TB-500 / Thymosin Beta-4 Fragment 10mg/mL

Route: Subcutaneous (SC) injection.

• Reconstitute lyophilized powder with sterile bacteriostatic water per labeled instructions prior to use; do not use if cloudy, discolored, or particulate matter is visible.
• Inject subcutaneously into the abdomen, thigh, or upper arm; rotate sites.
• Use a 27–31 gauge insulin-type syringe; inject at a 45-degree angle into pinched subcutaneous tissue.
• Discard reconstituted vials within the beyond-use date specified by Genesis Compounding.
• All administration is prescriber-directed.

Dosing is entirely prescriber-determined. No FDA-approved dosing regimens exist. Published investigational and clinical practice reference doses include:

• Loading phase (typical): 5–10 mg SC per week for 4–6 weeks.
• Maintenance phase: 2.5–5 mg SC biweekly or monthly, per clinical response.
• Specific dose, frequency, and duration vary by clinical context (acute injury support, chronic recovery, prescriber judgment) and are determined by the prescribing clinician.

• Actin sequestration: TB-500 (LKKTET peptide) binds monomeric G-actin (β4-thymosin domain) with high affinity, maintaining the intracellular pool of unpolymerized actin; this modulates actin dynamics, enabling lamellipodia formation required for cell migration and tissue repair.
• Cell migration: Promotes migration of keratinocytes (2–3× control rates in vitro), endothelial cells, and progenitor cells to sites of injury via upregulation of integrin expression and MAPK pathway activation.
• Angiogenesis: Stimulates VEGF expression and secretion, promoting endothelial cell proliferation, tube formation, and neovascularization at wound and ischemic sites.
• Anti-inflammatory: Inhibits NF-κB nuclear translocation, reducing downstream transcription of TNF-α, IL-1β, and other pro-inflammatory cytokines; reduces inflammatory cell infiltration.
• Stem cell mobilization: Promotes mobilization of CD34+ progenitor cells from bone marrow to peripheral circulation and injured tissues, augmenting endogenous regenerative responses.

Indication context: TB-500 is used off-label under prescriber direction for tissue repair and recovery support in contexts including wound healing, musculoskeletal injury recovery (tendon, ligament, muscle), and post-surgical recovery. All use is investigational. Clinical evidence consists primarily of in vitro and animal studies, with limited human data. Prescribers using this peptide do so on the basis of mechanism-of-action plausibility and patient-specific clinical judgment. No randomized controlled trials have established efficacy for specific human indications.

Monitoring:

• Prescriber should document indication, baseline status, and rationale for use.
• Assess response clinically (wound status, functional recovery metrics) at regular intervals.
• Monitor injection sites for erythema, induration, or infection.
• No established laboratory monitoring parameters; CMP and CBC at baseline and periodically if extended use.

Contraindications:

• Known hypersensitivity to thymosin beta-4 fragment or any component of the formulation.
• Active malignancy: theoretical concern that pro-angiogenic and cell migration-promoting effects could potentially promote tumor growth or metastasis; avoid in patients with known or suspected cancer.
• Pregnancy and breastfeeding: safety not established; avoid use.

Warnings & Precautions:

• Investigational status: TB-500 is not FDA-approved for any human therapeutic indication; all use is prescriber-directed and investigational in nature.
• Pro-angiogenic activity: theoretical oncological risk in patients with predisposition to malignancy; thorough clinical risk-benefit discussion required before prescribing.
• Sterility: as a compounded injectable, strict sterility standards (USP <797>) must be observed; inspect vial for cloudiness or particulate matter before use and discard if abnormal.
• Injection site reactions: erythema, pain, or nodule formation may occur; report persistent or worsening reactions.

Drug Interactions:

• No established clinical drug interactions identified; theoretical interactions with anticoagulants (enhanced wound healing) or immunosuppressants (additive anti-inflammatory effects) have not been characterized.

Common Side Effects: Injection site reactions (transient pain, erythema, bruising); fatigue; headache. Serious adverse effects have not been systematically characterized in human studies.

Store lyophilized powder at refrigerated temperature (2–8°C / 36–46°F). Do not freeze the reconstituted solution. Protect from light. After reconstitution with bacteriostatic water, store in the refrigerator and use within the beyond-use date assigned by Genesis Compounding per USP <797> guidelines. Do not use if the solution is cloudy or contains visible particles. Keep out of reach of children.

What is TB-500 and how does it work?

TB-500 is a synthetic fragment of thymosin beta-4, a peptide found naturally in all nucleated human cells. It binds actin, promotes cell migration and new blood vessel formation (angiogenesis), and reduces inflammation at the molecular level. These properties make it of interest for tissue repair and recovery applications in investigational settings.

Is this FDA-approved?

No. TB-500 is not FDA-approved for any human therapeutic indication. It is a compounded, patient-specific 503A preparation available only with a valid prescriber order. Its use is based on investigational evidence and prescriber clinical judgment.

Is there any cancer risk?

Because TB-500 promotes cell migration and angiogenesis, there is a theoretical concern that it could promote tumor growth in patients with active or occult malignancy. Prescribers must carefully assess oncological history before prescribing, and use is generally avoided in patients with known or suspected cancer.

How do I reconstitute and store this medication?

Reconstitute the lyophilized powder with the provided sterile bacteriostatic water per the instructions on the label. Store the reconstituted solution in the refrigerator (not frozen). Use within the beyond-use date printed on the label. Do not use if the solution is cloudy or contains particles.