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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.

  • Study of JANX007 in Subjects With Metastatic Castration-Resistant Prostate Cancer (ENGAGER-PSMA-01)

    NCT05519449 · start 2022-09-15

    Registered record
    Registry ID
    NCT05519449
    Conditions
    Prostate Cancer; Metastatic Castration-resistant Prostate Cancer; Castration Resistant Prostatic Cancer
    Interventions
    JANX007; Darolutamide
    Study type
    INTERVENTIONAL
    Phase
    Phase 1
    Registry status
    Recruiting
    Start
    2022-09-15
    Completion
    2028-12
    Enrolment
    272

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

    ConditionProstate Cancer; Metastatic Castration-resistant Prostate Cancer; Castration Resistant Prostatic Cancer
    InterventionJANX007; Darolutamide
    PhasePhase 1
    Registry statusRecruiting

  • Study of ORIC-944 in Patients With Metastatic Prostate Cancer

    NCT05413421 · start 2022-06-01

    Registered record
    Registry ID
    NCT05413421
    Conditions
    Metastatic Prostate Cancer
    Interventions
    ORIC-944; Abiraterone acetate (Zytiga®) 250 mg or 500 mg tablets; Apalutamide (Erleada™) 60 mg or 240 mg tablets; Darolutamide (Nubeqa®) 300 mg tablets; Enzalutamide (Xtandi®) 40 mg capsules or 40 mg and 80 mg tablets
    Study type
    INTERVENTIONAL
    Phase
    Phase 1
    Registry status
    Recruiting
    Start
    2022-06-01
    Completion
    2028-04
    Enrolment
    275

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

    ConditionMetastatic Prostate Cancer
    InterventionORIC-944; Abiraterone acetate (Zytiga®) 250 mg or 500 mg tablets; Apalutamide (Erleada™) 60 mg or 240 mg tablets; Darolutamide (Nubeqa®) 300 mg tablets +1 more
    PhasePhase 1
    Registry statusRecruiting

  • 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

    NCT05362149 · start 2022-04-04

    Registered record
    Registry ID
    NCT05362149
    Conditions
    Non-metastatic Castration-resistant Prostate Cancer
    Interventions
    Darolutamide (Nubeqa, BAY1841788); Enzalutamide; Apalutamide
    Study type
    OBSERVATIONAL
    Phase
    Not recorded
    Registry status
    Completed
    Start
    2022-04-04
    Completion
    2023-06-30
    Enrolment
    870

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

    ConditionNon-metastatic Castration-resistant Prostate Cancer
    InterventionDarolutamide (Nubeqa, BAY1841788); Enzalutamide; Apalutamide
    PhaseNot recorded
    Registry statusCompleted

  • 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

    NCT05202301 · start 2022-01-15

    Registered record
    Registry ID
    NCT05202301
    Conditions
    Prostate Cancer
    Interventions
    Darolutamide (Nubeqa, BAY1841788); Enzalutamide; Apalutamide
    Study type
    OBSERVATIONAL
    Phase
    Not recorded
    Registry status
    Completed
    Start
    2022-01-15
    Completion
    2025-07-15
    Enrolment
    13,779

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

    ConditionProstate Cancer
    InterventionDarolutamide (Nubeqa, BAY1841788); Enzalutamide; Apalutamide
    PhaseNot recorded
    Registry statusCompleted

  • Two Studies for Patients With Unfavorable Intermediate Risk Prostate Cancer Testing Less Intense Treatment for Patients With a Low Gene Risk Score and Testing a More Intense Treatment for Patients With a Higher Gene Risk Score, The Guidance Trial

    NCT05050084 · start 2021-12-06

    Registered record
    Registry ID
    NCT05050084
    Conditions
    Prostate Adenocarcinoma
    Interventions
    Bicalutamide; Buserelin; Darolutamide; Degarelix; Flutamide; Goserelin; Histrelin; Leuprolide; Radiation Therapy; Relugolix; Triptorelin
    Study type
    INTERVENTIONAL
    Phase
    Phase 3
    Registry status
    Active not recruiting
    Start
    2021-12-06
    Completion
    2031-11-11
    Enrolment
    2,050

