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Ta15.0
Thymosin Alpha-1 – Forschung
Überwiegend Mechanismus / Beobachtung
24 begutachtete Studien
Was die Evidenz sagt
Überwiegend Mechanismus / Beobachtung
Die meisten Studien zu Thymosin Alpha-1 sind mechanistisch oder beobachtend statt RCTs, die einen klinischen Effekt messen — betrachte die Ergebnisse als vorläufig.
Die meiste Evidenz stammt aus mittelwertigen Meta-Analysen und randomisierten Studien, veröffentlicht 1999–2026 mit einer typischen Studiengröße von 361 Teilnehmenden.
Basierend auf 24 Studien · 10 Meta-Analysen · 7 RCTs · 5,412 Teilnehmende insgesamt
Konfidenz
Hohe Konfidenz
Nach Outcome
Immune supportErhöht die CD4+-T-Zellen sowie das CD4+/CD8+-Verhältnis und reduziert in Metaanalysen die Kurzzeitmortalität und Infektionen bei Sepsis und schwerer akuter Pankreatitis (belegt keine allgemeine Immunstärkung bei gesunden Menschen) · Tage bis Wochen bei akuten Krankheitsbildern
Überwiegend Mechanismus / Beobachtung11 Studien
Hepatitis & liver
Überwiegend Mechanismus / Beobachtung6 Studien
Safety profile
Überwiegend Mechanismus / Beobachtung5 Studien
Respiratory & lung
Überwiegend Mechanismus / Beobachtung4 Studien
Aktives Forschungsgebiet
14 Studien in den letzten 5 Jahren · Neueste Meta-Analyse: 2025
199920122026
1Systematische Übersicht2025
Further research is needed to validate its long-term efficacy and safety in geriatrics.
Simonova MA, Ivanov I, Shoshina NS, Komyakova AM, Makarov DA, Baranovskii DS, Klabukov ID, Telepenina KP, Atiakshin DA, Shegay PV, Kaprin AD, Stepanenko VN. · International journal of molecular sciences (2025)
Preclinical and clinical studies show that Tα1 can improve vaccine response in the elderly and mitigate immunosenescence.
The hybrid drug Refnot (a fusion of tumor necrosis factor alpha (TNFα) and Tα1) combines Tα1's immunomodulation with TNF's antitumor activity but has reduced toxicity.
It represents a promising therapeutic approach to counteract age-related immune dysfunction and inflammation, potentially by slowing the aging process.
Cao A, Feng F, Zhou X. · Journal of the College of Physicians and Surgeons--Pakistan : JCPSP (2024)
Thymosin alpha 1 could significantly boost the immune function, and improve pulmonary function and arterial blood gas of AECOPD patients than routine treatment only.
More high-quality randomised controlled trials are needed to further confirm Thymosin alpha 1 efficacy.
Peptide therapeutics, therefore, represent a developing research domain whose relevance to thyroid care remains to be established through rigorous investigation.
Mazza AD. · Integrative medicine (Encinitas, Calif.) (2026)
Safety profiles vary across peptide classes, and clinical use remains largely investigational in the context of thyroid disease.
This review presents potential biologic pathways linking peptide activity to immune and metabolic aspects of thyroid disorders, as well as regulatory and ethical considerations surrounding emerging peptide applications.
Substantial evidence gaps persist, and well-designed thyroid-focused clinical trials are needed to clarify safety, efficacy, and appropriate clinical roles.
Liu H, Qian SC, Zhang YY, Tang CB, Yue HH, Fan GL, Zhao X, Jiang YY, Huang FH, Zeng ZH, Wang W, Lu XR, Luo XK, Bai XF, Zheng XX, Xie P, Ma C, Zhao S, Zhang HJ, On the behalf of China Additive Anti-inflammatory Actions for Aortopathy and Arteriopathy (5A) and PANDA Trial Investigators. · Future cardiology (2025)
The primary endpoint involves calculating the difference in mean postoperative Sequential Organ Failure Assessment (SOFA) scores between groups, measured daily from postoperative days 7.
By targeting post-operative immune system imbalance, this study aims to establish a novel therapeutic approach for reducing systemic inflammatory response syndrome (SIRS)-mediated organ injury and improving long-term outcomes in this high-risk population.
Results will be disseminated through peer-reviewed publications and international conferences.
