Drug

Solifenacin

As of the edition of 20 October 2026, Solifenacin is a small molecule: marketed, first approved in 2004 (ES); acts on CHRM2 and CHRM3.

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

The drug

Status
Marketed; latest approval 2006
Kind
Small molecule
Brand name
Vesicare
First approved
30 July 2004 (ES)
Approvals on record
7 in 4 regions
Holder of the most recent approval
Astellas; 2 holders in all
Registered trials
105, 7 stopped early
Disease areas
Urinary and reproductive; Pregnancy and women's health; Nervous system; Inherited and neonatal; Cancer; Infections

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 company-target rows on route B because of this drug.

Companies on route B for this drug

In the product

2 company-target rows are on route B because of Solifenacin.

Targets

GeneProteinUniProt
CHRM2Muscarinic acetylcholine receptor M2P08172
CHRM3Muscarinic acetylcholine receptor M3P20309

Registered trials

PhaseTrialsCompletedActiveStopped early
Phase not stated241722
Phase 1141400
Phase 27420
Phase 3211621
Phase 4392844
All trials105

Who has held its approvals

CompanyRoleYears
AstellasApplicant and Lead sponsor of trials2003 to now