Zadaxin (thymalfasin) / SciClone - LARVOL DELTA

Effect of Thymosin a-1 on Treatment Completion and Pneumonitis in Chemoradiation Plus Immunotherapy for LA-NSCLC: A Randomized Phase II Trial (IASLC-WCLC 2026) - "Methods : This prospective, randomized, phase II study (GASTO-1098) enrolled patients with unresectable LA-NSCLC who received induction chemo-immunotherapy followed by CCRT and tislelizumab consolidation...Conclusions : Adding Tα1 to CCRT followed by consolidation immunotherapy significantly improved the 12-month consolidation immunotherapy completion rate in LA-NSCLC patients, reduced grade ≥2 pneumonitis, and showed favorable PFS and immune reconstitution trends. Longer follow-up is warranted."

Clinical • P2 data • Inflammation • Lung Cancer • Non Small Cell Lung Cancer • Pneumonia • Solid Tumor

Clinical Applications and Evidence Landscape of Thymosin Alpha 1 as an Immunomodulatory Adjunct in Cancer Care: A Scoping Review. (PubMed, Pharmaceuticals (Basel)) - " Tα1 has been investigated mainly as an adjunctive immunomodulatory strategy in cancer care. Prospective controlled studies with standardized dosing, defined treatment contexts, consistent outcomes, and systematic harms reporting are needed."

IO biomarker • Journal • Review • Gastrointestinal Cancer • Oncology • Solid Tumor

Thymosin a-1 Plus Chemo-Immunotherpay Followed by TRT as First-Line Treatment for ES-SCLC: A Prospective, Single-Arm Trial (IASLC-WCLC 2026) - "The treatment is divided into three phases: Chemoimmunotherapy phase (4 cycles, Q3W): EP/EC chemotherapy (etoposide 100mg/m2 D1-3 + cisplatin 75mg/m2 D1 or carboplatin AUC=5 D1) combined with atezolizumab (1200mg, IV) or other guideline-recommended ICIs, plus subcutaneous Tα-1 1.6mg twice a week for 12 weeks...All tests are two-sided, with P<0.05 considered statistically significant. Patient recruitment will be completed from October 2025 to December 2026, followed by treatment and follow-up until December 2027, and data management and final analysis from January to June 2028."

Clinical • Immunology • Lung Cancer • Non Small Cell Lung Cancer • Pneumonia • Small Cell Lung Cancer • Solid Tumor

Adjuvant use of thymosin alpha 1 during postoperative intensity-modulated radiotherapy in patients with lymph node-positive breast cancer: phase II randomized controlled clinical study (ChiCTR) - P2 | N=208 | Not yet recruiting | Sponsor: Sun Yat-sen Memorial Hospital; Sun Yat-sen Memorial Hospital

New P2 trial • Breast Cancer • Oncology • Solid Tumor

Protective Effect of Thymosin α1 Against Negative Immune Dysregulation and Organ Dysfunction After Acute Aortic Dissection Surgery (PANDA II) (clinicaltrials.gov) - P=N/A | N=600 | Completed | Sponsor: Nanjing Medical University | Recruiting ➔ Completed | N=330 ➔ 600 | Trial completion date: Dec 2025 ➔ Jul 2026

Enrollment change • Trial completion • Trial completion date

Thymosin-ɑ1 for people with chronic hepatitis B. (PubMed, Cochrane Database Syst Rev) - "We assessed the certainty of evidence as very low for all outcomes except for serious adverse events (low). Therefore, we are not sure whether thymosin-α1 monotherapy versus placebo or no intervention, or with the same co-interventions, reduces all-cause mortality, serious adverse events, HBV-related mortality, and non-serious adverse events, nor whether it has any effect on quality of life (based on one trial) and histological improvement. The effect of thymosin-ɑ1 on HBV-related morbidity is very uncertain. We observed no statistically significant differences between trials with and without cointerventions. We found no ongoing trials."

Clinical • Journal • Review • Fibrosis • Hepatitis B • Hepatitis C • Hepatocellular Cancer • Hepatology • Immunology • Infectious Disease • Inflammation • Liver Cirrhosis • Liver Failure • Oncology • Solid Tumor

Thymalfasin May Lead to MRD Clearance for Post - Surgery NSCLC Patients and Thereby Achieve Survival Benefits (IASLC-WCLC 2026) - "Case 11 maintained persistent MRD positivity without recurrence, likely due to its stage IA1 classification. Conclusions : Thymalfasin, as an immunomodulator, can facilitate MRD clearance in postoperative NSCLC patients, thereby providing a novel therapeutic option for escalation therapy guided by positive MRD after NSCLC surgery."

Clinical • Surgery • Lung Cancer • Non Small Cell Lung Cancer • Solid Tumor

A prospective clinical study on the effectiveness of Phellinus igniarius decoction in treating immune dysfunction in colorectal cancer patients following chemfotherapy. (PubMed, J Tradit Complement Med) - "Participants were randomized (1:4:1) to receive placebo (N = 33), PEG (N = 132), or thymalfasin (N = 33)...Subgroup analysis revealed that patients with spleen-kidney deficiency syndrome composed the optimal responder subgroup. PEG effectively restored immune function, improved quality of life, and was favorable for in postchemotherapy patients with CRC, with those exhibiting spleen-kidney deficiency syndrome representing the primary beneficiary population."

