New Oral Minoxidil Pill Regrows Hair in Phase 3 Trial Results
Veradermics announced this week that its oral minoxidil hair loss pill, VDPHL01, produced clear hair regrowth in a Phase 3 trial of 536 men with mild to moderate male pattern hair loss, comparing two daily doses against a placebo over six months.
VDPHL01 is a novel extended-release minoxidil formulation taken as an 8.5mg tablet, once or twice daily. Once-daily users gained an average of 28.6 hairs per square centimetre after six months and twice-daily users gained 36.4 hairs, against 6.6 for placebo (p<0.0001 for both). The randomised, double-blind Study 304 met all primary and secondary endpoints, the company announced on October 19, measured through target area hair counts and patient-reported outcomes.
The trial followed the gold-standard design used in recent pancreatic cancer drug research.
Trial results show early and sustained regrowth
Patients reported strong improvement: 78.8 percent of once-daily users and 85 percent of twice-daily users saw visible improvement, against 35.3 percent on placebo. In addition, 55.7 percent and 68.7 percent of the two dose groups rated their hair coverage as “improved” or “much improved”, against 15 percent on placebo.
Investigators agreed, grading 78.4 percent and 82.7 percent as having improved coverage, with significant separation from placebo by the second month.
“The results showed a high likelihood of visible improvement, with a safety and tolerability profile that is encouraging,” said Antonella Tosti, M.D., Fredric Brandt Endowed Professor of Dermatology and Cutaneous Surgery at the University of Miami, in the company’s announcement.
A generally well-tolerated safety profile
The pill was generally well tolerated. Peripheral edema, swelling from fluid retention, appeared in 2.8 percent of once-daily users and 4.5 percent of twice-daily users. Hypertrichosis, excess hair growth elsewhere on the body, affected 2.2 percent and 9.0 percent respectively.
No treatment-related serious adverse events occurred, and the company reported no cardiac events of special interest. Trade publication Practical Dermatology noted that results matched the earlier Study 302, and that longer-term safety data are pending.
Why an oral minoxidil pill matters
Minoxidil began life as a blood-pressure medicine. When doctors noticed it encouraged hair growth, the drug was repurposed as a topical lotion applied directly to the scalp. It is now widely used as a topical treatment for hair loss in both men and women.
Veradermics says the extended-release design is the point of difference: its gel matrix releases minoxidil steadily, avoiding the high peak concentrations of immediate-release oral minoxidil while keeping the drug above the level needed for hair growth for longer.
The company notes there has been no new FDA-approved prescription medicine for pattern hair loss in nearly 30 years. It calls VDPHL01 a potential first FDA-approved non-hormonal oral treatment, but that is a company aim, not an established fact. Interest in hair health research is also rising elsewhere, including recent research into chemicals linked to cancer found in hair extensions.
What comes next: longer-term data and a women’s trial
Twelve-month data from Study 302 is expected later this year. A separate women’s trial, Study 306, has completed enrollment, with topline data expected in the first half of 2027. The company describes it as the first registration-directed US trial of an oral therapy for female pattern hair loss. Attention to treatment effects in women is also growing, seen in a recent study on the biological reasons behind chronic pain in women.
Cantor Fitzgerald analyst Prakhar Agrawal said the results strengthened the drug’s commercial potential, ProPakistani reported, despite cheaper generic oral minoxidil on the market. Veradermics named Nutrafol, a Unilever-backed supplement costing about $90 a month, as a possible pricing benchmark, while Pelage Pharmaceuticals and Cosmo Pharmaceuticals are also developing treatments. Readers weighing costs may also want to review the best family health insurance plans in Pakistan.
Frequently Asked Questions
What is the oral minoxidil hair loss pill?
VDPHL01 is an investigational oral tablet from Veradermics, containing extended-release minoxidil taken as an 8.5mg tablet once or twice daily. The company says the steady-release gel matrix avoids the high peak concentrations of immediate-release oral minoxidil.
Is the pill approved by the FDA yet?
No. Veradermics has reported positive topline results from Phase 3 studies 302 and 304 and expects 12-month data later this year. Its claim that VDPHL01 could be the first FDA-approved non-hormonal oral treatment awaits regulatory review.
How does oral minoxidil differ from the topical version?
Topical minoxidil is applied directly to the scalp as a liquid or foam and is widely available over the counter. An oral pill delivers the drug through the bloodstream to follicles across the scalp. Veradermics says its extended-release version keeps minoxidil above the minimum hair growth threshold for longer.
