Oral Minoxidil and VDPHL01: What the New Phase 3 Data Means for Hair Loss
An extended-release minoxidil pill called VDPHL01 just cleared its second large placebo-controlled trial in men, and it could become the first new FDA-approved hair loss pill in nearly 30 years. On October 19, 2026, developer Veradermics reported that men taking it twice daily gained an average of 36.4 hairs per square centimeter in six months, versus 6.6 on placebo.
Phase 3 Study '304'
Average increase in thick hairs per square centimeter of scalp
Source: Veradermics topline results, Oct 19, 2026. VDPHL01 8.5 mg in 536 men with mild-to-moderate pattern hair loss.
That result puts a spotlight on oral minoxidil, a decades-old blood pressure drug that dermatologists already prescribe off-label for thinning hair. Here is what oral minoxidil is, what makes VDPHL01 different, what the new data shows, and what it means if you are dealing with hair loss today.
What is oral minoxidil?
Oral minoxidil is a pill form of the same active ingredient in topical Rogaine. The FDA first approved it in 1979 to treat high blood pressure, and doctors soon noticed a side effect: patients grew more hair. That observation led to the topical foam and solution most people know today.
In recent years, many dermatologists and hair restoration physicians have prescribed low-dose oral minoxidil off-label for pattern hair loss. The doses are a small fraction of what is used for blood pressure. Patients often prefer a daily pill to applying a liquid or foam to the scalp twice a day.
Minoxidil does not block DHT, the hormone behind pattern hair loss. Instead, it is thought to improve blood flow to the follicle and extend the hair's active growth phase. That makes it non-hormonal, so it avoids the sexual side effects some men worry about with finasteride.
The catch is that generic oral minoxidil is an immediate-release tablet built for blood pressure. It spikes in the bloodstream soon after each dose, and those peaks are linked to side effects like a faster heart rate, fluid retention and dizziness. It is also not FDA-approved for hair loss, so there is no labeled dose for that use.
What is VDPHL01?
VDPHL01 is an investigational extended-release minoxidil tablet developed by Veradermics, a dermatologist-founded biotech in New Haven, Connecticut. It is being studied for pattern hair loss (androgenetic alopecia) in both men and women.
The tablet uses a proprietary gel matrix that releases minoxidil slowly over the day. According to Veradermics, this avoids the high peak blood levels of immediate-release minoxidil while keeping the drug above the level needed for hair growth for longer. The goal is better results with fewer side effects, especially cardiac ones.
Type: non-hormonal; it does not change DHT or other hormone levels
Doses studied: 8.5 mg once or twice daily in men; 4.5 mg once or twice daily in women
Status: investigational, not FDA-approved, not available to buy or prescribe
How it works
VDPHL01 keeps hair follicles in their growth phase longer, so hairs that were getting thinner and shorter can grow back thicker and longer. It does this without touching the hormones that cause pattern hair loss.
Pattern hair loss happens when DHT gradually shrinks genetically sensitive follicles, a process called miniaturization. Each growth cycle gets shorter and each hair comes in finer, until the follicle stops producing visible hair. Minoxidil works on the other side of that equation:
It extends the growth (anagen) phase, so each hair grows for longer before it sheds.
It enlarges shrinking follicles, which produces thicker hair shafts.
It improves blood flow around the follicle, as a vasodilator that widens small blood vessels.
Minoxidil also has to be converted into its active form, minoxidil sulfate, by an enzyme. With topical minoxidil, that happens in the scalp, and enzyme levels vary a lot from person to person. That is one reason some people see little from Rogaine. When taken by mouth, minoxidil is activated mainly in the liver, so it can work for people who did not respond to the topical form.
VDPHL01's extended-release design is meant to keep minoxidil above the level needed for hair growth through the day, without the sharp spikes of a standard tablet. According to Veradermics, those spikes are what drive most of the heart-related side effects.
What it can and cannot do
VDPHL01 is a treatment for thinning hair, not a cure for baldness. Set expectations around what the trials actually tested: adults with mild-to-moderate pattern hair loss over six months.
| What it can do | What it cannot do |
|---|---|
| Thicken and lengthen miniaturized hairs | Regrow hair where follicles are already gone (smooth, shiny bald areas) |
| Increase hair count in thinning areas (about 29 to 36 hairs/cm² in trials) | Stop the underlying cause; DHT keeps acting on follicles |
| Slow further thinning while you keep taking it | Keep working after you stop; gains are expected to shed within months |
| Work without changing hormone levels | Restore a lost hairline or fill advanced balding on its own |
| Show measurable results as early as two months | Work the same for everyone; response varies |
The practical takeaway: VDPHL01 is most useful for people whose follicles are still alive but shrinking. Someone with significant bald areas would likely need a transplant to restore density there, with medication helping to protect the remaining hair.
