A New Hair-Loss Pill Could Be a Boon for Both Women and Men

The oral medication options for hair loss have been about the same for a while now. Oral finasteride (also known as Propecia) was approved by the Food and Drug Administration (FDA) for the treatment of hair loss in men in 1997. And doctors have been prescribing oral minoxidil (which is approved to treat hypertension) off-label since the 2010s. But a significant development may be on the horizon.

Veradermics, a biopharmaceutical company, announced in October that it’s secured financing for the next phase of clinical trials for a drug it’s currently referring to as VDPHL01. If it’s ultimately approved by the FDA, it would be the first extended-release oral minoxidil treatment designed specifically for hair regrowth in women and men.

While topical minoxidil, known by its most popular brand name, Rogaine, is indicated specifically for treating hair loss, oral minoxidil is only FDA-approved for the treatment of hypertension. Although it’s proven to be an effective hair growth medication, it isn’t perfect in this regard. It tends to act quickly once it enters the body and dissipate quickly – which is great when you’re taking it treat high blood pressure, not so much for hair loss.

Veradermics claims VDPHL01 has been optimized for oral administration, hair growth, and cardiac safety by changing the way it interacts with the body. More specifically, with the drug, the company is aiming to extend the length of time during which minoxidil is released throughout the body, which would enable hair follicles to be exposed to it for longer periods while also eliminating the spikes that can cause cardiac events.

Limited as the oral medication options for hair loss are, they’re even more so for women. Finasteride, for example, works by blocking DHT, a male hormone produced by testosterone, that can lead to hair loss in men and women. However, because finasteride can cause birth defects, it’s generally not prescribed to women of childbearing age. Some research has also found that it isn’t as effective in women as it is in men. So the addition of another oral medication could be a boon for both women and men.

Promising as all this sounds, it’s still likely to be quite a while before that day comes. VDPHL01 is about to enter a phase three clinical trial, the final step for testing an experimental drug. Veradermics said the trial for men will be completed in 2026, and those for women will follow. If all goes well, the company expects to submit a New Drug Application in 2027. Standard FDA approvals typically come 10 to 12 months after that point.