Nubeqa

(Darolutamide)

ApprovedSmall molecule

Darolutamide is used to treat men with prostate cancer that hasn't spread to other parts of the body. It works by blocking male hormones that help prostate cancer grow.[2] Nubeqa is currently approved and in use across 27 indications[4].[1]

Nubeqa is one of 361 small molecule programs targeting Prostate Adenocarcinoma. It is currently in Approved.

Indications

101

Total Trials

Active Trials

360

Competitors

FDA Application

NDA/BLA/ANDA regulatory filings

Patents

Pipeline

Status by Indication[4][1]

Indication

Prostate AdenocarcinomaActive, not recruiting

Prostate NeoplasmActive, not recruiting

Prostate CarcinomaActive, not recruiting

Maligant Granulosa Cell Tumor of OvaryApproved

Metastatic Prostate CancerRecruiting

Prostate CancerNot yet recruiting

Metastatic Castration-Resistant Prostate CancerRecruiting

Solid TumorRecruiting

Advanced Solid TumorRecruiting

TreatmentRecruiting

Prostate AdenocarcinomaApproved

Active, not recruiting

Prostate NeoplasmApproved

Active, not recruiting

Prostate CarcinomaApproved

Active, not recruiting

Maligant Granulosa Cell Tumor of OvaryApproved

Approved

Metastatic Prostate CancerPhase 3

Recruiting

Prostate CancerApproved

Not yet recruiting

Metastatic Castration-Resistant Prostate CancerPhase 3

Recruiting

Solid TumorPreclinical

Recruiting

Advanced Solid TumorPhase 1

Recruiting

TreatmentPhase 3

Recruiting

Showing 10 of 27 indications

Competition

Competitive Landscape

348 competitors in Solid Tumor

#DrugCompanyPhaseTrials

Nubeqa

Bayer

Approved

2 2

Fludara

Sanofi

Preclinical

2 3

DATROWAY

Daiichi Sankyo

Preclinical

1 4

Sporanox

SSebela Pharmaceuticals Development LLC

Preclinical

3 5

Paxil

SSebela Pharmaceuticals Development LLC

Preclinical

1 6

Proleukin

IIovance Biotherapeutics, Inc.

Preclinical

1 7

Navmi

SSummit Therapeutics

Preclinical

1 8

Carboplatin AUC-5

Merck & Co.

Preclinical

1 9

Ifinatamab Deruxtecan

Daiichi Sankyo

Preclinical

1 10

Tulmimetostat

Novartis

Preclinical

Ranked by pipeline maturity and clinical activity. Current drug highlighted in teal.

Timeline

Expected Milestones

Q4 2026

Active, not recruiting

Castration Sensitive Prostate Cancer

NCT07779590

Phase 2Active, not recruiting

Locally Advanced Salivary Gland Carcinoma

NCT05669664

Phase 3Recruiting

Metastatic Prostate Cancer

NCT03903835

Q1 2027

Phase 3Recruiting

Prostate Cancer

NCT05116475

Phase 1Recruiting

Solid Tumor

NCT07620041

ApprovedActive, not recruiting

Prostate Cancer

NCT06627530

Clinical

Trials by Indication[1]

Prostate Cancer35 trials

Prostate Cancer Biomarker Enrichment and Treatment Selection

Active, not recruiting·CCanadian Cancer Trials Group·Phase 2·NCT03385655·200 enrolled

Neoadjuvant Androgen Deprivation, Darolutamide, and Ipatasertib in Men With Localized, High Risk Prostate Cancer

Terminated·DDavid VanderWeele·Phase 1/2·NCT04737109·6 enrolled

Neoadjuvant Therapy of Darolutamide Plus ADT for High Risk Prostate Cancer

Recruiting·XXijing Hospital·Phase 2·NCT06575257·80 enrolled

Show 32 more trials

Neoadjuvant Darolutamide and Relugolix Combination Preceding Radical Prostatectomy for Prostate Cancer

Recruiting·AAdventHealth·Phase 1·NCT06631521·30 enrolled

Darolutamide ± ADT as Neoadjuvant Therapy in High-Risk/Very High-Risk Localized Prostate Cancer

Not yet recruiting·—·Phase 2·NCT07476677·60 enrolled

Abiraterone and Prednisone or Darolutamide for the Treatment of Advanced Prostate Cancer

Recruiting·UUniversity of California, Davis·Phase 2·NCT06173362·75 enrolled

Evaluating Treatment Outcomes Using Darolutamide and Androgen Deprivation Therapy in Patients With Metastatic Hormone-Sensitive Prostate Cancer.

