Is there any update on Winsantor drug?

Posted by cherbear2cubs @cherbear2cubs, Jul 1, 2023

Does anyone have update on results of Winsantor drug to reverse neuropathy? Thank you

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

Hello @cherbear2cubs, Welcome to Connect. You might want to checkout these discussions on Pirenzepine the new neuropathy treatment from Winsantor.

--- Winsantor drug testing: https://connect.mayoclinic.org/discussion/winsantor-drug-testing/
--- Stage 2 Trials of Pirenzepine for Neuropathy: https://connect.mayoclinic.org/discussion/stage-2-trials-of-pirenzepine-for-neuropathy/
--- Anyone Heard of Pirenzepine for Small Fiber Neuropathy?: https://connect.mayoclinic.org/discussion/anyone-heard-of-pirenzepine-for-small-fiber-neuropathy/.

Here is what Winsantor currently is saying...
--- Peripheral Neuropathy and Our Drug: https://winsantor.com/peripheral-neuropathy-and-our-drug/
"Phase 1 and Phase 2 are now complete. Topical WST-057 was shown to be safe and tolerable when administered to diabetic peripheral neuropathy patients for up to six months in these studies, but will need to be studied in a larger Phase 3 population (several thousand)."
--- Peripheral Neuropathy Drug Pipeline: https://winsantor.com/pipeline/
--- WST-057 Clinical Trials For Peripheral Neuropathy: https://winsantor.com/peripheral-neuropathy-clinical-trials/.

You can find other discussions in the Neuropathy Support Group here: https://connect.mayoclinic.org/group/neuropathy/.

Have you been diagnosed with diabetic or other another type of neuropathy?

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A few remarks - To jump the gun, some people on Reddit have been buying Pirenzepine from Japan and taking it orally and some have been making topical creams. Someone on Reddit claimed it worked after taking it orally for 45 days. Others have not see the same results. Also Pirenzepine can result in stomach pain so it should only be used with caution. I also understand (second hand) that the reason Winsantour are doing it as a cream is that they believe that the concentration needed to make it work orally are so high that it can only be applied topically.

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Phase 1 and Phase 2 are now complete. Topical WST-057 (Pirenzepine was shown to be safe and tolerable when administered to diabetic peripheral neuropathy patients for up to six months in these studies, but will need to be studied in a larger Phase 3 population (several thousand). (per Winsantor's site) In parallel, we are preparing studies in other indications, such as chemo-induced peripheral neuropathy. (per Winsator's site) It is a topical cream.

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Yes! There is! Yesterday I received an email from Winsantor that the clinical trial results for trial 2 have been posted finally. They are also going to the FDA this month (August 23) to reveal the results to them. The results stated that pirenzepine grows nerve fibers in SFN and also the sural nerve conduction, which is large fiber, improved. The sural nerve is in the calf. Trial 3 will be starting soon. I'm sure it will be 2025 before the drug is available to people.

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No I am curious myself when is the phase 3 study completed I would like that there is more information

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@cipnsue

Phase 1 and Phase 2 are now complete. Topical WST-057 (Pirenzepine was shown to be safe and tolerable when administered to diabetic peripheral neuropathy patients for up to six months in these studies, but will need to be studied in a larger Phase 3 population (several thousand). (per Winsantor's site) In parallel, we are preparing studies in other indications, such as chemo-induced peripheral neuropathy. (per Winsator's site) It is a topical cream.

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Do you know when this phase 3 study started and when is it going to be finished

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@dutch975

Do you know when this phase 3 study started and when is it going to be finished

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@dutch975, You can sign up for the Winsantor Newsletter which will keep you up to date with the clinical trials. I don't think they have started their phase 3 trial yet.

https://winsantor.com/join-us-for-news-and-upcoming-trials/
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