BZ371 / Biozeus - LARVOL DELTA

Intravenous peptides and amino acids for erectile dysfunction: a narrative review of current applications and future directions. (PubMed, Expert Opin Pharmacother) - "PT-141 and PnPP-19 show efficacy through central nervous system activation and nitric oxide regulation, while L-arginine and L-citrulline enhance endothelial function. Although evidence suggests potential benefits, large-scale clinical trials are needed to establish safety profiles, optimal dosing regimens, and possible synergistic effects with existing ED treatments."

Journal • Review • Erectile Dysfunction

Evaluation of the Efficacy in Increasing Sexual Arousal, Safety and Tolerability of BZ371A in Women with Sexual Arousal Disorder (clinicaltrials.gov) - P2 | N=140 | Not yet recruiting | Sponsor: Biozeus Biopharmaceutical S.A.

New P2 trial • Sexual Disorders

Evaluation of the Efficacy, Safety and Tolerability of BZ371A in Women with Sexual Arousal Disorder (clinicaltrials.gov) - P2 | N=30 | Recruiting | Sponsor: Biozeus Biopharmaceutical S.A. | Not yet recruiting ➔ Recruiting | Trial completion date: Dec 2024 ➔ Mar 2025 | Trial primary completion date: Nov 2024 ➔ Feb 2025

Enrollment open • Trial completion date • Trial primary completion date • Sexual Disorders

Safety and Efficacy Evaluation of BZ371A Topically Applied on Prostatectomized Patients (clinicaltrials.gov) - P2 | N=72 | Recruiting | Sponsor: Biozeus Biopharmaceutical S.A. | Trial completion date: Sep 2024 ➔ Jan 2025 | Trial primary completion date: Aug 2024 ➔ Dec 2024

Trial completion date • Trial primary completion date • Erectile Dysfunction • Genito-urinary Cancer • Oncology • Prostate Cancer • Solid Tumor

Safety and Efficacy Evaluation of BZ371A Topically Applied on Prostatectomized Patients (clinicaltrials.gov) - P2 | N=72 | Recruiting | Sponsor: Biozeus Biopharmaceutical S.A. | Not yet recruiting ➔ Recruiting

Enrollment open • Erectile Dysfunction • Genito-urinary Cancer • Oncology • Prostate Cancer • Solid Tumor

Evaluation of the Efficacy, Safety and Tolerability of BZ371A in Women With Sexual Arousal Disorder (clinicaltrials.gov) - P2 | N=30 | Not yet recruiting | Sponsor: Biozeus Biopharmaceutical S.A.

New P2 trial • Sexual Disorders

Safety and Efficacy Evaluation of BZ371A Topically Applied on Prostatectomized Patients (clinicaltrials.gov) - P2 | N=72 | Not yet recruiting | Sponsor: Biozeus Biopharmaceutical S.A. | Trial completion date: Apr 2024 ➔ Sep 2024 | Trial primary completion date: Mar 2024 ➔ Aug 2024

Trial completion date • Trial primary completion date • Erectile Dysfunction • Genito-urinary Cancer • Oncology • Prostate Cancer • Solid Tumor

PnPP-15, a Synthetic Peptide Derived from a Toxin from Phoneutria nigriventer Spider Venom, Alleviates Diabetic Neuropathic Pain and Acts Synergistically with Pregabalin in Mice. (PubMed, Toxins (Basel)) - "PnPP-15 is a synthetic peptide derived from PnPP19, a peptide representing a discontinuous epitope of the primary structure of the toxin PnTx2-6 from the venom of the spider Phoneutria nigriventer. Treatment with PnPP-15 did not cause spontaneous or forced motor changes and did not cause any damage or signs of toxicity in the analyzed organs (pancreas, lung, heart, kidney, brain, or liver). In conclusion, PnPP-15 is a great candidate for an analgesic drug against neuropathic pain caused by diabetes and exerts a synergistic effect when combined with pregabalin, allowing for even more efficient treatment."

