TouchDERMATOLOGY coverage from AAD 2026:
Androgenetic alopecia (AGA) remains one of the most common causes of hair loss in both men and women, yet the therapeutic landscape remains relatively limited. As a result, there is strong clinical interest in novel therapies that can deliver faster, meaningful results while addressing some of the limitations of existing treatments.
One emerging approach is VDPHL01 (Veradermics; New Haven, CT, USA), an investigational extended-release oral formulation of minoxidil designed to improve the pharmacokinetic profile of immediate-release oral minoxidil.
To explore the current limitations of treatment for AGA, the rationale behind VDPHL01 and the significance of the latest data presented at the 2026 American Academy of Dermatology Annual Meeting, we spoke with Prof. Jerry Shapiro (Professor and Director of Disorders of the Hair and Scalp in The Ronald O. Perelman Department of Dermatology at New York University Grossman School of Medicine).
In this interview, we discuss the challenges of managing AGA, the promise of extended-release oral minoxidil and where this therapy may ultimately fit within the treatment landscape for men and women with the condition.
The ePoster “Faster Onset and Superior Efficacy of an Investigational Extended-Release Oral Minoxidil Tablet (VDPHL01) Versus Topical and Immediate-Release Oral Minoxidil for Androgenetic Alopecia: Results from a Blinded Retrospective Investigator Global Assessment” was presented at AAD 2026, Denver, CO, USA; 27–31 March.
What are the main limitations of the current therapeutic options for androgenetic alopecia?
When we treat AGA, one of the main limitations is that we still have a relatively limited range of options to offer patients. The cupboard is not especially full, certainly not in the way it is for conditions such as psoriasis or eczema.
In terms of topical treatment, minoxidil remains the main option, available in 2% and 5% formulations, with the 5% strength also available as a foam. These treatments are US Food and Drug Administration (FDA) approved, but they do have limitations. Their efficacy is relatively modest, and patients with AGA are not always satisfied with the results. It can also take time before any benefit becomes apparent. In addition, applying treatment to the scalp can be inconvenient, and local tolerability issues such as irritation or folliculitis-like eruptions can occur. That said, topical minoxidil does still have efficacy and remains an important part of treatment.
Finasteride is an oral medication that has been used for more than two decades. As a 5-alpha reductase inhibitor, it blocks the conversion of testosterone to dihydrotestosterone (DHT), thereby lowering DHT levels and targeting a key driver of hair loss pathophysiology. I was one of the early investigators involved in its development, and at the time it was very exciting to have an oral treatment option available.
However, although finasteride is an effective treatment, it is not without limitations. Sexual adverse effects were reported in some men; these were not common, but they did occur. There have also been concerns about mood-related adverse events, including depression, brain fog and, very rarely, suicidal ideation. Although these events are uncommon, they remain clinically relevant. In addition, efficacy is not always as robust or consistent as one might ideally want, and not all patients benefit to the same extent.
So, while both minoxidil and finasteride continue to play an important role in management, the overall treatment landscape remains relatively limited. This helps explain the strong interest in emerging therapies, particularly those that are effective, well tolerated and able to avoid hormonal or mood-related concerns.
Can you tell us about VDPHL01 and what sets it apart from existing therapies for androgenetic alopecia?
VDPHL01 is an investigational oral extended-release formulation of minoxidil, designed to address some of the limitations of the immediate-release formulation currently available.
With immediate-release minoxidil, drug levels rise rapidly and then fall quickly, creating a high peak concentration. Although associated cardiovascular adverse events are rare, that peak may increase the risk of complications such as pericarditis or pericardial effusion.
By contrast, the extended-release formulation is designed to provide more sustained drug exposure throughout the day without exceeding potentially cardiotoxic levels. This may be beneficial not only from a safety perspective, but also for efficacy. For minoxidil to work effectively, it needs to undergo sulfation, and a longer duration in the system may increase the opportunity for this process to occur.
Overall, the extended-release minoxidil formulation appears promising because it may offer a better pharmacokinetic profile, with lower peak levels, prolonged exposure and the potential for improved tolerability and efficacy compared with immediate-release oral minoxidil.
What were the aims and design of the retrospective Investigator Global Assessment?
A recent phase 2 trial (NCT06527365) evaluated oral minoxidil extended-release (VDPHL01) for AGA. To compare onset of action with existing minoxidil formulations, a structured, blinded, retrospective Investigator Global Assessment (IGA) was conducted and this was what we presented at AAD 2026.
