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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.

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.

Stem cell hair transplants are not FDA approved and remain theoretical, with concerns about effectiveness and safety. Current treatments like finasteride and minoxidil are still the main options, while hair cloning and new drug cures are likely years away.

People are discussing why some choose finasteride over dutasteride for hair loss, noting that while dutasteride is more effective, it's also more expensive, less researched, and potentially has more side effects. Some users shared personal experiences with side effects from both drugs, and others mentioned that finasteride is FDA approved for hair loss, while dutasteride is not, except in Japan.