Drug

Tolfenamic acid

As of the edition of 20 October 2026, Tolfenamic acid is a small molecule: marketed.

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

The drug

Status
Marketed
Kind
Small molecule
Brand name
Clotam
Approvals on record
5 in 5 regions
Holder of the most recent approval
Sandoz; 2 holders in all
Registered trials
1, 1 stopped early
Disease areas
Cancer; Digestive system; Hormones

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 11001
All trials1

Who ran its trials

CompanyRoleYears
Orlando HealthLead sponsor of trials2014 to now