FDA Trial-design UncertaintyProgression to mid-stage development depends on favorable Phase 1 results and alignment with the FDA on study design, creating regulatory and development uncertainty that could affect timelines and outcomes.
Formulation Availability DelayUse of separate tablets in the mid-stage study means a co-formulated single-pill option would only be evaluated later, potentially delaying access to a convenient fixed-dose product for patients.
Tolerability ConcernsPrevious clinical data showed hair thinning occurred more often with active treatment than placebo, posing a tolerability risk that could limit patient acceptance and prescriber uptake.