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Drug

Darolutamide

Approved medicine
ClassAndrogen Receptor antagonistResearchActive indication expansion

Also known as Nubeqa.

RxNorm2180325ChEMBLCHEMBL4297185ATCL02BB06UNIIX05U0N2RCO
2
Research papers
50
Active clinical trials
Androgen receptor
Primary target
7
Regulatory events
Latest activity
beta

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

Darolutamide Ups Metastasis-Free Survival in Prostate Cancer

Industry2026-10-28Medscape Medical News

ESMO26: Bayer’s Phase III Nubeqa win leaves survival and abiraterone questions open

Clinical trial2026-10-25Trial news · Pharmaceutical Technology

ESMO26: Bayer's Nubeqa finds new prostate cancer role

Industry2026-10-25pharmaphorum

#ESMO26: AstraZeneca eyes Keytruda's Padcev spot; Lilly's ADC takes on Elahere; Nubeqa targets earlier prostate cancer

Industry2026-10-24Endpoints News

A Phase 1b Study of JNJ-78278343, Targeting Human Kallikrein 2 (KLK2) in Combination With Other Agents for Metastatic Prostate Cancer

Clinical trial2026-09-25Results expected Q3 2027 · ClinicalTrials.gov

Label change: DAROLUTAMIDE (NDA212099)

Regulatory2026-09-22FDA

Open-label Study of Androgen Receptor Inhibition With dArolutamide Plus Androgen Deprivation Therapy (ADT) Versus ADT in Men With Metastatic Hormone-Sensitive Prostate Cancer Using an External Control Arm

Clinical trial2026-09-15Results posted · ClinicalTrials.gov

Open-label Study of Androgen Receptor Inhibition With dArolutamide Plus Androgen Deprivation Therapy (ADT) Versus ADT in Men With Metastatic Hormone-Sensitive Prostate Cancer Using an External Control Arm

Clinical trial2026-09-15Status changed to Completed · ClinicalTrials.gov

A Randomized Phase II Trial of Docetaxel or Cabazitaxel With or Without Darolutamide in Men With Metastatic Castration-resistant Prostate Cancer

Clinical trial2026-09-10Results expected Q2 2027 · ClinicalTrials.gov

Indication expansion: DAROLUTAMIDE (NDA212099)

Regulatory2025-06-03FDA

Darolutamide in Combination With Androgen-Deprivation Therapy in Patients With Metastatic Hormone-Sensitive Prostate Cancer From the Phase III ARANOTE Trial.

Research2024-09-16Journal of clinical oncology : official journal of the American Society of Clinical Oncology

Label change: DAROLUTAMIDE (NDA212099)

Regulatory2023-10-13FDA

Profile

Identifiers & mechanism

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

Canonical name
Darolutamide
Aliases & brands
Nubeqa
RxNorm CUI
2180325
ChEMBL ID
CHEMBL4297185
ATC codes
L02BB06
UNII
X05U0N2RCO
Primary mechanism
Androgen Receptor antagonist
Regulatory jurisdictions
fdaema

Pharmacology & targets

1 target

Known molecular targets and mechanisms supported by curated pharmacology databases.

Androgen receptor
AR · P10275
ANTAGONISTAndrogen Receptor antagonist

Regulatory timeline

7 events

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.

Approval / market entry confirmed across FDA and EMA (2019-07-30 → 2021-01-07)
Earliest approval
2019-07-30
Latest approval
2025-06-03
Authorities
FDA · EMA
Total events
7
fdaU.S. Food and Drug Administration· 6 events
2026-09-22Label change
Label change: DAROLUTAMIDE (NDA212099)
Evidence ↗
2025-06-03Indication expansion
Indication expansion: DAROLUTAMIDE (NDA212099)
Evidence ↗
2023-10-13Label change
Label change: DAROLUTAMIDE (NDA212099)
Evidence ↗
emaEuropean Medicines Agency· 1 event
2020-03-27Original application approvalMulti-authority
Marketing authorisation: Nubeqa (EMA)
Indication: NUBEQA is indicated for the treatment of adult men with non‑metastatic castration resistant prostate cancer (nmCRPC) who are at high risk of developing metastatic disease (see… Show full indication

NUBEQA is indicated for the treatment of adult men with non‑metastatic castration resistant prostate cancer (nmCRPC) who are at high risk of developing metastatic disease (see section 5.1). metastatic hormone‑sensitive prostate cancer (mHSPC) in combination with androgen deprivation therapy (see section 5.1). metastatic hormone‑sensitive prostate cancer (mHSPC) in combination with docetaxel and androgen deprivation therapy (see section 5.1).

