TB-500
Synthetic peptide fragment (Ac-LKKTETQ, sequence 17-23) corresponding to the central actin-binding domain of human Thymosin Beta-4. Preclinically studied for actin regulation, cell migration, and tissue repair. Distinct from full-length 43-aa Thymosin Beta-4. Not FDA-approved.
60-Second Scientific Briefing
TB-500 is a synthetic peptide representing the active actin-sequestering fragment (Ac-LKKTETQ, residues 17-23) of naturally occurring thymosin beta-4. Studied preclinically for wound healing, cell migration, and actin regulation. It is NOT identical to full-length recombinant thymosin beta-4 and is NOT FDA-approved.
What is TB-500?
Pharmacological Classification & Molecular IdentitySynthetic acetylated 7-amino-acid peptide corresponding to the central actin-binding domain of human thymosin beta-4.
Verified Chemical & Regulatory Registry Identifiers
Mechanism of Action & Receptor Targets
Biological Pathway and Target BindingBiological pathway and target receptor binding mechanism.
Receptor Selectivity: Binds globular actin (G-actin), modulates actin filament polymerization, and stimulates keratinocyte and endothelial cell migration.
Regulatory & FDA Approval Status
Legal and Regulatory ClassificationsNot approved by the US FDA for human medicine. Classified under FDA 503A Category 2 with safety concerns. Banned by WADA under Category S0/S2.
TB-500 is not approved for commercial sale, prescription therapy, or compounded medication distribution. It exists strictly within authorized scientific and clinical research frameworks.
Human Evidence & Clinical Trials
Clinical Study Readouts and Evidence SynthesesNo completed human Phase 2/3 clinical trials exist for commercial TB-500 formulations; clinical trials were historically conducted on full-length 43-aa Thymosin Beta-4.
Clinical Evidence
No completed human Phase 2/3 clinical trials exist for commercial TB-500 formulations; clinical trials were historically conducted on full-length 43-aa Thymosin Beta-4.
Safety Profile & Clinical Limitations
Documented Adverse Events and Known UncertaintiesSystematic human safety and toxicology data are unestablished due to absence of rigorous human clinical trial programs.
Unknown impact on neoplastic cell motility and angiogenesis in human subjects.
Dose Approval Status
Commercial Dosing Status and Policy DirectivesNOT ESTABLISHED. No approved human dose or clinical protocol exists.
Under Egypt Peptides medical governance policies, no personal dosages, titration intervals, cycles, stacking recommendations, or self-injection instructions may be provided for unapproved investigational compounds. Clinical study protocols represent controlled experimental research parameters exclusively.
What is Known vs. What is Unknown
Evidence Comparison and Clinical Evidence Boundaries✓ Confirmed Scientific Evidence
- Synthetic acetylated 7-amino-acid peptide corresponding to the central actin-binding domain of human thymosin beta-4.
- Targets & Selectivity: Binds globular actin (G-actin), modulates actin filament polymerization, and stimulates keratinocyte and endothelial cell migration.
- No completed human Phase 2/3 clinical trials exist for commercial TB-500 formulations; clinical trials were historically conducted on full-length 43-aa Thymosin Beta-4.
- Safety considerations: Systematic human safety and toxicology data are unestablished due to absence of rigorous human clinical trial programs.
? Unknown / Under Ongoing Investigation
- Unknown impact on neoplastic cell motility and angiogenesis in human subjects.
Verified Questions & Answers
10 Verified scientific answers with permanent anchor keysTB-500 is classified as a Actin-Sequestering Peptide Fragment. Molecular structure: Synthetic acetylated 7-amino-acid peptide corresponding to the central actin-binding domain of human thymosin beta-4..
Pharmacological classification and molecular integrity are documented in verified regulatory and scientific literature.
- Animal studies with thymosin beta, a multifunctional tissue repair and regeneration peptide (Annals of the New York Academy of Sciences, 2010-04-01)
TB-500 exerts biological activity via Binds globular actin (G-actin), modulates actin filament polymerization, and stimulates keratinocyte and endothelial cell migration..
Receptor binding affinity and selectivity dictate the physiological response observed in laboratory and clinical trials.
- Animal studies with thymosin beta, a multifunctional tissue repair and regeneration peptide (Annals of the New York Academy of Sciences, 2010-04-01)
Regulatory status: Not approved by the US FDA for human medicine. Classified under FDA 503A Category 2 with safety concerns. Banned by WADA under Category S0/S2.
Investigational and research-only compounds cannot be legally distributed or marketed as prescription drugs.
