Organon Announces Positive Interim Phase 3 Study Results for MIUDELLA®, a Hormone-Free, Intrauterine Device (IUD), Through 6 Years of Use to Be Presented at the 2026 Society of Family Planning Annual Meeting
Business Wire•16/10/2026•07:30 ET
0
Key Highlights
- ➤MIUDELLA six-year Pearl Index was 0.93 (95% CI, 0.62 to 1.34)
- ➤Six-year cumulative Kaplan-Meier pregnancy rate was 3.9% (95% CI, 2.7% to 5.8%)
- ➤FDA accepted MIUDELLA’s sNDA for six-year use; PDUFA action expected Q2 2027
- ➤Organon exclusively licensed global MIUDELLA rights from Sebela in June 2026
- ➤MIUDELLA six-year follow-up identified no new safety signals
Expert Statements
Juan Camilo Arjona Ferreira, MD, Head of Research & Development and Chief Medical Officer at Organon
“These interim Phase 3 results add to the clinical evidence for MIUDELLA and represent an important milestone in the ongoing study. The findings support the FDA review of the supplemental application as we work toward our ambition of expanding hormone-free contraceptive options.”
Kelly Culwell, MD, Chief Medical Officer and Head of Research and Development at Sebela Women’s Health
“Reaching 6 years of follow-up reflects the continued commitment of the participants, investigators, and study teams involved in this ongoing Phase 3 program. These findings provide valuable long-term data and contribute to the understanding of participant experience over time. We are grateful to everyone who has made this research possible.”
Organon Announces Positive Interim Phase 3 Study Results for MIUDELLA(®), a Hormone-Free, Intrauterine Device (IUD), Through 6 Years of Use to Be Presented at the 2026 Society of Family Planning Annual Meeting
No new safety signals identified during additional three years of extended use
Get started
Create a free account to read the full story.