Yselty (linzagolix) / Kissei, Theramex, Syneos Health, Synmosa Biopharma, Bio Genuine, JW Pharma, Apotex - LARVOL DELTA

Once-daily oral Gonadotropin-Releasing Hormone (GnRH) antagonists in the treatment of uterine fibroids: from evidence to clinical practice. (PubMed, Eur J Obstet Gynecol Reprod Biol) - "Among these agents, two once-daily oral GnRHa are approved for uterine fibroids: relugolix combination therapy (CT) (Ryeqo in the EU, Myfembree in the US), taken as a single tablet daily with add-back incorporated (relugolix 40 mg + estradiol 1 mg + norethindrone acetate 0.5 mg); and linzagolix, administered as 100 mg daily (partial suppression) or 200 mg daily (full suppression) (Yselty in the EU/UK), without or with add-back (an additional tablet with 1 mg estradiol + 0.5 mg norethindrone acetate). Linzagolix 200 mg is a suitable option for short-term preoperative fibroid reduction. Their distinct pharmacological profiles and dosing strategies may support different therapeutic objectives, including long-term symptom control and short-term preoperative management."

Journal • Review • Gynecology • Hematological Disorders • Solid Tumor • Uterine Leiomyoma • Women's Health

Role of oral gonadotropin-releasing hormone antagonists in the management of uterine adenomyosis: a narrative review. (PubMed, Reprod Fertil) - "The objective of this narrative review was to investigate the efficacy of oral gonadotropin-releasing hormone (GnRH) antagonists in the management of uterine adenomyosis by analyzing data from two post hoc analyses of two prospective randomized trials (elagolix and relugolix), one retrospective study (relugolix) and one prospective study (linzagolix). Oral gonadotropin-releasing hormone (GnRH) antagonists have recently emerged as a promising new therapeutic option. Their advantages over GnRH agonist depot formulations include an absence of the flare-up effect, hence avoiding initially worsening symptoms and rapid reversibility."

Clinical • Journal • Endometriosis • Gynecology • Infertility • Musculoskeletal Pain • Pain • Sexual Disorders • Solid Tumor • Uterine Leiomyoma • Women's Health

GnRH Analogues for the Treatment of Endometriosis-Related Pain: A Narrative Review. (PubMed, J Clin Med) - "Oral GnRH antagonists may offer practical advantages in selected patients through rapid action, the absence of a flare effect, and dose-adjustable hormonal suppression, although treatment choice must also consider long-term safety, cost, access, and individual patient characteristics. In summary, GnRH analogues remain useful second-line options, but treatment should be individualized according to symptom severity, previous treatment response, reproductive goals, tolerability, bone health, cost, and availability."

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

Oral GnRH Antagonist (Linzagolix) Versus Injectable GnRH Antagonist for Ovarian Stimulation in IVF/ICSI (clinicaltrials.gov) - P1 | N=189 | Not yet recruiting | Sponsor: Centro A.M.B.R.A. (Associazione Medici e Biologi per la Riproduzione Assistita)

Head-to-Head • New P1 trial • Gynecology • Infertility • Sexual Disorders

LINZA-RIF: Linzagolix in Adenomyosis and Recurrent Implantation Failure (clinicaltrials.gov) - P=N/A | N=35 | Not yet recruiting | Sponsor: Vida Fertility Institute

New trial • Endometriosis • Infertility • Sexual Disorders • Women's Health

Linzagolix versus leuprorelin in Japanese women with uterine leiomyomas: a phase 3, randomized, active-controlled, non-inferiority trial. (PubMed, Hum Reprod) - P3 | "This phase 3 study met its primary endpoint, and demonstrated the 24-week efficacy, safety, and pharmacodynamic effects of linzagolix in Japanese women with symptomatic uterine leiomyomas. While linzagolix offered comparable efficacy to leuprorelin over 24 weeks of treatment, its earlier onset of action may make linzagolix a favourable treatment option. In particular, rapid reductions in myoma and uterine volumes suggest that linzagolix may be a useful preoperative treatment. Moreover, earlier recovery of oestradiol levels and menstruation following linzagolix may be an important consideration for women planning pregnancy after treatment. Overall, these findings support the use of linzagolix over 24 weeks for the signs and symptoms of uterine leiomyomas."

