Veradermics Incorporated announced positive topline results from Part B of its Phase 2/3 clinical trial for VDPHL01, an oral extended-release minoxidil treatment for male pattern hair loss, Fierce Pharma reported.
Phase 2/3 Trial Results
The trial, known as Study 302, evaluated 519 male participants with mild-to-moderate hair loss over 12 months. Patients receiving a twice-daily 8.5 mg dose showed a non-vellus target area hair count increase of 43.9 hairs/cm² from baseline at Month 12, according to company data.
“The 12-month long-term data from Study '302' represent an important milestone in our efforts to provide a new standard of care for male pattern hair loss,” said Reid Waldman, M.D., Chief Executive Officer of Veradermics.
Participants on the once-daily 8.5 mg regimen achieved a hair count gain of 29.7 hairs/cm² at the one-year mark. These figures demonstrate target area hair count deepening in the twice-daily group and maintenance in the once-daily arm.
Patients who crossed over from the placebo group at six months also registered gains. Those switched to the twice-daily dose added 32.1 hairs/cm², while the once-daily crossover cohort gained 24.5 hairs/cm² by Month 12, Benzinga reported.
Safety Profile and Patient Feedback
Veradermics stated that VDPHL01 produced no treatment-related serious adverse events, no cardiac-related adverse events, and no treatment-emergent discontinuations between Month 6 and Month 12. Investing.com noted that the drug remained generally well tolerated with no new safety signals emerging.
Patient-reported outcomes aligned with physical measurements. On the Androgenetic Alopecia Impact Rating Scale, 89.1% of twice-daily participants and 79.8% of once-daily participants noted visible coverage improvements at 12 months.
$MANE Positive Study Results: On November 9, 2026, Veradermics, Inc reported positive topline data from a Phase 2/3 trial for VDPHL01, an oral treatment for hair loss, showing significant hair growth improvements in over 500 males. 89.1% of participants treated twice daily…
Clinicians reported similar findings on the Investigator Global Assessment scale. Investigators graded 92.2% of twice-daily and 74.4% of once-daily continuous participants as having improved hair coverage.
Drug Candidate Targets First FDA Approval for Pattern Hair Loss
The latest data release follows positive results from Study 302 Part A and Phase 3 Study 304 Part A. These trials position the drug candidate to potentially become the first FDA-approved oral pill for pattern hair loss in nearly 30 years, according to Benzinga.
Veradermics has not yet disclosed whether it will pursue a male-only FDA approval or wait for data from Study 306, its ongoing Phase 2/3 trial in female pattern hair loss, which is expected to read out in the first half of 2027.
Following the data announcement, Leerink Partners raised its price target for Veradermics stock to $150 from $135, Investing.com reported. The company operates in an addressable market estimated to reach $30 billion by 2028.
Common Questions About VDPHL01
What is VDPHL01?
VDPHL01 is an investigational, oral extended-release formulation of minoxidil developed by Veradermics for the treatment of pattern hair loss.
When will female clinical trial data be available?
Veradermics anticipates announcing topline results from Study 306, its Phase 2/3 trial evaluating female pattern hair loss, in the first half of 2027.
$MANE …. Veradermics reports 12-month Phase 2/3 VDPHL01 data, with twice-daily dosing increasing hair count by 43.9 hairs/cm² (138.78) Veradermics announces positive topline results from Part B of its Phase 2/3 Study '302' evaluating VDPHL01, an extended-release oral minoxidil… pic.twitter.com/917IavFUoM