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BRP-343 is a novel subcutaneous formulation of esketamine being developed by Bioron Pharma for the treatment of treatment-resistant depression (TRD). Esketamine, the S-enantiomer of ketamine, acts as a non-competitive antagonist of the N-methyl-D-aspartate (NMDA) receptor, modulating glutamatergic neurotransmission to provide rapid-acting antidepressant effects. Unlike the approved intranasal esketamine formulation, BRP-343 is designed for delivery via a prefilled subcutaneous syringe, which may offer improved bioavailability, dosing precision, or patient convenience. The program is currently in Phase 2b clinical development and is being advanced through the FDA 505(b)(2) regulatory pathway, leveraging existing safety and efficacy data from reference esketamine products.
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