Extended-release oral minoxidil tablet compared with generic minoxidil tablets
VDPHL01 is minoxidil — the same molecule as the generic tablets already prescribed off-label for hair loss — reformulated to release slowly. The Phase 3 data show it works. Whether it works better than what patients can already get is a different question.

On October 19, 2026, Veradermics (NYSE: MANE) announced that VDPHL01, its extended-release oral minoxidil, met every primary and secondary endpoint in its Phase 3 Study ‘304’ in men with pattern hair loss. It was the company's second positive registration-directed readout of the year, as Reuters reported. If approved, VDPHL01 would be pitched as the first new FDA-approved oral hair-loss pill since finasteride in the late 1990s — and the first non-hormonal one.

There is an obvious complication. Oral minoxidil is not new. Generic immediate-release minoxidil tablets, approved decades ago for severe high blood pressure, are already prescribed off-label at low doses for hair loss by dermatologists and telehealth clinics, and the evidence for that use is comparatively good — we covered it in our review of low-dose oral minoxidil (LDOM). So the question that matters for patients is not whether VDPHL01 beats a sugar pill. It is whether a branded, slow-release version of the same molecule is meaningfully better than the cheap tablet people can already get.

The Claim

“VDPHL01 achieved early, consistent, and robust hair growth” — an extended-release formulation designed to avoid “the high peak concentrations of immediate-release oral minoxidil” while keeping levels above the threshold needed for hair growth.

(Paraphrased and quoted from Veradermics' October 19, 2026 press release and its description of the formulation.)

What VDPHL01 Actually Is

VDPHL01 is minoxidil in an extended-release gel-matrix tablet. The active ingredient is identical to generic minoxidil; the innovation is the delivery. According to the company's October 19 data release filed with the SEC, the tablet is designed for steady, sustained release that avoids the sharp concentration peaks of immediate-release tablets and extends the time drug levels sit above a “minimum hair growth threshold.”

The pitch makes pharmacological sense. Immediate-release minoxidil is absorbed quickly and has a short plasma half-life, so blood levels spike after each dose and then fall. If the cardiovascular side effects — faster heart rate, fluid retention — track peak concentrations while the hair effect tracks sustained exposure, flattening the curve could, in principle, widen the gap between the dose that grows hair and the dose that bothers the heart. NYU dermatologist Jerry Shapiro made exactly this argument to Dermatology Times, saying the steady state “doesn't go above the cardiotoxic level.”

What is missing is most of the numbers behind the argument. The only description of VDPHL01's pharmacokinetics we could find is in the company's IPO registration statement (Form S-1), which summarizes a Phase 1 crossover study in healthy volunteers (registered as ISRCTN57359805) comparing modified-release prototypes of up to 10 mg against 2.5 mg of immediate-release minoxidil. According to the filing, 8.5 mg of VDPHL01 delivered “nearly twice the total amount of minoxidil in plasma over 12 hours,” kept levels above the hair growth threshold “two times longer,” and held peaks below the level at which signs of cardiac activity are typically observed.

Three things limit how much weight that can bear. First, the comparison is not dose-matched: 8.5 mg against 2.5 mg is more than three times the drug, so greater exposure is unsurprising and says little about the formulation itself. Second, the filing describes the study as exploratory, with no formal sample size calculation, and reports no Cmax, Tmax, half-life, or concentration values; neither the “hair growth threshold” nor the cardiac threshold is given as a number, and the registry lists publication of full results as deferred. Third, the company's patent application for the formulation states only broad claimed ranges (peak concentrations anywhere from 0.25 to 20 ng/mL, for example), which describes what is being protected, not what was measured.

We also found no published animal pharmacokinetic studies of VDPHL01, in mice, rats, or otherwise. That is less alarming than it sounds: Veradermics is pursuing the FDA's 505(b)(2) pathway, which lets a new formulation of an already-approved drug rely partly on existing data for that drug, so a fresh animal program is not necessarily required. But it means the human Phase 1 study is the whole pharmacokinetic case, and its data are not public. The Dermatology Times piece also carries no conflict-of-interest disclosure for its commentator. Until the curves are published, “avoids cardiotoxic peaks” is a plausible hypothesis, not a demonstrated property.

