As of 23 October 2026: VDPHL01, a new oral hair loss drug from US company Veradermics, has met its main goals in a second Phase 3 trial, the company says. It is an extended-release minoxidil tablet, and men taking it grew significantly more hair than placebo over six months. It is investigational: not licensed in the UK or US, and it cannot be prescribed here.
The new oral hair loss drug at a glance
- Name: VDPHL01, a once- or twice-daily extended-release minoxidil tablet made by Veradermics (New Haven, USA).
- Latest news: Study 304, a Phase 3 trial in 536 men with mild-to-moderate pattern hair loss, met all of its primary and secondary goals, according to the company (announced 19 October 2026).
- Result: after six months, hair count rose by 28.6 (once daily) and 36.4 (twice daily) hairs per cm², compared with 6.6 hairs per cm² on placebo.
- Side effects: ankle or leg swelling in 2.8–4.5% of men and unwanted body hair in 2.2–9.0%, with no treatment-related serious side effects reported over six months.
- UK status: not licensed by the MHRA, not available, and no UK application has been announced.
In this article
- What Is the New Oral Hair Loss Drug?
- What Did the Phase 3 Trial Show?
- What Side Effects Did the New Oral Hair Loss Pill Cause?
- How Is It Different From Current Oral Hair Loss Treatments?
- Will the New Oral Hair Loss Drug Be Available in the UK?
- What Can UK Men With Hair Loss Do Now?
- What Happens Next?
- Frequently Asked Questions
- Sources
What Is the New Oral Hair Loss Drug?
The new oral hair loss drug making headlines is VDPHL01, an extended-release tablet form of minoxidil developed specifically for pattern hair loss. On 19 October 2026, Reuters reported that it boosted hair growth in a late-stage study, after Veradermics released topline (early headline) results from its second male Phase 3 trial, Study 304.
Minoxidil itself is not new. It has been used as a scalp solution for decades, and as a tablet for severe high blood pressure since the 1970s. What is new is the formulation: a gel matrix that releases minoxidil slowly over the day. Veradermics says this avoids the sharp peaks in blood levels seen with standard immediate-release tablets, while keeping levels above the threshold it believes is needed for hair growth.
VDPHL01 is non-hormonal. Unlike finasteride, a licensed hair loss tablet, it does not work by blocking the hormone DHT.
Why is this news now?
Much of the coverage you may have seen earlier this year, including widely shared “up to 86%” headlines, was about the first male trial, Study 302, which reported in April 2026. Study 304 is a separate trial in a separate group of men, and its results line up closely with the first. Regulators such as the FDA generally expect consistent results from more than one well-controlled trial, so a second positive study is an important step.
Who makes it?
Veradermics is a US biotech company based in New Haven, Connecticut, founded by dermatologists Reid Waldman and Tim Durso. It listed on the New York Stock Exchange in February 2026 (ticker: MANE). VDPHL01 is its lead product. The company describes it as a potential first non-hormonal oral hair loss treatment to be approved by the US Food and Drug Administration (FDA).
What Did the Phase 3 Trial Show?
Study 304 (NCT06972264) is a randomised, double-blind, placebo-controlled trial. It enrolled 536 men aged 18 to 65 with mild-to-moderate pattern hair loss, all at US sites. Men took VDPHL01 8.5 mg once daily, 8.5 mg twice daily, or a placebo. The results published so far cover only the first six months (Part A). In the second six months, everyone receives the active drug.
Hair count at six months
The trial measured the change in the number of non-vellus hairs (thicker, visible hairs rather than fine “peach fuzz”) in a marked area of the scalp.
- Once daily: +28.6 hairs per cm²
- Twice daily: +36.4 hairs per cm²
- Placebo: +6.6 hairs per cm²
Both doses beat placebo with high statistical significance (p<0.0001), meaning the results are very unlikely to be due to chance. The difference from placebo was already statistically significant at month two, the earliest point measured.
What the “85%” figure actually means
You may see headlines saying up to 85% of men improved. That figure does not mean 85% of lost hair grew back. It is the share of men who reported any improvement in their hair coverage on a questionnaire, compared with 35.3% of men on placebo.
The stricter measure, and one of the trial’s two main endpoints, was the share of men who rated their hair as “improved” or “much improved”:
- Once daily: 55.7%
- Twice daily: 68.7%
- Placebo: 15.0%
Trial investigators also rated 78.4% (once daily) and 82.7% (twice daily) of men as having improved hair coverage. The company has not published the placebo figure for this measure.
How the two Phase 3 trials compare
The two trials (Study 302 was a combined Phase 2/3 trial) used the same doses and a similar design, and produced similar results:
| Six-month result | Study 304 (Oct 2026) | Study 302 (Apr 2026) |
|---|---|---|
| Men enrolled | 536 | 519 |
| Hair count change, once daily | +28.6 hairs/cm² | +30.3 hairs/cm² |
| Hair count change, twice daily | +36.4 hairs/cm² | +33.0 hairs/cm² |
| Hair count change, placebo | +6.6 hairs/cm² | +7.3 hairs/cm² |
| “Improved” or “much improved”, once / twice daily | 55.7% / 68.7% | 48.4% / 62.9% |
| “Improved” or “much improved”, placebo | 15.0% | 13.4% |
These are topline figures from the company’s press release. They have not yet been peer-reviewed or presented in full at a medical conference.
