Skip to content
AMR Drug RepurposingSmart Screeningresearch prototype

Darolutamide

FDA-approved product (tablet, oral), marketed as Nubeqa.

Registered studies
50+
Lab records
0
Pathogens at ≥40%
2 of 4

Chemical structure

Chemical structure of Darolutamide
A drawing shows what the molecule is, not what it does.

Existing / approved use

Documented · FDA, WHO, ChEMBL

Approved for

  • Cancer
  • Metastatic prostate cancer
  • Neoplasm
  • Prostate adenocarcinoma
  • Prostate cancer
  • Prostate carcinoma
  • Prostate neoplasm

Indications ChEMBL records as approved, from FDA and DailyMed labels. Label ↗

WHO therapeutic group
Anti-androgens
Anti-infective classification
Not classified as an anti-infective.

Repurposing investigation

This medicine is being investigated here for AI-predicted antimicrobial activity against MRSA and E. coli. It was surfaced computationally for further investigation; it is not an established treatment for these infections.

AI-predicted activity

AI prediction · nothing measured
  • MRSA53.3% AI-predicted activityAt or above the ≥40% mark this site uses to surface candidates.
  • E. coli40.4% AI-predicted activityAt or above the ≥40% mark this site uses to surface candidates.
  • K. pneumoniae21.4% AI-predicted activityBelow the ≥40% mark this site uses to surface candidates.
  • M. tuberculosis37.6% AI-predicted activityBelow the ≥40% mark this site uses to surface candidates.

A model’s estimate of laboratory activity against each pathogen species. It is not clinical effectiveness.

Evidence

Clinical and experimental

Documented evidence

Clinical

50+registered studies name this medicine, for any condition. The registry search keeps the first 50, so there may be more. See them below.

Experimental

No evidence found

No laboratory measurement against the four pathogens in the ChEMBL records loaded here.

Open Darolutamide in ChEMBL Registered studies below

Docking

Computational · nothing measured

Dihydrofolate reductase ↗ (E. coli)

-7.7 kcal/mol

0better fit →-12

KPC-2 carbapenemase ↗ (K. pneumoniae)

-7.9 kcal/mol

0better fit →-12

Enoyl-ACP reductase (InhA) ↗ (M. tuberculosis)

-8.5 kcal/mol

0better fit →-12

Dihydrofolate reductase ↗ (MRSA)

-8.5 kcal/mol

0better fit →-12

AutoDock Vina, one experimentally solved protein per pathogen. This project’s screening target is -7.0 kcal/mol, its own mark rather than a universal cutoff. A docking score is a structural hypothesis, not proof of binding, and requires experimental validation.

Other medicines to investigate

AI prediction · nothing measured

Other repurposing candidates: approved medicines besides Darolutamide with AI-predicted activity ≥40% against the chosen pathogen, leaving out existing antimicrobials. They are computational candidates for further investigation, not alternatives and not recommendations.

Sorted by AI-predicted activity, high to low. The order is not a ranking of which medicine is better.

Registered studies

A registration describes a study; it does not establish a positive result.

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

    NCT07016399 · start 2025-09-09

    Registered record
    Registry ID
    NCT07016399
    Conditions
    Anatomic Stage II Breast Cancer AJCC v8; Anatomic Stage IIIA Breast Cancer AJCC v8; Triple-Negative Breast Carcinoma
    Interventions
    Biospecimen Collection; Breast Biopsy Procedure; Carboplatin; Cyclophosphamide; Darolutamide; Doxorubicin; Epirubicin; Magnetic Resonance Imaging; Paclitaxel; Pembrolizumab; Surgical Procedure; Ultrasound Imaging
    Study type
    INTERVENTIONAL
    Phase
    Phase 2
    Registry status
    Recruiting
    Start
    2025-09-09
    Completion
    2033-10
    Enrolment
    51

    As stored from ClinicalTrials.gov. Registration describes a study; it does not mean the study worked.

    ConditionAnatomic Stage II Breast Cancer AJCC v8; Anatomic Stage IIIA Breast Cancer AJCC v8; Triple-Negative Breast Carcinoma
    InterventionBiospecimen Collection; Breast Biopsy Procedure; Carboplatin; Cyclophosphamide +8 more
    PhasePhase 2
    Registry statusRecruiting

  • A Phase 1b/2a Study of Pocenbrodib as Monotherapy and in Combination With Darolutamide in Participants With mCRPC

    NCT06785636 · start 2025-02-07

    Registered record
    Registry ID
    NCT06785636
    Conditions
    mCRPC (Metastatic Castration-resistant Prostate Cancer); Prostate Cancer
    Interventions
    Pocenbrodib; Pocenbrodib and Darolutamide
    Study type
    INTERVENTIONAL
    Phase
    Phase 1 / Phase 2
    Registry status
    Recruiting
    Start
    2025-02-07
    Completion
    2029-04-30
    Enrolment
    120

    As stored from ClinicalTrials.gov. Registration describes a study; it does not mean the study worked.

