VDPHL01: the delayed-release oral minoxidil in Phase 3 trials

Behind this code name sits the American laboratory Veradermics, four parallel clinical trials, more than 1,500 patients recruited, and early results that caught the attention of dermatologists at several major conferences. But before drawing conclusions, it helps to understand where this treatment came from, what sets it apart from existing options, and who it is actually for.

Oral minoxidil already exists, and it works

Oral minoxidil is not new. We have dedicated an entire article to oral minoxidil for hair loss. Thousands of dermatologists worldwide already prescribe it in tablet form for hair loss, off-label (without official authorisation). The results are frankly good, better than the classic lotion: the tablet enters the bloodstream directly and reaches all the hair follicles at once, whereas the lotion only penetrates the skin at a rate of 1 to 2%.

The problem with the current tablet? It is an “immediate-release” formulation: it releases all the minoxidil into the bloodstream at once. A massive spike, then nothing. Effective for hair, but this spike causes the cardiovascular side effects. That is precisely where VDPHL01 differs. First, the figures for the standard tablet.

Results of the standard tablet (immediate release)

In men with androgenetic alopecia, oral minoxidil at 5 mg/day increases hair transplant density per cm2 from 153 to 188 hairs/cm2 in 24 weeks. There is a dose effect: each additional milligram adds roughly 47 hairs/cm2.

In women, the doses are lower (0.5 to 2.5 mg/day), but the results hold up well: an average increase of 32 hairs/cm2, and a 38% increase in frontal density in some studies. For women with diffuse hair loss or postmenopausal alopecia, it is one of the only oral options, since finasteride is contraindicated in women of childbearing age.

So if it works so well, why has it never been approved?

The downside

Because minoxidil is a cardiovascular medication, and when taken orally, it does more than promote hair growth. It opens all the blood vessels in the body. The side effects increase with the dose.

First, there is hypertrichosis, meaning excessive hair growth in areas other than the head (face, arms, back). It affects 29% of patients at low doses and climbs to 87% at high doses. Women are more susceptible: 31% compared to 24% at equivalent doses. For a treatment meant to solve a cosmetic problem, that is quite a paradox. On the cardiac side: 4% of cardiovascular events occur at low doses, but 34% at high doses. These include ankle oedema, palpitations, and ECG abnormalities. Rare cases of pericardial effusion (fluid accumulating around the heart) have been documented, particularly in patients with kidney problems.

And the core issue: no FDA approval for hair loss. Everything is done off-label. Each dermatologist prescribes their own dose, with their own monitoring protocol. No standard, no regulatory safety net.

This is what VDPHL01 aims to change.

VDPHL01: the same molecule, different release profile

Classic oral minoxidil (immediate-release) releases everything at once. The blood receives a massive surge of vasodilator, the heart and blood vessels absorb it, then the concentration drops quickly. Effective for hair, but this surge causes the cardiovascular effects.

VDPHL01 is still minoxidil. Not a new molecule. But it is encapsulated in a sustained-release gel matrix that dissolves gradually in the stomach. Instead of a sudden surge followed by a rapid drop, the product is released steadily over several hours.

What this means in practice: fewer spikes, less stress on the heart and blood vessels. And because minoxidil remains above the threshold needed to stimulate follicles for longer, regrowth should be at least as good, possibly better.

To put it simply: the classic tablet is like a tap turned on full blast and then turned off. VDPHL01 is like a steady drip. Same amount of water, but the garden is watered more evenly.

That is Veradermics’s bet. To test it, they launched four parallel clinical trials.

Four parallel clinical trials

The VDPHL01 development programme covers four studies running simultaneously, on men and women. This kind of broad programme is rare among new hair loss treatments currently in development.

The two main studies

The first, Study 302, is a Phase 2/3 trial involving 360 men aged 18 to 55 with mild to moderate androgenetic alopecia (Norwood stages II to V). Three groups: 5 mg, 10 mg, and placebo. The trial lasted 52 weeks and is determining the optimal dosage. Results are expected in the first half of 2026.

The second, Study 304, is the real test. This Phase 3 trial involves 536 men, with a dose of 8.5 mg administered once or twice daily versus placebo. This is the study that will form the basis of the FDA application. Recruitment was completed by the end of 2025, and results are expected in the second half of 2026.

In total, roughly 1,000 men are participating in the Phase 3 trials. That is enough to detect rare side effects.

The study on women

This may well be the most important part. Veradermics has launched the very first Phase 3 trial of an oral treatment for female pattern baldness. More than 500 women were recruited in the United States.

Why does this matter? Because right now, no oral treatment is FDA-approved for female pattern baldness. None. Women with hair loss only have topical minoxidil as an approved option. Other treatments such as spironolactone for hair loss remain off-label. VDPHL01 would be the first. Nothing else has reached this stage in over 40 years of hair loss research.

