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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 M. tuberculosis, 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
  • 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.

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.

  • The University of Miami Adapt (UAdapt) Trial

    NCT06111313 · start 2024-11-06

    Registered record
    Registry ID
    NCT06111313
    Conditions
    Prostate Cancer
    Interventions
    FTLEAD; Ultra-Short-Term Androgen Deprivation Therapy with Relugolix; HypoLEAD; ADT Standard of Care
    Study type
    INTERVENTIONAL
    Phase
    Phase 2
    Registry status
    Recruiting
    Start
    2024-11-06
    Completion
    2033-11-30
    Enrolment
    130

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

    ConditionProstate Cancer
    InterventionFTLEAD; Ultra-Short-Term Androgen Deprivation Therapy with Relugolix; HypoLEAD; ADT Standard of Care
    PhasePhase 2
    Registry statusRecruiting
  • The Effect of Medical Management Following Excisional Surgery for Endometriosis: A Randomized Controlled Trial

    NCT06439524 · start 2024-08-15

    Registered record
    Registry ID
    NCT06439524
    Conditions
    Endometriosis
    Interventions
    40 mg relugolix, 1 mg estradiol, 0.5 mg norethindrone acetate
    Study type
    INTERVENTIONAL
    Phase
    Phase 3
    Registry status
    Recruiting
    Start
    2024-08-15
    Completion
    2028-12-01
    Enrolment
    110

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

    ConditionEndometriosis
    Intervention40 mg relugolix, 1 mg estradiol, 0.5 mg norethindrone acetate
    PhasePhase 3
    Registry statusRecruiting
  • NEPC Study: An Exploratory Safety and Efficacy Study With PSMA, SSTR2 and GRPR Targeted Radioligand Therapy in Metastatic Neuroendocrine Prostate Cancer.

    NCT06379217 · start 2024-07-29

    Registered record
    Registry ID
    NCT06379217
    Conditions
    Metastatic Neuroendocrine Prostate Cancer
    Interventions
    [68Ga]Ga-PSMA-11; [68Ga]GA-DOTA-TATE; [68Ga]Ga-NeoB; [177Lu]Lu-PSMA-617; [177Lu]Lu-DOTA-TATE; [177Lu]Lu-NeoB; L-Lysine HCl-L-Arginine HCl, 2.5 %,; Gonadotropin-releasing hormone (GnRH) analogues; GnRH antagonists; Antiemetics & antinauseants; Metoclopramide
    Study type
    INTERVENTIONAL
    Phase
    Phase 1
    Registry status
    Active not recruiting
    Start
    2024-07-29
    Completion
    2026-08-31
    Enrolment
    31

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

    ConditionMetastatic Neuroendocrine Prostate Cancer
    Intervention[68Ga]Ga-PSMA-11; [68Ga]GA-DOTA-TATE; [68Ga]Ga-NeoB; [177Lu]Lu-PSMA-617 +7 more
    PhasePhase 1
    Registry statusActive not recruiting
  • Phenotyping of Idiopathic Pelvic Pain With Real-time Uterine Imaging and Relugolix-Combination Therapy Treatment

    NCT06279195 · start 2024-06-01

    Registered record
    Registry ID
    NCT06279195
    Conditions
    Pelvic Pain
    Interventions
    Relugolix (40 mg) /estradiol (1 mg)/norethisterone acetate (0.5 mg) oral tablet
    Study type
    INTERVENTIONAL
    Phase
    Phase 2
    Registry status
    Withdrawn
    Start
    2024-06-01
    Completion
    2025-11-02
    Enrolment
    0

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

    ConditionPelvic Pain
    InterventionRelugolix (40 mg) /estradiol (1 mg)/norethisterone acetate (0.5 mg) oral tablet
    PhasePhase 2
    Registry statusWithdrawn
  • Single-Dose Pharmacokinetics of Oral Testosterone Undecanoate With and Without Concomitant Inhibition of UGT2B17

    NCT06312761 · start 2024-06-01

    Registered record
    Registry ID
    NCT06312761
    Conditions
    Hypogonadism, Male
    Interventions
    Relugolix 120Mg Tab; Curcumin; Testosterone Undecanoate 237 MG Oral Capsule
    Study type
    INTERVENTIONAL
    Phase
    Phase 1 / Phase 2
    Registry status
    Unknown
    Start
    2024-06-01
    Completion
    2025-12-31
    Enrolment
    10