Clinical • Head-to-Head • Journal • P3 data • Pain • Solid Tumor • Uterine Leiomyoma

The evaluation of pharmacotherapy in endometriosis: changes, challenges and difficulties. (PubMed, Ginekol Pol) - "Despite being effective, all of treatments may have additional negative effects. The best approach to pharmacotherapy depends on the individual patient's needs and circumstances. Taking into consideretion potential effects, an appropriate dose or a combination of the above options should be performed. The treatment options of Relugolix and Linzagolix are both promising and well-tolerated. Further researches should focuse on long-term bone health monitoring strategies and its safety profile."

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

GnRH antagonists for the treatment of fibroids and adenomyosis, current evidence and future perspectives. (PubMed, Expert Opin Pharmacother) - "This narrative, based on a targeted PubMed/MEDLINE literature search and review of major guideline documents published up to May 2026, summarizes the pharmacological properties, mechanisms of action, and clinical evidence regarding GnRH antagonists (elagolix, relugolix and linzagolix) in uterine fibroids and adenomyosis. These agents should currently be considered suppressive rather than curative therapies, as symptoms often recur after discontinuation. Long-term integration into individualized treatment strategies will require further safety and comparative effectiveness data."

Journal • Review • Endometriosis • Gynecology • Hematological Disorders • Musculoskeletal Pain • Pain • Solid Tumor • Uterine Leiomyoma • Women's Health

Linzagolix, with and without add-back therapy, in women with endometriosis-associated pain: results from EDELWEISS 6, a double-blind randomized extension and withdrawal study. (PubMed, Hum Reprod Open) - P3 | "Linzagolix, when administered orally once daily at a dose of 200 mg in combination with ABT, offers an additional option for effective, safe, and well-tolerated medical treatments for endometriosis that can be proposed in cases of estro-progestogen or progestogen inefficacy, as it can be used for a longer term, improving quality of life and reducing the need for analgesics and opioids. The risks of bone mineral loss and vasomotor symptoms were minimized due to the ABT. The 75 mg dose alone could be suitable for chronic treatment of endometriosis-associated pain without the need for concomitant hormonal ABT and may offer an option for some women, although further research is needed to confirm this finding."

Clinical • Journal • Addiction (Opioid and Alcohol) • Endometriosis • Gynecology • Musculoskeletal Pain • Obstetrics • Pain • Women's Health

First report of linzagolix as bridge therapy for progesterone hypersensitivity, an ultra-rare disorder. (PubMed, Eur J Contracept Reprod Health Care) - "Anakinra (an IL-1 receptor antagonist) was subsequently added. To our knowledge, this is the first use of linzagolix for progesterone hypersensitivity, suggesting GnRH antagonists may serve as bridge therapy. Multi-disciplinary care proved essential."

Journal • Cardiovascular • Dermatology • Hypotension • Immunology • Inflammation • Rare Diseases • Urticaria

Oral Gonadotropin-Releasing Hormone Antagonists for the Treatment of Endometriosis-Associated Pain: A Systematic Review and Meta-Analysis. (PubMed, J Minim Invasive Gynecol) - "Oral GnRH antagonists provide consistent, significant, and clinically meaningful reductions in dysmenorrhea and non-menstrual pelvic pain compared with placebo, with low heterogeneity across trials and similar efficacy among elagolix, relugolix combination therapy, and linzagolix with add-back, supporting their use as effective second-line therapy for endometriosis-associated pain."

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

New perspectives in managing chronic pelvic pain in Endometriosis: the role of GnRH antagonists versus dienogest. (PubMed, Expert Opin Pharmacother) - "We compare the pharmacological, pharmacokinetic, and safety profiles of dienogest and oral GnRH antagonists (elagolix, relugolix, linzagolix). Dienogest remains a well-tolerated long-term option in estrogen-sensitive patients, whereas GnRH antagonists are better suited for severe or refractory cases requiring rapid control. Integrating molecular and clinical profiling will be crucial to optimize individualized therapy and long-term outcomes."

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

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

EDELWEISS 6: A long-term extension study to assess the effect of Linzagolix in women with endometriosis-associated pain. (ISGE 2026) - "Methods EDELWEISS-3 was a prospective, randomized, double-blind, placebo-controlled Phase 3 study assessing linzagolix 75 mg (alone) and 200 mg with add-back therapy (ABT; 1 mg estradiol / 0.5 mg norethisterone acetate). Conclusions Linzagolix 200 mg with ABT provided substantial and sustained improvement in endometriosis-associated DYS and NMPP through 12 months of treatment. Although the 75 mg dose did not reach the co-primary endpoints at 3 months in EDELWEISS-3, continued treatment led to further symptom improvements through month 12, supporting the long-term efficacy and safety of linzagolix in women with moderate to severe endometriosis-associated pain."

