Enzalutamide
Approved · FDA / EMAAlso known as Xtandi, Enzalutamida.
Recent clinical, regulatory, research and industry developments relating to this drug.
Indication expansion: ENZALUTAMIDE (NDA203415)
Indication expansion: ENZALUTAMIDE (NDA213674)
‘Not simply saving cost’: Inside Astellas CEO’s 5-year strategy to counter Xtandi’s patent cliff
‘Not simply saving cost’: Inside Astellas CEO’s 5-year strategy to counter Xtandi’s patent cliff
Label change: ENZALUTAMIDE (NDA203415)
Label change: ENZALUTAMIDE (NDA213674)
Profile
Canonical identifiers, marketed brand names and mechanism, resolved across RxNorm, ChEMBL and ATC.
Pharmacology & targets
Known molecular targets and mechanisms supported by curated pharmacology databases.
Regulatory timeline
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.
Indication: Enzalutamide Viatris is indicated:• as monotherapy or in combination with androgen deprivation therapy for the treatment of adult men with high-risk biochemical recurrent (BCR)… Show full indicationShow less
Enzalutamide Viatris is indicated:• as monotherapy or in combination with androgen deprivation therapy for the treatment of adult men with high-risk biochemical recurrent (BCR) non-metastatic hormone-sensitive prostate cancer (nmHSPC) who are unsuitable for salvage-radiotherapy (see section 5.1);• in combination with androgen deprivation therapy for the treatment of adult men with metastatic hormone-sensitive prostate cancer (mHSPC) (see section 5.1); • for the treatment of adult men with high-risk non-metastatic castration-resistant prostate cancer (CRPC) (see section 5.1);• for the treatment of adult men with metastatic CRPC who are asymptomatic or mildly symptomatic after failure of androgen deprivation therapy in whom chemotherapy is not yet clinically indicated (see section 5.1);• for the treatment of adult men with metastatic CRPC whose disease has progressed on or after docetaxel therapy.
Indication: Xtandi is indicated for: as monotherapy or in combination with androgen deprivation therapy for the treatment of adult men with high risk biochemical recurrent (BCR)… Show full indicationShow less
Xtandi is indicated for: as monotherapy or in combination with androgen deprivation therapy for the treatment of adult men with high risk biochemical recurrent (BCR) non-metastatic hormone sensitive prostate cancer (nmHSPC) who are unsuitable for salvage radiotherapy (see section 5.1). the treatment of adult men with metastatic hormone-sensitive prostate cancer (mHSPC) in combination with androgen deprivation therapy (see section 5.1). the treatment of adult men with high-risk non-metastatic castration-resistant prostate cancer (CRPC) (see section 5.1). the treatment of adult men with metastatic CRPC who are asymptomatic or mildly symptomatic after failure of androgen deprivation therapy in whom chemotherapy is not yet clinically indicated (see section 5.1). the treatment of adult men with metastatic CRPC whose disease has progressed on or after docetaxel therapy.
Data from the U.S. Food and Drug Administration (U.S. Food and Drug Administration), public domain (CC0).
Contains information from the European Medicines Agency (European Medicines Agency), © EMA, reused under CC BY 4.0.
Clinical trials
The current development programme across all trial phases — status mix, phase distribution and the late-stage studies shaping the evidence base.
Late-stage studies
Phase III+ trials still open or recently active — where late-stage evidence is being generated.
Recent completions
Trials that read out recently, adding to the completed evidence base.
Research activity
Key research shaping understanding of this drug, combining the latest publications with the most influential evidence.
Major research themes8
Journals, researchers & institutions
- The New England journal of medicine5
- The Lancet. Oncology2
- Annals of oncology : official journal of the European Society for Medical Oncology1
- Clinical cancer research : an official journal of the American Association for Cancer Research1
- European urology1
- International journal of radiation oncology, biology, physics1
- Fizazi K8
- Sternberg CN5
- Tombal B5
- Armstrong AJ4
- de Bono JS4
- Miller K4
- Saad F4
- Scher HI4
- Institut Gustave Roussy4
- Carolina Urologic Research Center2
- Dana-Farber Cancer Institute2
- Duke Cancer Institute Center for Prostate and Urologic Cancers2
- Memorial Sloan Kettering Cancer Center2
- Memorial Sloan-Kettering Cancer Center and Weill Cornell Medical College2
Related diseases
Regulator-approved indications and conditions co-mentioned with this drug across the research literature. Number shows shared papers.
Related drugs
Drugs sharing diseases, protein targets and literature with this one. Ranked by graph evidence (shared targets + diseases weighted above co-mentions).
Acts on the same molecular target as Enzalutamide, with 4 overlapping disease areas.
Studied across 5 of the same disease areas as Enzalutamide in the shared literature.
Studied across 4 of the same disease areas as Enzalutamide in the shared literature.
Studied across 3 of the same disease areas as Enzalutamide in the shared literature.
Studied across 2 of the same disease areas as Enzalutamide in the shared literature.
Studied across 2 of the same disease areas as Enzalutamide in the shared literature.
Studied across 2 of the same disease areas as Enzalutamide in the shared literature.
Studied across the same disease area as Enzalutamide in the shared literature.
- 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.