Magic pill for baldness: scientists seek volunteers for testing

Scientists have developed a pill to treat androgenetic alopecia, known as male pattern baldness. A nationwide clinical trial to test the drug's safety and effectiveness has begun, reports NYPost.

There is no cure for androgenetic alopecia, although more than 80 million Americans suffer from it. The Food and medicines The U.S. Food and Drug Administration (FDA) has approved topical minoxidil (known as Rogaine) and oral finasteride (brand name Propecia) for treatment hair loss.

VDPHL01 is a non-hormonal pill. The new drug promises to restore hair without the hassle of topical treatments and the potentially serious side effects of hormonal drugs.

"This drug is non-hormonal. The only FDA-approved oral treatment for hair loss has a hormonal mechanism of action and is associated with potential hormonal side effects. It can cause erectile dysfunction, decreased libido and suicidal ideation," said Dr. Neil Sadik.

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"Topical options often have high discontinuation rates because they can be inconvenient and cumbersome to use," added Sadik, a clinical professor of dermatology at Weill Cornell Medical College.

What is VDPHL01

VDPHL01 is marketed by Veradermics, a biopharmaceutical company based in New Haven, Connecticut. In December, the company announced it had raised $75 million to fund the new study.

Veradermics recently developed a “modified-release” oral minoxidil tablet. Sadik declined to say whether VDPHL01 contains minoxidil.

"The sponsor of the Veradermics study chooses not to disclose further information about the drug's formula at this time," he noted.

“I can tell you that VDPHL01 has a unique profile, unlike current FDA-approved treatments, which are associated with cardiac and sexual side effects,” the professor said.

The VDPHL01 tablet is taken once or twice daily. Sadik said preliminary data from the phase XNUMX study showed hair growth as early as two months after treatment. These “encouraging” data should be available in the coming months, he said.

Veradermics expects to apply for approval within a year of completing its trials - if they are successful.

How VDPHL01 is different from other treatments

Finasteride, which is sold as Proscar or Propecia, was approved by the FDA in the 1990s. An estimated 2022 million people took finasteride in 2,6.

The pills prevent testosterone from being converted into another hormone called dihydrotestosterone (DHT). High levels of this can cause hair follicles to shrink. This leads to hair loss.

Although finasteride reduces hair loss and promotes hair growth, it is only intended for men. It can cause erectile dysfunction, decreased libido, and depression, among other potential side effects.

Meanwhile, the FDA approved oral minoxidil in the 1970s to treat high blood pressure and topical minoxidil in the 1980s to treat hair loss.

Minoxidil increases blood flow to the hair follicles, stimulating hair growth.

Side effects of the over-the-counter drug include scalp irritation, unwanted facial hair growth, chest pain, rapid heartbeat, and dizziness.

When asked about possible side effects of VDPHL01, Sadik said the conversation "is best between the researcher and the potential trial participant."

Who can participate in the VDPHL01 trial?

Sadick's Manhattan office, Sadick Dermatology, is one of 44 centers in the U.S. participating in the Phase 2/3 VDPHL01 clinical trial.

They are recruiting 480 men across all study sites.

The Sadick Center is seeking healthy men aged 18 to 65 who live in the New York City area and are experiencing hair loss. Candidates must be willing to maintain their hair length at least 0,635 centimeters for the duration of the study.

Volunteers will be compensated for their participation. They will have 13 visits to Sadick Dermatology over approximately 13 months. Enrolled patients will receive VDPHL01 or placebo.

Visit research site or call (212) 772-7242 for more information or to register.

The effects of VDPHL01 in women are also being studied, with a Phase 3 clinical trial expected to begin later this year.