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

    ConditionProstate Adenocarcinoma
    InterventionBicalutamide; Buserelin; Darolutamide; Degarelix +7 more
    PhasePhase 3
    Registry statusActive not recruiting

  • Darolutamide + Androgen Deprivation Therapy (ADT) in Chinese Men With High Risk, Nonmetastatic Prostate Cancer

    NCT05171387 · start 2021-11-30

    Registered record
    Registry ID
    NCT05171387
    Conditions
    Prostate Cancer
    Interventions
    Darolutamide 600 mg twice daily; Androgen deprivation therapy (ADT)
    Study type
    INTERVENTIONAL
    Phase
    Phase 2
    Registry status
    Completed
    Start
    2021-11-30
    Completion
    2025-02-24
    Enrolment
    78

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

    ConditionProstate Cancer
    InterventionDarolutamide 600 mg twice daily; Androgen deprivation therapy (ADT)
    PhasePhase 2
    Registry statusCompleted

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

    NCT04925648 · start 2021-10-18

    Registered record
    Registry ID
    NCT04925648
    Conditions
    Metastatic Prostate Cancer
    Interventions
    Dasatinib; Darolutamide
    Study type
    INTERVENTIONAL
    Phase
    Phase 2
    Registry status
    Completed
    Start
    2021-10-18
    Completion
    2025-12-01
    Enrolment
    4

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

    ConditionMetastatic Prostate Cancer
    InterventionDasatinib; Darolutamide
    PhasePhase 2
    Registry statusCompleted

  • Phase I/II Trial of Pembrolizumab and Androgen-receptor Inhibitor With or Without 225Ac-J591 for Progressive Metastatic Castration Resistant Prostate Cancer

    NCT04946370 · start 2021-08-12

    Registered record
    Registry ID
    NCT04946370
    Conditions
    Prostate Cancer
    Interventions
    225Ac-J591; Pembrolizumab; Androgen receptor inhibitor; 68Ga-PSMA-11
    Study type
    INTERVENTIONAL
    Phase
    Phase 1 / Phase 2
    Registry status
    Recruiting
    Start
    2021-08-12
    Completion
    2029-12
    Enrolment
    52

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

    ConditionProstate Cancer
    Intervention225Ac-J591; Pembrolizumab; Androgen receptor inhibitor; 68Ga-PSMA-11
    PhasePhase 1 / Phase 2
    Registry statusRecruiting

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

    NCT04737109 · start 2021-07-13

    Registered record
    Registry ID
    NCT04737109
    Conditions
    Castrate Resistant Prostate Cancer
    Interventions
    Ipatasertib; Darolutamide; Androgen Deprivation Therapy
    Study type
    INTERVENTIONAL
    Phase
    Phase 1 / Phase 2
    Registry status
    Terminated
    Start
    2021-07-13
    Completion
    2022-08-15
    Enrolment
    6

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

    ConditionCastrate Resistant Prostate Cancer
    InterventionIpatasertib; Darolutamide; Androgen Deprivation Therapy
    PhasePhase 1 / Phase 2
    Registry statusTerminated

  • A Safety and Dose-finding Study of PRL-02 Depot in Men With Advanced Prostate Cancer

    NCT04729114 · start 2021-06-14

    Registered record
    Registry ID
    NCT04729114
    Conditions
    Prostate Cancer; Metastatic Castration Resistant Prostate Cancer; Metastatic Castration-sensitive Prostate Cancer
    Interventions
    PRL-02 injection; prednisone; dexamethasone; enzalutamide
    Study type
    INTERVENTIONAL
    Phase
    Phase 1
    Registry status
    Recruiting
    Start
    2021-06-14
    Completion
    2029-05-31
    Enrolment
    174

