Veradermics口服VDPHL01女性脱发二期研究207取得阳性结果并强化2027年关键读出预期

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Veradermics’ Oral VDPHL01 Delivers Positive Study ‘207’ Phase 2 Clinical Trial Results in Female Pattern Hair Loss Ahead of Upcoming Phase 2/3 Study ‘306’ Readout

July 15, 2026

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VDPHL01, a novel orally-administered extended-release minoxidil formulation, achieved fast onset of hair growth with the majority of study participants reporting improvement in hair coverage as early as Month 2 and consistent treatment effect with approximately 88.9% (once daily) and 90.0% (twice-daily dosing) of patients reporting ‘improved’ or ‘much improved’ outcomes at Month 6

Robust hair growth was observed with a mean increase in non-vellus target area hair count (TAHC) of 22.7 hairs/cm² and 23.3 hairs/cm² at Month 6, in once and twice daily dosing regimens, respectively

VDPHL01 demonstrated a favorable safety and tolerability profile in females that was generally consistent with prior VDPHL01 trials with no treatment-related SAEs and no AESIs of cardiac origin observed

Veradermics anticipates topline results of ‘Study 306’, a Phase 2/3 clinical trial evaluating VDPHL01 in female pattern hair loss, in 1H 2027

Conference call and webcast scheduled for 8:00 a.m. ET today

NEW HAVEN, Conn. --(BUSINESS WIRE)--Jul. 15, 2026--
Veradermics, Incorporated (NYSE: MANE), a dermatologist-founded, late-stage biopharmaceutical company focused on developing innovative therapeutics for pattern hair loss, today announced positive topline results from its open-label Phase 2 clinical trial (Study ‘207’) evaluating VDPHL01, a proprietary extended-release oral minoxidil formulation, in females with mild-to-moderate pattern hair loss. VDPHL01 has the potential to become the first FDA-approved oral treatment for female pattern hair loss.

Among female participants who received either VDPHL01 4.5mg once daily or VDPHL01 4.5mg twice daily for 6 months, VDPHL01 demonstrated a potentially differentiated clinical profile defined by rapid onset of activity, consistent response across participants, and increases in hair count while being generally well tolerated with no treatment-related serious adverse events (SAEs) and no adverse events of special interest (AESIs) of cardiac origin.

In the study, VDPHL01 achieved consistent hair growth on the endpoint of non-vellus TAHC and patient reported outcome (PRO) benefits of ‘improved’ or ‘much improved’ on the Androgenetic Alopecia Impact Rating Scale (AAIRS) at Month 6. Participants achieved an average increase in non-vellus hair count of 22.7 hairs/cm² and 23.3 hairs/ cm² in once daily and twice daily VDPHL01 treatment arms, respectively. Additionally, 88.9% of participants in the once daily dose arm and 90.0% of participants in the twice daily dose arm achieved ‘improved’ or ‘much improved’ hair coverage on the AAIRS.

“Female pattern hair loss has long been underserved with no FDA-approved oral prescription treatment options and limited clinical research. As a result, females have disproportionately resorted to using topical over-the-counter options and unproven supplements that do not reliably help them reach their treatment goals,” said Dr. Jerry Shapiro , an internationally recognized board-certified dermatologist, Director of the Hair Clinic and Professor of Dermatology at NYU Langone Medical School who is a paid consultant of Veradermics. “Based on the results of the ‘207’ trial, VDPHL01 is positioned to transform how we treat female pattern hair loss as it moves towards potentially becoming the first and only FDA-approved oral treatment for females.”

The consistency of clinically meaningful hair growth reported by participants was further supported by investigator perception of hair growth, with investigators grading 100% (once daily dosing arm) and 90% (twice daily dosing arm) of female participants as having improvement in hair coverage at Month 6. Fast onset of hair growth was also observed by investigators and patients as early as Month 2, the earliest measured time point measured in the trial, with 67.2% of participants graded by investigators as demonstrating improvement and 63.2% of participants reporting improvement in hair coverage at Month 2.

Treatment with VDPHL01 was generally well tolerated through Month 6 with an overall safety profile consistent with prior studies with VDPHL01. No treatment-related SAEs and no AESIs of cardiac origin were observed in this study.

“We are highly encouraged by the positive results from Study ‘207’ evaluating our proprietary extended-release formulation of VDPHL01 in women with pattern hair loss,” said Reid Waldman , M.D., Chief Executive Officer of Veradermics. “Importantly, Study ‘207’ demonstrated strong proof-of-concept on the same endpoints being evaluated in our registration-directed Phase 2/3 Study ‘306’, further strengthening our conviction in that study ahead of its anticipated 1H 2027 readout. Taken together, these data reinforce our belief that VDPHL01, if approved, has the potential to become a differentiated oral treatment option for women with female pattern hair loss and to address the needs of an estimated 30 million women, representing a substantial additive commercial opportunity.”

VDPHL01 is currently being evaluated in an extensive pivotal development program designed to support the approval of VDPHL01 in both female and male pattern hair loss. Veradermics is actively recruiting female participants for its female pattern hair loss Phase 2/3 trial, Study ‘306’, with topline data anticipated in 1H 2027. In April, Veradermics announced topline results from Study ‘302’, a registration-directed Phase 2/3 trial in male pattern hair loss and, in February, Veradermics announced enrollment completion in its second Phase 3 male trial, Study ‘304’, with topline results anticipated in the second half of 2026.

Veradermics will host a conference call and live webcast today at 8:00 a.m. ET to discuss the Study ‘207’ results. A live webcast will be available on the Events page in the Investors section of the company’s website . A replay will be available following the call.

About VDPHL01

VDPHL01 (extended-release minoxidil tablet) is a proprietary investigational, oral non-hormonal drug in Phase 3 development for pattern hair loss in both women and men. VDPHL01 leverages extended-release technology to deliver a minoxidil product with the potential for improved efficacy and safety. The proprietary extended-release formulation utilizes a gel matrix designed to deliver long-lasting, steady release of minoxidil for sustained absorption. VDPHL01 has been shown to avoid the high peak concentrations of immediate-release oral minoxidil, while extending time above the minimum hair growth threshold to increase time for hair to grow. If approved, VDPHL01 would be the only FDA-approved oral non-hormonal treatment for pattern hair loss in both male and female patients. VDPHL01 is protected by a broad library of patents and patent applications related to the key innovations of VDPHL01. The earliest expiring patent term is 2043.

About Pattern Hair Loss

Pattern hair loss, also known as androgenetic alopecia, affects an estimated 80 million people in the United States (30 million women and 50 million men). Pattern hair loss can have a significant impact on quality of life, affecting an individual’s mental health and relationships. People with pattern hair loss often experience depression, low self-esteem, and social withdrawal. There have been no new FDA-approved prescription medicines for pattern hair loss in nearly 30 years. In addition, current treatments include over the counter “nutraceuticals” that produce inconsistent results and contribute to high dissatisfaction among participants and healthcare providers. The prevalence of p