Data edition of
Residue An evidence-graded reference for peptide science

Thymosin alpha-1 clinical trials

Every study registered on ClinicalTrials.gov that lists Thymosin alpha-1 as an intervention, as of the data edition — what is being tested, in whom, by whom, and how far it has got.

Registered studies
65
Active or recruiting
19
Completed
24
With posted results
2
Planned or actual enrollment
16,978participants, summed
Registered studies of Thymosin alpha-1 by phase and status
PhaseStudiesBreakdown
Early phase 1 1
1 completed, 0 active or recruiting, 0 stopped, 0 other
Phase 1 3
1 completed, 2 active or recruiting, 0 stopped, 0 other
Phase 2 31
9 completed, 10 active or recruiting, 5 stopped, 7 other
Phase 3 8
4 completed, 2 active or recruiting, 0 stopped, 2 other
Phase 4 10
5 completed, 0 active or recruiting, 0 stopped, 5 other
Not applicable 10
3 completed, 4 active or recruiting, 0 stopped, 3 other
Observational 2
1 completed, 1 active or recruiting, 0 stopped, 0 other
Figure 1. 65 studies on ClinicalTrials.gov match the registry search thymosin alpha 1 OR thymalfasin. Multi-phase studies are counted at their highest phase. Open the full trial feed

Conditions studied

  1. Thymalfasin4
  2. Non-small Cell Lung Cancer3
  3. Hepatitis B, Chronic3
  4. Sepsis3
  5. Esophageal Cancer2
  6. Gastric Cancer2
  7. Hepatitis C2
  8. Hepatitis C, Chronic2
  9. Radiotherapy2
  10. Liver Cirrhosis2
  11. Severe Sepsis1
  12. Resectable Non-Small-Cell Lung Cancer1

Lead sponsors

  1. Sun Yat-sen University10
  2. SciClone Pharmaceuticals5
  3. Beijing Friendship Hospital5
  4. Nanjing Medical University4
  5. Zhejiang Provincial People's Hospital3
  6. sigma-tau i.f.r. S.p.A.3
  7. Fudan University2
  8. Jiangsu Hansoh Pharmaceutical Co., Ltd.2

The registry, study by study

Registration is not evidence of benefit; many registered studies never publish. Status and dates are as reported by sponsors to ClinicalTrials.gov.

