● TIER 3 — Information onlyGRADE B (Tβ4) / C (TB-500)Healing / repair
TB-500 / Thymosin β4
Actin-binding peptide. Research verification: Yes (TGA pending). 1 human study record(s) in the FitClinicMD studies database.
GOALS · Recovery / injury
FDA status
Not approved.
Compounding (503A/503B)
Removed from 503A Category 2 on ~Apr 22 2026 after nominations were withdrawn; PCAC voted Jul 23-24 2026 to recommend 503A bulks-list inclusion, but no rulemaking yet, so not lawfully compoundable and not in Category 1. FDA list:
DEA
Not controlled.
WADA (sport)
S2.3 Growth factors & modulators (IGF-1/mecasermin & analogues, MGFs, thymosin-β4 & derivatives e.g. TB-500, HGF)
Mechanism
Tβ4 sequesters G-actin; TB-500 = LKKTETQ fragment.
Human evidence · 1
Trial Thymosin beta 4 ophthalmic solution for dry eye: a randomized, placebo-controlled, Phase II clinical trial conducted using the controlled adverse environment (CAE™) model.
Reference only. This page summarizes publicly available regulatory and research information about TB-500 / Thymosin β4. It is not a prescription, an endorsement, or an offer to dispense, and regulatory status can change. Clinicians should verify current status before prescribing or compounding.
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