Organon Reports Positive Six-Year Interim Phase 3 Results for Miudella IUD

By Public Technologies
  • Organon announced positive interim Phase 3 results showing contraceptive efficacy for its hormone-free copper IUD, MIUDELLA, through six years.
  • Bleeding- and pain-related discontinuations declined over time; reported adverse events included heavy menstrual bleeding, menstrual pain and pelvic discomfort.
  • Sebela Women's Health will present the findings October 17, 2026, at the Society of Family Planning Annual Meeting in San Francisco.
  • The FDA accepted an application to extend use to six years, with a decision expected in the second quarter of 2027.
  • Currently indicated for three years, MIUDELLA was exclusively licensed globally from Sebela Women's Health in June 2026.


Disclaimer: This news brief was created by Public Technologies (PUBT) using generative artificial intelligence. While PUBT strives to provide accurate and timely information, this AI-generated content is for informational purposes only and should not be interpreted as financial, investment, or legal advice. Organon & Co. published the original content used to generate this news brief via Business Wire (Ref. ID: 20261016500412) on October 16, 2026, and is solely responsible for the information contained therein.

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