New hair loss treatments don’t come around every day, which makes the latest research around VDPHL01 so intriguing. Currently in Phase 3 clinical trials, with the results of Phase 2/3 trials recently published, it uses an active ingredient that many are already familiar with: minoxidil. The difference is in how the minoxidil is delivered, which could allow higher doses to be used while minimising the risk of side effects.
What is VDPHL01?
VDPHL01 is a form of oral minoxidil which is encased in a sustained-release gel matrix. In simple terms, the minoxidil is coated in a gel that is slowly dissolved by your stomach acid over several hours, gradually releasing the medication into your bloodstream. This differs from conventional oral minoxidil, which is released all at once.
At the moment, oral minoxidil is prescribed at low doses (up to 5mg for treating hair loss) to balance efficacy with the potential risk of adverse events. Serious side effects are uncommon at the low doses used for hair loss treatment. The most commonly reported side effect is hypertrichosis, which refers to unwanted hair growth elsewhere on the body. Researchers believe extending the release of minoxidil over a longer time frame could help reduce the risk of cardiac side effects whilst allowing a higher dosage of oral minoxidil to be given.
Results from clinical trials
As mentioned, VDPHL01 has so far been evaluated in two Phase 2/3 trials, with a Phase 3 trial currently underway.
Results from Study 302, involving 519 men with mild to moderate androgenetic alopecia (male pattern baldness), were published in April 2026. Participants were split into three groups, receiving either VDPHL01 8.5mg once daily, VDPHL01 8.5mg twice daily, or placebo for a period of six months.
By month 6, participants using VDPHL01 once daily gained an average of 30.3 hairs/cm2, while those taking it twice daily gained 33 hairs/cm2. In comparison, the placebo group gained 7.3 hairs/cm2. The treatment was generally well tolerated, with no serious adverse events reported during the treatment period. Importantly, statistically significant improvements were observed as early as month 2, the earliest assessment point during the trial.
Researchers also carried out a trial on women with androgenetic alopecia, Study 207, which also found statistically significant increases in hair count compared with baseline.
Results of the next trial, Study 304, involving 536 male patients, are expected to be published later this year.
When might it potentially become available?
If the ongoing Phase 3 trial is successful and VDPHL01 receives FDA approval, it could potentially reach the US market in late 2027 or early 2028. However, that timeline will depend on the outcome of the current studies and the regulatory review process.
If, or when, it might become available in the UK depends on the treatment receiving approval from the MHRA, meaning it will be at least a few years away.
While the early results are encouraging, it's important not to put treatment on hold while waiting for future options. Male pattern baldness is progressive, which means hair loss typically becomes more advanced over time. Existing treatments such as Finasteride and Minoxidil Spray are already licensed by the MHRA and supported by decades of clinical research demonstrating their safety and effectiveness. For most men, starting proven treatment sooner rather than later offers the best chance of maintaining and regrowing hair.
All of our blog articles are reviewed by our Medical Director before publication.
