New Hair Loss Treatments: PP405, Clascoterone and What Is Next

This page lists each drug, its trial stage and dates, and what the companies have reported. We report trial readouts only. A trial result is not an approval, and most of these results are not yet in peer-reviewed journals. Statuses here were checked on 14 Nov 2026 and will change.

Status table: new hair loss treatments

Phase 1 trials test safety in a few people. Phase 2 tests whether it works in more. Phase 3 is the large test the FDA usually needs before approval.

Clascoterone for hair loss (Breezula)

Clascoterone is not a new molecule. The FDA already approved it as a cream for acne under the name Winlevi. Its label calls it "an androgen receptor inhibitor indicated for the topical treatment of acne vulgaris" (DailyMed: Winlevi label). An androgen receptor is the spot on a cell that male hormones like DHT latch onto. Clascoterone blocks that spot on the skin. The hair loss version is a 5% scalp solution, and you may see it called Breezula online. That use is not approved.

Its maker, Cosmo Pharmaceuticals, ran two phase 3 trials called SCALP 1 and SCALP 2. Dermatology Times reports the program "enrolled 1,465 male participants across 51 study centers in the United States and Europe" (Dermatology Times). Men used it for 6 months, then some kept going and some switched to a dummy liquid.

What the company reported at 12 months: "Twelve-month safety and tolerability were comparable to vehicle, with no significant systemic endocrine effects". Vehicle means the same liquid without the drug. Systemic endocrine effects means hormone changes across the whole body. It also reported that continuing the drug gave "a statistically significant 2.39-fold greater improvement versus switching to vehicle after 6 months".

These are company results passed on by a trade outlet. The full data still needs FDA review. The first trial is listed on ClinicalTrials.gov as completed.

PP405

PP405 comes from Pelage Pharmaceuticals. It works a different way. Drug Topics reports that it "targets the primary biological pathway that controls the natural hair growth cycle" by acting on "hair follicle stem cells", which it says remain even in balding areas (Drug Topics, June 2025).

The phase 2a trial was small and short. Drug Topics says "The study cohort included 78 patients aged 18 to 55 years" and that patients used the gel or a dummy gel "once per day for 4 weeks and were followed for up to 12 weeks". The trial "met its primary safety endpoint". Its main aim was to test safety, not how well it grows hair.

The next step is now under way. ClinicalTrials.gov lists a phase 2/3 trial of PP405 in adult men as recruiting (ClinicalTrials.gov: NCT07819435). Efficacy means how well it works. Results from that trial are needed before anyone can say PP405 regrows hair.

Pyrilutamide (KX-826)

Pyrilutamide comes from Kintor Pharmaceutical in China. Like clascoterone, it blocks the hormone signal on the scalp. A PharmCube report from March 2026 says the phase 3 trial in China "met its primary efficacy endpoint" and that "The 1.0% dose increased hair count by 10.65 hairs/cm² more than the placebo" (PharmCube, 20 Mar 2026). A placebo is a dummy liquid, like a sugar pill.

It adds that "Kintor plans to submit a new drug application for the 1.0% formulation in the near future". That filing is for China. We found no US phase 3 trial or US filing for it.

VDPHL01: a slow-release minoxidil pill

Not every new option is a new drug. Veradermics is testing a new form of an old one. Dermatology Times describes VDPHL01 as "an investigational extended-release oral formulation of minoxidil" (Dermatology Times, November 2026). Extended-release means the pill lets the drug out slowly.

The company reported 12-month results from a trial in 519 men in November 2026. The report says safety over 12 months "showed no treatment-related serious adverse events, cardiac adverse events of special interest, or new signals". An adverse event is a side effect. The aim of slow release is to avoid sharp peaks of the drug in the blood. Oral minoxidil in its current form is already prescribed off-label for hair, covered in our oral minoxidil guide.

What to watch with new treatment news

• Company releases come first. Most results above are from the makers. Peer-reviewed papers and FDA review come later.
• Topline means a summary. Topline results give the main numbers, not the full data.
• Approval takes time. Even after a filing, FDA review usually takes many months.
• Gray-market sellers. Some websites sell unapproved versions of these drugs. They have no FDA review of what is in the bottle. We do not list them.

What you can get today

Two drugs have FDA approval for male pattern hair loss right now, and two more are prescribed off-label:

Hair you keep now is easier to hold than hair you try to regrow later. Waiting for a new drug has a cost. Our finasteride for hair loss guide covers the approved pill. Every program, scored on price and care, is on the best online hair loss programs.