VDPHL01 & Sublingual Minoxidil: The Next Generation of Hair Loss Treatment

FEATURE – Minoxidil is already one of the best-known hair loss treatments — but a new wave of innovation is on its way: next-generation oral minoxidil (VDPHL01) and sublingual minoxidil (a tablet that dissolves under the tongue). The goal: preserve the recognised benefits of minoxidil while improving consistency of action and, potentially, tolerability. But how solid are these developments, and where do they actually stand?

Table of Contents

1. Why "reinvent" minoxidil?
2. How does minoxidil work? (simplified)
3. VDPHL01: extended-release oral minoxidil
4. What the VDPHL01 data actually shows
5. Sublingual minoxidil: why this route is generating interest
6. The studies: what we already know + what's in progress
7. Safety: the non-negotiable factor
8. Quick comparison (topical vs oral vs sublingual vs VDPHL01)
9. Key takeaways
10. Sources

1. Why "reinvent" minoxidil?

Minoxidil was originally developed as a cardiovascular drug. Its most famous "side effect": stimulating hair growth. That discovery led to its use in dermatology, primarily in topical form (foam or lotion).

Over recent years, interest has grown in low-dose oral minoxidil, often prescribed off-label in certain countries. The appeal is straightforward: it can be easier to stick to than daily scalp application, which sometimes improves adherence.

But classic oral minoxidil has one key limitation: it acts throughout the body, not just on the scalp. Depending on the dose and the patient's profile, certain side effects can emerge — more on that below.

2. How does minoxidil work? (simplified)

In plain terms: minoxidil helps certain follicles stay in their growth phase longer (the anagen phase), and can gradually improve both density and hair thickness.

Biologically, several mechanisms are at play, notably:

• action via potassium channels (often described as a "signal" that promotes follicle activity),
• indirect effects on pathways linked to growth (broadly referred to as "pro-growth signals").

Important: minoxidil does not "create" follicles where they no longer exist. It works primarily on follicles that are still present — even if miniaturised.

3. VDPHL01: extended-release oral minoxidil

VDPHL01 is a drug candidate developed as an extended-release version of oral minoxidil. The idea in plain terms: instead of producing a concentration "peak" followed by a drop, the formulation aims to deliver minoxidil more steadily over time.

Why does this matter? Because a more stable profile could:

• provide more consistent exposure at the follicle level,
• and potentially avoid the peaks associated with side effects in some individuals.

At this stage, this is still an active clinical development programme.

4. What the VDPHL01 data actually shows

Preliminary data (Phase 2)

Veradermics, the lab developing VDPHL01, has released preliminary results from a small group of men (Phase 2):

• 21 men receiving VDPHL01 at 8.5 mg twice daily for 4 months,
• average reported increase of +47.3 non-vellus hairs/cm² at 4 months,
• and as early as 2 months: +37.5 non-vellus hairs/cm²,
• 90.5% of participants reported "improved" or "much improved" coverage at 4 months,
• 95% reported increased satisfaction.

Key caveat: these figures are encouraging, but they currently come from a company communication — not a full peer-reviewed publication. That doesn't mean they're wrong — it means they need confirmation through complete, comparative, and ideally published results.

The bigger picture: the randomised trial

The same company has announced a randomised, double-blind, placebo-controlled trial in 519 men, over 52 weeks, testing two dosing regimens (8.5 mg once daily vs twice daily). This moves from a preliminary "signal" to a more robust protocol designed to generate regulatory-grade data.

5. Sublingual minoxidil: why this route is generating interest

Sublingual minoxidil involves taking a small tablet that dissolves under the tongue.

The theoretical appeal (simplified):

• a different absorption profile compared to standard oral administration,
• a more practical format than topical application,
• and the possibility of a more favourable efficacy/tolerability balance.

Important: sublingual is still a systemic treatment — it doesn't stay "local" to the scalp. The central question therefore remains: measurable efficacy + tolerability.

6. The studies: what we already know + what's in progress

A published study (an interesting scientific signal)

A study published in Clinical and Experimental Dermatology looked at a particularly telling marker: hair fibre diameter. In androgenetic alopecia, follicles tend to produce increasingly fine hair (miniaturisation).

Results at 24 weeks:

• Placebo: –2 µm (average decrease in diameter),
• Sublingual minoxidil (SLM): dose-dependent effect:
  • 0.45 mg: no significant improvement,
  • 1.35 mg: +3 µm,
  • 4.05 mg: +6 µm.

In plain terms: at certain doses, hair became thicker — pointing to less pronounced miniaturisation.

A registered Phase 3 trial: the real-world test

A Phase 3 trial (NCT06924632) is described as a randomised, double-blind, placebo-controlled study testing 2.5 mg sublingual minoxidil twice daily. Primary endpoint: change in non-vellus hair count in a target area at the vertex over 24 weeks (with safety follow-up). Samson Clinical has announced that enrolment is complete, with results expected mid-2026.

7. Safety: the non-negotiable factor

Because both oral and sublingual routes are systemic, safety must remain front of mind. Published literature and dermatology expert consensus describe low-dose oral minoxidil as increasingly used off-label, with recommendations for caution (patient profile, contraindications, monitoring). Reported side effects in the literature include:

• hypertrichosis (unwanted hair growth) — dose-dependent,
• oedema (swelling),
• palpitations/tachycardia in some cases,
• and more rarely, serious complications (particularly in at-risk profiles).

The right approach: never self-prescribe. These treatments should always be discussed with a healthcare professional, especially in the presence of cardiovascular, renal, or other concurrent conditions.

8. Quick comparison

9. Key takeaways

• VDPHL01 aims to "stabilise" minoxidil exposure (extended release) and is progressing toward robust trials.
• Preliminary VDPHL01 data reports +47.3 non-vellus hairs/cm² at 4 months (small group, sponsor data).
• Sublingual minoxidil already has a published signal: at certain doses, it can increase hair shaft thickness (dose-dependent effect).
• A Phase 3 sublingual trial is registered and targets a concrete endpoint: non-vellus hair count at 24 weeks.
• Both approaches remain systemic: efficacy matters, but safety and monitoring are paramount.

10. Sources

• Veradermics – VDPHL01 pipeline + preliminary data
• Veradermics – Phase 2/3 press release (519 men, 52 weeks)
• Clinical and Experimental Dermatology – Sublingual minoxidil & hair fibre diameter
• JAMA Dermatology (2025) – Delphi consensus on low-dose oral minoxidil
• Samson Clinical – Phase III enrolment press release
• Clinical trial registry – NCT06924632 (sublingual minoxidil 2.5 mg BID)

Important: if hair loss is rapid, extensive, or unusual, or before starting any systemic treatment, always consult a healthcare professional.