VDPHL01 Phase 3 Results: What Study 304 Reveals
Published by AmpleLab Research
On 19 October 2026 Veradermics reported topline results from Study ‘304’, the second placebo-controlled Phase 3 trial of VDPHL01, its extended-release oral minoxidil tablet, in men with pattern hair loss. Our earlier VDPHL01 article covered how the formulation is designed and the first male trial, Study ‘302’. Our fluid retention article examined the edema signal in that first trial. This article is only about what is new: what Study ‘304’ found, and whether the two trials agree.
The short answer is that they agree closely on efficacy, with a few differences worth reading carefully, and that both remain company-reported topline results rather than peer-reviewed publications.
What Study ‘304’ Tested
Study ‘304’ (NCT06972264) is described as a randomised, double-blind, placebo-controlled, registration-directed Phase 3. According to the company’s investor slides it enrolled 536 men at 45 US sites, aged 18 to 65 with mild-to-moderate pattern hair loss. Participants received VDPHL01 8.5 mg once daily, 8.5 mg twice daily or placebo for six months (Part A). Everyone takes tablets twice a day, so the once-daily group receives a matched placebo for the second dose, which keeps the trial blinded. In months 7 to 12 the placebo group moves onto VDPHL01 and the active groups continue. The twice-daily regimen delivers 17 mg of minoxidil per day, against 8.5 mg in the once-daily arm. These are investigational extended-release doses and should not be read as equivalent to conventional immediate-release oral minoxidil dosing.
The Headline Result
Both co-primary endpoints were met, and the company reports that every secondary endpoint was also met. Separation from placebo on hair count, patient ratings and investigator ratings was statistically significant by Month 2, the earliest time point measured.
At Month 6 non-vellus target-area hair count rose by 28.6 hairs/cm² (once daily) and 36.4 hairs/cm² (twice daily), versus 6.6 hairs/cm² on placebo (p<0.0001 for both). 55.7% and 68.7% of men rated their hair coverage improved or much improved, versus 15.0% on placebo (p<0.0001 for both). Investigators rated coverage improved in 78.4% (once daily) and 82.7% (twice daily). The company reports no treatment-related serious adverse events and no cardiac adverse events of special interest. This is a company press release of topline data, not a peer-reviewed paper.
302: +30.3 / +33.0 / +7.3
302: +23.1 / +25.8
302: 48.4% / 62.9% / 13.4%
302: 32.7% / 38.5% / 5.0%
Did the Second Trial Replicate the First?
On the measures that matter most for a regulator, yes. According to the company, Study ‘304’ ran at sites that did not overlap with Study ‘302’, used the same two doses and co-primary endpoints, and produced hair count gains of a similar size. Placebo-adjusted, the once-daily gain was 22.0 hairs/cm² in ‘304’ and 23.1 in ‘302’. This agreement across two separate study populations supports reproducibility, although both sets of results remain company-reported and have not undergone independent peer review.
A few details deserve closer reading:
The twice-daily advantage is clearer in the second trial
In ‘304’ the twice-daily arm gained 7.8 hairs/cm² more than the once-daily arm (36.4 versus 28.6). In ‘302’ the gap was 2.7 (33.0 versus 30.3). This is our arithmetic from the reported means. We have seen no formal statistical comparison between the two doses, so we would not call twice daily proven superior, although the pattern now points the same way in both trials.
Patient ratings were higher in the second trial
The share rating coverage improved or much improved was higher in ‘304’ at both doses, while the placebo rate was similar (15.0% versus 13.4%). The company slides show gains over placebo of 40.6 and 53.7 percentage points in ‘304’, against 35.0 and 49.4 in ‘302’. Patient ratings are subjective and the differences between the two trials are modest, so we would not read much into them.
An independent photo review points the same way
Three blinded reviewers assessed frontal photographs from baseline and Month 6, presented in random order. Each had to pick out the Month 6 photograph correctly and rate the improvement at +2 or better, and a response counted only when at least two of the three did both. In ‘304’ that was 35.1% (once daily) and 48.6% (twice daily) versus 5.5% on placebo. This is a stricter, less subjective check than a patient questionnaire.
What the gain means in proportion
Using the reported group baselines, a 28.6 to 36.4 hairs/cm² gain is roughly 20% to 25% of the average starting count of about 142 to 145 hairs/cm², against roughly 4.5% on placebo. This is our arithmetic, and it describes a small tattooed target area, not the whole scalp.
Evidence level
Two randomised, double-blind, placebo-controlled trials in 1,055 men across 89 US sites, reported by the company as topline results. Neither has been published in a peer-reviewed journal, and the six-month placebo-controlled window is the only controlled comparison.
The company’s slides also set the results beside figures from other treatments, including 5% minoxidil foam, oral finasteride and oral minoxidil 5 mg. The slide itself labels these as non-head-to-head and not directly comparable, and different trials differ in population, method and duration, so we have not reproduced those comparisons here.
