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Elagolix Sodium

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

Registered studies
24
Lab records
0
Pathogens at ≥40%
2 of 4

Chemical structure

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

Existing / approved use

Documented · FDA, WHO, ChEMBL

Approved for

  • Endometriosis

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

WHO therapeutic group
Anti-gonadotropin-releasing hormones
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 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
  • MRSA47.7% AI-predicted activityAt or above the ≥40% mark this site uses to surface candidates.
  • E. coli38.3% AI-predicted activityBelow the ≥40% mark this site uses to surface candidates.
  • K. pneumoniae29.8% AI-predicted activityBelow the ≥40% mark this site uses to surface candidates.
  • M. tuberculosis58.3% 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

24registered studies name this medicine, for any condition. 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 Elagolix Sodium 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.

  • Role of Menopause in Thermoregulation

    NCT06798571 · start 2025-03-01

    Registered record
    Registry ID
    NCT06798571
    Conditions
    Menopause; Aging
    Interventions
    Elagolix Oral Tablet; Estradiol patch; cellulose placebo; placebo patch
    Study type
    INTERVENTIONAL
    Phase
    Phase 4
    Registry status
    Recruiting
    Start
    2025-03-01
    Completion
    2026-09-01
    Enrolment
    24

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

    ConditionMenopause; Aging
    InterventionElagolix Oral Tablet; Estradiol patch; cellulose placebo; placebo patch
    PhasePhase 4
    Registry statusRecruiting
  • Brain Blood Flow Responses to Stress: Sex Differences

    NCT06253702 · start 2024-07-24

    Registered record
    Registry ID
    NCT06253702
    Conditions
    Cerebrovascular Disorders
    Interventions
    Indomethacin; Placebo; Orilissa; Testosterone gel; Anastrozole; Estradiol
    Study type
    INTERVENTIONAL
    Phase
    Phase 4
    Registry status
    Completed
    Start
    2024-07-24
    Completion
    2025-05-31
    Enrolment
    22

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

    ConditionCerebrovascular Disorders
    InterventionIndomethacin; Placebo; Orilissa; Testosterone gel +2 more
    PhasePhase 4
    Registry statusCompleted
  • Elagolix for Fertility Enhancement Clinical Trial

    NCT04039204 · start 2022-01-15

    Registered record
    Registry ID
    NCT04039204
    Conditions
    Endometriosis; Unexplained Infertility
    Interventions
    Elagolix; Ortho Cyclen
    Study type
    INTERVENTIONAL
    Phase
    Phase 2
    Registry status
    Completed
    Start
    2022-01-15
    Completion
    2023-08-09
    Enrolment
    10

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

    ConditionEndometriosis; Unexplained Infertility
    InterventionElagolix; Ortho Cyclen
    PhasePhase 2
    Registry statusCompleted
  • Study Of Oral Elagolix Tablets To Assess the Tolerability and Change in Disease Symptoms in Adult Female Participants With Moderate to Severe Endometriosis-associated Pain

    NCT04630990 · start 2020-12-14

    Registered record
    Registry ID
    NCT04630990
    Conditions
    Endometriosis
    Interventions
    Not recorded
    Study type
    OBSERVATIONAL
    Phase
    Not recorded
    Registry status
    Completed
    Start
    2020-12-14
    Completion
    2024-03-26
    Enrolment
    117

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

    ConditionEndometriosis
    InterventionNot recorded
    PhaseNot recorded
    Registry statusCompleted
  • Study Of Oral Elagolix Tablets In Combination With Combined Oral Contraceptive Capsules/Tablets To Assess Dysmenorrhea Response In Adult Female Participants With Endometriosis And Associated Moderate To Severe Pain

    NCT04333576 · start 2020-08-10

    Registered record
    Registry ID
    NCT04333576
    Conditions
    Endometriosis
    Interventions
    Elagolix; Placebo; Combined Oral Contraceptive
    Study type
    INTERVENTIONAL
    Phase
    Phase 3
    Registry status
    Active not recruiting
    Start
    2020-08-10
    Completion
    2027-07
    Enrolment
    800

