Orilissa (elagolix) / Neurocrine Biosciences, AbbVie - LARVOL DELTA

Insights on Medical Therapy for Uterine Fibroids: A Review. (PubMed, Adv Ther) - "Oral GnRH antagonists, which include elagolix, relugolix, and linzagolix, signify a substantial progression, providing rapid and reversible suppression of ovarian hormone synthesis with dose-dependent effects and enhanced convenience. Innovative treatment modalities that target nonhormonal mechanisms, such as extracellular matrix remodeling, angiogenesis, and gene modulation, provide promising prospects for future uterus-sparing interventions. This narrative review evaluates the current and advancing landscape of medical therapies for uterine fibroids, presenting evidence-based perspectives to inform clinical decision-making within an increasingly personalized therapeutic context."

Journal • Review • Gynecology • Hematological Disorders • Infertility • Oncology • Pain • Sexual Disorders • Solid Tumor • Uterine Leiomyoma • Women's Health • PGR

Comparison of Letrozole with Elagolix for the Management of Endometriosis-Associated Pain: A Quasi-Experimental Study. (PubMed, J Coll Physicians Surg Pak) - "Elagolix demonstrated greater efficacy than Letrozole in reducing endometriosis-related pain after three months of treatment. This efficacy was more evident for dysmenorrhoea among specific patient subgroups, including those with younger age, lower BMI, or regular menstrual periods."

Journal • Endometriosis • Gynecology • Musculoskeletal Pain • Obstetrics • Pain • Women's Health

Catamenial Temporal Lobe Epilepsy Presenting with Ictal Asystole: A Case of Hormonal Modulation and Cardiac Pacing (AAN 2026) - "Initiation of elagolix, a gonadotropin-releasing hormone (GnRH) antagonist, eliminated both seizures and syncopal events. This is the first reported case of IA triggered by hormonal fluctuations during the perimenstrual phase. Seizure onset in the left frontotemporal region likely induced excessive vagal activation, compounded by progesterone withdrawal. Combined therapy with cardiac pacing and hormonal suppression successfully prevented both ictal systole and seizure clustering."

Clinical • Cardiovascular • CNS Disorders • Epilepsy

Efficacy and tolerability of elagolix in adolescents and young adults with endometriosis: a small, single-center retrospective cohort study. (PubMed, J Pediatr Adolesc Gynecol) - "In this small cohort, elagolix was associated with modest symptom improvement but high discontinuation rates in AYA with endometriosis. Larger prospective studies are needed to define its role in the long-term management of adolescent endometriosis."

Journal • Retrospective data • Endometriosis • Gynecology • Long-acting Reversible Contraceptives • Musculoskeletal Pain • Pain • Pediatrics • Women's Health

Atypical gelation of Elagolix sodium in aqueous media: Mechanistic insights and Inhibition via coamorphization. (PubMed, Eur J Pharm Biopharm) - "Coamorphization of ELS with quercetin (QUE) not only completely inhibits gelation but also significantly reduces the hygroscopicity of ELS. Overall, this study provides fundamental insights into the mechanism of atypical small-molecule gelation while offering a practical strategy to overcome gelation challenges in the formulation and processing of ELS-based pharmaceuticals."

Journal • Endometriosis • Gynecology • Pain • Women's Health

Safety of 48 months of elagolix with add-back therapy for endometriosis-associated pain. (PubMed, AJOG Glob Rep) - "The addition of hormonal add-back (AB) therapy (1-mg estradiol/0.5-mg norethindrone acetate once daily) may attenuate BMD loss. BMD remained mostly stable through 48 months of continuous treatment. This analysis represents the longest safety study of ELA+AB therapy to date and supports long-term treatment with ELA+AB therapy."

Journal • Endometriosis • Gynecology • Infectious Disease • Musculoskeletal Pain • Novel Coronavirus Disease • Otorhinolaryngology • Pain • Respiratory Diseases • Sinusitis • Women's Health

Identifying Bioactive Conformation of GnRH1 Based on Molecular Docking of NMR Conformers to GnRH1R and mAbs. (PubMed, Proteins) - "Based on: (a) residues of GnRH1R interacting with antagonist elagolix (as ligand-binding pocket), (b) intermolecular hydrogen bonds (for specificity of interaction), and (c) total intermolecular non-covalent interactions (for stability of interaction), one NMR conformation, having an asymmetric U-turn reverse coil structure with a beta strand comprised of residues Gly6 and Leu7, is identified as the bioactive conformation of GnRH1...Molecular docking of the identified bioactive NMR conformation of GnRH1 to homology models of scFv attributes in vivo neutralizing ability of F1D3C5 to structure-specific recognition of GnRH1. The bioactive conformation of GnRH1 identified here could guide co-crystallization studies, design of analogs and GnRH1 vaccination efforts."

