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Veradermics' oral VDPHL01 posts hair-count gains in small open-label female trial

A 49-patient, uncontrolled Phase 2 readout showed hair-count increases and high patient-reported improvement rates, with the harder registration-directed Study 306 due in 1H 2027.

Trial NCT06527365

Executive Summary

  • Veradermics disclosed positive but uncontrolled topline results for its oral extended-release minoxidil tablet in women with pattern hair loss, showing hair-count gains and high patient-reported improvement rates at six months.
  • Because the trial had no placebo or active comparator and analyzed roughly two-thirds of its anticipated enrollment, the results support further study rather than establish a treatment effect on their own.
  • Veradermics is positioning this study as a rehearsal for its registration-directed Phase 2/3 trial in the same population, due to read out in the first half of 2027, which will be the first controlled test of the same endpoints.
  • Female pattern hair loss has no FDA-approved oral prescription option, and the company is framing VDPHL01 as a potential first entrant in a category where the standard of care remains topical or off-label treatments.

The result

Female participants treated with VDPHL01 at 4.5 mg once or twice daily for six months showed mean increases in non-vellus hair count of 22.7 and 23.3 hairs per square centimeter in the two arms. On the Androgenetic Alopecia Impact Rating Scale, 88.9% of once-daily patients and 90.0% of twice-daily patients reported improvement or marked improvement, with investigators grading 100% and 90% of the respective arms as improved. No treatment-related serious adverse events and no cardiac adverse events of special interest were reported. VeradermicsVeradermics’ Oral VDPHL01 Delivers Positive Study ‘207’ Phase 2 Clinical Trial Results in Female Pattern Hair Loss Ahead of Upcoming Phase 2/3 Study ‘306’ ReadoutJul 15, 2026

Probability of SuccessBased on the AppliedXL Probability of Success model. For more information about the methodology, read the research here.

Endpoint Met69%
Completes89%
Clinical Significance10%
Regulatory35%

The design

Study 207 is an open-label Phase 2 trial registered as NCT06527365, run in males and females with mild-to-moderate androgenetic alopecia, with an anticipated enrollment of 70. The results reported cover 49 enrolled participants and carry no placebo or active comparator arm. Dr. Jerry Shapiro of NYU Langone, a paid consultant to Veradermics, said the results position VDPHL01 to "transform how we treat female pattern hair loss" as it moves toward a potential approval. That kind of open-label, single-arm signal is hypothesis-generating rather than decision-grade on its own. NCT06527365+1Safety and Efficacy of VDPHL01 in Males and Females With AGANCT06527365Veradermics’ Oral VDPHL01 Delivers Positive Study ‘207’ Phase 2 Clinical Trial Results in Female Pattern Hair Loss Ahead of Upcoming Phase 2/3 Study ‘306’ ReadoutJul 15, 2026

Trial timeline

The trial's primary completion date moved twice, from August 2025 to February 2026 and then to August 2026, a cumulative 365-day shift recorded between January and November 2025. Enrollment guidance also rose from 20 to 70 participants over the same period. The trial has been Active, not recruiting since September 2025, consistent with enrollment closing ahead of the current primary completion date. NCT06527365Safety and Efficacy of VDPHL01 in Males and Females With AGANCT06527365

What comes next

Veradermics said Study 306, a registration-directed Phase 2/3 trial evaluating the same endpoints in a larger female population, is actively recruiting and anticipates topline data in the first half of 2027. Chief Executive Officer Reid Waldman said Study 207 "demonstrated strong proof-of-concept on the same endpoints being evaluated" in Study 306. That trial, not Study 207, is the one that will test the hair-count and AAIRS signal against a comparator. VeradermicsVeradermics’ Oral VDPHL01 Delivers Positive Study ‘207’ Phase 2 Clinical Trial Results in Female Pattern Hair Loss Ahead of Upcoming Phase 2/3 Study ‘306’ ReadoutJul 15, 2026

The competitive field

Veradermics runs three other VDPHL01 trials in androgenetic alopecia, including two Phase 3 male studies and the Phase 3 female trial NCT07146022. Direct comparators sharing the androgen receptor target and small-molecule modality include Cassiopea SpA's clascoterone and Suzhou Kintor Pharmaceutical's KX-826, both in Phase 2 or Phase 3 testing for pattern hair loss. Within the androgen receptor by androgenetic alopecia pairing, four completed Phase 2 trials recorded no terminations, though that reflects a small, indication-specific sample.

This analysis was produced using AI-assisted reporting systems, AppliedXL data, and official public records. These systems undergo editorial review, quality checks, and regular audits by human experts. Errors may still occur, as with any automated system. Always consult the linked primary sources. Read our AI Editorial Policy.