Veradermics Hair Loss Pill Shows Strong Phase II Signal in Women

Key Points

• Veradermics reported a strong phase II signal for its oral hair-loss drug VDPHL01 in women, with six-month hair-count gains of about 23 hairs per square centimeter and high rates of patient-reported improvement.
• The treatment appeared to have a favorable safety profile in the study, with no serious adverse events or cardiac concerns reported; the most common side effects were hypertrichosis and peripheral edema.
• The company says female pattern hair loss remains a large underserved market, and it expects results from its registration-directed Study 306 in the first half of 2027.

Veradermics NYSE: MANE said results from the female arms of Study 207, a phase II open-label trial of VDPHL01 for mild to moderate pattern hair loss, showed what company executives described as a strong proof-of-concept signal for the oral treatment.

Chief Executive Officer Dr. Reid Waldman said the six-month data marked “the first positive phase II outcome for an oral treatment for pattern hair loss in females in the U.S.” and increased the company’s confidence ahead of its registration-directed phase II/III female trial, Study 306. Veradermics now expects results from that study in the first half of 2027.

VDPHL01 is being developed as an oral, non-hormonal treatment for male and female pattern hair loss. Waldman described VDP-001 as an extended-release oral minoxidil tablet designed to provide more consistent exposure than immediate-release oral minoxidil, which is approved as a blood pressure medication and used off-label for hair loss.

Study 207 Shows Hair Count Gains in Female Patients

Study 207 evaluated female patients randomized to receive 4.5 milligrams of VDPHL01 either once daily or twice daily. The study measured target area hair count, defined as the number of non-vellus hairs greater than 30 microns in a square centimeter, and a patient-reported assessment of hair coverage change.

According to Waldman, the once-daily group showed an increase of 22.7 hairs per square centimeter, while the twice-daily group showed an increase of 23.3 hairs per square centimeter at six months. He said the company saw “strong conviction” in the potential translatability of the results because the median hair count change was nearly identical to the mean and the range was narrow.

Patients also reported visible improvement. Veradermics said 88.9% of patients in the once-daily group and 90% in the twice-daily group reported that their hair coverage was improved or much improved at month six. Investigators reported increased hair coverage in 100% of the once-daily group and 90% of the twice-daily group.

Waldman said the company observed visible results as early as two months. He also compared Study 207 results with historical precedent studies of topical minoxidil foam, off-label immediate-release oral minoxidil, oral finasteride and spironolactone, while emphasizing that those were not head-to-head comparisons and involved independent trials conducted by different sponsors.

Safety Profile and Tolerability

Veradermics said no serious adverse events were observed in the female study population. Waldman also said there were no adverse events of special interest of cardiac origin, including pericardial effusion, pleural effusion, heart failure or angina, and no clinically significant changes in heart rate, blood pressure or electrocardiograms.

The company said it did not observe post-treatment initiated shedding in the study, which Waldman described as encouraging given that shedding is a common reason patients discontinue minoxidil-based products. He cited literature showing shedding in up to 44% of women in one study of off-label immediate-release oral minoxidil.

The most common adverse events were hypertrichosis and peripheral edema. Waldman said hypertrichosis appeared directionally higher than what had been observed in males, which he said was consistent with expectations because women are more likely to note excess hair growth if it occurs. One patient discontinued the study due to hypertrichosis.

Physician Perspective on Unmet Need

Dr. Jerry Shapiro, a hair loss dermatologist at NYU Langone Health, said female pattern hair loss carries a significant emotional burden for patients and that current treatment options often do not work well enough. “In terms of an oral medication that is FDA approved, there is nothing,” Shapiro said.

Shapiro said the phase II results were notable for the reported patient satisfaction rate, speed of response and gains in hair count. He contrasted the potential product with immediate-release oral minoxidil, saying safety is important because immediate-release use can be associated with cardiac concerns. He also said excess hair growth is a manageable side effect in many patients, citing options such as dermaplaning, waxing, lasers and razors designed for women.

During the question-and-answer session, Shapiro said immediate-release oral minoxidil is currently a primary treatment in his clinic for women with pattern hair loss. If phase III data are positive and the product gains approval, he said he would expect to switch patients from immediate-release minoxidil to the extended-release product.

Commercial Opportunity and Next Steps

Mark Neumann, Veradermics’ Chief Commercial and Strategy Officer, said the company believes VDPHL01 could address a large underserved market of approximately 30 million women in the U.S. He said there are currently no FDA-approved oral or prescription treatment options for female pattern hair loss, leaving patients to use over-the-counter, off-label or difficult-to-use products.

Neumann said Veradermics has conducted market research with more than 500 female patients and physicians over the past 18 months. He said the research showed high physician willingness to prescribe a product with a profile like VDPHL01 and high patient willingness to use an oral treatment with proven efficacy and a faster onset of action.

Waldman said Study 306 will enroll a slightly more severe female population than Study 207, excluding Savin I-3 patients and focusing on patients with more visibly widened parts. He said the company is not yet providing guidance on whether it would pursue a regulatory filing for men first or seek male and female labeling together.

Waldman also said it was too early to make a final dosing decision for females, though he described the once-daily and twice-daily findings as encouraging. Veradermics expects Study 306 data in the first half of 2027.

About Veradermics NYSE: MANE

MANE is a global manufacturer and supplier of flavors, fragrances and ingredients for the food, beverage, personal care, household and fine fragrance markets. Headquartered in France, the company develops and produces aromatic solutions that are used by consumer goods companies, food processors, perfumers and formulators seeking sensory impact, taste modulation and olfactory character for their products.

The company's product portfolio includes savory and sweet flavor systems, beverage concentrates, natural extracts, essential oils, fragrance compounds, cosmetic ingredients and specialty functional solutions such as taste enhancers and odor masking agents.

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