COMPARISON
Difelikefalin 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
Difelikefalin is authorised or registered in 7 and Setmelanotide in 5 of the 10 registers read. Difelikefalin: 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.
| Difelikefalin | Setmelanotide | |
|---|---|---|
| Registered trials differs | 25 clinicaltrials.gov · 2026-10-03 | 29 clinicaltrials.gov · 2026-10-03 |
| FDA label differs | FDA-approved: Korsuva 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 | 2022-04-25 ema · 2026-10-03 | 2021-07-16 ema · 2026-10-03 |
| ATC code differs | V03AX ema · 2026-10-03 | A08AA ema · 2026-10-03 |
SIDE EFFECTS
Most common side effects, each beside its own placebo
| Side effect | Difelikefalin | placebo | Setmelanotide | placebo |
|---|---|---|---|---|
| Diarrhoea | 5.6% | 3.7% | 12.0% | 10.7% |
| Hyperkalaemia | 17.7% | 17.3% | - | - |
| Dialysis hypotension | 13.8% | 10.3% | - | - |
| Hypotension | 13.8% | 9.5% | - | - |
| Muscle spasms | 12.5% | 10.7% | - | - |
| Upper respiratory tract infection | 9.5% | 10.3% | - | - |
| Dizziness | 9.5% | 5.8% | - | - |
| Constipation | 5.6% | 2.1% | - | - |
| Palpitations | 5.2% | 4.9% | - | - |
| Hypocalcaemia | 4.3% | 1.6% | - | - |
| 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% |
| Injection site reaction | - | - | 11.4% | 14.0% |
Trial register Difelikefalin: 1 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. Difelikefalin side effects · Setmelanotide side effects
LEGAL STATUS
Approval in each country read
| Country | Difelikefalin | 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 | Registered | Status unknown | Regulator 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 | Registered | 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.
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