Evidence review: Open Peptide Project (verified against primary PubMed, ClinicalTrials.gov & FDA records) · Last checked 2026-10-27. ← Back to Evidence Library

Plecanatide (Trulance): what the evidence says

Name: Plecanatide (Trulance)
Published: 2026-10-27

At a glance

What it is: a 16-amino-acid analogue of uroguanylin, a gut hormone. It activates guanylate cyclase-C in the intestine, drawing fluid into the bowel. Taken as a pill and acts locally. FDA-approved Jan 2017 as Trulance (now Salix). ^{R1, R2}

What the evidence says: in phase 3 RCTs in chronic idiopathic constipation, about 20% responded vs 10% to 13% on placebo. ^{R3, R4} Two IBS-C trials with 2,189 adults also showed benefit. ^R5

Biggest risks: diarrhea (most common). Boxed warning: serious dehydration risk in children; contraindicated under 6 and to be avoided from 6 to under 18. ^R2

Rating


Human Human evidence	Strong for CIC and IBS-C in adults (multiple phase 3 RCTs) ^{R3, R4, R5} · Limited long-term safety ^R6
Animal Animal / lab evidence	Juvenile mice died of dehydration (label) ^R2
Regulatory	FDA-approved (NDA 208745) · not on the 503A/503B lists or FDA's safety-risk page · not named on WADA's 2026 list ^{R1, R7, R8, R9, R10}
Established human dose	Label dose for adults (see Study details and the FDA label)

Evidence verdict: Chronic idiopathic constipation and IBS with constipation in adults: Strong (FDA-approved; large phase 3 RCTs) · Children: contraindicated or avoided (boxed warning) · Anything else: No human data

This page reports what studies used. It is not dosing advice.

Legend: HUMAN data · ANIMAL / LAB data · UNKNOWN · UNVERIFIED: not yet confirmed against a primary source

About the evidence: the phase 3 trials were sponsored by Synergy Pharmaceuticals, its developer. Responder rates were modest in absolute terms. ^{R3, R4}

What is it?

Uroguanylin regulates fluid in the gut. Plecanatide copies it with one amino-acid change. It works on the same target as linaclotide.

Does it work?

Human CIC trial 1 (Miner 2017): 1,394 adults; durable responders 21.0% and 19.5% vs 10.2% placebo over 12 weeks. ^{R3, R11}
Human CIC trial 2 (DeMicco 2017): about 20% vs 12.8%. ^{R4, R12}
Human IBS-C (Brenner 2018): two RCTs, 2,189 adults; more responders than placebo. ^R5
Human Long-term IBS-C safety: 53-week open-label study. ^{R6, R13}

Is it safe?

Human Diarrhea is the main side effect. ^{R3, R2}
Human Boxed warning: contraindicated in children under 6 (deaths from dehydration in juvenile mice); avoid in ages 6 to under 18. Also contraindicated with known or suspected GI obstruction. ^R2

Gray-market "plecanatide": extra risks

A gray-market vial has no quality control and no guarantee of identity, strength or sterility. We test retail vials blind under the Open Peptide Standard; see /tests/. A passing test covers one batch on one date and does not mean the compound is safe.

Is it legal?

US (FDA): prescription drug for adults. ^{R2, R1}
Athletes: not named on WADA's 2026 list. ^R10

Study details

These are amounts researchers used, not recommendations.

Study	People / model	Route	Amount used	Follow-up	Reported	Citation
FDA label (Trulance)	Adults with CIC or IBS-C	Oral, once daily	3 mg	Ongoing	Approved use	FDA label
Miner 2017	1,394 adults with CIC	Oral, once daily	3 or 6 mg	12 weeks	21.0% / 19.5% vs 10.2%	PMID 28169285
Brenner 2018	2,189 adults with IBS-C	Oral, once daily	3 or 6 mg	12 weeks	More responders	PMID 29545635

Full reference list (PubMed, CT.gov, FDA and WADA checked Oct 26, 2026)

^R1 Drugs@FDA, Trulance, Salix, approved Jan 19, 2017, application 208745 (openFDA drugsfda record checked Oct 26, 2026). https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=208745
^R2 Trulance (plecanatide) tablets prescribing information, label published Apr 5, 2024 (DailyMed, checked Oct 26, 2026). https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=fe2895bf-71a6-493a-b0ca-e06b2dfefc82
^R3 Miner PB Jr, et al. Am J Gastroenterol. 2017. PMID 28169285
^R4 DeMicco M, et al. Ther Adv Gastroenterol. 2017. PMID 29147135
^R5 Brenner DM, et al. Am J Gastroenterol. 2018. PMID 29545635
^R6 Barish CF, et al. Curr Med Res Opin. 2019. PMID 30277094
^R7 FDA, 503A bulk drug substances categories list (updated May 14, 2026). https://www.fda.gov/media/94155/download
^R8 FDA, 503B bulk drug substances categories list (updated Mar 21, 2025). https://www.fda.gov/media/94164/download
^R9 FDA, Certain bulk drug substances for use in compounding that may present significant safety risks (content current Apr 22, 2026). https://www.fda.gov/drugs/human-drug-compounding/certain-bulk-drug-substances-use-compounding-may-present-significant-safety-risks
^R10 WADA. The 2026 Prohibited List, full list checked; compound not named. https://www.wada-ama.org/sites/default/files/2025-09/2026list_en_final_clean_september_2025.pdf
^R11 ClinicalTrials.gov NCT01982240, Synergy Pharmaceuticals, plecanatide in CIC, phase 3, completed (CT.gov API v2, checked Oct 26, 2026). https://clinicaltrials.gov/study/NCT01982240
^R12 ClinicalTrials.gov NCT02122471, Synergy Pharmaceuticals, plecanatide in CIC, phase 3, completed (CT.gov API v2, checked Oct 26, 2026). https://clinicaltrials.gov/study/NCT02122471
^R13 ClinicalTrials.gov NCT02706483, Synergy Pharmaceuticals, long-term safety in IBS-C, phase 3, completed (CT.gov API v2, checked Oct 26, 2026). https://clinicaltrials.gov/study/NCT02706483

Disclaimer

This page is for education and harm reduction, not medical advice or a recommendation to use Plecanatide (Trulance). It is a prescription pill. Talk to your clinician, and never give it to children: the label has a boxed warning about serious dehydration. Report problems to FDA MedWatch (https://www.fda.gov/safety/medwatch).