pirenzepine topical (WST-057) / WinSanTor - LARVOL DELTA

Topical application of the antimuscarinic pirenzepine increased lower limb nerve fibre density in a phase 2a study in type 2 patients with diabetes with peripheral neuropathy. (PubMed, EBioMedicine) - "The efficacy of topical pirenzepine in preclinical studies was translated to a clinical study. The overall systemic safety profile was similar between patient groups. However, local topical reactions were more prevalent in the active dose groups than in the placebo group. Topical pirenzepine administered once daily for 24 weeks in patients with DPN resulted in a statistically significant growth of nerve fibres as measured by IENFD at the ankle. This study in humans with DPN demonstrates that selective targeting of the muscarinic acetylcholine type 1 receptor promotes regeneration of distal axons. Future phase 2b, and phase 3 studies are needed to substantiate these observations."

Journal • P2a data • Diabetes • Diabetic Neuropathy • Metabolic Disorders • Pain • Type 2 Diabetes Mellitus

A Study of Topical Pirenzepine or Placebo in Oncology Patients With Chemotherapy Induced Peripheral Neuropathy (clinicaltrials.gov) - P2 | N=60 | Active, not recruiting | Sponsor: WinSanTor, Inc | Trial completion date: May 2024 ➔ May 2026 | Trial primary completion date: Apr 2024 ➔ Apr 2026 | Recruiting ➔ Active, not recruiting

Enrollment closed • Trial completion date • Trial primary completion date • Oncology • Pain

A 16-Week Study of Pirenzepine or Placebo to Treat HIV-Associated Distal Sensory Polyneuropathy in Patients With HIV (clinicaltrials.gov) - P2 | N=16 | Completed | Sponsor: WinSanTor, Inc | Phase classification: P2a ➔ P2

Phase classification • Human Immunodeficiency Virus • Infectious Disease • Pain

A 12-Week Study of Topical Pirenzepine or Placebo in Type 2 Diabetic Patients (T2DM) With Painful Peripheral Neuropathy (clinicaltrials.gov) - P2a | N=58 | Completed | Sponsor: WinSanTor, Inc | Trial completion date: Jun 2022 ➔ Dec 2022 | Trial primary completion date: May 2022 ➔ Dec 2022

Trial completion date • Trial primary completion date • Diabetes • Diabetic Neuropathy • Metabolic Disorders • Pain • Peripheral Neuropathic Pain • Type 2 Diabetes Mellitus

A 16-Week Study of Pirenzepine or Placebo to Treat HIV-Associated Distal Sensory Polyneuropathy in Patients With HIV (clinicaltrials.gov) - P2a | N=16 | Completed | Sponsor: WinSanTor, Inc | Recruiting ➔ Completed | N=60 ➔ 16 | Trial completion date: Nov 2023 ➔ Jan 2023

Enrollment change • Trial completion • Trial completion date • Human Immunodeficiency Virus • Infectious Disease • Pain

A Study of Topical Pirenzepine or Placebo in Oncology Patients With Chemotherapy Induced Peripheral Neuropathy (clinicaltrials.gov) - P2 | N=60 | Recruiting | Sponsor: WinSanTor, Inc | Not yet recruiting ➔ Recruiting | Initiation date: Aug 2022 ➔ Nov 2022

Enrollment open • Trial initiation date • Oncology • Pain • Solid Tumor

A Study of Topical Pirenzepine or Placebo in Oncology Patients With Chemotherapy Induced Peripheral Neuropathy (clinicaltrials.gov) - P2 | N=60 | Not yet recruiting | Sponsor: WinSanTor, Inc

New P2 trial • Oncology • Pain • Solid Tumor

A 12-Week Study of Topical Pirenzepine or Placebo in Type 2 Diabetic Patients (T2DM) With Painful Peripheral Neuropathy (clinicaltrials.gov) - P2a | N=58 | Completed | Sponsor: WinSanTor, Inc | Active, not recruiting ➔ Completed

Trial completion • Diabetes • Diabetic Neuropathy • Metabolic Disorders • Pain • Peripheral Neuropathic Pain • Type 2 Diabetes Mellitus

A 24-Week Study of Topical Pirenzepine or Placebo in Type 2 Diabetic Patients (T2DM) With Peripheral Neuropathy (clinicaltrials.gov) - P2a | N=58 | Completed | Sponsor: WinSanTor, Inc | Active, not recruiting ➔ Completed

Trial completion • Diabetes • Diabetic Neuropathy • Metabolic Disorders • Pain • Peripheral Neuropathic Pain • Type 2 Diabetes Mellitus

