Organon and Sebela report six-year results for MIUDELLA IUD

Organon and Sebela Women's Health presented positive six-year interim Phase 3 study results for MIUDELLA, a hormone-free copper intrauterine device, at the Society of Family Planning Meeting on October 17, 2026. The study reported a cumulative six-year Pearl Index of 0.93, supporting a regulatory submission to extend the device's approved usage period.

The medical trial results were shared during the conference held from October 17 to October 19, 2026, in San Francisco. The presentation covered long-term efficacy and safety outcomes from an ongoing clinical study conducted across trial locations in the United States.

Organon, a global healthcare company based in Jersey City, New Jersey, acquired the global commercial rights to MIUDELLA from Sebela Women's Health in June 2026. The product is a hormone-free copper intrauterine device created for long-term birth control.

Trial Outcomes and Efficacy Data

The single-arm Phase 3 clinical trial in the United States was conducted across 42 clinical study sites. Across the broader study, researchers gathered data from 1,601 participants monitored for safety and 1,397 participants who were evaluable for pregnancy.

In the six-year outcome analysis, researchers examined 465 of the 1,397 evaluable-for-pregnancy participants. The long-term safety analysis evaluated 592 of the 1,601 total safety participants who remained in the study through six years.

The clinical trial demonstrated a cumulative six-year Pearl Index of 0.93. In addition, the statistical evaluation established a cumulative six-year Kaplan-Meier pregnancy rate of 3.9% among participants monitored in the study.

Patient retention improved over the duration of the clinical study as side effects decreased. Discontinuation rates resulting from adverse events dropped from 8.7% during the first year of device use to 1.9% in the sixth year.

FDA Review and Expected Timeline

The findings support a supplemental New Drug Application submitted to the US Food and Drug Administration. The regulatory filing seeks approval to extend the official duration of use for MIUDELLA to six years.

The US Food and Drug Administration accepted the supplemental New Drug Application for review. The agency is expected to make a regulatory decision under the Prescription Drug User Fee Act in the second quarter of 2027.