on February 26, 2026
Understanding the Basics: What Is VDPHL01?
VDPHL01 is an investigational extended-release (ER) oral formulation of minoxidil being developed by Veradermics, Inc., a dermatology-focused biopharmaceutical company. It's designed to be a safer, smoother, and more effective oral version of minoxidil - a well-known medication used to stimulate hair growth.
If you've ever heard of topical minoxidil (commonly known by brand names like Rogaine®), you already know the molecule. The key difference is in how VDPHL01 delivers it: slowly, steadily, and purposefully, using modern delivery science to avoid the side effects and dosing challenges that have limited oral minoxidil’s widespread adoption.
As of early 2026, VDPHL01 is in Phase 3 clinical trials, meaning it’s in the final stage of testing before potential FDA approval. It is not yet approved or available for sale, but is being closely watched by dermatologists worldwide.
Who Is Behind VDPHL01?
A Dermatology-Driven Biotech Startup
Founded in 2019, Veradermics is a New Haven, Connecticut–based biopharmaceutical company built by dermatologists and life science entrepreneurs. Its mission: to develop “purpose-built” therapies for common but underserved conditions - like pattern hair loss - that have seen little innovation for decades.
Investor Confidence and Clinical Ambition
Veradermics has rapidly attracted serious attention from the investment world. In 2025, it completed a Series C funding round with participation from leading firms like Viking Global Investors, SR One, and Wellington Management, raising over $150 million to advance VDPHL01’s registration trials. The company filed for an IPO on the New York Stock Exchange under the ticker symbol “MANE”, reflecting the hair-focused nature of its pipeline.
Why Does VDPHL01 Exist?
To understand why VDPHL01 matters, it helps to look at the problems with existing treatments for pattern hair loss (also known as androgenetic alopecia).
Topical Minoxidil: Messy, Irritating, and Inconsistent
Topical minoxidil is the most widely used hair loss medication in the world. However, despite decades of availability, up to 86% of users quit within a year. Why? Because it’s messy, can irritate the scalp, and requires twice-daily application.
Even more frustratingly, some people are “non-responders” — meaning their scalp doesn’t convert minoxidil into its active form efficiently, making the product ineffective.
Immediate-Release Oral Minoxidil: Off-Label and Unstable
In recent years, dermatologists have started prescribing low-dose oral minoxidil (LDOM) off-label. Many patients prefer it because it’s convenient and avoids scalp irritation. But there’s a catch: oral minoxidil tablets were originally made for severe hypertension, not hair loss.
That means they release the drug immediately, causing sudden spikes in blood concentration that can lead to heart palpitations, fluid retention, and swelling.
These peaks fade quickly, causing uneven exposure and unpredictable results.
VDPHL01 was developed to solve these issues head-on.
The Science: How VDPHL01 Works
At its core, VDPHL01 is still minoxidil — a vasodilator that works by opening potassium channels in the hair follicle. This action increases blood flow, oxygen, and nutrient delivery, effectively “reawakening” miniaturised hair follicles and helping them return to the active growth (anagen) phase.
But how it’s delivered — and how your body absorbs it — is what sets VDPHL01 apart.
The Role of Potassium Channel Modulation
Minoxidil’s activity depends on how it interacts with K-ATP (ATP-sensitive potassium) channels. When these channels open, the follicle’s cellular environment changes — stimulating growth factors like VEGF and Wnt/β-catenin, both vital for healthy, thick hair regrowth.
Topical solutions can reach only part of the scalp, and their penetration is limited.
Oral formulations, however, deliver the active drug through the bloodstream, ensuring every follicle gets access to the same concentration.
The Gel-Matrix Extended-Release System
The innovation lies in VDPHL01’s gel-matrix extended-release tablet.
Unlike standard pills that dissolve rapidly, this formulation slowly releases minoxidil over time, maintaining a steady level in the bloodstream.
This approach:
- Avoids spikes that trigger side effects
- Sustains therapeutic levels for longer
- Maximises the window for hair follicle stimulation
- Reduces the need for multiple daily doses
In plain terms: instead of your body receiving a quick flood of drugs and then nothing, it receives a gentle, even supply throughout the day — like a drip-feed for your follicles.
Extended-Release vs Immediate-Release: A Plain-English Comparison
| Feature | Immediate-Release Oral Minoxidil | VDPHL01 (Extended-Release) |
| Purpose | Originally for hypertension | Designed for hair growth |
| Drug Delivery | Rapid spike, quick drop | Smooth, sustained release |
| Side Effects | More likely (heart rate, oedema) | Reduced due to steady dosing |
| Hair Growth Window | Short-lived | Prolonged |
| Convenience | Once daily (off-label) | Once or twice daily (optimised) |
| Safety | Requires close monitoring | Engineered for controlled exposure |
This is what dermatologists call a "pharmacokinetic upgrade" - the same molecule, delivered in a way that aligns better with the body's needs.
Clinical Evidence So Far
Phase 2 Results: Rapid, Visible Growth
Veradermics’ Phase 2 study was a head-to-head comparison between VDPHL01, immediate-release oral minoxidil, and topical 5% minoxidil.
