Elagolix dosing regimens for GnRH receptor antagonists

ChangeBridge: Patent Apps - Pharma (A61K)

Published August 26th, 2025

Detected April 3rd, 2026

Summary

USPTO published patent application US20260091036A1 for dosing regimens of Elagolix (a GnRH receptor antagonist) and related compounds. The application claims methods to minimize bone mineral density changes in subjects suffering from endometriosis, adenomyosis, PCOS, or uterine fibroids. Filing date August 26, 2025.

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What changed

The patent application covers dosing regimens for 4-((R)-2-[5-(2-fluoro-3-methoxy-phenyl)-3-(2-fluoro-6-trifluoromethyl-benzyl)-4-methyl-2,6-dioxo-3,6-dihydro-2H-pyrimidin-1-yl]-1-phenylethylamino)-butyric acid (Compound A/Elagolix) or salts thereof. The regimens are designed to treat reproductive health conditions while minimizing bone mineral density changes associated with GnRH receptor antagonists.

Pharmaceutical companies developing GnRH antagonists or treating related conditions should monitor this patent application. Competitors in the endometriosis, adenomyosis, PCOS, and uterine fibroids treatment spaces should review freedom-to-operate implications. No immediate compliance action required as this is a pending application.

Source document (simplified)

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Dosing Regimens for Elagolix

Application US20260091036A1 Kind: A1 Apr 02, 2026

Inventors

Mohamad Shebley

Abstract

The present invention relates to dosing regimens for GnRH receptor antagonists, and, in particular, dosing regimens for 4-((R)-2-[5-(2-fluoro-3-methoxy-phenyl)-3-(2-fluoro-6trifluoromethyl-benzyl)-4-methyl-2,6-dioxo-3,6-dihydro-2H-pyrimidin-1-yl]-1-phenylethylamino)-butyric acid (Compound A) or a pharmaceutically acceptable salt thereof, in subjects suffering from, for example, endometriosis, adenomyosis, polycystic ovary syndrome (PCOS), or uterine fibroids, to minimize changes in bone mineral density associated with such GnRH receptor antagonists.