opigolix (ASP1707) / Astellas - LARVOL DELTA

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

A Study to Evaluate the Efficacy and Safety of ASP1707 in Postmenopausal Female Patients With Rheumatoid Arthritis Taking Methotrexate (clinicaltrials.gov) - P2 | N=72 | Completed | Sponsor: Astellas Pharma Inc | Phase classification: P2a ➔ P2

Phase classification • Immunology • Inflammatory Arthritis • Rheumatoid Arthritis • Rheumatology • CRP

Efficacy and safety of oral gonadotropin-releasing hormone antagonists in moderate-to-severe endometriosis-associated pain: a systematic review and network meta-analysis. (PubMed, Arch Gynecol Obstet) - "Oral GnRH antagonists were effective in endometriosis-associated pain in 12w, and most of the efficiency and safety outcomes were expressed in a dose-dependent manner, but linzagolix 75 mg was an exception."

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

Current status and challenges of drug development for hormonal treatment of endometriosis: a systematic review of randomized control trials. (PubMed, Gynecol Endocrinol) - "Randomized control trials showed promising results with several oral gonadotropin-releasing hormone antagonists (elagolix, relugolix, ASP1707, linzagolix). Although numerous novel agents are being investigated for the treatment of endometriosis, there is still no significant progress in the development of curative rather than suppressive drugs. Therefore, further efforts are needed to develop an effective and hopefully curative treatment for this chronic, costly, and overwhelming disease."

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

Bone Mineral Density Changes Associated With Pregnancy, Lactation, and Medical Treatments in Premenopausal Women and Effects Later in Life. (PubMed, J Womens Health (Larchmt)) - P3 | "Development of newer medical therapies, principally GnRH antagonists (e.g., ASP1707, elagolix, linzagolix, relugolix), for treatment of endometriosis-associated pelvic pain and heavy menstrual bleeding due to uterine fibroids has renewed interest in the short- and long-term impacts of changes in BMD experienced by premenopausal women. This review summarizes what is known about the effects on bone health pregnancy, lactation, and use of DMPA, GnRH agonists, and GnRH antagonists in premenopausal women and potential consequences later in life. ClinicalTrials.gov identifier: NCT03213457."

Clinical • Journal • Endometriosis • Epilepsy • Gynecology • Musculoskeletal Diseases • Musculoskeletal Pain • Orthopedics • Osteoporosis • Pain • Rheumatology • Solid Tumor • Uterine Leiomyoma

A Study to Assess the Safety, Tolerability and Effects of Single and Multiple Ascending Doses of ASP1707 in Healthy Male and Pre-menopausal Female Subjects, Including a Comparison of the Effects Under Fasted and Fed Conditions in Healthy Young Male Sub... (clinicaltrials.gov) - P1; N=176; Completed; Sponsor: Astellas Pharma Europe B.V.

New P1 trial • Biosimilar

A Study to Evaluate the Effect of ASP1707 on the Bodies of Healthy Male Subjects After a Single Dose of Radioactive ASP1707 (clinicaltrials.gov) - P1; N=6; Completed; Sponsor: Astellas Pharma Europe BV; Not yet recruiting -> Completed

Trial completion • Acute Coronary Syndrome • Biosimilar • Heart Failure • Immunology