61%
Faster Re-epithelialization
vs controls at 7 days in rat wound model
⚠️ FOR RESEARCH PURPOSES ONLY — This compound is not FDA approved. All data presented is from clinical trials for educational reference.
Regenerative Peptide
TB-500
Thymosin Beta-4Tβ4TB4Thymosin β4
A 43-amino acid synthetic fragment of thymosin beta-4 that regulates actin polymerization and promotes cell migration in preclinical research. Premium Research Peptide.
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1
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No
Serious Adverse Events
Phase 1 trial with 42-1260mg IV doses
170+
Cited Studies
Goldstein et al. review cited 170+ times
43
Amino Acids
Naturally occurring peptide sequence
0.95-1.9hrs
Half-Life
Dose-dependent (42-1260mg IV)
How TB-500 Works
The Science, Simplified
Multi-Pathway Regeneration Mechanism
Thymosin Beta-4 (TB-500) is a naturally occurring 43-amino acid peptide that plays a vital role in tissue repair and regeneration. It sequesters G-actin monomers, promotes cell migration, inhibits inflammation, and stimulates angiogenesis — creating optimal conditions for healing after injury.
ActinPrimary
G-Actin Sequestration
Monomeric Globular Actin Binding
Regulates actin polymerization
Enables cytoskeletal remodeling
Facilitates cell motility and migration
ILKPrimary
Integrin-Linked Kinase
ILK/PINCH/Parvin Complex Activation
Promotes cell survival signaling
Activates Akt pathway
Supports cardiac cell migration
NF-κBModulatory
Anti-Inflammatory Pathways
NF-κB and Toll-like Receptor Modulation
Reduces inflammatory cytokines
Ameliorates inflammatory damage
Activates pro-resolving pathways
Key Mechanism
Actin-Based Cell Migration
TB-500 binds to G-actin monomers, preventing premature polymerization and allowing coordinated cytoskeletal remodeling. This promotes efficient cell migration to injury sites — a critical step in wound healing and tissue regeneration.
J Invest Dermatol (1999): Thymosin Beta-4 stimulated keratinocyte migration 2-3 fold over controls when as little as 10 pg was added to the assay.
Cell Migration↑ 2-3x increase
Re-epithelialization (Day 7)↑ 61%
Wound Contraction↑ 11% more
Collagen Deposition↑ Increased
Inflammation Control
NF-κB & Toll-like Receptor Modulation
TB-500 ameliorates inflammatory damage by regulating NF-κB and Toll-like receptor pathways. During tissue repair, it activates PI3K/Akt/eNOS and Notch signaling pathways, reducing inflammation while promoting regeneration.
PMC (2021): Tβ4 ameliorates inflammatory damage by regulating NF-κB and Toll-like receptor pathways. During tissue repair, Tβ4 regulates PI3K/Akt/eNOS and Notch pathways.
NF-κB Signaling↓ Modulated
Inflammatory Cytokines↓ Reduced
PI3K/Akt/eNOS↑ Activated
Notch Pathway↑ Regulated
What Research Has Shown
Summary of clinical and preclinical findings
0
Serious Adverse Events (42-1260mg IV, 14 days)
Key Wound Healing Findings
Re-epithelialization (Day 7)-61%
Re-epithelialization (Day 4)-42%
Keratinocyte Migration-200%
Wound Contraction Improvement-11%
Key finding: A randomized, placebo-controlled Phase 1 trial demonstrated that IV Tβ4 at doses of 42-1260mg for 14 days was well tolerated with no dose-limiting toxicities in healthy volunteers (Ruff et al., 2010).
Key Outcomes
Research Success Metrics
Summary of findings from peer-reviewed studies:
3.75of participants
mg/kg optimal doseFor neurological recovery (stroke model)
14of participants
days treatmentPhase 1 multiple dose regimen
100%of participants
completion rateNo dropouts due to adverse events
Important: Most wound healing evidence comes from preclinical (animal) studies. Human Phase 1 data confirms safety but efficacy trials are ongoing. FDA approval has not been granted.
Preclinical Evidence
Dose-Response Study Results (Stroke Model)
2 mg/kg
29%% improvement
12 mg/kg
32%% improvement
3.75 mg/kg (optimal)
35%% calculated
18 mg/kg
0%% (ceiling)
Dose response: The study demonstrated a ceiling effect at 18 mg/kg, with calculated optimal dose of 3.75 mg/kg for neurological functional recovery.
Wound Healing Acceleration
Improvement in wound healing markers (rat full-thickness wound model):
Re-epithelialization (7 days)vs saline control
+61%Re-epithelialization (4 days)Topical or IP
+42%Keratinocyte Migration2-3 fold increase
+200%Research Applications
Areas studied in preclinical and clinical research
Wound
HealingAccelerated wound closure and re-epithelialization in animal models
61% faster re-epithelialization at 7 days
J Invest DermatolCardiac
RepairCardioprotective effects studied in myocardial infarction models
Activates ILK, promotes cardiomyocyte survival
Nature (2004)Neuro
Recovery
Improved functional outcome in stroke and TBI models
J Neurol SciCorneal
HealingDry eye and corneal wound healing applications
Phase 2 trials for dry eye disease
Clin OphthalmolCardiovascular
Cardiac Cell Survival & Repair
Preclinical studies show significant cardioprotective effects and promotion of cardiac repair after injury.