Not yet recruiting·UUniversity of Chicago·Phase 4·NCT06660862·80 enrolled

PSA Biochemical Response as Prognostic Factor in Metastatic Castration-Sensitive Prostate Cancer

Recruiting·FFondazione Policlinico Universitario Agostino Gemelli IRCCS··NCT06652607·152 enrolled

A Study Using Available Data to Learn to What Extent Patients With Prostate Cancer Who Received Second Generation Androgen Receptor Inhibitors Took Their Medication as Prescribed or Stopped Taking Their Medication Completely

Completed· Bayer logo

Bayer··NCT05202301·13,779 enrolled

An Observational Cohort Study to Describe and Compare the Use of Darolutamide, Enzalutamide and Apalutamide and How Well These Work in Men With Non-metastatic Castration-resistant Prostate Cancer (nmCRPC) in Real World Settings

Completed· Bayer logo

Bayer··NCT06013475·1,375 enrolled

An Observational Study, Called DEAR, to Learn More About Treatment With Darolutamide, Enzalutamide and Apalutamide in Men With Non-metastatic Castration-resistant Prostate Cancer in Real World Settings

Completed· Bayer logo

Bayer··NCT05362149·870 enrolled

Management of Oligoprogressive Castration Resistant Prostate Cancer (PCS X)

Recruiting·SSir Mortimer B. Davis - Jewish General Hospital·Phase 2·NCT04070209·66 enrolled

Study to Compare the Effects of Drug Darolutamide and Drug Enzalutamide on Physical Function, Including Balance and Daily Activity, in Patients With Castration-resistant Prostate Cancer (CRPC)

Terminated· Bayer logo

Bayer·Phase 2·NCT04157088·30 enrolled

A Phase 2 Trial of Darolutamide as a Prostate-Specific Membrane Antigen (PSMA) Expression Enhancer in Patients With Localized Prostate Cancer

Unknown status·DD'Or Institute for Research and Education·Phase 2·NCT05900973·19 enrolled

A Study Called ARAMON to Learn to What Extent Does Study Treatment With Darolutamide Affects Testosterone Levels in Men With Prostate Cancer That Had Not Been Treated With Hormonal Therapy Compared to Treatment With Enzalutamide

Completed· Bayer logo

Bayer·Phase 2·NCT05526248·28 enrolled

Evaluation of dAroLutamide Addition to anDrogen Deprivation Therapy and radIatioN Therapy in Newly Diagnosed Prostate Cancer With Pelvic Lymph Nodes Metastases

Recruiting·AAssociation Pour La Recherche des Thérapeutiques Innovantes en Cancérologie·Phase 3·NCT05116475·152 enrolled

Efficacy and Safety Study of Darolutamide (ODM-201) in Men With High-risk Non-metastatic Castration-resistant Prostate Cancer

Completed· Bayer logo

Bayer·Phase 3·NCT02200614·1,509 enrolled

Study to Evaluate the Safety, Tolerability,Pharmacokinetics, and Antitumor Activity of a Thorium-227 Labeled Antibody-chelator Conjugate Alone and in Combination With Darolutamide, in Patients With Metastatic Castration Resistant Prostate Cancer

Completed· Bayer logo

Bayer·Phase 1·NCT03724747·63 enrolled

Study of Radiation Therapy in Combination With Darolutamide + Degarelix in Intermediate Risk Prostate Cancer

Not yet recruiting·UUniversity Health Network, Toronto·Phase 2·NCT04176081·208 enrolled

Stereotactic Body Radiotherapy With or Without Darolutamide for OligoRecurrent Prostate Cancer

Unknown status·UUniversity Hospital, Ghent·Phase 2·NCT04641078·124 enrolled

Efficacy and Safety of Darolutamide Combined With ADT in High-risk/Very High-risk Localized Prostate Cancer

Unknown status·TThe Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School·Phase 2·NCT05249712·30 enrolled

Treatment of High-Risk Prostate Cancer Guided by Novel Diagnostic Radio- and Molecular Tracers

