Gesynta Pharma Randomizes 50% of Patients in Phase 2 Endometriosis Trial of Vipoglanstat

STOCKHOLM, June 17, 2026 /PRNewswire/ -- Gesynta Pharma AB, a Swedish clinical stage pharmaceutical company focusing on chronic inflammatory diseases, today announced that 50% of the target of 190 patients have been randomized in its Phase 2 clinical proof-of-concept trial (NOVA). The study is evaluating vipoglanstat, a novel, non-hormonal, non-opioid drug candidate for the treatment of endometriosis. This painful, often debilitating, chronic inflammatory disease, which affects more than 10 % of women in reproductive age, is also a major cause of infertility. Top-line results from the study are expected in 2027.

The NOVA* trial is a randomized, double-blind, placebo-controlled Phase 2 clinical proof-of-concept trial evaluating 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.

"Reaching the halfway point in patient recruitment marks a major milestone for our Phase 2 clinical trial in endometriosis. Achieved well ahead of schedule, the rapid progress reflects strong participation from clinical sites and great interest among eligible participants. This momentum highlights the urgent need for better treatments," says Eva Johnsson, Chief Medical Officer (CMO) and VP Clinical Development. "We are now eager to complete enrollment and proceed to the next phase of evaluation."

"The NOVA trial is a significant advancement in a field with few ongoing clinical trials, and a key step toward establishing a strong foundation for a future Phase 3 program for vipoglanstat," comments Patric Stenberg, CEO of Gesynta Pharma. "Given the immense medical need, our focus remains on delivering a treatment that is highly effective, safe, and well-tolerated."

Vipoglanstat is an innovative, orally active drug candidate designed to reduce pain and inflammation by targeting mPGES-1, a key enzyme that produces the proinflammatory mediator prostaglandin E2 (PGE2) in endometriotic lesions. A preclinical proof-of-concept study in an advanced endometriosis model demonstrated that vipoglanstat significantly reduced pain-related behaviors and endometriotic lesion burden. Previous clinical studies confirm its safety, tolerability, and favorable pharmacodynamic effects in humans, supporting further development of the drug candidate as a non-hormonal, non-opioid treatment for endometriosis.

*NOVA: the Non-hormonal Option – a Vipoglanstat Assessment trial

For more information, please contact:
Patric Stenberg, CEO
Tel: + 46 (0)733 83 66 70
E-mail: [email protected]

About endometriosis

Endometriosis is a painful chronic inflammatory disorder in which tissue similar to the uterus lining grows outside the uterus, mainly in the pelvic cavity, causing inflammation, fibrosis, and the formation of endometriotic lesions and adhesions. It commonly presents with severe period pain (dysmenorrhea), pain between periods (non-menstrual pelvic pain, NMPP), pain during sexual intercourse (dyspareunia), gastrointestinal symptoms, and infertility. Current management is typically limited to analgesics, hormonal therapies, and surgery.

Despite its high prevalence, affecting more than 10% of women of reproductive age, endometriosis remains a critically underserved area of women's health. The disease is significantly underdiagnosed and undertreated, with few new treatment options available to patients. For millions of women worldwide, coping with severe pain alongside these diagnostic and therapeutic hurdles makes endometriosis profoundly challenging to live with.

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.

Approximately 190 patients aged 18 to 45 will receive vipoglanstat or placebo over a period of four menstrual cycles. 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 2027.

About Gesynta Pharma

Gesynta Pharma's research on targeting mPGES-1, an essential enzyme in inflammation, began at Karolinska Institutet in Sweden. The company's lead compound, vipoglanstat, is under development for endometriosis, offering a novel, non-hormonal, non-opioid therapeutic approach for a chronic inflammatory condition that affects more than 10% of women of reproductive age. Vipoglanstat significantly reduced pain-related behaviors and endometriotic lesions in an advanced preclinical disease model. The drug candidate is currently being evaluated in the Phase 2 clinical proof-of-concept NOVA trial.

A second drug candidate in the Gesynta Pharma portfolio, GS-073, is ready to enter clinical Phase 1 for the treatment of chronic inflammatory pain.

Gesynta Pharma's shareholders include Hadean Ventures, Industrifonden, Innovestor Life Science, Linc, HealthCap, XGen Venture, and other internationally renowned specialist investors.

For more information, please visit www.gesynta.se

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SOURCE Gesynta Pharma