What Side Effects Did the New Oral Hair Loss Pill Cause?
Veradermics said VDPHL01 was generally well tolerated over six months, with no treatment-related serious adverse events and no adverse events of special interest of cardiac origin. The company highlighted two side effects in Study 304:
| Side effect | Once daily | Twice daily | Placebo |
|---|---|---|---|
| Swelling of the legs or ankles (peripheral oedema) | 2.8% | 4.5% | 0.6% |
| Unwanted body or facial hair (hypertrichosis) | 2.2% | 9.0% | 0% |
A small number of men on the twice-daily dose (0.6% for each side effect) stopped treatment because of swelling or unwanted hair growth.
What we still don’t know
- Longer-term safety. These are six-month results. Twelve-month data from Study 302 are expected later in 2026.
- Heart and blood pressure detail. The company has not yet published blood pressure, heart rate, dizziness or overall dropout figures.
- Real-world use. Trials exclude many people, including men with uncontrolled blood pressure and certain heart or thyroid conditions. Results in everyday practice may differ.
Minoxidil tablets can cause side effects, including unwanted body and facial hair, fluid retention and ankle swelling, a fast heartbeat, dizziness or low blood pressure, headaches and temporary hair shedding. Fluid around the heart (pericardial effusion) can be serious; it was reported in about 3–5% of people taking minoxidil tablets for severe high blood pressure, according to the product information. Minoxidil tablets are not suitable for everyone, particularly people with heart conditions or those taking blood pressure medicines, and they are not recommended in pregnancy. Any benefit to hair stops when treatment stops. Any oral minoxidil product needs a proper medical assessment first.
How Is It Different From Current Oral Hair Loss Treatments?
In the UK, finasteride 1 mg is the tablet licensed for male pattern hair loss. Minoxidil tablets are licensed only for severe high blood pressure, although some prescribers use low doses for hair loss off-label after an individual assessment. No trial has compared VDPHL01 directly with either, so there is no evidence yet that the new drug works better than existing oral treatments.
Immediate-release minoxidil tablets (off-label)
VDPHL01 contains the same active ingredient as the minoxidil tablets some UK prescribers already use for hair loss. In the UK, minoxidil tablets are licensed only to treat severe high blood pressure. Using them for hair loss is “off-label”, meaning the prescriber takes clinical responsibility for using a medicine outside its licence after an individual assessment. The British Association of Dermatologists lists low-dose oral minoxidil under “other” treatments, separately from the licensed options, because it is not licensed for hair loss.
Standard minoxidil tablets release the drug quickly. According to Veradermics, blood levels peak within about an hour and largely clear within four hours. For hair loss, prescribers who use these immediate-release tablets off-label generally use low doses of up to 5 mg a day, as described in an international expert consensus. VDPHL01 is being tested at a higher 8.5 mg dose for men, released slowly over the day. Taken twice daily, that is 17 mg a day in total. Veradermics says this design keeps peak levels lower while extending the time the drug stays active, but full blood-level and blood pressure data from the Phase 3 trials have not been published.
The evidence for standard low-dose oral minoxidil is smaller but growing. A 2024 randomised trial in JAMA Dermatology found 5 mg oral minoxidil was not superior to 5% topical minoxidil overall, and unwanted hair growth affected 49% of men on the tablet. Two 2025 meta-analyses also found no significant difference in hair density between oral and topical minoxidil.
If the FDA approves it, VDPHL01 would be the first oral minoxidil product approved specifically for hair loss in the US. That would not make it licensed in the UK.
Finasteride tablets (licensed)
Finasteride 1 mg is a prescription-only medicine licensed in the UK for male pattern hair loss in men. It works differently from minoxidil, by reducing levels of the hormone DHT. The British Association of Dermatologists notes it can take up to 14 months to show a benefit.
The MHRA warns that finasteride can cause depression and suicidal thoughts, and sexual side effects, such as reduced sex drive and erection problems, that may continue after stopping. In May 2026 it added that sexual problems may contribute to mood changes. Anyone taking finasteride who develops low mood or suicidal thoughts should stop taking it and seek medical advice straight away. Finasteride packs include a patient alert card. Finasteride 1 mg is not for use by women. Our finasteride vs minoxidil guide explains how the two compare.
Will the New Oral Hair Loss Drug Be Available in the UK?
Not yet, and there is no confirmed date. VDPHL01 is an investigational medicine. It has no marketing authorisation from the UK’s Medicines and Healthcare products Regulatory Agency (MHRA) or the US FDA, and it can currently only be taken within a clinical trial. All of the trials have been run in the US.
The regulatory route: FDA first
Veradermics has said it plans to apply to the FDA through a 505(b)(2) New Drug Application, a route for new versions of existing medicines. It has not announced a filing date. Under the FDA’s standard timetable, a decision on this type of application is usually due about 10 months after it is submitted. The company has announced no plans to apply to the MHRA or to European regulators.
