JERSEY CITY, N.J., June 22, 2026
Organon has completed a global licensing agreement with Sebela Pharmaceuticals for MIUDELLA®, a hormone-free copper intrauterine device (IUD) designed to expand long-acting reversible contraceptive options for women worldwide. The agreement grants Organon exclusive global rights to commercialize MIUDELLA®, reinforcing the company’s long-term strategy to strengthen its Women’s Health portfolio with innovative contraceptive technologies. MIUDELLA®, which received U.S. FDA approval in February 2025, is the first hormone-free copper IUD introduced in the United States in more than 40 years and is indicated for pregnancy prevention for up to three years in women of reproductive potential. The product combines high contraceptive effectiveness with a flexible, patient-focused design that aims to improve insertion and overall user experience. The completed licensing transaction represents a significant commercial milestone for both companies while supporting broader access to non-hormonal contraceptive solutions.
Global Licensing Agreement Strengthens Women’s Health Portfolio
The completed agreement significantly expands Organon’s global contraception business, adding an innovative, long-acting, hormone-free option to its established reproductive health portfolio. Through the licensing arrangement, Organon will lead the commercialization of MIUDELLA® worldwide, utilizing its extensive commercial infrastructure and expertise in women’s healthcare across more than 140 international markets. The partnership enables the company to broaden contraceptive choices for women seeking reliable, reversible birth control without hormonal exposure. Developed by Sebela Women’s Health, MIUDELLA® incorporates the proprietary SLIMSERT™ technology, featuring a highly flexible frame and a fully preloaded inserter with a narrow insertion tube designed to facilitate placement while maintaining clinical effectiveness. The product is expected to become commercially available during late 2026, supported by a comprehensive launch strategy focused on healthcare provider education and patient access.
Innovative Hormone-Free Technology Offers Effective Contraception
MIUDELLA® was evaluated in three U.S. clinical studies involving 1,904 women aged 17 to 45 years, including a multicenter Phase 3 clinical trial conducted across 42 clinical sites. Clinical results demonstrated a 99% contraceptive effectiveness rate with a three-year cumulative Pearl Index of 1.05, confirming strong long-term pregnancy prevention. The product also achieved an overall placement success rate of 98.8%, supporting its ease of clinical use.
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Unlike hormonal contraceptives, MIUDELLA® provides pregnancy prevention through a low-dose copper intrauterine system, eliminating exposure to hormonal therapies while maintaining highly effective contraception. The device remains indicated for up to three years of pregnancy prevention, providing women with a convenient, long-acting, reversible birth control option. The prescribing information includes a Risk Evaluation and Mitigation Strategy (REMS) to support appropriate insertion training and minimize insertion-related complications.
Commercial Expansion Supports Global Access to Women’s Healthcare
The licensing agreement further reinforces Organon’s commitment to expanding access to innovative women’s healthcare solutions through strategic collaborations and product portfolio expansion. By combining Sebela Pharmaceuticals’ innovation with Organon’s global commercial capabilities, the companies aim to accelerate the worldwide availability of MIUDELLA®, particularly in markets where demand continues to grow for effective non-hormonal contraceptive options. The transaction also strengthens Organon’s position in the rapidly evolving reproductive health sector, where patient preference increasingly favors personalized contraceptive solutions offering flexibility, convenience, and long-term effectiveness.
As healthcare providers seek additional options for women who prefer to avoid hormonal therapies, MIUDELLA® is positioned to become an important addition to the global contraceptive market. The completed licensing agreement highlights the growing importance of strategic partnerships in accelerating the commercialization of innovative women’s health technologies while improving patient access to advanced reproductive healthcare solutions around the world.
Source: Organon,Sebela Pharmaceuticals press release