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

    ConditionEndometriosis
    InterventionElagolix; Placebo; Combined Oral Contraceptive
    PhasePhase 3
    Registry statusActive not recruiting
  • Hormonal Effects of the Oral Gonadotropin Releasing Hormone (GnRH) Antagonist at Different Periods of the Menstrual Cycle

    NCT04060992 · start 2019-10-01

    Registered record
    Registry ID
    NCT04060992
    Conditions
    Ovulation; Failure or Lack of
    Interventions
    Elagolix 200 MG Oral Tablet [Orilissa]
    Study type
    INTERVENTIONAL
    Phase
    Phase 4
    Registry status
    Unknown
    Start
    2019-10-01
    Completion
    2021-07-01
    Enrolment
    12

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

    ConditionOvulation; Failure or Lack of
    InterventionElagolix 200 MG Oral Tablet [Orilissa]
    PhasePhase 4
    Registry statusUnknown
  • Study of the Safety and Efficacy of Elagolix in Women With Polycystic Ovary Syndrome

    NCT03951077 · start 2019-08-12

    Registered record
    Registry ID
    NCT03951077
    Conditions
    Polycystic Ovary Syndrome
    Interventions
    Elagolix; Placebo
    Study type
    INTERVENTIONAL
    Phase
    Phase 2
    Registry status
    Completed
    Start
    2019-08-12
    Completion
    2021-02-10
    Enrolment
    118

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

    ConditionPolycystic Ovary Syndrome
    InterventionElagolix; Placebo
    PhasePhase 2
    Registry statusCompleted
  • A Study to Evaluate the Safety and Efficacy of Elagolix for the Management of Heavy Menstrual Bleeding Associated With Uterine Fibroids in Premenopausal Women

    NCT03886220 · start 2019-04-12

    Registered record
    Registry ID
    NCT03886220
    Conditions
    Uterine Fibroids
    Interventions
    Elagolix; Placebo
    Study type
    INTERVENTIONAL
    Phase
    Phase 4
    Registry status
    Completed
    Start
    2019-04-12
    Completion
    2021-04-28
    Enrolment
    82

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

    ConditionUterine Fibroids
    InterventionElagolix; Placebo
    PhasePhase 4
    Registry statusCompleted
  • Long-Term Safety Study of Elagolix in Combination With Estradiol/Norethindrone Acetate for the Management of Heavy Menstrual Bleeding Associated With Uterine Fibroids in Premenopausal Women

    NCT03271489 · start 2017-09-13

    Registered record
    Registry ID
    NCT03271489
    Conditions
    Heavy Menstrual Bleeding; Uterine Fibroids
    Interventions
    Elagolix; Estradiol /norethindrone acetate (E2/NETA); E2/NETA Placebo; Elagolix Placebo
    Study type
    INTERVENTIONAL
    Phase
    Phase 3
    Registry status
    Completed
    Start
    2017-09-13
    Completion
    2024-06-28
    Enrolment
    478

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

    ConditionHeavy Menstrual Bleeding; Uterine Fibroids
    InterventionElagolix; Estradiol /norethindrone acetate (E2/NETA); E2/NETA Placebo; Elagolix Placebo
    PhasePhase 3
    Registry statusCompleted
  • A Clinical Study to Evaluate the Safety and Efficacy of Elagolix in Participants With Moderate to Severe Endometriosis-Associated Pain

    NCT03213457 · start 2017-07-07

    Registered record
    Registry ID
    NCT03213457
    Conditions
    Endometriosis
    Interventions
    Estradiol/Norethindrone Acetate; Placebo for Elagolix; Elagolix; Placebo for E2/NETA
    Study type
    INTERVENTIONAL
    Phase
    Phase 3
    Registry status
    Completed
    Start
    2017-07-07
    Completion
    2023-12-06
    Enrolment
    681

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

    ConditionEndometriosis
    InterventionEstradiol/Norethindrone Acetate; Placebo for Elagolix; Elagolix; Placebo for E2/NETA
    PhasePhase 3
    Registry statusCompleted
  • An Extension Study to Evaluate the Efficacy and Safety of Elagolix in Premenopausal Women With Heavy Menstrual Bleeding Associated With Uterine Fibroids

