TB-500 / Thymosin Beta-4 2 mg vial price

Human trials of full-length thymosin beta-4 were run for wound, eye and cardiac conditions and were generally well tolerated. A nine-patient dry eye trial reported significant improvement in signs and symptoms; the larger trials did not, with three totaling 1,618 patients meeting no co-primary endpoint. TB-500 as sold is a fragment with no trial record of its own. As of October 28, 2026, Appendix B of the announced HHS section 503A policy covers TB-500 acetate, the N-acetylated seven-residue fragment, not full-length thymosin beta-4 for subcutaneous or intramuscular injectable dosage forms. HHS states that it "does not intend to take enforcement action against a State-licensed pharmacy, Federal facility, or licensed physician" when all policy conditions are met, including a patient-specific prescription and only a single Appendix A active pharmaceutical ingredient. This is interim, nonbinding enforcement discretion under a policy described as draft in the notice, not FDA approval or final placement on the 503A bulks list.