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Clinical Trial Results clinical-trials drug-development regulatory

Yangtze River Pharma Unveils Positive Phase III Results for Insomnia Drug Fazamorexant, Submits NDA

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Yangtze River Pharma Unveils Positive Phase III Results for Insomnia Drug Fazamorexant, Submits NDA

AI-Generated Summary

Yangtze River Pharmaceutical Group announced positive Phase III clinical trial results for its innovative anti-insomnia drug, Fazamorexant, at the World Sleep Congress 2025. The dual orexin receptor antagonist demonstrated rapid efficacy and a favorable safety profile, showing significant improvements in key sleep indicators. Following these promising results, the company has officially submitted a New Drug Application (NDA) to China’s NMPA, aiming for accelerated review and market access.

In a nutshell

This development represents a significant advancement in sleep medicine and underscores the growing influence of Chinese pharmaceutical innovation on the global stage. The NDA submission marks a crucial step towards potentially offering a new, effective treatment option for a widespread condition.

Source: GlobeNewswire

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by Newsdesk
Updated

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