Drug
Darolutamide clinical trials
Also written ODM-201, BAY 1841788 and Nubeqa.
- studies test it
- 76
- open now
- 34
- in phase 3
- 16
- first study started
- 2011
Keep track of what changes. Save the darolutamide studies recruiting or about to start, and get an email each week — studies that open, close, add sites or post results.
Watch these studiesHow studies write it
Studies that test it under each name
Studies by the year they started
75 studies that test it; most in 2021 (9); 1 more planned to start later
| Year | Studies |
|---|---|
| 2011 | 2 |
| 2013 | 1 |
| 2014 | 1 |
| 2015 | 2 |
| 2016 | 3 |
| 2017 | 6 |
| 2018 | 4 |
| 2019 | 2 |
| 2020 | 6 |
| 2021 | 9 |
| 2022 | 5 |
| 2023 | 9 |
| 2024 | 9 |
| 2025 | 7 |
| 2026 | 9 |
By phase
A phase 1/2 study counts in both.
- Early Phase 1
- 2
- Phase 1
- 21
- Phase 2
- 41
- Phase 3
- 16
- Phase 4
- 3
What it is tested for
Each study’s main condition, where its own words name it.
Who runs them
Industry 29 · Other 47
Bayer (17) · Orion Corporation, Orion Pharma (4) · UNICANCER (3) · National Cancer Institute (NCI) (2) · ECOG-ACRIN Cancer Research Group (2) · Peking University First Hospital (2) · NRG Oncology (1) · Sir Mortimer B. Davis - Jewish General Hospital (1)
Often tested with
Tested in the same studies.
Enzalutamide (6) · Leuprolide (5) · Abiraterone (5) · Bicalutamide (3) · Degarelix (3) · Relugolix (3) · Carboplatin (3) · Docetaxel (3)
Studies
Open first, then newest update. How each study uses darolutamide is read from its arms, and is right about nine times in ten.
Testing it · 76
- A Clinical Study of KTX-2001 in Subjects With Metastatic Castration-Resistant Prostate Cancer (STRIKE-001)RecruitingPhase 1K36 Therapeutics, Inc.NCT07103018Written as KTX-2001 + Darolutamide (NUBEQA®)
- A Study to Learn How Well a Combination of Darolutamide and Androgen Deprivation Therapy (ADT) Works as a Treatment Before Surgery for Men Who Have High-risk Localized Prostate Cancer.RecruitingPhase 2BayerNCT07450599Written as Darolutamide
- Darolutamide in Metastatic Castration-Resistant Prostate Cancer (mCRPC)RecruitingPhase 2Swiss Cancer InstituteNCT06401980Written as Darolutamide
- Neoadjuvant ADT + Darolutamide With Pembrolizumab, Followed by Adjuvant Pembrolizumab in Molecularly Stratified High-Risk Prostate CancerRecruitingPhase 2Icahn School of Medicine at Mount SinaiNCT07027124Written as Darolutamide
- Testing the Use of High Dose Testosterone Followed by Darolutamide Compared to the Usual Care for Patients With Metastatic Prostate CancerNot yet recruitingPhase 2/3ECOG-ACRIN Cancer Research GroupNCT07852195Written as Darolutamide
- TulmiSTAR-02: A Phase I/II Open-label Study of Tulmimetostat in Combination With Darolutamide vs. Darolutamide, and Tulmimetostat With Abiraterone in Patients With Metastatic Hormone-sensitive Prostate Cancer (mHSPC)RecruitingPhase 1/2Novartis PharmaceuticalsNCT07190300Written as Darolutamide
- Docetaxel or Cabazitaxel With or Without Darolutamide in mCRPCRecruitingPhase 2Erasmus Medical CenterNCT05762536Written as Darolutamide
- A Phase 1b/2a Study of Pocenbrodib as Monotherapy and in Combination With Darolutamide in Participants With mCRPCRecruitingPhase 1/2Pathos AI, Inc.NCT06785636Written as Pocenbrodib and Darolutamide
- Study Evaluating the Efficacy and Safety of Darolutamide and Stereotactic Dose Escalated Radiotherapy in Patients With Localized Prostate Cancer and High-risk Features of RelapseRecruitingPhase 3UNICANCERNCT06625970Written as Darolutamide
- Efficacy and Safety of Darolutamide Combined With Docetaxel and ADT as Neoadjuvant Therapy for Locally Advanced Prostate Cancer.Not yet recruitingPhase 2RenJi HospitalNCT07730151Written as Darolutamide
