VDPHL01 is a tablet of minoxidil, the drug best known as the active ingredient in Rogaine, built to release the drug slowly. Veradermics' case for it is that low-dose oral minoxidil already works for hair, and that a slow-release tablet tested in full FDA trials can turn an off-label practice into an approved product. Our dedicated VDPHL01 guide has the background; this section brings it up to date with the October result.
Study 304: the confirmatory male trial
On October 19, 2026, the company announced topline results from Part A of Study 304, a phase 3 trial in 536 men with mild-to-moderate male pattern hair loss randomised to VDPHL01 8.5 mg once daily, 8.5 mg twice daily, or placebo. Both doses beat placebo on the two co-primary endpoints, target-area non-vellus hair count and a patient-reported outcome, with p<0.0001. At six months the once-daily arm had gained an average of 28.6 hairs per square centimetre and the twice-daily arm 36.4, against 6.6 for placebo. The company reported no treatment-related serious adverse events and no cardiac adverse events of special interest. Sources: Veradermics release, Business Wire, October 19, 2026; the same data filed with the SEC; Medscape, October 22, 2026.
Coverage of the release reported that the drug met all of its co-primary endpoints and 17 secondary endpoints, that peripheral oedema (swelling, usually of the ankles) and hypertrichosis (unwanted hair growth elsewhere on the body) were the most common side effects, and that hypertrichosis was notably more frequent on twice-daily dosing. Sources: MarketBeat, October 19, 2026; Yahoo Finance; RTTNews, October 19, 2026. Fierce Pharma called it a continuing hot streak for the company. The company's shares rose about 7% on the day, to $116.42, according to RTTNews.
Study 302: the April trial it confirms
Study 304 was designed to repeat Study 302, a phase 2/3 trial in more than 500 men whose topline results Veradermics announced on April 27, 2026. In 302, the once-daily arm gained 30.3 hairs/cm² and the twice-daily arm 33.0 at month six, both p<0.0001 against placebo, which gained 7.3. Again, no treatment-related serious adverse events and no cardiac adverse events of special interest were reported. Sources: Veradermics release, April 27, 2026; Dermatology Times. With 304, the company says its placebo-controlled male programme is complete, and the two trials together cover more than 1,000 men.
| Male trial | Men | Once daily, 6 months | Twice daily, 6 months | Placebo, 6 months | Reported |
| Study 302 (phase 2/3) | More than 500 | +30.3 hairs/cm² | +33.0 hairs/cm² | +7.3 hairs/cm² | Company, April 27, 2026 |
| Study 304 (phase 3) | 536 | +28.6 hairs/cm² | +36.4 hairs/cm² | +6.6 hairs/cm² | Company, October 19, 2026 |
A worked example: what the numbers mean
The useful figure is not the gain on the drug but the gain beyond placebo. In Study 304 that is 28.6 minus 6.6, or 22.0 hairs/cm², for once-daily dosing, and 36.4 minus 6.6, or 29.8 hairs/cm², for twice daily. In Study 302 it was 30.3 minus 7.3, or 23.0, for once daily. The two trials agree closely on the once-daily effect, which is what a confirmatory trial is for. The twice-daily figure moved more between trials (33.0 in one, 36.4 in the other). An analysis by Pharmacally noted that the topline release does not include the complete statistical analysis, such as confidence intervals, so it cannot show that twice daily is better than once daily. The side-effect signal runs the other way, so the choice of dose is not settled by these numbers; full statistics await publication.
The placebo gain is also worth a sentence. Men on placebo gained six to seven hairs/cm² in both trials. Hair counts in a placebo group are rarely flat, which is why a result means nothing without its placebo arm, and why a clinic's before-and-after photographs, which have no placebo arm, cannot tell you how well a treatment works.
Why an extended-release tablet
Low-dose oral minoxidil prescribed for hair today is an immediate-release blood-pressure tablet used off-label. The company says VDPHL01's gel-matrix design is meant to avoid the peaks in blood concentration that are associated with the cardiac side effects of immediate-release oral minoxidil, as reported by Medscape. That is the company's rationale; the trials report no cardiac adverse events of special interest, but they were six-month studies in men without the conditions that would normally exclude someone from oral minoxidil, so they do not settle long-term cardiovascular safety in a broad population. Our oral versus topical minoxidil guide covers what is known about the off-label tablet.
Women: Studies 207 and 306
Veradermics reported on July 15, 2026 that Study 207, a small open-label phase 2 study in men and women with mild-to-moderate pattern hair loss, met its primary endpoint, with growth seen as early as month two. Endpoints News reported a hair-count gain of 22.7 hairs/cm² at six months in women. Open-label means everyone knew they were on the drug and there was no placebo group, so this is a signal, not proof. Sources: Veradermics release, July 15, 2026; Endpoints News; Fierce Pharma. The trial that matters for women is Study 306, a phase 2/3 trial that enrolled 556 women; the company expects Part A results in the first half of 2027 and describes it as the first registration-directed US trial of an oral therapy specifically for female pattern hair loss.
When could it be approved?
The company has not given an FDA submission date. Medscape reported on October 22, 2026 that Veradermics did not provide information on its filing plans. In its second-quarter 2026 results on August 11, the company reported $819.9 million in cash and marketable securities as of June 30, 2026, which it expects to fund operations into 2030 through multiple phase 3 readouts and a potential launch of VDPHL01. Source: Veradermics Q2 2026 results, SEC filing. A standard FDA review takes about ten months from acceptance of an application, so even a filing soon after the women's readout in 2027 would not produce an approval for at least a year after the filing. We do not give a date because the company does not.
What to do now
The ingredient in VDPHL01 is already prescribable. Men who want oral minoxidil can discuss the off-label immediate-release tablet with a prescriber today; the trade-off is that it is not the product in these trials and has not been through the same programme. Our guide to getting oral minoxidil online explains the process, and the cost section below lists the verified prices. Women should note that the women's trial results are not in yet.