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no official package insert Clinical trial status / No completed Phase III trials in humans for TB-500 specifically Bulk drug substance status / Subject to ongoing FDA review for compounding eligibility DEA scheduling / TB-500 is not a controlled substance Key safety concern / No large-scale human safety data from randomized controlled trials Regulatory trend / FDA has increased scrutiny of peptide compounding since 2023 Parent molecule research / Thymosin beta-4 studied in wound healing and cardiac repair preclinical models TB-500 Has No FDA Approval TB-500 has never been submitted to or approved by the FDA through a New Drug Application (NDA) or Biologics License Application (BLA)
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-20C, 1 month (sealed storage, away from moisture) Solvent & Solubility In Vitro : H 2 O : 100 mg/mL ( 70.45 mM ) DMSO : 50 mg/mL ( 35.22 mM