The dose is not “low”

The Phase 3 arms tested 8.5 mg once daily and 8.5 mg twice daily (17 mg a day). For comparison, men taking off-label LDOM typically take somewhere between 1.25 mg and 5 mg of immediate-release minoxidil a day; the authors of one heart-monitoring study advise against going above 5 mg except in exceptional circumstances. The milligram numbers are not directly comparable, because an extended-release tablet may not deliver the same fraction of its dose to the bloodstream as an immediate-release one, and Veradermics has not published an equivalence. But anyone reading “8.5 mg twice a day” should understand it is not a micro-dose; it is a formulation engineered to let a larger total amount of drug be given more smoothly.

The Phase 3 Data

VDPHL01 now has two large, randomized, double-blind, placebo-controlled trials in men with mild-to-moderate pattern hair loss. Study 304 enrolled 536 men; the earlier Phase 2/3 Study 302, reported in April 2026, enrolled 519. Both ran a six-month placebo-controlled phase (Part A), followed by an extension in which everyone receives the drug (Part B). The co-primary endpoints were the change in non-vellus target-area hair count (TAHC) and the share of men who rated their hair coverage “improved” or “much improved” at Month 6.

Month 6 outcome 8.5 mg once daily 8.5 mg twice daily Placebo
Hair count gain, Study 304 (hairs/cm²) +28.6 +36.4 +6.6
Hair count gain, Study 302 (hairs/cm²) +30.3 +33.0 +7.3
“Improved” or “much improved,” Study 304 55.7% 68.7% 15.0%
“Improved” or “much improved,” Study 302 48.4% 62.9% 13.4%
Any self-rated improvement, Study 304 78.8% 85.0% 35.3%
Investigator-rated improvement, Study 304 78.4% 82.7% Not reported

Every active-versus-placebo comparison was reported at p<0.0001, and hair count, patient ratings, and investigator ratings separated from placebo at Month 2, the first time point measured — early, given the hair growth cycle usually means months before visible change. Subtracting placebo, the drug added roughly 22 to 30 non-vellus hairs per square centimetre over six months across the two trials. That is a solid, replicated effect, and replication across two independent trials of this size is exactly what regulators want to see.

Two details are worth noticing. First, the advantage of twice-daily over once-daily dosing is inconsistent: about 8 extra hairs/cm² in Study 304 but under 3 in Study 302. The higher dose helps patient ratings more consistently than hair counts, and it roughly doubles to quadruples the rate of unwanted body hair (see below). Second, the placebo groups rated themselves improved surprisingly often — 35% reported some improvement — a reminder of how much expectation shapes self-assessed hair outcomes and why blinded counts matter.

What We Already Know About Low-Dose Oral Minoxidil

Much of the LDOM evidence base is observational — case series, cohorts, and expert reviews such as Randolph & Tosti (2020). The best randomized evidence in men is the Penha et al. (2024) trial in JAMA Dermatology, which randomized 90 men to 5 mg oral minoxidil daily or 5% topical minoxidil twice daily for 24 weeks, using a double-dummy design so neither group knew which active treatment it had.

In the 68 men who completed it, the oral group gained about 10 terminal hairs/cm² on the frontal scalp and about 15 on the vertex from baseline. Oral minoxidil was not statistically superior to topical on the primary outcome, though it trended better on the vertex and won on the vertex photographic assessment. Further randomized trials have since compared 2.5 mg against 5 mg and low-dose oral against topical, and a 2025 meta-analysis concluded that oral is at least comparable to topical. What LDOM lacks is a large placebo-controlled registration trial — nobody has had a commercial reason to run one for a generic pill.