ILK activationIntegrin-linked kinase
+90%Cardiomyocyte migrationCell motility
+85%Cell survival signalingAkt pathway
+80%Key finding: Thymosin Beta-4 activates integrin-linked kinase (ILK) and promotes cardiac cell migration, survival, and cardiac repair (Nature, 2004).
Neurological
Stroke & Brain Injury Recovery
TB-500 promotes neurological functional recovery through oligodendrogenesis and axonal remodeling.
Oligodendrocyte progenitors↑ Increased in SVZ
Mature oligodendrocytes↑ Increased in corpus callosum
Myelination↑ Enhanced in striatum
Functional recoveryImproved at 14-56 days
Ophthalmology
Corneal Healing & Dry Eye
Phase 2
Clinical trial completed for dry eye
Clinical development: Thymosin Beta-4 ophthalmic solution has progressed to Phase 2 clinical trials for dry eye disease, demonstrating safety and preliminary efficacy signals.
Research Combinations
Complementary Peptide Mechanisms
Research suggests TB-500 and BPC-157 work through different but complementary pathways, which is why they're often studied together in 'Wolverine blend' formulations.
TB-500 PrimaryActin/Cell migration
BPC-157 PrimaryVEGFR2/Angiogenesis
OverlapBoth reduce inflammation
Combined UseStudied in animal models
Research context: TB-500 promotes cell motility via G-actin sequestration while BPC-157 promotes blood vessel formation — potentially complementary mechanisms for tissue repair.
Dosing Information from Research
From clinical trials and preclinical studies
Thymosin Beta-4 has been administered via multiple routes in research settings. Human Phase 1 data established safety for IV doses up to 1260mg daily for 14 days. Animal studies typically use mg/kg dosing with the optimal neurological dose calculated at 3.75 mg/kg.
Human Clinical Trial
Phase 1 Clinical Trial (Ruff et al., 2010)
A randomized, double-blind, placebo-controlled Phase 1 study tested IV Tβ4 in 40 healthy volunteers. Four cohorts received ascending doses of 42, 140, 420, or 1260mg as single and multiple daily doses for 14 days.
42mg
Low dose cohort
Single dose, then daily × 14 days
t½ = 0.95 hours
140mg
Medium-low dose cohort
Single dose, then daily × 14 days
t½ = 1.2 hours
420mg
Medium-high dose cohort
Single dose, then daily × 14 days
Dose-proportional response
1260mg
High dose cohort
Single dose, then daily × 14 days
t½ = 1.9 hours (18 mg/kg avg adult)
All doses well tolerated with no dose-limiting toxicities
Pharmacokinetic profile showed dose-proportional response
Half-life increased with increasing dose (0.95-1.9 hrs)
Preclinical Research
Preclinical Dosing (Animal Studies)
Animal studies have established dose-response relationships, with optimal neurological improvement at 3.75 mg/kg calculated from a quartic response surface model. Ceiling effect observed at 18 mg/kg.
2mg/kg
Low dose
IP, day 1 then q3d × 5 doses
Significant improvement (p<0.05)
3.75mg/kg
Calculated optimal dose
Based on quartic regression model
Maximum predicted efficacy
12mg/kg
Medium-high dose
IP, day 1 then q3d × 5 doses
Significant improvement (p<0.05)
18mg/kg
Ceiling dose
IP, day 1 then q3d × 5 doses
No significant improvement (ceiling effect)
Optimal dose of 3.75 mg/kg calculated via quartic regression
Ceiling effect observed at 18 mg/kg
Treatment initiated 24 hours after injury (neurorestorative window)
Pharmacokinetics
Pharmacokinetic Profile
Half-life (42mg IV)Time for half the dose to be eliminated0.95 hours
Half-life (1260mg IV)Dose-dependent increase in half-life1.9 hours
Peak concentrationTime to maximum blood levels15 min post-dose
Dose responseRelationship between dose and plasma levelsDose-proportional
Molecular weight4,963 Da
Endogenous levelsPresent in all tissues
Half-life increases with increasing dose (dose-dependent kinetics)
Dose-proportional pharmacokinetic response observed
Tβ4 is naturally present in high concentrations in blood platelets
Safety Profile from Research
What clinical and preclinical studies report
Thymosin Beta-4 has demonstrated a favorable safety profile in Phase 1 clinical trials, with no serious adverse events or dose-limiting toxicities observed at doses up to 1260mg IV daily for 14 days. However, long-term human safety data remains limited.
Common Digestive Issues
15%
Headache
mild
10%
Upper Respiratory Infection
mild
5%
Injection Site Reactions
mild
Theoretical Concerns
Theoretical ConcernsPotential risks requiring further investigation
Because Tβ4 promotes cell migration and angiogenesis, there are theoretical concerns about potential effects on tumor growth and metastasis. This has not been definitively studied and remains speculative.
