Drug

Cyproterone acetate

As of the edition of 20 October 2026, Cyproterone acetate is a small molecule: marketed, first approved in 1974 (ES); acts on AR and PGR.

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

The drug

Status
Marketed; latest approval 1987
Kind
Small molecule
Brand name
Androcur
First approved
1 November 1974 (ES)
Approvals on record
3 in 2 regions
Holder of the most recent approval
Bayer; 3 holders in all
Registered trials
21, 1 stopped early
Disease areas
Cancer; Urinary and reproductive; Hormones; Pregnancy and women's health; Mental health; Skin and connective tissue

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

1 company-target row on route B because of this drug.

Companies on route B for this drug

In the product

1 company-target row is on route B because of Cyproterone acetate.

Targets

GeneProteinUniProt
PGRProgesterone receptorP06401
ARAndrogen receptorP10275

Registered trials

PhaseTrialsCompletedActiveStopped early
Phase not stated10811
Phase 21100
Phase 35310
Phase 45300
All trials21

Who has held its approvals

CompanyRoleYears
AmdipharmApplicant1987 to now
BayerLater holder and Lead sponsor of trials1997 to now