What is Elagolix (non-peptide)?

An oral non-peptide GnRH antagonist (Orilissa) approved for endometriosis pain; combined with add-back hormones (Oriahnn) for fibroid bleeding.

Elagolix (non-peptide) in the library · · Human Trials · What are peptides?

34 registered trials · 30 indexed papers · 4 human / 0 animal studies

From the PeptideWhiz library entry. "As described" sections summarize claims made in the sources; they are not PeptideWhiz endorsements.

Mechanism (as described)

  • It blocks pituitary GnRH receptors, lowering LH, FSH and estradiol.

Evidence (as described)

  • Phase 3 trials reported less endometriosis pain (Taylor et al., NEJM 2017) and less heavy menstrual bleeding with fibroids (Schlaff et al., NEJM 2020). Bone density is a key monitoring issue (Miller et al., 2024).

Status

FDA-approved (2018, Orilissa; 2020, Oriahnn).

Registered human trials (34)

TrialPhaseStatusYearEnrolled
Comparison of Elagolix and OCPs in Reducing Endometriosis Associated Pelvic PainPhase 4enrolling by invitation202690
Role of Menopause in ThermoregulationPhase 4recruiting202524
Effect of Elagolix in Symptomatic Endometrioma in Comparison to Combined Oral Contraceptive Pill.completed202560
Pre-IVF Treatment With a GnRH Antagonist in Women With endometriosis_tempPhase 3active not recruiting202497
A Clinical Trial to Evaluate Efficacy and Safety of Elagolix Tablets in Women With Moderate or Severe Endometriosis-associated PainPhase 3completed2023202
Cardiovascular Disease Risk in Women With EndometriosisEARLY_Phase 1completed202221
Elagolix for Fertility Enhancement Clinical TrialPhase 2completed202210
Pre-IVF Treatment With a GnRH Antagonist in Women With EndometriosisPhase 3completed2022103
A Study to Evaluate Safety and Efficacy of Elagolix in Patients With Moderate to Severe Endometriosis-Associated PainPhase 3unknown2022336
Study to Gather Information How Well Three Different Doses of BAY1817080 Given Twice Daily Over 12 Weeks Work in Comparison to an Inactive Pill (Placebo) and Elagolix in Women Suffering From Pain Related to a Condition Where the Tissue That Usually Grows Inside the Womb Grows Outside of the WombPhase 2terminated2021215
Myomectomy vs Uterine Artery Embolization vs GnRh Antagonist for AUB-Lunknown2021300
An Oral GnRH Antagonist to Treat Mild Autonomous Cortisol Excess (MACE) Due to Adrenal Adenomas in Postmenopausal WomenPhase 4terminated20214
Comparison Elagolix vs Depot Leuprolide Prior to Frozen Embryo Transfers in Patients With EndometriosisEARLY_Phase 1completed202030
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 PainPhase 3active not recruiting2020800
A Study to Evaluate the Safety and Efficacy of Elagolix for the Management of Heavy Menstrual Bleeding Associated With Uterine Fibroids in Premenopausal WomenPhase 4completed201982
Study of the Safety and Efficacy of Elagolix in Women With Polycystic Ovary SyndromePhase 2completed2019118
Hormonal Effects of the Oral Gonadotropin Releasing Hormone (GnRH) Antagonist at Different Periods of the Menstrual CyclePhase 4unknown201912
A Clinical Study to Evaluate the Safety and Efficacy of Elagolix in Participants With Moderate to Severe Endometriosis-Associated PainPhase 3completed2017681
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 WomenPhase 3completed2017478
A Study to Evaluate Safety and Efficacy of Elagolix in Participants With Endometriosis With Associated Moderate to Severe PainPhase 3terminated201711
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)Phase 3completed2016378
An Extension Study to Evaluate the Efficacy and Safety of Elagolix in Premenopausal Women With Heavy Menstrual Bleeding Associated With Uterine FibroidsPhase 3completed2016433
Efficacy and Safety of Elagolix in Combination With Estradiol/Norethindrone Acetate for the Management of Heavy Menstrual Bleeding Associated With Uterine Fibroids in Premenopausal WomenPhase 3completed2015413
Global Study to Evaluate the Long-Term Safety and Efficacy of Elagolix in Women With Moderate to Severe Endometriosis-associated PainPhase 3completed2014496
Safety and Efficacy in Premenopausal Women With Heavy Menstrual Bleeding (HMB) Associated With Uterine Fibroids (UF)Phase 2completed2013571
A Global Phase 3 Study to Evaluate the Safety and Efficacy of Elagolix in Subjects With Moderate to Severe Endometriosis-Associated PainPhase 3completed2013815
A Clinical Study to Evaluate the Safety and Efficacy of Elagolix in Subjects With Moderate to Severe Endometriosis-Associated PainPhase 3completed2012872
Study to Evaluate the Long-Term Safety and Efficacy of Elagolix in Adults With Moderate to Severe Endometriosis-Associated PainPhase 3completed2012506
An Open-label Study of the Effects of Elagolix in Adult Premenopausal FemalesPhase 1completed2011216
Safety and Efficacy of Elagolix in Pre-Menopausal Women With Heavy Uterine Bleeding and Uterine FibroidsPhase 2completed2011271
Efficacy and Safety Study of Elagolix in Women With EndometriosisPhase 2completed2009137
Efficacy and Safety Study of Elagolix Versus Placebo or Leuprorelin Acetate in EndometriosisPhase 2completed2008174
An Efficacy and Safety Study of Elagolix (NBI-56418) in Women With EndometriosisPhase 2completed2008155
Elagolix Versus Subcutaneous Depot Medroxyprogesterone Acetate for the Treatment of EndometriosisPhase 2completed2006252

