COMPARISON
Setmelanotide vs TB-500
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
Setmelanotide is authorised or registered in 5 and TB-500 in 0 of the 10 registers read. Setmelanotide: highest phase Phase 4 (after approval). TB-500: highest phase Phase 2. 0 registered trials include both.
States no view on which is preferable, safer or more effective. Not medical advice.
| Setmelanotide | TB-500 | |
|---|---|---|
| Registered trials differs | 29 clinicaltrials.gov · 2026-10-03 | 1 clinicaltrials.gov · 2026-10-03 |
| FDA label differs | FDA-approved: Imcivree openfda · 2026-10-03T17:23:44.062Z | Not checked no record of "fdaLabel" for tb-500 |
| EU authorisation differs | Authorised ema · 2026-10-03 | Nothing on record ema read 2026-08-31 |
| EU authorised on differs | 2021-07-16 ema · 2026-10-03 | Not checked no record of "authorisedOn" for tb-500 |
| ATC code differs | A08AA ema · 2026-10-03 | Not checked no record of "atcCode" for tb-500 |
SIDE EFFECTS
Most common side effects, each beside its own placebo
| Side effect | Setmelanotide | placebo | TB-500 | placebo |
|---|---|---|---|---|
| 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 Setmelanotide: 6 placebo-controlled trials; TB-500: 0. 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. Setmelanotide side effects · TB-500 side effects
LEGAL STATUS
Approval in each country read
| Country | Setmelanotide | TB-500 | Register |
|---|---|---|---|
| United States | FDA-approved | Not on the register | Regulator FDA |
| European Union | Authorised | Not on the register | Regulator EMA |
| United Kingdom | Authorised | Not on the register | Regulator MHRA |
| Canada | Authorised | Not on the register | Regulator Health Canada |
| Australia | Status unknown | Status unknown | TGA |
| Switzerland | Authorised | Not on the register | 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.