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Thymosin Beta-4

Also known as: TB-4, Tβ4, Timbetasin

At a glance

PeptiGuide dataset · reviewed Aug 2026

What it is

A 43-amino-acid actin-binding peptide with ophthalmic human studies and mainly preclinical systemic research.

Status

Clinical Trials

Typical dose

2.5–5mg

Researched for

Wound healing, cardiac repair, tissue regeneration

Trial progress

  1. PrePreclinical
  2. IPhase I
  3. IIPhase II
  4. IIIPhase III
  5. IVPhase IV
  6. FDAFDA approved

Phase III - Emerging human evidence with important limitations

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New studies, regulatory decisions and data corrections - delivered when they land.

  • A 43-amino-acid also known as TB-4, Tβ4, and Timbetasin.
  • The source identifies G-actin binding as a central biological feature.
  • Human research cited by the source is concentrated in ophthalmic formulations, while systemic findings are largely .
  • The source reports that it is not FDA approved.
  • TB-500 is described as a related fragment, not the intact natural peptide.

Thymosin Beta-4 is described as binding monomeric G-actin, an interaction that can affect actin availability and cytoskeletal turnover. The supplied evidence associates this biology with cell migration, , inflammation-related signaling, and recruitment of endothelial cells, keratinocytes, and progenitor or stem cells at injured sites. It also reports hypotheses involving epicardial activation and cardiac-cell survival under low-oxygen conditions. Mechanistic observations alone do not demonstrate clinical benefit.

Where the research stands

The supplied source describes randomized, vehicle-controlled ophthalmic studies of RGN-259, a 0.1 % Tbeta4 eye-drop formulation, in dry eye and neurotrophic keratopathy. It reports a 317-patient phase 2/3 dry-eye trial with significant improvements in corneal staining and ocular discomfort, published in peer-reviewed journals. It characterizes cardiac results, including a porcine myocardial-infarction model, as and reports effects on cell engraftment, infarct size, and recovery; it also says the human cardiac program did not produce an approved drug. Wound-healing and hair-growth findings are described as mainly rodent data. The source does not identify completed pivotal trials establishing systemic benefit outside the eye program, and it reports no controlled human trial data for TB-500 itself.

What it shows

Human studies

Emerging human evidence with important limitations

Limitations

Study protocols describe research and are not dosing recommendations.

Bottom line: The source reports that the Phase 3 dry-eye RGN-259/ARISE-3 study missed its primary endpoints while showing a secondary symptom benefit, and it notes a separate Phase 3 neurotrophic-keratopathy program. It also reports no FDA approval. Not FDA Approved

Typical dosing

Community

2.5–5 mg

2-3x weekly

1 mg10 mg

Community-reported values only, not dosing guidance. The source identifies the full 43-amino-acid protein as distinct from a TB-500 fragment, says their uses are similar, describes its half-life as shorter, and notes frequent confusion between them. · Subcutaneous injection, topical for eye conditions

Research dosing

Study-specific protocols

Doses observed in studies

750 mcg - 1.5 mg daily

Clinical Trial Data - Wound healing studies

Study protocols describe research and are not dosing recommendations.

Duration
4-8 weeks typical protocol
Administration
Subcutaneous injection, topical for eye conditions

Best time to take

Morning or split doses

Daily or every other day due to short half-life

Food recommendation

With or without food

Why this timing?

The source attributes protocol schedules to an approximately 2 hour half-life, notes that some protocols use multiple daily doses, and characterizes timing as flexible when consistency is maintained.

Not everyone experiences these. Individual responses vary with dose, duration, and personal factors.

  • Generally well-tolerated
  • Injection site reactions
  • Headache
  • Fatigue
  • May trigger histamine release
  • Theoretical concern for cancer cell motility
  • Contraindicated with active cancer
  • Limited long-term safety data

Not everyone experiences side effects, and severity can vary by context, purity, route, and individual health factors.

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One open dataset

Every fact on this page - doses, side effects, references - comes from the same PeptiGuide dataset that powers the Tracker, Compare, and the Lab.

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Educational resource, not medical advice. Talk to your clinician before acting on anything here.

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