    ConditionmCRPC (Metastatic Castration-resistant Prostate Cancer); Prostate Cancer
    InterventionPocenbrodib; Pocenbrodib and Darolutamide
    PhasePhase 1 / Phase 2
    Registry statusRecruiting

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

    NCT06463457 · start 2024-12-13

    Registered record
    Registry ID
    NCT06463457
    Conditions
    Prostate Cancer; Advanced Prostate Cancer; Hormone Sensitive Prostate Cancer
    Interventions
    Darolutamide; Relugolix
    Study type
    INTERVENTIONAL
    Phase
    Phase 2
    Registry status
    Active not recruiting
    Start
    2024-12-13
    Completion
    2028-11-30
    Enrolment
    33

    As stored from ClinicalTrials.gov. Registration describes a study; it does not mean the study worked.

    ConditionProstate Cancer; Advanced Prostate Cancer; Hormone Sensitive Prostate Cancer
    InterventionDarolutamide; Relugolix
    PhasePhase 2
    Registry statusActive not recruiting

  • A Study to Learn About How Safe Darolutamide is and How Well it Works in Combination With Androgen Deprivation Therapy and Docetaxel in Routine Medical Care for Japanese Men With Low Volume Metastatic Hormone-Sensitive Prostate Cancer

    NCT06661122 · start 2024-11-18

    Registered record
    Registry ID
    NCT06661122
    Conditions
    Metastatic Hormone-sensitive Prostate Cancer (mHSPC); Low-volume Metastasis
    Interventions
    Darolutamide (BAY1841788) + docetaxel + ADT
    Study type
    OBSERVATIONAL
    Phase
    Not recorded
    Registry status
    Recruiting
    Start
    2024-11-18
    Completion
    2031-08-31
    Enrolment
    100

    As stored from ClinicalTrials.gov. Registration describes a study; it does not mean the study worked.

    ConditionMetastatic Hormone-sensitive Prostate Cancer (mHSPC); Low-volume Metastasis
    InterventionDarolutamide (BAY1841788) + docetaxel + ADT
    PhaseNot recorded
    Registry statusRecruiting

  • Standard of Care +/- 177Lu-PSMA-617 In de Novo mHSPC Patients With Poor PSA Response (PEACE6-Poor Responders)

    NCT06496581 · start 2024-09-12

    Registered record
    Registry ID
    NCT06496581
    Conditions
    Prostate Cancer Metastatic
    Interventions
    177Lu-PMSA-617; Standard of Care
    Study type
    INTERVENTIONAL
    Phase
    Phase 3
    Registry status
    Recruiting
    Start
    2024-09-12
    Completion
    2039-08-01
    Enrolment
    500

    As stored from ClinicalTrials.gov. Registration describes a study; it does not mean the study worked.

    ConditionProstate Cancer Metastatic
    Intervention177Lu-PMSA-617; Standard of Care
    PhasePhase 3
    Registry statusRecruiting

  • Radiotherapy or Surgery Combined With Intense Androgen Deprivation Therapy for mCRPC

    NCT06992232 · start 2024-08-01

    Registered record
    Registry ID
    NCT06992232
    Conditions
    Prostate Cancer Metastatic Disease
    Interventions
    Intense androgen deprivation therapy; Radiation Therapy; radical prostatectomy
    Study type
    INTERVENTIONAL
    Phase
    Phase 2
    Registry status
    Recruiting
    Start
    2024-08-01
    Completion
    2028-07-31
    Enrolment
    144

    As stored from ClinicalTrials.gov. Registration describes a study; it does not mean the study worked.