Peer-reviewed studies (30)

PaperAuthorsJournalYearType
Efficacy and Safety of Elagolix Versus Dienogest for Treatment of Moderate-to-Severe Endometriosis Pain: A Phase III, Multicentric, Double-Blind, Active-Controlled, Non-Inferiority StudyBhoir S et al.BJOG : an international journal of obstetrics and gynaecology2026Randomized Controlled Trial
Single-Dose Bioequivalence Study of Elagolix Tablets [amount hidden] (Test Product) and Elagolix Tablets [amount hidden] (Reference Product) in Healthy Non-Pregnant, Non-Lactating Premenopausal Female Subjects Under Fasting ConditionsKumar S et al.Clinical pharmacology in drug development2026Randomized Controlled Trial
Prolonged oral GnRH-antagonist administration before euploid embryo transfer in patients with endometriosis: a prospective randomized pilot non-inferiority trialSurrey ES et al.Reproductive biomedicine online2025Clinical Study
Inflammatory Changes after Medical Suppression of Suspected Endometriosis for Implantation Failure: Preliminary ResultsLessey BA et al.International journal of molecular sciences2024Randomized Controlled Trial
Efficacy, tolerability, and bone density outcomes of elagolix with add-back therapy for endometriosis-associated pain: twelve months of an ongoing randomized phase 3 trialMiller CE et al.American journal of obstetrics and gynecology2024Randomized Controlled Trial
Efficacy and safety of eliapixant in endometriosis-associated pelvic pain: the randomized, placebo-controlled phase 2b SCHUMANN studyParke S et al.BMC women's health2024Randomized Controlled Trial
Bioequivalence of Elagolix/Estradiol/Norethindrone Acetate Fixed-Dose Combination Product: Phase 1 Results in Healthy Pre- and Postmenopausal WomenChen MJ et al.Clinical pharmacology in drug development2024Randomized Controlled Trial
Low-Dose Elagolix for the Treatment of Heavy Menstrual Bleeding in Patients With Uterine Leiomyomas: A Randomized Controlled TrialBrown E et al.Obstetrics and gynecology2023Randomized Controlled Trial
Reduction of Heavy Menstrual Bleeding in Women Not Designated as Responders to Elagolix Plus Add Back Therapy for Uterine FibroidsStewart EA et al.Journal of women's health (2002)2022Randomized Controlled Trial
Reductions in endometriosis-associated pain among women treated with elagolix are consistent across a range of baseline characteristics reflective of real-world patientsAbrao MS et al.BMC women's health2021Clinical Trial, Phase III
Responsiveness and thresholds for clinically meaningful changes in worst pain numerical rating scale for dysmenorrhea and nonmenstrual pelvic pain in women with moderate to severe endometriosisPokrzywinski RM et al.Fertility and sterility2021Randomized Controlled Trial
Assessment of Clinical Drug-Drug Interactions of Elagolix, a Gonadotropin-Releasing Hormone Receptor AntagonistPolepally AR et al.Journal of clinical pharmacology2020Clinical Trial, Phase I
Exposure-Safety Analyses Identify Predictors of Change in Bone Mineral Density and Support Elagolix Labeling for Endometriosis-Associated PainAbbas Suleiman A et al.CPT: pharmacometrics & systems pharmacology2020Clinical Trial, Phase III
Clinically Meaningful Reduction in Dyspareunia Is Associated With Significant Improvements in Health-Related Quality of Life Among Women With Moderate to Severe Pain Associated With Endometriosis: A Pooled Analysis of Two Phase III Trials of ElagolixAgarwal SK et al.The journal of sexual medicine2020Randomized Controlled Trial
Elagolix Treatment for Up to 12 Months in Women With Heavy Menstrual Bleeding and Uterine LeiomyomasSimon JA et al.Obstetrics and gynecology2020Randomized Controlled Trial
Elagolix for Heavy Menstrual Bleeding in Women with Uterine FibroidsSchlaff WD et al.The New England journal of medicine2020Randomized Controlled Trial