What the initial results show

The Phase 2 data comes from a small group of 21 men treated with 8.5 mg twice daily for 4 months. A modest sample, but the numbers are worth noting:

• +47.3 hairs/cm2 on average. For comparison, standard oral minoxidil at 5 mg produces roughly +35 hairs/cm2 over 6 months. VDPHL01 produced more regrowth, and it did so faster.
• 95% of participants reported being satisfied with their hair density.
• Zero cardiac events reported.
• Visible regrowth from the 2nd month of treatment.

21 patients is not enough for definitive conclusions. But the cardiac safety signal is encouraging. If the Phase 3 studies confirm the absence of cardiovascular effects across 1,500 patients, it will change how oral minoxidil is prescribed.

So what does that change in practice?

If VDPHL01 receives FDA approval, the implications go well beyond one pill.

For men: finally, a regulated oral treatment, with a standardised dosage and a safety profile validated by large-scale trials. No more haphazard prescriptions. It could also be combined with finasteride (which acts on DHT) to tackle hair loss on two fronts: blocking the hormone that miniaturises follicles while simultaneously stimulating regrowth. Understanding the reasons for hair transplant helps patients see where medical treatment fits alongside surgery.

For women: where there was only a lotion, there would be a tablet. Non-hormonal, which matters greatly. Women with female pattern baldness would finally have a serious oral option.

For hair transplants: VDPHL01 would not replace hair transplantation. It would strengthen it. The logic is straightforward: medical treatment stabilises hair loss and thickens weakened areas, while FUE DHI hybrid hair transplant restores bald patches. The two approaches work together rather than against each other. A patient using VDPHL01 before and after their transplant could achieve better results than either approach on its own. Those wondering whether they qualify should first check their hair transplant candidacy.

The timeline

Phase 3 results expected in 2026. FDA application submission planned for early 2027. Approval possible in late 2027 or early 2028. This remains conditional. But the timeline is plausible.

In the meantime, what can be done?

VDPHL01 is promising. But it is not available yet. If you are losing your hair today, options already exist.

Topical minoxidil remains effective, even if consistent daily application is where many patients struggle. Finasteride (in men) blocks DHT, the hormone responsible for follicle miniaturisation. Addressing stress related hair loss or diet for hair loss can also make a meaningful difference. In-clinic treatments such as PRP, exosomes, mesotherapy, or laser can stimulate regrowth without surgery. Some patients explore complementary options like best hair growth products or best oils for hair growth.

When hair loss has already created bald patches, a hair transplant in Turkey remains the gold standard for restoring natural hair. Dr Emrah Cinik combines hair transplant techniques and innovations with medical treatments in each protocol: PRP treatment is included in all procedures, and a follow-up plan tailored to the patient’s profile is put in place to maintain results over time. Patients benefit from a clear hair transplant healing time roadmap from day one.

More than 50,000 patients in 20 years. Before/after results and month-by-month progress are available to view. A free consultation allows the team to assess your situation and recommend a treatment plan, whether medical, surgical, or both. No obligation.

Scientific references

Gupta, A. K., Venkataraman, M., Engel, J., & Hall, D. C. (2024). Low-dose oral minoxidil for alopecia: a comprehensive review. Skin Appendage Disorders, 10(1), 1-12. https://pmc.ncbi.nlm.nih.gov/articles/PMC10806356/

Jimenez-Cauhe, J., Saceda-Corralo, D., Rodrigues-Barata, R., Moreno-Arrones, O. M., & Vano-Galvan, S. (2020). Efficacy and safety of oral minoxidil 5 mg once daily in the treatment of male patients with androgenetic alopecia. Journal of the American Academy of Dermatology, 82(2), 507-508. https://pmc.ncbi.nlm.nih.gov/articles/PMC7649170/

Pirmez, R., Salas-Callo, C. I., & Abraham, L. S. (2020). Low-dose oral minoxidil for female pattern hair loss: a unicenter descriptive study of 148 women. Journal of the American Academy of Dermatology, 82(6), 1468-1470. https://pmc.ncbi.nlm.nih.gov/articles/PMC7325226/

Randolph, M., & Tosti, A. (2021). Role of oral minoxidil in patterned hair loss. Indian Journal of Dermatology, 67(5), 489-495. https://pmc.ncbi.nlm.nih.gov/articles/PMC9650732/

Sharma, A., & Patil, R. (2022). There is a positive dose-dependent association between low-dose oral minoxidil and its efficacy for androgenetic alopecia. Skin Appendage Disorders, 8(5), 415-421. https://pmc.ncbi.nlm.nih.gov/articles/PMC9485924/

Shih, A. F., & Gupta, A. K. (2023). Safety and tolerability of low dose oral minoxidil monotherapy in female pattern hair loss. Journal of the American Academy of Dermatology, 89(4), 810-812. https://pmc.ncbi.nlm.nih.gov/articles/PMC10483043/