How Much Hair Oral Minoxidil Regrew in Phase 3 (VDPHL01 Data)

On 19 October 2026, Veradermics reported the second big trial of VDPHL01, an extended-release oral minoxidil tablet for male pattern hair loss. The headline numbers are strong: 536 men, two doses, both beating placebo by a wide margin from the second month onward. The stock jumped and the forums lit up with the same question: is this the pill that finally makes hair loss on TRT manageable?
Maybe. But the press release answers a narrower question than the one most of you are asking. Below: what the trial measured, what it left out, how VDPHL01 compares with the cheap generic oral minoxidil people already take off-label, how it fits with finasteride on TRT or a cycle, and what to log if you start any form of oral minoxidil.
This is harm reduction education, not medical advice. VDPHL01 is an investigational drug: it is not approved by the FDA, the TGA or any other regulator, and it is not available to buy. Oral minoxidil is a prescription blood pressure medicine. Talk to your doctor before starting it, especially if you have high blood pressure, a heart condition, or you use anabolic steroids.
Quick answer: In Study 304, men on VDPHL01 8.5 mg once daily gained 28.6 non-vellus hairs/cm² at six months, and 36.4 on twice daily, against 6.6 on placebo. That is 22 to 30 extra hairs/cm² over placebo, roughly 15 to 21% more hair in the counted area, which looks broadly comparable to oral finasteride, though the endpoints differ. Excess body hair hit 9% on the twice-daily dose, and ankle swelling reached 4.5% in Study 304 (6.3% in Study 302). The catch for this audience: the trials excluded anyone on hormone therapy or "hormonal modulators" in the previous six months, so men on TRT were very likely not in them, and no heart rate or blood pressure numbers have been published. If you use any oral minoxidil, track resting heart rate, morning weight and ankle swelling, not just blood pressure. Full evidence review and protocol below.
What Veradermics actually reported
Two large trials now exist, both in men aged 18 to 65 with mild to moderate pattern hair loss. Both compared 8.5 mg of VDPHL01 once daily (QD), 8.5 mg twice daily (BID) and placebo over six months. Both used the same co-primary endpoints: the change in non-vellus target area hair count (TAHC), counted by digital imaging in a tattooed patch of scalp, and the share of men who rated their own hair "improved" or "much improved" (Veradermics, Study 304 release; Veradermics, Study 302 release).
| Month 6 | Study 304 QD | Study 304 BID | Study 304 placebo | Study 302 QD | Study 302 BID | Study 302 placebo |
|---|---|---|---|---|---|---|
| Men randomised | 178 | 177 | 181 | 171 | 175 | 173 |
| Hair count gain (hairs/cm²) | +28.6 | +36.4 | +6.6 | +30.3 | +33.0 | +7.3 |
| Gain over placebo | +22.0 | +29.9 | +23.1 | +25.8 | ||
| Self-rated "improved/much improved" | 55.7% | 68.7% | 15.0% | 48.4% | 62.9% | 13.4% |
| Peripheral oedema | 2.8% | 4.5% | 0.6% | 5.3% | 6.3% | 0% |
| Excess body hair (hypertrichosis) | 2.2% | 9.0% | 0% | 3.5% | 6.3% | 0.6% |
Both active doses separated from placebo by month two, the earliest time point measured. There were no treatment-related serious adverse events and no cardiac adverse events of special interest in either trial. In Study 304, the only serious event in a VDPHL01 patient was a broken arm the company did not attribute to the drug.
How much is 22 to 30 extra hairs per cm²?
The raw number means little until you set it against the starting point. Men in Study 304 began with about 142 to 148 non-vellus hairs/cm² in the counted area (Veradermics, Study 304 call slides). So:
- Once daily: 22.0 ÷ 141.6 = about 15.5% more hair than placebo
- Twice daily: 29.9 ÷ 145.4 = about 20.6% more hair than placebo
For a rough benchmark, the original finasteride 1 mg trials counted hair in a 5.1 cm² circle on the vertex and found 107 more hairs than placebo at one year (Kaufman et al., 1998). Divide 107 by 5.1 and you get about 21 hairs/cm², in the same range as VDPHL01 once daily. The comparison is loose: different decade, younger men, vertex only, twelve months instead of six. Veradermics' own slides make a similar cross-trial comparison with the same warning. The fair summary is that VDPHL01 looks at least as good as finasteride on this kind of endpoint, not that it beats it.
