Organon To Present Data From Its Current Phase 3 Trial Of MIUDELLA Intrauterine Device At 2026 Society Of Family Planning Annual Meeting

Organon (NYSE: OGN), a global healthcare company with a mission to deliver impactful medicines and solutions for a healthier every day, today announced that Sebela Women’s Health will present interim results from an ongoing Phase 3 study evaluating MIUDELLA®, a hormone-free, copper intrauterine device (IUD), through 6 years of use at the 2026 Society of Family Planning (SFP) Annual Meeting, taking place October 17 to 19, 2026, in San Francisco, California. In June 2026, Organon exclusively licensed global rights to MIUDELLA from Sebela Women’s Health.

The prospective, single-arm Phase 3 study is being conducted by Sebela Women’s Health at 42 sites in the United States to evaluate the efficacy and safety of MIUDELLA through 6 years of use. The 6-year outcomes were evaluated in 465 of 1397 and 592 of 1601 enrolled participants in the evaluable-for-pregnancy and safety populations, respectively. The cumulative 6-year Pearl Index was 0.93 (95% CI, 0.62 to 1.34), and the cumulative Kaplan-Meier pregnancy rate was 3.9% (95% CI, 2.7% to 5.8%) at 6 years. Treatment-emergent adverse events reported through 6 years included heavy menstrual bleeding, dysmenorrhea and pelvic discomfort. Bleeding- and pain-related adverse events leading to study discontinuation were observed in 139 participants (8.7%) in year 1 and 11 participants (1.9%) in year 6.1 Follow-up in the study is ongoing.