The IGA was designed to compare extended-release oral minoxidil with the immediate-release formulation, with a particular focus on speed of response and improvement in hair density.
The analysis included 19 male participants with AGA who completed two months of treatment with VDPHL01 8.5 mg twice daily in the phase 2 study. These outcomes were compared with published datasets including 33 men with AGA treated with immediate-release oral minoxidil 5 mg once daily and 34 men treated with topical minoxidil 5% solution twice daily for six months.
Blinded retrospective image assessments were performed by five US board-certified dermatologists, who independently reviewed baseline and follow-up image pairs in random order. Reviewers first identified the baseline image and then assigned an Investigator Global Assessment improvement score ranging from 0 to +3. Where the baseline image was misidentified, the score direction was reversed to correct for this.
What were the key findings from the retrospective Investigator Global Assessment study?
Although this was a cross-study comparison rather than a direct randomized comparison, the results appeared to favor the extended-release formulation over immediate-release minoxidil.
In the frontal and vertex views, respectively, mean improvement in Investigator Global Assessment score was +1.12 and +0.98 with VDPHL01, compared with +0.39 and +0.13 with topical minoxidil, and +0.39 and +0.48 with immediate-release oral minoxidil.
Similarly, correct baseline image identification rates for the frontal and vertex views were 86.2% and 93.3% with VDPHL01, compared with 63.5% and 59.4% with topical minoxidil, and 64.0% and 81.7% with immediate-release oral minoxidil.
Overall, VDPHL01 showed superiority over the comparator treatments across both outcome measures, except for baseline image identification in the vertex view versus immediate-release oral minoxidil, where the difference was not statistically significant (p=0.1366).
The findings suggest that VDPHL01 may have a faster onset of action, with visible improvement seen within 2 months, and may deliver greater increases in hair density than would typically be expected after 6 months of treatment with topical or immediate-release oral minoxidil. These results should, however, be interpreted with caution because of the limitations of the analysis, including possible differences in baseline characteristics across trials and the retrospective nature of the Investigator Global Assessment study.
Although not yet confirmed, phase 3 data are anticipated later this year. There is considerable excitement surrounding the study, particularly in light of the impressive phase 2 results in AGA.
Assuming positive clinical development, where do you see this treatment fitting within the current treatment landscape for androgenetic alopecia?
In my opinion, these data are positive, and if future data continue to support this I would expect the extended-release oral formulation to be positioned quite high in the treatment paradigm.
Current results suggest that the extended-release oral formulation offers better results, with a faster onset of action, and those are both highly meaningful advantages in clinical practice.
Treatment decisions in AGA are typically made jointly between clinician and patient, with patients playing a central role in determining the approach. When presented with the available options, many patients are likely to be naturally drawn to treatments that appear to work more quickly and more effectively.
This formulation may also have an important advantage in that it is non-hormonal. Given that the extended-release formulation of oral minoxidil appears to perform better than immediate-release minoxidil, and may avoid some of the concerns associated with hormonal therapies such as finasteride, it has the potential to move near the top of the list and possibly become a leading option in routine practice.
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This content has been developed independently by Touch Medical Media for touchDERMATOLOGY. It is not affiliated with the American Academy of Dermatology (AAD). Views expressed are the speaker’s own and do not necessarily reflect the views of Touch Medical Media.
Disclosures: Jerry Shapiro, MD, FAAD, has acted as a consultant and medical advisory board member for Pfizer, Lilly and Sun Pharma; as a consultant for 30 Madison, Eirion, AbbVie and Genecis; and as a consultant and stockholder for Veradermics.
Cite: Shapiro J. Could extended-release oral minoxidil improve outcomes in androgenetic alopecia? TouchDERMATOLOGY, 07 April 2026
Editor: Gina Furnival
About Prof. Jerry Shapiro
Prof. Jerry Shapiro, MD, is a dermatologist and hair loss specialist at NYU Langone Health, where he is Professor in the Ronald O. Perelman Department of Dermatology at NYU Grossman School of Medicine. He is internationally recognised for his expertise in hair and scalp disorders, including androgenetic alopecia, alopecia areata and scarring alopecias. In addition to his clinical work, he is an active researcher, speaker and author, with more than 150 peer-reviewed publications, 30 book chapters and four textbooks on hair loss.