Recruiting·CCancer Research Antwerp·Phase 2/3·NCT06282588·493 enrolled

Efficacy and Safety of Darolutamide in Combination With Androgen-Deprivation Therapy in Prostate Cancer Patients With Lymph Node-positive After Radical Prostatectomy: A Prospective Observational Cohort Study

Not yet recruiting·PPeking University Third Hospital··NCT06435702·108 enrolled

How Darolutamide Plus Hormone Therapy Works for Men With Advanced Prostate Cancer in Everyday Medical Practice in Germany

Not yet recruiting· Bayer logo

Bayer··NCT07395804·500 enrolled

A Phase II Neoadjuvant Study of Darolutamide Plus ADT in Men With Localized Prostate Cancer

Recruiting·PPeking University First Hospital·Phase 2·NCT06029036·53 enrolled

Gedatolisib in Combination With Darolutamide in Metastatic Castration-Resistant Prostate Cancer

Recruiting·CCelcuity Inc·Phase 1/2·NCT06190899·54 enrolled

Darolutamide + Consolidation Radiotherapy in Advanced Prostate Cancer Detected by PSMA

Active, not recruiting·TTrans Tasman Radiation Oncology Group·Phase 2·NCT04319783·65 enrolled

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

Active, not recruiting·BBrazilian Clinical Research Institute·Approved·NCT06627530·144 enrolled

A Phase 1, Open-Label, Multicenter Study of JANX007 in Subjects With Metastatic Castration-Resistant Prostate Cancer

Recruiting·JJanux Therapeutics·Phase 1·NCT05519449·272 enrolled

Neoadjuvant ADT and Darolutamide With Pembrolizumab, Followed by Adjuvant Pembrolizumab in NCCN High-risk and Molecularly Stratified Prostate Cancer Patients

Recruiting·IIcahn School of Medicine at Mount Sinai·Phase 2·NCT07027124·40 enrolled

Extreme Bipolar Androgen Therapy With Darolutamide and Testosterone Cypionate in Patients With Metastatic Castration-Resistant Prostate Cancer (ExBAT Trial)

Completed·LLatin American Cooperative Oncology Group·Phase 2·NCT04558866·51 enrolled

Darolutamide Observational Study in Non-metastatic Castration-resistant Prostate Cancer Patients

Active, not recruiting· Bayer logo

Bayer··NCT04122976·805 enrolled

Efficacy and Safety of Darolutamide Combined With Docetaxel and ADT as Neoadjuvant Therapy for Locally Advanced Prostate Cancer: A Multicenter, Prospective, Randomized Controlled Study

Not yet recruiting·RRenJi Hospital·Phase 2·NCT07730151·200 enrolled

A Single-arm, Open-label Phase 2 Study of Darolutamide in Addition to Standard Androgen Deprivation Therapy (ADT) in Chinese Participants With High-risk Non-metastatic Castration-resistant Prostate Cancer (nmCRPC)

Completed· Bayer logo

Bayer·Phase 2·NCT05171387·78 enrolled

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)

Completed· AstraZeneca logo

AstraZeneca·Phase 1·NCT05938270·113 enrolled

Metastatic Prostate Cancer9 trials

ADT +/- Darolutamide in de Novo Metastatic Prostate Cancer Patients With Vulnerable Functional Ability (PEACE6-Vulnerable)

Recruiting·UUNICANCER·Phase 3·NCT04916613·300 enrolled

Evaluation of Clinical Outcomes of Chemotherapy or Androgen-receptor Targeting Agent (Alone or Combined) or Radiotherapy on Primary Tumor in Addition to Androgen Deprivation Therapy in HOrmone-Sensitive Metastatic Prostate Cancer Patients

Recruiting·SSanta Chiara Hospital··NCT06473259·3,000 enrolled

An Observational Study to Learn More About the Use of Androgen Receptor Inhibitors and How They Affect Men With Nonmetastatic Prostate Cancer in Routine Medical Care in the United States

Completed· Bayer logo

Bayer··NCT06204302·1,800 enrolled

Show 6 more trials

ProBio: A Biomarker Driven Study in Patients With Metastatic Prostate Cancer

Recruiting·KKarolinska Institutet·Phase 3·NCT03903835·750 enrolled

Outcomes of Local Treatment for Oligometastatic Prostate Cancer Diagnosed Using PSMA PET Imaging: OLIGOMET Study

