COMPARISON
Afamelanotide vs Difelikefalin
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
Afamelanotide is authorised or registered in 5 and Difelikefalin in 7 of the 10 registers read. Afamelanotide: highest phase Phase 2. Difelikefalin: 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.
| Afamelanotide | Difelikefalin | |
|---|---|---|
| Registered trials differs | 28 clinicaltrials.gov · 2026-10-03 | 25 clinicaltrials.gov · 2026-10-03 |
| FDA label differs | FDA-approved: SCENESSE openfda · 2026-10-03T17:23:44.062Z | FDA-approved: Korsuva openfda · 2026-10-03T17:23:44.062Z |
| EU authorisation | Authorised ema · 2026-10-03 | Authorised ema · 2026-10-03 |
| EU authorised on differs | 2014-12-22 ema · 2026-10-03 | 2022-04-25 ema · 2026-10-03 |
| ATC code differs | D02BB02 ema · 2026-10-03 | V03AX ema · 2026-10-03 |
SIDE EFFECTS
Most common side effects, each beside its own placebo
| Side effect | Afamelanotide | placebo | Difelikefalin | placebo |
|---|---|---|---|---|
| Dizziness | 10.1% | 3.7% | 9.5% | 5.8% |
| Diarrhoea | 10.1% | 11.0% | 5.6% | 3.7% |
| Headache | 33.8% | 31.1% | - | - |
| Nausea | 25.3% | 14.6% | - | - |
| Nasopharyngitis | 16.0% | 15.3% | - | - |
| Influenza | 10.1% | 7.6% | - | - |
| Back pain | 10.1% | 8.0% | - | - |
| Fatigue | 9.6% | 6.6% | - | - |
| Pyrexia | 7.2% | 3.6% | - | - |
| Migraine | 6.8% | 7.6% | - | - |
| 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% |
| Constipation | - | - | 5.6% | 2.1% |
| Palpitations | - | - | 5.2% | 4.9% |
| Hypocalcaemia | - | - | 4.3% | 1.6% |
Trial register Afamelanotide: 4 placebo-controlled trials; Difelikefalin: 1. 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 · Difelikefalin side effects
LEGAL STATUS
Approval in each country read
| Country | Afamelanotide | Difelikefalin | 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 | Registered | Regulator 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 | Registered | 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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