COMPARISON
Difelikefalin vs Icatibant
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 Icatibant in 10 of the 10 registers read. Difelikefalin: highest phase Phase 3 (1 phase 3 trial, 0 with posted results). Icatibant: highest phase Phase 3 (3 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.
| Difelikefalin | Icatibant | |
|---|---|---|
| Registered trials differs | 25 clinicaltrials.gov · 2026-10-03 | 37 clinicaltrials.gov · 2026-10-03 |
| FDA label differs | FDA-approved: Korsuva openfda · 2026-10-03T17:23:44.062Z | FDA-approved: SAJAZIR 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 | 2008-07-11 ema · 2026-10-03 |
| ATC code differs | V03AX ema · 2026-10-03 | B06AC02 ema · 2026-10-03 |
SIDE EFFECTS
Most common side effects, each beside its own placebo
| Side effect | Difelikefalin | placebo | Icatibant | placebo |
|---|---|---|---|---|
| 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% | - | - |
| Diarrhoea | 5.6% | 3.7% | - | - |
| Constipation | 5.6% | 2.1% | - | - |
| Palpitations | 5.2% | 4.9% | - | - |
| Hypocalcaemia | 4.3% | 1.6% | - | - |
| Hereditary angioedema | - | - | 18.1% | 18.7% |
| Headache | - | - | 10.1% | 6.7% |
Trial register Difelikefalin: 1 placebo-controlled trials; Icatibant: 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. Difelikefalin side effects · Icatibant side effects
LEGAL STATUS
Approval in each country read
| Country | Difelikefalin | Icatibant | 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 | Authorised | Authorised | Regulator Swissmedic |
| Brazil | Not on the register | Registado | Regulator ANVISA |
| Serbia | Not on the register | Authorised | Regulator ALIMS |
| Singapore | Registered | Registered | 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.
WEEKLY
Register Watch, weekly
New trials, approvals and enforcement actions. One email a week.