Compounds / Thymosin α1

Thymosin α1

Thymalfasin · Zadaxin · Tα1

Thymosin α1 has 63 registered human trials — it is genuinely well studied. The question worth asking is what those trials were studying, because it is often not what the compound is sold for.

In short

  • 63 registered human trials exist for Thymosin α1.
  • No registered trial lists autoimmune conditions or longevity / immune aging as a studied condition.
  • Thymosin α1 is not FDA-approved for any use.
  • What has actually been studied: soft tissue sarcoma (sts), aortic aneurysm and dissection.
  • 17 studies are open to new participants, so this may change.
  • Last checked against ClinicalTrials.gov on 2026-07-27.
63
Registered human trials
21
Recruiting or running
No
FDA approved
Pre
P1
P2
P3
Furthest stage reached

Not FDA-approved in the United States. Approved in over 30 other countries, mostly for hepatitis B and as a vaccine adjuvant.

What it's sold for

  • Autoimmune conditions
  • Immune system regulation
  • Chronic infection
  • Longevity / immune aging

What has actually been tested

  • Thymalfasin
  • Hepatitis B, Chronic
  • Non-small Cell Lung Cancer
  • Gastric Cancer
  • Hepatitis C
  • Hepatitis C, Chronic
  • Liver Cirrhosis
  • Radiotherapy

Is it studied for what it's sold for?

Each claim below is matched against the condition and title fields of every registered trial. Not listed means no trial names it as a studied condition — not that it has been disproven, and not that no trial touches it indirectly.

Not listed Autoimmune conditions
Studied Immune system regulation
Studied Chronic infection
Not listed Longevity / immune aging

Every trial on record

Every registered human study we can find for Thymosin α1. Click any ID to read the original record — we would rather you checked us than trusted us.

