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
Thymosin alpha-1’s largest trial (TESTS, 1,106 adults with sepsis) found no reduction in 28-day deaths: 23.4% versus 24.1%.
Thymosin beta-4’s human trials tested eye drops for dry eye; the larger trial missed both of its main measures.
TB-500, sold online, is described as a fragment of thymosin beta-4, not the full protein those trials used.
Neither is FDA-approved; trials of both report mostly mild side effects.
Thymosin 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 evidence
No randomized trials · phase 3 trial
2 randomized trials
Human safety data
Very 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 warning
No FDA label to carry one
No 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 flagged
None flagged, because there is too little human safety data to assess
Partly 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.
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.
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.
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.
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