After nearly three decades of limited progress in oral hair loss treatments, a new contender may be about to transform the conversation. The biopharmaceutical company Veradermics has announced phase-three clinical trials for a new drug, currently known as VDPHL01, an extended-release form of oral minoxidil developed specifically for hair regrowth in men and women.
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Unlike topical minoxidil—commonly known by its over-the-counter name Rogaine—or the oral version traditionally prescribed off-label for hair loss, VDPHL01 is being engineered from the ground up to target follicles more effectively and safely. The extended-release mechanism aims to maintain steady levels of minoxidil in the bloodstream, avoiding the spikes that can sometimes cause cardiovascular side effects.
If successful, the pill could mark a major milestone in the treatment of androgenetic alopecia, more commonly referred to as male and female pattern hair loss. The last FDA-approved oral treatment for hair loss, finasteride, arrived in 1997—and though it remains a widely used option, it has significant limitations. Finasteride’s mechanism, which blocks the hormone DHT, can result in unwanted side effects like reduced libido and is generally not recommended for women of childbearing age.
VDPHL01 seeks to fill that gap by offering a solution that works across genders without relying on hormone-blocking pathways. Early clinical data has suggested promising results in terms of both safety and efficacy.
The upcoming phase-three trials are expected to enroll about 1,500 participants diagnosed with androgenetic alopecia across several FDA-approved testing sites. Each participant will undergo a comprehensive evaluation process, including medical screenings, photographic assessments, and progress tracking over the course of the study. The trials for men are projected to conclude in 2026, followed by trials for women.
If all goes according to plan, Veradermics intends to file for FDA approval by 2027—meaning the first wave of patients could have access to the treatment within a few years.
While the company has not disclosed anticipated pricing, dermatologists and industry observers are already voicing optimism for broader accessibility. Current oral minoxidil treatments cost as little as $15 per month, and many hope the innovation in delivery won’t come at the expense of affordability.
For now, VDPHL01 represents not just a potential new drug but a new direction—one that prioritizes both clinical performance and patient safety. Should the trials confirm what early research suggests, this could become the most significant leap in hair regrowth science in a generation.
