A First-of-Its-Kind Hair Loss Pill Could Be On Its Way

17.10.2025, 22:59 allure.com

The landscape of oral medication options for hair loss hasn’t changed very much over the past few decades. Oral finasteride (aka Propecia) was approved by the FDA for the treatment of hair loss in men in 1997, and doctors began prescribing oral minoxidil (which is approved to treat hypertension) off-label in the 2010s. And that’s pretty much it. But we might not be all that far away from one of the most significant developments in the hair-loss field in decades: a reimagining of oral minoxidil.

Biopharmaceutical company Veradermics announced this week that it has secured financing for the phase three trials it needs to get FDA approval for a drug, currently known as VDPHL01, that would be the first extended-release oral minoxidil treatment designed specifically for hair regrowth in women and men.

While topical minoxidil (you probably know it by its most popular brand name, Rogaine) is indicated specifically for treating hair loss, oral minoxidil is only FDA-approved for the treatment of hypertension. So while oral minoxidil has been shown to have the ability to regrow hair, it’s technically being used “off label” when prescribed for hair loss—as it often is today, even available as adorable little gummies through online providers like Hers.

But despite its proven efficacy, oral minoxidil isn’t a perfect hair growth medication, which is what Veradermics aims to change with its new version of the drug. “Minoxidil comes into the body very rapidly. It spikes, and then it goes away, because it wants to rapidly lower your blood pressure. Great for blood pressure; not ideal for treating hair loss,” board-certified dermatologist and Veradermics CEO Reid Waldman, MD, tells Allure. “We saw an opportunity to take this ingredient that we recognize works for hair growth and optimize it for oral administration, hair growth, and cardiac safety by changing the way in which it interacts with your body.” With VDPHL01, Dr. Waldman explains, Veradermics intends to extend the length of time during which minoxidil is released throughout the body, allowing for sustained exposure at the hair follicle level while also avoiding spikes that can cause cardiac events. In other words, more hair-growth benefits and fewer risks.

“Nothing, nothing has been new in the field of androgenetic hair loss for almost three decades,” says Jerry Shapiro, MD, a board-certified dermatologist and dermatology professor at New York University who was involved in earlier clinical trials for VDPHL01. (Androgenetic alopecia is otherwise known as male and female pattern hair loss.) “I'm excited that there's something new, and also something [approved] for women, because there was really nothing except for topical minoxidil… and we need more things for women that are effective and that are approved by the FDA.”

Proven effectiveness and FDA approval for VDPHL01 would be a boon for both women and men, given the current lack of approved oral hair loss medications that work across the gender spectrum. Take finasteride, for example: It works by blocking DHT, a male hormone produced by testosterone, that can lead to hair loss in men and women. But because finasteride can cause birth defects, many doctors won’t prescribe it to women of childbearing age. In men, it’s been associated with side effects like erectile dysfunction and decreased libido. Some research has also found that finasteride isn’t as effective in women as it is in men. So while many patients have seen low-risk success with finasteride and the oral minoxidil currently available, there’s clearly room for improvement in both effectiveness and safety in this space.

We’ll still need to be patient, though—VDPHL01 is just entering phase-three trials now. A representative for Veradermics says that the trials for men will be completed in 2026, and those for women will follow. What will they involve? “[There will be] double-blind tests at hundreds of approved clinical testing centers to prove that this product meets all the criteria to treat the condition it is indicated for with benefits across a specific population,” says Ava Shamban, MD, a board-certified dermatologist who has extensive experience helping the FDA conduct pre-approval clinical trials. “This involves baseline screenings, treatment, and then potentially testing, photography, measurements, and other means for data collection weekly, monthly, bimonthly, etcetera, through the duration of the study period.”

Dr. Waldman tells Allure that Veradermics anticipates having approximately 1,500 participants who have androgenetic alopecia participate in the trials. (At this time, trials are not focused on any other types of hair loss.) Veradermics expects to submit a New Drug Application in 2027, and standard FDA approvals are typically obtained within 10 to 12 months of submission.

Once approved, it’s hard to say what patients can expect to pay for VDPHL01. “I welcome any new innovations in the drug that allow for better tolerability or efficacy, but I hope it’s not at the expense of affordability,” says board-certified dermatologist Dhaval Bhanusali, MD, noting that oral minoxidil is currently available for less than $15 per month. “While I hope we have more and more solutions for our patients, we want to make sure they also can access them."

So, yes, a few years and a few questions stand between hair-loss patients and VDPHL01 (which we assume will find a catchier name by the time it makes its debut). But for dermatologists familiar with its development, it’s worth the wait. “I really think this is going to be a pivotal product,” says Dr. Shapiro. “It looks very, very promising that it works quicker in terms of the swiftness of the response and the hair density. We finally have something that really works.”

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