Drug

Procarbazine

As of the edition of 20 October 2026, Procarbazine is a small molecule: marketed, first approved in 1965 (ES).

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

The drug

Status
Marketed; latest approval 1995
Kind
Small molecule
Brand name
Matulane
First approved
1 December 1965 (ES)
Approvals on record
4 in 4 regions
Holder of the most recent approval
LEADIANT BIOSCIENCES IRELAND (IRLANDE); 3 holders in all
Registered trials
60, 6 stopped early
Disease areas
Cancer; Immune system; Blood and lymph; Nervous system; Chemically induced; 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.

Registered trials

PhaseTrialsCompletedActiveStopped early
Phase not stated6200
Phase 13111
Phase 2332214
Phase 3181241
All trials60

Who has held its approvals

CompanyRoleYears
Leadiant BiosciencesApplicant1970 to now
RocheApplicant