Drug

Tinidazole

As of the edition of 20 October 2026, Tinidazole is a small molecule: marketed, first approved in 1974 (ES).

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
Tindamax
First approved
1 September 1974 (ES)
Approvals on record
5 in 3 regions
Holder of the most recent approval
MISSION PHARMA; 4 holders in all
Registered trials
18, 1 stopped early
Disease areas
Infections; Urinary and reproductive; Pregnancy and women's health; Digestive system; Cancer; Inherited and neonatal

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.

Registered trials

PhaseTrialsCompletedActiveStopped early
Phase not stated4010
Phase 24211
Phase 35400
Phase 45300
All trials18

Who has held its approvals

CompanyRoleYears
Mission PharmacalAcquired holder and Lead sponsor of trials2005 to now