Not yet recruiting·MMedical University of Vienna··NCT06430411·500 enrolled

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

Terminated·PPraful Ravi, MB BCHir, MRCP·Phase 1·NCT05617885·9 enrolled

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

Completed·AAlliance Foundation Trials, LLC.·Phase 2·NCT04335682·111 enrolled

A Multi-arm, Open-label Phase I/IIa Study to Assess the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics and Preliminary Efficacy of AZD5305 in Combination With New Hormonal Agents in Patients With Metastatic Prostate Cancer (PETRANHA)

Active, not recruiting· AstraZeneca logo

AstraZeneca·Preclinical·NCT05367440·174 enrolled

An Open-Label, Phase 1/1b Study of ORIC-944 as a Single Agent or in Combination With an Androgen Receptor Pathway Inhibitor in Patients With Metastatic Prostate Cancer

Recruiting·OORIC Pharmaceuticals·Phase 1·NCT05413421·275 enrolled

Metastatic Castration-Resistant Prostate Cancer6 trials

A Phase 3, Randomized, Open-Label Study of Rinzimetostat (ORIC-944) in Combination With Darolutamide Compared With ARPI or Docetaxel in Patients With Metastatic Castration Resistant Prostate Cancer Previously Treated With Abiraterone Acetate (Himalayas-1)

Recruiting·OORIC Pharmaceuticals·Phase 3·NCT07723248·600 enrolled

A Phase 1, Multicenter Trial Evaluating the Safety, Tolerability, and Efficacy of Valemetostat (DS-3201) in Combination With Darolutamide in Metastatic Castration Resistant Prostate Cancer (mCRPC)

Recruiting· Daiichi Sankyo logo

Daiichi Sankyo·Phase 1·NCT07244341·60 enrolled

A Phase III, Multicentre, Randomised Controlled Study to Evaluate the Efficacy and Safety of AZD2265 (FPI-2265) ²²⁵Ac-PSMA-I&T Compared With Standard of Care in Patients With PSMA-positive Metastatic Castration-resistant Prostate Cancer (VECTRA-01)

Recruiting· AstraZeneca logo

AstraZeneca·Phase 3·NCT07611110·670 enrolled

Show 3 more trials

Addition of Darolutamide to First Line Treatment of Metastatic Castration-Resistant Prostate Cancer (mCRPC): a Randomized Open Label Phase II Trial

Recruiting·SSwiss Cancer Institute·Phase 2·NCT06401980·162 enrolled

An Open-label Phase I/IIa Study to Evaluate the Safety and Efficacy of CCS1477 as Monotherapy and in Combination, in Patients With Advanced Solid/Metastatic Tumours.

Completed·CCellCentric Ltd.·Preclinical·NCT03568656·219 enrolled

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

Recruiting·EErasmus Medical Center·Phase 2·NCT05762536·245 enrolled

Metastatic Hormone-Sensitive Prostate Cancer (mHSPC)6 trials

An Active Post Marketing Surveillance (PMS) Observational Study of Darolutamide in Patients With Metastatic Hormone-sensitive Prostate Cancer (mHSPC)

Not yet recruiting· Bayer logo

Bayer··NCT07806591·60 enrolled

An Observational Study of Darolutamide in Addition to Standard Androgen Deprivation Therapy and Docetaxel in Patients With Low-volume Metastatic Hormone-sensitive Prostate Cancer

Recruiting· Bayer logo

Bayer··NCT06661122·100 enrolled

A Randomized, Double-Blind, Placebo-Controlled, 2-Cohort, Phase III Study of Saruparib Combined With Physician's Choice of Androgen Receptor Pathway Inhibitor in Patients With Metastatic Hormone-Sensitive Prostate Cancer, Previously Treated With Docetaxel or PSMA-directed 177Lutetium-Containing Therapy Without Disease Progression, and With Prostate-Specific Antigen ≥ 0.2 ng/mL: EvoPAR-Prostate05