- Radium-223 for High-Volume Metastatic Hormone Sensitive Prostate CancerNot yet recruitingPhase 2Alianza multidisciplinar para la investigación de los tumores genitourinarios -GUARDNCT07717099Written as Darolutamide Oral Tablet
- A Study to Learn More About How Safe Darolutamide is and How Well it Works Under Real World Conditions When Taken in Addition to Standard Androgen Deprivation Therapy (ADT) in Indian Participants With High-risk Non-metastatic Castration-resistant Prostate Cancer (nmCRPC)RecruitingPhase 4BayerNCT05348876Written as Darolutamide (Nubeqa, BAY1841788)
- SNV1521 in Participants With Advanced Solid TumorsRecruitingPhase 1Synnovation Therapeutics, Inc.NCT06220864Written as Darolutamide
- Prostate Androgen Response Investigation Using a Stratification BIOmarker; Predicting Prostate Cancer Downstaging by Neoadjuvant Darolutamide With PCAI ImmunoScoreRecruitingPhase 2Region StockholmNCT07617272Written as Darolutamide
- A Study of Valemetostat (DS-3201b) in Combination With Darolutamide in Metastatic Castration Resistant Prostate Cancer (mCRPC)RecruitingPhase 1Daiichi SankyoNCT07244341Written as Darolutamide
- ADT +/- Darolutamide in de Novo Metastatic Prostate Cancer Patients With Vulnerable Functional Ability (PEACE6-Vulnerable)RecruitingPhase 3UNICANCERNCT04916613Written as Darolutamide 300 mg
- Gedatolisib in Combination With Darolutamide in Metastatic Castration-Resistant Prostate CancerRecruitingPhase 1/2Celcuity IncNCT06190899Written as Darolutamide
- Safety and Efficacy of Docetaxel, Darolutamide, and Homoharringtonine Combined With Androgen Deprivation Therapy in Neoadjuvant Treatment of High-Risk Prostate Cancer: A Multicenter Prospective, Single-Arm Clinical StudyNot yet recruitingEarly Phase 1Zhongda HospitalNCT07516704Written as Docetaxel+ Darolutamide + Homoharringtonine+ Androgen Deprivation Therapy
- Treatment of High-Risk Prostate Cancer Guided by Novel Diagnostic Radio- and Molecular TracersRecruitingPhase 2/3Cancer Research AntwerpNCT06282588Written as Darolutamide
- Abiraterone and Prednisone or Darolutamide for the Treatment of Advanced Prostate CancerRecruitingPhase 2University of California, DavisNCT06173362Written as Darolutamide
See all 76 studies that test darolutamide →
Given in every arm · 18 — darolutamide is usual care beside what is tested
- Saruparib in Combination With Physician's Choice of ARPI in Patients With mHSPC Previously Treated With Docetaxel or 177Lu-PSMA Therapy Without Disease Progression and PSA ≥ 0.2 ng/mL (EvoPAR-PR05)RecruitingPhase 3AstraZenecaNCT07711002Written as Darolutamide
- A Study to Learn About the Investigational Drug Rinzimetostat (ORIC-944) in Patients With mCRPC Who Were Previously Treated With Abiraterone Acetate (Himalayas-1)RecruitingPhase 3ORIC PharmaceuticalsNCT07723248Written as Darolutamide
- A Study of Pasritamig (JNJ-78278343) in Combination With Other Agents for Metastatic Prostate CancerRecruitingPhase 1Janssen Research & Development, LLCNCT05818683Written as Darolutamide
- Phase I Study of QLC5508 in Advanced Solid Tumors: C-QTc, Pharmacokinetics (PK) Comparisons and Drug-drug InteractionRecruitingPhase 1Qilu Pharmaceutical Co., Ltd.NCT07620041Written as Darolutamide
- PSMA PET/CT-Guided SBRT Plus Darolutamide in mHSPCNot yet recruitingPhase 2West China HospitalNCT07649421Written as Darolutamide 600 mg twice daily
- Study of JANX007 in Subjects With Metastatic Castration-Resistant Prostate Cancer (ENGAGER-PSMA-01)RecruitingPhase 1Janux TherapeuticsNCT05519449Written as Darolutamide
- Docetaxel to Androgen Receptor Pathway Inhibitors in Patients With Metastatic Castration Sensitive Prostate Cancer and Suboptimal PSA ResponseRecruitingPhase 3Canadian Cancer Trials GroupNCT06592924Written as Darolutamide (BAY 1841788)
- Study of ORIC-944 in Patients With Metastatic Prostate CancerRecruitingPhase 1ORIC PharmaceuticalsNCT05413421Written as Darolutamide (Nubeqa®) 300 mg tablets
