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Most Thymalin studies are mechanism or observational rather than RCTs that measure a clinical effect — keep findings provisional.
Most evidence is from mixed-quality studies published 2003–2023.
Based on 6 studies
Confidence
Low
By outcome
Immune support
Mostly mechanism / observational6 studies
Inflammation
Mostly mechanism / observational4 studies
Active research area
3 studies in the last 5 years
200320132023
1Observational2003
Homeostasis restoration was accompanied by ... decreased mortality rate during observation ... 1.6-1.8-fold in the Epithalamin-treated group ... as compared to the control.
Khavinson VKh, Morozov VG. · Neuro Endocrinol Lett (2003)
Long (6-8 year) clinical observation in 266 elderly subjects by the originating institutes
Reported reduced mortality and lower incidence of cardiovascular/respiratory disease with pineal (Epithalamin) and thymic (Thymalin) peptides
Studied the crude pineal extract Epithalamin, NOT the pure Ala-Glu-Asp-Gly peptide
2Open-Label2022
Hospital mortality in COVID-19 patients after standard therapy, Tocilizumab and Thymalin application was 40,9; 28,4 and 20,6% accordingly.
Kuznik BI, Shapovalov KG, Smolyakov YN, Lukyanov SA, Tereshkov PP, Kazantseva LS, Linkova NS. · Adv Gerontol (2022)
Comparative (non-blinded) clinical study of severe COVID-19 in middle-aged/elderly patients: standard therapy vs +tocilizumab vs +thymalin
Reported hospital mortality of 40.9% (standard), 28.4% (tocilizumab) and 20.6% (thymalin)
Thymalin increased lymphocyte/monocyte counts and lowered fibrinogen, LDH and D-dimer, improving coagulation indices
3Open-Label2021
The addition of thymalin to standard therapy accelerated the decline in both these indicators and the indicators of the T cell system.
Khavinson VK, Kuznik BI, Trofimova SV, Volchkov VA, Rukavishnikova SA, Titova ON, Akhmedov TA, Trofimov AV, Potemkin VV, Magen E. · Stem Cell Rev Rep (2021)
Clinical report of thymalin added to standard COVID-19 therapy, framed around its effect on hematopoietic stem-cell differentiation
Adding thymalin accelerated the decline of IL-6, C-reactive protein and D-dimer versus standard care alone
Authors argue this helps reduce thrombotic risk and supports inclusion in complex COVID-19 treatment
An in vitro model of an inflammatory reaction demonstrated that Thymalin and EW and KE dipeptides reduced the synthesis of IL-1β, IL-6, and TNF-α cytokines in human peripheral blood mononuclear cells by 1.4-6.0 times.
Linkova N, Khavinson V, Diatlova A, Petukhov M, Vladimirova E, Sukhareva M, Ilina A. · Int J Mol Sci (2023)
Mechanistic study of thymalin's active dipeptides KE and EW using molecular docking, bioinformatics and an in-vitro LPS inflammation model
In LPS-stimulated human PBMCs, thymalin/KE/EW reduced IL-1β, IL-6 and TNF-α by 1.4-6-fold
Proposed gene targets (AKT1/AKT2, ACE2, CYSLTR1, CHUK) link the peptides to cytokine-storm pathways
Thymalin reduced the expression of CD44 (stem cell marker) and CD117... by 2-3 times and increased the expression of CD28 (marker of mature T lymphocytes) by 6.8 times.
Khavinson VK, Linkova NS, Kvetnoy IM, Polyakova VO, Drobintseva AO, Kvetnaia TV, Ivko OM. · Bull Exp Biol Med (2020)
In-vitro study of thymalin on human hematopoietic stem-cell differentiation and CD28 expression
Thymalin lowered stem/intermediate markers (CD44, CD117) and raised the mature-T-cell marker CD28 6.8-fold
Interpreted as thymalin driving differentiation of precursors into mature CD28+ T lymphocytes, relevant to COVID-19 immune suppression
FTS level in old mice increased after administration of thymalin, the rhythm of CD4+-cells number in bone marrow and of corticosterone serum content restored.