Journal • Preclinical • Diabetes • Diabetic Neuropathy • Metabolic Disorders • Neuralgia • Pain

Safety and Efficacy Evaluation of BZ371A Topically Applied on Prostatectomized Patients (clinicaltrials.gov) - P2 | N=72 | Not yet recruiting | Sponsor: Biozeus Biopharmaceutical S.A. | Trial completion date: Jan 2024 ➔ Apr 2024 | Initiation date: Jun 2023 ➔ Sep 2023 | Trial primary completion date: Dec 2023 ➔ Mar 2024

Trial completion date • Trial initiation date • Trial primary completion date • Erectile Dysfunction • Genito-urinary Cancer • Oncology • Prostate Cancer • Solid Tumor

Safety and Efficacy Evaluation of BZ371A Topically Applied on Prostatectomized Patients (clinicaltrials.gov) - P2 | N=72 | Not yet recruiting | Sponsor: Biozeus Biopharmaceutical S.A. | Trial completion date: Oct 2023 ➔ Jan 2024 | Initiation date: Mar 2023 ➔ Jun 2023 | Trial primary completion date: Sep 2023 ➔ Dec 2023

Trial completion date • Trial initiation date • Trial primary completion date • Erectile Dysfunction • Genito-urinary Cancer • Oncology • Prostate Cancer • Solid Tumor

Safety, Tolerability and Pharmacokinetics (PK) Evaluation of BZ371A, Topically Administered (clinicaltrials.gov) - P1 | N=12 | Completed | Sponsor: Biozeus Biopharmaceutical S.A. | Active, not recruiting ➔ Completed

Trial completion • Erectile Dysfunction • Genito-urinary Cancer • Oncology • Prostate Cancer • Solid Tumor

Safety, Tolerability and Pharmacokinetics (PK) Evaluation of BZ371A, Topically Administered (clinicaltrials.gov) - P1 | N=12 | Active, not recruiting | Sponsor: Biozeus Biopharmaceutical S.A. | Not yet recruiting ➔ Active, not recruiting | Trial completion date: Sep 2022 ➔ Nov 2022 | Trial primary completion date: Sep 2022 ➔ Nov 2022

Enrollment closed • Trial completion date • Trial primary completion date • Erectile Dysfunction • Genito-urinary Cancer • Oncology • Prostate Cancer • Solid Tumor

Safety and Efficacy Evaluation of BZ371A Topically Applied on Prostatectomized Patients (clinicaltrials.gov) - P2 | N=72 | Not yet recruiting | Sponsor: Biozeus Biopharmaceutical S.A.

New P2 trial • Erectile Dysfunction • Genito-urinary Cancer • Oncology • Prostate Cancer • Solid Tumor

Safety, Tolerability and Pharmacokinetics (PK) Evaluation of BZ371A, Topically Administered (clinicaltrials.gov) - P1 | N=12 | Not yet recruiting | Sponsor: Biozeus Biopharmaceutical S.A. | Trial completion date: Jun 2022 ➔ Sep 2022 | Initiation date: May 2022 ➔ Sep 2022 | Trial primary completion date: Jun 2022 ➔ Sep 2022

Trial completion date • Trial initiation date • Trial primary completion date • Erectile Dysfunction • Genito-urinary Cancer • Oncology • Prostate Cancer • Solid Tumor

From the PnTx2-6 Toxin to the PnPP-19 Engineered Peptide: Therapeutic Potential in Erectile Dysfunction, Nociception, and Glaucoma. (PubMed, Front Mol Biosci) - "Furthermore, considering that PnPP-19 increases NO availability in the corpus cavernosum, this peptide was also tested in a model of induced intraocular hypertension, characterized by low NO levels, and it showed promising results by decreasing the intraocular pressure which prevents retinal damage. Herein, we discuss how was engineered this smaller active non-toxic peptide with promising results in the treatment of erectile dysfunction, nociception, and glaucoma from the noxious PnTx2-6, as well as the pitfalls of this ongoing journey."

Journal • Review • Erectile Dysfunction • Glaucoma • Ophthalmology • Pain

Safety, Tolerability and PK Evaluation of BZ371A, Topically Administered (clinicaltrials.gov) - P1 | N=12 | Not yet recruiting | Sponsor: Biozeus Biopharmaceutical S.A.

New P1 trial • Erectile Dysfunction • Genito-urinary Cancer • Oncology • Prostate Cancer • Solid Tumor

The synthetic peptide PnPP-19 potentiates erectile function via nNOS and iNOS. (PubMed, Nitric Oxide) - "Surprisingly, iNOS enhanced the potentiation of erectile function evoked by PnPP-19. Our results demonstrate that this new synthetic peptide potentiates erectile function via nitric oxide activation and reinforce its role as a new pharmacological tool for the treatment of erectile dysfunction."

Journal • Erectile Dysfunction • NOS1 • NOS3