Trial IDTitleConditionPhaseStatusEnrolled
NCT07342322 A Prospective, Multicenter, Open-label, Single-arm Phase II Clinical Study Evaluating the Efficacy and Safety of Spatially Fractionated Radiotherapy Combined With the PraG Strategy for the Treatment of Soft Tissue Sarcoma Soft Tissue Sarcoma (STS) Phase 2 Not yet recruiting 25
NCT07382375 AI-assisted Subtyping-directed Precision Treatment in Acute Aortic Dissection Aortic Aneurysm and Dissection Not phased Not yet recruiting 300
NCT05086614 Thymosin-alpha 1 for Adjuvant Treatment After Radical Resection of High-risk Stage II and III Colorectal Cancer Stage II Colorectal Cancer, Stage III Colorectal Cancer Phase 3 Recruiting now 2500
NCT06598839 Immuno-effect of Tα1 for Stage I NSCLC Non Small Cell Lung Cancer Not phased Recruiting now 40
NCT06573398 Radiotherapy With Sequential Chemotherapy Combined With PD-1 Inhibitor and Thymalfasin for BRPC Carcinoma, Pancreatic Ductal Phase 2 Not yet recruiting 20
NCT07103395 A Study Evaluating Neoadjuvant Chemotherapy, Concurrent Chemoradiotherapy Combined With Dual Immune Checkpoint Blockade in Patients With Locally Advanced Non-Small Cell Lung Cancer Lung Cancer (NSCLC) Phase 2 Recruiting now 56
NCT06461910 Efficacy and Safety of Anti-PD-1, Thymalfasin, and SOX in Neoadjuvant Treatment of cStage III Gastric/Gastroesophageal Junction Adenocarcinoma Gastric Cancer, Esophagogastric Junction Adenocarcinoma Phase 2 Recruiting now 30
NCT06552598 The Safety, Tolerability, and Efficacy of KD01 in Gynecologic Malignancies Cervical Cancer, Gynecologic Malignancies Phase 1 Recruiting now 97
NCT06829355 "Thymalfasin Immunotherapy Study with Triple Regimen in Advanced MSS/pMMR Colorectal Cancer" MCRC Phase 2 Recruiting now 52
NCT06584006 Thymalfasin and Recombinant Human IL-2 Injections in Treating Lymphocytopenia for Patients With Malignant Hematological Tumors Hematological Malignancy, Lymphocytopenia Phase 2 Recruiting now 50
NCT07103408 A Study Evaluating Concurrent Chemoradiotherapy Combined With Dual Immune Checkpoint Blockade for Limited-stage Small Cell Lung Cancer Small-Cell Lung Cancer (SCLC) Phase 2 Not yet recruiting 56
NCT06821100 Thymalfasin (Thymosin Alpha 1; Ta1) as an Enhancer of Vaccine Response Among Older Adults Receiving Booster Doses of COVID-19 Vaccine Vaccine Response, COVID-19 Vaccine Phase 1 Recruiting now 75
NCT05339529 Protective Effect of Thymosin Α1 Against Negative Immune Dysregulation and Organ Dysfunction After Acute Aortic Dissection Surgery (PANDA II) Acute Aortic Syndrome, Aortic Dissection Type a Not phased Recruiting now 330
NCT07675980 Thymosin-α1 for Recurrent Implantation Failure Recurrent Implantation Faliure Phase 3 Recruiting now 136
NCT07644897 Thymosin Alpha 1 Combined With Anti-PD-1 Monoclonal Antibody in Elderly Patients With Advanced Melanoma Melanoma, Immune-related Adverse Event Phase 2 Recruiting now 55
NCT07277439 Phase II Trial of Neoadjuvant Thymalfasin, PD-1 Inhibitor, and Chemoradiotherapy for cStage III GEJ Adenocarcinoma Gastric Cancer Phase 2 Recruiting now 48
NCT06607926 Neoadjuvant With Tα1 Plus Immuno-chemotherapy for Resectable NSCLC Resectable Non-Small-Cell Lung Cancer Not phased Not yet recruiting 40
NCT01938820 Optimized Treatment and Regression of HBV-induced Early Cirrhosis Liver Cirrhosis Phase 4 Completed 82
NCT03082885 The Efficacy and Safety of Thymosin-α1 in Patients With HBV-related ACLF Liver Failure Not phased Completed 120
NCT04963712 Zadaxin and HIV-positive Patients With Immune Reconstitution Disorder HIV-1-infection Phase 1 Completed 20
NCT02867267 The Efficacy and Safety of Ta1 for Sepsis Sepsis Phase 3 Completed 1106
NCT00711620 Efficacy of Thymosin alpha1 for Severe Sepsis Severe Sepsis Not phased Completed 366
NCT00082082 A Trial of Thymalfasin in Adult Patients With Hepatocellular Carcinoma Carcinoma, Hepatocellular Phase 2 Completed
NCT01031966 A Pilot Study to Evaluate ZADAXIN's® (Thymalfasin) Ability to Enhance Immune Response to the H1N1sw Influenza Vaccine END STAGE RENAL DISEASE Phase 2 Completed 120