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

    ConditionProstate Cancer; Metastatic Castration Resistant Prostate Cancer; Metastatic Castration-sensitive Prostate Cancer
    InterventionPRL-02 injection; prednisone; dexamethasone; enzalutamide
    PhasePhase 1
    Registry statusRecruiting

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

    NCT04558866 · start 2021-06-09

    Registered record
    Registry ID
    NCT04558866
    Conditions
    Prostate Cancer
    Interventions
    Testosterone Cypionate; Darolutamide
    Study type
    INTERVENTIONAL
    Phase
    Phase 2
    Registry status
    Completed
    Start
    2021-06-09
    Completion
    2024-04-02
    Enrolment
    51

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

    ConditionProstate Cancer
    InterventionTestosterone Cypionate; Darolutamide
    PhasePhase 2
    Registry statusCompleted

  • Testing the Addition of Darolutamide to Hormonal Therapy (Androgen Deprivation Therapy [ADT]) After Surgery for Men With High-Risk Prostate Cancer, The ERADICATE Study

    NCT04484818 · start 2021-03-01

    Registered record
    Registry ID
    NCT04484818
    Conditions
    Prostate Carcinoma
    Interventions
    Darolutamide; Goserelin Acetate; Leuprolide Acetate; Placebo Administration; Quality-of-Life Assessment; Triptorelin
    Study type
    INTERVENTIONAL
    Phase
    Phase 3
    Registry status
    Active not recruiting
    Start
    2021-03-01
    Completion
    2028-05-31
    Enrolment
    27

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

    ConditionProstate Carcinoma
    InterventionDarolutamide; Goserelin Acetate; Leuprolide Acetate; Placebo Administration +2 more
    PhasePhase 3
    Registry statusActive not recruiting

  • Darolutamide in Addition to ADT Versus ADT in Metastatic Hormone-sensitive Prostate Cancer

    NCT04736199 · start 2021-02-23

    Registered record
    Registry ID
    NCT04736199
    Conditions
    Prostatic Neoplasms
    Interventions
    Darolutamide (Nubeqa, BAY1841788); Placebo; Androgen deprivation therapy (ADT)
    Study type
    INTERVENTIONAL
    Phase
    Phase 3
    Registry status
    Completed
    Start
    2021-02-23
    Completion
    2026-01-23
    Enrolment
    669

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

    ConditionProstatic Neoplasms
    InterventionDarolutamide (Nubeqa, BAY1841788); Placebo; Androgen deprivation therapy (ADT)
    PhasePhase 3
    Registry statusCompleted

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

    NCT05694819 · start 2020-04-17

    Registered record
    Registry ID
    NCT05694819
    Conditions
    Salivary Gland Cancer
    Interventions
    Darolutamide; Goserelin
    Study type
    INTERVENTIONAL
    Phase
    Phase 2
    Registry status
    Completed
    Start
    2020-04-17
    Completion
    2026-03-23
    Enrolment
    57

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

    ConditionSalivary Gland Cancer
    InterventionDarolutamide; Goserelin
    PhasePhase 2
    Registry statusCompleted

  • A Study of CHeckpoint Inhibitors in Men With prOgressive Metastatic Castrate Resistant Prostate Cancer Characterized by a Mismatch Repair Deficiency or Biallelic CDK12 Inactivation

    NCT04104893 · start 2020-02-20

    Registered record
    Registry ID
    NCT04104893
    Conditions
    Metastatic Castration Resistant Prostate Cancer
    Interventions
    Pembrolizumab
    Study type
    INTERVENTIONAL
    Phase
    Phase 2
    Registry status
    Active not recruiting
    Start
    2020-02-20
    Completion
    2026-12-31
    Enrolment
    40

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

    ConditionMetastatic Castration Resistant Prostate Cancer
    InterventionPembrolizumab
    PhasePhase 2
    Registry statusActive not recruiting