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

    ConditionHypogonadism, Male
    InterventionRelugolix 120Mg Tab; Curcumin; Testosterone Undecanoate 237 MG Oral Capsule
    PhasePhase 1 / Phase 2
    Registry statusUnknown
  • ADT and SBRT vs SBRT Alone for Unfavorable Intermediate Risk Prostate Cancer

    NCT06397703 · start 2024-04-16

    Registered record
    Registry ID
    NCT06397703
    Conditions
    Prostate Cancer
    Interventions
    Leuprolide, Degarelix or Relugolix; Stereotactic body radiation therapy/radiosurgery (SBRT)
    Study type
    INTERVENTIONAL
    Phase
    Phase 2
    Registry status
    Recruiting
    Start
    2024-04-16
    Completion
    2031-04-16
    Enrolment
    392

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

    ConditionProstate Cancer
    InterventionLeuprolide, Degarelix or Relugolix; Stereotactic body radiation therapy/radiosurgery (SBRT)
    PhasePhase 2
    Registry statusRecruiting
  • The SUGAR Study; SBRT and Relugolix) for Prostate Cancer

    NCT06111781 · start 2024-04-15

    Registered record
    Registry ID
    NCT06111781
    Conditions
    Prostate Cancer
    Interventions
    Relugolix 120 MG [Orgovyx]; SBRT standard of care radiotherapy treatment
    Study type
    INTERVENTIONAL
    Phase
    Phase 2
    Registry status
    Recruiting
    Start
    2024-04-15
    Completion
    2028-02
    Enrolment
    60

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

    ConditionProstate Cancer
    InterventionRelugolix 120 MG [Orgovyx]; SBRT standard of care radiotherapy treatment
    PhasePhase 2
    Registry statusRecruiting
  • Difluoromethylornithine and High Dose Testosterone With Enzalutamide in Metastatic Castration-Resistant Prostate Cancer

    NCT06059118 · start 2023-10-04

    Registered record
    Registry ID
    NCT06059118
    Conditions
    Prostate Cancer
    Interventions
    DFMO; testosterone cypionate; Luteinizing hormone-releasing hormone (LHRH) analogue; Enzalutamide
    Study type
    INTERVENTIONAL
    Phase
    Phase 2
    Registry status
    Recruiting
    Start
    2023-10-04
    Completion
    2029-11-30
    Enrolment
    50

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

    ConditionProstate Cancer
    InterventionDFMO; testosterone cypionate; Luteinizing hormone-releasing hormone (LHRH) analogue; Enzalutamide
    PhasePhase 2
    Registry statusRecruiting
  • A Phase 3B Study to Evaluate Bone Mineral Density With Long-Term Use of Relugolix Combination Tablet in Women With Uterine Fibroids or Endometriosis

    NCT05862272 · start 2023-08-14

    Registered record
    Registry ID
    NCT05862272
    Conditions
    Uterine Fibroids; Endometriosis
    Interventions
    Relugolix Combination Tablet
    Study type
    INTERVENTIONAL
    Phase
    Phase 3
    Registry status
    Recruiting
    Start
    2023-08-14
    Completion
    2030-09
    Enrolment
    1,000

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

    ConditionUterine Fibroids; Endometriosis
    InterventionRelugolix Combination Tablet
    PhasePhase 3
    Registry statusRecruiting
  • Relugolix Pregnancy Registry: An Observational Study of the Safety of Relugolix-Containing Therapy Exposure in Pregnant Women and Their Offspring

    NCT05739123 · start 2023-05-08

    Registered record
    Registry ID
    NCT05739123
    Conditions
    Pregnancy Related; Pregnancy Complications; Pregnancy, High Risk
    Interventions
    Relugolix-Containing Product
    Study type
    OBSERVATIONAL
    Phase
    Not recorded
    Registry status
    Recruiting
    Start
    2023-05-08
    Completion
    2033-05
    Enrolment
    728

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

    ConditionPregnancy Related; Pregnancy Complications; Pregnancy, High Risk
    InterventionRelugolix-Containing Product
    PhaseNot recorded
    Registry statusRecruiting
  • A Study of Extending Relugolix Dosing Intervals Through Addition of Itraconazole or Ritonavir in Prostate Cancer Patients