Journal • B3GAT1

Elagolix as a Diagnostic and Therapeutic Bridge to Surgery in Refractory Progestogen Hypersensitivity. (PubMed, JCEM Case Rep) - "This case highlights the diagnostic complexity of PH, the therapeutic potential of GnRH antagonists as a bridge to surgery, and the importance of a multidisciplinary approach. It underscores the need for greater awareness, standardized diagnostic criteria, and further research into the immunologic mechanisms underlying PH to guide future management strategies."

Journal • Allergy • Cardiovascular • Dermatology • Gynecology • Immunology • Urticaria

Bone mineral density with elagolix plus add-back therapy in women with heavy menstrual bleeding and uterine fibroids: open-label and post-treatment results of a 60-month phase 3 trial. (PubMed, AJOG Glob Rep) - P3 | "Premenopausal women aged 18-50 years with HMB associated with uterine fibroids were randomized 2:1 to receive ELA+AB therapy (ELA 300 mg twice daily plus estradiol 1.0 mg/norethindrone acetate 0.5 mg once daily) or placebo during double-blind treatment. The long-term use of ELA+AB therapy was well tolerated, with no new safety signals identified. These findings support the potential of long-term ELA+AB therapy for HMB associated with uterine fibroids."

Clinical • Journal • P3 data • Gynecology • Infectious Disease • Musculoskeletal Diseases • Novel Coronavirus Disease • Orthopedics • Solid Tumor • Uterine Leiomyoma • Women's Health

Potency of oral gonadotropin-releasing hormone antagonist as endometriosis-associated pain novel treatments: An updated meta-analysis of randomized controlled trials. (PubMed, Int J Reprod Biomed) - "Bone mineral density in the spine was significantly lower in the treatment group (p 0.001). This meta-analysis provides updated evidence on Elagolix, Linzagolix, and Relugolix, confirming their effectiveness in managing endometriosis-associated pain, while highlighting important considerations regarding metabolic and bone health."

Journal • Retrospective data • Review • Dyslipidemia • Endometriosis • Gynecology • Musculoskeletal Pain • Pain • Women's Health

ELARIS EM-COC: 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 (clinicaltrials.gov) - P3 | N=800 | Active, not recruiting | Sponsor: AbbVie | Recruiting ➔ Active, not recruiting

Enrollment closed • Endometriosis • Gynecology • Pain • Women's Health

Generating Control Groups for Organ Impairment Studies: A Case-Study Comparing Statistical and Population Pharmacokinetic-Based Matching Approaches. (PubMed, CPT Pharmacometrics Syst Pharmacol) - "Similarly, the population pharmacokinetic approach used models developed from phase 1 data in healthy participants and found that the results were generally comparable to the in-study results, with differences in geometric mean ratios ranging from -30% to 17% and -24% to 41% for upadacitinib and elagolix, respectively. These analyses demonstrate that both approaches may be viable alternatives to assess the impact of organ impairment on pharmacokinetics."

Journal • PK/PD data • Hepatology • Renal Disease

Prolonged oral GnRH-antagonist administration before euploid embryo transfer in patients with endometriosis: a prospective randomized pilot non-inferiority trial. (PubMed, Reprod Biomed Online) - "Administration of the oral GnRH antagonist elagolix in appropriate doses for 2 months in women with endometriosis before euploid embryo transfer yields highly encouraging outcomes that are equivalent to those achieved with parenteral administration of a GnRH agonist, which could make this a more desired approach in these patients."

Head-to-Head • Journal • Endometriosis • Gynecology • Infertility • Sexual Disorders • Women's Health

Efficacy of Elagolix and Relugolix for the Treatment of Pelvic Pain in Patients With Endometriosis: A Systematic Review. (PubMed, Cureus) - "Importantly, the strongest and most consistent evidence supports the use of relugolix in combination with add-back therapy, which appears to provide sustained efficacy and a more favorable long-term safety profile than monotherapy. Thus, relugolix with hormonal add-back therapy emerges as a safe and effective long-term treatment option for endometriosis-related symptoms, offering significant clinical benefits while mitigating hypoestrogenic side effects."

Clinical • Journal • Review • Endometriosis • Gynecology • Infertility • Musculoskeletal Pain • Pain • Sexual Disorders • Women's Health

Efficacy of Elagolix in Alleviating Endometriosis-Related Symptoms and Reducing Lesion Size: (FIGO 2025) - "Elagolix appears to effectively alleviate endometriosis-related symptoms and lesion size reduction. Preliminary findings support its use as non-surgical management option. Ongoing follow-up will help determine long-term efficacy, recurrence, and fertility impact."

