Immune peptides

Thymulin

Thymulin acetate; serum thymic factor

US status
No lawful route
Class
Immune peptides
Approved product
None
Route
None lawful; sold as research-use-only material

Regulatory record

3 dated actions on record; FDA final action still open (hollow marker).
May 2026
The section 503A bulks list FDA published May 14, 2026 lists Thymulin acetate in Category 3, the file for substances nominated without adequate support to evaluate. It sits in neither of the other two 503A categories, and Category 3 carries no authorization to compound.
September 2026
Drugs@FDA holds no approved product with thymulin as an active ingredient, and the substance was not among the seven peptides the advisory committee reviewed in July 2026.
FDA final action
None as of September 2026.

Every entry above is dated; the record is current as of the review date.

Definition

Thymulin is a nonapeptide produced by the thymus, and it is unusual among the peptides in this index in that its activity depends on a metal: the molecule is biologically active only when bound to zinc. That dependence is the reason its name appears throughout a literature that is not about it.

It is sold as research-use-only material on claims about immune function and thymic aging. The federal record and the published record are both thinner than that marketing implies, and the published record is thin in a way a count conceals rather than reveals.

Evidence

Across two name variants PubMed returns 498 indexed records, of which 226 carry the Humans subject heading, 8 the clinical-trial publication type, and 5 the randomized-controlled-trial type [1]. The publication-type filter was proved live in the same run against a control term returning 8,906 records under the clinical-trial type and 6,115 under the randomized type, the invalid tag returned zero for that control term, and a deliberately invalid record identifier errored in the same run [1].

Eight is small enough to itemize, so all eight were opened, and the reading reverses what the number suggests. Seven of the eight do not administer thymulin at all. They measure the concentration of the body's own thymulin as a readout of zinc status inside trials of zinc supplementation: in patients with Crohn's disease, where zinc restored plasma zinc and thymulin concentrations [2]; in young rural Gambian children [3]; in children with Down's syndrome; and as an adjunct to zidovudine therapy [1]. Others track thymulin against melatonin, against a zinc-fortified milk, and against prenatal and childhood exposures [1].

The eighth record does administer something, and it is not thymulin. A 1989 double-blind pilot study tested nonathymulin, a synthetic analogue, in multiple sclerosis [4]. That is the entire administered human record indexed under these names: one pilot study, of a different molecule, in a different field, thirty-seven years ago.

The correct statement is therefore not that thymulin has eight human trials. It is that thymulin has none, that a synthetic analogue has one pilot, and that the count exists because the peptide is a convenient biomarker for something else. The human trial record prints the count with that reading attached, which is the only form in which the count is not misleading.

Lawful access

There is no lawful United States supply route. Drugs@FDA holds no approved product with thymulin as an active ingredient; the same query form in the same session returned one application for bremelanotide and fourteen for liraglutide, and returned nothing for a deliberately invented ingredient name [5].

The section 503A bulks list FDA published May 14, 2026 lists Thymulin acetate in Category 3 — the file for substances nominated without adequate support to evaluate — and in neither of the other two categories [6]. Category 3 confers nothing. It is not the safety finding that Category 2 records, and it is not the permission during review that Category 1 grants; it records that the nomination itself was inadequate to evaluate.

The substance was not among the seven peptides the advisory committee reviewed in July 2026, so no vote, recommendation or pending rulemaking attaches to it [6]. What is sold is research-use-only material, outside pharmacy licensure and outside every quality obligation that attaches to a drug.

Elsewhere in this index

Filed under

Evidence reviews

Reference tables

Same class

References

  1. PubMed, National Library of Medicine. Census run 2026-09-02 across two name variants — "thymulin" OR "serum thymic factor" — returning 498 indexed records, 226 carrying the Humans MeSH term, 8 under "clinical trial"[Publication Type] and 5 under "randomized controlled trial"[Publication Type]. All 8 trial-type records were retrieved through esummary and read individually; seven measure endogenous thymulin as a marker of zinc status and one administers a synthetic analogue. In the same run the control term aspirin returned 8,906 records under the clinical-trial filter and 6,115 under the randomized filter; the invalid tag clinicaltrial[pt] returned 0 for that same control term; and esummary on the invalid record identifier 99999999 errored. Source
  2. Brignola C, Belloli C, De Simone G, Evangelisti A, Parente R, Mancini R, et al. Zinc supplementation restores plasma concentrations of zinc and thymulin in patients with Crohn's disease. Aliment Pharmacol Ther. 1993 Jun;7(3):275-80. PMID 8364132
  3. Bates CJ, Evans PH, Dardenne M, Prentice A, Lunn PG, Northrop-Clewes CA, et al. A trial of zinc supplementation in young rural Gambian children. Br J Nutr. 1993 Jan;69(1):243-55. PMID 8457531
  4. Roullet E, Cesaro P, Simon-Lavoine N, Degos JD, Marteau R. Nonathymulin treatment of multiple sclerosis: double-blind pilot study. Acta Neurol Scand. 1989 Dec;80(6):575-8. PMID 2618585
  5. US Food and Drug Administration, openFDA Drugs@FDA endpoint. Absence probe run 2026-09-02: a search by active-ingredient name returned no records for thymulin. In the same run and the same query form, bremelanotide returned one application and liraglutide returned fourteen, and a deliberately invented ingredient name returned none — a positive and a negative control beside the zero. Source
  6. US Food and Drug Administration. Bulk Drug Substances Nominated for Use in Compounding Under Section 503A of the Federal Food, Drug, and Cosmetic Act, updated May 14, 2026. Fetched and read in full 2026-09-02: Thymulin acetate appears in Category 3 and in neither Category 1 nor Category 2. Source

The editor is not a licensed clinician; this monograph is a regulatory and evidence reference, not medical advice. Statuses are re-verified on the date shown, and every quantitative claim resolves to a numbered reference. Corrections: editor@peptideamerica.org. See how this reference is funded.