Why You Can't Line These Numbers Up

It is tempting to put “+22 to +30 hairs/cm² vs placebo” next to “+10 to +15 hairs/cm² from baseline” and declare VDPHL01 twice as good. That comparison does not hold up, for several reasons:

The honest conclusion is narrow: VDPHL01 clearly works, and its effect size looks at least in the same range as what oral minoxidil has shown elsewhere. Whether it regrows more hair than a well-chosen dose of the generic is unknown. As we noted in our piece on how pharma and beauty trials differ, “beats placebo” and “beats the alternative” are separate claims that need separate evidence.

Safety: Where VDPHL01 Might Genuinely Differ

If VDPHL01 has a real edge, the safety and tolerability data are where it would show. Here the reported numbers look striking.

Measure VDPHL01 (Studies 304 / 302) Generic oral minoxidil 5 mg (Penha 2024)
Hypertrichosis (unwanted body hair) Once daily 2.2% / 3.5%; twice daily 9.0% / 6.3%; placebo 0% / 0.6% 49% (vs 25% on topical)
Peripheral edema (swelling) Once daily 2.8% / 5.3%; twice daily 4.5% / 6.3%; placebo 0.6% / 0% 2% (1 of 45)
Stopped for side effects 0–1.2% per arm for edema or hypertrichosis 2% (1 man, headache)
Heart rate and blood pressure Not released No meaningful change in heart rate (72.1 to 72.9 bpm)
Serious or cardiac events None treatment-related in Study 304; no cardiac adverse events of special interest None reported

On paper, unwanted body hair at 2–9% versus 49% is a dramatic difference, and hypertrichosis is the side effect that most often makes people quit LDOM. But the comparison is weaker than it looks. Side-effect rates depend heavily on how they are collected: a small academic trial focused on minoxidil's known effects is likely to notice mild body hair that a large trial relying on spontaneously reported adverse events could miss. Veradermics has published only a summary table of events above 5% in any arm, and has not described how hypertrichosis was assessed. Until it does, the gap may be partly real and partly methodological. Even taken at face value, the twice-daily arm's 9.0% rate in Study 304 shows the problem does not disappear at higher exposure.

The bigger gap is cardiovascular. The extended-release rationale is explicitly about heart effects, yet heart rate and blood pressure data have not been released. For context, in a small Holter-monitoring study of generic minoxidil, Sanabria et al. (2024) followed 11 men and found average 24-hour heart rate went from about 73 bpm before treatment to 76 bpm on 5 mg and 81 bpm after six weeks on 7.5 mg, with no significant change in blood pressure — while Penha saw no heart-rate change at 5 mg. If VDPHL01 delivers high exposure with a flat heart-rate profile, that would be its strongest selling point. It has not yet been shown. Rare but serious effects of minoxidil, such as pericardial effusion, are catalogued in reviews of LDOM adverse events; six-month trials of around 500 men each are too small and short to rule those in or out.

Dose, Cost and Access

Beyond efficacy and safety, there are practical differences that will matter to many patients:

If You'd Rather Skip Minoxidil Altogether

VDPHL01 and generic LDOM are the same active molecule, so they ultimate share the same core trade-offs: a systemic drug, unwanted body hair, and fluid retention in some users. These are not 100% avoidable trade-offs. For people who want to stay off minoxidil entirely, the established alternative in men is a DHT blocker such as finasteride or dutasteride, which comes with its own hormonal trade-offs.

Two pipeline candidates worth watching

Clascoterone 5% (Breezula), from Cosmo Pharmaceuticals, is the closest parallel to VDPHL01. It is a topical androgen receptor blocker — the same molecule is already approved at 1% as the acne cream Winlevi — designed to block DHT at the follicle with minimal absorption into the bloodstream. Its Phase 3 program (SCALP 1 and SCALP 2) enrolled 1,465 men and used the same target-area hair count endpoint as VDPHL01. According to Cosmo's December 2025 topline release, both trials beat vehicle on hair count at six months; the patient-reported outcome was significant in one trial and only trended positive in the other. Cosmo plans to file with the FDA in early 2027. Two cautions: the headline figures (539% and 168%) are relative improvements over vehicle rather than absolute hair counts, and the 12-month result re-randomized only men who had responded in the first six months, which flatters the comparison. It is also, like VDPHL01, being marketed as the first new mechanism for male hair loss in roughly 30 years — both cannot be first, and neither has published peer-reviewed results.

