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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.

  • A Study of Darolutamide Plus Androgen Deprivation Therapy in Patients With Metastatic Hormone-sensitive Prostate Cancer in India

    NCT07806591 · start 2026-10-05

    Registered record
    Registry ID
    NCT07806591
    Conditions
    Metastatic Hormone-Sensitive Prostate Cancer (mHSPC)
    Interventions
    Darolutamide plus androgen deprivation therapy
    Study type
    OBSERVATIONAL
    Phase
    Not recorded
    Registry status
    Not yet recruiting
    Start
    2026-10-05
    Completion
    2028-10-31
    Enrolment
    50

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

    ConditionMetastatic Hormone-Sensitive Prostate Cancer (mHSPC)
    InterventionDarolutamide plus androgen deprivation therapy
    PhaseNot recorded
    Registry statusNot yet recruiting

  • RISK-ADAPT Protocol in Metastatic Hormone-Sensitive Prostate Cancer (mHSPC)

    NCT07645326 · start 2026-08

    Registered record
    Registry ID
    NCT07645326
    Conditions
    Metastatic Hormone-sensitive Prostate Cancer (mHSPC)
    Interventions
    Androgen Deprivation Therapy (ADT); Androgen Receptor Pathway Inhibitor (ARPI); Prostate Radiation; Docetaxel
    Study type
    INTERVENTIONAL
    Phase
    Phase 2
    Registry status
    Not yet recruiting
    Start
    2026-08
    Completion
    2032-08
    Enrolment
    108

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

    ConditionMetastatic Hormone-sensitive Prostate Cancer (mHSPC)
    InterventionAndrogen Deprivation Therapy (ADT); Androgen Receptor Pathway Inhibitor (ARPI); Prostate Radiation; Docetaxel
    PhasePhase 2
    Registry statusNot yet recruiting

  • Phase I Study of QLC5508 in Advanced Solid Tumors: C-QTc, Pharmacokinetics (PK) Comparisons and Drug-drug Interaction

    NCT07620041 · start 2026-06-09

    Registered record
    Registry ID
    NCT07620041
    Conditions
    Refractory or Relapsed Solid Tumors
    Interventions
    QLC5508 (Investigational Product / Formulation T); QLC5508 (Reference Product / Formulation R); Itraconazole; Darolutamide; Rifampicin
    Study type
    INTERVENTIONAL
    Phase
    Phase 1
    Registry status
    Recruiting
    Start
    2026-06-09
    Completion
    2027-02-05
    Enrolment
    48

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

    ConditionRefractory or Relapsed Solid Tumors
    InterventionQLC5508 (Investigational Product / Formulation T); QLC5508 (Reference Product / Formulation R); Itraconazole; Darolutamide +1 more
    PhasePhase 1
    Registry statusRecruiting

  • A Study of Talazoparib With or Without Enzalutamide in People With Prostate Cancer Who Have Previously Received Abiraterone Acetate or Darolutamide

    NCT06844383 · start 2026-05-04

    Registered record
    Registry ID
    NCT06844383
    Conditions
    Prostate Cancer (Adenocarcinoma); mCRPC (Metastatic Castration-resistant Prostate Cancer)
    Interventions
    Talazoparib with enzalutamide; Talazoparib
    Study type
    INTERVENTIONAL
    Phase
    Phase 2
    Registry status
    Recruiting
    Start
    2026-05-04
    Completion
    2030-03
    Enrolment
    126

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

    ConditionProstate Cancer (Adenocarcinoma); mCRPC (Metastatic Castration-resistant Prostate Cancer)
    InterventionTalazoparib with enzalutamide; Talazoparib
    PhasePhase 2
    Registry statusRecruiting

  • 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.

