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Drug

Cyproterone Acetate

Regulatory activity · MHRA
ClassGlucocorticoid receptor antagonistEmerging researchLate-stage development

Also known as Cyproterone 17-O-acetate.

RxNorm22054ChEMBLCHEMBL139835ATCG03HA01UNII4KM2BN5JHF
1
Research papers
3
Protein targets
1
Regulatory events
Latest activity
beta

Recent clinical, regulatory, research and industry developments relating to this drug.

Comparing the Effects of Sublingual Estradiol Treatment Versus Oral Estradiol With Cyproterone Acetate (CPA) Treatment on The Coagulation System in Transgender Women: A Prospective, Controlled Cohort Study

Clinical trial2024-11-10Completed · ClinicalTrials.gov

Effects of Sex Steroid Hormones on Serotonin Synthesis and Degradation Measured With PET

Clinical trial2020-12-01Primary completion · ClinicalTrials.gov

The Effect of Short Term Use of Finasteride Versus Cyproterone Acetate on Perioperative Blood Loss With Mono Polar Transurethral Resection of Prostate

Clinical trial2020-07-09Completed · ClinicalTrials.gov

Drug Safety Update: Cyproterone acetate: new advice to minimise risk of meningioma

Regulatory2020-06-29MHRA

Effect of Decreasing Iron Tissue Depots on the Cardiovascular Risk of Women With Polycystic Ovary Syndrome

Clinical trial2020-06-01Completed · ClinicalTrials.gov

The Influence of Sex Steroid Hormones on Serotonin Transporter Binding in the Human Brain Investigated by Positron Emission Tomography

Clinical trial2014-01-01Completed · ClinicalTrials.gov

Intermittent Hormone Therapy for Newly Diagnosed Metastatic Prostate Cancer

Clinical trial2013-08-26Status unknown · ClinicalTrials.gov

A Phase III Randomized Trial Comparing Intermittent Versus Continuous Androgen Suppression for Patients With Prostate-Specific-Antigen Progression in the Clinical Absence of Distant Metastases Following Radiotherapy for Prostate Cancer

Clinical trial2013-01-10Completed · ClinicalTrials.gov

Phase III Randomized Comparison of Pelvic Radiotherapy Alone vs Pelvic Radiotherapy Plus the LHRH Analogue Goserelin and Cyproterone Acetate in Carcinoma of the Prostate at High Risk for Metastasis

Clinical trial2012-07-11Completed · ClinicalTrials.gov

Comparative Controlled Clinical Trial of Two Pharmacological Treatments of Pedophilia

Clinical trial2009-06-01Terminated · ClinicalTrials.gov

Efficacy and Tolerance of Cyproterone Acetate Versus Medroxyprogesterone Acetate Versus Venlafaxine LP in the Treatment of Hot Flushes Caused by Leuprorelin 11.25 mg in Patients Treated for a Prostate Adenocarcinoma

Clinical trial2007-12-01Completed · ClinicalTrials.gov

Improved survival in patients with locally advanced prostate cancer treated with radiotherapy and goserelin.

Research1997-07-01The New England journal of medicine

Profile

Identifiers & mechanism

Canonical identifiers, marketed brand names and mechanism, resolved across RxNorm, ChEMBL and ATC.

Canonical name
Cyproterone Acetate
Aliases & brands
Cyproterone 17-O-acetate
RxNorm CUI
22054
ChEMBL ID
CHEMBL139835
ATC codes
G03HA01
UNII
4KM2BN5JHF
Primary mechanism
Glucocorticoid receptor antagonist
Regulatory jurisdictions
mhra

Pharmacology & targets

3 targets

Known molecular targets and mechanisms supported by curated pharmacology databases.

Glucocorticoid receptor
NR3C1 · P04150
ANTAGONISTGlucocorticoid receptor antagonist
Progesterone receptor
PGR · P06401
AGONISTProgesterone receptor agonist
Androgen receptor
AR · P10275
ANTAGONISTAndrogen Receptor antagonist

Regulatory timeline

1 event

The complete regulatory record, grouped by authority — approvals, safety advisories and label changes. Each authority shows its most recent events; expand one to read its full history.

