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ALA-3000, Long-acting Injectable of Ketamine for Treatment-resistant depression
Category:Finished Dosage > Nervous System Preparations Product Name:ALA-3000, Long-acting Injectable of Ketamine for Treatment-resistant depression CAS No.:NA Standard:In-house Standards Price(USD):Negotiable Company:Alar Pharmaceuticals Inc.
Main Sales Markets: North America,Western Europe,Australasia,Asia
Sample Provided: no
Payment Terms: L/C
Alar pharmaceuticals Inc is developing ALA-3000, a sustained release injectable of ketamine, indicating for treatment-resistant depression (TRD) subcutaneously. Through the controlled release formulation, it is anticipated that the pharmacokinetic profile without dumping/burst effect would reduce the risks of adverse events (e.g. dissociation, sedation, and perceptual changes) and improve patient compliance.
The preclinical studies for proof of concept and GMP production of drug substance and drug product have been completed. The pre-IND meeting with US FDA has also been completed, agreeing with the development plans of Chemistry, Manufacturing, and Controls (CMC), nonclinical studies, and phase 1 clinical study for ALA-3000, and also provides feedback beyond the studies required for opening phase 1 study. The outcomes of this pre-IND meeting deem the development of ALA-3000 through 505(b)(2) regulatory pathway and advance towards an IND submission. The IND submission for the first-in-human study is anticipated later 2022.