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Description

Frequent side effects comprise nausea, flushing, and headache

Key mechanistic observations from laboratory studies: G-actin sequestration: TB-500 binds monomeric G-actin, regulating the pool available for filament polymerization

Per NCCI policy, the E/M component inherent to administering an injection (confirming the drug, route, and patient tolerance) is bundled into CPT code 96372 and does not independently support a separately billed E/M

Not confirmed at the pivotal stage: The Phase 3 CeD-Lara trial (~525 patients) did not meet its primary endpoint and was discontinued in 2022 a positive mid-stage signal that failed to replicate [6]