What the press release leaves out
A topline press release is a sales document, even when the numbers are real. Here is what is missing or easy to miss.
No heart rate or blood pressure numbers. The safety slide says there were "no clinically significant differences in heart rate, blood pressure, or ECG changes compared to placebo". That is a conclusion without the data behind it. For a drug whose parent molecule is a powerful blood pressure medicine, you want the actual means and the share of men whose resting heart rate rose by 10 bpm or more.
Side effects were more common on the drug. Any treatment-emergent adverse event: 42.1% on QD, 42.9% on BID, 28.2% on placebo. Mostly mild, but not "similar to placebo".
Men on TRT were almost certainly excluded. The ClinicalTrials.gov record for Study 304 excludes anyone who used "hormone replacement therapy or hormonal modulators within 6 months prior to screening", anyone with uncontrolled blood pressure, certain heart conditions, any oral hair-growth treatment in the previous six months (which covers finasteride and dutasteride), and anyone using beta blockers or calcium channel blockers in the previous 12 weeks. The wording does not name testosterone, but a man on TRT or a cycle would very likely fail screening. The trial population is not you.
Half the men had a high blood pressure flag. Slide 12 lists 52.2% of participants as "hypertensive at baseline" without defining it or showing how they fared. That is either reassuring (the drug was tested in men with treated hypertension) or meaningless (a loose history flag). We cannot tell yet.
No head-to-head trial. Veradermics says on its own slides that no efficacy study has compared VDPHL01 with finasteride or with other forms of minoxidil. There is no peer-reviewed paper yet, no confidence intervals, and no twelve-month data. The Study 302 twelve-month safety readout is due later in 2026.
Is VDPHL01 just oral minoxidil in a new tablet?
In the molecule, yes. In the delivery, no. VDPHL01 is minoxidil in a gel-matrix extended-release tablet. The aim is to avoid the sharp peak in blood levels you get from an immediate-release tablet, since the dizziness and racing heart people get from minoxidil are thought to track that peak. That is the company's design rationale. The only pharmacokinetic data are company-sponsored Phase 1 results in its 10-K, from small studies in healthy volunteers, including a head-to-head against 2.5 mg immediate-release minoxidil in 10 men. Nothing independent or peer reviewed exists yet.
The clearest hint is in that 10-K: in a Phase 1 study in 24 healthy women, a single 20 mg dose of immediate-release minoxidil was linked to heart rate increases and palpitations, while neither appeared among the most frequent adverse events on VDPHL01 4.5 mg (Veradermics 10-K, 2025). Twenty milligrams is a blood pressure dose, so that is not a fair fight against the 2.5 to 5 mg men take for hair.
What the cheap version already does
Minoxidil does not block androgens. Its active form, minoxidil sulphate, is made inside the hair follicle by sulfotransferase enzymes, and it shortens the resting phase of the hair cycle and may lengthen the growth phase (Messenger and Rundegren, 2004). Follicular sulfotransferase activity is linked to who responds, though in an unexpected direction: in one 41-patient study, people with low activity improved more often (85% vs 43%), and 73.1% of men improved versus 40.0% of women (Jimenez-Cauhe et al., 2024).
Off-label low-dose oral minoxidil (LDOM) has been prescribed for hair since about 2017. The evidence in men:
- 5 mg oral vs 5% topical: in a 24-week double-blind trial, oral was not superior to topical on hair density, though photographic assessment of the vertex did favour oral (P = .04). The vertex density difference of 23.4 hairs/cm² missed significance (P = .09). Unwanted body hair hit 49% (22 of 45) on the oral form (Penha et al., 2024).
- Oral vs topical, pooled: four trials, 279 patients, no difference in hair density, and twice the risk of hypertrichosis on oral (Sobral et al., 2025).
- 5 mg open-label in men: total hair count rose 35.1 hairs/cm² at 24 weeks, with hypertrichosis in 93% and ankle swelling in 10% (Panchaprateep and Lueangarun, 2020).
- 2.5 mg vs 5 mg: a small double-blind trial compared the two doses directly (Carvalho Fonseca et al., 2026), and Veradermics' slides cite a 10.0 hairs/cm² gain on 5 mg from it.
The 2025 international consensus recommends a starting dose of 2.5 mg for men, with a usual range of 1.25 to 5 mg (Akiska et al., 2025).
