Update: January 2, 2025
Veradermics Phase 2/3 Clinical Trial Enrollment Link
Veradermics Phase 2/3 US clinical trial enrollment link is live. Their 40 plus locations are pretty widely spread across the country. Please note that we are not certain of the active ingredient(s) in this tablet. From the company’s patent, I previously guessed that it is an extended release oral Minoxidil, plus hopefully some other surprises (see bottom of this post). But it could end up being something totally different too.
The study involves 13 visits to a clinic over the course of 12 months. Participants will either get the new treatment or be part of the placebo group (that will still also get a tablet).
Update: December 11, 2024
Veradermics Raises $75 Million for Phase 2/3 Trials
Veradermics just raised $75 million in Series B financing (h/t “meko”). They have also initiated a Phase 2/3 trial for their lead candidate VDPHL01 for the treatment of androgenetic alopecia (AGA). The trial will enroll 480 patients across 44 sites in the US.
Note that Veradermics also has an ongoing 20-patient Phase 2 trial for VDPHL. Per this latest press release, the company plans to report topline data from that Phase 2 study in the first half of 2025.
VDPHL Clinical Trial Updated Links
- 20 patients.
- Start date = 2024-07-08.
- Completion date =2025-08-01.
- 480 patients.
- Start date = 2024-11-06.
- Completion date =2026-07.
August 9, 2024
Veradermics VDPHL Tablet: Phase 2 Trials Begin
Veradermics is a US-based startup that is working on a new tablet to treat androgenetic alopecia (AGA). They just started Phase 2 clinical trials for VDPHL01 in male subjects with AGA. Only 20 patients are enrolled, and the completion date is listed as August 1, 2025. The trial will take place at Therapeutic Research’s center in San Diego, California. Interestingly, Therapeutic Research is also conducting a topical hair loss product study at this very moment.
However, on Veradermics’ website, the pipeline page suggests that Phase 2 trials for VDPHL are finished (screenshot above). Thanks to reader “John Doe” for e-mailing me about this difference in time frame (and acronym — VDPHL01 versus VDPHL). In any case, this product is still a few years away from reaching the market assuming successful trial results. Note that VDPHL likely stands for Veradermics Pattern Hair Loss.
The tablet does not impact hormone levels as do dihydrotestosterone (DHT) inhibitors finasteride and dutasteride. Thus avoiding potential side effects. Veradermics’ CEO is a young dermatologist named Reid Waldman.
Modified Release/Extended Release Oral Minoxidil
The mechanism of action (MOA) and key ingredient(s) in this tablet are both confidential. However, when I searched through the company’s patent, it seems like the drug candidate will be a “modified release” oral minoxidil tablet. In the patent, they use the term “extended release (ER)”.
Note that they do not use the term “sublingual minoxidil” anywhere in the patent. Also, I wonder how they will be able to differentiate from the existing oral minoxidil based “Hairy Pill” from Australian dermatologist Dr. Rodney Sinclair’s company?
Other Potential Ingredients in VDPHL
In the patent, they also have a massive list of 191 claims. Within that section, all of the following drugs are listed 11 times each:
- Setipiprant (11 times).
- Valproic acid (11 times).
- Cetirizine (11 times).
- Medrogestone (11 times).
For long time readers of this blog, setipiprant (and Kythera) will ring a bell. It caused so much excitement a decade ago. I cannot believe that the very optimistic 9-yr old audio interview with Kythera’s CEO is still online. Setipiprant is an oral antagonist to the prostaglandin D2 (PGD2) receptor.
I covered valproic acid and hair growth in detail in the past. Follica also has a patent that covers valproic acid and hair regrowth. Valproic acid activates the Wnt/β-catenin signaling pathway.
Cetirizine is a PGD2 inhibitor that has been shown to benefit hair growth even when used topically.
I have never covered medrogestone on this site before. Per Wikipedia, it is a progestin that is an agonist of the progesterone receptor and a weak anti-androgen. Progesterone is a female sex hormone that has beneficial properties towards hair growth.