    NCT05679388 · start 2023-02-13

    Registered record
    Registry ID
    NCT05679388
    Conditions
    Prostate Cancer; Prostate Cancer Metastatic; Prostate Adenocarcinoma
    Interventions
    Relugolix Pill; Ritonavir; Itraconazole
    Study type
    INTERVENTIONAL
    Phase
    Phase 1
    Registry status
    Terminated
    Start
    2023-02-13
    Completion
    2024-08-05
    Enrolment
    60

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

    ConditionProstate Cancer; Prostate Cancer Metastatic; Prostate Adenocarcinoma
    InterventionRelugolix Pill; Ritonavir; Itraconazole
    PhasePhase 1
    Registry statusTerminated
  • Randomized Study to Evaluate MACE in Patients With Prostate Cancer Treated With Relugolix or Leuprolide Acetate

    NCT05605964 · start 2023-01-28

    Registered record
    Registry ID
    NCT05605964
    Conditions
    Prostate Cancer
    Interventions
    Relugolix; Leuprolide Acetate
    Study type
    INTERVENTIONAL
    Phase
    Phase 3
    Registry status
    Completed
    Start
    2023-01-28
    Completion
    2024-12-31
    Enrolment
    387

    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
  • Testing Interruption of Hormonal Medications in Patients Responding Exceptionally to Therapy for Metastatic Prostate Cancer, (A-DREAM)

    NCT05241860 · start 2022-11-21

    Registered record
    Registry ID
    NCT05241860
    Conditions
    Castration-Sensitive Prostate Carcinoma; Metastatic Prostate Carcinoma; Stage IV Prostate Cancer AJCC v8; Stage IVA Prostate Cancer AJCC v8; Stage IVB Prostate Cancer AJCC v8
    Interventions
    Pharmacotherapy Discontinuation; Follow-Up; Questionnaire Administration; Quality-of-Life Assessment
    Study type
    INTERVENTIONAL
    Phase
    Phase 2
    Registry status
    Active not recruiting
    Start
    2022-11-21
    Completion
    2033-09-01
    Enrolment
    79

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

    ConditionCastration-Sensitive Prostate Carcinoma; Metastatic Prostate Carcinoma; Stage IV Prostate Cancer AJCC v8; Stage IVA Prostate Cancer AJCC v8 +1 more
    InterventionPharmacotherapy Discontinuation; Follow-Up; Questionnaire Administration; Quality-of-Life Assessment
    PhasePhase 2
    Registry statusActive not recruiting
  • Testing the Addition of the Drug Relugolix to the Usual Radiation Therapy for Advanced-Stage Prostate Cancer, The NRG Promethean Study

    NCT05053152 · start 2022-04-20

    Registered record
    Registry ID
    NCT05053152
    Conditions
    Oligometastatic Prostate Carcinoma; Prostate Adenocarcinoma; Prostate Ductal Adenocarcinoma; Prostate Intraductal Carcinoma; Stage IVB Prostate Cancer AJCC v8
    Interventions
    Biospecimen Collection; Bone Scan; Computed Tomography; Fluciclovine F18; Magnetic Resonance Imaging; Placebo Administration; Positron Emission Tomography; PSMA PET Scan; Relugolix; Stereotactic Body Radiation Therapy
    Study type
    INTERVENTIONAL
    Phase
    Phase 2
    Registry status
    Active not recruiting
    Start
    2022-04-20
    Completion
    2034-02-01
    Enrolment
    194

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

    ConditionOligometastatic Prostate Carcinoma; Prostate Adenocarcinoma; Prostate Ductal Adenocarcinoma; Prostate Intraductal Carcinoma +1 more
    InterventionBiospecimen Collection; Bone Scan; Computed Tomography; Fluciclovine F18 +6 more
    PhasePhase 2
    Registry statusActive not recruiting
  • First Strike, Second Strike Therapies for High Risk Metastatic Castration Sensitive Prostate Cancer

    NCT05189457 · start 2022-01-25

    Registered record
    Registry ID
    NCT05189457
    Conditions
    Prostate Cancer; Stage IV Prostate Cancer
    Interventions
    Luteinizing Hormone Releasing Hormone; New Hormonal Agent; Docetaxel; Tislelizumab
    Study type
    INTERVENTIONAL
    Phase
    Phase 2
    Registry status
    Active not recruiting
    Start
    2022-01-25
    Completion
    2028-07
    Enrolment
    32

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

    ConditionProstate Cancer; Stage IV Prostate Cancer
    InterventionLuteinizing Hormone Releasing Hormone; New Hormonal Agent; Docetaxel; Tislelizumab
    PhasePhase 2
    Registry statusActive not recruiting