Recruiting· AstraZeneca logo

AstraZeneca·Phase 3·NCT07711002·1,330 enrolled

Show 3 more trials

TulmiSTAR-02: A Two-part Phase I Dose Escalation Study of Tulmimetostat (DZR123) in Combination With Darolutamide or Abiraterone Followed by Open-label, Randomized, Phase II Dose Expansion Study to Assess the Safety and Efficacy of Tulmimetostat in Combination With Darolutamide Versus Darolutamide Alone in Patients With Metastatic Hormone-sensitive Prostate Cancer

Recruiting· Novartis logo

Novartis·Preclinical·NCT07190300·181 enrolled

A Multicenter, Prospective, Randomized Controlled Phase II Trial of PSMA PET/CT-Guided Stereotactic Body Radiotherapy Combined With Darolutamide and Androgen Deprivation Therapy in Patients With Metastatic Hormone-Sensitive Prostate Cancer

Not yet recruiting·WWest China Hospital·Phase 2·NCT07649421·254 enrolled

A Phase 1b Open-label, Multicenter Study Evaluating the Safety, Tolerability, and Efficacy of Xaluritamig in Combination With Androgen Receptor Pathway Inhibitors in Participants With Metastatic Hormone-sensitive Prostate Cancer

Recruiting· Amgen logo

Amgen·Phase 1·NCT07140900·60 enrolled

Non-metastatic Castration-resistant Prostate Cancer3 trials

Post-marketing Surveillance Study for Approved Darolutamide Use in Korean Patients

Recruiting· Bayer logo

Bayer··NCT06334120·600 enrolled

A Multicenter, Real-world Study Evaluating the Effectiveness of Darolutamide Plus ADT in Patients Progressing to nmCRPC After Bicalutamide Plus ADT Treatment During nmHSPC Stage

Recruiting· Bayer logo

Bayer··NCT07538843·800 enrolled

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)

Recruiting· Bayer logo

Bayer·Approved·NCT05348876·50 enrolled

34 more indications

Prostatic Neoplasms3 trials

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)

Completed· Bayer logo

Bayer·Phase 3·NCT04736199·669 enrolled

Double-DARE: Analysis of Doublet and Triplet Therapy With Darolutamide and Other Androgen Receptor Pathway Inhibitors in de Novo mHSPC Patients Seen in Urology Clinics in the USA

Recruiting· Bayer logo

Bayer··NCT07406282·1,400 enrolled

A Phase 1b Study of Abemaciclib Plus Darolutamide in Men With Metastatic Castration-Resistant Prostate Cancer

Terminated· Eli Lilly logo

Eli Lilly·Phase 1·NCT05999968·10 enrolled

Trial2 trials

Serial Measurements of Molecular and Architectural Responses to Therapy (SMMART) PRIME Trial

Terminated·OOHSU Knight Cancer Institute·Phase 1·NCT03878524·2 enrolled

INTREPId (INTermediate Risk Erection PreservatIon Trial)

Active, not recruiting·—·Phase 2·NCT04025372·234 enrolled

Breast Cancer2 trials

Study on Androgen Receptor and Triple Negative Breast Cancer

Completed·UUNICANCER·Phase 2·NCT03383679·94 enrolled

A Study to Evaluate Changes in Human Breast Cancer Tissue Following Short-Term Use of Darolutamide

Completed·TTranslational Research in Oncology·Phase 1·NCT03004534·36 enrolled

Metastatic Hormone Sensitive Prostate Cancer2 trials

ROAD - Real-World Outcomes of Darolutamide, ADT, With or Without Docetaxel in Metastatic Hormone-Sensitive Prostate Cancer

Recruiting· Bayer logo

Bayer··NCT07344779·1,600 enrolled

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

Completed· Bayer logo

Bayer·Phase 2·NCT05059236·223 enrolled

Prostate Carcinoma2 trials

An Open-label, Multicenter, Phase II Clinical Study to Evaluate the Safety, Efficacy and Pharmacokinetics of TT00420 Tablets Combined With Novel Endocrine Therapy in Patients With Metastatic Castration-resistant Prostate Cancer (mCRPC) Progressing After Prior Treatment

Recruiting·TTransThera Sciences (Nanjing), Inc.·Phase 2·NCT07871110·182 enrolled

A Phase III Double Blinded Study of Early Intervention After RADICAl ProstaTEctomy With Androgen Deprivation Therapy With or Without Darolutamide vs. Placebo in Men at Highest Risk of Prostate Cancer Metastasis by Genomic Stratification (ERADICATE)

