Source disclosure: March 04, 2026, 15:30 JST
Published by Pulse News Wire: March 04, 2026, 15:43 JST
Nxera Pharma Co.,Ltd. [4565.T]
TOKYO, Mar 04 (Pulse News Wire) – Nxera Pharma CO.,LTD. (4565.T) announced today that it submitted a manufacturing and marketing approval application for dual orexin receptor antagonist daridorexant to the Ministry of Food and Drug Safety (MFDS) in South Korea for the treatment of insomnia patients.
This submission follows successful Phase 3 trial results, which met primary endpoints for total sleep time (sTST) and secondary endpoints for sleep latency (sLSO) and wake after sleep onset (sWASO). Daridorexant is currently marketed in Japan as Cubibic® tablets and is part of a global strategy involving partnerships with various pharmaceutical companies. In South Korea, Nxera Pharma Korea Co., Ltd.'s CEO MinBok Lee stated that this application marks a significant milestone toward potential approval in 2027.
The impact on Nxera Pharma's consolidated performance for the fiscal year ending December 2026 is expected to be minor. Insomnia affects approximately 15-25% of adults in South Korea, totaling around 6.5 to people. Research shows that chronic insomnia sufferers in South Korea increased by 21% from 597,529 in 2018 to 722,440 in 2022, with half being over 60 years old and 61% female.
Treatment goals aim to improve sleep quality and quantity while reducing daytime impairment and avoiding adverse effects.
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