Why 8.5 mg is not "more minoxidil" than 5 mg
The milligram numbers do not translate. An extended-release tablet can absorb less in total and deliver it more slowly, so 8.5 mg of VDPHL01 is not 70% more drug in your blood than 5 mg of generic. Nobody outside the company knows the conversion yet. Do not try to recreate VDPHL01 with 8.5 mg of immediate-release minoxidil; that is well above anything tested for hair.
What VDPHL01 might genuinely add is tolerability. In Study 304, hypertrichosis was 2.2% on once daily. Generic 5 mg produced unwanted body hair in about half of men in Penha's trial. Different trials, different ways of counting it, but it is the most striking gap in the whole dataset, and if it holds up head to head, it is the real selling point.
Does oral minoxidil raise heart rate or lower blood pressure?
Mostly the first. The best data in men comes from 24-hour Holter and ambulatory blood pressure monitoring:
- 5 mg, 34 men, 24 weeks: 24-hour blood pressure fell slightly (systolic about 125 to 122 mmHg, diastolic 76 to 74). Heart rate rose 2.4 bpm, which was not significant. No clinical hypotension (Sanabria et al., 2023).
- 7.5 mg, 11 men from that group: average 24-hour heart rate went from 72.6 bpm at their untreated baseline (75.7 on 5 mg) to 81.3 bpm. Blood pressure did not change, the normal night-time dip was preserved, and there was no increase in extra beats (Sanabria et al., 2024).
The mechanism explains the pattern. Minoxidil opens potassium channels in the small arteries and relaxes them. Your body senses the drop in pressure and answers with a faster heart rate and more renin and aldosterone, which holds on to sodium and water (Jimenez-Cauhe et al., 2025). At the 10 to 40 mg doses once used for severe hypertension, that reflex was strong enough that minoxidil had to be paired with a beta blocker and a diuretic. At hair-loss doses it mostly shows up as a few extra beats per minute and, in a minority, swollen ankles.
Across 1,404 patients on low-dose oral minoxidil, lightheadedness affected 1.7%, fluid retention 1.3%, tachycardia 0.9% and periorbital swelling 0.3%. Only 1.2% stopped because of these, and there were no life-threatening events (Vañó-Galván et al., 2021). Two-thirds of that group were women, who are usually prescribed lower doses, so it probably understates the male experience.
Why this matters more on a cycle
Nobody has studied oral minoxidil in anabolic steroid users. What we do know: steroid use is associated with blood pressure about 12/8 mmHg higher on average (Mingxing et al., 2025), and long-term users had a left ventricular mass index of 106 g/m² versus 80 g/m² in drug-free lifters, with lower pumping function (Abdullah et al., 2024). Add a drug that pushes heart rate up and holds water, and the stress stacks. That is reasoning, not trial data, but it is why the consensus lists heart failure and a history of pericardial disease as contraindications (Akiska et al., 2025).
Fluid around the heart, the scary complication on the old blood pressure label, is very rare at hair-loss doses. Cardiologist ultrasound screening found small effusions in 5.8% of people on LDOM versus 6% of controls, none of them symptomatic (Kincaid et al., 2024). The serious published cases mostly involved compounding errors (capsules with far more drug than the label said) or people with prior pericardial disease. If you buy minoxidil from a compounding pharmacy or a grey-market source, dose errors are the real risk.
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Oral minoxidil and finasteride on TRT
This is the most searched pairing for a reason. The two drugs work on different parts of the problem. Finasteride stops testosterone being converted to DHT: 1 mg cut scalp DHT by 64.1% and serum DHT by 71.4% (Drake et al., 1999). Minoxidil ignores androgens and pushes the follicle to grow. One removes the brake, the other presses the accelerator.
On TRT, the main worry with finasteride is whether blocking DHT costs you muscle. In a 52-week randomised trial of hypogonadal men aged 60 and over on testosterone enanthate 125 mg a week, adding finasteride 5 mg did not change the gains in strength, fat-free mass or bone density (Borst et al., 2014). The authors call that testosterone dose higher than replacement, but it is nowhere near a blast, and the 1 mg hair dose suppresses DHT slightly less than the 5 mg used here.
Does the combination beat either drug alone? For topical minoxidil plus finasteride, a meta-analysis of five trials found better photographic scores than either alone, but no clear difference in hair density (Chen et al., 2020). For oral minoxidil 2.5 mg plus finasteride 1 mg, the only data is a retrospective review of 502 men from a UK telehealth service: 92.4% were stable or improved at 12 months, with no control group, and the authors work for the service (Johnson et al., 2025). Reasonable logic, thin proof.
