COMPARISON
Bremelanotide vs Linaclotide
5 attributes held for at least one of the two. 5 differ. Each value carries the register it came from and the date that register was read.
Answer
Bremelanotide is authorised or registered in 1 and Linaclotide in 5 of the 10 registers read. Bremelanotide: highest phase Phase 2. Linaclotide: highest phase Phase 3 (1 phase 3 trial, 0 with posted results). 0 registered trials include both.
States no view on which is preferable, safer or more effective. Not medical advice.
| Bremelanotide | Linaclotide | |
|---|---|---|
| Registered trials differs | 10 clinicaltrials.gov · 2026-10-03 | 62 clinicaltrials.gov · 2026-10-03 |
| FDA label differs | FDA-approved: Vyleesi openfda · 2026-10-03T17:23:44.062Z | FDA-approved: Linzess openfda · 2026-10-03T17:23:44.062Z |
| EU authorisation differs | Nothing on record ema read 2026-08-31 | Authorised ema · 2026-10-03 |
| EU authorised on differs | Not checked no record of "authorisedOn" for bremelanotide | 2012-11-26 ema · 2026-10-03 |
| ATC code differs | Not checked no record of "atcCode" for bremelanotide | A06AX04 ema · 2026-10-03 |
SIDE EFFECTS
Most common side effects, each beside its own placebo
| Side effect | Bremelanotide | placebo | Linaclotide | placebo |
|---|---|---|---|---|
| Nausea | 33.6% | 17.7% | - | - |
| Flushing | 17.9% | 9.4% | - | - |
| Headache | 10.7% | 6.5% | - | - |
| Sunburn | 6.8% | 11.3% | - | - |
| Upper respiratory tract infection | 5.8% | 5.8% | - | - |
| Injection site pain | 5.1% | 5.7% | - | - |
| Injection site reaction | 4.5% | 2.1% | - | - |
| Urinary tract infection | 4.3% | 4.2% | - | - |
| Vomiting | 4.1% | 2.2% | - | - |
| Nasopharyngitis | 3.3% | 3.4% | - | - |
| Diarrhea | - | - | 14.0% | 4.6% |
Trial register Bremelanotide: 4 placebo-controlled trials; Linaclotide: 14. 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. Bremelanotide side effects · Linaclotide side effects
LEGAL STATUS
Approval in each country read
| Country | Bremelanotide | Linaclotide | Register |
|---|---|---|---|
| United States | FDA-approved | FDA-approved | Regulator FDA |
| European Union | Not on the register | Authorised | Regulator EMA |
| United Kingdom | Not on the register | Authorised | Regulator MHRA |
| Canada | Not on the register | Authorised | Regulator Health Canada |
| Australia | Status unknown | Status unknown | TGA |
| Switzerland | Not on the register | 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.