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AMR Drug RepurposingSmart Screeningresearch prototype

Relugolix

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

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

Chemical structure

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

Existing / approved use

Documented · FDA, WHO, ChEMBL

Approved for

  • Metastatic prostate cancer
  • Neoplasm
  • Prostate adenocarcinoma
  • Prostate cancer

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

WHO therapeutic group
Other hormone antagonists and related agents
FDA pharmacologic class
Gonadotropin Releasing Hormone Receptor Antagonist FDA label ↗
Anti-infective classification
Not classified as an anti-infective.

Repurposing investigation

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

AI-predicted activity

AI prediction · nothing measured
  • MRSA55.4% AI-predicted activityAt or above the ≥40% mark this site uses to surface candidates.
  • E. coli43.9% AI-predicted activityAt or above the ≥40% mark this site uses to surface candidates.
  • K. pneumoniae31.7% AI-predicted activityBelow the ≥40% mark this site uses to surface candidates.
  • M. tuberculosis51.1% AI-predicted activityAt or above 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 Relugolix in ChEMBL Registered studies below

Docking

Computational · nothing measured

Dihydrofolate reductase ↗ (E. coli)

Not yet docked: queued in the docking rundetails

KPC-2 carbapenemase ↗ (K. pneumoniae)

Not yet docked: queued in the docking rundetails

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

Not yet docked: queued in the docking rundetails

Dihydrofolate reductase ↗ (MRSA)

Not yet docked: queued in the docking rundetails

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 Relugolix 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.

  • 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

  • Study of the Safety and Contraceptive Efficacy of Relugolix Combination Therapy in Women With Uterine Fibroids or Endometriosis Who Are at Risk for Pregnancy

    NCT04756037 · start 2021-03-18

    Registered record
    Registry ID
    NCT04756037
    Conditions
    Contraception
    Interventions
    Relugolix Combination Therapy
    Study type
    INTERVENTIONAL
    Phase
    Phase 3
    Registry status
    Completed
    Start
    2021-03-18
    Completion
    2026-03-31
    Enrolment
    1,164

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

    ConditionContraception
    InterventionRelugolix Combination Therapy
    PhasePhase 3
    Registry statusCompleted

  • Two Studies for Patients With High 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 High Gene Risk Score, The PREDICT-RT Trial

    NCT04513717 · start 2021-01-21

    Registered record
    Registry ID
    NCT04513717
    Conditions
    Prostate Adenocarcinoma; Stage III Prostate Cancer AJCC v8; Stage IVA Prostate Cancer AJCC v8
    Interventions
    Apalutamide; Bicalutamide; Biospecimen Collection; Bone Scan; Buserelin; Computed Tomography; Degarelix; Flutamide; Goserelin; Histrelin; Leuprolide; Magnetic Resonance Elastography; Positron Emission Tomography; Quality-of-Life Assessment; Questionnaire Administration; Radiation Therapy; Relugolix; Triptorelin
    Study type
    INTERVENTIONAL
    Phase
    Phase 3
    Registry status
    Active not recruiting
    Start
    2021-01-21
    Completion
    2038-12-31
    Enrolment
    2,753

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

    ConditionProstate Adenocarcinoma; Stage III Prostate Cancer AJCC v8; Stage IVA Prostate Cancer AJCC v8
    InterventionApalutamide; Bicalutamide; Biospecimen Collection; Bone Scan +14 more
    PhasePhase 3
    Registry statusActive not recruiting

  • A Study of the Effects of Erythromycin on the Pharmacokinetics of Relugolix, Estradiol, and Norethindrone in Healthy Postmenopausal Women and on the Pharmacokinetics of Relugolix in Healthy Adult Men

    NCT04714554 · start 2021-01-06

    Registered record
    Registry ID
    NCT04714554
    Conditions
    Healthy
    Interventions
    Relugolix/E2/NETA FDC; Relugolix; Erythromycin
    Study type
    INTERVENTIONAL
    Phase
    Phase 1
    Registry status
    Completed
    Start
    2021-01-06
    Completion
    2021-03-29
    Enrolment
    43

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

    ConditionHealthy
    InterventionRelugolix/E2/NETA FDC; Relugolix; Erythromycin
    PhasePhase 1
    Registry statusCompleted

  • Treating Prostate Cancer That Has Come Back After Surgery With Apalutamide and Targeted Radiation Based on PET Imaging

