VDPHL01 is an oral, non-hormonal treatment for androgenetic alopecia developed by Veradermics. Both pivotal Phase 3 trials in men are positive; the drug is not yet approved and not yet on sale. This page tracks every milestone — clinical, regulatory, commercial — until launch.
Phase 01
Safety established
Completed
Phase 02
Positive topline: +30.3 hairs/cm²
Apr 27, 2026
Phase 03
Positive topline: +36.4 hairs/cm²
Oct 19, 2026
Phase 04
Submission to FDA — preparation underway
Early 2027 (est.)
Phase 05
Regulatory decision
Late 2027 (est.)
Phase 06
On-market availability
2027–2028 (est.)
Launch alert
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The most common questions about VDPHL01 — short answers, links to detail.
Estimated late 2027 to early 2028. Both Phase 3 trials are positive; NDA filing and FDA review come next.
Not on the market yet. After FDA approval it will be sold through licensed pharmacies only.
Not announced. Analysts project $200–400/month at launch — well above generic finasteride.
An oral, non-hormonal AGA treatment by Veradermics. Protects follicles without altering hormones.
Side-by-side with finasteride, dutasteride, topical/oral minoxidil, clascoterone, pyrilutamide.
A reformulated oral minoxidil. The drug drives blood flow to follicles; a gel-matrix flattens the plasma peaks behind cardiac side effects of standard oral minoxidil.
Two pivotal trials, same answer. Study '302' (April 27, 2026) and confirmatory Study '304' (October 19, 2026) both met every primary and secondary endpoint in more than 1,000 men.
Hair density change at 6 months — Phase 3 Study '304' (536 men)
Study '302' for comparison: +30.3 (1× daily) / +33.0 (2× daily) vs +7.3 placebo. Most common side effects in '304': peripheral edema 2.8% / 4.5%, hypertrichosis 2.2% / 9.0% (1× / 2× daily). Full Study '304' breakdown →
Sources: Veradermics press release, Oct 19, 2026 · NCT06972264 · NCT06724614
Chronological log of Veradermics announcements and trial milestones.
The second pivotal male trial replicated and improved on Study '302': +28.6 (once daily) and +36.4 hairs/cm² (twice daily) vs +6.6 for placebo; 55.7% / 68.7% of patients rated their hair "improved" or "much improved" vs 15%. Effect significant from Month 2. No cardiac adverse events of special interest, no treatment-related SAEs across 1,055 men in two trials. VDPHL01 now has the full efficacy package for an NDA.
Read full breakdownStudy '306' — the registration trial in female pattern hair loss — completed enrollment at 556 women (4.5 mg once or twice daily); topline data expected H1 2027. Veradermics reported $819.9M in cash after its February IPO and May follow-on, enough to carry VDPHL01 through approval and commercial launch. Study '302' data were presented at the AAD Innovation Academy.
Read the updateVDPHL01 met the primary endpoint in the female arms of open-label Study '207'. Once-daily 4.5 mg dosing produced a statistically significant increase in nonvellus target area hair count at week 24 — about 23 hairs/cm², above the 15–20 analysts expected — the first efficacy data for the drug in women. No treatment-related serious adverse events.
Read the resultsAnswers to the most common search queries about VDPHL01.
Across Phase 3 Studies '302' and '304' (1,055 men, 6 months), VDPHL01 caused no treatment-related serious adverse events and no cardiac adverse events of special interest. The only side effects seen in more than 5% of patients were peripheral edema (2.8–6.3% on VDPHL01 vs 0–0.6% on placebo) and hypertrichosis — unwanted body hair (2.2–9.0% vs 0–0.6%), both more frequent at the twice-daily dose; fewer than 1.2% of patients stopped treatment for either. Because the drug does not act on hormones, the libido and erectile-dysfunction effects associated with finasteride have not been observed.
No, not yet. Both pivotal male trials are now positive — Study '302' (April 27, 2026) and confirmatory Study '304' (October 19, 2026) — which is the efficacy package the FDA requires. Veradermics says the data support a regulatory submission; its prior guidance was an NDA filing in early 2027, followed by a 6–10-month FDA review. Twelve-month data from Study '302' are due later in 2026.
Early evidence says yes. In Phase 2 Study '207', once-daily 4.5 mg VDPHL01 met the primary endpoint in women (July 2026). The registration trial in women — Study '306', NCT07146022, 556 participants — is fully enrolled, with topline results expected in the first half of 2027. If positive, VDPHL01 would be the first FDA-approved oral treatment for female pattern hair loss. Recruitment is closed.
Yes. If approved, VDPHL01 will require a physician's prescription — consistent with how oral minoxidil is currently managed off-label and similar to finasteride. It will not be available over the counter.
We'll send one email when VDPHL01 becomes available to buy. Rare milestone notes in between — only if something material happens.