Status
Phase

65 shown

Registered studies of Thymosin alpha-1
StudyPhaseStatusStartnSponsor
NCT07382375AI-assisted Subtyping-directed Precision Treatment in Acute Aortic Dissection N/A Not yet recruiting Dec 2027 300 Nanjing Medical University
NCT07866118Thymalfasin for Immune Recovery in Adults With Sepsis N/A Recruiting Oct 2026 60 Shanghai Zhongshan Hospital
NCT07780721Study of Adebrelimab Combined With Thymalfasin and Chemotherapy for Neoadjuvant Treatment of Esophageal Cancer Phase 2 Not yet recruiting Aug 2026 31 The Affiliated Hospital of Putian University
NCT07675980Thymosin-α1 for Recurrent Implantation Failure Phase 2/Phase 3 Recruiting Feb 2026 136 Fakih IVF Fertility Center
NCT07103395A Study Evaluating Neoadjuvant Chemotherapy, Concurrent Chemoradiotherapy Combined With Dual Immune Checkpoint Blockade in Patients With Locally Advanced Non-Small Cell Lung Cancer Phase 2 Recruiting Jan 2026 56 Sun Yat-sen University
NCT07277439Phase II Trial of Neoadjuvant Thymalfasin, PD-1 Inhibitor, and Chemoradiotherapy for cStage III GEJ Adenocarcinoma Phase 2 Recruiting Dec 2025 48 The First Affiliated Hospital with Nanjing Medical University
NCT07103408A Study Evaluating Concurrent Chemoradiotherapy Combined With Dual Immune Checkpoint Blockade for Limited-stage Small Cell Lung Cancer Phase 2 Not yet recruiting Oct 2025 56 Sun Yat-sen University
NCT06966687Protective Effect of Ulinastatin and Thymosin α1 Against Negative Immune Dysregulation and Organ Dysfunction After Acute Aortic Dissection Surgery (PANDA XI) N/A Enrolling by invitation Apr 2025 200 Nanjing Medical University
NCT06829355"Thymalfasin Immunotherapy Study with Triple Regimen in Advanced MSS/pMMR Colorectal Cancer" Phase 2 Recruiting Feb 2025 52 Beijing Friendship Hospital
NCT06821100Thymalfasin (Thymosin Alpha 1; Ta1) as an Enhancer of Vaccine Response Among Older Adults Receiving Booster Doses of COVID-19 Vaccine Phase 1 Recruiting Dec 2024 75 The Methodist Hospital Research Institute
NCT06573398Radiotherapy With Sequential Chemotherapy Combined With PD-1 Inhibitor and Thymalfasin for BRPC Phase 2 Not yet recruiting Sep 2024 20 Ruijin Hospital
NCT06584006Thymalfasin and Recombinant Human IL-2 Injections in Treating Lymphocytopenia for Patients With Malignant Hematological Tumors Phase 2 Recruiting Sep 2024 50 The First Affiliated Hospital of Xiamen University
NCT06461910Efficacy and Safety of Anti-PD-1, Thymalfasin, and SOX in Neoadjuvant Treatment of cStage III Gastric/Gastroesophageal Junction Adenocarcinoma Phase 2 Recruiting Jun 2024 30 Zekuan Xu
NCT06552598The Safety, Tolerability, and Efficacy of KD01 in Gynecologic Malignancies Phase 1 Recruiting Apr 2024 97 Tongji Hospital
NCT06056804Neoadjuvant Chemoradiotherapy Combined With PD-1 Inhibitor and Thymalfasin for pMMR/MSS Locally Advanced Mid-low Rectal Cancer Phase 2 Active, not recruiting Jan 2024 20 Beijing Friendship Hospital
NCT06401447TPF Concurrent Chemo-radiotherapy Plus Immunotherapy for Local Advanced Esophageal Squamous Cell Carcinoma N/A Active, not recruiting Dec 2023 50 Fudan University
NCT07644897Thymosin Alpha 1 Combined With Anti-PD-1 Monoclonal Antibody in Elderly Patients With Advanced Melanoma Phase 2 Recruiting May 2023 55 Sun Yat-sen University
NCT04901104Long-term Prognosis of Patients With Sepsis After Immunotherapy Observational Not yet recruiting Jul 2021 900 Sun Yat-sen University
NCT05086614Thymosin-alpha 1 for Adjuvant Treatment After Radical Resection of High-risk Stage II and III Colorectal Cancer Phase 3 Recruiting Apr 2021 2,500 Fudan University
NCT06607926Neoadjuvant With Tα1 Plus Immuno-chemotherapy for Resectable NSCLC N/A Unknown status Oct 2024 40 Xuanwu Hospital, Beijing
