Organon Completes Global Licensing Agreement for MIUDELLA, a Hormone-Free Copper IUD – Organon

Organon announced the completion of a global licensing agreement with Sebela Pharmaceuticals, granting Organon exclusive rights to MIUDELLA, a hormone-free, copper intrauterine device (IUD). Please see our prior announcement for a summary of the transaction terms.

Approved by the FDA on February 24, 2025, MIUDELLA is the first hormone-free copper IUD to be introduced in the US in over 40 years. Indicated for the prevention of pregnancy for up to three years in females of reproductive potential, MIUDELLA is 99% effective. It features a proprietary SLIMSERTTM technology, which consists of a highly flexible frame and a fully preloaded inserter with a small, tapered insertion tube diameter of 3.7mm.1

MIUDELLA is anticipated to be commercially available in late 2026. The MIUDELLA label includes a Risk Evaluation and Mitigation Strategy (REMS). A REMS is a strategy used by the FDA to manage known or potential risks associated with a product. To mitigate complications due to potential improper insertion, MIUDELLA will only be available in the US through the MIUDELLA REMS program. See additional safety information below.

“MIUDELLA represents an important hormone-free option in contraception, expanding choices for women seeking long-acting reversible birth control. 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.” – Joe Morrissey, Chief Executive Officer of Organon.

“Developed by Sebela Women’s Health, MIUDELLA represents an effective option for pregnancy prevention. 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.” – Alan Cooke, Chief Executive Officer and President of Sebela Pharmaceuticals.

Truist Securities, Inc. acted as financial advisor to Sebela Pharmaceuticals.