Drug

Oteracil

As of the edition of 20 October 2026, Oteracil is a small molecule: marketed, first approved in 1999 (JP); acts on UMPS.

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

The drug

Status
Marketed; latest approval 2011
Kind
Small molecule
Brand name
Teysuno
First approved
1 March 1999 (JP)
Approvals on record
2 in 2 regions
Holder of the most recent approval
Nordic; 2 holders in all
Registered trials
53, 5 stopped early
Disease areas
Cancer; Digestive system; Skin and connective tissue; Hormones; Mouth and teeth; Chemically induced

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 Oteracil.

Target

GeneProteinUniProt
UMPSUridine 5'-monophosphate synthaseP11172

Registered trials

PhaseTrialsCompletedActiveStopped early
Phase 12100
Phase 232393
Phase 319752
All trials53

Who has held its approvals

CompanyRoleYears
TaihoOriginator and Lead sponsor of trials1999 to now
NordicApplicant2011 to now