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Regulatory Status Summary (as of July 29, 2026) Category 2 restricted status: Removed (April 2026) FDA approval: None USP/NF monograph: None 503A Bulks List: PCAC recommended inclusion (July 2324, 2026, nonbinding)

The dose-dependent activation of the FAK-paxillin pathway has been documented in multiple studies

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Changes in body composition directly affect cardiovascular health, joint stress, energy, and disease risk

(1) Given that osteoarthritis (OA) is the leading indication for arthroplasty and obesity is the most significant modifiable risk factor for OA development, it is unsurprising that a substantial proportion of arthroplasty patients are affected by obesity