Veradermics’ stock was up nearly 6% at market open today after a Phase III trial evaluating its hair loss drug met all endpoints.
In Study ‘304’ (NCT06972264), patients treated with VDPHL01 achieved superior hair growth compared with placebo on the co‑primary endpoints of non-vellus Target Area Hair Count (TAHC) and patient-reported outcome (PRO) benefit of ‘improved’ or ‘much improved’ on the Androgenetic Alopecia Impact Rating Scale (AAIRS) after six months.
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Patients achieved an average increase in non-vellus hair count of 28.6 hairs/cm² and 36.4 hairs/cm² in once-daily and twice-daily VDPHL01 treatment arms, respectively. Those receiving placebo showed a 6.6 hairs/cm² increase from baseline.
At the same six-month time point, 78.8% of patients in the once-daily dose arm and 85.0% of participants in the twice-daily dose arm reported improvement in hair coverage on the AAIRS versus 35.3% of placebo participants.
In addition, 55.7% and 68.7% in the once-daily and twice-daily dose arms, respectively, achieved ‘improved’ or ‘much improved’ hair coverage on the AAIRS compared to 15% of placebo patients.
Investigator gradings were 78.4% and 82.7% of male participants as having improved hair coverage after six months in the two cohorts using the Investigator Global Assessment (IGA) scale, with hair growth noted as early as month two.
The drug was generally well tolerated with an overall safety profile consistent with other trials, with no treatment-related serious adverse events (SAEs) or cardiac events observed in the study.
The Phase III trial enrolled 536 males with mild-to-moderate pattern hair loss to receive VDPHL01 8.5mg either once or twice daily, or placebo. VDPHL01, a proprietary, extended-release oral minoxidil formulation, utilises a well-established drug in the hair loss market, however, it has previously been administered as a liquid or foam treatment.
Veradermics said that the positive data from Study 304, combined with previously reported positive topline findings from Part A of the company’s Phase II/III Study 302, position VDPHL01 to potentially become the first US Food and Drug Administration (FDA)-approved oral pill in nearly 30 years for pattern hair loss.
Dr Antonella Tosti, Fredric Brandt Endowed Professor of Dermatology and Cutaneous Surgery at the University of Miami, said: “The Phase III data for VDPHL01 for males helps address two important questions patients ask about a hair loss treatment: ‘Am I likely to see a difference, and will I feel comfortable taking it?’ The results showed a high likelihood of visible improvement, with a safety and tolerability profile that is encouraging.”
Veradermics announced the Study 304 data on 19 October before market open. When trading started on the Nasdaq exchange, the company’s stock opened 5.9% up, at $115.34 compared to $108.82 at close on 16 October.
While Part A of Study 302 has read out, data from Part B is expected later in 2026. A study in female pattern hair loss is also fully enrolled, with topline data expected in H1 2027.
In a research note from 22 April, Jefferies analysts noted that VDPHL01 could represent a more than $2bn market opportunity if the drug were to exceed the efficacy bars of a 15–20 hairs/cm² change in non-vellus TAHC growth and a 15- 25% change in patient-reported outcomes versus placebo – both of which VDPHL01 achieved in both Study 302 and Study 304.
