Comprehensive Report on BZ371A (DrugBank ID: DB18101)

I. Executive Summary

BZ371A (DrugBank ID: DB18101) is an investigational biotech therapeutic, specifically a synthetic peptide, developed by Biozeus Biopharmaceutical S.A. It is a lead candidate derived from the company's BZ371 peptide platform. The primary mechanism of action of BZ371A is the enhancement of nitric oxide synthase (NOS) activity, which leads to increased local production of endogenous nitric oxide (NO) and subsequent vasodilation.[1] This localized action is a key feature, aiming to minimize systemic exposure and associated side effects.[1]

The BZ371A clinical development program is currently focused on sexual dysfunction. It is being investigated for erectile dysfunction (ED), particularly in patients who have undergone radical prostatectomy, and for Female Sexual Arousal Disorder (FSAD), where it is also associated with the product name APHRA.[2] Phase 1 clinical trials for these sexual dysfunction indications have been completed, reportedly demonstrating good local tolerability and no systemic exposure with topical gel formulations.[4] Phase 2 trials are ongoing or planned for ED and FSAD.[6]

Beyond sexual health, the BZ371 platform, and BZ371A specifically, show preclinical promise for ophthalmic conditions. Notably, BZ371A has received Orphan Drug Designation (ODD) from the U.S. Food and Drug Administration (FDA) for the treatment of Anterior Ischemic Optic Neuropathy (AION).[8] Other eye diseases like glaucoma are also under preclinical investigation.[2] Furthermore, a related peptide from the platform, BZ371B, is in preclinical development for pulmonary diseases, administered via inhalation.[2] The consistent emphasis on local action across different formulations (topical gel, eye drops, inhalation) underscores a core strategic advantage of the BZ371 platform.

II. Introduction to BZ371A