Safety in the Second Trial
Through Month 6, any treatment-emergent adverse event occurred in 42.1% (once daily) and 42.9% (twice daily) of men on VDPHL01, versus 28.2% on placebo. Adverse events led to discontinuation in 2.2%, 2.8% and 1.1% respectively. There were no treatment-related serious adverse events and no cardiac adverse events of special interest. The only serious adverse event in a VDPHL01 patient was a humerus fracture judged unrelated to the drug. The company reports no clinically significant differences from placebo in heart rate, blood pressure or ECG, but the slides give no values. This is company-reported data.
The edema rate was lower in the second trial than in the first (2.8% and 4.5% in ‘304’, 5.3% and 6.3% in ‘302’), while twice-daily hypertrichosis was higher (9.0% versus 6.3%). Pooling the two trials is our own simple arithmetic from the arm counts the company reports, not a pre-specified analysis, but it gives the most stable picture so far:
Edema is therefore more common on VDPHL01 than on placebo in both trials, and the fuller 304 data do not change the conclusion of our fluid retention article that extended release has not been shown to remove it. They do show it was less frequent in the second trial, and the question of whether dose or formulation drives it remains open. Edema and hypertrichosis each led to discontinuation in at most one participant in the twice-daily arm of ‘304’.
Two cautions on the cardiac picture. First, the claim of no clinically significant change in heart rate, blood pressure or ECG comes without numbers. Second, the baseline slide lists about half of participants (52.2%) as hypertensive, without a definition in the material we reviewed, so it is not clear how much of the trial population was at low cardiovascular risk. Twelve-month data will matter more here than six-month data.
What the Topline Does Not Tell Us
It is not peer reviewed
The numbers come from a press release and investor slides. Full methods, analysis populations and safety tables are not yet published.
Only six months are placebo-controlled
After Month 6 everyone receives VDPHL01, so durability, long-term safety and whether benefits continue are uncontrolled questions answered only by extension data.
The measure is a small area
Hair count is taken in a tattoo-marked target area by image analysis. It is a standard approach in hair trials, but a gain of 30 hairs/cm² in that area does not translate directly into how a scalp looks.
The population is specific
Men aged 18 to 65 with mild-to-moderate loss (Norwood IIIv to V), enrolled at US sites and 84.5% White. It tells us little about advanced loss, other ethnic groups or women.
Cardiac detail is thin
No heart rate, blood pressure or ECG values are shown, and nothing beyond six months of controlled exposure is reported.
What Happens Next
Three results are still to come. The 12-month data from Study ‘302’ are expected in the second half of 2026, and Study ‘304’ also runs to 12 months with its own extension. The female registration trial, Study ‘306’, has completed enrolment of 556 women on 4.5 mg once or twice daily, with topline data expected in the first half of 2027.
Neither the press release nor the investor slides give a date for submitting a New Drug Application. The company’s annual report describes a 505(b)(2) pathway, which relies partly on existing knowledge of minoxidil, and says an application could seek approval in men first, followed by a supplemental application for women, or could cover both sexes together depending on trial timing. It is also still subject to FDA acceptance of that pathway. VDPHL01 is not approved anywhere and is not available through any legitimate channel.
For how this fits among other treatments in development, see our hair loss pipeline tracker. For the current off-label route, see our article on oral versus topical minoxidil.
Frequently Asked Questions
Did the second Phase 3 confirm the first?
On efficacy, closely. Hair count gains over placebo were 22.0 and 29.9 hairs/cm² in Study ‘304’ and 23.1 and 25.8 in Study ‘302’, and both met their co-primary endpoints. These are company-reported topline results, not peer-reviewed publications.
How much hair is 36 hairs/cm²?
It is the average gain in the twice-daily group at Month 6, in a small target area, against a baseline of about 145 hairs/cm². That is roughly a quarter of the starting count, and about 30 hairs/cm² more than the placebo group gained. Individual results varied, and the company shows examples at the 25th, 50th and 75th percentiles of response.
Is twice daily better than once daily?
Numerically yes in both trials, and by a wider margin in ‘304’. No formal comparison between the two doses has been published, and twice daily also had more hypertrichosis (9.0% in ‘304’).
Is VDPHL01 approved, or has it been submitted to the FDA?
It is not approved anywhere. The company has not given a submission date in its results materials. Women are covered by a separate trial that reads out in the first half of 2027.
Is the safety profile any different from the first trial?
It is broadly similar. Peripheral edema was lower in ‘304’ than in ‘302’, and twice-daily hypertrichosis was higher. Both effects were more common than on placebo, and no treatment-related serious or cardiac events were reported in either trial.
Selected Research
Status checked on 31 October 2026. All efficacy and safety figures for VDPHL01 are company-reported topline data that have not been peer reviewed, and pooled figures marked as our arithmetic are not company analyses.
This article is provided for educational purposes and does not constitute medical advice. VDPHL01 is an investigational drug not approved by any regulator and not available for purchase through any legitimate channel. AmpleLab products are cosmetic formulations, unrelated to VDPHL01, and are not intended to diagnose, treat, cure, or prevent any condition.
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