Drug

Darifenacin

As of the edition of 20 October 2026, Darifenacin is a small molecule: marketed, first approved in 2004 (EU); acts on CHRM3.

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

The drug

Status
Marketed; latest approval 2004
Kind
Small molecule
Brand name
Enablex
First approved
22 October 2004 (EU)
Approvals on record
3 in 2 regions
Holder of the most recent approval
AbbVie; 2 holders in all
Registered trials
22, 3 stopped early
Disease areas
Pregnancy and women's health; Urinary and reproductive; Nervous system; Immune system; Inherited and neonatal; Injuries

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.

Companies that need a new molecule because of this drug

2 companies on route B because of this drug.

Companies on route B for this drug

In the product

2 companies are on route B because of Darifenacin.

Target

GeneProteinUniProt
CHRM3Muscarinic acetylcholine receptor M3P20309

Registered trials

PhaseTrialsCompletedActiveStopped early
Phase not stated5500
Phase 14200
Phase 25212
Phase 33300
Phase 45401
All trials22

Who has held its approvals

CompanyRoleYears
NovartisApplicant and Lead sponsor of trials2002 to now
pharmaandApplicant2004 to now
AbbVieAcquired holder2023 to now