Authorities
MHRA
Total events
1
mhraMedicines and Healthcare products Regulatory Agency· 1 event
2020-06-29Safety communicationSafety
Drug Safety Update: Cyproterone acetate: new advice to minimise risk of meningioma
Evidence ↗

Contains public sector information from the Medicines and Healthcare products Regulatory Agency (MHRA) licensed under the Open Government Licence (OGL v3).

Clinical trials

11 trials

The current development programme across all trial phases — status mix, phase distribution and the late-stage studies shaping the evidence base.

Development programme
CLINICALTRIALS.GOV · LIVE REGISTRY
11
registered trials across all phases
LATEST COMPLETION 2024
10
Late-stage (III+)
8
Completed
3
Discontinued
PHASE DISTRIBUTIONn = 11
Early Phase 11Phase 36Phase 42Phase N / A2

Late-stage studies

Phase III+ trials still open or recently active — where late-stage evidence is being generated.

Effects of Sex Steroid Hormones on Serotonin Synthesis and Degradation Measured With PET

Unknown statusPH IVMedical University of Viennan=922020

The Influence of Sex Steroid Hormones on Serotonin Transporter Binding in the Human Brain Investigated by Positron Emission Tomography

CompletedPH IVMedical University of Viennan=322014

Intermittent Hormone Therapy for Newly Diagnosed Metastatic Prostate Cancer

Unknown statusPH IIISt. Bartholomew's Hospitaln=9002013

A Phase III Randomized Trial Comparing Intermittent Versus Continuous Androgen Suppression for Patients With Prostate-Specific-Antigen Progression in the Clinical Absence of Distant Metastases Following Radiotherapy for Prostate Cancer

CompletedPH IIIKey trialNCIC Clinical Trials Groupn=1,3862013

Comparative Controlled Clinical Trial of Two Pharmacological Treatments of Pedophilia

TerminatedPH IIIInstitut National de la Santé Et de la Recherche Médicale, Francen=482009

Recent completions

Trials that read out recently, adding to the completed evidence base.

Comparing the Effects of Sublingual Estradiol Treatment Versus Oral Estradiol With Cyproterone Acetate (CPA) Treatment on The Coagulation System in Transgender Women: A Prospective, Controlled Cohort Study

CompletedN/ATel-Aviv Sourasky Medical Centern=302024

The Effect of Short Term Use of Finasteride Versus Cyproterone Acetate on Perioperative Blood Loss With Mono Polar Transurethral Resection of Prostate

CompletedPH IBenha Universityn=602020

Effect of Decreasing Iron Tissue Depots on the Cardiovascular Risk of Women With Polycystic Ovary Syndrome

CompletedN/AManuel Luque Ramírezn=372020

The Influence of Sex Steroid Hormones on Serotonin Transporter Binding in the Human Brain Investigated by Positron Emission Tomography

CompletedPH IVMedical University of Viennan=322014

A Phase III Randomized Trial Comparing Intermittent Versus Continuous Androgen Suppression for Patients With Prostate-Specific-Antigen Progression in the Clinical Absence of Distant Metastases Following Radiotherapy for Prostate Cancer

CompletedPH IIIKey trialNCIC Clinical Trials Groupn=1,3862013

Efficacy and Tolerance of Cyproterone Acetate Versus Medroxyprogesterone Acetate Versus Venlafaxine LP in the Treatment of Hot Flushes Caused by Leuprorelin 11.25 mg in Patients Treated for a Prostate Adenocarcinoma

CompletedPH IIITakedan=3112007

Research activity

1 papers

Key research shaping understanding of this drug, combining the latest publications with the most influential evidence.

Most influential

Improved survival in patients with locally advanced prostate cancer treated with radiotherapy and goserelin.

The New England journal of medicine · 1997 · 1,029 cites
Journals, researchers & institutions
Top journals
  • The New England journal of medicine1
Leading researchers
  • Bernier J1
  • Bolla M1
  • Collette L1
  • Dubois JB1
  • Gil T1
  • Gonzalez D1
  • Kuten A1
  • Mirimanoff RO1
Leading institutions
free-text, unnormalised
  • University Hospital1
References & data sources
  • RxNorm (U.S. National Library of Medicine) — drug identity
  • ChEMBL (EMBL-EBI) & UniProt — pharmacology and targets
  • Europe PMC — research literature
  • ClinicalTrials.gov — clinical trials
  • Regulatory event sources are credited in the Regulatory Timeline above.