Thymosin Beta-4
Overview
Promotes healing and reduces inflammation for various pain types.
Reported benefits
Multi-tissue pain relief, healing promotion, inflammation control
Protocols & dosing
Typical dosage: 2-10 mg (weekly).
Detailed dosing protocols have not yet been catalogued.
FDA & legal status
Thymosin Beta-4 is not currently FDA-approved for any indication. Effective April 22, 2026, the FDA removed Thymosin Beta-4 from Category 2 of its Section 503A bulk drug substances list after the original nominators withdrew their nominations. This removal lifts the prior “significant safety risk” designation but does not place Thymosin Beta-4 on the 503A Bulks List. Compounding pharmacies may prepare it with a valid physician prescription and pharmaceutical-grade API from an FDA-registered manufacturer. The FDA’s Pharmacy Compounding Advisory Committee (PCAC) is scheduled to review this substance at its July 23–24, 2026 public meeting. Removed from FDA Category 2 effective April 22, 2026. Selected for PCAC review Day 1 — July 23, 2026. PCAC agenda: BPC-157, KPV, TB-500, MOTS-c. NOT currently on 503A Bulks List — requires physician Rx. Source: FDA Advisory Committee Calendar / Lengea Law, May 2026.
| Country | Status |
|---|---|
| United States | Category 2 removed — compounding permitted with Rx (as of Apr 22, 2026) |
| United Kingdom | Prescription-only / not licensed |
| Canada | Prescription-only / Schedule F if licensed |
| Australia | TGA-scheduled |
Vendor information
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Side effects & safety
Reported side effects: Well-tolerated
References
No external sources have been catalogued for this article yet.