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  • Takeda receives P3T approval for TAK-861 in Korea
  • by Lee, Hye-Kyung | translator Kang, Shin-Kook | Aug 21, 2024 05:48am
its narcolepsy drug
MFDS approves the clinical trial on the 20th...will evaluate the safety and efficacy of the drug in treating Type 1 narcolepsy
The Japanese pharmaceutical company Takeda Pharmaceuticals will enter Phase III clinical trials for TAK-861, its new drug candidate for narcolepsy, in Korea.

On the 20th, the Ministry of Food and Drug Safety (MFDS) on Tuesday approved a randomized, double-blind, placebo-controlled Phase III clinical trial to evaluate the efficacy and safety of TAK-861 for the treatment of narcolepsy with cataplexy (narcolepsy type 1).

The Phase III trial will be conducted at Seoul National University Hospital, St. Vincent's Hospital, and Keimyung University Dongsan Medical Center.

Narcolepsy is a neurological disorder and sleep disorder characterized by episodic drowsiness during daily life.

Narcolepsy is categorized into
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