Veradermics VDPHL01 Delivers Positive Phase 2 Clinical Trial Results

[jondoeuk]

In female pattern hair loss

Today, the company announced positive topline results from its open-label Phase 2 clinical trial (Study ‘207’) evaluating VDPHL01 in females with mild-to-moderate pattern hair loss. More here.

• • Participants achieved an average increase in non-vellus hair counts of 22.7 hairs/cm² and 23.3 hairs/ cm² in once daily and twice daily VDPHL01 4.5mg treatment arms, respectively. So almost a negligible difference, meaning that once daily treatment will likely be sufficient if these results hold in future trials.
  • 88.9% of participants in the once daily dose arm and 90.0% of participants in the twice daily dose arm achieved ‘improved’ or ‘much improved’ hair coverage. These classifications are based on the Androgenetic Alopecia Impact Rating Scale (AAIRS).
  • There were no treatment-related serious adverse events (SAEs) or adverse events of special interest (AESIs) of cardiac origin. They do not mention anything about the most common side effect of oral minoxidil in the form of hirsutism (excess body hair, especially on the face).
  • The ongoing Study ‘306‘ Phase 2/3 trial evaluating VDPHLO1 in females with pattern hair loss has an anticipated 1H 2027 readout date. Female trial enrollment link.
  • They also mention that the topline results from the ongoing Study ‘304‘ second Phase 3 male trial are anticipated in the second half of 2026. Study ‘302‘ topline results for men were released in April 2026.

 

[bulli103]

there was a studie before, it doesn't works better than 5 mg minoxidil oral, it's only for people who are afraid about sides, and have too much money.....

 

[jondoeuk]

there was a studie before, it doesn't works better than 5 mg minoxidil oral, it's only for people who are afraid about sides, and have too much money.....

It is safer. It looks to be more effective as well.

 

[jondoeuk]

Veradermics announced positive top-line results from Part A of its phase three clinical trial (Study ‘304’). It entailed over 500 males with mild-to-moderate pattern hair loss who took oral VDPHL01 (extended-release oral minoxidil). https://finance.yahoo.com/healthcare/articles/veradermics-phase-iii-hair-loss-170221319.html

In Part A of Study '304', VDPHL01 achieved superior hair growth compared with placebo when it comes to non-vellus Target Area Hair Count (TAHC). After six months, participants achieved an average increase in non-vellus hair count of 28.6 hairs/cm² and 36.4 hairs/cm² in once-daily and twice-daily VDPHL01 treatment arms, respectively. Those receiving placebo showed a 6.6 hairs/cm² increase from baseline at month six.

These results are similar to findings from Study '302' in April 26, 2026. The numbers there were an increase of 30.3 hairs/cm² and 33.0 hairs/cm² in once daily and twice daily VDPHL01 treatment arms. https://www.dermatologytimes.com/vi...air-growth-outcomes-in-male-pattern-hair-loss

It almost looks certain that Veradermics' VDPHL01 and Cosmo Pharmaceuticals' Clascoterone will become the third and fourth hair loss drugs ever approved by the US FDA. After topical Minoxidil (in 1988) and oral Finasteride (in 1997).

 

[jondoeuk]

Also of interest, the Reuters article on this has the following statement about the potential price of VDPHL01: ''The company said Nutrafol, a Unilever-backed hair-growth supplement that costs about $90 a month or about $1,000 a year, is a good price benchmark for its drug.'' https://www.reuters.com/business/he...oost-hair-growth-late-stage-study-2026-10-19/

 

[bulli103]

It is safer. It looks to be more effective as well.

it's not more effective, there are studies out about, also no reason why it should be......minoxidil oral is at the market for more than 50 years, how many deads since then ?... don' t belive everything you read
it's for our hypochondriacs, that's all...

 

[jondoeuk]

it's not more effective, there are studies out about, also no reason why it should be......minoxidil oral is at the market for more than 50 years, how many deads since then ?... don' t belive everything you read
it's for our hypochondriacs, that's all...

I said it looks to be more effective, not that it is.

Standard oral minoxidil dissolves and absorbs quickly, causing a sharp blood concentration spike within about an hour that largely clears within four hours. VDPHL01 slowly dissolves over hours to provide a steady, extended release. VDPHL01 delivers nearly twice the total minoxidil exposure over twelve hours compared to standard doses while keeping plasma levels above the hair growth threshold for far longer.

VDPHL01 blunts peak concentration to stay below cardiac safety thresholds, unlike standard oral minoxidil (that carries a boxed warning). https://pubmed.ncbi.nlm.nih.gov/36117778/ https://pubmed.ncbi.nlm.nih.gov/36267649/ https://pubmed.ncbi.nlm.nih.gov/38598226/

Lowering peak concentrations does not eliminate all systemic side effects. Fluid retention (ankle/leg swelling) and hypertrichosis (unwanted body hair growth) still occur with VDPHL01, but both at a low rate.

 

[bulli103]

if it is like you told, it should be better, but it isn't.....there are even positive studies about rosemary, you shouldn't belife everything you read...
as i wrote, it's for people who are afraid abour sides, i take 10 mg each day since more than 20 years, i know from guys who take 20 mg each day, still now nobody have died from oral minoxidil, sides can happen like always, 1 of 1 million is the unlucky one

 

[jondoeuk]

More positive data. https://www.biospace.com/press-rele...onth-study-302-data-in-male-pattern-hair-loss

''VDPHL01, a novel orally-administered extended-release minoxidil formulation, demonstrated Target Area Hair Count (TAHC) deepening in twice-daily (BID) and maintenance in once-daily (QD) treatment arms with increases in non-vellus hair counts of 43.9 hairs/cm 2 (BID) and 29.7 hairs/cm2 (QD) from baseline at Month 12

12-month long-term data demonstrated consistency of hair growth across patient-reported outcomes (PRO) with 89.1% (BID) and 79.8% (QD) reporting visible improvement and 68.0% (BID) and 48.4% (QD) of participants reporting ‘much improved’ or ‘improved’ hair coverage

Favorable 12-month long-term safety and tolerability profile remained consistent with previously reported data, with no new safety signals and no adverse event-related study discontinuations observed after an additional 6 months of treatment''

 

[RXShopMD_Team]

On the "why bother with a new formulation when oral minoxidil already exists" question, the main argument is pharmacokinetics rather than efficacy:

• Peaks drive the side effects. Immediate-release minoxidil reaches a peak blood level about an hour after the dose. Palpitations, a faster heart rate, ankle swelling and headaches tend to track that peak. An extended-release tablet aims for a lower, flatter curve, so the same daily exposure for the follicle with fewer peak-related effects. Whether that works in practice is what the Phase 3 data need to show.
• Efficacy is not expected to be dramatically higher. bulli103 is right that it is still minoxidil. The realistic win is tolerability and consistency, which matters for people who stopped low-dose oral minoxidil because of side effects.
• Dose context: the low-dose oral minoxidil used off-label for hair is usually 0.625-5 mg a day. 10 mg or more is the range where it is used as a blood pressure drug, and where fluid retention, heart-rate changes and body hair growth become much more common. Anyone at those doses should have blood pressure and heart checks with their doctor.
• Approval matters: if it gets approved, it would be the first oral minoxidil product with a formal hair-loss indication, proper dosing guidance and safety monitoring data.

Disclosure: I am on the editorial team of an online pharmacy, so this is general information, not medical advice.