COMPARISON

Ciclosporin vs Linaclotide

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 Linaclotide in 5 of the 10 registers read. Ciclosporin: highest phase Phase 4 (after approval). Linaclotide: 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.

CiclosporinLinaclotide
Registered trials
differs
1328
clinicaltrials.gov · 2026-10-03
62
clinicaltrials.gov · 2026-10-03
FDA label
differs
FDA label, application not recorded: VEVYE
openfda · 2026-08-31T07:37:14Z
FDA-approved: Linzess
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
2012-11-26
ema · 2026-10-03
ATC code
differs
S01XA18
ema · 2026-10-03
A06AX04
ema · 2026-10-03

SIDE EFFECTS

Most common side effects, each beside its own placebo

Side effectCiclosporinplaceboLinaclotideplacebo
Punctate Keratitis5.8%4.5%--
Diarrhea--14.0%4.6%

Trial register Ciclosporin: 7 placebo-controlled trials; Linaclotide: 14. 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 · Linaclotide side effects

LEGAL STATUS

Approval in each country read

CountryCiclosporinLinaclotideRegister
United StatesFDA label, application not recordedFDA-approvedRegulator FDA
European UnionAuthorisedAuthorisedRegulator EMA
United KingdomAuthorisedAuthorisedRegulator MHRA
CanadaAuthorisedAuthorisedRegulator Health Canada
AustraliaRegisteredStatus unknownRegulator TGA
SwitzerlandAuthorisedAuthorisedRegulator Swissmedic
BrazilRegistadoNot on the registerRegulator ANVISA
SerbiaAuthorisedNot on the registerRegulator ALIMS
SingaporeRegisteredNot on the registerRegulator 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

Register Watch, weekly

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