Key papers ✓ 5~ 1? 3

• ✓ Positive human RCTNeuro Endocrinol Lett · 2003

  Peptides of pineal gland and thymus prolong human life.

  Humans266 peopleRandomized6-8 years of observation; bioregulators given for the first 2-3 years

  Clinical assessment by the bioregulator developers; randomization and blinding not described in the abstract

  Developer-run study of 266 elderly people followed 6-8 years: those given thymalin (alone or with epithalamin) for the first 2-3 years had 2.0-2.1-fold lower mortality and fewer respiratory infections than controls; randomization and blinding details are not given.

  Key resultMortality decreased 2.0-2.1-fold in the Thymalin group, 1.6-1.8-fold with Epithalamin and 2.5-fold with both vs control; 4.1 times lower with annual combined treatment for 6 years

  Study details

  Studied

  Elderly and older persons (over 60) treated with Thymalin and/or Epithalamin

  Compared with

  Control group

  Main outcome

  Mortality and disease incidence

  Sample

  266 elderly and older persons followed 6-8 years

  Authors' conclusion

  The authors state the data confirmed high geroprotective efficacy of Thymalin and Epithalamin for health maintenance in persons over 60.

  Limitations

  Study run by the developing institutes; allocation and blinding not described; combination arms.

  PubMed 14523363
• ✓ Positive human trialAdv Gerontol · 2022

  [Morphological compound and indicators of the blood clotting system in severe COVID-19 patients of middle aged and elderly during treatment of Tocilizumab and Thymalin.].

  Humanssize not reported

  Comparative study of three groups (basic therapy; plus Tocilizumab; plus Thymalin); allocation method not described

  Severe COVID-19 patients given thymalin with standard therapy had 20.6% hospital mortality vs 40.9% on standard therapy alone (28.4% with tocilizumab), with improved lymphocyte counts and clotting markers; allocation method not described.

  Key resultHospital mortality 40.9% (standard therapy), 28.4% (Tocilizumab) and 20.6% (Thymalin)

  Study details

  Studied

  Middle-aged and elderly patients with severe COVID-19

  Compared with

  Basic therapy alone and basic therapy plus Tocilizumab

  Main outcome

  Hospital mortality; blood morphology and clotting indicators

  Sample

  Three groups; group sizes not given in the abstract

  Authors' conclusion

  Thymalin, compared with Tocilizumab, was judged to meet the principles of pathogenic therapy for severe COVID-19 to a greater extent, normalizing blood morphology and clotting indicators.

  Limitations

  Group sizes and randomization not stated; mortality not tested statistically in the abstract.

  PubMed 36169363
• ~ Mixed human trialStomatologiia (Mosk) · 1994

  [Thymalin in the treatment of herpetic stomatitis in children].

  Humans44 peopleNo control group

  Clinical treatment study with laboratory and immunological monitoring; no control group described

  In 44 children with herpetic stomatitis, thymalin did not speed relief of acute symptoms but was reported to reduce relapses.

  Study details

  Studied

  Children with herpetic stomatitis

  Main outcome

  Relief of acute symptoms; relapse prevention; immune status

  Sample

  44 children with acute and relapsing herpetic stomatitis

  Authors' conclusion

  Thymalin did not rapidly abate acute symptoms but is considered justified because it helps attain a stable antirelapse effect in children at high risk of recurrences.

  Limitations

  No comparator described and no quantitative results in the abstract.

  PubMed 8191521
• ? Inconclusive human trialLik Sprava · 1999

  [Thymalin in the combined treatment of parkinsonism patients].

  HumansFifteen patients (written as a word)No control group

  Before-and-after examination around a thymalin course; no control group

  Uncontrolled study of 15 people with Parkinson's disease: authors report improved well-being, symptoms and EEG measures after a thymalin course; no control group.

  Study details

  Studied

  Patients aged 45 to 72 with idiopathic parkinsonism (stage 1.5 to 2.5)

  Main outcome

  Well-being, parkinsonian symptoms, EEG mapping

  Authors' conclusion

  The authors report a positive course of well-being and parkinsonian symptoms, with EEG changes suggesting improved cortical neurodynamics.

  Limitations

  Uncontrolled, 15 patients, no numerical results in the abstract.

  PubMed 10424021
• ? Inconclusive human trialKhirurgiia (Mosk) · 1994

  [Prevention of postoperative complications in diffuse purulent peritonitis in children].

  Humans21 people

  Complex multi-component surgical protocol including wound-edge infiltration with 0.01% thymalin, compared with controls

  In 21 children with purulent peritonitis, a multi-component surgical protocol that included thymalin wound infiltration reduced complications vs controls; thymalin's own contribution cannot be separated.

  Study details

  Studied

  Children with generalized fibrinopyogenic peritonitis

  Compared with

  Control group of patients operated on conventionally

  Main outcome

  Postoperative complications

  Sample

  21 children

  Authors' conclusion

  Results were significantly improved with the complex protocol and complications were much fewer than in controls; the effect of thymalin alone cannot be separated.

  Limitations

  Thymalin was only one part of a multi-component protocol; no numerical data in the abstract.