NCT06598839Immuno-effect of Tα1 for Stage I NSCLC N/A Unknown status Jun 2024 40 Yousheng Mao
NCT06024356Neoadjuvant Chemoradiotherapy Combined With PD-1 Inhibitor and Thymalfasin for Locally Advanced Mid-low Rectal Cancer Observational Completed Sep 2023 47 Beijing Friendship Hospital
NCT06178146Thymosin Alpha-1 for irAE Secondary to ICIs Phase 4 Unknown status Sep 2023 40 Jun Wang
NCT06139419The Impact of Thymosin α-1 on the Efficacy of Concurrent Chemoradiotherapy Followed by Immunotherpay Consolidation for Locally Advanced NSCLC Phase 2 Completed Jul 2023 114 Sun Yat-sen University
NCT05790447Thymalfasin-based PRaG Mode for Advanced Refractory Solid Tumors Phase 2 Unknown status Apr 2023 60 Second Affiliated Hospital of Soochow University
NCT05658692Platform Adaptive Embedded Trial for Acute Respiratory Distress Syndrome Phase 4 Unknown status Oct 2022 1,000 Second Affiliated Hospital, Zhejiang University, School of Medicine
NCT05339529Protective Effect of Thymosin α1 Against Negative Immune Dysregulation and Organ Dysfunction After Acute Aortic Dissection Surgery (PANDA II) N/A Completed Jul 2022 600 Nanjing Medical University
NCT05487469Thymosin α1 Use in Rheumatic Heart Disease Patients Undergoing Cardiac Surgery on Cardiopulmonary Bypass N/A Unknown status Jul 2022 200 Nanjing Medical University
NCT04963712Zadaxin and HIV-positive Patients With Immune Reconstitution Disorder Early Ph 1 Completed Sep 2021 20 Shanghai Public Health Clinical Center
NCT04428008Thymosin Alpha 1 to Prevent COVID-19 Infection in Renal Dialysis PatientsResults posted Phase 2 Completed Jan 2021 189 William B. Ershler, MD
NCT04524169Immunotherapy for Elderly Patients With Chronic Osteoporotic Pain Phase 4 Unknown status Nov 2020 100 RenJi Hospital
NCT04487444Thymalfasin (Thymosin Alpha 1) to Treat COVID-19 Infection Phase 2 Terminated Sep 2020 56 Rhode Island Hospital
NCT04320238Experimental Trial of rhIFNα Nasal Drops to Prevent 2019-nCOV in Medical Staff Phase 3 Unknown status Jan 2020 2,944 Shanghai Jiao Tong University School of Medicine
NCT03659578Study of Thymosin α1 to Reduce Acute Pneumonia For Bulky None-small Cell Lung Cancer Phase 2 Completed Aug 2018 69 Sun Yat-sen University
NCT02473406Thymosin Alpha 1 in the Prevention of Pancreatic Infection Following Acute Necrotizing Pancreatitis Phase 4 Completed Mar 2018 508 Weiqin Li
NCT03448744Efficacy and Safety of Combination Therapy of Thymalfasin and Entecavir in HBeAg-positive ETV-experienced Patients Phase 4 Unknown status Oct 2017 240 Wen-hong Zhang
NCT03082885The Efficacy and Safety of Thymosin-α1 in Patients With HBV-related ACLF N/A Completed Apr 2017 120 Sun Yat-sen University
NCT02976740SBRT Combination With rhGM-CSF and Tα1 for Stage IV NSCLC Patients Who Failed in Second-line Chemotherapy Phase 2 Unknown status Nov 2016 48 The First Affiliated Hospital of Xiamen University
NCT02906163First Line Bio-immunotherapy With Thymosin Alpha 1 in Patients With Sensitizing EGFR Mutation Positive Non Small Cell Lung Cancer Who Are Taking Standard of Care Therapy Phase 1/Phase 2 Unknown status Oct 2016 188 SciClone Pharmaceuticals
NCT02867267The Efficacy and Safety of Ta1 for Sepsis Phase 3 Completed Sep 2016 1,106 Sun Yat-sen University
NCT02906150Thymosin Alpha 1 Plus Maintenance Therapy With the Standard of Care (SoC) in Patients With Metastatic Non-Small Cell Lung Cancer (NSCLC), EGFR Wild Type Phase 2 Unknown status Sep 2016 140 SciClone Pharmaceuticals
NCT02787447Radiotherapy Combined With Thymosin for Metastatic NSCLC Patients Who Showed Stable Disease After First Line TKI Therapy Phase 2 Unknown status May 2016 46 First People's Hospital of Hangzhou
NCT02883595Efficacy of Thymosin Alpha 1 on Improving Monocyte Function for Sepsis Phase 4 Completed Mar 2016 20 Sun Yat-sen University
