2025-01-06
On December 9, 2024, Criantics announced that the FDA has accepted the submission of a New Drug Application (NDA) for Paltusotine, an investigational drug candidate designed for the treatment and long-term maintenance treatment of adult patients with acromegaly. NDA submissions include positive safety and efficacy data from the PATHFNDR-1 (NCT04837040) and PATHFNDR-2 (NCT05192382) Phase 3 clinical trials. These trials evaluated the efficacy of paltusotine in previously treated and drug-free adult patients with acromegaly, providing strong support for the clinical use of the drug.