What is TB-500 (thymosin beta-4 fragment LKKTETQ)?
The short answer
TB-500 is a short, lab-made piece of thymosin beta-4, a protein found in the body.
What it is
Actin-binding piece of thymosin beta-4, studied in tissue research.
What people look into
Muscle and exercise
- 8 sources
- Status as of
- How we source
- Ellum doesn't sell peptides.
Get updates on TB-500 (thymosin beta-4 fragment LKKTETQ)
What it is
- Type
- Thymosin beta-4 fragment (7-aa peptide)
- Also known as
- thymosin beta-4 fragment, lkktetq
- How it works
- Actin-binding piece of thymosin beta-4, studied in tissue research.
Regulatory status
Not FDA-approved · advisory vote July 2026 · no FDA decision How we label status
As of October 4, 2026, TB-500 (thymosin beta-4 fragment LKKTETQ) is not FDA-approved. On July 23, 2026, FDA's compounding advisory committee voted to recommend adding it to the 503A bulks list; FDA staff had recommended against it. FDA has not proposed that change.
See TB-500 (thymosin beta-4 fragment LKKTETQ) in the Index →
- Federal (FDA)
- Not FDA-approved
- 503A compounding
- No category since 2026-04-22 (nomination withdrawn); PCAC recommended 2026-07-23/24; no proposed rule as of 2026-10-04 (as of October 4, 2026)
- PCAC history
- 2026-07-23: recommended 8-6-1 (free base and acetate; use reviewed: wound healing; count as read into FDA's meeting recording; written minutes not posted as of 2026-10-04); FDA staff: against
- WADA 2026
- S2.3
Timeline
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| Date | What happened | Source |
|---|---|---|
| Federal Register notice of an FDA Pharmacy Compounding Advisory Committee meeting lists TB-500 among bulk drug substances under consideration for the 503A bulks list. | Federal Register, event of April 16, 2026, on federalregister.gov | |
| FDA presentations for the Pharmacy Compounding Advisory Committee meeting cover TB-500 as a bulk drug substance under consideration for the 503A bulks list. | FDA, event of July 23, 2026, on fda.gov |
US enforcement actions
2 US enforcement actions since 2023.
Actions by US federal and state agencies whose documents name TB-500 (thymosin beta-4 fragment LKKTETQ). Each row links to the government's own document.
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| Date | Agency | Action | Document |
|---|---|---|---|
| US Justice Department | Indictment | Justice Department document, indictment, April 1, 2026, on justice.gov | |
| FDA | Warning letter | FDA document, warning letter, June 12, 2023, on fda.gov |
References
Sources as of October 4, 2026
- FDA: www.fda.gov/advisory-committees/advisory-committee-calendar/july-23-24-2026-meeting-pharmacy-compounding-advisory-committee-07232026
- FDA: www.fda.gov/media/193349/download
- FDA: www.fda.gov/media/193342/download
- Federal Register: www.federalregister.gov/documents/2026/04/16/2026-07361/pharmacy-compounding-advisory-committee-notice-of-meeting-establishment-of-a-public-docket-request
- FDA: www.fda.gov/media/94155/download
- FDA: www.fda.gov/drugs/human-drug-compounding/certain-bulk-drug-substances-use-compounding-may-present-significant-safety-risks
- WADA: www.wada-ama.org/sites/default/files/2025-09/2026list_en_final_clean_september_2025.pdf
- YouTube: youtube.com/live/DhDC0DAYdBI