ApprovedClinical / approved drugOralEvidence 4/5

Plecanatide

Also known as: Trulance

Plecanatide is a uroguanylin analog that activates guanylate cyclase-C on the luminal surface of the intestine, raising cyclic GMP and driving chloride and bicarbonate secretion through CFTR to increase intestinal fluid and transit.

Plecanatide
Drug class
Guanylate cyclase-C (GC-C) agonist
Primary targets
Guanylate cyclase-C (GC-C), CFTR chloride channel, Intestinal epithelium
Dose reference
Reference (label, not a recommendation): one 3 mg tablet orally once daily; phase 3 trials studied 3 mg and 6 mg
Half-life
Not calculable; minimally absorbed with negligible systemic availability, plasma levels below limit of quantitation
Developer / origin
Synergy Pharmaceuticals (Trulance assets later acquired by Bausch Health)
Reference year
2017
Evidence score
4/5 - Approved with supportive randomized phase 3 evidence

Approved uses

  • Chronic idiopathic constipation (CIC) in adults
  • Irritable bowel syndrome with constipation (IBS-C) in adults
Evidence 4/5

Approved with supportive randomized phase 3 evidence

Plecanatide is FDA-approved for chronic idiopathic constipation (2017) and IBS-C in adults (2018), supported by multiple randomized, double-blind, placebo-controlled phase 3 trials showing modest but statistically significant symptom improvement at a 3 mg once-daily oral dose.

Investigational compound with human randomized or phase 2/3 evidence.

Evidence basis

  • FDA Trulance prescribing information establishing approved indications, 3 mg once-daily dosing, boxed dehydration warning, and negligible systemic absorption
  • Phase 3 CIC trial (n=1,394) showing durable CSBM responder rates of ~21% (3 mg) and ~19.5% (6 mg) vs ~10% placebo
  • Two identical phase 3 IBS-C trials (Brenner et al., Am J Gastroenterol 2018) showing improved abdominal pain and constipation vs placebo over 12 weeks
  • Modest absolute benefit and lack of head-to-head superiority data versus linaclotide and standard laxatives temper the strength of evidence

How to read this entry

Dose references and half-life values are pulled from trial protocols, labels, reviews, or published summaries where available. They are context for research and comparison, not a personal dosing recommendation.

Status matters: approved drugs have regulated indications; investigational compounds are still being studied; research-only peptides do not have established human dosing, safety, or efficacy for consumer use.

Plecanatide guides

Read the matching guide or adjacent research pages for more context.

Peptide calculators

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