PP405, from Pelage Pharmaceuticals, is earlier and more speculative. It is a topical gel that targets a metabolic switch in dormant follicle stem cells, which we examined in PP405 vs. NOVOGRO™. Its only efficacy signal comes from a small Phase 2a trial whose primary endpoint was safety; the widely quoted figure — 31% of men with more advanced loss gaining over 20% in hair density at week 8, versus 0% on placebo — comes from an exploratory subgroup. The real test is the roughly 600-man AWAKEN Phase 2/3 trial, which dosed its first patient on October 14, 2026 and is not expected to complete until late 2027.

Tested against minoxidil

A newer minoxidil-free option is NOVOGRO™, a topical serum from RE:YOU built on AI-discovered molecules (NV-623, NV-624, and NV-273) designed to act on the dermal papilla cells inside the follicle rather than on blood flow around it. We covered the preclinical data in Minoxidil vs. NOVOGRO™. The clinical evidence is early but notable: interim 90-day results from a registered (NCT07785869), double-blind trial in 190 women with mild-to-moderate female pattern hair loss reported about 50% greater hair counts and density than topical minoxidil, with no adverse events identified to date.

The same standards apply here as to VDPHL01: these are company-reported interim figures, the full 6-month readout is pending, and the trial enrolled women and compared against topical minoxidil, so it is not yet a like-for-like substitute for an oral pill in men. But it is one of the few minoxidil-free options tested head-to-head against minoxidil — a comparison VDPHL01 has yet to face against generic LDOM.

What's Still Missing

What the Evidence Actually Shows

VDPHL01 is an effective hair-loss treatment: two large, placebo-controlled trials in more than 1,000 men show a replicated gain of roughly 22–30 non-vellus hairs/cm² over placebo at six months, with benefits from Month 2. That is stronger regulatory-grade evidence than generic LDOM has ever had. But it has never been compared directly with generic oral minoxidil, and cross-trial comparisons are confounded by different hair-count methods, populations, and doses. Its lower reported rates of unwanted body hair may reflect a genuine tolerability advantage, a difference in how side effects were recorded, or both. The core pharmacokinetic and cardiovascular claims remain unpublished.

Verdict & Practical Implications

Verdict: Partially Supported

“Early, consistent, and robust” hair growth versus placebo is well supported by two strong trials. The implied claim that an extended-release pill is better than existing low-dose oral minoxidil is not established: there is no head-to-head data, the efficacy figures are not comparable across trials, and the safety advantage — the formulation's whole reason for existing — rests on unreleased heart-rate, blood-pressure, and pharmacokinetic data. Evidence rating: 3/5 — excellent placebo-controlled efficacy evidence, docked because the comparison that matters to patients hasn't been tested and the data are still topline.

For men already doing well on generic LDOM with no bothersome side effects, there is currently no evidence that switching would regrow more hair, and it would likely cost considerably more. For men who stopped LDOM because of unwanted body hair or swelling, or whose doctors won't prescribe minoxidil off-label, an approved extended-release option could be genuinely useful — if the full data hold up. The sensible move for most people is to wait for the peer-reviewed results, the 12-month safety data, and the heart-rate numbers before treating VDPHL01 as an upgrade. If you are weighing oral minoxidil in any form, the advice from our LDOM review still applies: it is a systemic cardiovascular drug, and the decision belongs in a real conversation with a clinician, and our list of things to know before you start minoxidil covers the practical basics. If topical minoxidil hasn't worked for you, our piece on minoxidil non-responders explains why oral delivery can help.

References & Further Reading