COMPARISON

Afamelanotide vs Bremelanotide

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

Afamelanotide is authorised or registered in 5 and Bremelanotide in 1 of the 10 registers read. Afamelanotide: highest phase Phase 2. Bremelanotide: highest phase Phase 2. 0 registered trials include both.

States no view on which is preferable, safer or more effective. Not medical advice.

AfamelanotideBremelanotide
Registered trials
differs
28
clinicaltrials.gov · 2026-10-03
10
clinicaltrials.gov · 2026-10-03
FDA label
differs
FDA-approved: SCENESSE
openfda · 2026-10-03T17:23:44.062Z
FDA-approved: Vyleesi
openfda · 2026-10-03T17:23:44.062Z
EU authorisation
differs
Authorised
ema · 2026-10-03
Nothing on record
ema read 2026-08-31
EU authorised on
differs
2014-12-22
ema · 2026-10-03
Not checked
no record of "authorisedOn" for bremelanotide
ATC code
differs
D02BB02
ema · 2026-10-03
Not checked
no record of "atcCode" for bremelanotide

SIDE EFFECTS

Most common side effects, each beside its own placebo

Side effectAfamelanotideplaceboBremelanotideplacebo
Headache33.8%31.1%10.7%6.5%
Nausea25.3%14.6%33.6%17.7%
Nasopharyngitis16.0%15.3%3.3%3.4%
Dizziness10.1%3.7%--
Diarrhoea10.1%11.0%--
Influenza10.1%7.6%--
Back pain10.1%8.0%--
Fatigue9.6%6.6%--
Pyrexia7.2%3.6%--
Migraine6.8%7.6%--
Flushing--17.9%9.4%
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%

Trial register Afamelanotide: 4 placebo-controlled trials; Bremelanotide: 4. 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. Afamelanotide side effects · Bremelanotide side effects

LEGAL STATUS

Approval in each country read

CountryAfamelanotideBremelanotideRegister
United StatesFDA-approvedFDA-approvedRegulator FDA
European UnionAuthorisedNot on the registerRegulator EMA
United KingdomAuthorisedNot on the registerRegulator MHRA
CanadaAuthorisedNot on the registerRegulator Health Canada
AustraliaRegisteredStatus unknownRegulator TGA
SwitzerlandNot on the registerNot on the registerRegulator Swissmedic
BrazilNot on the registerNot on the registerRegulator ANVISA
SerbiaNot on the registerNot on the registerRegulator ALIMS
SingaporeNot on the registerNot on the registerRegulator HSA
TurkeyNot on the registerNot on the registerRegulator 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.