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

ISGE 3: Bridging science and clinical practice in endometriosis and uterine fibroids: the role of linzagolix▼ (ISGE 2026) - "Sponsored by Theramex"

Clinical • Endometriosis • Gynecology • Solid Tumor • Uterine Leiomyoma • Women's Health

Uterine fibroids in practice: real-world patient cases with linzagolix (ISGE 2026) - "Sponsored by Theramex"

Clinical • Real-world • Real-world evidence • Gynecology • Solid Tumor • Uterine Leiomyoma • Women's Health

Uterine fibroids in practice: real-world patient cases with linzagolix (ISGE 2026) - "Sponsored by Theramex"

Clinical • Real-world • Real-world evidence • Gynecology • Solid Tumor • Uterine Leiomyoma • Women's Health

Endometriosis in practice: real-world patient cases with linzagolix (ISGE 2026) - "Sponsored by Theramex"

Clinical • Real-world • Real-world evidence • Endometriosis • Gynecology • Women's Health

Rapid Improvement in Heavy Menstrual Bleeding and Anaemia with Linzagolix in Women with Uterine Fibroids: Post-hoc Analysis of the PRIMROSE 1 and 2 Trials. (ISGE 2026) - "Eligible women were randomized equally to receive linzagolix 100 or 200 mg, with or without add-back therapy (ABT; 1 mg oestradiol/ 0.5 mg norethisterone acetate) or placebo, once daily for 24 weeks. In anaemic women, linzagolix also led to greater and faster improvements in Hb and iron-deficiency biomarkers than placebo. These results support linzagolix as an effective treatment for symptomatic uterine fibroids requiring rapid, sustained bleeding control and concurrent correction of anaemia."

Clinical • Retrospective data • Anemia • Gynecology • Hematological Disorders • Solid Tumor • Uterine Leiomyoma • Women's Health

Clinical Applicability of Linzagolix Therapeutic Flexibility Illustrated Through Clinical Cases (ISGE 2026) - "Case 3: Linzagolix 100 mg with estradiol/norethisterone acetate A 43 year old woman with anemia and multiple fibroids (type 3–5, 96 cc; type 6, 15.53 cc) requiring long term symptom control. Linzagolix (100–200 mg), with or without ABT, is indicated for the treatment of moderate to severe symptoms associated with uterine fibroids. Lower doses (100 mg), with or without ABT, are suitable for long term symptom control, whereas higher doses (200 mg) are appropriate for short treatment periods or when the primary objective is uterine volume reduction."

Clinical • CNS Disorders • Gynecology • Hematological Disorders • Migraine • Solid Tumor • Uterine Leiomyoma • Women's Health

A Clinical Study of KLH-2109 in Patients With Endometriosis (clinicaltrials.gov) - P3 | N=288 | Active, not recruiting | Sponsor: Kissei Pharmaceutical Co., Ltd. | Recruiting ➔ Active, not recruiting

Enrollment closed • Endometriosis • Gynecology • Women's Health

NICE Appraisals of Relugolix-CT and Linzagolix for Endometriosis Symptom Management: Commentary on Clinical and Economic Uncertainties. (PubMed, Pharmacoeconomics) - No abstract available

Journal • Endometriosis • Gynecology • Women's Health

to Evaluate the Efficacy and Safety of KLH-2109 in Patients With Uterine Fibroids and Menorrhagia (clinicaltrials.gov) - P3 | N=254 | Recruiting | Sponsor: JW Pharmaceutical

New P3 trial • Gynecology • 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

Cost-Utility Analysis of Linzagolix 200 mg Plus Add-back Therapy (Linzagolix+ABT) for Symptomatic Treatment of Endometriosis (ISPOR-EU 2025) - "Linzagolix was compared against a composite of injectable GnRH agonists (leuprorelin acetate, goserelin, triptorelin). Linzagolix+ABT is cost-effective, enhances HRQoL, and reduces the need for radical surgeries, thereby also helping to preserve fertility. These benefits strongly support the adoption of linzagolix into clinical practice for endometriosis management."

HEOR • Endometriosis • Gynecology • Musculoskeletal Pain • Osteoporosis • Rheumatology • Women's Health