT01982240
12-Week Study of Plecanatide for CIC (The CIC3 Study)
completed · register updated 2019-12-26
NCT03551873
A Postmarketing Study of Plecanatide in Breast Milk of Lactating Women Treated With TRULANCE®
completed · register updated 2019-11-22
NCT03120520
An Efficacy and Safety Study of Plecanatide in Adolescents 12 to <18 Years of Age With Chronic Idiopathic Constipation
completed · register updated 2019-10-04
NCT01919697
Open-label Extension (OLE) Study of Plecanatide for Chronic Idiopathic Constipation (CIC)
completed · register updated 2019-07-02

All peptides · Method

WEEKLY

Register Watch, weekly

New trials, approvals and enforcement actions. One email a week.