Pill vs. topical minoxidil
Oral and topical minoxidil grow hair about equally well in head-to-head research; the pill's biggest advantage is that people actually keep taking it. VDPHL01 has not been tested directly against topical minoxidil, so the best comparison comes from studies of generic oral minoxidil.
In a 2024 randomized trial in JAMA Dermatology, men took either a 5 mg minoxidil pill once daily or 5% topical minoxidil twice daily for 24 weeks, each with a placebo of the other form. Overall hair density gains were not significantly different. The pill did better on the crown in photo assessments, but not on the front of the scalp. The study was small: 68 of 90 men finished.
| Oral minoxidil | Topical minoxidil | |
|---|---|---|
| Routine | One pill a day (VDPHL01: once or twice) | Liquid or foam on the scalp, twice a day |
| Hair growth | Similar overall; better on the crown in one trial | Similar overall |
| Common side effects | Body hair growth, headache, fluid retention | Scalp itching, flaking, irritation |
| Effect on hair styling | None | Can leave hair greasy or stiff |
| Works for topical non-responders | Often, since it is activated in the liver | No |
| FDA-approved for hair loss | Not yet (VDPHL01 under study; generic is off-label) | Yes |
Why sticking with it matters. Minoxidil only works while you use it, and many people quit the topical form. In one review of 400 patients prescribed topical minoxidil, 86% had stopped, often because of side effects or the hassle. A smaller comparison of 100 men found higher adherence with the pill (90%) than the topical (80%). A treatment that is no stronger on paper can still deliver better real-world results if people stay on it.
Each form has its own trade-offs. In the JAMA trial, the pill caused more unwanted body hair (49% vs. 24%) and headaches (14% vs. 2%). The topical caused more scalp eczema (16% vs. 2%). VDPHL01's slow-release design is meant to reduce the pill's side effects, but it has not been compared head-to-head with generic oral minoxidil either.
The Phase 3 results in men
Study '304' met all of its primary and secondary goals, and its results closely match an earlier trial, Study '302', reported in April 2026. Together the two studies include more than 1,000 men with mild-to-moderate pattern hair loss.
In Study '304', 536 men were randomly assigned to VDPHL01 8.5 mg once daily, 8.5 mg twice daily, or a placebo for six months. Neither patients nor investigators knew who was taking what. The main measures were the change in thick (non-vellus) hairs in a marked scalp area, called target area hair count (TAHC), and whether patients themselves rated their coverage as improved.
| Result at 6 months | Once daily | 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 |
| Men reporting any visible improvement, '304' | 78.8% | 85.0% | 35.3% |
| Men rating hair "improved" or "much improved," '304' | 55.7% | 68.7% | 15.0% |
| Investigators rating coverage improved, '304' | 78.4% | 82.7% | Not reported |
Source: Veradermics topline results, Oct 19, 2026. All VDPHL01 results vs. placebo: p<0.0001.
All VDPHL01 results beat placebo with high statistical significance (p<0.0001). Notably, the drug separated from placebo at Month 2, the earliest point measured. Topical minoxidil usually takes four to six months before people see a change, so an earlier signal matters for patients who give up too soon.
Source: Veradermics press release, Oct 19, 2026
Safety and side effects
Veradermics reported no treatment-related serious adverse events and no cardiac adverse events of special interest in Study '304'. That is the headline safety finding, because heart-related effects are the main concern with oral minoxidil.
The two most common side effects were familiar ones for minoxidil:
Swelling in the legs or ankles (peripheral edema): 2.8% once daily and 4.5% twice daily, versus 0.6% on placebo
Unwanted hair growth elsewhere on the body (hypertrichosis): 2.2% once daily and 9.0% twice daily, versus 0% on placebo
Very few men stopped treatment because of these effects (0.6% or less in any group). The twice-daily dose grew more hair but also caused more body hair, which is a trade-off patients and doctors would weigh.
