DATABASE · 2,000+ PEER-REVIEWED CITATIONS INDEXEDCOMPOUND LIBRARY · 100+ EVIDENCE-GRADED RECORDSGRADE A EVIDENCE · 45 COMPOUNDS WITH MULTIPLE HUMAN RCTSHUMAN EVIDENCE · 97 COMPOUNDS WITH HUMAN STUDY DATAVENDOR DIRECTORY · 11 RESEARCH VENDORS TRACKEDCLINIC DIRECTORY · 10 TELEHEALTH PROVIDERS VETTEDCOA RECORDS · 7 BATCH CERTIFICATES ON FILELIVE DATABASE · UPDATED 2D AGODATABASE · 2,000+ PEER-REVIEWED CITATIONS INDEXEDCOMPOUND LIBRARY · 100+ EVIDENCE-GRADED RECORDSGRADE A EVIDENCE · 45 COMPOUNDS WITH MULTIPLE HUMAN RCTSHUMAN EVIDENCE · 97 COMPOUNDS WITH HUMAN STUDY DATAVENDOR DIRECTORY · 11 RESEARCH VENDORS TRACKEDCLINIC DIRECTORY · 10 TELEHEALTH PROVIDERS VETTEDCOA RECORDS · 7 BATCH CERTIFICATES ON FILELIVE DATABASE · UPDATED 2D AGO
Home/Compounds/Plecanatide
OtherFDA approvedRx required

Plecanatide

Also known as: Trulance
Brands: Trulance

16-amino-acid guanylate cyclase-C agonist approved for chronic idiopathic constipation and IBS-C.

A
Grade A
Multiple human RCTs
Human studies28
PubMed citations29
Routeoral
Regulatory (US)FDA approved · Rx
Last verified2 days ago

Mechanism of action

Analog of human uroguanylin; activates guanylate cyclase-C in a pH-dependent manner, producing effects similar to linaclotide.

Evidence summary

28
Human studies
29
PubMed citations
14
Clinical trials
A
Evidence grade

Evidence summary in progress. See the citations section below for the underlying research papers.

Dosing protocols

Educational information only. Consult a licensed provider before using any peptide.
Administration routes
oral

Side effects & safety

From the FDA label
Source
constipationdiarrheadizzinessnausearashvomiting

Terms pulled directly from the referenced source. We don't fabricate frequencies — when a label doesn't publish a percentage, we don't either.

Interactions

No documented drug interactions on file.

Regulatory status

United States
FDA approved

FDA approved for chronic idiopathic constipation and IBS-C (Trulance). Contraindicated under age 6.

Compounding
Not permitted

Not available via 503A/503B compounding pharmacies.

Regulatory data last verified 4/19/2026

Clinical trials

NCT05107219Pilot Study of GCC Agonists to Identify a Cyclic-GMP Signal in Duodenal Tissue of VolunteersCompleted · Phase 1 · Barrett Esophagus · n=43NCT03596905A Randomized, Double-blind, Placebo-Controlled, Dose Ranging, Parallel-Group Study of the Efficacy and Safety of Plecanatide in Children 6 to <18 Years of Age With Irritable Bowel Syndrome With Constipation (IBS-C)Completed · Phase 2 · Irritable Bowel Syndrome With Constipation · n=218NCT05151328A Multi-center, Randomized, Double-blind, Placebo-controlled Phase III Clinical Study to Evaluate the Efficacy and Safety of Plecanatide in the Treatment of Functional Constipation in Chinese Patients for up to 12 WeeksCompleted · Phase 3 · Functional Constipation · n=648NCT02706483An Open Label, Long Term Safety and Tolerability Study of Plecanatide in Patients With Irritable Bowel Syndrome With Constipation (IBS-C)Completed · Phase 3 · Irritable Bowel Syndrome · n=2272NCT01053962A Phase 2 Randomized, Double-Blind, Placebo-Controlled, 14-Day Repeat, Oral, Dose Ranging Study to Assess the Safety, Pharmacokinetic and Pharmacodynamic Effects of SP-304 in Patients With Chronic Idiopathic ConstipationCompleted · Phase 2 · Chronic Idiopathic Constipation · n=84NCT01982240A Randomized, 12-Week, Double-Blind, Placebo-Controlled Study to Assess the Safety and Efficacy of Plecanatide (3.0 and 6.0 mg) in Patients With Chronic Idiopathic Constipation (The CIC3 Study)Completed · Phase 3 · Chronic Idiopathic Constipation · n=1394NCT03551873A Phase 4 Open-label, Non-randomized Study Evaluating the Pharmacokinetics and Safety of TRULANCE® (Plecanatide) in Breast Milk of Lactating Women Treated With TRULANCECompleted · Chronic Idiopathic Constipation · n=7NCT03120520A Randomized, Double-blind, Placebo-controlled, 3 Dose Level, Parallel Group Study of the Efficacy and Safety of Plecanatide in Adolescents 12 to < 18 Years of Age With Chronic Idiopathic Constipation (CIC)Completed · Phase 2 · Chronic Idiopathic Constipation · n=124NCT01919697An Open-Label Extension (OLE), Long-term Safety and Tolerability Study of Plecanatide in Patients With Chronic Idiopathic Constipation (CIC)Completed · Phase 3 · Chronic Idiopathic Constipation · n=2370NCT02493452Second Phase 3 Randomized, 12-Week, Double-Blind, Placebo-Controlled Study of the Safety and Efficacy of Plecanatide in Patients With Irritable Bowel Syndrome With Constipation (IBS-C)Completed · Phase 3 · Irritable Bowel Syndrome Characterized by Constipation · n=1135NCT02387359A Randomized, 12-Week, Double-Blind, Placebo-Controlled Study of the Safety and Efficacy of Plecanatide in Patients With Irritable Bowel Syndrome With Constipation (IBS-C)Completed · Phase 3 · Irritable Bowel Syndrome Characterized by Constipation · n=1054NCT02122471A National, Randomized, 12-Week, Double-Blind, Placebo-Controlled Study to Assess the Safety and Efficacy of Plecanatide (3.0 and 6.0 mg) in Patients With Chronic Idiopathic ConstipationCompleted · Phase 3 · Chronic Idiopathic Constipation · n=1410