    ConditionProstate Cancer Metastatic Disease
    InterventionIntense androgen deprivation therapy; Radiation Therapy; radical prostatectomy
    PhasePhase 2
    Registry statusRecruiting

  • An Observational Study to Learn More About the Use of Darolutamide as a Part of a Combination Therapy in Belgian Men With Metastatic Hormone-Sensitive Prostate Cancer in Routine Medical Care

    NCT06498921 · start 2024-07-15

    Registered record
    Registry ID
    NCT06498921
    Conditions
    Metastatic Hormone-sensitive Prostate Cancer
    Interventions
    Darolutamide (Nubeqa, BAY1841788) in combination with androgen deprivation therapy (ADT) and docetaxel
    Study type
    OBSERVATIONAL
    Phase
    Not recorded
    Registry status
    Completed
    Start
    2024-07-15
    Completion
    2024-09-15
    Enrolment
    106

    As stored from ClinicalTrials.gov. Registration describes a study; it does not mean the study worked.

    ConditionMetastatic Hormone-sensitive Prostate Cancer
    InterventionDarolutamide (Nubeqa, BAY1841788) in combination with androgen deprivation therapy (ADT) and docetaxel
    PhaseNot recorded
    Registry statusCompleted

  • 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

    NCT06435702 · start 2024-06-01

    Registered record
    Registry ID
    NCT06435702
    Conditions
    Prostate Cancer
    Interventions
    Darolutamide in addition to androgen deprivation therapy; androgen deprivation therapy only
    Study type
    OBSERVATIONAL
    Phase
    Not recorded
    Registry status
    Not yet recruiting
    Start
    2024-06-01
    Completion
    2029-12-31
    Enrolment
    108

    As stored from ClinicalTrials.gov. Registration describes a study; it does not mean the study worked.

    ConditionProstate Cancer
    InterventionDarolutamide in addition to androgen deprivation therapy; androgen deprivation therapy only
    PhaseNot recorded
    Registry statusNot yet recruiting

  • Study to Test the Drug Darolutamide Along With the Drugs Leuprolide Acetate and Exemestane in Patients With Recurrent Ovarian Granulosa Cell Tumors

    NCT06169124 · start 2024-02-08

    Registered record
    Registry ID
    NCT06169124
    Conditions
    Adult Ovarian Granulosa Cell Tumor
    Interventions
    Biospecimen Collection; Chest Radiography; Computed Tomography; Darolutamide; Exemestane; Leuprolide Acetate; Magnetic Resonance Imaging; Positron Emission Tomography
    Study type
    INTERVENTIONAL
    Phase
    Phase 2
    Registry status
    Active not recruiting
    Start
    2024-02-08
    Completion
    2027-07-24
    Enrolment
    17

    As stored from ClinicalTrials.gov. Registration describes a study; it does not mean the study worked.

    ConditionAdult Ovarian Granulosa Cell Tumor
    InterventionBiospecimen Collection; Chest Radiography; Computed Tomography; Darolutamide +4 more
    PhasePhase 2
    Registry statusActive not recruiting

  • Saruparib (AZD5305) vs Placebo in Men With Metastatic Castration-Sensitive Prostate Cancer Receiving Physician's Choice New Hormonal Agents

    NCT06120491 · start 2023-11-21

    Registered record
    Registry ID
    NCT06120491
    Conditions
    Metastatic Castration-Sensitive Prostate Cancer
    Interventions
    Saruparib; Placebo; Abiraterone Acetate; Darolutamide; Enzalutamide
    Study type
    INTERVENTIONAL
    Phase
    Phase 3
    Registry status
    Active not recruiting
    Start
    2023-11-21
    Completion
    2031-04-30
    Enrolment
    1,898

    As stored from ClinicalTrials.gov. Registration describes a study; it does not mean the study worked.

    ConditionMetastatic Castration-Sensitive Prostate Cancer
    InterventionSaruparib; Placebo; Abiraterone Acetate; Darolutamide +1 more
    PhasePhase 3
    Registry statusActive not recruiting

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

    NCT05771896 · start 2023-09

    Registered record
    Registry ID
    NCT05771896
    Conditions
    Metastatic Prostate Cancer
    Interventions
    Darolutamide; Radium-223
    Study type
    INTERVENTIONAL
    Phase
    Phase 3
    Registry status
    Withdrawn
    Start
    2023-09
    Completion
    2029-04
    Enrolment
    0

    As stored from ClinicalTrials.gov. Registration describes a study; it does not mean the study worked.

