VDPHL01 Clinical Trials

Last updated February 9, 2026

Latest Updates on VDPHL01 (February 2026)

Update (Feb 9, 2026): Veradermics announced completion of enrollment in its second pivotal Phase 3 trial (‘304’ study) for male pattern hair loss. This marks the completion of enrollment across all male Phase 3 studies, with approximately 1,000 male patients enrolled across studies. Source: Business Wire.

As of February 2026, the Phase 2/3 (‘302’) clinical trial for VDPHL01 is ongoing with topline data anticipated in the first half of 2026. The drug is not approved and is not available for purchase.

Official milestones and any status changes are posted in the trial registry: ClinicalTrials.gov (NCT06724614).

This page summarises the public data on VDPHL01 clinical development: key dates, study design, and what the timeline means for eventual market availability.

Timeline

Date Milestone Status / Source
2024-11-06 Phase 2/3 (‘302’) study officially started (first participant) NCT06724614 — record posted 2024-11-05
2025-03-03 Protocol version 2.0 uploaded (dose-adjustment arm added) NCT06724614 update 2025-03-04
2025-09-03 Recruitment status updated: Recruiting → Active, not recruiting NCT06724614 update 2025-09-03
2025-10-16 USD 150M Series C financing announced to advance VDPHL01 through multiple Phase 3 trials; Veradermics listed on NYSE (ticker: MANE) Press release
2026-02-09 Enrollment completed in second Phase 3 male trial (‘304’ study); ~1,000 male patients enrolled across studies Business Wire
H1 2026 Topline data expected — ‘302’ Phase 2/3 trial (males) Veradermics forecast
2026-07-01 Planned primary completion — ‘302’ study (last visit) Registry estimate
H2 2026 Topline data expected — ‘304’ Phase 3 trial (males) Veradermics forecast
2026 Q4 – 2027 Q1 Data analysis, NDA preparation (estimated) Sponsor forecast

Study design — Phase 2/3 ‘302’ trial (males)

  • Type: randomised, double-blind, placebo-controlled.
  • Participants: 360 males (18–55 y) with Norwood-Hamilton II–V AGA.
  • Dosing groups: VDPHL01 5 mg, VDPHL01 10 mg, placebo (1:1:1).
  • Duration: 52 weeks treatment + 4-week follow-up.
  • Primary endpoint: change in non-vellus hair count within a 1 cm2 target area (week 52 vs baseline).
  • Secondary endpoints: hair shaft diameter, investigator global assessment, patient self-assessment, safety labs, adverse events.
  • Key exclusion: prior finasteride/dutasteride within 12 months; scalp surgery or PRP in past 6 months; uncontrolled hypertension.

Study design — Phase 3 ‘304’ trial (males)

  • Type: multi-center, randomised, double-blind, placebo-controlled.
  • Participants: 536 males with mild-to-moderate pattern hair loss.
  • Dosing groups: VDPHL01 8.5 mg once-daily (QD) and twice-daily (BID) vs placebo.
  • Duration: 52 weeks.
  • Co-primary endpoints: change in non-vellus hair count AND patient-reported hair coverage benefit at 24 weeks.
  • Enrollment completed: February 9, 2026.
  • Topline data expected: H2 2026.

Phase 2/3 female trial (actively recruiting)

Veradermics is actively recruiting participants for its Phase 2/3 trial in females with pattern hair loss (NCT07146022). For enrollment information, visit www.phlstudy.com/female.

About VDPHL01

VDPHL01 is an oral, extended-release (ER) formulation of minoxidil. Its proprietary gel-matrix technology delivers a steady, long-lasting release designed to maximise hair growth while avoiding plasma concentration spikes associated with cardiac activity in immediate-release oral minoxidil. Patent protection runs to 2043.

Preliminary results

Preliminary data from a separate Phase 2 trial in males (announced 2025) indicated visible and measurable hair growth following VDPHL01 treatment. No peer-reviewed numerical data have been released; top-line results from the ‘302’ study are anticipated H1 2026.

What these dates mean for availability

With topline data expected in H1–H2 2026 and NDA preparation targeting early 2027, the earliest hypothetical FDA approval falls in late 2027 – mid-2028 (standard review 10 months; priority review 6 months). If approved, VDPHL01 would be the first FDA-approved oral non-hormonal treatment for pattern hair loss in both men and women.

For a detailed regulatory timeline see the Availability page.

Sources

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