(O-30) BZ371A: a first-in-class topical peptide for erectile dysfunction post-prostatectomy – clinical research protocol implementation

Abstract Introduction BZ371A is a synthetic peptide developed at the Federal University of Minas Gerais (UFMG) and currently under clinical development by Biozeus Biopharmaceutical S.A. Derived from Phoneutria nigriventer venom, BZ371A activates local nitric oxide production via nNOS and iNOS pathways. Its topical formulation and novel mechanism represent a first-in-class therapeutic approach for erectile dysfunction (ED), especially in post-prostatectomy patients and those contraindicated for PDE5 inhibitors. Methods This Phase II randomized, double-blind, placebo-controlled trial (approved by ANVISA and CEP/CONEP) evaluated the safety and preliminary efficacy of BZ371A in penile rehabilitation following radical prostatectomy (PR). After a 30-day run-in phase with tadalafil 5 mg/day, 120 patients were screened; 72 were eligible and randomized into three groups for 60 days of treatment: BZ371A + tadalafil; BZ371A + oral placebo; topical placebo + tadalafil. A 15-day post-treatment follow-up completed the protocol. Outcomes included IIEF-EF, SEP-3, EDITS, penile Doppler, and length variation. Results The protocol was successfully implemented, with high retention and adherence. Major challenges involved patient inclusion within the restricted 30–60 day post-PR window and strict exclusion criteria. Of the 120 patients evaluated, 48 were excluded primarily due to time-point ineligibility or preexisting contraindications. No serious adverse events related to the investigational product were observed. Conclusion BZ371A introduces a first-in-class, nerve-independent approach to ED treatment via topical nitric oxide modulation. Itsprofile may address an unmet need in post-PR rehabilitation, especially for patients ineligible for systemic drugs. Despite recruitment challenges, the protocol was fully executed with strong operational performance. These findings support both the clinical potential and fesibility of BZ371A. Financing Biozeus Biopharmaceutica S.A.