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because rigorously controlled human safety data specific to the TB-500 fragment does not exist, its longer-term risk profile, including possible immune reactions, remains unknown Evidence snapshot: Evidence for TB-500 itself is preclinical, drawn mainly from cell-culture and animal studies (a 1999 rat wound-healing study and later rodent cardiac- and tendon-injury models), with a 2026 scoping review describing the musculoskeletal literature on thymosin beta-4 and TB-500 as sparse and largely preclinical

Conversely, TB-500 is highly sensitive to gastric enzymes

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3 It is widely accepted that the initial wave of C-fiber activity in phase 1 leads to phase 2, which depends on the inflammatory response and central sensitization