Veradermics, Incorporated filed a Form 8-K on November 9, 2026, disclosing positive topline results from Part B of its Phase 2/3 clinical trial, Study '302', evaluating investigational oral minoxidil formulation VDPHL01 in males with mild-to-moderate pattern hair loss.

Key Highlights

  • Trial enrollment: Study '302' enrolled 519 patients randomized to VDPHL01 8.5mg once daily (QD), VDPHL01 8.5mg twice daily (BID), or placebo for 6 months, with placebo patients crossed over to VDPHL01 arms for the remaining 6 months.
  • Hair count results (continued group): At Month 12, participants in the BID arm had an increase in non-vellus hair count of 43.9 hairs/cm2 from baseline, and QD arm participants had an increase of 29.7 hairs/cm2.
  • Participant-reported improvement (continued group): 89.1% of BID participants and 79.8% of QD participants reported visible improvement in hair coverage on the AAIRS at Month 12.
  • Investigator assessment (continued group): Investigators graded 92.2% of BID participants and 74.4% of QD participants as having improved hair coverage using the Investigator Global Assessment (IGA) scale.
  • Placebo-crossed group results: At Month 12, BID and QD placebo-crossed participants had non-vellus hair count increases of 32.1 hairs/cm2 and 24.5 hairs/cm2, respectively.
  • Safety profile: No treatment-related serious adverse events (SAEs), no adverse events of special interest (AESIs) of cardiac origin, and no new safety signals were observed; no treatment-emergent adverse events (TEAEs) led to discontinuation between Month 6 and Month 12 in the continued group.

Veradermics Reports Study '302' Part B Results for VDPHL01 at Month 12

According to the filing, Veradermics, Incorporated (NYSE:MANE) announced positive topline data from Part B of Study '302', a randomized, double-blind, placebo-controlled, registration-directed Phase 2/3 clinical trial evaluating VDPHL01, described as "an investigational, proprietary, extended-release oral minoxidil formulation," in over 500 males with mild-to-moderate pattern hair loss. The trial's 519 enrolled patients were assigned to one of three arms: VDPHL01 8.5mg QD, VDPHL01 8.5mg BID, or placebo for the first 6 months.

In the VDPHL01 continued group at Month 12, the filing reported non-vellus hair count increases of 43.9 hairs/cm2 (BID) and 29.7 hairs/cm2 (QD) from baseline. The company disclosed that these results "demonstrated a deepening of hair growth in the BID dose arm and maintenance of hair growth for the QD dose arm." Patient-reported outcomes on the AAIRS scale showed 89.1% (BID) and 79.8% (QD) of continued-group participants reporting visible improvement. Among those, 68.0% (BID) and 48.4% (QD) achieved 'improved' or 'much improved' ratings. Investigator assessments via the IGA scale corroborated these findings, with 92.2% (BID) and 74.4% (QD) graded as improved.

For the placebo-crossed group, the filing reported non-vellus hair count gains of 32.1 hairs/cm2 (BID) and 24.5 hairs/cm2 (QD) at Month 12. Visible improvement on the AAIRS was reported by 82.0% (BID) and 73.2% (QD) of participants, while investigators graded 83.9% (BID) and 80.0% (QD) of participants as having improved hair coverage. The filing stated that treatment in both groups "was generally well tolerated" with a safety profile consistent with Part A of Study '302' and Study '304'. The filing notes that statements regarding perceived efficacy and clinical profile of VDPHL01 are forward-looking and subject to risks and uncertainties described in Veradermics' filings with the SEC.

What Was Disclosed

Veradermics filed an 8-K on November 9, 2026, reporting Part B topline data from Study '302' evaluating VDPHL01 in 519 males with pattern hair loss. The filing covered Month 12 efficacy and safety outcomes for both the continued VDPHL01 group and the placebo-crossed group, along with a press release and investor presentation as exhibits.