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Drugs in development · updated 30 October 2026

Darolutamide: clinical trials and development status

Other names and codes: Nubeqa, ODM-201, BAY1841788

NLM verified identityApproved in the US (FDA)Authorised in the EU (EMA) since 27 March 2020

As of 30 October 2026 Darolutamide is in 62 active clinical trials (recruiting or ongoing, phases I–III) for 15 diseases. The most advanced phase is III.

62Active trials
IIIMost advanced phase
15Diseases studied

Summary updated every week · data as of 30 October 2026. In Phuturdex you can follow Darolutamide and get an email at every change or safety alert.

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Diseases studied

For each disease: the drug’s most advanced phase and active trials, with the reference trial on ClinicalTrials.gov.

DiseaseMost advanced phaseActive trialsReference trial
Prostatic NeoplasmsIII42NCT07611110
AdenocarcinomaIII3NCT06592924
Castration-resistant prostatic neoplasmIII3NCT06276465
NeoplasmIII2NCT04464226
Male urogenital diseaseI–II2NCT06190899
Prostatic DiseasesI–II2NCT06190899
Bulbo-Spinal Atrophy, X-LinkedI–II1NCT07190300
Genital Diseases, MaleI–II1NCT06190899
Intraductal carcinoma of the breastII1NCT04176081
Ovarian granulosa cell tumorII1NCT06169124
Salivary gland neoplasmII1NCT05669664
Triple-negative breast neoplasmII1NCT07016399
MetastasisI1NCT07103018
Urogenital DiseasesI1NCT07103018
Urogenital neoplasmI1NCT07103018

Everything on Darolutamide

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Source: Phuturdex analysis of ClinicalTrials.gov (U.S. National Library of Medicine), FDA and EMA data, updated 30 October 2026. Active trials = recruiting or ongoing, phases I–III. Diseases are those named by each trial (NLM MeSH terms). The estimated launch, when shown, is a Phuturdex calculation described on the Method page, not official data.

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