Organon licenses MIUDELLA®, the first hormone-free copper IUD FDA-approved in 40+ years, expanding women’s reproductive health options with key safety details on REMS, insertion risks, and STIs.
Written By: Pharmacally Medical News Desk
Organon has agreed to exclusively license global rights to MIUDELLA®, a hormone-free copper intrauterine device (IUD) from Sebela Pharmaceuticals, expanding its women’s health portfolio. This deal, announced February 23, 2026, awaits Hart-Scott-Rodino antitrust review, FDA approval of supply chain changes, and other conditions.
Deal Overview
Organon will pay $27.5 million upfront, with up to $505 million in sales milestones and tiered double-digit royalties on net sales. The transaction supports Organon’s focus on diverse reproductive health options, as MIUDELLA complements existing products. It is not yet commercially available, pending these approvals.
MIUDELLA® Features
Approved by the FDA on February 24, 2025, MIUDELLA® prevents pregnancy for up to three years in females of reproductive potential. This marks the first hormone-free copper IUD approval in the U.S. in over 40 years, featuring a flexible nitinol frame, copper sleeves (175 mm² exposed surface), and a preloaded inserter with a 3.7 mm tapered tube for easier placement.
Copper release interferes with sperm transport and fertilization, offering long-acting, reversible, hormone-free contraception.
Key Safety Information
MIUDELLA® does not protect against HIV or other STIs.
It is available only through the MIUDELLA® REMS program.
Improper insertion raises risks of perforation, infection, bleeding, expulsion, and pregnancy complications; providers must enrol and complete MIUDELLA® REMS training before use.
pharmacies must be certified to dispense solely to certified providers.
Available only through certified pharmacies via miudellarems.com.
Promptly evaluate pregnant users for ectopic pregnancy.
MRI scans are safe only under specific conditions, and high Radiofrequency (RF) medical diathermy should be avoided due to tissue heating risks from the metal frame.
For full details on warnings (e.g., ectopic pregnancy, sepsis, PID, perforation), precautions (e.g., expulsion risk 3.6% over 3 years, bleeding changes), and contraindications (e.g., pregnancy, PID, Wilson’s disease, uterine anomalies), see the FDA Prescribing Information.
Clinical Context
In trials with 1,904 women, common adverse reactions (≥5%) included heavy menstrual bleeding, dysmenorrhea, and pelvic pain; discontinuation for bleeding/pain was 8.5% in year 1, dropping to 3.2% by year 3. Pearl Index showed low pregnancy rates (e.g., 0.94 in year 1).
References
Organon Enters into Agreement to License MIUDELLA®, Sebela Pharmaceuticals’ Hormone-Free Intrauterine Device, 23 February 2026, Organon Enters into Agreement to License MIUDELLA®, Sebela Pharmaceuticals’ Hormone-Free Intrauterine Device | Organon
FDA Approves MIUDELLA®, the First Hormone-Free Copper Intrauterine System (IUS) in the U.S. in Over 40 Years, from Sebela Women’s Health Inc., 24 February 2025, https://www.sebelapharma.com/assets/media/FDA_Approval_Release.pdf
MIUDELLA, Prescribing Information, https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/218201s000lbl.pdf