On October 19, 2026, Veradermics (NYSE: MANE) announced positive topline results from Study ‘304’ — the confirmatory Phase 3 trial of VDPHL01, its extended-release oral minoxidil tablet, in men with mild-to-moderate pattern hair loss. Every primary and secondary endpoint was met. With Study ‘302’ already positive in April, VDPHL01 now has two completed, placebo-controlled pivotal trials in more than 1,000 men — the full efficacy package the FDA will expect in a New Drug Application.
The headline number: men on the twice-daily dose gained +36.4 hairs/cm² at six months versus +6.6 on placebo, and 68.7% of them rated their hair coverage as “improved” or “much improved.” Both figures are higher than in Study ‘302’.
What the Trial Showed
Study ‘304’ (NCT06972264) enrolled 536 men in a randomized, double-blind, placebo-controlled design. Participants received VDPHL01 8.5 mg once daily (QD), 8.5 mg twice daily (BID), or placebo. Part A — the six-month placebo-controlled period — is what read out today; all participants now continue on VDPHL01 through Month 12.
Co-primary endpoint 1: Hair Count (Non-Vellus Target Area Hair Count at Month 6)
| Group | Mean Increase (hairs/cm²) | p-value vs. placebo |
|---|---|---|
| VDPHL01 once daily (QD) | +28.6 | <0.0001 |
| VDPHL01 twice daily (BID) | +36.4 | <0.0001 |
| Placebo | +6.6 | — |
Co-primary endpoint 2: Patient-Reported Hair Coverage (AAIRS Scale)
Patients rating their hair coverage as “improved” or “much improved” at Month 6:
- 55.7% — VDPHL01 QD (vs. 15.0% placebo; p<0.0001)
- 68.7% — VDPHL01 BID (vs. 15.0% placebo; p<0.0001)
Patients reporting any visible improvement:
- 78.8% — VDPHL01 QD
- 85.0% — VDPHL01 BID
- 35.3% — Placebo
Blinded investigators agreed: 78.4% (QD) and 82.7% (BID) of patients were graded as having improved hair coverage on the Investigator Global Assessment (p<0.0001 vs. placebo for both arms).
Early onset — again
As in Study ‘302’, statistically significant separation from placebo on hair count, patient-reported outcomes and investigator assessment was observed at Month 2, the earliest time point measured. Two independent trials now show the same pattern: visible response inside the first two months, continuing to build through Month 6.
Study ‘304’ vs. Study ‘302’: How Consistent Are the Data?
Consistency between the two pivotal trials is what regulators look for — and what analysts had flagged as the main risk ahead of today’s readout. Side by side:
| Endpoint (Month 6) | Study ‘302’ (n=519) | Study ‘304’ (n=536) |
|---|---|---|
| Hair count, QD vs. placebo | +30.3 vs. +7.3 | +28.6 vs. +6.6 |
| Hair count, BID vs. placebo | +33.0 vs. +7.3 | +36.4 vs. +6.6 |
| “Improved / much improved,” QD | 48.4% (placebo 13.4%) | 55.7% (placebo 15.0%) |
| “Improved / much improved,” BID | 62.9% (placebo 13.4%) | 68.7% (placebo 15.0%) |
| Any patient-reported improvement, BID | 86.0% | 85.0% |
| Investigator-graded improvement, BID | 84.4% | 82.7% |
| Onset of significant effect | Month 2 | Month 2 |
| Cardiac adverse events of special interest | None | None |
The placebo-adjusted hair-count gain in the BID arm rose from +25.7 hairs/cm² in Study ‘302’ to +29.8 hairs/cm² in Study ‘304’ — well above the 20-hair benchmark Wall Street had set before the first readout. The once-daily arm replicated almost exactly. In short: Study ‘304’ did not merely confirm Study ‘302’; on the patient-reported endpoints it improved on it.
