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Head’s up!
A new potential treatment for androgenetic alopecia, also known as male pattern baldness, is making waves as a nationwide clinical trial to test its safety and effectiveness gets underway.
Proponents are abuzz about VDPHL01, a non-hormonal pill that shows promise in restoring hair without the hassle of topical treatments and the potentially serious side effects of hormonal medication.
“I emphasize non-hormonal because the only FDA-approved oral treatment for pattern hair loss has a hormonal mechanism of action and is associated with potential hormonal side effects like erectile dysfunction, decreased libido and suicidal thoughts,” Dr. Neil Sadick told The Post.
“Topical options also often have high discontinuation rates as they can be messy and cumbersome to apply,” added Sadick, a clinical professor of dermatology at Weill Cornell Medical College.
There’s no cure for androgenetic alopecia even as it affects over 80 million Americans. The US Food and Drug Administration has approved topical minoxidil (also known as Rogaine) and oral finasteride (brand name Propecia) to treat hair loss.
Here’s what you need to know about VDPHL01.
What is VDPHL01?
VDPHL01 is hawked by Veradermics, a biopharmaceutical company based in New Haven, Conn., which announced in December it raised $75 million to fund the new trial.
Veradermics recently developed a “modified release” oral minoxidil tablet. Sadick declined to say if VDPHL01 contains minoxidil.
“The trial sponsor, Veradermics, is choosing not to disclose additional information about the drug formulation at this time,” Sadick said.
“I can tell you that VDPHL01 has a unique profile unlike current FDA-approved treatments, which are associated with cardiac activity and unwanted sexual side effects,” he continued.
VDPHL01 is being studied as a once- or twice-daily pill. Sadick said preliminary Phase 2 data revealed hair growth as early as two months after treatment. This “encouraging” data should be available in the coming months, he noted.
Veradermics expects to file for an approval within a year of completion of its trials — if they go well.
How does VDPHL01 differ from other treatments?
Finasteride, which is sold as Proscar or Propecia, was approved by the FDA in the ’90s. An estimated 2.6 million people took finasteride in 2022.
The pill prevents testosterone from turning into another hormone called dihydrotestosterone (DHT). High levels of DHT can cause hair follicles to shrink, leading to hair loss.
While finasteride reduces hair loss and promotes hair growth, it’s intended only for men and can cause erectile dysfunction, decreased sex drive and depression, among other potential side effects.
The FDA, meanwhile, approved oral minoxidil in the ’70s to treat high blood pressure and topical minoxidil in the ’80s for hair loss.
Minoxidil increases blood flow to hair follicles, stimulating hair growth.
Side effects of the OTC med include scalp irritation, unwanted facial hair growth, chest pain, fast heartbeats and dizziness.
When asked about VDPHL01’s potential side effects, Sadick said that conversation is “best had between a study investigator and a potential trial participant.”
Who can participate in the VDPHL01 trial?
Sadick’s Manhattan office, Sadick Dermatology, is one of 44 US sites involved in the Phase 2/3 clinical trial of VDPHL01.
The goal is to enroll about 480 men across all study sites.
Sadick is seeking healthy men between 18 and 65 living in the NYC area and experiencing pattern hair loss. Applicants must be willing to keep their hair at least a quarter-inch long throughout the study.
Those selected will be compensated for their participation, which involves 13 visits to Sadick Dermatology over approximately 13 months. Enrolled patients will receive VDPHL01 or a placebo. Visit phlstudy.com or call (212) 772-7242 for more information or to sign up.
VDPHL01 is also being studied in women, with a Phase 3 clinical trial expected to start later this year.