    NCT04423211 · start 2020-10-08

    Registered record
    Registry ID
    NCT04423211
    Conditions
    Biochemically Recurrent Prostate Carcinoma; Metastatic Prostate Carcinoma; Prostate Adenocarcinoma; Stage IVB Prostate Cancer AJCC v8
    Interventions
    3-Dimensional Conformal Radiation Therapy; Apalutamide; Computed Tomography; Degarelix; External Beam Radiation Therapy; Fluciclovine F18; Goserelin Acetate; Intensity-Modulated Proton Therapy; Intensity-Modulated Radiation Therapy; Leuprolide Acetate; Magnetic Resonance Imaging; Positron Emission Tomography; Quality-of-Life Assessment; Questionnaire Administration; Relugolix; Stereotactic Body Radiation Therapy; Triptorelin; Volume Modulated Arc Therapy
    Study type
    INTERVENTIONAL
    Phase
    Phase 3
    Registry status
    Recruiting
    Start
    2020-10-08
    Completion
    2032-12-31
    Enrolment
    804

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

    ConditionBiochemically Recurrent Prostate Carcinoma; Metastatic Prostate Carcinoma; Prostate Adenocarcinoma; Stage IVB Prostate Cancer AJCC v8
    Intervention3-Dimensional Conformal Radiation Therapy; Apalutamide; Computed Tomography; Degarelix +14 more
    PhasePhase 3
    Registry statusRecruiting

  • Clinical Study to Evaluate Efficacy and Safety of TAK-385 40 mg Compared With Leuprorelin in Patients With Endometriosis

    NCT03931915 · start 2019-05-08

    Registered record
    Registry ID
    NCT03931915
    Conditions
    Endometriosis
    Interventions
    TAK-385; Leuprorelin acetate
    Study type
    INTERVENTIONAL
    Phase
    Phase 3
    Registry status
    Completed
    Start
    2019-05-08
    Completion
    2020-09-28
    Enrolment
    335

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

    ConditionEndometriosis
    InterventionTAK-385; Leuprorelin acetate
    PhasePhase 3
    Registry statusCompleted

  • Study of Relugolix With Estradiol and Norethindrone Acetate in Women With Heavy Menstrual Bleeding Associated With Uterine Fibroids

    NCT03751124 · start 2018-10-16

    Registered record
    Registry ID
    NCT03751124
    Conditions
    Uterine Leiomyoma; Uterine Fibroids
    Interventions
    Relugolix; Estradiol/norethindrone acetate; Placebo for relugolix; Placebo for E2/NETA
    Study type
    INTERVENTIONAL
    Phase
    Phase 3
    Registry status
    Completed
    Start
    2018-10-16
    Completion
    2021-10-20
    Enrolment
    229

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

    ConditionUterine Leiomyoma; Uterine Fibroids
    InterventionRelugolix; Estradiol/norethindrone acetate; Placebo for relugolix; Placebo for E2/NETA
    PhasePhase 3
    Registry statusCompleted

  • SPIRIT EXTENSION: Efficacy and Safety Extension Study of Relugolix in Women With Endometriosis-Associated Pain

    NCT03654274 · start 2018-05-22

    Registered record
    Registry ID
    NCT03654274
    Conditions
    Endometriosis
    Interventions
    Relugolix; Estradiol/norethindrone acetate
    Study type
    INTERVENTIONAL
    Phase
    Phase 3
    Registry status
    Completed
    Start
    2018-05-22
    Completion
    2023-01-31
    Enrolment
    802

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

    ConditionEndometriosis
    InterventionRelugolix; Estradiol/norethindrone acetate
    PhasePhase 3
    Registry statusCompleted

  • SPIRIT 1: Efficacy and Safety Study of Relugolix in Women With Endometriosis-Associated Pain

    NCT03204318 · start 2017-12-07

    Registered record
    Registry ID
    NCT03204318
    Conditions
    Endometriosis Related Pain
    Interventions
    Relugolix; Estradiol/norethindrone acetate; Estradiol/norethindrone acetate placebo; Relugolix placebo
    Study type
    INTERVENTIONAL
    Phase
    Phase 3
    Registry status
    Completed
    Start
    2017-12-07
    Completion
    2021-04-08
    Enrolment
    638

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

    ConditionEndometriosis Related Pain
    InterventionRelugolix; Estradiol/norethindrone acetate; Estradiol/norethindrone acetate placebo; Relugolix placebo
    PhasePhase 3
    Registry statusCompleted

  • SPIRIT 2: Efficacy and Safety Study of Relugolix in Women With Endometriosis-Associated Pain

