Gastrointestinal · FDA Approved
Plecanatide (Trulance)
FDA-approved
01 · Overview
A synthetic 16-amino acid analog of uroguanylin, an endogenous intestinal peptide that regulates fluid and electrolyte balance in the GI tract. Plecanatide stimulates guanylate cyclase-C (GC-C) receptors on the intestinal lining with pH-sensitive receptor binding, mimicking uroguanylin (PMID 29376436).
GC-C activation raises intracellular cGMP, stimulating intestinal fluid secretion (PMID 29376436).
02 · Research summary & key findings
FDA-approved in 2017 for chronic idiopathic constipation (CIC) as the first uroguanylin analog for this use (PMID 28169285), and in 2018 for irritable bowel syndrome with constipation (IBS-C). In a phase 3 CIC trial of 1,394 patients, about 20% on plecanatide vs. 10% on placebo were durable complete spontaneous bowel movement responders (PMID 28169285). Two phase 3 IBS-C trials found more overall responders (improvement in both abdominal pain and bowel movements) than placebo (PMID 29545635). Diarrhea was the most common side effect, occurring in roughly 4% to 6% of treated patients, and rarely led to stopping treatment (PMID 28169285) (PMID 29545635).
03 · Regulatory status
Plecanatide (Trulance) has received FDA approval and is available for clinical use under appropriate medical supervision. Consult a qualified healthcare provider for prescribing information.
Plecanatide (Trulance) is an FDA-approved medicine prescribed for the conditions on its label. It is not part of our intake, so we do not propose protocols for it. If you think it may be relevant to you, talk to your own doctor. How to ask your doctor.
04 · Administration routes
- Oral
References
- [1]A Randomized Phase III Clinical Trial of Plecanatide, a Uroguanylin Analog, in Patients With Chronic Idiopathic Constipation Am J Gastroenterol, 2017. PMID 28169285
- [2]Efficacy and safety of plecanatide in treating constipation predominant irritable bowel syndrome Expert Opin Pharmacother, 2018. PMID 29376436
- [3]Efficacy, safety, and tolerability of plecanatide in patients with irritable bowel syndrome with constipation: results of two phase 3 randomized clinical trials Am J Gastroenterol, 2018. PMID 29545635
Primary literature
- PubMed: "Plecanatide"
Peer-reviewed literature indexed by the National Library of Medicine.
- ClinicalTrials.gov: "Plecanatide"
Registered interventional and observational studies, including status and phase.
- PubChem: "Plecanatide"
Chemical structure, molecular properties, and bioactivity data.
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