Veradermics' hair-loss pill meets every goal in a second late-stage trial

Veradermics said on Monday, Oct. 19, that its extended-release minoxidil pill, VDPHL01, met all of its main and secondary goals in a Phase 3 trial of 536 men with pattern hair loss. It is the company's second positive late-stage study of the drug, and Veradermics says the two together make up the full placebo-controlled data set it will use to seek U.S. approval.

What the trial showed

Study '304' enrolled 536 men with mild-to-moderate pattern hair loss and randomly assigned them to an 8.5 mg VDPHL01 tablet once a day, the same dose twice a day, or a placebo. After six months, men on the once-daily dose had gained an average of 28.6 non-vellus hairs per square centimeter in the target area of the scalp, and men on the twice-daily dose gained 36.4. The placebo group gained 6.6. Both doses beat placebo with p-values below 0.0001, the company said.

The trial's second co-primary goal asked the men themselves. On the Androgenetic Alopecia Impact Rating Scale, a patient questionnaire, 55.7% of the once-daily group and 68.7% of the twice-daily group said their hair coverage was "improved" or "much improved," compared with 15% on placebo. Investigators graded 78.4% and 82.7% of the two treated groups as having improved coverage, against 38.9% on placebo, according to the company's presentation. The company said the drug separated from placebo on hair count, patient ratings and investigator grades at month 2, the first time point measured.

The new numbers closely track the first study. In Part A of Study '302', reported in April, the two doses added 30.3 and 33.0 hairs per square centimeter against 7.3 for placebo, according to the company's comparison table.

Why a pill version of an old drug matters

Minoxidil is not new. It is the active ingredient in Rogaine, which is applied to the scalp, and inexpensive generic minoxidil tablets are already widely available. VDPHL01 is an extended-release tablet built on a gel matrix that releases the drug slowly. Veradermics says this avoids the high blood-level peaks of immediate-release minoxidil while keeping the drug above the level needed for hair growth for longer.

That design is the commercial argument. "The key push back we hear is around the rationale for using VDPHL01 when inexpensive generic oral minoxidil is widely available," Cantor Fitzgerald analyst Prakhar Agrawal said, according to Reuters. "However, with these efficacy data, we believe the commercial case for VDPHL01 is now very strong."

The company said Nutrafol, a Unilever-backed hair supplement that costs about $90 a month, or about $1,000 a year, is a good price benchmark for its drug, Reuters reported. Neither the release nor the presentation gives a price.

Safety

Veradermics designed VDPHL01 to keep blood levels of minoxidil below what its presentation calls the drug's cardiac activity threshold. The company said there were no treatment-related serious adverse events and no cardiac adverse events of special interest, and the presentation reported no clinically significant differences from placebo in heart rate, blood pressure or ECG readings. Peripheral edema, a type of swelling, affected 2.8% of the once-daily group and 4.5% of the twice-daily group, against 0.6% on placebo. Unwanted hair growth elsewhere on the body, called hypertrichosis, affected 2.2% and 9%, against none on placebo. The presentation shows that 2.2% and 2.8% of men on the drug left the trial because of side effects, against 1.1% on placebo.

What comes next

Veradermics has not given a date for filing with the Food and Drug Administration, BioSpace reported. The company plans to use the two male studies, which together enrolled more than 1,000 men, to support an application. It expects 12-month safety data from Part B of Study '302' later this year. A separate trial in 556 women, Study '306', finished enrollment in August and should report topline results in the first half of 2027.

If approved, VDPHL01 would be the first new FDA-approved pill for pattern hair loss in nearly 30 years, the company said. Its earliest-expiring patent runs to 2043. Rivals include Pelage Pharmaceuticals, whose PP405 is in Phase 2/3 testing, according to BioSpace, and Cosmo Pharmaceuticals, Reuters reported.

How the stock reacted

Veradermics shares traded at $122.67 on the New York Stock Exchange at 3:27 p.m. ET on Monday, up 12.7% from Friday's close of $108.82, according to Yahoo Finance data. Reuters reported that they were up 7.5% before the market opened. The company went public in February, raising more than $256 million, BioSpace reported.