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?

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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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@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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@windsorchris you will notice that I have moved your recent post on the stage 2 trials back into your original discussion on the same topic to allow for the discussion to continue to mature.

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thank you. this topic I believe needs to be shared, discussed and investigated as it is the only potential CURE and reversal of dying nerves with new nerve growth for folks with PN.

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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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Hi, Can you tell me how you found out about Winsantor using DMSO? Or maybe a link that shows it.

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Winsantor just updated the clinical trials finally. They are going to the FDA this month to reveal the results and then trial 3 will be started very soon. You can go to the clinical trials website and view it.

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@lupusgirl

Winsantor just updated the clinical trials finally. They are going to the FDA this month to reveal the results and then trial 3 will be started very soon. You can go to the clinical trials website and view it.

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Any idea of the result? I can't seem to find it. I remembered reading earlier it needed to show at least 11% success. Which Clinical trials website are you saying it can be viewed on?

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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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I'm going to try my luck with the Gastrozepin (pirenzepine) tablets, the DMSO that it's been said Winsantor uses and maybe also a clean herbal cream. each tablet is 20mg so I will calculate the 4% as a portion of the added ingredients. I see a few trials underway and see that some use 2% and some 4%. At this point, I'm in pain, and other than numbing the pain, I do not see much other hope in the way of nerve regeneration.

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@donniemontgomery

Any idea of the result? I can't seem to find it. I remembered reading earlier it needed to show at least 11% success. Which Clinical trials website are you saying it can be viewed on?

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Hi @donniemontgomery, I would like to add my welcome to Connect along with @lupusgirl, @windsorchris and others. I'm sorry to hear you haven't found any relief for your pain. There is another discussion with links to Winsantor drug information that might provide some answers for your questions:

--- Is there any update on Winsantor drug?: https://connect.mayoclinic.org/discussion/is-there-any-update-on-winsantor-drug/.

If you haven't already seen the Foundation for Peripheral Neuropathy website, you might find some helpful information there - https://www.foundationforpn.org/living-well/.

Have you done any research on neuropathy?

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@jfouts1979

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

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You have to sign up for a Reddit account. Super simple. Once you do that you will find the r/sfn section if you type in that wording on the search icon. Someone just posted the link on Google that has the ingredients on the topical gel that you mix with pirenzepine. It has the milligrams and you would need a milligram scale which Amazon has. DMSO, propylene glycol, polyethylene glycol, polyoxyethylene glycol, citric acid, sodium hydroxide, methylcellulose, glycerine, NAOH, ethanol, benzyl alcohol, water, sodium citrate are the ingredients for the topical. This is for the straight up pirenzepine dihydrochloride raw powder not the freebase monohydrate pirenzepine. All freebase does is increase the drying time. It doesn’t affect the efficacy. It was used in the clinical trials for that reason.

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