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 group.

I had asked Win-San-Tor about availability of WST-057 (4% Topical Pirenzepine Cream) via the FDA Expanded Drug Access program. They told me there was some kind of a hiccup, and I would have to ask the FDA for permission to try it directly. I wrote to them and am awaiting on further guidance.

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@jfouts1979

I had asked Win-San-Tor about availability of WST-057 (4% Topical Pirenzepine Cream) via the FDA Expanded Drug Access program. They told me there was some kind of a hiccup, and I would have to ask the FDA for permission to try it directly. I wrote to them and am awaiting on further guidance.

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I am not aware of this topical medication but if you can post your experience after using it it, I am sure many of us would appreciate your findings.

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@jfouts1979

I had asked Win-San-Tor about availability of WST-057 (4% Topical Pirenzepine Cream) via the FDA Expanded Drug Access program. They told me there was some kind of a hiccup, and I would have to ask the FDA for permission to try it directly. I wrote to them and am awaiting on further guidance.

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I tried pharmacies in Mexico and Europe to try and get them to compound pirenzepine as a topical treatment for neuropathy but for legal reasons, they will not allow. My Kaiser docs will not complete the application for "extended use." The application has been streamlined and simplified so that now it takes about 45 minutes to complete. I,am 74 so believe it is worth the chance as this med has been touted as a possible reversal of this condition. Please advise any thing new learned,

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My doctor straight up told me I was not worth the time to complete the application for. At least he was being honest about how he felt. The legality of this is something that you would have to consider on your own – but I know that Pirenzepine tablets are available for sale through other countries – I have seen others talking about that online. DMSO is available in the US. That is what Win-San-Tor is using as a carrier for the Pirenzepine. I am not sure how you would go about mixing up a 4% cream with those two pieces of information though. I also know that Win-San-Tor does not have enough supply for their clinical trials yet – and that they are working on building it up (to include supply for the expanded use program). They told me they expect to have enough supply by early next year for the expanded use fda program.

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@jfouts1979

My doctor straight up told me I was not worth the time to complete the application for. At least he was being honest about how he felt. The legality of this is something that you would have to consider on your own – but I know that Pirenzepine tablets are available for sale through other countries – I have seen others talking about that online. DMSO is available in the US. That is what Win-San-Tor is using as a carrier for the Pirenzepine. I am not sure how you would go about mixing up a 4% cream with those two pieces of information though. I also know that Win-San-Tor does not have enough supply for their clinical trials yet – and that they are working on building it up (to include supply for the expanded use program). They told me they expect to have enough supply by early next year for the expanded use fda program.

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Thank you for this information. If I could manage to find a place to compound a clean 4% topical absorbent topical, I'd do it but to date no luck. I am aware of the availability of pirenzepine in tablet form in Japan but not sure if it is the proper grade. I wonder why they have not published the stage 2 trials. My doc also questioned the small number of participants (59). I was hoping to find someone who has been down this road and has at minimum, anecdotal report on how it went so far. Please let me know if you should learn anything else on this subject. Chris

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@windsorchris

Thank you for this information. If I could manage to find a place to compound a clean 4% topical absorbent topical, I'd do it but to date no luck. I am aware of the availability of pirenzepine in tablet form in Japan but not sure if it is the proper grade. I wonder why they have not published the stage 2 trials. My doc also questioned the small number of participants (59). I was hoping to find someone who has been down this road and has at minimum, anecdotal report on how it went so far. Please let me know if you should learn anything else on this subject. Chris

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There is a subreddit r/smallfiberneuropathy on reddit. There are people there that have. You should join that subreddit.

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@jfouts1979

There is a subreddit r/smallfiberneuropathy on reddit. There are people there that have. You should join that subreddit.

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Thanks for input. Could you provide a bit more info on the Reddit group and how to find this group?

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@windsorchris

Thanks for input. Could you provide a bit more info on the Reddit group and how to find this group?

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Join reddit. Look for the subreddit called r/smallfiberneuropathy.

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Why are the Stage II trial results completed in July of 2021 for Pirenzepine not posted to date? This therapy is touted as a possible cure for Neuropathy as Pirenzepine promotes regeneration of peripheral nerves.

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@windsorchris

Why are the Stage II trial results completed in July of 2021 for Pirenzepine not posted to date? This therapy is touted as a possible cure for Neuropathy as Pirenzepine promotes regeneration of peripheral nerves.

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This is what I found. On 3/12/21 it qas discontinued in the US. Most Recent Events
13 Aug 2021
WinSanTor plans a phase IIa trial for Distal sensory polyneuropathy (In adults, in the elderly) in USA (Topical) in October 2021 (NCT05005078)
12 Mar 2021
Discontinued for Neuropathic pain in USA (Transdermal)
20 Nov 2020
Phase-I clinical trials in Diabetic neuropathies (In adults, In the elderly) in USA (Topical)

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