TB-500 and Cannabis Interaction Profile: What the Evidence Actually Shows
At a glance
- Compound / synthetic 7-amino-acid, N-acetylated fragment of thymosin beta-4 [1]
- Approval / not FDA-approved; FDA found no approved product in Canada, Australia, the UK or the EU countries it checked [1]
- Human studies of TB-500 / none found [1]
- TB-500 with cannabis / no study found
- Stated concern for the injectable / immunogenicity, possibly amplified by aggregation and impurities [1]
- Sport / WADA category S2.3; prohibited at all times [3]
Is there a known interaction between TB-500 and cannabis?
No. FDA's July 2026 evaluation found no published article in which TB-500 was given to a person, and none of the three papers the nominator cited involved TB-500 in humans [1]. With no human data on TB-500 alone, there is nothing from which to describe how cannabis would change its effects or risks.
What TB-500 is and what is known about it
TB-500 is a synthetic 7-amino-acid, N-acetylated fragment (residues 17 to 23) of the 43-amino-acid protein thymosin beta-4; it is not full-length thymosin beta-4 and not thymosin alpha-1 [1]. Animal studies indicate it reaches the bloodstream after subcutaneous or intraperitoneal injection and is broken down into smaller peptides; FDA found no human pharmacokinetic or pharmacodynamic data [1]. There is no approved dose [1].
What safety information exists
An FDA adverse-event database search through March 26, 2025 retrieved no TB-500 reports, and its food and supplement complaint system returned two cases about a blended TB-500 and BPC-157 product with no safety assessment [1]. FDA found no nonclinical toxicity studies and no immunogenicity studies of TB-500 [1].
FDA's BPC-157 review describes a 40-year-old woman who used a research-purpose BPC-157 plus TB-500 (5 mg/5 mg) product subcutaneously twice daily and developed widespread skin hyperpigmentation and gum darkening within a week, recurring when she tried it again two weeks later; because the product held two peptides, FDA said it could not tell whether either caused it [2].
Regulatory status
FDA found no USP or National Formulary monograph for TB-500, no FDA-approved drug containing it, and no approved product in Canada, Australia, the UK, Belgium, Ireland, France, Norway, Germany, Spain or Italy, or authorized by the European Medicines Agency [1]. It sits in the 'nominated but withdrawn' table of FDA's page on bulk substances that may present significant safety risks; removal from the older category 2 was not a finding that it is safe [4].
FDA's advisory committee voted on July 23, 2026 in favor of adding it to the bulks list, against FDA staff's recommendation; that advice is non-binding and TB-500 is not on the list [5][6]. A separate HHS draft policy, filed October 28, 2026, says HHS does not intend to take enforcement action against certain state-licensed pharmacies and physicians compounding TB-500 acetate for injection if its conditions are met; it is a non-binding draft, not an approval [6].
WADA names 'Thymosin-beta4 and its derivatives e.g. TB-500' in S2.3, prohibited at all times, in 2026 and on the 2027 List [3][7].
For someone using cannabis
Whether cannabis changes TB-500's effects, or the reverse, has not been measured in any study found. The one safety concern FDA states for injectable TB-500 is immunogenicity, potentially amplified by peptide aggregation and impurities [1]; no source links that concern to cannabis.
Frequently asked questions
Does cannabis interact with TB-500?
Is TB-500 FDA approved?
What safety concerns are reported for TB-500?
References
- U.S. Food and Drug Administration. U.S. Food and Drug Administration
- U.S. Food and Drug Administration. U.S. Food and Drug Administration
- World Anti-Doping Agency. World Anti-Doping Agency
- Certain Bulk Drug Substances for Use in Compounding that May Present Significant Safety Risks | FDA. Certain Bulk Drug Substances for Use in Compounding that May Present Significant Safety Risks | FDA
- U.S. Food and Drug Administration. U.S. Food and Drug Administration
- Official web page. Official web page
- World Anti-Doping Agency. World Anti-Doping Agency