    NCT07450599 · start 2026-04-27

    Registered record
    Registry ID
    NCT07450599
    Conditions
    High-risk Localized Prostate Cancer
    Interventions
    Darolutamide; ADT
    Study type
    INTERVENTIONAL
    Phase
    Phase 2
    Registry status
    Recruiting
    Start
    2026-04-27
    Completion
    2030-10-15
    Enrolment
    250

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

    ConditionHigh-risk Localized Prostate Cancer
    InterventionDarolutamide; ADT
    PhasePhase 2
    Registry statusRecruiting

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

    NCT07395804 · start 2026-04-14

    Registered record
    Registry ID
    NCT07395804
    Conditions
    Metastatic Hormone-sensitive Prostate Cancer (mHSPC)
    Interventions
    darolutamide plus ADT treatment
    Study type
    OBSERVATIONAL
    Phase
    Not recorded
    Registry status
    Recruiting
    Start
    2026-04-14
    Completion
    2031-02-15
    Enrolment
    500

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

    ConditionMetastatic Hormone-sensitive Prostate Cancer (mHSPC)
    Interventiondarolutamide plus ADT treatment
    PhaseNot recorded
    Registry statusRecruiting

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

    NCT07476677 · start 2026-04-01

    Registered record
    Registry ID
    NCT07476677
    Conditions
    Prostate Cancer
    Interventions
    Darolutamide; Darolutamide combined with ADT
    Study type
    INTERVENTIONAL
    Phase
    Phase 2
    Registry status
    Not yet recruiting
    Start
    2026-04-01
    Completion
    2028-03-31
    Enrolment
    60

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

    ConditionProstate Cancer
    InterventionDarolutamide; Darolutamide combined with ADT
    PhasePhase 2
    Registry statusNot yet recruiting

  • Supraphysiologic Testosterone Priming Induces Darolutamide Extended Response

    NCT07142551 · start 2026-03-09

    Registered record
    Registry ID
    NCT07142551
    Conditions
    Metastatic Castration-resistant Prostate Cancer
    Interventions
    Testosterone cypionate; Luteinizing hormone-releasing hormone (LHRH) analogue; Darolutamide
    Study type
    INTERVENTIONAL
    Phase
    Phase 2
    Registry status
    Recruiting
    Start
    2026-03-09
    Completion
    2034-06-01
    Enrolment
    60

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

    ConditionMetastatic Castration-resistant Prostate Cancer
    InterventionTestosterone cypionate; Luteinizing hormone-releasing hormone (LHRH) analogue; Darolutamide
    PhasePhase 2
    Registry statusRecruiting

  • Safety and Efficacy Evaluation of LC-K76 in Patients With Metastatic Hormone-Sensitive Prostate Cancer

    NCT07389174 · start 2026-02

    Registered record
    Registry ID
    NCT07389174
    Conditions
    mHSPC; mHNPC; Prostate Cancer Adenocarcinoma
    Interventions
    Standard Endocrine Therapy; LC-K76
    Study type
    INTERVENTIONAL
    Phase
    Early phase 1
    Registry status
    Not yet recruiting
    Start
    2026-02
    Completion
    2027-06
    Enrolment
    40

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

    ConditionmHSPC; mHNPC; Prostate Cancer Adenocarcinoma
    InterventionStandard Endocrine Therapy; LC-K76
    PhaseEarly phase 1
    Registry statusNot yet recruiting

  • 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)

    NCT07190300 · start 2026-01-13

    Registered record
    Registry ID
    NCT07190300
    Conditions
    Metastatic Hormone-Sensitive Prostate Cancer (mHSPC)
    Interventions
    Tulmimetostat; Darolutamide; Abiraterone
    Study type
    INTERVENTIONAL
    Phase
    Phase 1 / Phase 2
    Registry status
    Recruiting
    Start
    2026-01-13
    Completion
    2032-08-02
    Enrolment
    181

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

    ConditionMetastatic Hormone-Sensitive Prostate Cancer (mHSPC)
    InterventionTulmimetostat; Darolutamide; Abiraterone
    PhasePhase 1 / Phase 2
    Registry statusRecruiting

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

    NCT07282197 · start 2026-01

    Registered record
    Registry ID
    NCT07282197
    Conditions
    Prostate Cancer
    Interventions
    Darolutamide (BAY 1841788)
    Study type
    INTERVENTIONAL
    Phase
    Phase 2
    Registry status
    Not yet recruiting
    Start
    2026-01
    Completion
    2029-06
    Enrolment
    40

