Evidence record · ER-TB500-HEALING-004
Does TB-500 improve soft-tissue or wound healing?
TB-500 improves soft-tissue or wound healing in people
TB-500 has not been shown to improve soft-tissue or wound healing in dependable human outcome trials. Research on full-length thymosin beta-4, fragments and laboratory models is indirect and cannot be transferred automatically to the product marketed as TB-500, its route, or a specific injury.
Claim boundary
What this verdict covers
This record asks whether a defined TB-500 product improves healing, function, pain or return to activity in people. It does not merge full-length thymosin beta-4, Ac-SDKP and marketed TB-500 into one intervention.
- Compound
- TB-500
- Population
- People with soft-tissue injuries or wounds
- Outcome
- Healing, pain or function
- Record ID
- ER-TB500-HEALING-004
Evidence synthesis
What the research can support
A phase I study of full-length recombinant thymosin beta-4 primarily addressed exposure and tolerability, not soft-tissue recovery. Research on the Ac-SDKP fragment and animal wound models is mechanistically relevant but does not establish the marketed claim.
Why the confidence is very low
The intervention identity is often ambiguous, and no suitable human trial of marketed TB-500 for a defined injury was identified. Safety and product-quality evidence are also inadequate.
Decision boundary
What this record cannot tell you
This record cannot identify the contents, strength, purity, sterility or stability of a particular vial. It does not provide a dosing plan, administration instructions or a personal treatment recommendation. A supported narrow outcome cannot be transferred to a different route, population or product.
This publication has not independently tested a product for this record. Product evidence belongs to a named batch and method; clinical evidence belongs to the intervention actually studied.
From our work: how we checked this claim
ER-TB500-HEALING-004 addresses one bounded question: Does TB-500 improve soft-tissue or wound healing?. Yianni Kiromitis checked the search record, source descriptions, study design, population, intervention identity, comparator and patient-important outcomes against the published evidence method. The source ledger contains 4 primary or official sources. Each was assigned only the proposition it can support; a regulatory document was not treated as a treatment trial, and an animal or laboratory finding was not presented as a dependable human outcome.
The recorded evidence basis is Preclinical or indirect, the verdict is Insufficient and confidence is Very low. Eleni Kiromitis reviewed study design, biomedical evidence, laboratory context and analytical limits. Dr Stavroula Nikitopoulou reviewed the clinical claim, adverse effects, contraindications, red flags and patient-facing safety wording. Both completed their assigned review on 10 August 2026. Yianni retained publication and correction responsibility. The review notes identify which source supports each material claim and which limitation must remain beside the conclusion.
No direct product testing, seller data, personal treatment experience or patient experience was used to set this verdict. The record cannot establish the contents, strength, purity, sterility or stability of a particular vial, and it does not provide dosing, administration or personalised treatment advice. A finding cannot be transferred to a different route, population, product or outcome without new evidence. We also checked the visible review date against the publication record and structured data. A new controlled study, regulator update, corrected source, analytical report or credible safety signal can trigger reassessment through the public correction route.
Source ledger
Evidence used for this verdict
Each source supports only the proposition stated beside it. Regulatory scope and study scope remain visible.
| Source | What it establishes | What it does not establish | Checked |
|---|---|---|---|
| First-in-human study of full-length thymosin beta-4 | The study provides early exposure and tolerability data for a defined recombinant molecule. | It is not a trial of TB-500 for injury recovery. | 10 August 2026 |
| Review of the Ac-SDKP fragment | The paper describes biological activity of a thymosin beta-4 fragment. | A fragment cannot be treated as evidence for a marketed TB-500 product. | 10 August 2026 |
| FDA thymosin beta-4 fragment briefing | FDA reviewed identity, evidence and safety gaps for the compounded substance. | It does not establish human healing benefit. | 10 August 2026 |
| WADA 2026 Prohibited List | Thymosin beta-4 and derivatives are prohibited at all times. | Sport status is not an effectiveness verdict. | 10 August 2026 |
Quick answers
Frequently asked questions
What is the verdict on TB-500 for this claim?
The verdict is insufficient for the precise claim stated on this page. It combines the evidence type, directness, consistency and study limits; it is not a rating of the compound as a whole. The confidence field shows how readily new evidence could change the conclusion.
What evidence supports this verdict?
A phase I study of full-length recombinant thymosin beta-4 primarily addressed exposure and tolerability, not soft-tissue recovery. Research on the Ac-SDKP fragment and animal wound models is mechanistically relevant but does not establish the marketed claim. The source ledger below links the primary or regulatory records used and states what each source cannot establish.
Does this evidence apply to a peptide vial sold online?
No. A study or authorisation applies to the exact material, formulation, route, population and controls that were evaluated. It cannot verify the identity, amount, purity, sterility, stability or delivery of a separate vial. Those are batch-specific product questions, not automatic extensions of an efficacy result.
Is TB-500 authorised in the UK for this use?
No UK marketing authorisation was identified for this use or for a medicine sold under this peptide name. The MHRA products database should be checked for the exact product and presentation. The boundary matters because evidence, authorisation and product quality answer different questions and should not be merged into one conclusion.
What should competitive athletes know?
Thymosin beta-4 and its derivatives, including TB-500, are prohibited at all times under the WADA growth-factor rules. The boundary matters because evidence, authorisation and product quality answer different questions and should not be merged into one conclusion. Read the cited source and stated scope together before relying on it.
What could change this verdict?
A controlled human trial that identifies the exact sequence and formulation, measures patient-important healing and function, and reports exposure and harms. Any update would be dated and recorded through the site correction and version process. The boundary matters because evidence, authorisation and product quality answer different questions and should not be merged into one conclusion.
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