    NCT02925494 · start 2016-09-14

    Registered record
    Registry ID
    NCT02925494
    Conditions
    Uterine Fibroids; Heavy Menstrual Bleeding
    Interventions
    Estradiol/Norethindrone Acetate; Elagolix
    Study type
    INTERVENTIONAL
    Phase
    Phase 3
    Registry status
    Completed
    Start
    2016-09-14
    Completion
    2019-03-22
    Enrolment
    433

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

    ConditionUterine Fibroids; Heavy Menstrual Bleeding
    InterventionEstradiol/Norethindrone Acetate; Elagolix
    PhasePhase 3
    Registry statusCompleted
  • Efficacy and Safety of Elagolix in Combination With Estradiol/Norethindrone Acetate for the Management of Heavy Menstrual Bleeding Associated With Uterine Fibroids in Premenopausal Women (Replicate Study)

    NCT02691494 · start 2016-02-03

    Registered record
    Registry ID
    NCT02691494
    Conditions
    Uterine Fibroids; Heavy Menstrual Bleeding
    Interventions
    Elagolix; Placebo for Estradiol/Norethindrone Acetate; Estradiol/Norethindrone Acetate; Placebo for Elagolix
    Study type
    INTERVENTIONAL
    Phase
    Phase 3
    Registry status
    Completed
    Start
    2016-02-03
    Completion
    2019-01-23
    Enrolment
    378

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

    ConditionUterine Fibroids; Heavy Menstrual Bleeding
    InterventionElagolix; Placebo for Estradiol/Norethindrone Acetate; Estradiol/Norethindrone Acetate; Placebo for Elagolix
    PhasePhase 3
    Registry statusCompleted
  • Efficacy and Safety of Elagolix in Combination With Estradiol/Norethindrone Acetate for the Management of Heavy Menstrual Bleeding Associated With Uterine Fibroids in Premenopausal Women

    NCT02654054 · start 2015-12-22

    Registered record
    Registry ID
    NCT02654054
    Conditions
    Uterine Fibroids; Heavy Menstrual Bleeding
    Interventions
    Elagolix; Placebo for Estradiol/Norethindrone Acetate; Estradiol/Norethindrone Acetate; Placebo for Elagolix
    Study type
    INTERVENTIONAL
    Phase
    Phase 3
    Registry status
    Completed
    Start
    2015-12-22
    Completion
    2018-12-12
    Enrolment
    413

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

    ConditionUterine Fibroids; Heavy Menstrual Bleeding
    InterventionElagolix; Placebo for Estradiol/Norethindrone Acetate; Estradiol/Norethindrone Acetate; Placebo for Elagolix
    PhasePhase 3
    Registry statusCompleted
  • Global Study to Evaluate the Long-Term Safety and Efficacy of Elagolix in Women With Moderate to Severe Endometriosis-associated Pain

    NCT02143713 · start 2014-05-27

    Registered record
    Registry ID
    NCT02143713
    Conditions
    Endometriosis
    Interventions
    Elagolix
    Study type
    INTERVENTIONAL
    Phase
    Phase 3
    Registry status
    Completed
    Start
    2014-05-27
    Completion
    2017-05-23
    Enrolment
    496

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

    ConditionEndometriosis
    InterventionElagolix
    PhasePhase 3
    Registry statusCompleted
  • A Global Phase 3 Study to Evaluate the Safety and Efficacy of Elagolix in Subjects With Moderate to Severe Endometriosis-Associated Pain

    NCT01931670 · start 2013-09-09

    Registered record
    Registry ID
    NCT01931670
    Conditions
    Endometriosis
    Interventions
    placebo; Elagolix
    Study type
    INTERVENTIONAL
    Phase
    Phase 3
    Registry status
    Completed
    Start
    2013-09-09
    Completion
    2016-12-19
    Enrolment
    815

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

    ConditionEndometriosis
    Interventionplacebo; Elagolix
    PhasePhase 3
    Registry statusCompleted