Therapy Areas: Central Nervous System
Luye Pharma Group files NDA for antidepressant drug LY03005
5 March 2020 -

Pharmaceutical company Luye Pharma Group said on Wednesday that it has submitted its New Drug Application (NDA) for LY03005, a new chemical drug for the treatment of major depressive disorder, with US Food and Drug Administration (FDA).

LY03005 is the company's second drug in the central nervous system (CNS) therapeutic area in the FDA's NDA phase. It is an exclusive CNS product developed under Luye Pharma's New Chemical and Therapeutic Entities (NCE/NTE) R&D platform. The drug is a serotonin-norepinephrine-dopamine triple reuptake inhibitor (SNDRI), with one of the active metabolites being a serotonin-norepinephrine reuptake inhibitor (SNRI).

Luye Pharma has received patents covering the chemical compound and crystal form in target markets such as China, the US, Europe, Japan and Korea.