NCT01178996 Thymosin 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. Chronic Hepatitis C Phase 3 Completed 552
NCT03659578 Study of Thymosin α1 to Reduce Acute Pneumonia For Bulky None-small Cell Lung Cancer Non-small Cell Lung Cancer Phase 2 Completed 69
NCT02646189 Therapeutic Safety and Efficacy of REP 2139 (REP 9AC') in HBV Infected Patients Hepatitis B, Chronic Phase 2 Completed 12
NCT02366208 Phase II Trial for Combination Treatment of PEG-Tα1 and Adefovir for HBeAg Positive Chronic Hepatitis B Hepatitis B, Chronic Phase 2 Completed 116
NCT04428008 Thymosin Alpha 1 to Prevent COVID-19 Infection in Renal Dialysis Patients COVID-19 Phase 2 Completed 189
NCT01943617 Optimized Treatment and Regression of HBV-induced Compensated Liver Cirrhosis Liver Cirrhosis Phase 4 Completed 606
NCT00039962 Thymosin Plus PEG-Interferon in Hepatitis C Patients With Cirrhosis Who Did Not Respond to Interferon or Interferon Plus Ribavirin Hepatitis C, Hepatitis C, Chronic Phase 3 Completed 500
NCT00001036 The Safety and Effectiveness of a Type of Interleukin-2 Plus Zidovudine Plus Thymosin in HIV-Positive Patients With and Without Symptoms of Infection HIV Infections Phase 1 Completed 12
NCT00911443 Thymosin Alpha 1, Interferon Alpha, or Both, in Combination With Dacarbazine in Patients With Malignant Melanoma Malignant Melanoma Phase 2 Completed 488
NCT00291616 Efficacy Study of Thymosin alpha1 & Pegylated Interferon-alpha2a to Treat Chronic Hepatitis B Chronic Hepatitis B Phase 4 Completed 52
NCT02233075 REP 2139-Ca / Pegasys™ Combination Therapy in Hepatitis B / Hepatitis D Co-infection Chronic HBV Infection (HBeAg Negative) Phase 2 Completed 12
NCT00040027 Thymosin Plus PEG-Interferon in Non-Cirrhotic Hepatitis C Patients Who Did Not Respond to Interferon or Interferon Plus Ribavirin Hepatitis C, Hepatitis C, Chronic Phase 3 Completed 500
NCT02473406 Thymosin Alpha 1 in the Prevention of Pancreatic Infection Following Acute Necrotizing Pancreatitis Pancreatitis, Acute Necrotizing Phase 4 Completed 508
NCT02883595 Efficacy of Thymosin Alpha 1 on Improving Monocyte Function for Sepsis Sepsis Phase 4 Completed 20
NCT00197860 Dendritic Cell Based Therapy of Renal Cell Carcinoma Advanced Renal Cell Carcinoma Phase 2 Completed 40
NCT00580450 Thymosin Alfa 1 in Recipients of Allogeneic Hematopoietic Transplantation for Hematological Malignancies Hematological Malignancies Phase 2 Status not updated 9
NCT06056804 Neoadjuvant Chemoradiotherapy Combined With PD-1 Inhibitor and Thymalfasin for pMMR/MSS Locally Advanced Mid-low Rectal Cancer Locally Advanced Rectal Cancer Phase 2 Running, closed to new participants 20
NCT02542930 Abscopal Effect for Metastatic Non-small Cell Lung Cancer. Non-small Cell Lung Cancer, Metastatic Non-small Cell Lung Cancer Phase 2 Withdrawn before enrolling 0 — nobody enrolled
NCT05487469 Thymosin α1 Use in Rheumatic Heart Disease Patients Undergoing Cardiac Surgery on Cardiopulmonary Bypass Rheumatic Heart Disease, Cardiopulmonary Bypass Not phased Status not updated 200
NCT02545751 SBRT Combined With Thymalfasin for Metastatic Esophageal Cancer Esophageal Cancer, Metastatic Esophageal Cancer Phase 2 Status not updated 29
NCT04524169 Immunotherapy for Elderly Patients With Chronic Osteoporotic Pain Osteoporotic Pain Phase 4 Status not updated 100
NCT04320238 Experimental Trial of rhIFNα Nasal Drops to Prevent 2019-nCOV in Medical Staff 2019 Novel Coronavirus Infection Phase 3 Status not updated 2944
NCT04487444 Thymalfasin (Thymosin Alpha 1) to Treat COVID-19 Infection Covid19 Phase 2 Stopped early 56
NCT02542137 Abscopal Effect for Metastatic Small Cell Lung Cancer Small Cell Lung Cancer, Radiotherapy Phase 2 Withdrawn before enrolling 0 — nobody enrolled
NCT02906150 Thymosin Alpha 1 Plus Maintenance Therapy With the Standard of Care (SoC) in Patients With Metastatic Non-Small Cell Lung Cancer (NSCLC), EGFR Wild Type Non-Small Cell Lung Cancer Phase 2 Status not updated 140
