Organon announces six-year MIUDELLA Phase 3 data

• Organon announced that Sebela Women's Health will present interim six-year Phase 3 results for MIUDELLA, a hormone-free copper IUD, at the Society of Family Planning Annual Meeting on October 17, 2026.
• The study reported a cumulative six-year Pearl Index of 0.93 and a Kaplan-Meier pregnancy rate of 3.9%, while bleeding and pain were among reported adverse events.
• The FDA is reviewing an application to extend MIUDELLA's approved duration of use to six years, with a regulatory decision expected in Q2 2027.

Organon (NYSE:OGN) announced interim six-year Phase 3 results for its licensed hormone-free MIUDELLA contraceptive device, reporting a cumulative Pearl Index of 0.93.

The ongoing U.S. study enrolled 1,397 participants in the pregnancy-evaluable population and 1,601 in the safety population across 42 sites, with six-year outcomes available for 465 and 592 participants, respectively.

"These interim Phase 3 results add to the clinical evidence for MIUDELLA and represent an important milestone in the ongoing study," said Organon Chief Medical Officer Juan Camilo Arjona Ferreira.

The study reported a 3.9% cumulative six-year pregnancy rate, while bleeding- and pain-related discontinuations affected 8.7% of participants in year one and 1.9% in year six.

Organon expects an FDA decision on extending MIUDELLA's authorized duration to six years in Q2 2027.

Organon exclusively licensed global rights to MIUDELLA from Sebela Women's Health in June 2026, adding the copper intrauterine device to its women's health portfolio.

MIUDELLA's existing U.S. labeling requires healthcare providers and facilities to enroll in a Risk Evaluation and Mitigation Strategy program intended to reduce complications associated with improper device insertion.