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

    ConditionProstate Cancer
    InterventionDarolutamide (BAY 1841788)
    PhasePhase 2
    Registry statusNot yet recruiting

  • A Study of Valemetostat (DS-3201b) in Combination With Darolutamide in Metastatic Castration Resistant Prostate Cancer (mCRPC)

    NCT07244341 · start 2025-12-03

    Registered record
    Registry ID
    NCT07244341
    Conditions
    Metastatic Castration-resistant Prostate Cancer
    Interventions
    Valemetostat; Darolutamide
    Study type
    INTERVENTIONAL
    Phase
    Phase 1
    Registry status
    Recruiting
    Start
    2025-12-03
    Completion
    2029-11-30
    Enrolment
    60

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

    ConditionMetastatic Castration-resistant Prostate Cancer
    InterventionValemetostat; Darolutamide
    PhasePhase 1
    Registry statusRecruiting

  • CONVERT-HB1: Radical Prostatectomy After Systemic Therapy for High-volume Metastatic Hormone-sensitive Prostate Cancer

    NCT07268794 · start 2025-11-30

    Registered record
    Registry ID
    NCT07268794
    Conditions
    Metastatic Prostate Cancer; Prostate Cancer (Adenocarcinoma); Metastatic Hormone-Sensitive Prostate Cancer (mHSPC)
    Interventions
    Androgen Deprivation Therapy (ADT); Docetaxel; PARP Inhibitors and Other Systemic Agents; Radical Prostatectomy; Prostate Radiotherapy
    Study type
    INTERVENTIONAL
    Phase
    Phase 2
    Registry status
    Not yet recruiting
    Start
    2025-11-30
    Completion
    2027-12-30
    Enrolment
    112

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

    ConditionMetastatic Prostate Cancer; Prostate Cancer (Adenocarcinoma); Metastatic Hormone-Sensitive Prostate Cancer (mHSPC)
    InterventionAndrogen Deprivation Therapy (ADT); Docetaxel; PARP Inhibitors and Other Systemic Agents; Radical Prostatectomy +1 more
    PhasePhase 2
    Registry statusNot yet recruiting

  • A Clinical Study of KTX-2001 in Subjects With Metastatic Castration-Resistant Prostate Cancer (STRIKE-001)

    NCT07103018 · start 2025-11-21

    Registered record
    Registry ID
    NCT07103018
    Conditions
    Metastatic Castration-resistant Prostate Cancer; Metastatic Castration-Resistant Prostate Cancer Patients; Metastatic Castration-resistant Prostate Cancer, mCRPC; mCRPC; mCRPC (Metastatic Castration-resistant Prostate Cancer)
    Interventions
    KTX-2001; KTX-2001 + Darolutamide (NUBEQA®)
    Study type
    INTERVENTIONAL
    Phase
    Phase 1
    Registry status
    Recruiting
    Start
    2025-11-21
    Completion
    2028-09
    Enrolment
    144

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

    ConditionMetastatic Castration-resistant Prostate Cancer; Metastatic Castration-Resistant Prostate Cancer Patients; Metastatic Castration-resistant Prostate Cancer, mCRPC; mCRPC +1 more
    InterventionKTX-2001; KTX-2001 + Darolutamide (NUBEQA®)
    PhasePhase 1
    Registry statusRecruiting

  • An Open-label Study of Lutetium (177Lu) Vipivotide Tetraxetan (AAA617) in Combination With ARPI Versus AAA617 in PSMA Positive First-line mCRPC

    NCT06894511 · start 2025-09-11

    Registered record
    Registry ID
    NCT06894511
    Conditions
    Metastatic Castration Resistant Prostate Cancer (mCRPC)
    Interventions
    AAA617; ARPI: Abiraterone; ARPI: Enzalutamide
    Study type
    INTERVENTIONAL
    Phase
    Phase 2
    Registry status
    Active not recruiting
    Start
    2025-09-11
    Completion
    2026-10-15
    Enrolment
    7

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

    ConditionMetastatic Castration Resistant Prostate Cancer (mCRPC)
    InterventionAAA617; ARPI: Abiraterone; ARPI: Enzalutamide
    PhasePhase 2
    Registry statusActive not recruiting