NCT05790447 Thymalfasin-based PRaG Mode for Advanced Refractory Solid Tumors Advanced Solid Tumor, Refractory Tumor Phase 2 Status not updated 60
NCT06178146 Thymosin Alpha-1 for irAE Secondary to ICIs IrAE Phase 4 Status not updated 40
NCT06139419 The Impact of Thymosin α-1 on the Efficacy of Concurrent Chemoradiotherapy Followed by Immunotherpay Consolidation for Locally Advanced NSCLC Non-small Cell Lung Cancer Phase 2 Running, closed to new participants 114
NCT05658692 Platform Adaptive Embedded Trial for Acute Respiratory Distress Syndrome Acute Respiratory Distress Syndrome Phase 4 Status not updated 1000
NCT00935558 Dendritic Cell Based Therapy for Breast Cancer Patients Breast Cancer Phase 2 Withdrawn before enrolling 0 — nobody enrolled
NCT02787447 Radiotherapy Combined With Thymosin for Metastatic NSCLC Patients Who Showed Stable Disease After First Line TKI Therapy Lung Adenocarcinoma Phase 2 Status not updated 46
NCT02976740 SBRT Combination With rhGM-CSF and Tα1 for Stage IV NSCLC Patients Who Failed in Second-line Chemotherapy Lung Cancer Metastatic Phase 2 Status not updated 48
NCT06966687 Protective Effect of Ulinastatin and Thymosin α1 Against Negative Immune Dysregulation and Organ Dysfunction After Acute Aortic Dissection Surgery (PANDA XI) Aortic Dissection, Aortic Dissection Aneurysm Not phased ENROLLING_BY_INVITATION 200
NCT02535988 Abscopal Effect for Metastatic Colorectal Cancer Colorectal Cancer, Metastatic Colorectal Cancer Phase 2 Withdrawn before enrolling 0 — nobody enrolled
NCT02366247 Phase Ⅲ Trial for Combination Treatment of PEG-Tα1 and Adefovir for HBeAg-positive Chronic Hepatitis B Hepatitis B, Chronic Phase 3 Status not updated 463
NCT02906163 First 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 EGFR Mutation Positive Non Small Cell Lung Cancer Phase 2 Status not updated 188
NCT02281266 Thymalfasin Adjuvant Therapy in Hepatitis B Virus (HBV)-Related Hepatocellular Carcinoma (HCC) After Curative Resection Curable Hepatitis B Virus-Related Hepatocellular Carcinoma Phase 4 Status not updated 360
NCT06401447 TPF Concurrent Chemo-radiotherapy Plus Immunotherapy for Local Advanced Esophageal Squamous Cell Carcinoma Esophageal Squamous Cell Carcinoma Not phased Running, closed to new participants 50
NCT03448744 Efficacy and Safety of Combination Therapy of Thymalfasin and Entecavir in HBeAg-positive ETV-experienced Patients Chronic Hepatitis b Phase 4 Status not updated 240
Read this
A trial count is not a verdict
These numbers describe how much has been formally studied in humans, not whether something works or is safe for you. A compound can be tested for one condition and sold for another — which is usually the story. This page is automated aggregation from public registries; no physician has reviewed it. Take anything here to a clinician.

Common questions about Thymosin α1

How many human trials does Thymosin α1 have?

63. That is the number of registered interventional human studies we can find, each listed on this page with a link to its original record.

Is Thymosin α1 FDA approved?

No. Thymosin α1 is not approved by the FDA for any indication. Compounded or "research use only" preparations are not FDA-approved and receive no premarket review for safety, effectiveness, or manufacturing quality.

What is Thymosin α1 actually being tested for?

Registered studies cover: soft tissue sarcoma (sts), aortic aneurysm and dissection, stage ii colorectal cancer. Compare that to what it is marketed for — the two lists are often different, which is the whole point of this page.

Where does this data come from?

ClinicalTrials.gov, the US public registry of clinical studies. We count interventional human studies only — observational studies are not evidence of effect. Every trial on this page links to its original record so you can check us rather than trust us.

Get told when this changes

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