A 12-Week Study of Topical Pirenzepine or Placebo in Type 2 Diabetic Patients (T2DM) With Painful Peripheral Neuropathy (clinicaltrials.gov) - P2a | N=54 | Active, not recruiting | Sponsor: WinSanTor, Inc | Recruiting ➔ Active, not recruiting

Enrollment closed • Diabetes • Diabetic Neuropathy • Metabolic Disorders • Pain • Peripheral Neuropathic Pain • Type 2 Diabetes Mellitus

A 16-Week Study of Pirenzepine or Placebo to Treat HIV-Associated Distal Sensory Polyneuropathy in Patients With HIV (clinicaltrials.gov) - P2a; N=60; Recruiting; Sponsor: WinSanTor, Inc; Not yet recruiting ➔ Recruiting

Clinical • Enrollment open • Human Immunodeficiency Virus • Infectious Disease • Pain

A 12-Week Study of Topical Pirenzepine or Placebo in Type 2 Diabetic Patients (T2DM) With Painful Peripheral Neuropathy (clinicaltrials.gov) - P2a; N=54; Recruiting; Sponsor: WinSanTor, Inc; Trial completion date: Aug 2021 ➔ May 2022; Trial primary completion date: Jul 2021 ➔ Apr 2022

Clinical • Trial completion date • Trial primary completion date • Diabetes • Diabetic Neuropathy • Metabolic Disorders • Pain • Type 2 Diabetes Mellitus

A 16-Week Study of Pirenzepine or Placebo to Treat HIV-Associated Distal Sensory Polyneuropathy in Patients With HIV (clinicaltrials.gov) - P2a; N=60; Not yet recruiting; Sponsor: WinSanTor, Inc

New P2a trial • Human Immunodeficiency Virus • Infectious Disease • Pain

A 24-Week Study of Topical Pirenzepine or Placebo in Type 2 Diabetic Patients (T2DM) With Peripheral Neuropathy (clinicaltrials.gov) - P2a; N=58; Active, not recruiting; Sponsor: WinSanTor, Inc; Recruiting ➔ Active, not recruiting

Enrollment closed • Diabetes • Diabetic Neuropathy • Metabolic Disorders • Pain • Type 2 Diabetes Mellitus

A 24-Week Study of Topical Pirenzepine or Placebo in Type 2 Diabetic Patients (T2DM) With Peripheral Neuropathy (clinicaltrials.gov) - P2a; N=60; Recruiting; Sponsor: WinSanTor, Inc; Trial completion date: Dec 2020 ➔ Dec 2021; Trial primary completion date: Dec 2020 ➔ Oct 2021

Clinical • Trial completion date • Trial primary completion date • Diabetes • Diabetic Neuropathy • Metabolic Disorders • Pain • Type 2 Diabetes Mellitus

A 12-Week Study of Topical Pirenzepine or Placebo in Type 2 Diabetic Patients (T2DM) With Painful Peripheral Neuropathy (clinicaltrials.gov) - P2a; N=54; Recruiting; Sponsor: WinSanTor, Inc

Clinical • New P2a trial • Diabetes • Diabetic Neuropathy • Metabolic Disorders • Pain • Type 2 Diabetes Mellitus

Topical delivery of muscarinic receptor antagonists prevents and reverses peripheral neuropathy in female diabetic mice. (PubMed, J Pharmacol Exp Ther) - "We measured plasma concentrations of the M receptor-selective muscarinic antagonist pirenzepine when delivered by subcutaneous injection, oral gavage, or topical application to the skin and investigated efficacy of topically delivered pirenzepine against indices of peripheral neuropathy in diabetic mice...Topical delivery of muscarinic antagonists may serve as a practical therapeutic approach to treating diabetic and other peripheral neuropathies. SIGNIFICANCE STATEMENT: Muscarinic antagonist pirenzepine alleviates diabetic peripheral neuropathy when applied topically in mice."

Journal • Preclinical • Diabetes • Diabetic Neuropathy • Human Immunodeficiency Virus • Infectious Disease • Metabolic Disorders • Pain

A 24-Week Study of Topical Pirenzepine or Placebo in Type 2 Diabetic Patients (T2DM) With Peripheral Neuropathy (clinicaltrials.gov) - P2a; N=60; Recruiting; Sponsor: WinSanTor, Inc; Not yet recruiting ➔ Recruiting; Initiation date: Aug 2019 ➔ Nov 2019

Clinical • Enrollment open • Trial initiation date

A 24-Week Study of Topical Pirenzepine or Placebo in Type 2 Diabetic Patients (T2DM) With Peripheral Neuropathy (clinicaltrials.gov) - P2a; N=60; Not yet recruiting; Sponsor: WinSanTor, Inc

Clinical • New P2a trial