Organon has completed a global licensing agreement with Sebela Pharmaceuticals for exclusive rights to MIUDELLA, a hormone-free copper intrauterine device approved by the FDA in February 2025. MIUDELLA is anticipated to be commercially available in late 2026.
The device is indicated for pregnancy prevention for up to three years and is 99% effective. It features proprietary SLIMSERT technology with a highly flexible frame and a fully preloaded inserter with a 3.7mm tapered insertion tube, designed to improve the placement experience. In the Phase 3 study of 1,397 women aged 17-35, the first-year Pearl Index was 0.94 and the cumulative three-year Pearl Index was 1.05.
“MIUDELLA represents an important hormone-free option in contraception, expanding choices for women seeking long-acting reversible birth control,” said Organon CEO Joe Morrissey. “This agreement strengthens Organon’s ability to deliver contraceptive options that meet the needs of women.”
The licensing deal comes shortly after Sun Pharma’s $11.75 billion acquisition of Organon. MIUDELLA adds a hormone-free contraceptive option to Organon’s portfolio at a time when demand for non-hormonal alternatives continues to grow.