Evidence ↗

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

74 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
74
registered trials across all phases
LATEST COMPLETION 2026
50
Active studies
35
Recruiting
20
Late-stage (III+)
16
Completed
8
Discontinued
PHASE DISTRIBUTIONn = 74
Early Phase 11Phase 114Phase 1 / 26Phase 233Phase 2 / 31Phase 316Phase 43

Late-stage studies

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

DAROSTEP: Evaluating Step Counts as a Biomarker and Its Relationship on Treatment Outcomes in Vulnerable Patients With Metastatic Hormone-Sensitive Prostate Cancer on Darolutamide and Androgen Deprivation Therapy

Not yet recruitingPH IVUniversity of Chicagon=802029

A Single-arm, Open-label Phase 4 Study of Darolutamide in Addition to Standard Androgen Deprivation Therapy for Participants in India With High-risk Non-metastatic Castration-resistant Prostate Cancer (nmCRPC)

RecruitingPH IVBayern=502027

A Randomized Trial of Neoadjuvant Leuprorelin, Darolutamide or Both Prior to Radical Prostatectomy for Intermediate or High-risk Prostate Cancer

Active, not recruitingPH IVBrazilian Clinical Research Instituten=1442026

A Randomized Phase III Trial With a Factorial Design Evaluating the Efficacy and Safety of Darolutamide and Stereotactic Dose Escalated Radiotherapy in Patients With Localized Prostate Cancer and High-risk Features of Relapse, From the Prostate Cancer Consortium in Europe (PEACE)

RecruitingPH IIIUNICANCERn=7002045

A Double-blind Randomised Phase III Trial Evaluating the Efficacy of ADT +/- Darolutamide in de Novo Metastatic Prostate Cancer Patients With Vulnerable Functional Ability and Not Elected for Docetaxel or Androgen Receptor Targeted Agents

RecruitingPH IIIUNICANCERn=3002037

Recent completions

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

An Open-label, Randomised, Phase-I, Multi-Centre Study to Investigate the Biological Effects of Saruparib (AZD5305) Alone, Darolutamide Alone, and in Combination Given Prior to Radical Prostatectomy in Men With Newly Diagnosed Prostate Cancer (ASCERTAIN)

CompletedPH IAstraZenecan=1132026

Open-label Study of Androgen Receptor Inhibition With dArolutamide Plus Androgen Deprivation Therapy (ADT) Versus ADT in Men With Metastatic Hormone-Sensitive Prostate Cancer Using an External Control Arm

CompletedPH IIBayern=2232026

A Phase 1/2 Study of Darolutamide and Abemaciclib in High-Risk Prostate Cancer

CompletedPH IPraful Ravi, MB BCHir, MRCPn=92026

A Randomized Phase II Study of Androgen Receptor Directed Therapy on COGnitive Function in Patients Treated With Darolutamide or Enzalutamide (ARACOG)

CompletedPH IIAlliance Foundation Trials, LLC.n=1112026

Phase II Study of Darolutamide (ODM-201) in Patients With Androgen Receptor-positive Salivary Gland Carcinoma (Discovary Study)

CompletedPH IINational Cancer Center Hospital Eastn=572026

A Randomized, Double-blind, Placebo-controlled Phase 3 Study of Darolutamide in Addition to Androgen Deprivation Therapy (ADT) Versus Placebo Plus ADT in Men With Metastatic Hormone-sensitive Prostate Cancer (mHSPC)

CompletedPH IIIBayern=6692026

Research activity

2 papers

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

Publications over time
2020–2024
Most influential

Nonmetastatic, Castration-Resistant Prostate Cancer and Survival with Darolutamide.

The New England journal of medicine · 2020 · 260 cites

Darolutamide in Combination With Androgen-Deprivation Therapy in Patients With Metastatic Hormone-Sensitive Prostate Cancer From the Phase III ARANOTE Trial.

Journal of clinical oncology : official journal of the American Society of Clinical Oncology · 2024 · 103 cites
Recent papers

Darolutamide in Combination With Androgen-Deprivation Therapy in Patients With Metastatic Hormone-Sensitive Prostate Cancer From the Phase III ARANOTE Trial.

Journal of clinical oncology : official journal of the American Society of Clinical Oncology · 2024 · 103 cites

Nonmetastatic, Castration-Resistant Prostate Cancer and Survival with Darolutamide.

The New England journal of medicine · 2020 · 260 cites
Major research themes3
Androgen Antagonists1Antineoplastic Combined Chemotherapy Protocols1Pyrazoles1
Journals, researchers & institutions
Top journals
  • Journal of clinical oncology : official journal of the American Society of Clinical Oncology1
  • The New England journal of medicine1
Leading researchers
  • Jievaltas M2
  • Kuss I2
  • Le Berre MA2
  • Shore N2
  • Ulys A2
  • Vjaters E2
  • Alekseev B1
  • Cesar de Andrade Mota A1
Leading institutions
free-text, unnormalised
  • 0National Cancer Institute1
  • All India Institute of Medical Sciences1
  • Carolina Urologic Research Center and AUC Urology Specialists1
  • Centre Hospitalier de l'Université de Montréal1
  • Clinic of Urology and Oncological Urology1
  • Clinical Oncological Dispensary of Omsk Region1

Related diseases

1 conditions

Regulator-approved indications and conditions co-mentioned with this drug across the research literature. Number shows shared papers.

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.