The Wall Street Journal recently reported on a pharmaceutical company named Veradermics, and their stock has been soaring due to the positive results in FDA Phase 2/3 trials for androgenetic alopecia. A new oral medication, VDPHL01, to treat androgenetic alopecia is presently undergoing FDA trials, and the results are looking promising to be FDA-approved. It is no longer “if” it will be FDA-approved, but rather “when” it will be FDA-approved. Veradermics’ VDPHL01 will be the first FDA-approved oral pill for hair loss in nearly 30 years and the only non-hormonally related oral pill FDA-approved.[1][2]

What is VDPHL01?

VDPHL01 is an extended-release 8.5 mg minoxidil oral pill that is presently in FDA trials for the treatment of androgenetic alopecia. Oral minoxidil was first FDA-approved for hypertension in 1979.

Also Read: Is Topical Pyrilutamide the Next Big Treatment for Hair Loss?

The FDA Trials

Part A of the randomized, double-blind, placebo-controlled phase 2/3 trial enrolled 519 adult men with mild to moderate androgenetic alopecia (AGA) who were randomly assigned to either placebo, VDPHL01 8.5 mg once daily, or VDPHL01 twice daily.

Results

The results of the Part A trial were released on April 27, 2026. They showed significant improvements in hair growth in both the once-daily and twice-daily VDPHL01 over the placebo in all study endpoints: 

1. 1. Total Area Hair Count (TAHC)
   2. Patient-reported outcomes (AAIRS)
   3. Investigator Global Assessments (IGA)

Further Studies

The Part B trials (Adult males): results are expected in the second half of 2026, with the potential FDA approval in late 2027 or early 2028.

Study 306 (Adult females): currently enrolling 500+ female participants with androgenetic alopecia.

Safety/Side Effects

The treatment population generally tolerated VDPHL01 well. In fact, the discontinuation rates were lower in the VDPHL01 group versus the placebo. There were similar rates of adverse event-associated discontinuation between the drug and the placebo groups. No patients experienced serious cardiac adverse events (a known side effect associated with higher doses of oral minoxidil used to treat hypertension).

Also Read: Do Peptides Help Hair Loss?

Extended-release minoxidil versus Current minoxidil

Dermatologists have been prescribing off-label low-dose oral minoxidil for their patients with androgenetic alopecia for decades.

Minoxidil has no effect on the hair follicle itself. Minoxidil must be broken down into its active metabolite, minoxidil sulfate, by the enzyme sulfotransferase to cause the beneficial effect of thicker and longer hair production by the hair follicle. The present FDA-approved immediate-release minoxidil pills only have a serum half-life of approximately 4 hours, which limits their duration of exposure to sulfotransferase to convert it to the active metabolite minoxidil sulfate.

Veradermics designed an extended-release pill to avoid the peak plasma concentrations associated with cardiac side effects seen with the present FDA-approved immediate-release pills for hypertension. This extended-release formulation also extends the length of time the minoxidil is interacting with sulfotransferase to produce the active metabolite minoxidil sulfate to stimulate the hair follicle.

Also Read: Finasteride for Hair Loss: A Guide by Dr. Paul J. McAndrews

My Opinion

When VDPHL01 gets FDA approved (which could be late 2027 or early 2028), it will become the first non-hormonal pill for pattern hair loss to get the US Food and Drug Administration (FDA) approval, which could reach a patient population of approximately 80 million in the US alone. Once approved, VDPHL01’s patent will last until 2043, which will keep the cost of this new extended-release pill high. The potential drawback for the company Veradermics, not so much for the hair loss patients, is that many dermatologists and other doctors might prescribe or continue to off-label prescribe the already current FDA-approved immediate-release minoxidil since it is generic and will be drastically cheaper for their patients.

Sources

1. https://www.wsj.com/health/wellness/looking-to-regrow-hair-new-options-are-on-the-horizon-83a3a4f5 
2. https://www.wsj.com/pro/venture-capital/why-this-hair-loss-biotech-is-killing-it-dafae61c