Drug

Trimethoprim

As of the edition of 20 October 2026, Trimethoprim is a small molecule: marketed, first approved in 1968 (ES).

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

The drug

Status
Marketed; latest approval 1982
Kind
Small molecule
Brand name
Bactrim
First approved
1 February 1968 (ES)
Approvals on record
36 in 5 regions
Holder of the most recent approval
ABLE LABORATORIES INC; 17 holders in all
Registered trials
105, 13 stopped early
Disease areas
Infections; Urinary and reproductive; Immune system; Lungs and airways; Pregnancy and women's health; Cancer

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 stated191124
Phase 110720
Phase 2281565
Phase 3251653
Phase 4231281
All trials105

Who has held its approvals

CompanyRoleYears
TevaLater holder1982 to now
PfizerAcquired holder and Lead sponsor of trials2003 to now
RocheLater holder and Lead sponsor of trials2016 to now
Dr. Reddy'sAcquired holder2023 to now
Pangea PharmaceuticalsAcquired holder2024 to now
GSKEarlier holder
ShionogiApplicant