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  • P3T for new insomnia drug will be conducted in KOR
  • by Lee, Hye-Kyung | translator Kang, Shin-Kook | Jul 29, 2024 05:47am
A new drug candidate that is approved in the US and EU
Daridorexant was approved by the FDA and EMA in 2022
New Phase III trial will evaluate the drug¡¯s safety and efficacy in adults and the elderly
 ¡ã New drug candidate for insomnia

The Swiss biotechnology company Idorsia will conduct a Phase III clinical trial in Korea for ACT-541468 (daridorexant), its new drug candidate for insomnia.

The Ministry of Food and Drug Safety (MFDS) approved Nxera Pharma Korea's application for a "multicenter, randomized, double-blind, placebo-controlled, parallel-group, Phase III clinical trial to evaluate the efficacy and safety of ACT-541468 (daridorexant) in adults and older adults with insomnia disorders¡± on the 26th.

Daridorexant was previously approved by the U.S. FDA on January 10, 2022, and the European Commission on May 3, 2022, for the treatment of adult patients with insomnia who have difficulty initiating and maintaining sleep.

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