MANE (MANE) FDA Approvals

MANE's Drug in the FDA Approval Process

This section highlights FDA-related milestones and regulatory updates for drugs developed by MANE (MANE). Over the past two years, MANE has reported clinical trial outcomes, regulatory submissions, approvals, and other FDA events for drugs and therapies such as VDPHL01. For definitions of regulatory abbreviations such as NDA, BLA, or PDUFA, see the event status legend.

VDPHL01 FDA Regulatory Timeline and Events

VDPHL01 is a drug developed by MANE for the following indication: Patient Experiences With Pattern Hair Loss. This drug is under review by the U.S. Food and Drug Administration (FDA). Below is a timeline of key regulatory milestones for this therapy.

Poster Presentation - May 14,2026

• Drug: VDPHL01
• Announced Date: May 14, 2026
• Indication: Patient Experiences With Pattern Hair Loss

Veradermics, Incorporated announced that two E-posters will be presented at the 2026 Music City Symposium for Cosmetic Advances and Laser Education (SCALE) beginning today in Nashville, Tennessee until May 17, 2026.

Veradermics, Incorporated said two e-posters will be presented at the 2026 Music City Symposium for Cosmetic Advances and Laser Education (SCALE) in Nashville from May 14 to May 17, 2026. The posters focus on VDPHL01, an investigational extended-release oral minoxidil tablet being studied for androgenetic alopecia, also known as pattern hair loss.

The first poster, “Concordance of AI-Derived Quantitative Measures and IGA Scores Demonstrates Superior Efficacy with Faster Onset for an Investigational Extended-Release Oral Minoxidil Tablet (VDPHL01) Versus Immediate-Release Oral Minoxidil for Androgenetic Alopecia (AGA),” looks at how the treatment compares with immediate-release oral minoxidil. The second poster, “Comparative Efficacy of an Investigational Oral Minoxidil Extended-Release Tablet (VDPHL01) Versus Existing Minoxidil Formulations in Androgenetic Alopecia: A Blinded Retrospective IGA Analysis,” compares VDPHL01 with other minoxidil options.

The e-posters will appear on touchscreen televisions in the E-Poster area and will also be available in the SCALE meeting mobile app.

Top-line results - April 27,2026

Phase 2/3

• Drug: VDPHL01
• Announced Date: April 27, 2026
• Indication: Patient Experiences With Pattern Hair Loss

Veradermics, Incorporated announced positive topline results from Part A of its randomized, double-blind, placebo-controlled Phase 2/3 clinical trial (Study ‘302') evaluating VDPHL01, a proprietary extended-release oral minoxidil formulation, in over 500 males with mild-to-moderate pattern hair loss.

Veradermics, Inc. reported positive topline results from Part A of Study “302,” a randomized, double‑blind, placebo‑controlled Phase 2/3 trial testing VDPHL01 in over 500 males with mild‑to‑moderate pattern hair loss. VDPHL01 met all primary and key secondary endpoints with high statistical significance in both once‑daily (QD) and twice‑daily (BID) arms. Mean non‑vellus target area hair count increased by 30.3 hairs/cm² (QD; p<0.0001) and 33.0 hairs/cm² (BID; p<0.0001) versus 7.3 hairs/cm² for placebo at Month 6.

Patient‑reported outcomes also favored VDPHL01: about 79.3% (QD) and 86.0% (BID) reported any improvement versus 35.6% for placebo, and 48.4% (QD; p<0.0001) and 62.9% (BID; p<0.0001) reported “improved” or “much improved” at Month 6 versus 13.4% for placebo. Statistically significant hair growth appeared as early as Month 2. Safety and tolerability were favorable, with overall adverse event rates similar to placebo, supporting further development of the oral extended‑release minoxidil formulation.

Provided Update - April 26,2026

• Drug: VDPHL01
• Announced Date: April 26, 2026
• Indication: Patient Experiences With Pattern Hair Loss

Veradermics, Incorporated announced it will host an investor call and live webcast to review topline results from Part A of its randomized, double-blind, placebo-controlled Phase 2/3 ‘302' clinical trial evaluating VDPHL01, a proprietary extended-release oral minoxidil tablet, in males with mild-to-moderate pattern hair loss.

Veradermics, Inc. announced it will host an investor call and live webcast on Monday, April 27, 2026 at 8:00 am ET to review topline results from Part A of its randomized, double‑blind, placebo‑controlled Phase 2/3 "302" clinical trial. The trial is evaluating VDPHL01, the company’s proprietary extended‑release oral minoxidil tablet, in males with mild‑to‑moderate pattern hair loss.

The company said the presentation will cover the Part A topline findings and their implications for the program’s next steps. The study’s randomized, double‑blind, placebo‑controlled design is intended to rigorously assess safety and efficacy in the target male population. Investors and other interested parties were directed to join the live webcast for full details and to hear management’s interpretation of the results. Additional webcast and participation information was provided in the company’s release.

Abstract Presentation - March 18,2026

• Drug: VDPHL01
• Announced Date: March 18, 2026
• Indication: Patient Experiences With Pattern Hair Loss

Veradermics, Incorporated announced that three abstracts will be presented at the 2026 American Academy of Dermatology (AAD) Annual Meeting being held in Denver, Colorado on March 27 – 31, 2026.

Veradermics, Incorporated announced that three abstracts will be presented at the 2026 American Academy of Dermatology (AAD) Annual Meeting in Denver, Colorado, taking place March 27–31, 2026. The company said these abstracts represent its latest dermatology research and clinical findings and will be shared with attendees at the AAD conference. The presentations offer an opportunity for Veradermics to highlight its ongoing scientific work and engage with dermatology professionals at a major industry meeting.

The company cautioned that forward-looking statements include risks and uncertainties that may change over time. Such statements speak only as of the date of the press release, and Veradermics is not obligated to publicly update them unless required by law. New risks or events could affect future outcomes and plans.