After just 4 months, over 82% of participants taking VDPHL01 achieved clinically meaningful improvement in their hair density — four times higher than either comparator group. Participants saw visible regrowth as early as 2 months in, significantly faster than the typical 6–9 month timeline of topical therapy.
Investigators also noted that VDPHL01 had no serious side effects, with no cardiac adverse events reported.
Phase 3: The Final Trials Before Approval
Veradermics is now running three major Phase 3 studies across the U.S. and internationally:
- Men’s Study (NCT06972264) — 519 men with mild-to-moderate pattern hair loss, testing once-daily and twice-daily doses.
- Women’s Study (NCT07146022) — Over 500 women enrolled, marking the first large-scale Phase 3 oral therapy trial for female hair loss.
- Global Validation Study — Designed to confirm consistency and standardise digital hair-density metrics.
These trials are the foundation for the company’s planned U.S. Food and Drug Administration New Drug Application (NDA) under the 505(b)(2) pathway, which allows new formulations of existing drugs to reach approval faster when backed by strong data.
Safety and Tolerability: Designed to Stay Below the “Cardiac Activity Threshold”
High doses of oral minoxidil (up to 100 mg/day, used for blood pressure) can cause tachycardia, fluid retention, and, rarely, pericardial effusion. Even lower off-label doses (2.5–5 mg) can occasionally lead to swelling or lightheadedness in sensitive individuals.
VDPHL01 is formulated to avoid these issues. By maintaining drug levels below the hemodynamic threshold — the concentration at which cardiovascular effects appear — it aims to decouple efficacy from risk.
In trials so far, VDPHL01 has been described as “generally well tolerated”, with most side effects limited to mild hypertrichosis (unwanted hair growth) or temporary dizziness.
That’s a meaningful improvement in both safety and patient confidence.
How Does VDPHL01 Compare to Other Hair Loss Treatments?
Versus Topical Minoxidil
Topical minoxidil depends heavily on scalp enzyme activity to activate the drug. If your body produces low levels of the SULT1A1 enzyme, you might not respond well.
VDPHL01 bypasses this problem entirely — your liver handles the conversion, ensuring activation for all users.
It’s also easier to use: no sticky residue, no scalp irritation, and no daily hassle of applying foam or liquid.
Versus Finasteride and Other Hormonal Options
Finasteride and dutasteride work by blocking DHT, a hormone linked to hair loss.
While effective for men, they can cause sexual side effects and are unsafe for women of childbearing age.
VDPHL01, on the other hand, is non-hormonal — making it suitable for both men and women without affecting hormonal balance.
VDPHL01 vs At-Home “Cosmeceuticals”
The hair care market is filled with shampoos and serums that promise thicker, healthier hair — products like BioScalp DHTI Control Shampoo use peptides and botanical extracts to strengthen hair and reduce shedding.
These work topically, often improving scalp environment and inflammation, but they don’t stimulate new hair follicle growth the way a systemic drug can.
VDPHL01 represents the pharmaceutical-grade counterpart — a clinically tested oral medication designed to treat the root biological cause of follicular miniaturisation.
Think of BioScalp as skincare for your scalp, and VDPHL01 as prescription therapy for your hair.
What Could This Mean for the Future of Hair Restoration?
If the ongoing Phase 3 studies confirm what the early data suggest, VDPHL01 could become the first new oral prescription for hair loss in nearly 30 years. It would also be the first-ever systemic therapy specifically approved for women, opening the door to millions who currently have no safe oral option.
This milestone could reshape the field of hair restoration medicine, influencing everything from transplant aftercare to combination therapy strategies with topical or procedural treatments like microneedling and PRP.
In other words, we’re witnessing a renaissance in hair loss therapeutics — and VDPHL01 is leading the charge.
Frequently Asked Questions
Q1. Is VDPHL01 available to the public?
Not yet. It’s still in Phase 3 clinical trials, meaning it’s not available for prescription or purchase outside of research programs.
Q2. How is VDPHL01 different from oral minoxidil prescribed off-label today?
VDPHL01 uses extended-release technology that provides smoother blood levels and fewer cardiovascular side effects.
Q3. Who can benefit from VDPHL01?
Both men and women with pattern hair loss (androgenetic alopecia) may be candidates once approved.
Q4. What are the most common side effects?
The most frequently reported are mild facial hair growth, lightheadedness, or water retention, typically temporary and dose-dependent.
Q5. Is it safer than finasteride?
Yes — VDPHL01 is non-hormonal, so it doesn’t affect testosterone or DHT pathways, making it suitable for women as well.
Q6. When could it become available?
If Phase 3 results are positive, Veradermics plans to seek FDA approval by late 2026.
Q7. Will it replace topical minoxidil?
Not necessarily. Many dermatologists envision VDPHL01 being used alongside topical or procedural treatments for enhanced regrowth.
Conclusion: The Next Evolution in Hair Regrowth
For decades, hair loss sufferers have faced a frustrating choice: messy topical treatments that barely work or risky oral drugs designed for something else. VDPHL01 could finally change that narrative.
By merging a proven molecule (minoxidil) with modern extended-release technology, Veradermics has created a therapy that may offer the best of both worlds — convenience, safety, and results.
If approved, VDPHL01 could become the first new systemic hair growth medication in three decades, helping millions regain not only their hair but their confidence.