Achieving clinically meaningful response in endometriosis pain symptoms is associated with improvements in health-related quality of life and work productivity: analysis of 2 phase III clinical trialsPokrzywinski RM et al.American journal of obstetrics and gynecology2020Randomized Controlled Trial
Elagolix Suppresses Ovulation in a Dose-Dependent Manner: Results From a 3-Month, Randomized Study in Ovulatory WomenArcher DF et al.The Journal of clinical endocrinology and metabolism2020Randomized Controlled Trial
Impact of elagolix on work loss due to endometriosis-associated pain: estimates based on the results of two phase III clinical trialsPokrzywinski RM et al.Fertility and sterility2019Randomized Controlled Trial
Impact of elagolix treatment on fatigue experienced by women with moderate to severe pain associated with endometriosisSurrey ES et al.Fertility and sterility2019Randomized Controlled Trial
Cost-effectiveness of elagolix versus leuprolide acetate for treating moderate-to-severe endometriosis pain in the USAWang ST et al.Journal of comparative effectiveness research2019Clinical Trial, Phase III
Elagolix Pharmacokinetic Profiles in Women With Renal or Hepatic ImpairmentNg J et al.Clinical pharmacology in drug development2019Clinical Trial, Phase I
Elagolix Alone or With Add-Back Therapy in Women With Heavy Menstrual Bleeding and Uterine Leiomyomas: A Randomized Controlled TrialCarr BR et al.Obstetrics and gynecology2018Randomized Controlled Trial
Long-Term Outcomes of Elagolix in Women With Endometriosis: Results From Two Extension StudiesSurrey E et al.Obstetrics and gynecology2018Randomized Controlled Trial
Elagolix for the management of heavy menstrual bleeding associated with uterine fibroids: results from a phase 2a proof-of-concept studyArcher DF et al.Fertility and sterility2017Randomized Controlled Trial
Treatment of Endometriosis-Associated Pain with Elagolix, an Oral GnRH AntagonistTaylor HS et al.The New England journal of medicine2017Randomized Controlled Trial
Dose-Dependent Suppression of Gonadotropins and Ovarian Hormones by Elagolix in Healthy Premenopausal WomenNg J et al.The Journal of clinical endocrinology and metabolism2017Randomized Controlled Trial
Elagolix, an oral GnRH antagonist, versus subcutaneous depot medroxyprogesterone acetate for the treatment of endometriosis: effects on bone mineral densityCarr B et al.Reproductive sciences (Thousand Oaks, Calif.)2014Randomized Controlled Trial
Elagolix treatment for endometriosis-associated pain: results from a phase 2, randomized, double-blind, placebo-controlled studyDiamond MP et al.Reproductive sciences (Thousand Oaks, Calif.)2014Randomized Controlled Trial
Suppression of gonadotropins and estradiol in premenopausal women by oral administration of the nonpeptide gonadotropin-releasing hormone antagonist elagolixStruthers RS et al.The Journal of clinical endocrinology and metabolism2009Randomized Controlled Trial

Conditions researched

Related compounds

FAQ

What is Elagolix (non-peptide)?

An oral non-peptide GnRH antagonist (Orilissa) approved for endometriosis pain; combined with add-back hormones (Oriahnn) for fibroid bleeding.

How many registered human trials study Elagolix (non-peptide)?

The PeptideWhiz trial index lists 34 registered trials for Elagolix (non-peptide), the most recent from 2026.

How much published research exists on Elagolix (non-peptide)?

The PeptideWhiz paper index links 30 PubMed papers to Elagolix (non-peptide); by study type, 4 human and 0 animal studies.

Which conditions is Elagolix (non-peptide) researched for?

Anti-aging & longevity, Endometriosis, Fatigue & low energy (incl. midlife), Female fertility, Menopause & perimenopause, Menstrual cramps (dysmenorrhea), Osteoporosis and bone density, PCOS.

Research and education only. Not medical advice. No dosing guidance. Data: ClinicalTrials.gov registry and PubMed via the PeptideWhiz index (204,289 studies).

Reported dosing ranges from research