The conventional-dose and high-dose thymalfasin for injection effectively improves the perioperative immune function of CRC patients and reduces the incidence of postoperative complications, as an effective treatment for such patients, which can benefit patients.
Niu W, Li Z, Li Z, Hu X, Wang X, Ding Y, Li C, Yu B. · Biotechnology & genetic engineering reviews (2024)
Compared with control group, the conventional-dose group and high-dose group had notably lower incidences of perioperative infection (P < 0.05), with no significant difference in both groups (P > 0.05).
The experimental group had significantly lower overall incidence of early and late postoperative complications, local recurrence rate and the incidence of distant metastasis, and higher perioperative immune function indexes and median disease free survival (DFS) (P < 0.05).
The conventional-dose and high-dose thymalfasin for injection effectively improves the perioperative immune function of CRC patients and reduces the incidence of postoperative complications, as an effective treatment for such patients, which can benefit patients.
This article explores the experiences of researchers testing the effect of a thymic peptide hormone, thymosin alpha-1, in preclinical and clinical settings and discuss how its therapeutic utility in the precision medicine era can be accommodated within the PDD framework.
Garaci E, Paci M, Matteucci C, Costantini C, Puccetti P, Romani L. · Frontiers in medicine (2024)
Ultimately, disease definitions are mostly symptom-based rather than mechanism-based, and the therapeutics should be likewise.
In recent years, there has been a renewed interest in PDD due to its potential to address the complexity of human diseases, including the holistic picture of multiple metabolites engaging with multiple targets constituting the central hub of the metabolic host-microbe interactions.
Although PDD presents challenges such as hit validation and target deconvolution, significant achievements have been reached in the era of big data.
Conclusions Among ANP patients with hyperglycemia, immune-enhancing Tα1 treatment was associated with a reduced risk of IPN (ClinicalTrials.gov, Registry number: NCT02473406).
Huang X, Mao W, Hu X, Qin F, Zhao H, Zhang A, Wang X, Stoppe C, Zhou D, Ke L, Ni H, Chinese Acute Pancreatitis Clinical Trials Group (CAPCTG). · Gut and liver (2024)
Among them, 271 (54.0%) had hyperglycemia, 371 (73.9%) had hypertriglyceridemia and 229 (45.6%) had both.
Tα1 therapy was associated with reduced incidence of IPN among patients with hyperglycemia (18.8% vs 29.7%: hazard ratio, 0.80; 95% confidence interval, 0.37 to 0.97; p=0.03), but not in the other subgroups.
Additional multivariate regression models using three propensity-score methods yielded similar results.
Therefore, it is recommended that the FDA permits 503A compounding pharmacies to compound Tα1, considering its potential to treat a variety of conditions effectively.
Dinetz E, Lee E. · Alternative therapies in health and medicine (2024)
Conclusions Based on substantial evidence from clinical trials, Tα1 emerges as a well-tolerated and effective immune modulator.
The FDA›s restriction appears unfounded, as Tα1 has shown safety and efficacy beyond the initially specified conditions.
Urgent attention and intervention are warranted to ensure the continued availability of this life-saving peptide through prescription.
Xu H, Li F, Li B, Yang D, Liu T, Xia Y, Hua H, Li Q, Wang J, Liu H, Xu Z. · BMC medicine (2026)
Results Thirty patients were enrolled and all underwent curative-intent minimally invasive gastrectomy. pCR was achieved in 30.0% (9/30), and MPR in 56.7% (17/30). ypN0 status was observed in 63.3% (19/30), with N-stage downstaging in 80.0% (24/30).
Any-grade adverse events (AEs) occurred in 93.3% of patients, grade ≥ 3 AEs in 26.7%, and immune-related AEs in 23.3%.
Conclusions Neoadjuvant serplulimab, SOX, and thymalfasin produced encouraging pathological response, substantial nodal clearance, and an acceptable safety profile in stage III G/EGJ adenocarcinoma.
Lessons This treatment regimen may offer a promising treatment strategy for patients with mTNBC and other metastatic solid cancers.
Yu J, Wang Q, Wang L, Zong D, He X. · Medicine (2024)
The target lesion and the 3 observed lesions achieved a partial response according to the RECIST v1.1 criteria. reevaluation scans after 2 cycles of immunotherapy indicated a regression rate of -78.97% for the target lesion and -56.73% for the observed lesions.
Also, the tumor marker CA-199 exhibited a downward trend.
During the course of treatment, the patient experienced a grade 2 skin reaction, which improved after receiving antiallergic treatment.