These are six-month results from company-reported topline data. Longer 12-month safety data from Study '302' is expected later in 2026, and the full picture will come from the FDA's review.
When could it be available?
VDPHL01 is not approved and cannot be prescribed yet. Veradermics says the '302' and '304' studies form the placebo-controlled data package it plans to submit to the FDA for men.
Late 2026: 12-month results from Study '302' (company guidance)
First half of 2027: results from Study '306' in 556 women (company guidance)
Early 2027: FDA application expected, per industry trackers
Late 2027 to early 2028: possible launch if approved, per outside estimates
The last two dates are estimates, not company announcements. A standard FDA review typically takes about 10 to 12 months after a filing is accepted. If approved, VDPHL01 would be the first FDA-approved non-hormonal pill for pattern hair loss, and the first oral treatment approved specifically for women.
How it fits with other hair loss treatments
VDPHL01 would not replace every option; it would add a stronger non-hormonal medication to the toolkit. Medications like minoxidil and finasteride work best at slowing loss and thickening existing, miniaturizing hair. They cannot regrow hair where follicles are already gone.
| Treatment | How it works | Best for | Limits |
|---|---|---|---|
| Topical minoxidil | Non-hormonal; applied to scalp | Early thinning, men and women | Twice-daily routine, slower results |
| Finasteride | Blocks DHT | Slowing loss in men | Sexual side effects in some men; not for women of childbearing age |
| Off-label oral minoxidil | Non-hormonal; immediate-release pill | Patients who prefer a pill | Not FDA-approved for hair loss; peak-related side effects |
| VDPHL01 (if approved) | Non-hormonal; extended-release pill | Mild-to-moderate loss, men and women | Not yet available; long-term data still coming |
| Hair transplant | Moves permanent follicles to thinning areas | Restoring density where hair is gone | Surgical; needs adequate donor hair |
For many people, the best results come from combining approaches. A transplant restores hair in areas that are already bald, while medication helps protect the native hair around it from continued thinning.
If you are losing hair now, there is no reason to wait for a pill that may be a year or more away. Pattern hair loss is progressive, and hair lost today is harder to get back later. A consultation with a hair restoration physician can show where you are on the hair loss scale, which treatments make sense now, and how a future option like VDPHL01 might fit into your plan.
Frequently asked questions
Can I get VDPHL01 now? No. It is an investigational drug available only to people enrolled in clinical trials. Any website selling "VDPHL01" today is not selling the real product.
Is oral minoxidil the same as VDPHL01? They share the same active ingredient, but not the same delivery. Generic oral minoxidil releases the drug all at once; VDPHL01 releases it slowly over the day, which is designed to reduce side effects.
Does oral minoxidil work for women? Veradermics is testing a 4.5 mg dose of VDPHL01 in 556 women in Study '306', with results expected in the first half of 2027. An earlier, smaller Phase 2 study in women was positive.
Will I lose the hair if I stop taking it? Like other minoxidil products, the benefits are expected to last only while you take it. Hair gained from medication generally sheds within months of stopping.
Is VDPHL01 safer than finasteride? They work differently. VDPHL01 is non-hormonal, so it does not carry finasteride's sexual side effects, but it has its own, such as fluid retention and extra body hair. Your doctor can help you weigh the options.
Can I use it after a hair transplant? If approved, it could be used alongside a transplant, much as minoxidil and finasteride are today. Talk to your surgeon about timing after your procedure.
Sources
Veradermics' Oral VDPHL01 Achieved Early, Consistent, and Robust Hair Growth in Positive Phase 3 '304' Clinical Trial, Business Wire, Oct 19, 2026
Veradermics' hot streak continues with another phase 3 win in hair loss, Fierce Pharma, Oct 20, 2026
Oral Minoxidil vs Topical Minoxidil for Male Androgenetic Alopecia: A Randomized Clinical Trial, Penha et al., JAMA Dermatology, 2024
Compliance to Topical Minoxidil and Reasons for Discontinuation among Patients with Androgenetic Alopecia, Dermatology and Therapy, 2023
Comparative study of low-dose oral minoxidil vs. topical minoxidil (5%) in male androgenetic alopecia, Journal of Pakistan Association of Dermatologists
What is VDPHL01?, VDPHL01.com (independent tracker site, not affiliated with Veradermics)
Veradermics, company website
This article is for general information and is not medical advice. VDPHL01 is an investigational drug that has not been approved by the FDA.