Journal • Colorectal Cancer • Oncology • Solid Tumor • CD4 • IFNG • IL10 • IL2 • IL4 • TNFA

Thymosin Alpha-1 Provides Direct Neuroprotection by Engaging the Orexin Receptor HCRTR1 to Suppress Neuronal Necroptosis. (PubMed, Adv Sci (Weinh)) - "Our findings identify a novel thymus-brain signaling pathway, revealing a new neuroprotective function for an immune peptide and an unexpected role for a canonical neuronal receptor. This work establishes Tα1 as a promising dual-action therapeutic candidate, capable of both direct neuronal protection and systemic immunomodulation."

Journal • Cardiovascular • Immunology • Ischemic stroke

Thymosin α-1 in Cancer Therapy: Immunomodulatory Mechanisms, Clinical Applications, and Translational Perspectives. (PubMed, Eur J Pharmacol) - "We discuss recent advances in Tα1-based combination strategies, clinical observations, translational opportunities, and current limitations of the evidence. Furthermore, key challenges and future research directions are highlighted to provide an updated perspective on the role of Tα1 as a potential adjunctive immunomodulatory agent in modern cancer immunotherapy."

Journal • Review • Hepatocellular Cancer • Lung Cancer • Melanoma • Non Small Cell Lung Cancer • Oncology • Solid Tumor

Study of Adebrelimab Combined With Thymalfasin and Chemotherapy for Neoadjuvant Treatment of Esophageal Cancer (clinicaltrials.gov) - P2 | N=31 | Not yet recruiting | Sponsor: The Affiliated Hospital of Putian University

New P2 trial • Esophageal Cancer • Esophageal Squamous Cell Carcinoma • Oncology • Squamous Cell Carcinoma

Risk factors of death in patients with bloodstream infections in a medical intensive care unit (PubMed, Zhonghua Wei Zhong Bing Ji Jiu Yi Xue) - "Bloodstream infection is a common complication among patients in the medical ICU, with Enterobacteriaceae being the most frequently isolated pathogens. The mortality of bloodstream infection is high. LYM≤0.5×109/L at bloodstream infection onset, septic shock at bloodstream infection onset, and the need for mechanical ventilation are independent risk factors for 3-month all-cause death in patients with bloodstream infection, while receipt of appropriate empirical antibiotic therapy after bloodstream infection onset is a protective factor."

Journal • Retrospective data • Chronic Obstructive Pulmonary Disease • Critical care • Diabetes • Gastroenterology • Immunology • Infectious Disease • Metabolic Disorders • Oncology • Pneumonia • Pulmonary Disease • Renal Disease • Respiratory Diseases • Septic Shock • Systemic Inflammatory Response Syndrome • Type 2 Diabetes Mellitus • CRP

GASTO-1098: The Impact of Thymosin ?-1 on the Efficacy of Concurrent Chemoradiotherapy Followed by Immunotherpay Consolidation for Locally Advanced NSCLC (clinicaltrials.gov) - P2 | N=114 | Completed | Sponsor: Sun Yat-sen University | Active, not recruiting ➔ Completed

IO biomarker • Trial completion • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • HAVCR2 • IL4

Methodological Considerations in Interpreting IL-15 Plus Thymosin α1 Therapy for Hepatocellular Carcinoma. (PubMed, J Gastroenterol Hepatol) - No abstract available

Journal • Hepatocellular Cancer • Oncology • Solid Tumor • IL15

Comments on IL-15 Plus Thymosin α1 Reduces Senescent Hepatic CD8+ T Cells in Hepatocellular Carcinoma via PI3K/AKT Suppression. (PubMed, J Gastroenterol Hepatol) - No abstract available

Journal • Hepatocellular Cancer • Oncology • Solid Tumor • IL15

Thy-?1 for RIF: Thymosin-?1 for Recurrent Implantation Failure (clinicaltrials.gov) - P2/3 | N=136 | Recruiting | Sponsor: Fakih IVF Fertility Center

New P2/3 trial

Thymosin α1 Augments CD8⁺ T-Cell Activation and Reverses Exhaustion In Vitro. (PubMed, Asian Pac J Cancer Prev) - "Tα1 promotes functional activation of CD8⁺ T-cells and mitigates exhaustion marker expression following chronic stimulation. These findings suggest that Tα1 could potentially serve as a supportive agent in T-cell-based immunotherapies by enhancing activation and partially reversing exhaustion in vitro, warranting further in vivo validation."

