Relugolix: First Global Approval
The orally active GnRH-receptor antagonist relugolix, developed for sex hormone disorders, received its first global marketing approval in Japan for uterine fibroid symptoms.
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This review article describes the development milestones of the orally active GnRH receptor antagonist relugolix (TAK-385/Relumina/Rerumina) leading to its first global approval in Japan for symptoms associated with uterine fibroids, summarizing key preclinical and clinical study phases and regulatory steps. It notes that relugolix’s further efficacy studies for endometriosis-associated pain and prostate cancer were underway at the time of publication, while the paper’s main focus remains on the uterine fibroid approval trajectory. A stated limitation is that the piece is an article profile/review rather than new experimental research, and it does not provide detailed efficacy outcomes beyond describing development progress. Relevance to endometriosis: the paper explicitly mentions ongoing studies evaluating relugolix for endometriosis-associated pain, though the paper’s main focus is the drug’s first approval for uterine fibroids.
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References (7)
- W1878336561 via openalex
- W2008203144 via openalex
- W2327794806 via openalex
- W2587863482 via openalex
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Cited by (13)
- Abnormal uterine bleeding: The well-known and the hidden face 2024
- Computational drug repurposing effort for identifying novel hits for the treatment of diseases such as endometriosis, uterine fibroids, and prostate cancer 2024
- Orale GnRH-Antagonisten in der kontrollierten ovariellen Stimulation: noch viele Fragen offen 2024
- Efficacy and Safety of Oral Gonadotropin-Releasing Hormone Antagonist, Relugolix, in Endometriosis: A Meta-Analysis of Randomized Clinical Trials 2024
- Oral GnRH Antagonists in Combination with Estradiol and Norethindrone Acetate for Pain Relief Associated with Endometriosis: A Review of Evidence of a Novel Class of Hormonal Agents 2024
- Gynecological uses of GnRH antagonists: review article 2022
- Comparing the pharmacokinetic and pharmacodynamic qualities of current and future therapies for uterine fibroids 2022
- Novel pharmacological therapies for the treatment of endometriosis 2022
- Advances in targeting estrogen synthesis and receptors in patients with endometriosis 2022
- Endometriosis and Medical Therapy: From Progestogens to Progesterone Resistance to GnRH Antagonists: A Review 2021
- <p>Clinical Utility Of Elagolix As An Oral Treatment For Women With Uterine Fibroids: A Short Report On The Emerging Efficacy Data</p> 2019
- Endometriosis and pain in the adolescent- striking early to limit suffering: A narrative review 2019
- Clinical Evaluation of the Oral Gonadotropin-Releasing Hormone-Antagonist Elagolix for the Management of Endometriosis-Associated Pain 2019
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