At a glance
- Plecanatide is an FDA-approved drug, marketed as Trulance (first approval: January 19, 2017).
- PubMed lists 128 publications mentioning it, including 11 randomized controlled trials and 0 animal-only studies.
- ClinicalTrials.gov lists 15 registered studies testing it (1 active).
- FDA's adverse event system (FAERS) holds 2,016 reports mentioning it; 742 classified as serious. Reports do not prove causation.
Research topics
Most frequent MeSH subject headings in the latest PubMed records (English, as indexed).
Regulatory status
Drugs@FDA applications
| Application | Product | Status | First approval | Sponsor |
|---|---|---|---|---|
| NDA208745 | TRULANCE | Approved, marketed | January 19, 2017 | SALIX |
Source: Drugs@FDA (openFDA) · verified October 30, 2026 · API query
FDA compounding safety list
Not on FDA's list of bulk drug substances that may present significant safety risks in compounding.
Source: FDA.gov — Category 2 bulk drug substances · verified October 30, 2026
Removal of a substance from a regulatory list does not mean it has been approved. A "research use only" label does not make a product safe or legal for human use.
Scientific publications
Counts are PubMed records that mention the peptide in the title or abstract. Categories overlap, and a mention is not the same as testing the peptide as a treatment. Each number opens the exact PubMed search. Effects seen in laboratory or animal studies may not occur in humans. A registered clinical trial does not show that a substance is effective or safe.
Latest publications
- Gut relief revisited: plecanatide in chronic idiopathic constipation and irritable bowel syndrome with constipation - a systematic review and meta-analysis with GRADE assessment.
- Pharmacotherapy of Irritable Bowel Syndrome with Constipation in Children: An Update on Clinical Progress and Successes.
- Patients' Real-World Experiences With Pharmacologic Therapies for Irritable Bowel Syndrome With Constipation: A Mixed-Methods Analysis and Classification of Social Media and E-Forum Posts.
- Constipation with bloating: a clinical approach to evaluation and management.
- Irritable Bowel Syndrome with Constipation: Diagnosis and Multisymptom Management Beyond Abdominal Pain and Bowel Movement Frequency: A Review.
- A targeted partial reduction cyanylation strategy coupled with HRMS for accurate disulfide bridge mapping in disulfide rich cyclic peptides.
- Efficacy and safety of Guanylyl cyclase C agonists (linaclotide and plecanatide) in patients with irritable bowel syndrome with constipation: a systematic review and meta-analysis of randomized controlled trials.
- Reconsidering Bloating as a Core Endpoint in IBS-C: Commentary on Brenner et al. (2025).
- Reconsidering Multisymptom Composite Endpoints in IBS-C Trials.
- Efficacy and tolerability of plecanatide for irritable bowel syndrome with constipation and chronic idiopathic constipation: a systematic review and meta-analysis.
Source: PubMed (NCBI) · verified October 30, 2026
Clinical trials
- Registered
- 15
- Active
- 1
- With posted results
- 11
Conditions studied
Show 5 more studies
| Study | Status | Phase | Start |
|---|---|---|---|
| 12-Week Study of Plecanatide for CIC (The CIC3 Study) | Completed | Phase 3 | Nov 2013 |
| Open-label Extension (OLE) Study of Plecanatide for Chronic Idiopathic Constipation (CIC) | Completed | Phase 3 | Aug 2013 |
| The Plecanatide Irritable Bowel Syndrome With Constipation Study (IBS-C) | Completed | Phase 2 | Nov 2012 |
| The Plecanatide Chronic Idiopathic Constipation (CIC) Study | Completed | Phase 2, Phase 3 | Oct 2011 |
| SP-304 Dose Ranging Study in Patients With Chronic Idiopathic Constipation | Completed | Phase 2 | Mar 2010 |
All 15 studies on ClinicalTrials.gov ↗
Source: ClinicalTrials.gov · verified October 30, 2026
Adverse event reports
- Reports
- 2,016
- Serious
- 742
- With death outcome
- 76
Most reported reactions
Adverse event reports do not prove that the substance caused these effects. Side effects not listed here may still occur. Reaction terms are MedDRA terms as reported to FAERS.
Source: FDA FAERS (FAERS data as of July 30, 2026) · verified October 30, 2026 · API query
FDA prescribing information
Official US prescribing information. Dosing sections are intentionally not shown.
Original FDA text (English) WARNING: RISK OF SERIOUS DEHYDRATION IN PEDIATRIC PATIENTS TRULANCE is contraindicated in patients less than 6 years of age; in nonclinical studies in young juvenile mice, administration of a single oral dose of plecanatide caused deaths due to dehydration [see Contraindications (4) , Use in Specific Populations (8.4) ] . Avoid use of TRULANCE in patients 6 years to less than 18 years of age [see Warnings and Precautions (5.1) , Use in Specific Populations (8.4) ] . The safety and effectiveness of TRULANCE have not been established in patients less than 18 years of age [see Use in Specific Populations (8.4) ] . WARNING: RISK OF SERIOUS DEHYDRATION IN PEDIATRIC PATIENTS See full prescribing information for complete boxed warning. TRULANCE is contraindicated in patients less than 6 years of age; in young juvenile mice, plecanatide caused death due to dehydration. ( 4 , 8.4 ) Avoid use of TRULANCE in patients 6 years to less than 18 years of age. ( 5.1 , 8.4 ) The safety and effectiveness of TRULANCE have not been established in patients less than 18 years of age. ( 8.4 ) Source: DailyMed / openFDA
Change history
No changes since monitoring began on October 30, 2026.