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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 E. coli and MRSA. 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.

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 to Evaluate CCS1477 in Advanced Tumours

    NCT03568656 · start 2018-07-23

    Registered record
    Registry ID
    NCT03568656
    Conditions
    Metastatic Castration-Resistant Prostate Cancer; Metastatic Breast Cancer; Non-small Cell Lung Cancer; Advanced Solid Tumors
    Interventions
    CCS1477; Abiraterone acetate; Enzalutamide; Darolutamide; Olaparib; Atezolizumab
    Study type
    INTERVENTIONAL
    Phase
    Phase 1 / Phase 2
    Registry status
    Completed
    Start
    2018-07-23
    Completion
    2025-07-06
    Enrolment
    220

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

    ConditionMetastatic Castration-Resistant Prostate Cancer; Metastatic Breast Cancer; Non-small Cell Lung Cancer; Advanced Solid Tumors
    InterventionCCS1477; Abiraterone acetate; Enzalutamide; Darolutamide +2 more
    PhasePhase 1 / Phase 2
    Registry statusCompleted
  • 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

    NCT06473259 · start 2016-12-16

    Registered record
    Registry ID
    NCT06473259
    Conditions
    Prostate Cancer; Hormone Sensitive Prostate Cancer; Metastatic Tumor
    Interventions
    Docetaxel; Apalutamide Oral Tablet; Enzalutamide Oral Tablet; Abiraterone acetate tablets; Darolutamide Oral Tablet; radiotherapy; Triptorelin
    Study type
    OBSERVATIONAL
    Phase
    Not recorded
    Registry status
    Recruiting
    Start
    2016-12-16
    Completion
    2028-12
    Enrolment
    3,000

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

    ConditionProstate Cancer; Hormone Sensitive Prostate Cancer; Metastatic Tumor
    InterventionDocetaxel; Apalutamide Oral Tablet; Enzalutamide Oral Tablet; Abiraterone acetate tablets +3 more
    PhaseNot recorded
    Registry statusRecruiting
  • Drug-drug Interaction Study Using Rosuvastatin as a Breast Cancer Resistant Protein (Efflux Transporter), Organic Anion-transporting Polypeptide (OATP)1B1, and OATP1B3 (Uptake Transporters) Probe Substrate

    NCT02671097 · start 2016-02

    Registered record
    Registry ID
    NCT02671097
    Conditions
    Healthy Volunteers; Pharmacokinetics; Drug Interaction
    Interventions
    Rosuvastatin; BAY1841788 (ODM-201)
    Study type
    INTERVENTIONAL
    Phase
    Phase 1
    Registry status
    Completed
    Start
    2016-02
    Completion
    2016-08
    Enrolment
    30

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

    ConditionHealthy Volunteers; Pharmacokinetics; Drug Interaction
    InterventionRosuvastatin; BAY1841788 (ODM-201)
    PhasePhase 1
    Registry statusCompleted
  • Mass Balance, Pharmacokinetics, Biotransformation and Bioavailability Study of ODM-201 in Healthy Male Subjects

    NCT02418650 · start 2015-03

    Registered record
    Registry ID
    NCT02418650
    Conditions
    Healthy
    Interventions
    ODM-201 300 mg tablet; intravenous14C-ODM-201; 300 mg 14C-ODM-201 oral solution
    Study type
    INTERVENTIONAL
    Phase
    Phase 1
    Registry status
    Completed
    Start
    2015-03
    Completion
    2015-06
    Enrolment
    12

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

    ConditionHealthy
    InterventionODM-201 300 mg tablet; intravenous14C-ODM-201; 300 mg 14C-ODM-201 oral solution
    PhasePhase 1
    Registry statusCompleted
  • Safety and Pharmacokinetics Study of ODM-201 in Castrate Resistant Prostate Cancer

    NCT01317641 · start 2011-03

    Registered record
    Registry ID
    NCT01317641
    Conditions
    Prostate Cancer
    Interventions
    ODM-201
    Study type
    INTERVENTIONAL
    Phase
    Phase 1 / Phase 2
    Registry status
    Completed
    Start
    2011-03
    Completion
    2013-07
    Enrolment
    136

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

    ConditionProstate Cancer
    InterventionODM-201
    PhasePhase 1 / Phase 2
    Registry statusCompleted