COMPARISON
Linaclotide vs Setmelanotide
5 attributes held for at least one of the two. 4 differ. Each value carries the register it came from and the date that register was read.
Answer
Linaclotide is authorised or registered in 5 and Setmelanotide in 5 of the 10 registers read. Linaclotide: highest phase Phase 3 (1 phase 3 trial, 0 with posted results). Setmelanotide: highest phase Phase 4 (after approval). 0 registered trials include both.
States no view on which is preferable, safer or more effective. Not medical advice.
| Linaclotide | Setmelanotide | |
|---|---|---|
| Registered trials differs | 62 clinicaltrials.gov · 2026-10-03 | 29 clinicaltrials.gov · 2026-10-03 |
| FDA label differs | FDA-approved: Linzess openfda · 2026-10-03T17:23:44.062Z | FDA-approved: Imcivree openfda · 2026-10-03T17:23:44.062Z |
| EU authorisation | Authorised ema · 2026-10-03 | Authorised ema · 2026-10-03 |
| EU authorised on differs | 2012-11-26 ema · 2026-10-03 | 2021-07-16 ema · 2026-10-03 |
| ATC code differs | A06AX04 ema · 2026-10-03 | A08AA ema · 2026-10-03 |
SIDE EFFECTS
Most common side effects, each beside its own placebo
| Side effect | Linaclotide | placebo | Setmelanotide | placebo |
|---|---|---|---|---|
| Diarrhea | 14.0% | 4.6% | - | - |
| Skin hyperpigmentation | - | - | 36.9% | 7.7% |
| Nausea | - | - | 29.6% | 14.5% |
| Injection site erythema | - | - | 23.0% | 20.0% |
| Vomiting | - | - | 21.3% | 10.7% |
| Headache | - | - | 19.7% | 18.4% |
| Injection site pain | - | - | 16.7% | 21.2% |
| Injection site pruritus | - | - | 13.2% | 11.6% |
| Decreased appetite | - | - | 12.1% | 1.9% |
| Diarrhoea | - | - | 12.0% | 10.7% |
| Injection site reaction | - | - | 11.4% | 14.0% |
Trial register Linaclotide: 14 placebo-controlled trials; Setmelanotide: 6. Each peptide is compared with placebo in its own trials, not with the other: a dash means the event is not in that peptide's top list. Linaclotide side effects · Setmelanotide side effects
LEGAL STATUS
Approval in each country read
| Country | Linaclotide | Setmelanotide | Register |
|---|---|---|---|
| United States | FDA-approved | FDA-approved | Regulator FDA |
| European Union | Authorised | Authorised | Regulator EMA |
| United Kingdom | Authorised | Authorised | Regulator MHRA |
| Canada | Authorised | Authorised | Regulator Health Canada |
| Australia | Status unknown | Status unknown | TGA |
| Switzerland | Authorised | Authorised | Regulator Swissmedic |
| Brazil | Not on the register | Not on the register | Regulator ANVISA |
| Serbia | Not on the register | Not on the register | Regulator ALIMS |
| Singapore | Not on the register | Not on the register | Regulator HSA |
| Turkey | Not on the register | Not on the register | Regulator TITCK |
Values reproduce public registers on the dates shown. This comparison states no view on which compound is preferable, safer or more effective. Not medical, legal or regulatory advice.
WEEKLY
Register Watch, weekly
New trials, approvals and enforcement actions. One email a week.