thymosin beta-4 fragment peptide
Is TB-500 legal?
Answer
TB-500 is not authorised or registered in any of the 10 registers read.
Each row is what that country's own register said on the date shown. Not legal advice.
| Country | Status | Products on the register | Register | Read |
|---|---|---|---|---|
| United States | Not on the register | - | Regulator FDA | 2026-10-03 |
| European Union | Not on the register | - | Regulator EMA | 2026-08-31 |
| United Kingdom | Not on the register | - | Regulator MHRA | 2026-09-03 |
| Canada | Not on the register | - | Regulator Health Canada | 2026-09-03 |
| Australia | Status unknown | - | TGA | Not read yet |
| Switzerland | Not on the register | - | Regulator Swissmedic | 2026-09-03 |
| Brazil | Not on the register | - | Regulator ANVISA | 2026-09-03 |
| Serbia | Not on the register | - | Regulator ALIMS | 2026-09-03 |
| Singapore | Not on the register | - | Regulator HSA | 2026-09-03 |
| Turkey | Not on the register | - | Regulator TITCK | 2026-09-03 |
A country not listed has no register read yet; see the world map. EU decisions also apply in Iceland, Liechtenstein and Norway.
FDA COMPOUNDING LIST (503A)
TB-500 is on FDA's 503A bulk-substances list (nominated for compounding, withdrawn by the nominator).
Compounded drugs containing thymosin Beta-4, Fragment (LKKTETQ) may pose risk for immunogenicity for certain routes of administration due to the potential for aggregation as well as peptide-related impurities. FDA has not identified any human exposure data drug products containing Thymosin Beta-4, Fragment. FDA lacks important information regarding any safety issues raised by this drug, including whether it would cause harm if administered to humans.
Regulator FDA list, read 2026-10-03. Not legal advice.
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