guanylate cyclase-C agonist
Linaclotide
Answer
Linaclotide is authorised or registered in the US, the EU, the UK, Canada and Switzerland: 5 of the 10 registers read. Highest trial phase: Phase 3 (1 phase 3 trial, 0 with posted results). It has 62 registered trials, 7 of them running. Brand names on the FDA label register: Linzess.
RegulatorTrial register10 regulators' registers, read 2026-09-03 to 2026-10-03 · ClinicalTrials.gov and EU CTIS, read 2026-10-03
Not medical, legal or regulatory advice.
62 trials by status
Trial registerClinicalTrials.gov and EU CTIS · read 2026-10-03 · 24 trials have posted results
Trials first submitted per year
Trial registerClinicalTrials.gov first-submitted date, last 10 years · read 2026-10-03. 2026 is not complete. 35 trials carry no first-submitted date (EU CTIS publishes none, or the year is outside this range).
Status by jurisdiction
World map| Where | Status | Register | Read |
|---|---|---|---|
| United States | FDA-approved | FDA, openfda | 2026-10-03 |
| European Union | Authorised | EMA, ema | 2026-10-03 |
| United Kingdom | Authorised | MHRA, uk-mhra | 2026-10-03 |
| Canada | Authorised | Health Canada, ca-dpd | 2026-10-03 |
| Australia | Status unknown | TGA, au-artg | not read |
| Switzerland | Authorised | Swissmedic, ch-swissmedic | 2026-10-03 |
| Brazil | Not on the register | ANVISA, br-anvisa | 2026-09-03 |
| Serbia | Not on the register | ALIMS, rs-alims | 2026-09-03 |
| Singapore | Not on the register | HSA, sg-hsa | 2026-09-03 |
| Turkey | Not on the register | TITCK, tr-titck | 2026-09-03 |
An EU decision applies in the 30 territories the EU register covers: its member states, and Iceland, Liechtenstein and Norway. A dashed tile has no register read for this peptide.
Side effects
Trial registerCHANGE ALERTS
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REGISTERED TRIALS
Newest 10 of 62 trials
| NCT07780344 | MRI Parameters as Biomarkers in Cystic Fibrosis (FEMPTO) not yet recruiting participants · register updated 2026-08-21 |
|---|---|
| NCT05796388 | A Study of Virtual Reality and Linaclotide for IBS-C currently recruiting participants · register updated 2026-07-29 |
| NCT03796884 | Linaclotide in Treating Patients With Stages 0-3 Colorectal Cancer running, but no longer enrolling · register updated 2026-07-22 |
| NCT05652205 | A Study to Assess Adverse Events and Change in Symptoms With Linaclotide Versus Placebo in Pediatric Subjects, Ages 2 to 5 Years, completed · register updated 2026-05-14 |
| NCT07569419 | Proof of Principle Study for an Efficacy Trial of Linaclotide for Cystic Fibrosis currently recruiting participants · register updated 2026-05-06 |
| NCT05107219 | GCC Agonist Signal in the Small Intestine completed · register updated 2026-04-07 |
| NCT03119584 | Efficacy of Linaclotide in Type II Diabetics With Chronic Constipation running, but no longer enrolling · register updated 2026-04-03 |
| NCT07431957 | "Efficacy and Safety of Linaclotide in Chronic Constipation" not yet recruiting participants · register updated 2026-02-25 |
| NCT06692673 | Linaclotide for Colonoscopy Bowel Prep currently recruiting participants · register updated 2026-01-23 |
| NCT04166058 | Long-term Safety of Linaclotide in Pediatric Participants With FC or IBS-C completed · register updated 2026-01-06 |
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New trials, approvals and enforcement actions. One email a week.