Digestive & weight Guanylate cyclase-C agonist
Plecanatide
Regulatory status
Status at a glance
503A compounding status
Not nominated
We found no pending nomination for the 503A bulks list. Unless the substance has another legal pathway (for example, a USP monograph or use in an FDA-approved drug), 503A pharmacies generally may not compound with it.
- FDA approval
- An FDA-approved product contains this peptide
- 503B outsourcing
- Not determined
- Anti-doping (WADA)
- Not on the WADA Prohibited List
- DEA schedule
- Not a controlled substance
About peptide status
Most peptides discussed here are not FDA-approved for any use, and products labeled “research use only” are not for human use. Removal from Category 2 does not authorize compounding. PCAC votes are non-binding recommendations; FDA and HHS make the final decisions.
This is not medical or legal advice, and we do not publish dosing, sourcing or reconstitution information. Talk with a licensed clinician before using any peptide.
If you think you are having a medical emergency, call 911.
Key takeaway
Plecanatide (sold as Trulance) is a peptide modeled on the natural gut hormone uroguanylin that increases intestinal fluid to relieve chronic constipation and constipation-predominant irritable bowel syndrome. Like other drugs in its class, it activates a receptor on the intestinal lining, but its design is meant to mirror the body's own pH-sensitive signaling. It has been FDA-approved in the U.S. since 2017 and is taken as a once-daily tablet.
At a glance
- What it is
- A guanylate cyclase-C agonist peptide and uroguanylin analog
- Approved for
- Chronic idiopathic constipation and irritable bowel syndrome with constipation
- Key fact
- In a phase 3 constipation trial, about 21 percent of patients were durable responders versus roughly 10 percent on placebo
- Route
- Oral (once-daily tablet)
- Evidence strength
- FDA approved
Summary
Plecanatide is an FDA-approved oral peptide for chronic constipation and IBS-C. Learn how it works, what trials showed, and its boxed dehydration warning.
What is plecanatide?
Plecanatide, sold under the brand Trulance, is a peptide that closely mirrors uroguanylin, one of the body's own hormones that regulates fluid in the intestine. It is used for chronic idiopathic constipation and for irritable bowel syndrome with constipation. It was developed under the code SP-304 and approved in the United States in 2017.
How does plecanatide work?
Plecanatide activates guanylate cyclase-C on the lining of the intestine, raising cyclic GMP, which drives secretion of chloride, bicarbonate, and water into the gut. The added fluid softens stool and promotes movement through the bowel. Because it is built to resemble natural uroguanylin, its activity is pH-sensitive, favoring the mildly acidic environment of the upper small intestine, a feature its developers describe as more closely matching the body's own regional signaling.
Like other drugs in its class, plecanatide stays largely within the gut and is minimally absorbed, so its action is local. Durable responder rates in a phase 3 trial in chronic idiopathic constipation:
| Group | Durable responder rate |
|---|---|
| Plecanatide | About 21 percent |
| Placebo | Roughly 10 percent |
Diarrhea was the most common side effect in that trial.
Is it FDA-approved?
Editor’s note
Status: Yes. Plecanatide was approved by the FDA in 2017 for chronic idiopathic constipation and later for irritable bowel syndrome with constipation in adults. Its label carries a boxed warning about the risk of serious dehydration in children: it is contraindicated in children under 6 and should be avoided in those 6 to under 18.
Category: FDA-approved · Primary body area: Digestive & weight
Yes. Plecanatide was approved by the FDA in 2017 for chronic idiopathic constipation and later for irritable bowel syndrome with constipation in adults. Its label carries a boxed warning about the risk of serious dehydration in children: it is contraindicated in children under 6 and should be avoided in those 6 to under 18.
What is plecanatide prescribed for?
Plecanatide is prescribed for chronic idiopathic constipation and irritable bowel syndrome with constipation in adults. It is taken once daily, with or without food, and is not for use in children.
What are the side effects?
According to the prescribing information, common side effects include:
- Diarrhea, the most frequent effect
More serious considerations include:
- Severe diarrhea and dehydration
Plecanatide is contraindicated in children under 6 and in people with a known or suspected mechanical bowel obstruction.
Sources: FDA prescribing information for Trulance; the phase 3 chronic constipation trial (Miner et al., American Journal of Gastroenterology, 2017, DOI: 10.1038/ajg.2016.611), indexed on PubMed. This document is educational and does not constitute medical advice.
Registered human trials
0 registered human trials on ClinicalTrials.gov that we reviewed
Sources
- [1]
- [2]
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