NCT02542930Abscopal Effect for Metastatic Non-small Cell Lung Cancer. Phase 2 Withdrawn Jan 2016 0 Zhejiang Provincial People's Hospital
NCT02545751SBRT Combined With Thymalfasin for Metastatic Esophageal Cancer Phase 2 Unknown status Jan 2016 29 Hangzhou Cancer Hospital
NCT02535988Abscopal Effect for Metastatic Colorectal Cancer Phase 2 Withdrawn Sep 2015 0 Zhejiang Provincial People's Hospital
NCT02542137Abscopal Effect for Metastatic Small Cell Lung Cancer Phase 2 Withdrawn Sep 2015 0 Zhejiang Provincial People's Hospital
NCT02281266Thymalfasin Adjuvant Therapy in Hepatitis B Virus (HBV)-Related Hepatocellular Carcinoma (HCC) After Curative Resection Phase 4 Unknown status Jan 2015 360 Jia Fan
NCT02366247Phase Ⅲ Trial for Combination Treatment of PEG-Tα1 and Adefovir for HBeAg-positive Chronic Hepatitis B Phase 3 Unknown status Aug 2013 463 Jiangsu Hansoh Pharmaceutical Co., Ltd.
NCT01943617Optimized Treatment and Regression of HBV-induced Compensated Liver Cirrhosis Phase 4 Completed Jun 2013 606 Beijing Friendship Hospital
NCT01938820Optimized Treatment and Regression of HBV-induced Early Cirrhosis Phase 4 Completed Jun 2013 82 Beijing Friendship Hospital
NCT02646189Therapeutic Safety and Efficacy of REP 2139 (REP 9AC') in HBV Infected Patients Phase 1/Phase 2 Completed Aug 2011 12 Replicor Inc.
NCT02366208Phase II Trial for Combination Treatment of PEG-Tα1 and Adefovir for HBeAg Positive Chronic Hepatitis B Phase 2 Completed May 2011 116 Jiangsu Hansoh Pharmaceutical Co., Ltd.
NCT01031966A Pilot Study to Evaluate ZADAXIN's® (Thymalfasin) Ability to Enhance Immune Response to the H1N1sw Influenza Vaccine Phase 2 Completed Nov 2009 120 sigma-tau i.f.r. S.p.A.
NCT00935558Dendritic Cell Based Therapy for Breast Cancer Patients Phase 2 Withdrawn Jul 2009 0 Inge Marie Svane
NCT00711620Efficacy of Thymosin alpha1 for Severe Sepsis N/A Completed May 2008 366 Sun Yat-sen University
NCT00580450Thymosin Alfa 1 in Recipients of Allogeneic Hematopoietic Transplantation for Hematological Malignancies Phase 1/Phase 2 Unknown status Dec 2007 9 University Of Perugia
NCT00291616Efficacy Study of Thymosin alpha1 & Pegylated Interferon-alpha2a to Treat Chronic Hepatitis B Phase 4 Completed Dec 2005 52 Seoul National University Hospital
NCT01178996Thymosin Alpha-1 in Combination With Peg-Interferon Alfa- 2a and Ribavirin for the Therapy of Chronic Hepatitis C Nonresponsive to the Combination of IFN and Ribavirin. Phase 3 Completed Dec 2004 552 sigma-tau i.f.r. S.p.A.
NCT00197860Dendritic Cell Based Therapy of Renal Cell Carcinoma Phase 1/Phase 2 Completed Sep 2004 40 Inge Marie Svane
NCT00911443Thymosin Alpha 1, Interferon Alpha, or Both, in Combination With Dacarbazine in Patients With Malignant MelanomaResults posted Phase 2 Completed Jul 2002 488 sigma-tau i.f.r. S.p.A.
NCT00039962Thymosin Plus PEG-Interferon in Hepatitis C Patients With Cirrhosis Who Did Not Respond to Interferon or Interferon Plus Ribavirin Phase 3 Completed May 2002 500 SciClone Pharmaceuticals
NCT00040027Thymosin Plus PEG-Interferon in Non-Cirrhotic Hepatitis C Patients Who Did Not Respond to Interferon or Interferon Plus Ribavirin Phase 3 Completed Apr 2002 500 SciClone Pharmaceuticals
NCT00082082A Trial of Thymalfasin in Adult Patients With Hepatocellular Carcinoma Phase 2 Completed — — SciClone Pharmaceuticals
NCT00001036The Safety and Effectiveness of a Type of Interleukin-2 Plus Zidovudine Plus Thymosin in HIV-Positive Patients With and Without Symptoms of Infection Phase 1 Completed — 12 National Institute of Allergy and Infectious Diseases (NIAID)

Run this search on ClinicalTrials.gov → Query term: thymosin alpha 1 OR thymalfasin