Re-Innovation in Clinical Trial Designs Based on Precision Therapy

PP405 trials have completed phase 2a, showing promising results with a 31% stat for hair density increase, and are moving directly to phase 3. Detailed results will be presented at a medical conference in 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.

PP405's phase 2a trial results were presented, focusing on safety and pharmacokinetics, with a future meeting planned to share the full dataset. The trial includes a randomized controlled portion and an open-label extension, with no indication of phase 2B completion.

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.

PP405 is a new hair loss treatment targeting dormant hair follicles, with ongoing trials. Some users consider stopping finasteride and minoxidil to join trials, while others doubt its effectiveness.

Pelage is delaying the start of phase 3 trials for PP405 to 2026 due to necessary regulatory processes, despite having $120 million in funding. Users discuss the potential of PP405 for hair regrowth, with some expressing skepticism and others hopeful for new treatments like Breezula.