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The FDA notes compounded drugs can be useful but warns they pose higher risks since they're not reviewed for safety, effectiveness, or quality

PIO = pioglitazone

While safety and tolerability have traditionally been used as go/no-go criteria in early-phase clinical trials (Stallard et al., 2001), a growing repertoire of biomarkers that can be used to evaluate short-term intervention effects, such as target engagement, pharmacodynamics, and effects predictive of clinical benefit, may additionally be used to inform go/no-go decisions and over time begin to reduce the number of negative phase 3 clinical trials (Boxer and Sperling, 2023