Thymalin

Developer-run controlled follow-up report

Khavinson VKh, Morozov VG. Neuro Endocrinology Letters, 2003.

The paper describes 266 older people overall, but the St Petersburg randomized mortality comparison used 24 thymalin recipients and 22 placebo recipients. Over six years, 10 of 24 in the thymalin arm and 18 of 22 in placebo died. The paper reports no confidence intervals, survival model, allocation-concealment detail, or dropout accounting, and the developers authored the work.

Participants / model

266 older adults across St Petersburg and Kyiv cohorts; randomized mortality arms of 24 thymalin and 22 placebo in St Petersburg

Treatment

Thymalin, epithalamin, their combination, or placebo in course-based regimens

Follow-up

6 to 8 years of follow-up depending on cohort

Study design

Developer-run stratified controlled follow-up, described as double-blind for the St Petersburg arm

The overall 266 is not the denominator for the key thymalin-versus-placebo mortality comparison.

Russian-language clinical report

Хавинсон ВХ, Морозов ВГ. Успехи геронтологии, 2002.

The Russian-language publication reports the same geroprotective program later published in English in 2003. It is evidence that a Russian human report exists, but it should not be counted as an independent replication.

Participants / model

Older adults in the same St Petersburg and Kyiv research program

Treatment

Thymalin and epithalamin course-based interventions

Study design

Russian-language report of the developer-run controlled cohorts

The 2002 and 2003 reports describe overlapping cohorts and are not independent replications.

Open-label randomized clinical study

Khavinson V et al. Stem Cell Reviews and Reports, 2021.

Forty-two patients received thymalin plus standard care and 50 received standard care. Both arms had no deaths. The paper emphasizes within-group immune and inflammatory marker changes and provides no prespecified between-group clinical effect estimate with confidence interval.

Participants / model

92 hospitalized adults with moderate to severe COVID-19, lymphopenia, and bilateral pneumonia

Treatment

Thymalin plus standard care versus standard care

Follow-up

Five-day treatment with in-hospital follow-up

Study design

Single-center open-label randomized study

Within-group fold changes do not substitute for a direct randomized between-group effect.

Russian-language retrospective study

Кузник БИ et al. Успехи геронтологии, 2022.

The Russian abstract reports mortality percentages for standard therapy, tocilizumab, and thymalin groups but does not state group sizes, so deaths cannot be reconstructed or compared reliably from the abstract alone.

Participants / model

Hospitalized people with severe COVID-19; group sizes not reported in the abstract

Treatment

Standard therapy, tocilizumab, or thymalin

Study design

Retrospective Russian-language comparison

The abstract does not report group sizes, so deaths and treatment effects cannot be reconstructed.

Developer patent

Morozov VG, Khavinson VK. US Patent 5,070,076, granted 1991.

The patent describes a calf-thymus preparation as peptide fractions across roughly 600 to 6,000 Da with process and physicochemical characteristics. It provides no clinical efficacy data or independent batch verification.

Study design

Granted composition and process patent

A patent is not a clinical trial, regulator assay, or proof that a current vial matches the claimed process.

Trial registrations

ClinicalTrials.gov search for thymalin, with Cyrillic spellings and extract aliases, run on 8 September 2026.

ClinicalTrials.gov lists no exact-name Thymalin intervention study. Older Russian-language clinical reports without matching registrations remain separate evidence.

Human-cell laboratory study

Linkova N et al. International Journal of Molecular Sciences, 2023.

Peripheral blood mononuclear cells from four donors were exposed to thymalin and two named dipeptides. Several inflammatory outputs changed in vitro. No donor received thymalin and the experiment cannot establish a clinical immune effect.

Participants / model

Cultured blood cells from 4 human donors

Treatment

Laboratory thymalin, Lys-Glu, and Glu-Trp exposure

Study design

In vitro human-cell experiment

In vitro comparative study

Avolio F et al. International Journal of Molecular Sciences, 2022.

Four defined peptides reduced monocyte adhesion in the assay, while the heterogeneous thymalin extract increased it and differed on other cellular outputs. The result demonstrates that named fractions cannot stand in for the parent extract.

Treatment

Thymalin extract and four defined peptides in THP-1 cells

Study design

Replicated in vitro comparative experiment

Russian-language animal study

Суходоева ГС et al. Журнал микробиологии, эпидемиологии и иммунобиологии, 1993.

The Russian-language animal report describes increased sensitization to a microbial antigen after thymalin, with repeated injections producing a stronger effect than a single exposure. It is a heterologous animal-protein extract signal in guinea pigs, not a measured human adverse-event rate.

Participants / model

Guinea pigs

Treatment

Single or repeated thymalin exposure with microbial antigen challenge

Study design

Animal immunogenicity experiment

Randomized double-blind placebo-controlled trial of a related fraction

Noy A et al. Journal of Clinical Oncology, 2005.

In 202 participants, response was 23% with IM862 and 21% with placebo (P=.46). Median time to progression was 16 versus 35 weeks (P=.012), although the active arm had less concurrent antiretroviral therapy. This tested defined Glu-Trp, not the parent thymalin extract.

Participants / model

202 people with AIDS-related Kaposi sarcoma

Treatment

Intranasal IM862 or placebo

Follow-up

24 weeks

Study design

Randomized double-blind phase 3 trial

The negative Glu-Trp trial does not establish the parent extract's efficacy or inefficacy; earlier uncontrolled fraction signals do not establish a Thymalin effect.

Regulatory status

FDA, EMA, and a developer-authored history of Thymalin.

The cited US and EU records contain no Thymalin approval. A developer-authored account reports USSR registration certificate 82/1108/8 under Ministry of Health Order 1108 dated November 10, 1982.

The 1982 registration is supported by a developer-authored account rather than the original certificate and does not imply US or EU approval.