Active, not recruiting·EECOG-ACRIN Cancer Research Group·Phase 3·NCT04484818·27 enrolled

Prostate Adenocarcinoma2 trials

A Randomized Phase II/III Trial Evaluating Bipolar Androgen Therapy Followed by Darolutamide vs. Standard of Care in Patients With Metastatic Castration Resistant Prostate Cancer

Not yet recruiting·EECOG-ACRIN Cancer Research Group·Preclinical·NCT07852195·432 enrolled

Parallel Phase III Randomized Trials of Genomic-Risk Stratified Unfavorable Intermediate Risk Prostate Cancer: De-Intensification and Intensification Clinical Trial Evaluation (GUIDANCE)

Active, not recruiting·NNRG Oncology·Phase 3·NCT05050084·2,050 enrolled

Solid Tumor2 trials

A Phase 1 Study to Evaluate the C-QTc Interval of QLC5508, Compare the Pharmacokinetics of Two Different Formulations, and Assess Drug-Drug Interaction Potential in Participants With Advanced Solid Tumors

Recruiting· Qilu Pharmaceutical Co., Ltd. logo

Qilu Pharmaceutical Co., Ltd.·Phase 1·NCT07620041·48 enrolled

CURATE: A Cancer Research UK Phase I/II, Dose Escalation and Expansion Trial of TT-702, A Selective Adenosine A2BR Antagonist, Given Orally as a Monotherapy Agent and in Combination, in Patients With Advanced Solid Tumours

Recruiting·CCancer Research UK·Preclinical·NCT05272709·60 enrolled

IgAN1 trial

Darolutamide+ADT Post-RP w/o ePLND in hrPC: Briganti 2019

Not yet recruiting·PPeking University First Hospital·Phase 2·NCT07282197·40 enrolled

Salivary Gland Carcinoma1 trial

Darolutamide in Patients With Androgen Receptor-Positive Salivary Gland Carcinoma (DISCOVARY)

Active, not recruiting·NNational Cancer Center Hospital East·Phase 2·NCT05694819·56 enrolled

Cancer of the Prostate1 trial

Darolutamide Augments Standard Therapy for Localised Very High-Risk Cancer of the Prostate

Active, not recruiting·UUniversity of Sydney·Phase 3·NCT04136353·1,100 enrolled

Progression-Free Survival1 trial

Darolutamide With Radium-223 or Placebo and the Effect on Radiological Progression-Free Survival for Patients With mCSPC

Withdrawn·GGenesisCare USA·Phase 3·NCT05771896

Radiation Therapy1 trial

Treatment With Darolutamide +/- Radiation Therapy for Patients With a Castration Resistant Cancer and Metastases Detected by Functional Imaging

Recruiting·UUNICANCER·Phase 3·NCT06276465·336 enrolled

Testosterone1 trial

Supraphysiologic Testosterone Priming Induces Darolutamide Extended Response

Recruiting·SSidney Kimmel Comprehensive Cancer Center at Johns Hopkins·Phase 2·NCT07142551·60 enrolled

Imaging1 trial

Imaging Study to Compare Effects of Darolutamide and Enzalutamide With Respect to Placebo on the Blood Flow in the Brain in Healthy Male Volunteers.

Completed· Bayer logo

Bayer·Phase 1·NCT03704519·26 enrolled

Androgen Deprivation Therapy1 trial

Comeback From Long coursE Androgen Deprivation Therapy (ADT) With RElugolix and Darolutamide (CLEARED)

Active, not recruiting·—·Phase 2·NCT06463457·33 enrolled

Neoadjuvant1 trial

Neoadjuvant Darolutamide Alone or in Combination With Standard Therapy for Stage II-IIIA, AR+, TNBC

Recruiting·VVandana Abramson·Phase 2·NCT07016399·51 enrolled

Treatment1 trial

Intermittent Darolutamide Treatment in the Triple Therapy of mHSPC

Recruiting·TThe First Affiliated Hospital with Nanjing Medical University·Phase 3·NCT06177015·200 enrolled

Survival1 trial

A Study Comparing ARB With Radium-223 vs ARB Therapy With Placebo and the Effect Upon Survival for mCRPC Patients

Terminated·MMANA RBM·Phase 3·NCT04237584·23 enrolled

First Line Therapy1 trial

PSMA PET/CT-Based Multimodal Model for Predicting Response to First-Line Therapy in mHSPC.

