At a glance
- Dolcanatide is not an FDA-approved drug: Drugs@FDA has no record of it.
- PubMed lists 7 publications mentioning it, including 0 randomized controlled trials and 1 animal-only study.
- ClinicalTrials.gov lists 3 registered studies testing it (0 active).
- FDA’s adverse event system (FAERS) has no reports mentioning it.
Research topics
Most frequent MeSH subject headings in the latest PubMed records (English, as indexed).
Regulatory status
Drugs@FDA applications
No application found in Drugs@FDA, FDA's database of approved drugs.
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
- Phase I double-blind, placebo-controlled trial of dolcanatide (SP-333) 27 mg to explore colorectal bioactivity in healthy volunteers.
- The Guanylate Cyclase C-cGMP Signaling Axis Opposes Intestinal Epithelial Injury and Neoplasia.
- Oral treatment with plecanatide or dolcanatide attenuates visceral hypersensitivity via activation of guanylate cyclase-C in rat models.
- Plecanatide and dolcanatide, novel guanylate cyclase-C agonists, ameliorate gastrointestinal inflammation in experimental models of murine colitis.
- Emerging treatments in Neurogastroenterology: Perspectives of guanylyl cyclase C agonists use in functional gastrointestinal disorders and inflammatory bowel diseases.
- Pharmacology and clinical potential of guanylyl cyclase C agonists in the treatment of ulcerative colitis.
- Caffeine and ryanodine demonstrate a role for the ryanodine receptor in the organ of Corti.
Source: PubMed (NCBI) · verified October 30, 2026
Clinical trials
- Registered
- 3
- Active
- 0
- With posted results
- 1
Conditions studied
| Study | Status | Phase | Start |
|---|---|---|---|
| Dolcanatide in Preventing Colorectal Cancer in Healthy Volunteers | Completed | Phase 1 | July 27, 2018 |
| Dose-ranging Study to Assess Safety and Efficacy of SP-333 for the Treatment of Opioid-induced Constipation (OIC) | Completed | Phase 2 | Nov 2013 |
| Single Ascending Dose Study to Evaluate the Safety, Tolerability and Pharmacokinetics (PK) of SP-333 Tablets in Healthy Adult Subjects | Completed | Phase 1 | Oct 2012 |
All 3 studies on ClinicalTrials.gov ↗
Source: ClinicalTrials.gov · verified October 30, 2026
Adverse event reports
No FAERS reports mention this peptide.
Change history
No changes since monitoring began on October 30, 2026.