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Thymagen research

What published studies found for Thymagen: 11 papers, 8 in humans, with sample sizes and key results.

B
Some human evidence
Why: Two RCTs conflict: a 202-patient phase 3 trial (as IM862) failed in Kaposi sarcoma, while a small Russian surgical trial was positive; the rest is uncontrolled.

Thymagen (Thymogen, the dipeptide Glu-Trp) has a Soviet and Russian clinical literature from the 1990s reporting immune and clinical improvement when added to treatment for infections, tuberculosis and surgery, but those studies are small, mostly open-label and poorly reported by modern standards. The same dipeptide, developed in the West as IM862 for AIDS-related Kaposi sarcoma, failed a proper phase 3 randomized trial.

✓ 8 positive✗ 1 negative~ 1 mixed? 1 inconclusive

The best-controlled human trial (phase 3, 202 patients) found no benefit and a shorter time to tumour progression than placebo; the Russian clinical reports are small and mostly uncontrolled.

US compounding: Not compoundable. Not an FDA-approved drug and not nominated for FDA's 503A bulks list, so US pharmacies can't legally compound it. Status for every peptide.

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Reported side effects

Human studies

✗ Negativehuman RCTJ Clin Oncol · 2005

Angiogenesis inhibitor IM862 is ineffective against AIDS-Kaposi's sarcoma in a phase III trial, but demonstrates sustained, potent effect of highly active antiretroviral therapy: from the AIDS Malignancy Consortium and IM862 Study Team.

202 HIV-positive patients enrolled: 104 on IM862, 98 on placeboRandomized, double-blinded, placebo-controlled phase III trial of IM862 (dipeptide L-Glu-L-Trp), 5 mg intranasally every other day24 weeks

In 202 HIV-positive patients with Kaposi sarcoma, intranasal IM862 (the Glu-Trp dipeptide) gave no better response rate than placebo (23% vs 21%) and was associated with a shorter time to progression (16 vs 35 weeks).

Key resultResponse rate 23% with IM862 vs 21% with placebo (P = .46); median time to progression 16 vs 35 weeks (P = .012)
Studied
HIV-positive patients with AIDS-related Kaposi's sarcoma
Compared with
Placebo
Main outcome
Tumor response rate
Authors' conclusion
IM862 was not superior to placebo and may accelerate time to progression. Antiretroviral therapy alone gave substantial sustained responses and may have confounded earlier estimates.
Limitations
Antiretroviral use differed between arms (88% vs 96%); IM862 is the thymogen-related dipeptide, not thymogen itself.
PubMed 15598977DOI
✓ Positivehuman RCTAdv Gerontol · 2011

[Application thymogen for preoperative preparation of elderly patients with tumor processes in abdominal cavity].

HumansDouble-blind, randomized, placebo-controlled study of Thymogen 100 mg intranasally once daily7 days before surgery

In a double-blind placebo-controlled trial in elderly patients before abdominal tumour surgery, 7 days of intranasal thymogen restored cellular immunity measures and was reported to reduce postoperative complications and shorten recovery; patient numbers and effect sizes are not given in the abstract.

Studied
Elderly patients undergoing surgery for solid tumors in the abdominal cavity and retroperitoneal space
Compared with
Isotonic sodium chloride placebo
Main outcome
Cellular immunity parameters, postoperative complications, postoperative period
Authors' conclusion
Preoperative Thymogen helped restore cellular immunity parameters and significantly decreased postoperative complications and shortened the postoperative period.
Limitations
Abstract gives no sample size or numerical results.
PubMed 21957588
? Inconclusivehuman trialВестник Авиценны · 2008Russian-language

Эффективность тимогена и кларитина в комплексном лечении больных крапивницей

n = 79 humansUncontrolled treatment series (no control group described in abstract)

In 79 patients with urticaria given thymogen plus the antihistamine loratadine (Claritin), symptoms cleared in about 9-10 days and 25.4% had remission of at least 6 months; uncontrolled, and the effect cannot be attributed to thymogen.

