Extended-release minoxidil pill promotes hair growth in 4 months

In patients with androgenetic alopecia, 4 months of treatment with the investigational extended-release oral minoxidil (VDPHL01) appears to induce superior hair growth compared with 6 months of treatment with the topical and immediate-release (IR) formulations, according to the results of a blinded retrospective Investigator Global Assessment (IGA) analysis.

IGA scores for the frontal region improved by a mean of 2.02 points with VDPHL01 vs 0.29 points with topical minoxidil and 0.59 points with IR oral minoxidil (p<0.0001 for both). The corresponding improvements in IGA scores for the vertex region were 2.05 vs 0.02 and 0.53 points (p<0.0001 for both). [EADV 2025, abstract LBA-318]

These scores demonstrate that the average patient on VDPHL01 achieved at least a “moderate” improvement, whereas the average patients on comparator minoxidil formulations did not achieve even a “slight” improvement, noted one of the study authors Dr Jerry Shapiro from the New York University Grossman School of Medicine, New York, New York, US.

VDPHL01 was also associated with a higher likelihood of achieving a moderate-to-great improvement in hair coverage, more than three times than that observed with IR oral and topical minoxidil formulations, Shapiro added.

The percentage of patients who received IGA scores ≥2 points for the frontal region was 82.8 percent with VDPHL01 vs 19.2 percent with topical minoxidil and 21.6 percent with IR oral minoxidil (p<0.0001 for both). For the vertex region, the respective percentages were 82.1 percent vs 14.3 percent and 23.3 percent (p<0.0001 for both).

VDPHL01 demonstrated equal efficacy in frontal and vertex regions, and no difference was found between topical and IR minoxidil formulations, according to Shapiro.

Optimized oral formulation

The use of minoxidil both as a topical solution and as an IR oral tablet for the treatment of androgenetic alopecia has increased in recent years. However, Shapiro pointed out that outcomes remain suboptimal, with 46 percent of patients actively seeking new treatment alternatives and fewer than one in 10 patients reporting satisfaction with their current regimen. Treatment dissatisfaction for many is driven by a lack of effect (53 percent) or a slow onset of therapeutic effect (42 percent).

VDPHL01 was developed to optimize oral minoxidil for hair growth and cardiac safety, Shapiro said. It provides long-lasting minoxidil concentrations above the therapeutic effect threshold (1.62 ng/mL) but below the cardiac safety threshold (20 ng/mL).

On the other hand, the existing IR oral 2.5- to 5-mg-dose formulations quickly reach peak blood plasma concentrations, risking cardiac activity while sustaining therapeutic concentrations for hair growth for about 4 h, he added. [J Clin Pharmacol 1989;29:162-167]

In light of the findings of the present study, Shapiro pointed to VDPHL01 as a “potentially best-in-indication treatment delivering in 4 months what current minoxidil formulations cannot achieve in 6 months.”

Blinded IGA analysis

In the current study, Shapiro and colleagues compared the efficacy of VDPHL01 for androgenetic alopecia using a phase II trial data against the efficacy of IR oral and topical minoxidil formulations using data obtained from a published head-to-head study. [JAMA Dermatol 2024;160:600-605]

IGA ratings were made by board-certified dermatologists on the basis of before-and-after photos (three vertex and superior scalp image pairs) for each patient. The dermatologists had no knowledge of which photos were taken before or after treatment and what formulation was used.

The analysis included 20 patients who received 8.5 mg VDPHL01 twice daily for 4 months, 33 patients who received 5 mg IR oral minoxidil once daily for 6 months, and 34 patients who received 1 mL of 5% topical minoxidil solution twice daily for 6 months.

Baseline identification accuracy of the before and after photos was high for VDPHL01, at 97.5 percent for the frontal region and 96.2 percent for the vertex region. In contrast, it was lower for topical minoxidil (60.3 percent and 49.6 percent, respectively) and IR oral minoxidil (72.9 percent and 72.3 percent, respectively). This finding, according to Shapiro, indicates dramatic visible changes with VDPHL01 vs the comparators.

The author acknowledged that the study was limited by the retrospective study design methodology and the potential differences in baseline characteristics of patients across trials.