A Systematic Review on Drug Re-Profiling/Re-Purposing

The conversation discusses the safety study of PP405, emphasizing that early trials focus on safety rather than efficacy, and that any efficacy data from such a short study should be viewed skeptically. It also highlights that the information released is primarily for securing funding, and that meaningful efficacy results are expected in later phases.

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 conversation discusses potential hair loss treatments, including clascoterone, GT20029, ET-02, VDPHL01, and PP405, with hopes for new options by 2028. Current treatments like minoxidil and finasteride are expected to remain effective, with clascoterone and VDPHL01 as promising alternatives.

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 trial for TDM-105795 has been completed, and it was in phase 2A. The discussion seeks input on the next phases, 2B or 3, based on safety and efficacy.

OP seeks advice on alternative hair loss treatments like Redensyl, Capixyl, and Procapil, instead of lifelong Minoxidil and Finasteride. Users suggest hair transplants and discuss the potential future availability of better treatments.