On November 9, 2026, Veradermics (NYSE: MANE) reported 12-month results from Part B of Study ‘302’, the Phase 2/3 trial of VDPHL01, its extended-release oral minoxidil tablet, in 519 men with mild-to-moderate pattern hair loss. Men who stayed on the twice-daily dose for a full year reached +43.9 hairs/cm² — the highest hair count reported in the VDPHL01 Phase 3 program to date. The once-daily dose held the gain it had at six months. No new safety signals appeared in the second six months.
Until now, every VDPHL01 efficacy number was a six-month number. This is the first look at what happens when men keep taking the drug.
How the Trial Was Run
Study ‘302’ (NCT06724614) randomized 519 men to VDPHL01 8.5 mg once daily (QD), 8.5 mg twice daily (BID), or placebo. Part A — the six-month placebo-controlled period — read out positive on April 27, 2026. In Part B, everyone took VDPHL01 for another six months: men already on the drug stayed on their dose (the “continued” group), and men on placebo were switched to one of the two active doses (the “crossed” group).
That design means there is no placebo arm at Month 12. The placebo comparison was made at Month 6; Month 12 shows whether the effect lasts, grows or fades on continued treatment.
Month 6 vs. Month 12: Men Who Stayed on VDPHL01
| Endpoint | QD, Month 6 | QD, Month 12 | BID, Month 6 | BID, Month 12 |
|---|---|---|---|---|
| Non-vellus hair count, change from baseline (hairs/cm²) | +30.3 | +29.7 | +33.0 | +43.9 |
| Any visible improvement, patient-rated (AAIRS) | 79.3% | 79.8% | 86.0% | 89.1% |
| “Improved” or “much improved,” patient-rated (AAIRS) | 48.4% | 48.4% | 62.9% | 68.0% |
| Improved hair coverage, investigator-rated (IGA) | 72.0% | 74.4% | 84.4% | 92.2% |
Month 6: Study ‘302’ Part A, all randomized patients in each arm (April 27, 2026). Month 12: VDPHL01 continued group (November 9, 2026). Veradermics did not publish separate Month 6 values for the Part B population.
The two doses behaved differently in the second half-year:
- Twice daily kept working. Hair count rose by another 10.9 hairs/cm² between Month 6 and Month 12, and every patient- and investigator-rated measure moved up. Veradermics calls this “deepening” of hair growth.
- Once daily plateaued at its six-month level. Hair count (+30.3 → +29.7) and patient ratings are essentially unchanged; investigator ratings rose from 72.0% to 74.4%. The company’s term is “maintenance.”
At six months the gap between the doses was 2.7 hairs/cm². At twelve months it is 14.2. For the FDA label and for prescribers, that turns dose selection into a real question: twice daily delivers more hair over a year, but in Study ‘304’ it also came with more hypertrichosis (9.0% vs 2.2% on once daily at six months).
Men Who Switched From Placebo
Men who spent the first six months on placebo and then took VDPHL01 for six months reached the following at Month 12:
| Endpoint (Month 12) | Switched to QD | Switched to BID |
|---|---|---|
| Non-vellus hair count, change from original baseline (hairs/cm²) | +24.5 | +32.1 |
| Any visible improvement (AAIRS) | 73.2% | 82.0% |
| “Improved” or “much improved” (AAIRS) | 42.9% | 60.7% |
| Improved hair coverage (IGA) | 80.0% | 83.9% |
The placebo group as a whole had gained +7.3 hairs/cm² by Month 6. After six months on the drug, the switched patients came close to what the original VDPHL01 arms had reached at Month 6: +32.1 vs +33.0 hairs/cm² on twice daily, +24.5 vs +30.3 on once daily. Their safety profile was comparable to the continued group.
Safety Through 12 Months
The key question for any oral minoxidil is cardiovascular safety over long-term use. Through Month 12, Veradermics reported:
- No treatment-related serious adverse events
- No adverse events of special interest of cardiac origin
- No new safety signals compared with Study ‘302’ Part A and Study ‘304’
- No treatment-emergent adverse events leading to discontinuation between Month 6 and Month 12 in the continued group
What the release does not include: adverse-event rates by arm for Months 6–12, such as how often peripheral edema or hypertrichosis occurred. Veradermics has not published them yet. For the six-month rates from both pivotal trials, see our Study ‘304’ breakdown.
“The 12-month long-term data from Study ‘302’ represent an important milestone in our efforts to provide a new standard of care for male pattern hair loss.”
Reid Waldman, M.D., Chief Executive Officer, Veradermics
What This Means for the NDA
For a drug that patients would take indefinitely, regulators require exposure data beyond six months. The international guideline the FDA follows (ICH E1) asks for at least 100 patients treated for a full year. Study ‘302’ Part B covers that requirement with more than 500 men, and the 12-month data from Study ‘304’ will add to it.
This was the last male data readout Veradermics had scheduled before the NDA. The company did not give a filing date on November 9; its earlier guidance pointed to early 2027.
| Milestone | Status / expected |
|---|---|
| Study ‘302’ Part A — six-month placebo-controlled data | ✓ Positive, April 27, 2026 |
| Study ‘304’ Part A — confirmatory six-month data | ✓ Positive, October 19, 2026 |
| Study ‘302’ Part B — 12-month data | ✓ Positive, November 9, 2026 |
| NDA submission to FDA (male pattern hair loss) | Early 2027 (prior guidance; not reconfirmed) |
| Study ‘306’ — topline results in 556 women | First half of 2027 |
| Potential FDA approval | Late 2027 – 2028, depending on review type |
Veradermics reviewed the data on a conference call at 8:00 a.m. ET on November 9; a replay is on the Investors section of its website. MANE shares traded higher on the day. For the full regulatory roadmap, see Availability; for every trial date, see Clinical Trials.
Bottom Line
Six-month results showed that VDPHL01 grows hair. The 12-month results answer the next question — whether the effect holds — and the answer depends on the dose: once daily holds, twice daily keeps adding. Safety did not change with longer use. The remaining unknowns are the NDA date, the length of FDA review, and the women’s data from Study ‘306’.
Sources: Veradermics Form 8-K (November 9, 2026); Veradermics press release via BioSpace (November 9, 2026); Study ‘302’ Part A results, Business Wire (April 27, 2026); ClinicalTrials.gov NCT06724614.