Montana Experimental Treatment Review Board Announces Review Decision on WST-057 Under SB 535
MONTANA, November 4, 2026
The Montana Experimental Treatment Review Board (ETRB) announces the completion of its review and the issuance of Review Decision Letter RDL-2026-003 under Montana SB 535 (69th Legislature, Chapter 621) and ARM 37.106.3301 through 37.106.3325.
On October 26, 2026, the Board voted unanimously (5-0) to approve, with conditions, WST-057 (Topical Pirenzepine 4%), submitted by WinSanTor, Inc. of San Diego, California, for the treatment of peripheral neuropathy in adults.
The approval is subject to binding conditions concerning informed consent revisions, adverse-event classification, and consistent eligibility criteria.
The approval becomes effective upon written confirmation by the Chair that the conditions have been satisfied and, for use at a given experimental treatment center (ETC), upon that ETC's valid designation of the Board as its ETRB.
The full Review Decision Letter, RDL-2026-002, sets forth the Board's determinations, conditions of approval, and continuing obligations.
MONTANA, November 4, 2026
The Montana Experimental Treatment Review Board (ETRB) announces the completion of its review and the issuance of Review Decision Letter RDL-2026-003 under Montana SB 535 (69th Legislature, Chapter 621) and ARM 37.106.3301 through 37.106.3325.
On October 26, 2026, the Board voted unanimously (5-0) to approve, with conditions, WST-057 (Topical Pirenzepine 4%), submitted by WinSanTor, Inc. of San Diego, California, for the treatment of peripheral neuropathy in adults.
The approval is subject to binding conditions concerning informed consent revisions, adverse-event classification, and consistent eligibility criteria.
The approval becomes effective upon written confirmation by the Chair that the conditions have been satisfied and, for use at a given experimental treatment center (ETC), upon that ETC's valid designation of the Board as its ETRB.
The full Review Decision Letter, RDL-2026-002, sets forth the Board's determinations, conditions of approval, and continuing obligations.
This approval reflects the Board's professional judgment on the record submitted. It is not FDA approval or clearance, is not a determination of efficacy or therapeutic benefit, is not medical advice or a recommendation to any patient, and is not a warranty that the treatment is safe. Responsibility for development, manufacture, supply, and clinical delivery rests with the Applicant, the ETC, and treating providers.