The FDA policy change may speed up approval for hair loss drugs like PP405, VDPHL-01, and Breezula by potentially eliminating the need for a second confirmatory Phase 3 trial. Approval timelines could be as early as 2028 for some treatments if Phase 3 results are strong.
The FDA will now require only one clinical trial for drug approval, potentially speeding up the release of hair loss treatments like PP405. Pelage is expected to present full results of PP405 Phase 2a trials and move to Phase III in mid-2026.
The conversation is about a new acne treatment cream called Clascoterone Cream 1%, which is the first new mechanism of action for acne in nearly 40 years. One person joked about hoping their face will be as clean as their bald head after using the cream.
A new hair loss protocol using FDA-approved topical treatments targets eight pathways, potentially improving results by 60-75% compared to the standard 40-50% from oral minoxidil and finasteride. The protocol includes minoxidil, finasteride, tacrolimus, cetirizine, bimatoprost, lithium gluconate, losartan, melatonin, NAC, caffeine, and tretinoin, with a monthly cost of $35-50 in Mexico and $80-150 in the US.
The conversation is about creating a higher concentration of the newly FDA-approved hair loss treatment, Clascoterone (Winlevi), through compounding pharmacies and possibly organizing group purchases. Some users are unfamiliar with Winlevi and are asking for an explanation of the drug.