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Category 1 Bulk substance the FDA considers eligible for use in compounding pending final rulemaking Generally permitted Category 2 Bulk substance the FDA has significant safety, identity, or quality concerns about Not permitted during review Category 3 Substance requiring further evaluation Case-by-case Critically, Category 1 status is not FDA approval
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Additionally, the phase 2 MOMENTUM clinical trial of pemvidutide (a dual GLP-1/GCG agonist) showed that only 21.9% of WL was attributable to reductions in lean mass at 48 weeks (overall WL 10.315.6% across doses) [64]
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