- World Anti-Doping Agency (WADA) Prohibited List: Non-Approved Substances (S0) and Peptide Hormones (S2) (World Anti-Doping Agency, 2024-01-01)
- FDA Bulk Drug Substances Used in Compounding Under Section 503A of the FD&C Act (Category 2 Safety Evaluation) (U.S. Food and Drug Administration, 2023-09-29)
Clinical evaluation status: No completed human Phase 2/3 clinical trials exist for commercial TB-500 formulations; clinical trials were historically conducted on full-length 43-aa Thymosin Beta-4.
Clinical trial readouts and systematic analyses establish the boundary between demonstrated findings and experimental hypotheses.
- FDA Bulk Drug Substances Used in Compounding Under Section 503A of the FD&C Act (Category 2 Safety Evaluation) (U.S. Food and Drug Administration, 2023-09-29)
- Animal studies with thymosin beta, a multifunctional tissue repair and regeneration peptide (Annals of the New York Academy of Sciences, 2010-04-01)
Reported safety profile: Systematic human safety and toxicology data are unestablished due to absence of rigorous human clinical trial programs.
Adverse reaction monitoring and contraindications are critical parameters in pharmacological risk-benefit evaluation.
- FDA Bulk Drug Substances Used in Compounding Under Section 503A of the FD&C Act (Category 2 Safety Evaluation) (U.S. Food and Drug Administration, 2023-09-29)
Key scientific uncertainties: Unknown impact on neoplastic cell motility and angiogenesis in human subjects.
Egypt Peptides enforces strict transparency regarding scientific limitations and gaps in longitudinal clinical data.
- FDA Bulk Drug Substances Used in Compounding Under Section 503A of the FD&C Act (Category 2 Safety Evaluation) (U.S. Food and Drug Administration, 2023-09-29)
NOT ESTABLISHED. No approved human dose or clinical protocol exists.
Under medical governance mandates, clinical study dosages represent strictly controlled experimental parameters and must never be interpreted as individual therapeutic advice.
- FDA Bulk Drug Substances Used in Compounding Under Section 503A of the FD&C Act (Category 2 Safety Evaluation) (U.S. Food and Drug Administration, 2023-09-29)
Storage status: NOT ESTABLISHED. Chemical research standard storage requires -20°C lyophilized or 2-8°C short-term laboratory handling.
Peptide integrity degrades rapidly when exposed to elevated temperatures, repeated freeze-thaw cycles, or direct UV light exposure.
- FDA Bulk Drug Substances Used in Compounding Under Section 503A of the FD&C Act (Category 2 Safety Evaluation) (U.S. Food and Drug Administration, 2023-09-29)
Yes. Unapproved pharmacological substances are strictly prohibited at all times in competitive sports under WADA Category S0 (Non-approved substances) or Category S2.
Athletes subject to drug testing face strict liability and multi-year competition bans upon detection of prohibited peptides or their metabolites.
- World Anti-Doping Agency (WADA) Prohibited List: Non-Approved Substances (S0) and Peptide Hormones (S2) (World Anti-Doping Agency, 2024-01-01)
- FDA Bulk Drug Substances Used in Compounding Under Section 503A of the FD&C Act (Category 2 Safety Evaluation) (U.S. Food and Drug Administration, 2023-09-29)
Egypt Peptides provides peer-reviewed scientific reference monographs for research documentation. We strictly prohibit individual medical consultations, reconstitution guides, stacking recipes, or off-label use instructions.
All scientific claims must link to verified authoritative sources (FDA, PubMed, ClinicalTrials.gov) with zero tolerance for ungrounded marketing claims.
- Animal studies with thymosin beta, a multifunctional tissue repair and regeneration peptide (Annals of the New York Academy of Sciences, 2010-04-01)
Authoritative Sources & Literature Registry
Regulatory dossiers, clinical trial registries, and peer-reviewed studiesWorld Anti-Doping Agency (WADA) Prohibited List: Non-Approved Substances (S0) and Peptide Hormones (S2) ↗
https://www.wada-ama.org/en/prohibited-list
FDA Bulk Drug Substances Used in Compounding Under Section 503A of the FD&C Act (Category 2 Safety Evaluation) ↗
https://www.fda.gov/drugs/human-drug-compounding/bulk-drug-substances-used-compounding-under-section-503a-fdc-act
Animal studies with thymosin beta, a multifunctional tissue repair and regeneration peptide ↗
https://doi.org/10.1111/j.1749-6632.2010.05479.x