Organon (NYSE: OGN) announced the completion of a global licensing agreement with Sebela Pharmaceuticals, granting Organon exclusive rights to Miudella, a hormone-free copper intrauterine device (IUD).

The U.S. Food and Drug Administration approved Miudella on February 24, 2025. According to the companies, it is the first hormone-free copper IUD introduced in the U.S. in over 40 years. The device is indicated for pregnancy prevention for up to three years and carries a claimed 99% effectiveness rate based on clinical trial data.

Miudella features a proprietary SlimSert technology, which includes a flexible frame and a preloaded inserter with a 3.7mm insertion tube diameter. The device is subject to a Risk Evaluation and Mitigation Strategy (REMS) program, meaning it will only be available through certified healthcare providers who have completed required insertion training.

Commercial availability in the U.S. is anticipated in late 2026.

Clinical data from a Phase 3 study conducted across 42 U.S. centers in 1,904 women aged 17 to 45 showed a first-year Pearl Index of 0.94 and a cumulative three-year Pearl Index of 1.05 in women aged 17 to 35. The most common adverse reactions reported in trials included heavy menstrual bleeding, dysmenorrhea, and pelvic pain. In the first year, 8.5% of participants discontinued due to bleeding or pain, a rate that declined to 3.2% by year three.

"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.

Alan Cooke, Chief Executive Officer and President of Sebela Pharmaceuticals, said Organon offers "the scale, launch readiness and access capabilities needed to bring this valuable product efficiently into clinical practice."

Truist Securities acted as financial advisor to Sebela Pharmaceuticals. Financial terms of the agreement were not disclosed in the announcement.