Last updated 22 Oct 2025
Latest Updates on VDPHL01 (October 2025)
As of October 2025, the Phase 2/3 clinical trial for VDPHL01 is ongoing. The study started on 6 November 2024, with primary completion currently scheduled for 1 July 2026 (NCT06724614). The drug is not approved and is not available for purchase yet.
Official milestones and any status changes are posted in the trial registry.
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 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 |
| 2026-07-01 | Planned primary completion (last visit) | Registry estimate |
| 2026 Q4 – 2027 Q1 | Data analysis, top-line results (estimated) | sponsor forecast, Veradermics Q2 2025 deck |
Study design (Phase 2/3)
- 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.
Preliminary results
No peer-reviewed interim data have been released. The sponsor reported “favourable safety and hair-density trends” at a closed investigator meeting (July 2025) — no numerical values disclosed.
If top-line data become public after primary completion, this section will be updated.
What these dates mean for availability
Assuming the study meets its primary endpoint on 1 Jul 2026 and no major safety signals emerge, a New Drug Application could be filed in early 2027. Typical FDA review windows (priority vs standard) range from 6 to 10 months, placing the earliest hypothetical approval in late 2027 – mid-2028.
For a detailed regulatory timeline see the Availability page.
Sources
- ClinicalTrials.gov — NCT06724614 (accessed 22 Oct 2025)
- Veradermics Investor Deck, Q2 2025 (slide 14) [accessed 22 Oct 2025]
- Investigator webcast notes, 15 Jul 2025 (on file)