Showing 12 of 14 indexed studies. View all on ClinicalTrials.gov →

Citations

PMID 40843382Fan X, Li Y et al. · A pharmacovigilance study of the association between linaclotide/plecanatide and muscle spasms based on food and drug administration adverse event reporting system.Frontiers in pharmacology (2025)HumanPMID 40503810Andrews MB, Adler DG · Constipation-predominant irritable bowel syndrome treatment options Linaclotide, Lubiprostone, Plecanatide, and Tenapanor: analysis of the FDA Adverse Event Reporting System (FAERS) database.Expert opinion on drug safety (2025)PMID 40571893Bai T, Xu Z et al. · Efficacy and Safety of Plecanatide in Chinese Patients with Functional Constipation: A Phase III Multicenter, Randomized, Double-Blind, Placebo-Controlled Trial.Drugs (2025)HumanPMID 38594429Brenner DM, Sharma A et al. · Plecanatide Improves Abdominal Bloating and Bowel Symptoms of Irritable Bowel Syndrome with Constipation.Digestive diseases and sciences (2024)HumanPMID 29942351Rao SSC · Plecanatide: a new guanylate cyclase agonist for the treatment of chronic idiopathic constipation.Therapeutic advances in gastroenterology (2024)HumanPMID 39321115Cash BD, Lu M et al. · A real-world study of persistence and adherence to prescription medications in patients with chronic idiopathic constipation in the United States.Journal of managed care &amp; specialty pharmacy (2024)HumanPMID 37204227Chang L, Chey WD et al. · American Gastroenterological Association-American College of Gastroenterology Clinical Practice Guideline: Pharmacological Management of Chronic Idiopathic Constipation.The American journal of gastroenterology (2023)HumanPMID 30127634Islam BN, Sharman SK et al. · Clinical utility of plecanatide in the treatment of chronic idiopathic constipation.International journal of general medicine (2023)HumanPMID 37162147Rao SSC, Laitman AP et al. · Influence of Demographic Factors on Clinical Outcomes in Adults With Chronic Idiopathic Constipation Treated With Plecanatide.Clinical and translational gastroenterology (2023)HumanPMID 37211380Chang L, Chey WD et al. · American Gastroenterological Association-American College of Gastroenterology Clinical Practice Guideline: Pharmacological Management of Chronic Idiopathic Constipation.Gastroenterology (2023)HumanPMID 37332239Cash BD, Sharma A et al. · Plecanatide for the treatment of chronic idiopathic constipation and irritable bowel syndrome with constipation: Post hoc analyses of placebo-controlled trials in adults with severe constipation.Neurogastroenterology and motility (2023)HumanPMID 35086735Moshiree B, Schoenfeld P et al. · The Effect of Acid Suppression Therapy on the Safety and Efficacy of Plecanatide: Analysis of Randomized Phase III Trials.Clinical therapeutics (2022)HumanPMID 35738724Chang L, Sultan S et al. · AGA Clinical Practice Guideline on the Pharmacological Management of Irritable Bowel Syndrome With Constipation.Gastroenterology (2022)HumanPMID 34727333Wechsler EV, Shah ED · Diarrhea-Predominant and Constipation-Predominant Irritable Bowel Syndrome: Current Prescription Drug Treatment Options.Drugs (2022)HumanPMID 32185662Barish C, Dorn S et al. · Plecanatide Is Effective and Safe in the Treatment for Chronic Idiopathic Constipation: Results of a Phase II Trial.Digestive diseases and sciences (2021)HumanPMID 33213776Lucak S, Lunsford TN et al. · Evaluation and Treatment of Constipation in the Geriatric Population.Clinics in geriatric medicine (2021)HumanPMID 34388141Shah ED, Staller K et al. · Evaluating the Impact of Cost on the Treatment Algorithm for Chronic Idiopathic Constipation: Cost-Effectiveness Analysis.The American journal of gastroenterology (2021)HumanPMID 30277094Barish CF, Crozier RA et al. · Long-term treatment with plecanatide was safe and tolerable in patients with irritable bowel syndrome with constipation.Current medical research and opinion (2020)HumanPMID 30550753Love BL · Plecanatide for Treatment of Chronic Constipation and Irritable Bowel Syndrome.The American journal of medicine (2020)HumanPMID 31474542Luthra P, Camilleri M et al. · Efficacy of drugs in chronic idiopathic constipation: a systematic review and network meta-analysis.The lancet. Gastroenterology &amp; hepatology (2020)Human

Showing 20 of 29 papers. View all on PubMed →