Completed·FFirst Affiliated Hospital of Wenzhou Medical University··NCT07428642·168 enrolled

SMA1 trial

Psma Intensity Can be Altered by Androgen and Phospho-SrC Obstruction

Recruiting·SSt Vincent's Hospital, Sydney·Phase 2·NCT04925648·22 enrolled

Observational Study1 trial

Observational Study of the Effectiveness of Funded Drugs for Genitourinary Tumors.

Recruiting·SSpanish Oncology Genito-Urinary Group··NCT06724159·500 enrolled

Metastatic Castration-resistant Prostate Neoplasms1 trial

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

Recruiting· Johnson & Johnson logo

Johnson & Johnson·Phase 1·NCT05818683·300 enrolled

Adult Ovarian Granulosa Cell Tumor1 trial

A Phase II Study of Androgen Receptor (AR) Inhibition by Darolutamide in Combination With Leuprolide Acetate and Exemestane in Recurrent Adult-Type Ovarian Granulosa Cell Tumor

Completed·NNational Cancer Institute (NCI)·Phase 2·NCT06169124·17 enrolled

Localized Prostate Cancer1 trial

A China Interventional Phase II, Single Arm, Multicenter Study Evaluating the Effectiveness and Safety of Darolutamide + ADT as Neo-Adjuvant Treatment in Treatment-naïve Patients Who Have Planned for Radical Prostatectomy (RP) With High Risk Localized Prostate Cancer

Recruiting· Bayer logo

Bayer·Phase 2·NCT07450599·250 enrolled

Castration Sensitive Prostate Cancer1 trial

Real-World Outcomes Among Patients Receiving Enzalutamide Plus ADT or Darolutamide Plus ADT in Metastatic Castration Sensitive Prostate Cancer (mCSPC)

Active, not recruiting· Pfizer logo

Pfizer··NCT07779590·4,700 enrolled

mHSPC1 trial

Evaluation of the Efficacy and Safety of Darolutamide + ADT Combined With Low-dose Docetaxel in mHSPC: a Multi-center, Prospective, Single-arm Study

Recruiting·YYonghong Li·Phase 2·NCT07503379·109 enrolled

Locally Advanced Salivary Gland Carcinoma1 trial

A Phase 2 Study of Darolutamide in Combination With Leuprolide Acetate in Hormone-Therapy Naive Recurrent and/or Metastatic Androgen Receptor (AR) Positive Salivary Gland Cancer

Active, not recruiting·NNational Cancer Institute (NCI)·Phase 2·NCT05669664·21 enrolled

High Risk Prostate Carcinoma1 trial

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)

Recruiting·UUNICANCER·Phase 3·NCT06625970·700 enrolled

Metastatic Castration-sensitive Prostate Cancer1 trial

A Randomized, 2-cohort, Double-blind, Placebo-controlled, Phase III Study of Saruparib (AZD5305) in Combination With Physician's Choice New Hormonal Agents in Patients With HRRm and Non-HRRm Metastatic Castration-Sensitive Prostate Cancer (EvoPAR-Prostate01)

Active, not recruiting· AstraZeneca logo

AstraZeneca·Phase 3·NCT06120491·1,898 enrolled

Recurrent Castration-Sensitive Prostate Carcinoma1 trial

MC230502 Dynamic Investigator Initiated Enterprise (DIVINE) in Prostate Cancer

Recruiting·MMayo Clinic·Phase 2·NCT06378866·532 enrolled

Prostate Cancer (Adenocarcinoma)1 trial

A Randomized Phase III Clinical Trial for the Addition of Docetaxel to Androgen Receptor Pathway Inhibitors in Patients With Metastatic Castration Sensitive Prostate Cancer and Suboptimal PSA Response

Recruiting·CCanadian Cancer Trials Group·Phase 3·NCT06592924·830 enrolled

Biochemically Recurrent Prostate Cancer1 trial

A Randomized, Double-blind, Placebo-controlled Phase 3 Study of Darolutamide Plus Androgen Deprivation Therapy (ADT) Compared With Placebo Plus ADT in Patients With High-risk Biochemical Recurrence (BCR) of Prostate Cancer