- Pro-angiogenic and pro-migratory effects could theoretically affect tumors
- Some studies suggest anti-metastatic effects in certain models
- Long-term effects in humans unknown
- Not approved by FDA or any regulatory agency
Discontinuation Rates
Phase 1 Safety Summary
Serious adverse events0 (none)
Dose-limiting toxicities0 (none)
Study discontinuation (AE)0 (none)
Treatment-emergent AEsMild/moderate only
No serious adverse events in any cohort (42-1260mg)
No dose-limiting toxicities identified
All adverse events were mild or moderate in intensity
Trial Exclusions
Important Considerations
Not FDA approved for any indicationBanned by WADA (S0 category - non-approved substances)Limited long-term safety dataTheoretical cancer risk not ruled outQuality control issues with unregulated productsPregnant or breastfeeding — not studied
Regulatory Status
Classified as unapproved drug by FDA
Investigational compound in clinical trials
Phase 2 trials completed for dry eye disease
Not available through legitimate prescriptions in most countries
Researcher Notes
- Phase 1 data in 40 healthy volunteers showed excellent tolerability
- Animal toxicology studies in rats and dogs showed NOEL ≥18 mg/kg
- Salivation observed in dogs at higher doses (25-60 mg/kg) — significance unclear
Compound Information
Technical specifications
Molecular Profile
What Is TB-500?
TypeEndogenous peptide/synthetic analog
CAS Number77591-33-4
Molecular Weight4,963 Da
Amino Acids43
Active RegionAc-SDKP (N-terminal)
Key Sequence17LKKTET22 (actin binding)
Storage Requirements
Stability Information
Protect from lightStore desiccatedSterile handling
Lyophilized (powder)
-20°C•stable long-term
Reconstituted
2-8°C•use within 14-30 days
Avoid
Repeated freeze-thaw cycles
Research Status
Where It Stands
Phase 1 CompleteNot FDA Approved
OriginNaturally occurring (thymus, platelets)
Discovery1960s (thymosin fraction)
Clinical trialsPhase 2 (dry eye), Phase 1 (cardiac)
Regulatory statusInvestigational drug
Frequently Asked Questions
Common questions about TB-500 research
TB-500 is a synthetic version of a naturally occurring 43-amino acid peptide called Thymosin Beta-4 (Tβ4). It was first identified in the thymus gland in the 1960s and is now known to be present in virtually all cells and tissues, with particularly high concentrations in blood platelets, wound fluid, and developing tissues. The peptide plays a fundamental role in tissue repair, cell migration, and wound healing.
No, TB-500/Thymosin Beta-4 is not FDA approved for any indication. It is an investigational drug that has completed Phase 1 safety trials and Phase 2 trials for dry eye disease. It is classified as an unapproved drug by the FDA and is banned by WADA under category S0 (non-approved substances).
Preclinical research has shown TB-500 accelerates wound healing (61% faster re-epithelialization), promotes cell migration, reduces inflammation, and supports tissue regeneration across multiple organ systems including skin, heart, brain, and eye. Human Phase 1 trials demonstrated safety at IV doses up to 1260mg daily for 14 days with no serious adverse events.
In research settings, TB-500 has been administered via intravenous infusion, subcutaneous injection, intramuscular injection, intraperitoneal injection (in animals), and topically. Human clinical trials used IV administration with single and multiple daily doses. The half-life ranges from approximately 1-2 hours depending on dose.
While Phase 1 trials showed no serious adverse events, key concerns include: lack of FDA approval, theoretical cancer risk due to pro-angiogenic/pro-migratory properties (not proven), limited long-term data, WADA ban, and quality control issues with unregulated products. The compound is not recommended for human use outside of clinical research settings.
TB-500 primarily works through G-actin sequestration to promote cell migration and cytoskeletal remodeling, while BPC-157 primarily activates the VEGFR2-Akt-eNOS pathway for angiogenesis. TB-500 is a 43-amino acid peptide from thymus/platelets, while BPC-157 is a 15-amino acid peptide derived from gastric juice. They are often studied together due to potentially complementary mechanisms.
Sources & References
Peer-reviewed research
Expert Opinion on Biological Therapy
Thymosin β4: a multi-functional regenerative peptide. Basic properties and clinical applications
2012•DOI: 10.1517/14712598.2012.634793•PMID: 22074294
Goldstein AL, Hannappel E, Sosne G, Kleinman HK
View Source
Annals of the New York Academy of SciencesA randomized, placebo-controlled, single and multiple dose study of intravenous thymosin beta4 in healthy volunteers
2010•DOI: 10.1111/j.1749-6632.2010.05474.x•PMID: 20536472
Ruff D, Crockford D, Girardi G, Zhang Y
View Source
⚠️Important Research Notice
Not for human consumption. This product is sold exclusively for research and educational purposes. It is not intended to diagnose, treat, cure, or prevent any disease.
All clinical trial data and research findings presented on this page are sourced from peer-reviewed journals and official publications. They are provided for educational reference only and should not be interpreted as medical advice or product claims.
By purchasing this product, you confirm that you are a qualified researcher and will use it in accordance with all applicable laws and regulations.
