COMPARISON
Setmelanotide vs Zilucoplan
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
Setmelanotide is authorised or registered in 5 and Zilucoplan in 7 of the 10 registers read. Setmelanotide: highest phase Phase 4 (after approval). Zilucoplan: highest phase Phase 3 (4 phase 3 trials, 0 with posted results). 0 registered trials include both.
States no view on which is preferable, safer or more effective. Not medical advice.
| Setmelanotide | Zilucoplan | |
|---|---|---|
| Registered trials differs | 29 clinicaltrials.gov · 2026-10-03 | 24 clinicaltrials.gov · 2026-10-03 |
| FDA label differs | FDA-approved: Imcivree openfda · 2026-10-03T17:23:44.062Z | FDA-approved: ZILBRYSQ openfda · 2026-10-03T17:23:44.062Z |
| EU authorisation | Authorised ema · 2026-10-03 | Authorised ema · 2026-10-03 |
| EU authorised on differs | 2021-07-16 ema · 2026-10-03 | 2023-12-01 ema · 2026-10-03 |
| ATC code differs | A08AA ema · 2026-10-03 | L04AJ06 ema · 2026-10-03 |
SIDE EFFECTS
Most common side effects, each beside its own placebo
| Side effect | Setmelanotide | placebo | Zilucoplan | placebo |
|---|---|---|---|---|
| Nausea | 29.6% | 14.5% | 6.0% | 3.6% |
| Headache | 19.7% | 18.4% | 9.6% | 6.8% |
| Injection site pain | 16.7% | 21.2% | 12.5% | 3.9% |
| Diarrhoea | 12.0% | 10.7% | 8.2% | 3.9% |
| Skin hyperpigmentation | 36.9% | 7.7% | - | - |
| Injection site erythema | 23.0% | 20.0% | - | - |
| Vomiting | 21.3% | 10.7% | - | - |
| Injection site pruritus | 13.2% | 11.6% | - | - |
| Decreased appetite | 12.1% | 1.9% | - | - |
| Injection site reaction | 11.4% | 14.0% | - | - |
| Injection site bruising | - | - | 17.3% | 10.9% |
| Constipation | - | - | 13.4% | 5.9% |
| Hypertension | - | - | 6.9% | 4.1% |
| Contusion | - | - | 6.7% | 3.9% |
| Dysphagia | - | - | 5.5% | 2.3% |
| Anaemia | - | - | 5.5% | 1.5% |
Trial register Setmelanotide: 6 placebo-controlled trials; Zilucoplan: 3. 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 · Zilucoplan side effects
LEGAL STATUS
Approval in each country read
| Country | Setmelanotide | Zilucoplan | 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 | Registered | 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 | Ruhsatli | 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.
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