Active, not recruiting· Bayer logo

Bayer·Phase 3·NCT05794906·985 enrolled

Advanced Solid Tumor1 trial

A Phase 1, Open-Label Dose Escalation and Expansion Study of SNV1521 in Participants With Advanced Solid Tumors

Recruiting·SSynnovation Therapeutics, Inc.·Phase 1·NCT06220864·400 enrolled

Unspecified1 trial

An Open-label, Single Arm, Roll-over Study to Provide Continued Treatment With Darolutamide in Participants Who Were Enrolled in Previous Bayer Sponsored Studies

Active, not recruiting· Bayer logo

Bayer·Phase 3·NCT04464226·774 enrolled

Regulatory

FDA Approval Timeline[5]

Jul 30, 2019

NUBEQA

NDA NDA212099

Sources

References

[1]
ClinicalTrials.gov — 101 trial records for Darolutamide. U.S. National Library of Medicine, National Institutes of Health.
[2]
MedlinePlus Drug Information — Nubeqa drug information. U.S. National Library of Medicine, National Institutes of Health.
[3]
ChEMBL — Darolutamide compound record. European Bioinformatics Institute (EMBL-EBI).
[4]
Open Targets Platform — Drug–disease associations for Darolutamide. EMBL-EBI & Wellcome Sanger Institute.
[5]
OpenFDA — FDA approval records (NDA NDA212099). U.S. Food & Drug Administration.
[6]
FDA Orange Book — Patent and exclusivity data for Nubeqa. U.S. Food & Drug Administration.
[7]
SEC EDGAR — Bayer company filings. U.S. Securities and Exchange Commission.

Details

Drug Info

Quick Facts

Mechanism of Action: Androgen Receptor Antagonist[3]
Modality: Small molecule[3]
Highest Phase: Approved[1]
Company: Bayer

Patent Landscape[6]

Patent Cliff

Oct 27, 2030

Earliest patent expiration — generic entry possible after this date

Patent #Expires

11046713Oct 27, 2030

9657003Oct 27, 2030

10711013Oct 27, 2030

8975254Mar 25, 2033

10835515Jan 28, 2036

5 more patents

10010530Jan 28, 2036

10383853Jan 28, 2036

11168058Feb 27, 2038

12611397Jul 2, 2040

12329742Jun 17, 2042

Nubeqa

Status by Indication[4][1]

Competitive Landscape

Expected Milestones

Q4 2026

Q1 2027

Trials by Indication[1]

Prostate Cancer35 trials

Metastatic Prostate Cancer9 trials

Metastatic Castration-Resistant Prostate Cancer6 trials

Metastatic Hormone-Sensitive Prostate Cancer (mHSPC)6 trials

Non-metastatic Castration-resistant Prostate Cancer3 trials

Prostatic Neoplasms3 trials

Trial2 trials

Breast Cancer2 trials

Metastatic Hormone Sensitive Prostate Cancer2 trials

Prostate Carcinoma2 trials

Prostate Adenocarcinoma2 trials

Solid Tumor2 trials

IgAN1 trial

Salivary Gland Carcinoma1 trial

Cancer of the Prostate1 trial

Progression-Free Survival1 trial

Radiation Therapy1 trial

Testosterone1 trial

Imaging1 trial

Androgen Deprivation Therapy1 trial

Neoadjuvant1 trial

Treatment1 trial

Survival1 trial

First Line Therapy1 trial

SMA1 trial

Observational Study1 trial

Metastatic Castration-resistant Prostate Neoplasms1 trial

Adult Ovarian Granulosa Cell Tumor1 trial

Localized Prostate Cancer1 trial

Castration Sensitive Prostate Cancer1 trial

mHSPC1 trial

Locally Advanced Salivary Gland Carcinoma1 trial

High Risk Prostate Carcinoma1 trial

Metastatic Castration-sensitive Prostate Cancer1 trial

Recurrent Castration-Sensitive Prostate Carcinoma1 trial

Prostate Cancer (Adenocarcinoma)1 trial

Biochemically Recurrent Prostate Cancer1 trial

Advanced Solid Tumor1 trial

Unspecified1 trial

FDA Approval Timeline[5]

References

Drug Info

Quick Facts

Patent Landscape[6]

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