A new chapter in hair loss treatment may be on the horizon.
Dermatologist-founded biopharmaceutical company Veradermics Inc. says it is moving into Phase 3 clinical trials of VDPHL01, a daily extended-release oral minoxidil designed to treat pattern hair loss.
If approved, it would be the first and only oral minoxidil developed and tested for hair growth — marking a major shift in a space that hasn’t seen a new FDA-approved prescription option in nearly three decades.
Minoxidil is already a familiar name, best known as a topical treatment. Oral versions, while widely prescribed off label, were never designed or formally studied for long-term hair growth.
Veradermics has engineered an extended-release formulation intended to deliver consistent exposure to hair follicles while avoiding the blood-level spikes associated with cardiovascular side effects, the company says.
Veradermics recently completed enrollment in a large Phase 2/3 study involving more than 500 men with mild to moderate hair loss, and is actively enrolling participants in a second Phase 3 male trial, along with a late-stage study in women.
Early results are encouraging. In preliminary Phase 2 data, participants saw visible improvements in hair density within just two months, with continued gains over four months, the company says.
Most reported improved hair coverage and higher satisfaction, and the treatment was generally well tolerated, with no serious adverse events reported.
If successful, VDPHL01 could offer a long-awaited alternative to finasteride, the only approved oral prescription for hair loss, which works hormonally and is often associated with unwanted side effects.