Which hair-loss drug fits your stack?
Pick by which androgen is doing the damage, not by which drug ranks highest. Work through these in order:
- Testosterone only (TRT or a test-only cycle). Finasteride targets the actual mechanism. If 1 mg is not enough, dutasteride 0.5 mg (off-label for hair in most countries) cut serum DHT by about 95% versus 71% for finasteride 5 mg in men with enlarged prostates (Clark et al., 2004) and beat finasteride 1 mg on hair counts at 24 weeks (Gubelin Harcha et al., 2014). Minoxidil is the add-on.
- Your stack includes Masteron, Primobolan, Anavar or Winstrol. These are already DHT-derived and do not need 5α-reductase, so finasteride can only reduce the DHT coming from your testosterone base. Minoxidil still works on the rest. Our Masteron article covers this in more detail.
- Your stack includes nandrolone. Skip finasteride. 5α-reductase turns nandrolone into a weaker androgen, DHN, in rat and cell studies, which may be why nandrolone has a reputation for being kinder to the scalp (Bergink et al., 1985; Kicman, 2008). Block that step and more of the strong parent hormone reaches the follicle. No human trial has tested this, but the chemistry points one way. Minoxidil is the cleaner choice.
- You have had sexual side effects on finasteride, or you are scared of them. The pooled risk of erectile dysfunction is about doubled versus placebo (number needed to harm about 82) (Mella et al., 2010), and expectation alone raises reporting. Minoxidil first, topical before oral.
- Your resting heart rate is already above about 80, or your blood pressure is already high on cycle. Fix that first. Topical minoxidil or a 5α-reductase inhibitor, not oral minoxidil.
Ankle swelling: minoxidil, estradiol or sodium?
On a cycle, puffy ankles can have three sources, and the fix is different for each. No study has compared them head to head, so this is a working method, not a validated test:
| Clue | Minoxidil | High estradiol | High sodium intake |
|---|---|---|---|
| Timing | Weeks 4 to 12 after starting, or after a dose increase | After adding an aromatising compound or raising test | After a salty day or a diet change |
| Blood pressure | Flat or slightly lower | Up | Up |
| Resting heart rate | Up a few bpm | Usually unchanged | Unchanged |
| Other signs | Puffy eyelids on waking, new body hair | Nipple sensitivity, bloat, mood changes | Settles within two to three days |
| What helps | Lower dose or stop; talk to your doctor | Adjust the estradiol plan using bloodwork | Cut sodium |
The tell for minoxidil is swelling with a flat or falling blood pressure and a rising resting heart rate. Estradiol and sodium oedema usually come with blood pressure going up. If you are not sure, check sodium, potassium and estradiol at your next blood test, and see our guide to high estradiol on TRT.
What if my resting heart rate goes from 62 to 75?
That is +13 bpm, larger than the +8.7 bpm average rise from untreated baseline seen at 7.5 mg in the 11-man Holter study. It is not dangerous on its own, but it is more than the typical response, so treat it as a signal:
- Re-measure at the same time each morning for a week before deciding anything. Training, caffeine, sleep and a recent cycle change all move resting heart rate.
- If it stays up, drop back to the previous dose. Most of the hair benefit comes from the first few milligrams.
- If it comes with palpitations, breathlessness, chest pain, or swelling that spreads beyond the ankles, stop and see a doctor promptly.
- A beta blocker blunts the reflex, and the consensus allows one with specialist input (Akiska et al., 2025). Do not add nebivolol yourself to keep a hair drug going.
When will VDPHL01 be available?
Not soon. Veradermics' SEC filings say it plans to file a 505(b)(2) application with the FDA after its pivotal studies finish, but none gives a filing date (Veradermics 10-K, 2025). An "early 2027" filing has been reported secondhand, not by the company in its filings. Add a standard review of about 10 to 12 months and US approval in 2028 is a realistic earliest guess, if it is approved at all. Australia and other markets would come later.
The women's trial, Study 306 (556 women, 4.5 mg QD and BID), finished enrolling in August 2026 and is due to report in the first half of 2027.
Anything sold online as "VDPHL01" before then is not VDPHL01. The extended-release formulation is the whole product, and nobody can copy it from a press release.