Safety: Two Trials, 1,000+ Men, No Cardiac Signal
Cardiac safety is the reason oral minoxidil has lived in off-label limbo for decades. Veradermics’ extended-release gel matrix is designed to keep peak plasma levels below the threshold linked to fluid retention and pericardial effusion. Study ‘304’ safety data through Month 6:
- No treatment-related serious adverse events (SAEs)
- No adverse events of special interest (AESIs) of cardiac origin
- No new safety signals versus Study ‘302’
- Generally well tolerated; discontinuations for adverse events were rare (see table)
Veradermics also published the two adverse events that occurred in more than 5% of patients in either trial — the first granular tolerability data for VDPHL01:
| Adverse event (through Month 6) | ‘304’ QD | ‘304’ BID | ‘304’ Placebo | ‘302’ QD | ‘302’ BID | ‘302’ Placebo |
|---|---|---|---|---|---|---|
| Peripheral edema | 2.8% | 4.5% | 0.6% | 5.3% | 6.3% | 0% |
| → leading to discontinuation | 0% | 0.6% | 0% | 1.2% | 1.1% | 0% |
| Hypertrichosis (unwanted body hair) | 2.2% | 9.0% | 0% | 3.5% | 6.3% | 0.6% |
| → leading to discontinuation | 0% | 0.6% | 0% | 0% | 0% | 0% |
For context: published series of off-label immediate-release oral minoxidil report hypertrichosis in anywhere from 15% to over 80% of patients depending on dose, and edema in up to 10%. VDPHL01’s once-daily arm came in at 2.2% and 2.8% respectively — with no one in that arm stopping treatment for either reason.
What Experts Are Saying
“The consistency across studies and the rigor of the assessments give me confidence. If approved, I believe VDPHL01 could become the new standard of care for pattern hair loss.”
Antonella Tosti, M.D., Fredric Brandt Endowed Professor of Dermatology and Cutaneous Surgery, University of Miami
“These results give physicians reason to expect more from treatment — and greater confidence to raise hair loss with patients and actually offer them something.”
Michael J. Payette, M.D., M.B.A., Central Connecticut Dermatology; Associate Clinical Professor, UConn Health
“The data show marked increases in hair growth, while minimizing side effects and cardiac risk.”
Reid Waldman, M.D., Chief Executive Officer, Veradermics
What Comes Next
Veradermics said the Study ‘304’ data, together with Study ‘302’, “support a regulatory submission” — but did not put a date on the NDA. The company’s earlier guidance pointed to a filing in early 2027. Three more catalysts sit between now and then:
| Milestone | Expected |
|---|---|
| Study ‘302’ Part B — 12-month data (long-term efficacy and safety) | Later in 2026 |
| NDA submission to FDA (male pattern hair loss) | Early 2027 (company’s prior guidance; not reconfirmed today) |
| Study ‘306’ — topline results in 556 women (fully enrolled since August 2026) | First half of 2027 |
| Potential FDA approval | Late 2027 – 2028, depending on review type |
Veradermics hosted a conference call at 8:00 a.m. ET on October 19 to review the results; a replay is available on the Investors section of its website. Our full regulatory roadmap is here: Study 304, Study 306 and the FDA path →
The Bigger Picture
No new FDA-approved prescription drug for pattern hair loss has reached the U.S. market in almost 30 years. An estimated 80 million Americans — 50 million men and 30 million women — live with the condition, and most are managed today with generic topical minoxidil, finasteride, or oral minoxidil prescribed off-label in a formulation designed for blood pressure.
Veradermics is the first company to put oral minoxidil through full-scale, placebo-controlled Phase 3 trials, and it is doing so from a position of financial strength: the company reported $819.9 million in cash and marketable securities at June 30, 2026, after a February IPO and a May follow-on offering, and says that funds operations — including a potential commercial launch — into 2030. Analysts at Cantor Fitzgerald project peak VDPHL01 sales above $2 billion by 2033, with women accounting for roughly 40% of that if Study ‘306’ succeeds.
Competition is coming but is further behind. Pelage Pharmaceuticals’ PP405, a topical follicle-stem-cell activator, is in Phase 2/3; Kintor’s pyrilutamide and Cosmo’s clascoterone are topical anti-androgens with more modest effect sizes. None has two positive pivotal trials. See our treatment comparison for the side-by-side.
What changed today is simple: the question is no longer whether VDPHL01 works in men. Two trials, two doses, more than 1,000 patients — same answer. The open questions are now timing (NDA, FDA review), the 12-month durability data, and whether women respond as well as men. Those answers arrive over the next eight months.
Sources: Veradermics press release via Business Wire (October 19, 2026); BioSpace; GeneOnline; Veradermics Q2 2026 results (August 11, 2026); ClinicalTrials.gov NCT06972264.