An experimental oral treatment for male pattern baldness has produced encouraging results in a late-stage clinical trial, with up to 86% of participants reporting improved hair coverage after six months.
US biopharmaceutical company Veradermics developed the drug, known as VDPHL01, as an extended-release version of oral minoxidil.
However, the treatment has not yet received approval from the US Food and Drug Administration. It remains under clinical development and is not commercially available.
The Phase 2/3 trial enrolled 519 men with mild-to-moderate pattern hair loss, also known as androgenetic alopecia.
Researchers randomly assigned participants to three main groups.
One group received 8.5mg of VDPHL01 once a day. Another took the same dose twice daily. The remaining participants received a placebo.
The study used a randomised, double-blind and placebo-controlled design. This meant neither participants nor investigators knew who was receiving the active treatment during the trial.
Veradermics said the drug met all primary and major secondary study goals with statistically significant results.
Researchers measured the number of non-vellus hairs within a defined section of the scalp. Non-vellus hairs are thicker and generally more visible than fine, short hairs.
After six months, men taking VDPHL01 once daily recorded an average increase of 30.3 hairs per square centimetre.
Those using the twice-daily dose gained an average of 33 hairs per square centimetre.
By comparison, the placebo group recorded an average increase of 7.3 hairs per square centimetre.
The company also reported statistically significant separation from the placebo group after two months, the earliest point at which investigators measured the treatment’s effect.
Participants also assessed changes in their hair using the Androgenetic Alopecia Impact Rating Scale.
Around 79.3% of men taking the once-daily treatment reported some improvement in hair coverage after six months.
The proportion rose to 86% among those taking the drug twice daily. In comparison, 35.6% of participants receiving a placebo reported an improvement.
However, the result does not mean that the drug increased hair coverage by 86%. It means 86% of participants in the twice-daily group noticed some level of improvement.
When researchers used the stricter categories of “improved” or “much improved,” 48.4% of once-daily users and 62.9% of twice-daily users met the threshold.
Only 13.4% of the placebo group achieved the same rating.
Investigators also assessed the participants independently. They found improved hair coverage in 72% of the once-daily group and 84.4% of the twice-daily group after six months.
Minoxidil was originally developed as a medicine for high blood pressure. Doctors later discovered that it could stimulate hair growth.
Topical minoxidil is already widely used for pattern hair loss. Doctors also sometimes prescribe low-dose oral minoxidil for hair loss even though immediate-release oral formulations were not originally developed for this purpose.
VDPHL01 does not introduce a completely new active ingredient. Instead, it uses a proprietary extended-release formulation of minoxidil.
The tablet contains a gel matrix designed to release the medicine more gradually and maintain steadier exposure over time.
According to Veradermics, immediate-release oral minoxidil reaches its highest concentration quickly and then clears from the body within several hours.
The company believes a slower release could expose hair follicles to the drug for longer while avoiding sharp concentration peaks linked to cardiovascular side effects.
However, regulators must still review the full evidence before deciding whether the treatment is safe and effective enough for approval.
Veradermics said the overall rate of treatment-related adverse events was similar between the VDPHL01 and placebo groups during the six-month study.
The company reported no treatment-related serious adverse events and no cardiac events classified as adverse events of special interest.
Peripheral oedema, or swelling caused by fluid accumulation, affected 5.3% of once-daily users and 6.3% of twice-daily users.
Hypertrichosis, which refers to increased hair growth elsewhere on the body, affected 3.5% of the once-daily group and 6.3% of the twice-daily group.
Around 1% of participants in each treatment group discontinued because of peripheral oedema. No participants stopped treatment because of hypertrichosis.
Still, the findings are based on preliminary topline results shared by the drug’s developer. Full data, longer follow-up and regulatory assessment will be needed to confirm the treatment’s benefits and risks.
The completed study forms part of a wider clinical programme involving three major trials.
Veradermics has completed enrolment in a second confirmatory Phase 3 study involving men. The company expects to release six-month results from that trial during the second half of 2026.
It also plans to publish 12-month data from the first study later in the year. These results will help show whether the reported hair growth continues over a longer period.
Meanwhile, the company is recruiting more than 500 women for a separate Phase 2/3 study of VDPHL01.
Pattern hair loss affects an estimated 80 million people in the United States, including around 50 million men and 30 million women.
Women currently have no FDA-approved oral prescription treatment specifically for pattern hair loss.
If the remaining trials succeed and regulators approve VDPHL01, the medicine could become the first FDA-approved non-hormonal oral treatment for pattern hair loss in both men and women.
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