Key resultRemission over 6 months in 25% of patients and over 3 months in 43%
Studied
Patients with urticaria and reduced T-suppressor/T-helper levels and raised IgE
Main outcome
Remission duration and immune indices
Sample
79 patients with urticaria
Authors' conclusion
The authors report that the thymogen and Claritin regimen produced long remissions and improved immune indices.
Limitations
No control group; combined with an antihistamine, so the effect of thymogen cannot be isolated.
CyberLeninka (Russian)
✓ Positivehuman trialМедицинская иммунология · 2011Russian-language

Сравнительное влияние тималина и тимогена на иммунитет, гемостаз и течение послеоперационного эндометрита

n = 60 humansControlled comparison of thymalin or thymogen added to standard complex therapy; randomization not stated10 days of intramuscular treatment

In 60 women with endometritis after caesarean section, adding thymalin or thymogen to standard therapy (25 controls on standard therapy alone) was reported to correct immune and clotting disturbances faster, with a favourable clinical effect; no randomization stated and results not split by peptide.

Studied
Women with postoperative endometritis after caesarean section
Compared with
Standard complex therapy alone (25 women)
Main outcome
Immune status, coagulation/fibrinolysis, course of endometritis
Sample
60 treated women (thymalin or thymogen) plus 25 controls
Authors' conclusion
Thymic peptides (thymalin or thymogen) in complex therapy were accompanied by more rapid correction of immune and haemostasis disorders and a good clinical effect.
Limitations
No stated randomization or blinding; thymalin and thymogen groups pooled in the abstract; numbers not given in the abstract.
CyberLeninka (Russian)
✓ Positivehuman trialAkush Ginekol (Mosk) · 1992

[Thymogen in the complex treatment of inflammatory diseases of the female genital system].

n = 46 humansThymogen added to combined therapy

In 46 women with acute endomyometritis or other genital inflammatory disease, thymogen added to standard therapy normalized lymphocyte counts and was reported to give a marked clinical effect with no complications; uncontrolled.

Studied
Patients with acute endomyometritis, exacerbated chronic salpingo-oophoritis or purulent tubo-ovarian formations
Main outcome
Lymphocyte counts, T and B lymphocytes, T-cell function
Sample
46 patients
Authors' conclusion
Thymogen normalized lymphocyte counts and increased T lymphocyte functional activity without complications; recommended for combined therapy.
Limitations
No control group described in the abstract; no numerical results.
PubMed 1476231
✓ Positivehuman trialProbl Tuberk · 1994

[Changes of immune and non-specific reactivity in patients with chronic suppurative obstructive bronchitis in comprehensive treatment with thymogen].

n = 33 humansThymogen added to multimodality treatment

In 33 patients with chronic suppurative obstructive bronchitis, adding thymogen normalized T-cell and non-specific immunity measures with higher reported clinical efficacy.

Studied
Patients with chronic pyoobstructive bronchitis with immunological disorders
Main outcome
T-cell immunity and nonspecific responsiveness parameters
Sample
33 patients
Authors' conclusion
Thymogen in multimodality treatment contributed to normalization of T-cell immunity and nonspecific responsiveness, with higher clinical efficacy.
Limitations
Abstract describes no control group.
PubMed 7984617
✓ Positivehuman trialJ Clin Oncol · 2000

Results of a randomized study of IM862 nasal solution in the treatment of AIDS-related Kaposi's sarcoma.

44 patients randomized to two schedules (18 five-days-on/off, 26 every-other-day)Randomized comparison of two IM862 5 mg intranasal dosing schedulesRepeated cycles until progression or toxicity

In an earlier randomized dose-schedule study of 44 patients with AIDS-related Kaposi sarcoma, IM862 produced major responses in 36% with only mild transient headache, fatigue, tingling and nausea; there was no placebo arm.

