COMPARISON

Ciclosporin 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

Ciclosporin is authorised or registered in 9 and Difelikefalin in 7 of the 10 registers read. Ciclosporin: highest phase Phase 4 (after approval). 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.

CiclosporinDifelikefalin
Registered trials
differs
1328
clinicaltrials.gov · 2026-10-03
25
clinicaltrials.gov · 2026-10-03
FDA label
differs
FDA label, application not recorded: VEVYE
openfda · 2026-08-31T07:37:14Z
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
2015-03-19
ema · 2026-10-03
2022-04-25
ema · 2026-10-03
ATC code
differs
S01XA18
ema · 2026-10-03
V03AX
ema · 2026-10-03

SIDE EFFECTS

Most common side effects, each beside its own placebo

Side effectCiclosporinplaceboDifelikefalinplacebo
Punctate Keratitis5.8%4.5%--
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%

Trial register Ciclosporin: 7 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. Ciclosporin side effects · Difelikefalin side effects

LEGAL STATUS

Approval in each country read

CountryCiclosporinDifelikefalinRegister
United StatesFDA label, application not recordedFDA-approvedRegulator FDA
European UnionAuthorisedAuthorisedRegulator EMA
United KingdomAuthorisedAuthorisedRegulator MHRA
CanadaAuthorisedAuthorisedRegulator Health Canada
AustraliaRegisteredRegisteredRegulator TGA
SwitzerlandAuthorisedAuthorisedRegulator Swissmedic
BrazilRegistadoNot on the registerRegulator ANVISA
SerbiaAuthorisedNot on the registerRegulator ALIMS
SingaporeRegisteredRegisteredRegulator HSA
TurkeyRuhsatliNot on the registerRegulator 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

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New trials, approvals and enforcement actions. One email a week.