COMPARISON

Icatibant 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

Icatibant is authorised or registered in 10 and Linaclotide in 5 of the 10 registers read. Icatibant: highest phase Phase 3 (3 phase 3 trials, 0 with posted results). 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.

IcatibantLinaclotide
Registered trials
differs
37
clinicaltrials.gov · 2026-10-03
62
clinicaltrials.gov · 2026-10-03
FDA label
differs
FDA-approved: SAJAZIR
openfda · 2026-10-03T17:23:44.062Z
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
2008-07-11
ema · 2026-10-03
2012-11-26
ema · 2026-10-03
ATC code
differs
B06AC02
ema · 2026-10-03
A06AX04
ema · 2026-10-03

SIDE EFFECTS

Most common side effects, each beside its own placebo

Side effectIcatibantplaceboLinaclotideplacebo
Hereditary angioedema18.1%18.7%--
Headache10.1%6.7%--
Diarrhea--14.0%4.6%

Trial register Icatibant: 4 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. Icatibant side effects · Linaclotide side effects

LEGAL STATUS

Approval in each country read

CountryIcatibantLinaclotideRegister
United StatesFDA-approvedFDA-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

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