Key resultMajor responses in 36% (five complete and 11 partial remissions)
Studied
Patients with AIDS-related Kaposi's sarcoma (median age 38 years)
Compared with
Two dosing schedules (no placebo)
Main outcome
Tumor response
Authors' conclusion
Intranasal IM862 was well tolerated and had antitumor activity in AIDS-KS; a randomized double-blinded study was in progress.
Limitations
No placebo arm; most patients on concurrent protease inhibitors.
PubMed 10673512DOI
✓ Positivehuman trialVoen Med Zh · 1999

[The effect of thymogen on the state of immunity in destructive pulmonary tuberculosis].

HumansClinical immunocorrection studyCourses of 2 and 4 months

In destructive pulmonary tuberculosis, thymogen stimulated T-cell measures and was reported to improve cavity healing and reduce bacterial shedding; a small non-randomized clinical study.

Studied
Patients with destructive pulmonary tuberculosis
Main outcome
T-cell immunity, tolerance of antituberculosis drugs, cavity healing
Authors' conclusion
Thymogen stimulated the T-cell link, improved tolerance of treatment and was associated with cavity healing and cessation of bacterial discharge; two courses are recommended.
Limitations
Abstract gives no sample size, control group or numbers.
PubMed 10605346

Animal & lab studies

✓ PositiveanimalVopr Onkol · 1992

[The effect of the synthetic immunomodulator thymogen on radiation-induced carcinogenesis in rats].

AnimalsAnimal carcinogenesis study; 12 monthly courses of thymogen 5 micrograms/animal for 5 days12 months

In rats given radioactive strontium and caesium, monthly thymogen courses reduced total tumour and cancer incidence and lengthened lifespan.

Studied
Female rats given Sr-90 and Cs-137 in drinking water
Compared with
Radionuclide-only and untreated animals
Main outcome
Tumor and cancer incidence, life span
Authors' conclusion
Thymogen inhibited radionuclide-induced carcinogenesis, and thymogen alone was associated with longer life span and lower tumor incidence in rats.
Limitations
Animal study; sample size not given in abstract.
PubMed 1300740
✓ PositiveanimalBull Exp Biol Med · 2025

Hepatoprotective Effects of Thymogen Analogues in Hydrazine Hepatopathy in Rats.

AnimalsAnimal study of thymogen and D-Ala analogues

In rats with hydrazine-induced liver injury, thymogen and D-alanine-modified analogues at lower doses reduced lipid peroxidation and stimulated hepatocyte repair, with no added benefit at higher doses.

Studied
Rats with hydrazine-induced hepatopathy
Main outcome
Catalase activity, malondialdehyde and hepatocyte regeneration
Authors' conclusion
Lower doses of thymogen and its analogues inhibited lipid peroxidation and stimulated hepatocyte regeneration; the C-terminal D-Ala analogue was most effective.
Limitations
Animal study; sample size not given in abstract.
PubMed 40442470DOI
~ Mixedin vitroCell tissue biol · 2023

The Effect of Drugs with α-Glutamyl-Tryptophan for Cytokine Secretion and Level of Surface Molecule ICAM-1 In Vitro.

Cells / labIn vitro inflammation model with alpha-Glu-Trp and Cytovir-3

In cultured endothelial cells and blood mononuclear cells, alpha-Glu-Trp (the thymogen dipeptide) reduced TNF-alpha-induced IL-1alpha and IL-8 secretion but raised ICAM-1, an anti-inflammatory yet cell-activating profile.

Studied
EA.hy 926 endothelial cells and peripheral blood mononuclear cells from healthy donors
Compared with
Untreated / TNF-alpha-stimulated cells
Main outcome
IL-1alpha and IL-8 secretion and ICAM-1 level
Authors' conclusion
Suppression of stimulated pro-inflammatory cytokines by alpha-Glu-Trp may underlie anti-inflammatory properties, while raised ICAM-1 indicates enhanced functional activity of the cells.
Limitations
In vitro only; cells from healthy donors; Cytovir-3 is a multi-ingredient drug.
PubMed 37131521DOIFree full text

Verdicts are judged on each paper's own main outcome; grades run from A (strong human evidence) to D (little or none). Details are read from the abstracts, and figures are reproduced only from openly licensed full texts. Not medical advice.