Thymopentin

Also known as: Timunox

Not FDA-approved

Last verified: October 30, 2026

At a glance

FDA approval Not FDA-approved No record in Drugs@FDA
Randomized controlled trials 46 of 447 publications on PubMed
Registered clinical trials 10 1 active
Adverse event reports 77 75 classified as serious
  • Thymopentin is not an FDA-approved drug: Drugs@FDA has no record of it.
  • PubMed lists 447 publications mentioning it, including 46 randomized controlled trials and 111 animal-only studies.
  • ClinicalTrials.gov lists 10 registered studies testing it (1 active).
  • FDA's adverse event system (FAERS) holds 77 reports mentioning it; 75 classified as serious. Reports do not prove causation.

Research topics

  • Adjuvants, Immunologic 51
  • Nanoparticles 17
  • Particle Size 17
  • Drug Carriers 15
  • T-Lymphocytes 14
  • Thymus Gland 14
  • Cytokines 13
  • Drug Stability 12
  • Immunologic Factors 11
  • Immunosuppressive Agents 11

Most frequent MeSH subject headings in the latest PubMed records (English, as indexed).

Regulatory status

Drugs@FDA applications

No application found in Drugs@FDA, FDA's database of approved drugs.

Source: Drugs@FDA (openFDA) · verified October 30, 2026 · API query

FDA compounding safety list

Not on FDA's list of bulk drug substances that may present significant safety risks in compounding.

Source: FDA.gov — Category 2 bulk drug substances · verified October 30, 2026

Removal of a substance from a regulatory list does not mean it has been approved. A "research use only" label does not make a product safe or legal for human use.

Scientific publications

  • All publications 447
  • Human (MeSH) 272
  • Animal only 111
  • Clinical trials 86
  • Randomized controlled trials 46
  • Systematic reviews & meta-analyses 6
  • Case reports 14
  • Retracted 1

Counts are PubMed records that mention the peptide in the title or abstract. Categories overlap, and a mention is not the same as testing the peptide as a treatment. Each number opens the exact PubMed search. Effects seen in laboratory or animal studies may not occur in humans. A registered clinical trial does not show that a substance is effective or safe.

Latest publications

Source: PubMed (NCBI) · verified October 30, 2026

Clinical trials

Registered
10
Active
1
With posted results
0

Conditions studied

  • HIV Infections 7
  • Carcinoma 1
  • Solid Tumor 1
  • Safety Issues 1
  • Tolerance 1
  • Hepatocellular Carcinoma 1
Study Status Phase Start
The Prospective Clinical Study of Precision PRaG Therapy in Elderly Patients With Advanced Solid Malignant Tumors (PRaG9.0)
NCT06112041 Second Affiliated Hospital of Soochow University
Not yet recruiting Phase 2 October 25, 2023
Phase1 First in Human Ascending Dose Study to Evaluate the Safety and Tolerability of FC-12738 in Health Adults
NCT05978908 Neurodegenerative Disease Research Inc
Completed Phase 1 February 20, 2024
Study of Thymopentin in Patients After Curative Resection of Small Hepatocellular Carcinoma
NCT00460681 Fudan University
Unknown status Phase 3 Feb 2007
Double-Blind Study of Timunox (Thymopentin) in Asymptomatic HIV-Infected Patients Receiving Either Mono (AZT or ddI) or Combination (AZT / ddI or AZT / ddC) Anti-Retroviral Therapy
NCT00002109 Immunobiology Research Institute
Completed Phase 3 —
A Study of Thymopentin Effects on HIV-1 Infectivity of Blood Mononuclear Cells and Semen in HIV Infected Patients
NCT00002050 Immunobiology Research Institute
Completed N/A —
Double Blind Study of Thymopentin Effects on HIV-1 Infectivity of Blood Mononuclear Cells and Semen in HIV Infected Patients
NCT00002049 Immunobiology Research Institute
Completed N/A —
Double Blind Study of Thymopentin Effects on Patients With HIV-1 Infection
NCT00002051 Immunobiology Research Institute
Completed N/A —
A Study of Timunox (Thymopentin) in HIV-Infected Patients Receiving Other Anti-HIV Drugs
NCT00002332 Immunobiology Research Institute
Completed Phase 2 —
Double Blind Study of Thymopentin Effects on Patients With HIV-1 Infection
NCT00002066 Immunobiology Research Institute
Completed N/A —
The Effects of Thymopentin on HIV Infectivity of Blood Cells and Semen in HIV-Infected Patients
NCT00002289 Immunobiology Research Institute
Completed N/A —

All 10 studies on ClinicalTrials.gov ↗

Source: ClinicalTrials.gov · verified October 30, 2026

Adverse event reports

Reports
77
Serious
75
With death outcome
17

Most reported reactions

  • Bone marrow failure 7
  • Off label use 6
  • Pneumonia 6
  • Ascites 4
  • Diarrhoea 4
  • Neutrophil count decreased 4
  • Anaemia 3
  • Dizziness 3
  • Drug-induced liver injury 3
  • Interstitial lung disease 3
  • Platelet count decreased 3
  • Pneumonitis 3

Adverse event reports do not prove that the substance caused these effects. Side effects not listed here may still occur. Reaction terms are MedDRA terms as reported to FAERS.

Source: FDA FAERS (FAERS data as of July 30, 2026) · verified October 30, 2026 · API query

Change history

No changes since monitoring began on October 30, 2026.