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Thymosin alpha-1 vs Thymosin beta-4: evidence, safety and FDA status

PepsRadar · Comparison · AI-assisted, written from the checked facts on each profile · Content updated (how dates work) · Not reviewed by a medical professional

The short answer

Despite the shared name, these are unrelated proteins with different jobs. Thymosin alpha-1 (thymalfasin) is an immune peptide approved in many countries but not by FDA. Thymosin beta-4 is a 43-amino-acid protein that helps organize the cell’s internal skeleton and is studied for tissue repair.

Key differences

Side by side

FactThymosin alpha-1Thymosin beta-4
FDA statusNot FDA-approvedNot FDA-approved
What it isThymosin alpha-1, also called thymalfasin, is investigated for immune-related effects. The clinical value of immune modulation depends on the disease and endpoint.Thymosin beta-4 is a full-length 43-residue peptide studied in tissue biology. The selected human study tested an ophthalmic preparation for dry eye, with negative primary endpoints.
Human evidenceNo randomized trials · phase 3 trial2 randomized trials
Human safety dataVery limited. Approved in many countries outside the US but not FDA-approved. Trials report good tolerability, mainly injection-site irritation; FDA calls compounded-product safety information inadequate.Trials only. Investigational protein, not FDA-approved. Small trials of eye drops and infusions reported mostly mild side effects, but long-term and whole-body safety remain unknown.
Boxed warningNo FDA label to carry oneNo FDA label to carry one
Serious risks
  • Possible immune reactions (immunogenicity) and impurities in compounded products, per FDA's compounding safety listing
None listed
Conditions flaggedNone flagged, because there is too little human safety data to assessCancer, now or in the past
Claim checkPartly supported: Thymosin alpha-1 boosts the immune system and prevents infections.False: TB-500 is the same thing as thymosin beta-4 and works the same way.

Each row comes from the Thymosin alpha-1 and Thymosin beta-4 profiles, where every fact links to its source. “Conditions flagged” lists the health conditions each profile’s Risks & interactions section mentions.

The human studies

Thymosin alpha-1

TESTS (2025)

Human phase 3 trial · 1,106 adults with sepsis randomized across 22 centers in China.

Twenty-eight-day mortality was 23.4% versus 24.1%; hazard ratio 0.99 (95% CI 0.77–1.27). No clear mortality benefit was demonstrated.

Limitation: A large negative overall result should not be replaced by favorable subgroup headlines. Sepsis treatment also differs substantially from immune-enhancement claims in healthy people.

The efficacy and safety of thymosin α1 for sepsis (TESTS): multicentre, double blinded, randomised, placebo controlled, phase 3 trial. ↗

Thymosin beta-4

RGN-259 dry-eye phase 2 study (2015)

Human randomized trial · 72 people with moderate to severe dry eye.

Neither primary endpoint—ocular discomfort nor inferior corneal staining at day 29—showed a statistically significant treatment benefit. Some secondary outcomes favored treatment.

Limitation: Secondary findings should be interpreted alongside failure of the primary endpoints. The ophthalmic route and dry-eye population do not establish safety or efficacy of systemic use.

Thymosin beta 4 ophthalmic solution for dry eye: a randomized, placebo-controlled, Phase II clinical trial conducted using the controlled adverse environment (CAE™) model. · 2015 ↗

RGN-259 · small severe dry-eye trial

Human phase 2 randomized trial · Nine patients with severe dry eye; the abstract reports outcomes for 12 treated eyes and six control eyes.

At day 56, the reported reductions relative to vehicle were 35.1% for ocular discomfort and 59.1% for total corneal fluorescein staining. Treatment was described as well tolerated.

Limitation: Very small sample and multiple assessment times limit confidence. Read beside the larger 72-person trial, which missed its primary endpoints. Ophthalmic findings do not establish systemic injury recovery or equivalence to TB-500 fragments.

RGN-259 · small severe dry-eye trial · undefined ↗

Results from different trials are not a head-to-head comparison: the people, preparations, durations and measures differ.

Bottom line

Neither is FDA-approved, and the trials summarized here do not show the broad immune-boosting or healing effects they are marketed for.

PepsRadar does not give doses or usage instructions, and this page is not medical advice. For a prescription medicine, talk to your prescriber or pharmacist.

Read more

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