ALM003

ALM003 is an investigational, proprietary modified-release oral formulation of **fluoxetine**, a selective serotonin reuptake inhibitor (SSRI), being developed by **Almatica Pharma** (a subsidiary of Alvogen) for the treatment of **Major Depressive Disorder (MDD)**. Fluoxetine primarily works by inhibiting the serotonin transporter (SERT), thereby increasing the concentration of serotonin in the synaptic cleft and enhancing serotonergic neurotransmission. ALM003 is currently in **Phase 3** clinical development (e.g., trial NCT05443308), where it is being evaluated for its efficacy and safety in adult patients with MDD. As a new formulation of an established antidepressant, ALM003 likely utilizes the 505(b)(2) regulatory pathway, aiming to provide optimized pharmacokinetic properties or dosing advantages compared to existing fluoxetine products.

Other names

Fluoxetine modified-releaseFluoxetine hydrochloride