- Study Evaluating the Safety, Tolerability, and Efficacy of Xaluritamig in Combination With Androgen Receptor Pathway Inhibitors in Participants With Metastatic Hormone-sensitive Prostate CancerRecruitingPhase 1AmgenNCT07140900Written as Darolutamide
- Treatment With Darolutamide +/- Radiation Therapy for Patients With a Castration Resistant Cancer and Metastases Detected by Functional ImagingRecruitingPhase 3UNICANCERNCT06276465Written as Darolutamide 300 mg
- Neo-DAB: Darolutamide and Abemaciclib in Prostate CancerTerminatedPhase 1Praful Ravi, MB BCHir, MRCPNCT05617885Written as Darolutamide
- Study to Evaluate CCS1477 in Advanced TumoursCompletedPhase 1/2CellCentric Ltd.NCT03568656Written as Darolutamide
- Study of AZD5305 When Given in Combination With New Hormonal Agents in Patients With Metastatic Prostate CancerActive, not recruitingPhase 1/2AstraZenecaNCT05367440Written as Darolutamide
- Saruparib (AZD5305) vs Placebo in Men With Metastatic Castration-Sensitive Prostate Cancer Receiving Physician's Choice New Hormonal AgentsActive, not recruitingPhase 3AstraZenecaNCT06120491Written as Darolutamide
- Darolutamide + Androgen Deprivation Therapy (ADT) in Chinese Men With High Risk, Nonmetastatic Prostate CancerCompletedPhase 2BayerNCT05171387Written as Darolutamide 600 mg twice daily
- Darolutamide in Patients With Androgen Receptor-Positive Salivary Gland Carcinoma (DISCOVARY)CompletedPhase 2National Cancer Center Hospital EastNCT05694819Written as Darolutamide
- Darolutamide + Consolidation Radiotherapy in Advanced Prostate Cancer Detected by PSMAActive, not recruitingPhase 2Trans Tasman Radiation Oncology GroupNCT04319783Written as Darolutamide
- Darolutamide With Radium-223 or Placebo and the Effect on Radiological Progression-Free Survival for Patients With mCSPCWithdrawnPhase 3GenesisCare USANCT05771896Written as Darolutamide
As the comparator · 4 — what is tested is compared with darolutamide
- AZD2265 Compared With Standard of Care in PSMA-positive Metastatic Castration-resistant Prostate Cancer (VECTRA-01)RecruitingPhase 3AstraZenecaNCT07611110Written as Darolutamide
- Safety, Efficacy and Pharmacokinetics of TT00420 Tablets Combined With Novel Endocrine Therapy in Patients With Metastatic Castration-resistant Prostate Cancer (mCRPC)RecruitingPhase 2TransThera Sciences (Nanjing), Inc.NCT07871110Written as Darolutamide 600 mg twice daily
- Stereotactic Body Radiation Therapy Plus Immediate or Delayed Androgen Receptor Pathway Inhibitor and Androgen Deprivation Therapy or Salvage Radiation Therapy for the Treatment of Prostate Cancer, DIVINE TrialRecruitingPhase 2Mayo ClinicNCT06378866Written as Darolutamide
- Darolutamide ± ADT as Neoadjuvant Therapy in High-Risk/Very High-Risk Localized Prostate CancerNot yet recruitingPhase 2Cancer Institute and Hospital, Chinese Academy of Medical SciencesNCT07476677Written as Darolutamide
Codes
What other systems call darolutamide · ClinicalTrials.gg INT000459
- MeSH (NLM) C000607739darolutamideOne source ClinicalTrials.gov
- UNII (FDA) X05U0N2RCODAROLUTAMIDEConfirmed FDA, Wikidata
- RxNorm 2180325Confirmed FDA, Wikidata
- Wikidata Q25091391darolutamideConfirmed FDA, Wikidata
- NCI Thesaurus C104748DarolutamideOne source FDA
- DrugBank DB12941One source Wikidata
| System | Code | Name there | Checked by |
|---|---|---|---|
| MeSH (NLM) | C000607739 | darolutamide | One source ClinicalTrials.gov |
| UNII (FDA) | X05U0N2RCO | DAROLUTAMIDE | Confirmed FDA, Wikidata |
| RxNorm | 2180325 | — | Confirmed FDA, Wikidata |
| Wikidata | Q25091391 | darolutamide | Confirmed FDA, Wikidata |
| NCI Thesaurus | C104748 | Darolutamide | One source FDA |
| DrugBank | DB12941 | — | One source Wikidata |
“Confirmed” means two independent publishers link the code to this drug; “one source”, one does and its name agrees.