    ConditionMetastatic Prostate Cancer
    InterventionDarolutamide; Radium-223
    PhasePhase 3
    Registry statusWithdrawn

  • Precision Treatment of Recurrent/Metastatic Salivary Gland Carcinoma Guided by Molecular Typing

    NCT06145308 · start 2023-08-15

    Registered record
    Registry ID
    NCT06145308
    Conditions
    Salivary Gland Carcinoma; Precision Therapy
    Interventions
    Cohort 1 (HER2-positive, RC48-ADC); Cohort 2 (NTRK-fusion or NTRK-mutant); Cohort 3 (AR-positive, leuprolide + bicalutamide + abiraterone); TROP2 ADC; TKI; Albumin-paclitaxel + platinum; Albumin-paclitaxel + carboplatin + apatinib + camrelizumab; albumin-bound paclitaxel+trastuzumab+pyrotinib; HER2,trastuzumab deruxtecan± pertuzumab; AR,AR antagonist ++ goserelin + pertuzumab + trastuzumab; AR,AR antagonist +goserelin +docetaxel; ivonescimab + investigator-choice platinum doublet+; iparomlimab + tuvonralimab; cadonilimab; CDK4/6 inhibitor+AI or fulvestrant; alpelisib+fulvestrant; PARP inhibitor; enfortumab vedotin; HER2, pyrotinib + pertuzumab/trastuzumab; vebecotutamab ±lenvatinib
    Study type
    INTERVENTIONAL
    Phase
    Phase 2
    Registry status
    Recruiting
    Start
    2023-08-15
    Completion
    2028-07-10
    Enrolment
    39

    As stored from ClinicalTrials.gov. Registration describes a study; it does not mean the study worked.

    ConditionSalivary Gland Carcinoma; Precision Therapy
    InterventionCohort 1 (HER2-positive, RC48-ADC); Cohort 2 (NTRK-fusion or NTRK-mutant); Cohort 3 (AR-positive, leuprolide + bicalutamide + abiraterone); TROP2 ADC +16 more
    PhasePhase 2
    Registry statusRecruiting

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

    NCT05900973 · start 2023-07-20

    Registered record
    Registry ID
    NCT05900973
    Conditions
    Prostate Cancer
    Interventions
    Darolutamide Oral Tablet [Nubeqa]
    Study type
    INTERVENTIONAL
    Phase
    Phase 2
    Registry status
    Unknown
    Start
    2023-07-20
    Completion
    2025-05-24
    Enrolment
    19

    As stored from ClinicalTrials.gov. Registration describes a study; it does not mean the study worked.

    ConditionProstate Cancer
    InterventionDarolutamide Oral Tablet [Nubeqa]
    PhasePhase 2
    Registry statusUnknown

  • A Trial Comparing Docetaxel 75 mg/m2 (3w) Versus Docetaxel 50 mg/m2 (2w) in Combination With Darolutamide + ADT in mHSPC Patients

    NCT05676203 · start 2023-05-16

    Registered record
    Registry ID
    NCT05676203
    Conditions
    Metastatic Hormone-Sensitive Prostate Cancer (mHSPC)
    Interventions
    Standard ADT (androgen deprivation therapy); Standard Darolutamide; Docetaxel
    Study type
    INTERVENTIONAL
    Phase
    Phase 3
    Registry status
    Active not recruiting
    Start
    2023-05-16
    Completion
    2026-12
    Enrolment
    250

    As stored from ClinicalTrials.gov. Registration describes a study; it does not mean the study worked.

    ConditionMetastatic Hormone-Sensitive Prostate Cancer (mHSPC)
    InterventionStandard ADT (androgen deprivation therapy); Standard Darolutamide; Docetaxel
    PhasePhase 3
    Registry statusActive not recruiting

  • A Study to Compare Darolutamide Given With Androgen Deprivation Therapy (ADT) and Placebo Given With ADT in Men With Hormone Sensitive Prostate Cancer and Raise of Prostate Specific Antigen (PSA) Levels After Local Therapies

    NCT05794906 · start 2023-04-03

    Registered record
    Registry ID
    NCT05794906
    Conditions
    Biochemically Recurrent Prostate Cancer
    Interventions
    Darolutamide (BAY1841788, Nubeqa); Placebo matching darolutamide; ADT
    Study type
    INTERVENTIONAL
    Phase
    Phase 3
    Registry status
    Active not recruiting
    Start
    2023-04-03
    Completion
    2030-03-29
    Enrolment
    985

    As stored from ClinicalTrials.gov. Registration describes a study; it does not mean the study worked.

    ConditionBiochemically Recurrent Prostate Cancer
    InterventionDarolutamide (BAY1841788, Nubeqa); Placebo matching darolutamide; ADT
    PhasePhase 3
    Registry statusActive not recruiting