Mithra to Initiate PK Study for Estelle®

  • First step toward bringing Estelle® to the Japanese and ASEAN markets with partner Fuji Pharma
  • Bridging study aims to characterize and compare the pharmacokinetic (PK) profile of Estetrol (E4) and its combination with Drospirenone (DRSP) in Japanese and Caucasian subjects
  • Liège, Belgium May 12, 2017 – Mithra, a company dedicated to Women’s Health, announces that the Company received IRB[1] approval for the launch of a PK ethnobridging study for Estelle®. Estelle® is Mithra’s novel oral contraceptive product candidate composed of 15 mg E4, its unique native estrogen, and 3 mg DRSP. Currently, pivotal Phase III Estelle® trials are ongoing in the US and Canada as well as in Europe and Russia.