Clinical • Endometriosis • Gynecology • Infertility • Musculoskeletal Pain • Women's Health

A Clinical Trial to Evaluate Efficacy and Safety of Elagolix Tablets in Women With Moderate or Severe Endometriosis-associated Pain (clinicaltrials.gov) - P3 | N=202 | Completed | Sponsor: Nanjing Chia-tai Tianqing Pharmaceutical | N=330 ➔ 202 | Trial completion date: Sep 2026 ➔ Apr 2025 | Trial primary completion date: Sep 2026 ➔ Nov 2024 | Recruiting ➔ Completed

Enrollment change • Trial completion • Trial completion date • Trial primary completion date • Endometriosis • Gynecology • Pain • Women's Health

A Study to Evaluate Pregnancy Outcomes in Females Treated With Oral Elagolix Tablets and Capsules (clinicaltrials.gov) - P=N/A | N=173 | Terminated | Sponsor: AbbVie | N=584 ➔ 173 | Trial completion date: Jan 2029 ➔ Jul 2025 | Recruiting ➔ Terminated | Trial primary completion date: Jan 2029 ➔ Jul 2025; Company Decision

Enrollment change • Trial completion date • Trial primary completion date • Trial termination • Endometriosis • Gynecology • Women's Health

Brain Blood Flow Responses to Stress: Sex Differences (clinicaltrials.gov) - P4 | N=22 | Completed | Sponsor: University of Wisconsin, Madison | Recruiting ➔ Completed | Trial completion date: Jul 2026 ➔ May 2025

Trial completion • Trial completion date • CNS Disorders • Vascular Neurology

CalOPT: A Specialty Pharmacy-Dietitian Quality Improvement Initiative for Calcium Optimization in Patients with Osteoporosis Risk. (PubMed, Pharmacy (Basel)) - "Patients aged 18 to 90 years old receiving osteoporosis therapy (denosumab, teriparatide, zoledronic acid) or medications that increase bone loss (elagolix, oral prednisone) were provided with a structured assessment and educational intervention. Over half of the store coupons were redeemed. A specialty pharmacy-RDN customized intervention program provides a model for aiding patients to modify calcium intake."

Journal • Osteoporosis • Rheumatology

Oral Gonadotropin-Releasing Hormone Antagonists in the Treatment of Endometriosis: Advances in Research. (PubMed, J Clin Med Res) - "The primary objective of this review is to comprehensively evaluate the clinical efficacy and safety profile of oral GnRH antagonists, specifically elagolix, relugolix, linzagolix, and opigolix, for the management of endometriosis-associated pain. Furthermore, when combined with add-back therapy, these medications enhance treatment safety and contribute to greater patient compliance. Compared to alternative hormonal treatments, oral GnRH antagonists emerge as a particularly promising approach for managing endometriosis."

Journal • Review • Endometriosis • Gynecology • Musculoskeletal Pain • Pain • Women's Health

Pre-IVF Treatment With a GnRH Antagonist in Women With Endometriosis (clinicaltrials.gov) - P3 | N=103 | Completed | Sponsor: Yale University | Active, not recruiting ➔ Completed

Trial completion • Endometriosis • Gynecology • Infertility • Sexual Disorders • Women's Health

Antagonizing the Corticotropin-releasing Hormone Receptor 1 with an Orally Bioavailable Drug Reduces Endometriosis Pain and Associated Adhesions (WCE 2025) - "Materials and Methods Starting 25 days after endometriosis induction by auto-transplantation, rats received orally 10 mg/kg of Drug P, a selective CRHR1 antagonist or vehicle in oyster crackers, or elagolix (14 mg/kg positive control)...Furthermore, the compound effectively minimizes endometriosis-associated adhesions for which no pharmacological treatment options exist. A decrease in mechanical and inflammatory pain represents a clinically relevant finding."

Endometriosis • Gynecology • Pain • Women's Health • IL6 • LEP • TNFA

Cardiovascular Disease Risk in Women With Endometriosis (clinicaltrials.gov) - P1 | N=40 | Recruiting | Sponsor: Yale University | N=17 ➔ 40

Enrollment change • Cardiovascular • Endometriosis • Gynecology • Women's Health

Pharmacologic Interventions for Endometriosis-Related Pain: A Systematic Review and Meta-analysis. (PubMed, Obstet Gynecol) - "This network meta-analysis indicates that leuprolide in combination with combined OCP, elagolix, vitamins C and E, and gestrinone may represent the most effective therapeutic options for alleviating endometriosis-associated pelvic pain, dysmenorrhea, dyspareunia, and nonmenstrual pelvic pain. These findings enhance our understanding of the relative efficacy of treatment strategies for pain associated with endometriosis. Future research should focus on conducting larger-scale and rigorously designed clinical trials within the target patient populations to further validate these results."

Journal • Retrospective data • Endometriosis • Gynecology • Musculoskeletal Pain • Pain • Women's Health

Oral GnRH antagonists for ovulation suppression during ovarian stimulation protocols: systemic review and meta-analysis. (PubMed, J Assist Reprod Genet) - "This is the first systemic review and meta-analysis to examine the usage of oral GnRH antagonists for ovulation suppression during IVF treatments. Our findings suggest the use of oral GnRH antagonists may be beneficial in infertility treatments; however, caution should be taken, as robust establishment of their effectivity and safety in clinical practice is still pending."

Journal • Retrospective data • Review • Infertility • Sexual Disorders