Jersey City, N.J. — Organon has completed a global licensing agreement with Sebela Pharmaceuticals for exclusive rights to MIUDELLA, an FDA-approved hormone-free copper intrauterine device.
The agreement expands Organon’s contraception portfolio and gives the company rights to commercialize the long-acting reversible contraceptive globally.
The U.S. Food and Drug Administration approved MIUDELLA on Feb. 24, 2025, for the prevention of pregnancy for up to three years in females of reproductive potential. Organon said it is the first hormone-free copper IUD introduced in the United States in more than 40 years and is expected to become commercially available in late 2026.
MIUDELLA uses Sebela’s proprietary SLIMSERT technology, which includes a flexible frame and a fully preloaded inserter with a tapered insertion tube measuring 3.7 millimeters in diameter.
“MIUDELLA represents an important hormone-free option in contraception, expanding choices for women seeking long-acting reversible birth control,” said Joe Morrissey, Chief Executive Officer of Organon. “By building on our long history in contraception and leveraging our deep expertise and capabilities, this agreement strengthens Organon’s ability to deliver contraceptive options that meet the needs of women.”
MIUDELLA will be available in the United States only through a Risk Evaluation and Mitigation Strategy program intended to reduce complications associated with improper insertion.
“Developed by Sebela Women’s Health, MIUDELLA represents an effective option for pregnancy prevention,” said Alan Cooke, Chief Executive Officer and President of Sebela Pharmaceuticals. “We are delighted to complete this global license agreement with Organon. Organon offers the scale, launch readiness and access capabilities needed to bring this valuable product efficiently into clinical practice and help ensure MIUDELLA reaches more women who are looking for hormone-free contraception options.”
MIUDELLA was studied in three U.S. clinical trials involving 1,904 women ages 17 to 45. A Phase 3 study conducted at 42 U.S. centers evaluated contraceptive effectiveness over three years.
Among 1,397 participants ages 17 to 35 in the efficacy group, the first-year Pearl Index was 0.94 and the cumulative three-year Pearl Index was 1.05. The overall placement success rate was 98.8%.
The most frequently reported adverse reactions included heavy menstrual bleeding, painful menstruation, bleeding between periods, pelvic discomfort, procedural pain, pelvic pain, post-procedural bleeding and pain during intercourse.
During the first year, 8.5% of participants across the three studies discontinued treatment because of bleeding or pain-related adverse events. That rate declined to 3.2% by the third year. Expulsion rates ranged from 1.9% in the first year to 0.9% in the third year.
Truist Securities served as financial adviser to Sebela Pharmaceuticals.
