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.
The conversation is about a user seeking information on a clinical trial by Amplifica - Scube3 for Androgenetic Alopecia (AGA). The user is unsure if it's a formal phase 1 study.
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 user considering joining a clinical study for Clascoterone (Breezula) after experiencing no results with topical finasteride and minoxidil, and side effects from oral finasteride. The user is seeking advice on clinical study participation and experiences.
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.