The use of Tα1 therapy in combination with conventional medical therapies may be effective in improving clinical outcomes in a targeted population of severe sepsis.
Wu J, Zhou L, Liu J, Ma G, Kou Q, He Z, Chen J, Ou-Yang B, Chen M, Li Y, Wu X, Gu B, Chen L, Zou Z, Qiang X, Chen Y, Lin A, Zhang G, Guan X. · Crit Care (2013)
ETASS: the pivotal multicenter RCT — 361 severe-sepsis patients across six Chinese teaching hospitals randomized 1:1 to Tα1 or control
28-day all-cause mortality 26.0% (Tα1) vs 35.0% (control); relative risk 0.74 (95% CI 0.54-1.02) — a borderline result (nonstratified P = 0.062; log-rank P = 0.049)
Tα1 produced greater recovery of monocyte HLA-DR (an immune-restoration marker) on days 3 and 7, consistent with its immunomodulatory mechanism
Tα1 has the potential to decrease 28-day mortality rates in patients with sepsis; however, it is crucial to recognize that its efficacy differs among various subgroups.
Gu B, Zhou Y, Nie Y, Wang L, Liang L, Liao Z, Wen J, Guan X, Chen M, Wu J, Pei F. · Front Cell Infect Microbiol (2025)
Overall 28-day mortality was reduced (OR 0.73, 95% CI 0.59-0.90) — but the benefit DISAPPEARED in the high-quality subgroup (OR 0.82, 0.65-1.03) and the multicenter subgroup (OR 0.86, 0.68-1.08)
Trial sequential analysis indicated the pooled sample size is still inadequate to confirm benefit; subgroup signals (cancer, diabetes, coronary disease) were low-to-moderate credibility
ETV plus Tα1 might lead to a higher clinical response and a lower comprehensive adverse reaction rate in HBV-related patients with cirrhosis, compared to ETV alone.
Peng D, Xing HY, Li C, Wang XF, Hou M, Li B, Chen JH. · BMC Gastroenterol (2020)
Seven RCTs, 1144 subjects with HBV-related cirrhosis
Entecavir + Tα1 gave higher complete response (RR 1.18) and higher HBV-DNA-undetectable and HBeAg-loss rates at 24 weeks versus entecavir alone
Differences were not significant at 48-52 weeks, and HBsAg loss was unchanged — benefit attenuates over time
There was a trend towards HBeAg loss when using combination therapy... This could clinically indicate a potential important difference that would need confirmation in subsequent trials.
Lim SG, Wai CT, Lee YM, Dan YY, Sutedja DS, Wee A, Suresh S, Wu YJ, Machin D, et al. · Antivir Ther (2006)
Double-blind RCT, 98 HBeAg-positive chronic hepatitis B patients; Tα1 + interferon versus interferon + placebo for 24 weeks
HBeAg loss at 72 weeks 45.8% (combination) vs 28.0% (monotherapy) — a 17.8% difference that did NOT reach significance (95% CI -1.2% to 35.3%, P = 0.067)
No significant differences in HBeAg seroconversion, histology, ALT normalization or HBV-DNA loss
16Meta-Analyse2016
Thymosin α1 alone was associated with significantly lower 28-day mortality... but there was no significant difference in the 90-day mortality.
Feng Z, Shi Q, Fan Y, Wang Q, Yin W. · J Trauma Acute Care Surg (2016)
12 studies in severe sepsis comparing ulinastatin and/or Tα1 immunomodulatory therapy
Tα1 alone reduced 28-day mortality (RR 0.72, 95% CI 0.55-0.93) but NOT 90-day mortality (RR 0.84, 95% CI 0.54-1.31) — GRADE rating low/very low for Tα1 alone
Combination (ulinastatin + Tα1) reduced both 28- and 90-day mortality (moderate GRADE)
Interferon and thymosin alpha-1 combination therapy achieves superior effect with no increase in the adverse effects as compared to interferon monotherapy for HBeAg positive chronic hepatitis B.
Mao HY, Shi TD. · Zhonghua Gan Zang Bing Za Zhi (2011)
Seven RCTs, 535 HBeAg-positive chronic hepatitis B patients
Combination was more effective than interferon alone for HBV-DNA-negative rate, ALT normalization, HBeAg loss and seroconversion, both at end of treatment and follow-up
HBsAg loss rate higher with combination only at end of follow-up