# Thymosin α1

Thymosin α1 has 63 registered human trials. It is marketed for 4 different uses.

**In short**

- 63 registered human trials exist for Thymosin α1.
- Thymosin α1 is not FDA-approved for any use.
- What has actually been studied: hematological malignancies, locally advanced rectal cancer, liver cirrhosis.
- Last checked against ClinicalTrials.gov on 2026-07-27.

## What it is sold for

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

## What has actually been tested

- Hematological Malignancies
- Locally Advanced Rectal Cancer
- Liver Cirrhosis
- Non-small Cell Lung Cancer
- Metastatic Non-small Cell Lung Cancer
- Radiotherapy
- Thymalfasin
- Rheumatic Heart Disease
- Cardiopulmonary Bypass
- Immunotherapy
- Esophageal Cancer
- Metastatic Esophageal Cancer
- Stereotactic Body Radiation Therapy
- Soft Tissue Sarcoma (STS)
- Osteoporotic Pain
- Liver Failure
- 2019 Novel Coronavirus Infection
- Aortic Aneurysm and Dissection
- Stage II Colorectal Cancer
- Stage III Colorectal Cancer
- HIV-1-infection
- Covid19
- Small Cell Lung Cancer
- Non-Small Cell Lung Cancer
- Sepsis
- Advanced Solid Tumor
- Refractory Tumor
- IrAE
- Severe Sepsis
- Carcinoma, Hepatocellular
- Non Small Cell Lung Cancer
- END STAGE RENAL DISEASE
- Chronic Hepatitis C
- Acute Respiratory Distress Syndrome
- Breast Cancer
- Carcinoma, Pancreatic Ductal
- Hepatitis B, Chronic
- Lung Cancer (NSCLC)
- Lung Adenocarcinoma
- COVID-19
- Gastric Cancer
- Esophagogastric Junction Adenocarcinoma
- Hepatitis C
- Hepatitis C, Chronic
- Cervical Cancer
- Gynecologic Malignancies
- Endometrial Cancer
- HIV Infections
- Lung Cancer Metastatic
- Malignant Melanoma
- Chronic Hepatitis B
- MCRC
- Hematological Malignancy
- Lymphocytopenia
- Aortic Dissection
- Aortic Dissection Aneurysm
- Colorectal Cancer
- Metastatic Colorectal Cancer
- Small-Cell Lung Cancer (SCLC)
- Vaccine Response
- COVID-19 Vaccine
- Immune Response to Covid 19 Vaccination
- Acute Aortic Syndrome
- Aortic Dissection Type a
- EGFR Mutation Positive Non Small Cell Lung Cancer
- Chronic HBV Infection (HBeAg Negative)
- Curable Hepatitis B Virus-Related Hepatocellular Carcinoma
- Recurrent Implantation Faliure
- Pancreatitis, Acute Necrotizing
- Melanoma
- Immune-related Adverse Event
- Immune Checkpoint Inhibitor
- Esophageal Squamous Cell Carcinoma
- Chronic Hepatitis b
- Advanced Renal Cell Carcinoma
- Resectable Non-Small-Cell Lung Cancer

