Organon has started new fertility hormone phase III clinical studies
Organon announced that it has started phase III clinical studies for Org 36286 (corifollitropin alfa). The Org 36286 LIFE clinical trial program has been designed to evaluate a new regimen for the treatment of infertility. A single injection of Org 36286 will eliminate the need for seven consecutive days of injections. In a recent survey, 91% of the infertility experts questioned said that they expect their patients to be positive about this new treatment regimen. Organon sees Org 36286 as an important next step in order to expand and improve fertility treatment options.
Org 36286 is a New Biological Entity. Its distinct structure and pharmacokinetic properties set Org 36286 apart from existing classes of fertility hormones and make it the first Sustained Follicle Stimulant (SFS). Org 36286 is intended for use in women undergoing controlled ovarian stimulation (COS) during infertility treatment. Worldwide, over 700,000 cycles using COS for assisted reproduction treatment for in vitro fertilization and/or intracytoplasmic sperm injection take place each year.
The LIFE clinical trial program will focus on establishing Org 36286's efficacy and safety in infertile women, as well determining its potential to simplify treatment. The LIFE program will take place in about 75 fertility clinics in Europe, USA, Canada, Asia, Latin America, and Australia.
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