A few people have commented or emailed me about Topadur Pharma (Switzerland)’s TOP-M119 hair growth compound in the past year. The company has yet to even begin Phase 1 clinical trials, so I was reluctant to write a post about this new product. However, two news items about Topadur in June 2024 have changed my mind.

Topadur Pharma: TOP-M119 for Hair Loss

Topadur Pharma’s TOP-M119 hair loss drug candidate promotes hair growth by activating the cyclic guanosine monophosphate (cGMP) enzyme regulatory system. This results in increased scalp blood flow via the restoration of optimal intracellular cGMP levels. The increased blood supply to the hair bulb subsequently allows for better hair growth. Cell-to-cell communication is also improved.

On Topadur’s website, they have an image that compares TOP-M119 0.002% (1.2 new hairs) versus Minoxidil 2% (0.5 new hairs). So this is not a cure, but a potentially superior treatment. The website also mentions that TOP-M119 and its structurally-related compound TOP-M111 were both very potent hair growth promoters in a predictive animal model.

Topadur Pharma and Oshen Holdings Partner to Develop Alopecia Treatment

On June 6th, it was announced that Topadur Pharma AG and Oshen Holdings SA (Switzerland) would partner to develop the former’s treatment for androgenetic alopecia. According to Topadur CEO Pascal Brenneisen:

“Based on our pre-clinical data, we believe that TOP-M119 can become a game changer in treating hair loss and improving hair quality.”

The contract between Topadur and Oshen includes the following:

• Co-development, licensing and commercialization rights for China.
• Initial focus on the completion of IND studies, followed by Phase 1 and Phase 2 clinical trials.
• An initial investment of CHF 3 million ($3.4 million) by Oshen in Topadur. Thereafter, milestone payments totaling CHF 12 million ($13.6 million).

In addition to the topical formulation of TOP-M119, Topadur is also developing intradermal sustained release formulations. Note that Topadur is also working on treatments for chronic wounds.

TOP-M119: Same Active Ingredient as Viagra

Yesterday, two new articles about Topadur got published and both highlight the fact that TOP-M119 has the same active ingredient (Sildenafil) as Viagra, plus Nitroglycerin and possibly other compounds. Note that in pill form, the combination of Viagra and Nitroglycerin can cause a major decrease in blood pressure. Topadur, however, is working on a slow release localized scalp formulation.

The first of these two articles is far more detailed, while the second one is on a site with too many ads. The author of the first article managed to interview the ex-CEO and founder of Topadur, Mr. Reto Naef. Among the highlights:

• TOP-M119 can increasing scalp blood circulation levels 1,000-fold.
• This new candidate drug will be administered into the scalp through dissolving microneedles (DMNs), allowing transdermal release.
• Human clinical trials will start in 1-2 years.
• It has been shown that Viagra improves the active phase in the hair growth of rodents
• The active ingredients of the candidate drug can protect against hair loss triggered by chemotherapy drug cyclophosphamide.

It should be noted that one of the ways that Minoxidil works is via its vasodilatory effects. If they add other compounds into the drug, I would not be surprised if one of them is caffeine, due its hair growth stimulatory effect.