    NCT03204331 · start 2017-11-01

    Registered record
    Registry ID
    NCT03204331
    Conditions
    Endometriosis Related Pain
    Interventions
    Relugolix; Estradiol/norethindrone acetate; Estradiol/norethindrone acetate placebo; Relugolix placebo
    Study type
    INTERVENTIONAL
    Phase
    Phase 3
    Registry status
    Completed
    Start
    2017-11-01
    Completion
    2021-05-31
    Enrolment
    623

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

    ConditionEndometriosis Related Pain
    InterventionRelugolix; Estradiol/norethindrone acetate; Estradiol/norethindrone acetate placebo; Relugolix placebo
    PhasePhase 3
    Registry statusCompleted

  • LIBERTY 2: Efficacy & Safety Study of Relugolix in Women With Heavy Menstrual Bleeding Associated With Uterine Fibroids

    NCT03103087 · start 2017-06-14

    Registered record
    Registry ID
    NCT03103087
    Conditions
    Heavy Menstrual Bleeding; Uterine Fibroid
    Interventions
    Relugolix; Estradiol/norethindrone acetate; Relugolix placebo; Estradiol/norethindrone acetate placebo
    Study type
    INTERVENTIONAL
    Phase
    Phase 3
    Registry status
    Completed
    Start
    2017-06-14
    Completion
    2020-09-16
    Enrolment
    382

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

    ConditionHeavy Menstrual Bleeding; Uterine Fibroid
    InterventionRelugolix; Estradiol/norethindrone acetate; Relugolix placebo; Estradiol/norethindrone acetate placebo
    PhasePhase 3
    Registry statusCompleted

  • A Study to Evaluate the Safety and Efficacy of Relugolix in Men With Advanced Prostate Cancer

    NCT03085095 · start 2017-04-18

    Registered record
    Registry ID
    NCT03085095
    Conditions
    Prostate Cancer
    Interventions
    Relugolix; Leuprolide Acetate
    Study type
    INTERVENTIONAL
    Phase
    Phase 3
    Registry status
    Completed
    Start
    2017-04-18
    Completion
    2021-11-26
    Enrolment
    1,134

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

    ConditionProstate Cancer
    InterventionRelugolix; Leuprolide Acetate
    PhasePhase 3
    Registry statusCompleted

  • Study of Relugolix Alone and Relugolix Combined With Hormonal Add-Back Therapy in Healthy Premenopausal Female Participants

    NCT04978688 · start 2016-06-16

    Registered record
    Registry ID
    NCT04978688
    Conditions
    Healthy
    Interventions
    Relugolix; E2/NETA
    Study type
    INTERVENTIONAL
    Phase
    Phase 1
    Registry status
    Completed
    Start
    2016-06-16
    Completion
    2016-09-21
    Enrolment
    48

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

    ConditionHealthy
    InterventionRelugolix; E2/NETA
    PhasePhase 1
    Registry statusCompleted

  • A Phase 3 Study to Evaluate the Efficacy and Safety of Relugolix (TAK-385) 40 mg Compared With Leuprorelin in the Treatment of Uterine Fibroids

    NCT02655237 · start 2016-03-05

    Registered record
    Registry ID
    NCT02655237
    Conditions
    Uterine Fibroids
    Interventions
    Relugolix; Relugolix Placebo; Leuprorelin; Leuprorelin Placebo
    Study type
    INTERVENTIONAL
    Phase
    Phase 3
    Registry status
    Completed
    Start
    2016-03-05
    Completion
    2017-09-25
    Enrolment
    281

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

    ConditionUterine Fibroids
    InterventionRelugolix; Relugolix Placebo; Leuprorelin; Leuprorelin Placebo
    PhasePhase 3
    Registry statusCompleted

  • TAK-385 Phase I Absorption, Distribution, Metabolism, Excretion and Absolute Bioavailability Study

    NCT02252354 · start 2014-09

    Registered record
    Registry ID
    NCT02252354
    Conditions
    Healthy Volunteers
    Interventions
    [14C]-TAK-385 Oral Solution; TAK-385 Tablets; [14C]-TAK-385 Solution for Intravenous Infusion
    Study type
    INTERVENTIONAL
    Phase
    Phase 1
    Registry status
    Completed
    Start
    2014-09
    Completion
    2014-10
    Enrolment
    12

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

    ConditionHealthy Volunteers
    Intervention[14C]-TAK-385 Oral Solution; TAK-385 Tablets; [14C]-TAK-385 Solution for Intravenous Infusion
    PhasePhase 1
    Registry statusCompleted