Veradermics' Drug in the FDA Approval Process
This section highlights FDA-related milestones and regulatory updates for drugs developed by Veradermics (MANE).
Over the past two years, Veradermics 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 Veradermics 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.
- Drug:
- VDPHL01
- Announced Date:
- July 17, 2026
- Indication:
- Patient Experiences With Pattern Hair Loss
Announcement
Veradermics, Incorporated announced the presentation of data from the Phase 2/3 Study ‘302’ of VDPHL01 in male patients with mild-to-moderate pattern hair loss.
AI Summary
Veradermics, Incorporated announced new data from its Phase 2/3 Study 302 of VDPHL01, a proprietary extended-release oral minoxidil treatment for male pattern hair loss. The study was randomized, double-blind, and placebo-controlled, and it included more than 500 men with mild-to-moderate hair loss. The company said the new results come from an age-based subgroup analysis that compared men younger than 40 with men 40 and older.
The presentation focuses on how VDPHL01 performed in both efficacy and safety across these age groups. This is important because pattern hair loss can affect men differently depending on age, and treatment response may vary as well. Veradermics is highlighting the data as part of its ongoing work to develop VDPHL01 as a potential oral option for people seeking treatment for hair loss.
Read Announcement- Drug:
- VDPHL01
- Announced Date:
- July 15, 2026
- Indication:
- Patient Experiences With Pattern Hair Loss
Announcement
Veradermics, Incorporated 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.
AI Summary
Veradermics, Incorporated said its open-label Phase 2 Study 207 showed positive early results for VDPHL01, a once- or twice-daily extended-release oral minoxidil designed for female pattern hair loss. The trial involved women with mild-to-moderate hair loss and found a fast response, with many participants reporting better hair coverage by Month 2. By Month 6, about 88.9% of women taking the drug once daily and 90.0% taking it twice daily said their hair had improved or much improved.
The treatment also showed strong hair growth, with mean increases in target area hair count of 22.7 hairs/cm² and 23.3 hairs/cm², respectively. VDPHL01 was generally well tolerated, and the company reported no treatment-related serious side effects or heart-related safety concerns. Veradermics said it expects topline results from its larger Study 306 in the first half of 2027.
Read Announcement- Drug:
- VDPHL01
- Announced Date:
- July 14, 2026
- Indication:
- Patient Experiences With Pattern Hair Loss
Announcement
Veradermics, Incorporated announced it will host an investor call and live webcast on Wednesday, July 15, 2026 at 8:00 am ET to review results from female treatment arms of the Phase 2 open-label Study ‘207’ evaluating VDPHL01, a proprietary extended-release oral minoxidil tablet, in males and females with mild-to-moderate pattern hair loss.
AI Summary
Veradermics, Incorporated announced it will host an investor call and live webcast on Wednesday, July 15, 2026, at 8:00 a.m. ET. The company said the event will review results from the female treatment arms of its Phase 2 open-label Study “207.”
The study is evaluating VDPHL01, an extended-release oral minoxidil tablet, in both males and females with mild-to-moderate pattern hair loss. Veradermics expects the discussion to focus on how the treatment performed in women and what the findings may mean for the program moving forward.
Investors and interested listeners can follow the webcast to hear more about the data and the company’s next steps.
Read Announcement- Drug:
- VDPHL01
- Announced Date:
- May 27, 2026
- Indication:
- Patient Experiences With Pattern Hair Loss
Announcement
Veradermics, Incorporated announced that topline results from Phase 2/3 ‘302' Study of VDPHL01 will be presented at the 2026 World Congress for Hair Research on May 30, 2026.
AI Summary
Veradermics, Incorporated said topline results from its Phase 2/3 “302” study of VDPHL01 will be presented at the 2026 World Congress for Hair Research on May 30, 2026. The company said the presentation will include positive results from Part A of the trial, which tested VDPHL01, an extended-release oral minoxidil pill, in more than 500 men with mild-to-moderate pattern hair loss.
Veradermics said the findings could support VDPHL01 as a major new treatment option for pattern hair loss. The company believes the drug may become the first FDA-approved oral pill for this condition in nearly 30 years and could offer a leading option for the millions of men in the U.S. who are affected by pattern hair loss.
Read Announcement- Drug:
- VDPHL01
- Announced Date:
- May 14, 2026
- Indication:
- Patient Experiences With Pattern Hair Loss
Announcement
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.
AI Summary
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.
Read Announcement- Drug:
- VDPHL01
- Announced Date:
- April 27, 2026
- Indication:
- Patient Experiences With Pattern Hair Loss
Announcement
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.
AI Summary
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.
Read Announcement- Drug:
- VDPHL01
- Announced Date:
- April 26, 2026
- Indication:
- Patient Experiences With Pattern Hair Loss
Announcement
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.
AI Summary
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.
Read Announcement- Drug:
- VDPHL01
- Announced Date:
- March 18, 2026
- Indication:
- Patient Experiences With Pattern Hair Loss
Announcement
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.
AI Summary
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.
Read Announcement
Veradermics FDA Events - Frequently Asked Questions
As of now, Veradermics (MANE) has not received any FDA approvals for its therapy in the last two years.
In the past two years, Veradermics (MANE) has reported FDA regulatory activity for VDPHL01.
The most recent FDA-related event for Veradermics occurred on July 17, 2026, involving VDPHL01. The update was categorized as "Presentation," with the company reporting: "Veradermics, Incorporated announced the presentation of data from the Phase 2/3 Study ‘302’ of VDPHL01 in male patients with mild-to-moderate pattern hair loss."
Currently, Veradermics has one therapy (VDPHL01) targeting the following condition: Patient Experiences With Pattern Hair Loss.
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FDA Event Stage Terminology & Abbreviation Guide
- NDA: New Drug Application
- ANDA: Abbreviated New Drug Application
- sNDA: Supplemental New Drug Application
- BLA: Biologics License Application
- sBLA: Supplemental Biologics License Application
- FDA Approved: Approved by the FDA
- EMA: European Medicines Agency
- CE Mark: European Union Certification
- NMPA: China National Medical Products Administration
- MHLW: Japanese Ministry of Health
- FDA Meeting: Consultation with FDA
- Pre-IND: Pre-Investigational New Drug Meeting
- Breakthrough Therapy: Special FDA designation for promising therapies
- Fast Track: Accelerated FDA approval pathway
- Orphan Drug: Designation for rare disease treatments
- RPD: Rare Pediatric Disease Designation
- RMAT: Regenerative Medicine Advanced Therapy
- DSMB Review: Data Safety Monitoring Board Review
- IDMC Review: Independent Data Monitoring Committee
- MAA: MHRA Marketing Authorization Application
- RTF: Refusal to File (Rejected Application)
- 510(k): FDA Clearance for Medical Devices
- Rolling Submission: Staggered regulatory review process
FDA progress for NYSE:MANE last updated on 7/17/2026 by MarketBeat.com Staff. We continuously monitor for new FDA events and market data.
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