Stage 2 Trials of Pirenzepine for Neuropathy

Posted by windsorchris @windsorchris, Aug 1, 2021

Stage 2 Trials were scheduled to end in July. Does anyone have any information on results?

Interested in more discussions like this? Go to the Neuropathy Support Group.

Please share how you got the Pirenzepine....otherwise it is a teaser for those of us who would like relief. Thank you. I am grateful every day for this site and the sharing of information.

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Results of the 2a study just published in one of the Lancet group publications. Jan 2026. Generally promising results.
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ARTICLESVolume 123106055January 2026Open Access
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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
Ajith Sivadasana ∙ Paul Fernyhoughb,c ∙ Nigel A. Calcuttd ∙ Katie E. Frizzid,e ∙ Kimberly Gardnerd ∙ Angela Hansene ∙ et al.

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Results of the 2a study just published in one of the Lancet group publications. Jan 2026. Generally promising results.
eBioMedicine Home

Advanced search
ARTICLESVolume 123106055January 2026Open Access
Download Full Issue
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
Ajith Sivadasana ∙ Paul Fernyhoughb,c ∙ Nigel A. Calcuttd ∙ Katie E. Frizzid,e ∙ Kimberly Gardnerd ∙ Angela Hansene ∙ et al.

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@proteusx - I thought I would share the link to the research article you posted so that other members can find it easier.
-- 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:
https://www.thelancet.com/journals/ebiom/article/PIIS2352-3964(25)00499-2/fulltext

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Thanks. And I would like to add that though WinSanTor's studies have focused primarily on diabetic peripheral neuropathy their researchers have indicated that the drug will likely also have benefits in several other forms of PN, including chemotherapy induced PN, though this remains to be demonstrated. At some point I will comment on my personal experience with "scrambler therapy" in Rome last summer and with my ongoing use of red light therapy and carboxy therapy.

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I received some encouraging news from Winsantor this morning that it plans to make its pirenzepine drug available through the state of Montana's enlightened "Right to Try" legislation which allows use of not-yet FDA approved drugs by those suffering from severe debilitating diseases not satisfactorily treatable by other means. Winsantor recently published its Phase 2a clinical trial results in the highly respected journal Lancet, demonstrating both safety and efficacy. This is the first drug that shows the ability to actually modify the underlying causes of the disease rather than merely treat symptoms, such as pain, which the FDA, to the detriment of all of us, has chosen to prioritize for the last several decades. Winsantor has indicated that the drug may become available at state- designated Experimental Treatment Centers in Montana as early as this summer. Applicants will need statements from their physicians attesting to their neuropathic conditions and their resistance to other treatment modalities and, of course, they will need to provide informed consent. Patients will have to travel to Montana. Treatment costs will not be covered by insurance. Meanwhile, Winsantor will continue to pursue phase 3 studies, but these may take years to complete and. thanks to FDA's misplaced priorities. will prove highly costly.

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I wander why there is no mention of releasing this drug in Canada before releasing it in the States? I mean lots of the research was done in Winnipeg and Toronto…. Comes down to money ultimately I suppose. I heard it could possibly be released earlier in Europe however. Anyone planning on going to Montana if it becomes available there?

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Profile picture for proteusx @proteusx

I received some encouraging news from Winsantor this morning that it plans to make its pirenzepine drug available through the state of Montana's enlightened "Right to Try" legislation which allows use of not-yet FDA approved drugs by those suffering from severe debilitating diseases not satisfactorily treatable by other means. Winsantor recently published its Phase 2a clinical trial results in the highly respected journal Lancet, demonstrating both safety and efficacy. This is the first drug that shows the ability to actually modify the underlying causes of the disease rather than merely treat symptoms, such as pain, which the FDA, to the detriment of all of us, has chosen to prioritize for the last several decades. Winsantor has indicated that the drug may become available at state- designated Experimental Treatment Centers in Montana as early as this summer. Applicants will need statements from their physicians attesting to their neuropathic conditions and their resistance to other treatment modalities and, of course, they will need to provide informed consent. Patients will have to travel to Montana. Treatment costs will not be covered by insurance. Meanwhile, Winsantor will continue to pursue phase 3 studies, but these may take years to complete and. thanks to FDA's misplaced priorities. will prove highly costly.

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@proteusx I would love to volunteer for the project.

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Godspeed to this project.

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Go to winsantor.com and click on Join Our Right To Try. I don't think they are taking people til this summer some time but you can get on their list so you will know when you can sign up.

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After hours of research: oral pirenzipine WAS available in Europe and Japan BEFORE WinSanTor bought the patent. Saw it worked on vagus nerve. Found posts oral med helped with painful neuropathy after continued use!
I'm told WinSanTor took it OFF the market.
WHY would they do that?
Research finds:
Patent law states "another guide is whether a patent Monopoly is exploited in a manner that leads to substantial perverse social consequences to the extent that this practices disproportionately generate socially undesirable consequences".
I think this is saying that a patent should not cause negative consequences for society...
I don't know much about patent law in U.S. versus worldwide. I don't know if and when their patent expires.
What I do believe is that a company has no legitimate right to take away availability of meds that have been tested and approved (in this case for ulcer treatment on vagus nerve)
My hope is that enough of us join together to file a complaint to get this unusual health problem resolved.
LindaHarding

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