If VDPHL01 is approved in the US, the company would still need to apply separately for a UK licence. The MHRA’s International Recognition Procedure can speed this up for medicines already approved by trusted regulators such as the FDA, but only if the company chooses to apply.
A realistic timeline
Our estimate, not a company forecast, is that a US decision is unlikely before late 2027, and UK availability would come after that, if at all. Any dates you see online beyond what Veradermics has officially said are speculation.
Why you shouldn’t buy “VDPHL01” online
VDPHL01 is not on sale anywhere. Anything advertised online as VDPHL01, or as an equivalent, is not the trial medicine and comes from an unregulated source. Buying prescription-strength minoxidil without an assessment also carries real risk, particularly if you have a heart condition, low blood pressure or take blood pressure medicines.
What Can UK Men With Hair Loss Do Now?
Pattern hair loss tends to progress gradually. Whatever happens with the new oral hair loss drug, if hair loss is bothering you now, it is worth getting it properly assessed.
- Get the cause confirmed. Not all thinning is male pattern hair loss. Thyroid problems, low iron, stress and some medicines can all cause hair loss. Our guide to male pattern baldness explains the typical signs.
- Know the licensed options. In the UK, 5% topical minoxidil is licensed and available from pharmacies without a prescription. Finasteride 1 mg tablets are a prescription-only medicine licensed for men (see the safety warnings above).
- Set realistic expectations. Treatments usually take 6 to 12 months to show results (finasteride can take up to 14 months), can cause temporary shedding early on, and only work while you keep using them.
- Talk to a professional. A GP, pharmacist or UK-registered prescriber can check whether a treatment is suitable, taking your health and other medicines into account.
- Report side effects. If you think a medicine has caused a side effect, report it through the MHRA’s Yellow Card scheme.
What Happens Next?
- Later in 2026: 12-month results from Study 302, giving the first longer-term safety data in men.
- First half of 2027: results from Study 306, a trial of a 4.5 mg dose in 556 women.
- To be confirmed: a US FDA application. Veradermics has not given a date.
VDPHL01 is not the only new hair loss drug in development. Others include clascoterone, a topical anti-androgen solution being developed by Cosmo Pharmaceuticals, and PP405, a topical treatment from Pelage Pharmaceuticals. Neither is licensed for hair loss in the UK or the US.
We will update this article as new results and regulatory news are published.
Frequently Asked Questions
What is the new oral hair loss drug?
The new oral hair loss drug in the news is VDPHL01, an extended-release minoxidil tablet developed by US company Veradermics for pattern hair loss. It met its goals in a second Phase 3 trial in October 2026, but it is not yet approved anywhere.
Is the new oral hair loss drug available in the UK?
No. VDPHL01 is an investigational medicine with no marketing authorisation from the MHRA or the US FDA. It can currently only be taken within a clinical trial, and no UK application has been announced.
Will the new oral hair loss pill be approved, and when?
Veradermics plans to apply to the US FDA but has not announced a filing date. In our estimate, not a company forecast, a US decision is unlikely before late 2027. A UK licence would need a separate MHRA application, which has not been announced.
Are any oral hair loss treatments licensed in the UK?
Finasteride 1 mg is licensed in the UK for male pattern hair loss in men and is a prescription-only medicine. The MHRA warns it can cause depression, suicidal thoughts and sexual side effects that may continue after stopping. Minoxidil tablets are licensed only for severe high blood pressure. Using them for hair loss is off-label, and they can cause unwanted hair growth, fluid retention and a fast heartbeat. A prescriber decides whether any treatment is suitable after an assessment.
Is the new oral hair loss drug better than existing tablets?
It is not known. No trial has compared VDPHL01 directly with standard low-dose oral minoxidil or with finasteride. Both Phase 3 trials compared it only with placebo.
What are the side effects of VDPHL01?
Over six months in Study 304, the side effects the company highlighted were leg or ankle swelling (2.8% once daily, 4.5% twice daily, 0.6% placebo) and unwanted body hair (2.2% once daily, 9.0% twice daily, 0% placebo). No treatment-related serious side effects were reported. Longer-term data are still to come.
Did the new hair loss pill regrow 86% of hair?
No. Figures of around 85% refer to the share of men who reported any improvement in hair coverage, not the amount of hair regrown. In Study 304 this was 78.8% (once daily) and 85.0% (twice daily), compared with 35.3% on placebo. On the stricter measure, 55.7% to 68.7% of men rated their hair “improved” or “much improved”, compared with 15.0% on placebo.
Is VDPHL01 hormonal?
No. VDPHL01 is non-hormonal and does not block DHT, unlike finasteride. It has its own possible side effects, including fluid retention and unwanted hair growth.
Does VDPHL01 work for women?
An open-label Phase 2 study in women reported positive results, but it had no placebo group. A larger placebo-controlled trial in 556 women (Study 306) is expected to report in the first half of 2027. Women worried about hair loss should speak to their GP or a pharmacist.
Can I buy VDPHL01 online?
No. VDPHL01 is not approved or on sale anywhere. Anything sold online as VDPHL01 is not the trial medicine and comes from an unregulated source.
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