A 24-Week Study of Topical Pirenzepine or Placebo in Type 2 Diabetic Patients (T2DM) With Peripheral Neuropathy

Summary

This is a randomized outpatient, double-blind, placebo-controlled, multiple-site study of the safety, tolerability, and exploratory efficacy of topically administered WST-057 (4% pirenzepine free base monohydrate) for 24 weeks in subjects with T2DM with peripheral neuropathy.

Timeline

Start

2019-10-15

Primary completion

2021-12-15

Completion

2021-12-15

Publications

• Sivadasan A, Fernyhough P, Calcutt NA, Frizzi KE, Gardner K, Hansen A, Breiner A, Zochodne DW, McInnes N, Punthakee Z, Gosselin S, Perkins BA, Bril V. 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. EBioMedicine. 2026 Jan;123:106055. doi: 10.1016/j.ebiom.2025.106055. Epub 2025 Dec 5.

Drugs

Indications