The Stockholm-based company randomized 213 patients, against an original target of 190. NOVA (Non-hormonal Option – a Vipoglanstat Assessment) is a randomized, double-blind, placebo-controlled proof-of-concept and dose-finding trial running at multiple sites in Europe. It is assessing the efficacy and safety of two dose levels of vipoglanstat, and the results will inform the design of a subsequent Phase III program.

“Completing enrollment in NOVA ahead of schedule is an important milestone for Gesynta. We believe the non-hormonal profile of vipoglanstat has been a strong contributing factor to the robust recruitment, resonating with both investigators and patients. Most importantly, it brings us a step closer to offering women with endometriosis a much-needed new treatment option,” says Patric Stenberg, CEO, Gesynta Pharma.

Vipoglanstat is an oral drug that selectively inhibits mPGES-1, a key enzyme that produces prostaglandin E2 (PGE₂). PGE₂ is a major driver of inflammation, pain, and lesion growth in endometriosis. The approach aims to avoid the limitations of current therapies, which include menopause-like side effects, restrictions on treatment duration, and impacts on fertility.

In a preclinical study, vipoglanstat significantly reduced both pain-related behaviors and endometriotic lesion burden. Clinical studies to date have shown the drug to be well tolerated with no safety signals, and it fully inhibits the target enzyme.

“For women living with endometriosis, pain and other symptoms can have a profound impact on daily life and well-being. Many continue to experience significant symptoms despite existing treatments, highlighting the need for new, non-hormonal therapeutic approaches,” says Christian Becker, Professor of Reproductive Sciences, Co-Director of the Oxford Endometriosis CaRe Centre, and International Coordinating Investigator for the NOVA trial.