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doi: 10.1172/JCI84431 69 ONeillLAJKishtonRJRathmellJ

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This next-generation therapy offers broader genetic mutation coverage and features once-daily dosing, making it a compelling alternative to the existing standard treatment

The company explicitly states that these compounded medications "are not evaluated by the FDA for safety, quality or efficacy." TMates describes treatment pathways that may involve FDA-approved branded medications or compounded formulations, depending on patient eligibility, prescriber determination, state regulations, and availability

Additionally, in vivo pharmacokinetic (PK) parameters were evaluated to determine oral bioavailability, and pharmacodynamics were evaluated to determine the glucose-lowering effects in diabetic db/db mice