A daily pill for male hair loss passed its second big trial, maker says

Veradermics said on October 19 that its experimental pill VDPHL01 met all primary and secondary endpoints in Study 304, its second late-stage trial in men with pattern hair loss.¹ The drug is an extended-release version of minoxidil, the main ingredient in the topical treatment Rogaine.² The company says the results, together with those of its earlier Study 302, complete the placebo-controlled data it needs to seek approval for what could be the first new oral pill for pattern hair loss in nearly 30 years.¹

What happened

Study 304 was a randomized, double-blind, placebo-controlled Phase 3 trial in 536 men with mild to moderate pattern hair loss.¹ The men were aged 18 to 65. They were enrolled at 45 U.S. sites, none of which overlapped with the sites used in Study 302.³ Participants were randomized to VDPHL01 once daily, VDPHL01 twice daily, or placebo.¹ The topline data cover the six-month placebo-controlled part of a 52-week design. After that, all participants continue on the active drug.⁴

The trial had two co-primary endpoints. The first was the change in non-vellus target area hair count, a count of thicker, non-fine hairs in a marked patch of scalp. The second was the share of participants who rated their hair coverage “improved” or “much improved” on a patient questionnaire, the Androgenetic Alopecia Impact Rating Scale.¹ Chief executive Reid Waldman said the drug separated from placebo on both co-primary endpoints and on all 17 secondary endpoints.³

The evidence so far

At month 6, average hair count rose by 28.6 hairs/cm² in the once-daily arm and 36.4 hairs/cm² in the twice-daily arm, compared with 6.6 hairs/cm² on placebo (p<0.0001 for both).¹ Waldman said the twice-daily result was the largest six-month change reported in a placebo-controlled pattern hair loss study to date.³ That is the company’s own comparison. No independent analysis of it appears in the sources.

• Patient ratings: 55.7% (once daily) and 68.7% (twice daily) rated their coverage “improved” or “much improved”, versus 15.0% on placebo. Counting any improvement, the figures were 78.8% and 85.0%, versus 35.3% on placebo.¹
• Investigator ratings: investigators graded 78.4% and 82.7% of men on the drug as having improved coverage at month 6.¹
• Timing: the drug separated from placebo on hair count, patient ratings and investigator ratings at month 2, the earliest point measured.¹
• Frontal hair: three blinded reviewers assessed frontal scalp photographs. More than one-third of once-daily patients and nearly half of twice-daily patients met the responder definition, versus 5% on placebo. Waldman said this supports a possible benefit in frontal hair loss, for which he said no current treatment is labeled.³

The new numbers are close to those from Study 302, which enrolled 519 men and reported in April. In that trial, hair count rose by 30.3 and 33.0 hairs/cm² on the drug, versus 7.3 on placebo, and 48.4% and 62.9% rated their hair “improved” or “much improved”, versus 13.4% on placebo.⁵ One difference in wording: Study 302 was reported to meet all primary and all key secondary endpoints,⁵ while Study 304 was reported to meet all primary and secondary endpoints.¹

Safety

The company reported no treatment-related serious adverse events and no cardiac adverse events of special interest, a category that included pericardial effusion, pleural effusion, heart failure and angina. It also reported no clinically meaningful changes in heart rate, blood pressure or ECGs. According to the company, adverse events were mostly mild to moderate.³ Hypertrichosis, meaning extra hair growth on the body, was the only event that occurred in more than 5% of patients and was more common on the drug than on placebo. Across both trials, Waldman said one patient stopped treatment because of hypertrichosis, and five of more than 700 treated patients stopped because of peripheral edema, or fluid retention.³ A separate summary listed peripheral edema and hypertrichosis as the most commonly reported side effects, both more frequent with twice-daily dosing.⁴ The two accounts frame the safety data a little differently, and full tables have not been published.

What it does not show yet

These are topline results reported by the company. They have not been peer reviewed or evaluated by the FDA, and VDPHL01 remains an investigational drug.⁴ The placebo-controlled comparison lasted six months.⁴ Whether the gains hold up, and whether rarer side effects appear over a longer period, will depend on extension data. The first of these, 12-month data from Study 302’s Part B, in which all participants receive the drug, are expected late in 2026.⁶

The trials compared VDPHL01 with placebo. They did not compare it with immediate-release oral minoxidil, which dermatologists already prescribe off label, so the sources contain no head-to-head data. Michael Payette, co-founder of Central Connecticut Dermatology, said immediate-release oral minoxidil can be disappointing in practice. He also said the lack of reported shedding after starting treatment could matter, because shedding can lead patients to stop.³ These are a clinician’s views, not trial comparisons.

All the participants were men. The women’s trial, Study 306, enrolled 556 women, and its results are expected in the first half of 2027.³

Who is behind it

Veradermics is a dermatologist-founded biopharmaceutical company in New Haven, Connecticut, listed on the New York Stock Exchange as MANE.¹ It sponsored both trials and announced the results itself. A $150 million Series C financing in October 2025 was meant to take VDPHL01 through Phase 3, and the company went public in February 2026, according to an independent tracking site.⁶ Veradermics said it had about $820 million on its balance sheet as of its latest quarterly report.³

Some of the experts quoted alongside the data have ties to the company or its trials. Dermatologist Maryanne Makredes Senna, who commented on the Study 302 results, sits on Veradermics’ scientific advisory board. Michael Gold, who also commented, was a Study 302 trial investigator.⁵ Gold said:

Dermatology has been treating hair loss with a drug borrowed from cardiology, in a formulation never intended for our patients, at doses we arrived at informally.

⁵

On the Study 304 call, chief commercial officer Mark Neumann presented company market research on 198 dermatologists and primary care providers. Nearly 90% rated VDPHL01 as positively differentiated after reviewing its Phase 3 profile.³ This was a survey commissioned by the company, not clinical evidence.

How it fits the field

Pattern hair loss, also called androgenetic alopecia, affects an estimated 80 million people in the United States, 50 million of them men, according to the company. Veradermics says no new prescription medicine for the condition has been approved by the FDA in nearly 30 years.⁷ The only approved oral prescription option for men is finasteride. It acts on hormones and, according to the company, is linked to tolerability problems including reproductive, psychological and hormonal side effects.⁷ VDPHL01 does not act on hormones. The company describes it as a possible first FDA-approved non-hormonal oral treatment for men with pattern hair loss.¹

The tablet uses a gel matrix designed to release minoxidil steadily. Veradermics says the aim is to avoid the high peak blood levels of immediate-release oral minoxidil, which it ties to minoxidil’s cardiac effects, while keeping levels above the threshold needed for hair growth.⁷ Minoxidil was originally a heart and blood pressure drug, which is why the company focused on cardiac safety.⁵

What to watch next

• 12-month data: extension results from Study 302 are expected later this year.³
• Women: Study 306 results are due in the first half of 2027.³
• Filing: Waldman said the company has not decided whether to file for men alone or for men and women together.³ Earlier company guidance pointed to an FDA submission for men in early 2027, but no date has been announced, according to the tracking site.⁶
• Full data: peer-reviewed publication and complete safety tables, which the sources do not yet show.⁴