Organon announced on July 2, 2025, that its Phase 2 ELENA proof-of-concept study evaluating the investigational candidate OG-6219 in endometriosis-related pain did not meet its primary efficacy endpoint. Based on these results, the company plans to discontinue the OG-6219 clinical development program.
OG-6219, an oral 17β-hydroxysteroid dehydrogenase type 1 (HSD17B1) inhibitor, was acquired through Organon's acquisition of Forendo Pharma in 2021. The study aimed to evaluate the efficacy, safety, and tolerability of three dose levels of OG-6219 in pre-menopausal women with surgically diagnosed endometriosis-related pain.
The primary efficacy endpoint was the change from baseline in the mean endometriosis-related overall pelvic pain score, but OG-6219 did not demonstrate improvement compared to placebo. This discontinuation represents a setback in Organon's efforts to develop novel non-hormonal treatment options for endometriosis.
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