IO biomarker • Journal • Preclinical • Immunology • CD69 • CD8 • HAVCR2 • IFNG • IL10 • IL2RA • ISG20 • LAG3 • PD-1 • TNFA

Neoadjuvant Chemoradiotherapy Combined With PD-1 Inhibitor and Thymalfasin for Locally Advanced Mid-low Rectal Cancer (clinicaltrials.gov) - P=N/A | N=47 | Completed | Sponsor: Beijing Friendship Hospital | Not yet recruiting ➔ Completed | N=26 ➔ 47 | Trial completion date: Mar 2024 ➔ May 2026 | Trial primary completion date: Dec 2023 ➔ Apr 2026

Enrollment change • Trial completion • Trial completion date • Trial primary completion date • Colorectal Cancer • Oncology • Rectal Adenocarcinoma • Rectal Cancer • Solid Tumor

Thymosin Alpha-1 Restores Chemotherapy-Induced Antitumor Immunity by Chaperoning a MicroRNA Ligand of TLR7 in Dendritic Cells. (PubMed, Cancer Res) - "Therapeutic Tα-1 supplementation produced strong synergy with chemotherapy to control established tumors in mice with high miR146a-5p expression in a TLR7-dependent manner. These findings establish Tα-1 as a pivotal endogenous microRNA chaperone that unlocks a critical limiting step of DC licensing, empowering robust antitumor immunity after chemotherapy."

IO biomarker • Journal • Oncology • CD8 • MIR146A • TLR7

Thymosin α1 combined with immune checkpoint inhibitors: synergistic remodeling of the tumor immune microenvironment to enhance clinical efficacy and safety. (PubMed, Front Immunol) - "Preliminary findings suggest that this combination exhibits promising clinical efficacy with manageable safety profiles in cancer therapy. Nevertheless, large-scale and long-term clinical studies are warranted to further validate its sustained clinical benefits."

Checkpoint inhibition • Journal • Review • Oncology • Solid Tumor

Neoadjuvant immunochemotherapy plus thymalfasin in locally advanced gastric cancer: A prospective clinical trial. (ASCO 2026) - P2 | "Treatment included three 21-day cycles of serplulimab (anti-PD-1) plus SOX (S-1 and oxaliplatin) and nine weeks of thymalfasin, followed by curative gastrectomy... Neoadjuvant serplulimab, SOX, and thymalfasin produced encouraging pathological response, substantial nodal clearance, and an acceptable safety profile in stage III G/EGJ adenocarcinoma. Peripheral immune and transcriptomic profiling are consistent with a hypothesis in which thymalfasin may help preserve and coordinate systemic antitumor immunity without excessive toxicity. These findings warrant confirmation in larger randomized trials."

Clinical • IO biomarker • Metastases • Gastric Cancer • Oncology • Solid Tumor • CD69 • CD8

Stage I results of a phase II study evaluating thymosin α1 combined with toripalimab in elderly patients with advanced melanoma. (ASCO 2026) - "Tα-1 combined with toripalimab demonstrated promising efficacy and excellent tolerability in elderly patients with advanced melanoma. The prespecified criteria for Stage II expansion were met, and enrollment of an additional 36 patients is ongoing. Patient demographics."

Clinical • Metastases • P2 data • Cutaneous Melanoma • Endocrine Disorders • Immunology • Melanoma • Solid Tumor • Vitiligo

PRaG 5.0: Personalized thymosin alpha-1 and radioimmunotherapy for advanced refractory solid tumors—Data from an expanded cohort. (ASCO 2026) - P2 | "Integrating of Tα-1 into the PRaG regimen is a promising therapeutic strategy, offering enhanced efficacy and a favorable safety profile. Detailed immune profiling identified distinct T-cell dynamics associated with treatment response, highlighting potential biomarkers for clinical application. Further validation in larger cohorts is warranted."

IO biomarker • Metastases • Oncology • Solid Tumor • CD4 • CD8 • CSF2 • GZMK

Peptide Therapies in Thyroid Health: Emerging Applications in Endocrine and Immune Modulation. (PubMed, Integr Med (Encinitas)) - "This review examines the mechanistic rationale for peptide interventions relevant to thyroid biology and summarizes the current state of evidence for selected peptides, including thymosin alpha-1, thymosin beta-4, BPC-157, and growth hormone secretagogues. Substantial evidence gaps persist, and well-designed thyroid-focused clinical trials are needed to clarify safety, efficacy, and appropriate clinical roles. Peptide therapeutics, therefore, represent a developing research domain whose relevance to thyroid care remains to be established through rigorous investigation."

Journal • Review • Endocrine Disorders • Immune Modulation • Immunology • Solid Tumor • TMSB4X

Regarding IL-15 Plus Thymosin α1 Reduces Senescent Hepatic CD8+ T Cells in Hepatocellular Carcinoma via PI3K/AKT Suppression. (PubMed, J Gastroenterol Hepatol) - "This commentary emphasizes that distinguishing between population replacement and cellular rejuvenation is paramount for predicting long-term durability. Future clinical translations should look beyond the CD8+ compartment to integrate the pleiotropic effects of these agents on the broader immune landscape to ensure both oncological efficacy and systemic immunological safety."

IO biomarker • Journal • Hepatocellular Cancer • Oncology • Solid Tumor • CD27 • CD8 • GZMB • IL15