Zhimeng Biopharma’s investigational drug approved to begin phase 2 epilepsy clinical trial in China
This approval follows the CDE’s clearance in July of this year for Phase 2/3 clinical studies of CB03-154 in amyotrophic lateral sclerosis
This approval follows the CDE’s clearance in July of this year for Phase 2/3 clinical studies of CB03-154 in amyotrophic lateral sclerosis
There is a significant unmet medical need for antidepressants that are effective, rapid onset of action and to be well tolerated
The approved ANDA is therapeutically equivalent to the reference listed drug product (RLD), Rexulti Tablets
The company plans to advance Ropanicant into double-blind, placebo-controlled Phase-2b clinical study in MDD patients, anticipated to start in early 2025
The primary objective was to evaluate safety and tolerability of Ropanicant in patients with MDD
Emraclidine, a potential best-in-class, next-generation antipsychotic, is in trials designed to be registration enabling for schizophrenia
This marks the first FDA approval of an AI-based brain disorder analysis solution from Korea
The product is bioequivalent and therapeutically equivalent to the Reference Listed Drug (RLD) Prozac Tablets of Eli Lilly
Studies will Investigate Antidepressant Properties of Ketamir to Position for Initial IND Application in 2024
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