Drug

Racecadotril

As of the edition of 20 October 2026, Racecadotril is a small molecule: marketed, first approved in 1992 (FR); acts on MME.

Sources: FDA Orange Book and Purple Book, other approval registers, ClinicalTrials.gov, ChEMBL.

The drug

Status
Marketed; latest approval 2005
Kind
Small molecule
Brand name
Tiorfan
First approved
10 July 1992 (FR)
Approvals on record
3 in 3 regions
Holder of the most recent approval
LABORATÓRIOS BAGÓ DO BRASIL S/A; 3 holders in all
Registered trials
11, 0 stopped early
Disease areas
Digestive system; Infections; Lungs and airways

US protection

No US approval on record.

With no US approval on record there are no listed US patents or exclusivities.

This is the US only.

Target

GeneProteinUniProt
MMENeprilysinP08473

Registered trials

PhaseTrialsCompletedActiveStopped early
Phase not stated3110
Phase 15400
Phase 22110
Phase 31100
All trials11