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TB-500 Topical (Creams and Serums): What Studies Show

Which studies gave TB-500 as a topical form, what they measured, and what is approved. No product recommendations.

Medical review pendingSynthetic fragment of thymosin beta-4Updated
Route
topical
FDA-approved product for this route
None
Route studies (human / animal)
4 / 1
in our evidence file (PubMed search, 11 Oct 2026)

Studies that gave TB-500 topical

Each row is a study whose stated route matches. Animal and cell results are labelled and are not human results.

TB-500 studies by topical route
StudyDesignnDoseFirst outcome
Microbial biotechnology 2021, PMID 34318587Human controlled trial710.5 mg/ml gelScalp seborrheic dermatitis: The thymosin beta-4 gel was reported more effective than ketoconazole lotion for scalp seborrheic dermatitis (randomization not stated in abstract).
Cornea 2015, PMID 25826322Human RCT90.1%Ocular discomfort and corneal staining: At day 56, the treated group had a 35.1% greater reduction in ocular discomfort and a 59.1% greater reduction in total corneal fluorescein staining than vehicle (very small trial).
Clinical ophthalmology 2015, PMID 26056426Human RCT720.1%Primary endpoints: Neither primary endpoint (ocular discomfort, inferior corneal staining) differed significantly between groups.
Annals of the New York Academy of Sciences 2010, PMID 20536470Human RCT73topical, 0.03% dose highlightedWound healing: Phase 2 findings suggest a 0.03% dose may accelerate healing, with complete healing within 3 months in about 25% of patients, mainly those with smaller or milder ulcers.
ACS applied materials & interfaces 2025, PMID 41359360Animal · human corneal cells in vitro plus an animal alkali burn model (species not stated in abstract) (not a human result)Not statedNot statedCorneal alkali burn: The peptide-containing hydrogel accelerated corneal epithelial regeneration and reduced inflammation in an alkali burn model; this is a formulation study.

For the injected form, see TB-500 how to inject and TB-500 half-life.

Gel and cream studies (full-length thymosin beta-4)

A double-blind, placebo-controlled, dose-escalation trial gave topical full-length thymosin beta-4 (not TB-500) to 73 patients with venous stasis ulcers at eight European sites.[4]

A 4-week study of 71 scalp seborrheic dermatitis patients compared a 0.5 mg/ml recombinant full-length thymosin beta-4 gel (not TB-500) with 2% ketoconazole lotion.[1]

Eye drop and hydrogel studies

Nine patients with severe dry eye received 0.1% full-length thymosin beta-4 eye drops (not TB-500) or vehicle 6 times daily over 28 days.[2]

A second dry-eye trial randomized 72 subjects 1:1 to 0.1% thymosin beta-4 solution (full-length, not TB-500) or placebo for 28 days.[3]

The only topical study naming the TB500 sequence is a hydrogel in human corneal cells and an alkali-burn animal model, with no people treated.[5]

Safety reported by route

The 72-subject dry-eye trial reported no adverse events.[3]

The venous ulcer trial judged the safety profile of all doses acceptable and comparable to placebo.[4]

Absorption compared with injection

None of the 5 topical studies cited on this page reports a blood level or bioavailability figure for the topical route, so no comparison with injection can be drawn from them.

Calculated from topical studies 5; studies reporting topical absorption 0. Formula: studies with topical absorption data = 0 of 5

Common questions

Is there an FDA-approved topical form of TB-500?

We found no FDA-approved topical product for TB-500 in our evidence file. Products sold as topical forms are not checked by the FDA.

Have studies given TB-500 as a topical form?

5 studies in our evidence file gave TB-500 by a topical route: 4 in people and 1 in animals.

Is there a TB-500 cream or topical?

No product is approved: the Drugs@FDA lookup for thymosin beta returned no matches. The topical trials used full-length thymosin beta-4.[6]

More on TB-500

Sources

  1. 1Recombinant human thymosin beta-4 (rhTβ4) improved scalp condition and microbiome homeostasis in seborrheic dermatitis.Microbial biotechnology · 2021PMID 34318587Accessed 2 Oct 2026
  2. 2Thymosin β4 significantly improves signs and symptoms of severe dry eye in a phase 2 randomized trial.Cornea · 2015PMID 25826322Accessed 2 Oct 2026
  3. 3Thymosin beta 4 ophthalmic solution for dry eye: a randomized, placebo-controlled, Phase II clinical trial conducted using the controlled adverse environment (CAE™) model.Clinical ophthalmology (Auckland, N.Z.) · 2015PMID 26056426Accessed 2 Oct 2026
  4. 4The effect of thymosin treatment of venous ulcers.Annals of the New York Academy of Sciences · 2010PMID 20536470Accessed 2 Oct 2026
  5. 5Alkaline Phosphatase-Triggered Spatiotemporal Repair of Corneal Injury with TB500 Peptide Hydrogel.ACS applied materials & interfaces · 2025PMID 41359360Accessed 2 Oct 2026
  6. 6Drugs@FDA (openFDA) search: active ingredient "thymosin beta"U.S. Food and Drug Administration · 2026api.fda.govAccessed 2 Oct 2026

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