What to log before and after you start
Whether it is generic oral minoxidil now or VDPHL01 later, the data is cheap to collect:
- Baseline for one to two weeks before starting: morning resting heart rate, seated systolic and diastolic blood pressure, and morning bodyweight.
- Days 1 to 7: watch for lightheadedness and a racing or irregular heartbeat. The consensus counsels people to watch for these for at least three to seven days (Akiska et al., 2025).
- Weeks 4 to 12: watch for ankle and eyelid swelling and creeping weight. Fluid retention typically shows up within 1 to 3 months, most often around month 2 (Jimenez-Cauhe et al., 2025).
- Every dose change: repeat steps 2 and 3. Log the date and dose so you can line it up against your numbers.
- Your normal bloodwork: keep running haematocrit, estradiol, eGFR, sodium and potassium on your usual schedule. Minoxidil does not raise haematocrit, but if you are retaining water, a slightly lower reading may be dilution, not a fix.
VitalMetrics' practical thresholds, not consensus figures: a sustained resting heart rate rise of 10 bpm or more over your baseline, or morning weight up more than 2 kg in a week without a diet change, means reduce the dose and talk to your doctor. If your blood pressure is already the bigger problem, our on-cycle blood pressure guide comes first.
Take your resting heart rate before you get out of bed, before coffee, at the same time each day. A smartwatch average is fine for spotting trends, but stick to one device, because switching can shift the reading by several bpm.
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Practical recommendations
- If you are on TRT with early thinning: finasteride 1 mg remains the first move, and the evidence says it will not cost you muscle at TRT doses. Add minoxidil, topical first, if you need more. Our TRT hair loss guide covers the full protocol.
- If you run DHT-derived compounds or nandrolone: minoxidil carries more of the load because finasteride cannot reach those compounds, and with nandrolone it may make things worse.
- If you want oral minoxidil now: generic at 2.5 mg is the consensus starting dose for men, through a doctor and a normal pharmacy, with the logging above. Avoid compounded or grey-market capsules.
- If you are waiting for VDPHL01: the case for it is tolerability, especially less body hair, more than extra regrowth. Wait for the peer-reviewed paper and the heart rate data before treating it as the safer option.
Log your heart rate, blood pressure and bloodwork in one place
Track resting heart rate, blood pressure, estradiol and haematocrit alongside every compound and dose change, so you can see what a new drug is doing.
Try it FreeKey takeaways
- VDPHL01 added 22.0 (once daily) and 29.9 (twice daily) hairs/cm² over placebo at six months in Study 304, about 15 to 21% more hair in the counted area.
- That looks broadly comparable to oral finasteride, but the endpoints differ, there is no head-to-head trial, and there is no peer-reviewed paper yet.
- Men on hormone therapy in the previous six months were excluded, so TRT and AAS users were very likely not studied.
- No heart rate or blood pressure numbers have been released, only a statement that there were no clinically significant differences.
- Oral minoxidil mainly raises resting heart rate (72.6 to 81.3 bpm from untreated baseline at 7.5 mg, in 11 men) rather than lowering blood pressure at hair-loss doses.
- Finasteride does not touch DHT-derived steroids and may worsen nandrolone's effect on the scalp. Minoxidil works regardless of the androgen.
- VDPHL01 is not approved and has no announced filing date. Realistic US availability is 2028 at the earliest.

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References
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- Sanabria, B. D., Perdomo, Y. C., Miot, H. A., & Ramos, P. M. (2024). Oral minoxidil 7.5 mg for hair loss increases heart rate with no change in blood pressure in 24 h Holter and 24 h ambulatory blood pressure monitoring. Anais Brasileiros de Dermatologia, 99(5), 734-736. PubMed
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- Vañó-Galván, S., Pirmez, R., Hermosa-Gelbard, A., et al. (2021). Safety of low-dose oral minoxidil for hair loss: A multicenter study of 1404 patients. Journal of the American Academy of Dermatology, 84(6), 1644-1651. PubMed
- Veradermics, Inc. (2026, October 19). Veradermics oral VDPHL01 achieved early, consistent and robust hair growth in positive Phase 3 304 clinical trial in male pattern hair loss [Press release, SEC Form 8-K Exhibit 99.1]. SEC
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- Veradermics, Inc. (2026). Annual report on Form 10-K for the fiscal year ended December 31, 2025. SEC
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