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VDPHL01
Phase 3 · 12-month '302' data positive · Nov 9, 2026

VDPHL01 — News, Trials & Hair-Loss Treatment Updates

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 clinical, regulatory and commercial milestones until launch.

Last updated November 9, 2026 Estimated launch Late 2027 – early 2028 Registry NCT06724614

Step 01

Phase 1

Safety established

Completed

Step 02

Phase 2/3 ('302')

+33.0 hairs/cm² at 6 mo → +43.9 at 12 mo

Apr 27 / Nov 9, 2026

Step 03

Phase 3 conf. ('304')

Positive topline: +36.4 hairs/cm²

Oct 19, 2026

Step 04

NDA filing

Submission to FDA, date not announced

Early 2027 (prior guidance)

Step 05

FDA approval

Regulatory decision

Late 2027 – 2028 (est.)

Step 06

Launch

On-market availability

2027–2028 (est.)

Launch alert

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Quick answers

Short answers to common questions, with links to the details.

When will it launch?

Estimated late 2027 to early 2028. Both Phase 3 trials are positive; NDA filing and FDA review come next.

Where can I buy it?

Not on the market yet. After FDA approval it will be sold through licensed pharmacies only.

How much will it cost?

Not announced. Veradermics' commercial chief named Nutrafol, about $90 a month, as a price benchmark.

What is VDPHL01?

An oral, non-hormonal AGA treatment by Veradermics. Stimulates hair growth without acting on hormones.

How it compares to other AGA treatments

Side-by-side with finasteride, dutasteride, topical/oral minoxidil, clascoterone, pyrilutamide.

How does it work?

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.

Phase 3 program: topline results

Study '302' (April 27, 2026) and confirmatory Study '304' (October 19, 2026) both met their primary endpoints, in more than 1,000 men in total. At 12 months (Study '302', November 9, 2026) the twice-daily gain grew to +43.9 hairs/cm² and the once-daily gain held.

+36.4 / 28.6hairs/cm² at 6 months, Study '304' (BID / QD) vs +6.6 placebo
69%rated hair "improved" or "much improved" (placebo 15%)
Month 2first statistically significant growth, in both trials
0cardiac adverse events of special interest across 1,055 men

Hair density change at 6 months, Phase 3 Study '304' (536 men)

2× daily
+36.4
1× daily
+28.6
Placebo
+6.6

Study '302' at 12 months (Nov 9, 2026): +43.9 hairs/cm² (2× daily, up from +33.0 at 6 months), +29.7 (1× daily, maintained); no new safety signals. 12-month results →

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

Latest updates

Chronological log of Veradermics announcements and trial milestones.

Nov 9, 2026 · 12-month data

Study '302' at 12 months: twice-daily dose reaches +43.9 hairs/cm²

Men who stayed on twice-daily VDPHL01 for a year gained +43.9 hairs/cm², up from +33.0 at six months, the highest figure in the Phase 3 program. The once-daily arm held its gain (+29.7). 89.1% of twice-daily patients reported visible improvement. Men switched from placebo at Month 6 reached +32.1. No new safety signals, no cardiac adverse events of special interest, no discontinuations for adverse events in the second six months.

Read full breakdown
Oct 19, 2026 · Phase 3 readout

Confirmatory Phase 3 Study '304' meets all endpoints

The second pivotal male trial confirmed 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 breakdown
Aug 11, 2026 · Company update

Women's trial fully enrolled; $820M funds launch into 2030

Study '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, which management says funds the company through a potential launch, into 2030. Study '302' data were presented at the AAD Innovation Academy.

Read the update

View all updates →

Frequently asked questions

Safety, approval status, women, prescriptions.

What are the side effects of 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, i.e. 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. Twelve-month data from Study '302' showed no new safety signals with longer use. The drug does not act on hormones, and sexual side effects were not among the effects reported in the trials.

Is VDPHL01 FDA approved?

No, not yet. Both pivotal male trials are positive: Study '302' (April 27, 2026) and confirmatory Study '304' (October 19, 2026). Veradermics says the data support a regulatory submission. Its prior guidance was an NDA filing in early 2027; on October 19 it said the guidance had not been updated and that it is still deciding whether to file for men alone or for men and women together. FDA review takes 6 months (priority) or 10 months (standard). Twelve-month data from Study '302', released November 9, 2026, showed the effect holding on once-daily dosing and growing on twice-daily dosing (+43.9 hairs/cm²), with no new safety signals.

Will VDPHL01 work for women?

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.

Will VDPHL01 be prescription-only?

Yes. If approved, VDPHL01 will require a prescription, like finasteride and off-label oral minoxidil today. It will not be sold over the counter.

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