LevoCept

LevoCept is a hormonal intrauterine device (IUD) currently in late-stage development by Sebela Pharmaceuticals. It is designed as a long-acting reversible contraceptive that releases levonorgestrel, similar to other hormonal IUDs on the market. Its distinguishing feature is an innovative frame design made of a flexible, super-elastic nitinol material with a spring-type shape. This design is intended to conform to the shape of the uterus, potentially providing more comfort during insertion and use. The device has completed a three-year Phase 2 trial demonstrating its safety and efficacy. It is currently undergoing Phase 3 clinical trials to further assess its contraceptive efficacy in approximately 1,525 pre-menopausal women up to age 45. The Phase 3 trial is a prospective, multi-center, single-arm, open-label study following subjects for up to 3 years with a possible extension to 5 years.