  PubMed 7990325
• ✓ Positive animalBull Exp Biol Med · 2018

  Effect of Thymalin on the Tumor and Thymus under Conditions of Activation Therapy In Vivo.

  Animalssize not reported

  Animal experiment with low-dose thymalin under activation-therapy regimens

  In rats with transplanted sarcoma, low-dose thymalin arrested or regressed tumor growth in over half the animals.

  Key resultTumor growth arrest and regression in more than half of animals; in other cases growth was suppressed by 78%

  Study details

  Studied

  Albino outbred male rats with transplanted sarcoma 45

  Main outcome

  Tumor growth and thymus microstructure

  Authors' conclusion

  Thymalin at doses lower than therapeutic doses showed a pronounced antitumor effect in rats, which the authors attribute to lower, modulated dosing.

  Limitations

  Rat model; numbers of animals not stated in the abstract.

  DOI 10.1007/s10517-018-4104-zPubMed 29797130
• ✓ Positive in vitroBull Exp Biol Med · 2020

  Thymalin: Activation of Differentiation of Human Hematopoietic Stem Cells.

  Cells / lab

  In vitro differentiation study

  In human hematopoietic stem cell cultures, thymalin reduced stem-cell markers and increased the mature T-cell marker CD28 6.8-fold.

  Key resultThymalin reduced CD44 and CD117 expression by 2-3 times and increased CD28 expression by 6.8 times

  Study details

  Studied

  Human hematopoietic stem cells in culture

  Main outcome

  Expression of CD44, CD117 and CD28

  Authors' conclusion

  Thymalin appears to stimulate differentiation of CD117+ cells into mature CD28+ T lymphocytes; the authors suggest it could be an immunoprotective drug for COVID-19 prevention.

  Limitations

  In vitro; effect on COVID-19 is a hypothesis.

  DOI 10.1007/s10517-020-05016-zPubMed 33237528Free full text
• ✓ Positive human trialRussian-languageБайкальский медицинский журнал · 2012

  Сравнительное действие тималина , тимогена и ронколейкина на состояние иммунитета и гемостаза при развитии эндометрита после кесарева сечения

  Humanssize not reportedRandomized10 days of thymalin

  Comparative clinical study versus standard complex therapy (randomization not described)

  60 women with endometritis after caesarean section received standard therapy plus thymalin, thymogen or ronkoleykin and were compared with 25 on standard therapy alone: the thymalin group had higher CD4+ cells (37.4% vs 22.5%) and fewer clotting abnormalities, but randomization and blinding are not described.

  Key resultCD4+ cells 37.4% with thymalin vs 22.5% with standard therapy alone (healthy postpartum women 62.6%); IgG 11.4 vs 9.1 g/l.

  Study details

  Studied

  Women with endometritis after caesarean section

  Compared with

  Standard complex therapy alone; thymogen; ronkoleykin

  Main outcome

  Lymphocyte subsets, immunoglobulins and haemostasis markers; clinical course

  Sample

  60 women treated with thymalin, thymogen or ronkoleykin; 25 controls on standard therapy

  Authors' conclusion

  Adding thymalin, thymogen or ronkoleykin to complex therapy was followed by rapid disappearance of the immune and clotting disturbances and a good clinical effect.

  Limitations

  Not blinded; no randomization described; small groups; surrogate lab markers.

  CyberLeninka (Russian)
• ? Inconclusive human trialRussian-languageActa Biomedica Scientifica · 2005

  Применение иммуномодулятора тималина при лечении хронических заболеваний легких у детей

  Humans28 people5 to 10 days of treatment, re-tested after 2 weeks

  Open comparison by random selection: usual care with or without thymalin

  In 28 children with chronic lung disease (10 given intramuscular thymalin plus usual care, 18 usual care only), thymalin moved immune markers toward normal (lymphocyte-platelet adhesion 13.92% vs 13.2%, healthy 15.9%), but groups were tiny, only lab markers were measured and no clinical outcome was reported.

  Key resultLymphocyte-platelet adhesion rose to 13.92% with thymalin vs 13.2% with traditional therapy (healthy children 15.9%).

  Study details

  Studied

  Children aged 7 to 14 with bronchiectasis or chronic deforming bronchitis

  Compared with

  Traditional therapy alone

  Main outcome

  Lymphocyte subsets, immunoglobulins, lymphocyte-platelet adhesion

  Sample

  28 children with chronic lung disease (10 thymalin, 18 control) plus 20 healthy children

  Authors' conclusion

  The author concluded that thymalin brought cellular and humoral immune indices closer to normal and improved treatment results.

  Limitations

  Only 10 treated children; surrogate immune markers; no clinical outcomes; no blinding.

  CyberLeninka (Russian)

Reported side effects

No adverse effects are described in the human study abstracts reviewed; systematic safety reporting is lacking.

✓ positive · ✗ negative · ~ mixed · ? inconclusive, judged on each paper's own main outcome. Grades: A strong human evidence → D little or none. Papers and verdicts are drawn from PubMed, Europe PMC and Russian journals (CyberLeninka); not medical advice.