Gesynta Pharma completes enrollment in Phase 2 NOVA trial evaluating vipoglanstat in endometriosis
- Enrollment completed three months ahead of schedule
- NOVA is evaluating vipoglanstat, a novel, non-hormonal, non-opioid drug candidate for the treatment of endometriosis
- Topline data anticipated in Q2 2027
STOCKHOLM, SWEDEN – October 20, 2026 – Gesynta Pharma AB, a clinical-stage biotech company developing vipoglanstat, a non-hormonal, non-opioid therapy that could transform the standard of care for women with endometriosis, today announced that it has completed enrollment in NOVA*, its Phase 2 clinical proof-of-concept and dose-finding trial. With 213 patients randomized against the original target of 190, the trial reached full enrollment more than three months ahead of schedule.
NOVA is a randomized, double-blind, placebo-controlled Phase 2 clinical proof-of-concept trial evaluating vipoglanstat in women with endometriosis across multiple sites in Europe. The study is designed to assess the efficacy and safety of two dose levels of vipoglanstat and will generate key data for the design of a subsequent Phase 3 program.
Patric Stenberg, Chief Executive Officer at Gesynta Pharma, said: “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. We look forward to completing the trial and reporting top-line results in the second quarter of 2027, to further inform the design of a Phase 3 program.”
Vipoglanstat is a novel, non-hormonal, non-opioid oral drug, designed to reduce pain and inflammation by selectively inhibiting mPGES-1, a key enzyme responsible for producing prostaglandin E2 (PGE), a major driver of inflammation, pain, and lesion growth in endometriosis. By targeting mPGES-1, vipoglanstat has the potential to offer a differentiated treatment approach while addressing the limitations of current therapies, such as menopause-like side effects, treatment duration restrictions and impacts on fertility.
Christian Becker, Professor of Reproductive Sciences, Co-Director of the Oxford Endometriosis CaRe Centre, and International Coordinating Investigator for the NOVA trial, commented: “For women living with endometriosis, pain and other symptoms can have a profound impact on daily life and wellbeing. Many continue to experience significant symptoms despite existing treatments, highlighting the need for new, non-hormonal therapeutic approaches. We look forward to seeing the clinical results next year and what they could mean for patients.”
In a preclinical proof-of-concept study using an advanced endometriosis model, vipoglanstat demonstrated a significant reduction in both pain-related behaviors and endometriotic lesion burden. Clinical studies to date have shown vipoglanstat to be well tolerated with no safety signals, and to fully inhibit the target enzyme, supporting its continued development as a novel, non-hormonal, non-opioid treatment for endometriosis.
*NOVA: the Non-hormonal Option – a Vipoglanstat Assessment trial
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For more information, please contact:
Gesynta Pharma
Email: info@gesynta.se
Optimum Strategic Communications
Mary Clark, Isabelle Abdou, Katie Flint, Aoife Minihan
Tel: +44 20 3821 6420
Email: Gesynta@optimumcomms.com
About Endometriosis
Endometriosis is a painful, chronic inflammatory disease that affects more than one in ten women of fertile age globally and remains a significantly underserved area of women’s health. It is caused by tissue similar to the uterine lining growing outside the uterus, primarily within the pelvic cavity, leading to inflammation, fibrosis, and the formation of endometriotic lesions and adhesions. Symptoms are wide-ranging, frequently severe and commonly include debilitating period pain (dysmenorrhea), persistent pain between periods (non-menstrual pelvic pain, NMPP), pain during sexual intercourse (dyspareunia), fatigue, gastrointestinal symptoms and infertility.
Despite its substantial impact on quality of life, treatment options are limited and typically confined to pain management, hormonal therapies and surgery, all of which can present significant challenges and limitations for patients. Current second-line hormonal therapies (GnRH agonists and antagonists) induce menopause-like side effects, have treatment-duration limits, and compromise fertility.
About NOVA
The NOVA trial is a randomized, double-blind, placebo-controlled clinical Phase 2 proof-of-concept trial evaluating the drug candidate vipoglanstat in women with endometriosis across Europe. The trial assesses the efficacy and safety of two dose levels of vipoglanstat and will provide important information for the design of a subsequent Phase 3 program.
213 patients aged 18 to 45 have been randomized to receive vipoglanstat or placebo over a period of four menstrual cycles (approximately four months). The primary objective is to evaluate the efficacy of vipoglanstat on endometriosis-related pain during non-menstrual days. Secondary objectives include assessing the effect on menstrual pain (dysmenorrhea), pain during sexual intercourse (dyspareunia), use of opioid rescue medication, and quality-of-life measures. Changes in endometriotic lesions assessed by MRI will be explored. Top-line results are anticipated in the second quarter of 2027.
About Gesynta Pharma
Gesynta Pharma is a clinical-stage biotech company developing an innovative treatment for endometriosis. Its lead program, vipoglanstat, is a novel oral, non-hormonal and non-opioid treatment candidate intended for long-term use, designed to target pain, inflammation and lesion development through selective inhibition of mPGES-1.
Building on deep expertise in prostaglandin biology and inflammation, Gesynta has generated a broad body of preclinical and clinical evidence supporting the development of vipoglanstat for endometriosis. Preclinical studies have demonstrated strong and sustained pain relief, together with a 70% reduction in endometriotic lesions in an advanced disease model. Clinical studies have shown full target engagement, robust pharmacokinetics and a favorable safety and tolerability profile.
Gesynta is backed by a highly experienced team with extensive drug development expertise, leading scientific and clinical advisors, and an international investor base spanning European life science and US women’s health specialists.
For more information, visit www.gesynta.se and follow Gesynta Pharma on LinkedIn.