## Every trial on record

| Trial ID | Title | Condition | Phase | Status | Enrolled |
|---|---|---|---|---|---|
| [NCT00580450](https://clinicaltrials.gov/study/NCT00580450) | Thymosin Alfa 1 in Recipients of Allogeneic Hematopoietic Transplantation for Hematological Malignancies | Hematological Malignancies | Phase 2 | UNKNOWN | 9 |
| [NCT06056804](https://clinicaltrials.gov/study/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 | ACTIVE_NOT_RECRUITING | 20 |
| [NCT01938820](https://clinicaltrials.gov/study/NCT01938820) | Optimized Treatment and Regression of HBV-induced Early Cirrhosis | Liver Cirrhosis | Phase 4 | COMPLETED | 82 |
| [NCT02542930](https://clinicaltrials.gov/study/NCT02542930) | Abscopal Effect for Metastatic Non-small Cell Lung Cancer. | Non-small Cell Lung Cancer, Metastatic Non-small Cell Lung Cancer | Phase 2 | WITHDRAWN | 0 |
| [NCT05487469](https://clinicaltrials.gov/study/NCT05487469) | Thymosin α1 Use in Rheumatic Heart Disease Patients Undergoing Cardiac Surgery on Cardiopulmonary Bypass | Rheumatic Heart Disease, Cardiopulmonary Bypass | Not phased | UNKNOWN | 200 |
| [NCT02545751](https://clinicaltrials.gov/study/NCT02545751) | SBRT Combined With Thymalfasin for Metastatic Esophageal Cancer | Esophageal Cancer, Metastatic Esophageal Cancer | Phase 2 | UNKNOWN | 29 |
| [NCT07342322](https://clinicaltrials.gov/study/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 |
| [NCT04524169](https://clinicaltrials.gov/study/NCT04524169) | Immunotherapy for Elderly Patients With Chronic Osteoporotic Pain | Osteoporotic Pain | Phase 4 | UNKNOWN | 100 |
| [NCT03082885](https://clinicaltrials.gov/study/NCT03082885) | The Efficacy and Safety of Thymosin-α1 in Patients With HBV-related ACLF | Liver Failure | Not phased | COMPLETED | 120 |
| [NCT04320238](https://clinicaltrials.gov/study/NCT04320238) | Experimental Trial of rhIFNα Nasal Drops to Prevent 2019-nCOV in Medical Staff | 2019 Novel Coronavirus Infection | Phase 3 | UNKNOWN | 2944 |
| [NCT07382375](https://clinicaltrials.gov/study/NCT07382375) | AI-assisted Subtyping-directed Precision Treatment in Acute Aortic Dissection | Aortic Aneurysm and Dissection | Not phased | NOT_YET_RECRUITING | 300 |
| [NCT05086614](https://clinicaltrials.gov/study/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 | 2500 |
| [NCT04963712](https://clinicaltrials.gov/study/NCT04963712) | Zadaxin and HIV-positive Patients With Immune Reconstitution Disorder | HIV-1-infection | Phase 1 | COMPLETED | 20 |
| [NCT04487444](https://clinicaltrials.gov/study/NCT04487444) | Thymalfasin (Thymosin Alpha 1) to Treat COVID-19 Infection | Covid19 | Phase 2 | TERMINATED | 56 |
| [NCT02542137](https://clinicaltrials.gov/study/NCT02542137) | Abscopal Effect for Metastatic Small Cell Lung Cancer | Small Cell Lung Cancer, Radiotherapy | Phase 2 | WITHDRAWN | 0 |
| [NCT02906150](https://clinicaltrials.gov/study/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 | UNKNOWN | 140 |
| [NCT02867267](https://clinicaltrials.gov/study/NCT02867267) | The Efficacy and Safety of Ta1 for Sepsis | Sepsis | Phase 3 | COMPLETED | 1106 |
| [NCT05790447](https://clinicaltrials.gov/study/NCT05790447) | Thymalfasin-based PRaG Mode for Advanced Refractory Solid Tumors | Advanced Solid Tumor, Refractory Tumor | Phase 2 | UNKNOWN | 60 |
| [NCT06178146](https://clinicaltrials.gov/study/NCT06178146) | Thymosin Alpha-1 for irAE Secondary to ICIs | IrAE | Phase 4 | UNKNOWN | 40 |
| [NCT00711620](https://clinicaltrials.gov/study/NCT00711620) | Efficacy of Thymosin alpha1 for Severe Sepsis | Severe Sepsis | Not phased | COMPLETED | 366 |
| [NCT00082082](https://clinicaltrials.gov/study/NCT00082082) | A Trial of Thymalfasin in Adult Patients With Hepatocellular Carcinoma | Carcinoma, Hepatocellular | Phase 2 | COMPLETED | — |
| [NCT06598839](https://clinicaltrials.gov/study/NCT06598839) | Immuno-effect of Tα1 for Stage I NSCLC | Non Small Cell Lung Cancer | Not phased | RECRUITING | 40 |
| [NCT01031966](https://clinicaltrials.gov/study/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 |
| [NCT06139419](https://clinicaltrials.gov/study/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 | ACTIVE_NOT_RECRUITING | 114 |
| [NCT01178996](https://clinicaltrials.gov/study/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 |
| [NCT05658692](https://clinicaltrials.gov/study/NCT05658692) | Platform Adaptive Embedded Trial for Acute Respiratory Distress Syndrome | Acute Respiratory Distress Syndrome | Phase 4 | UNKNOWN | 1000 |
| [NCT00935558](https://clinicaltrials.gov/study/NCT00935558) | Dendritic Cell Based Therapy for Breast Cancer Patients | Breast Cancer | Phase 2 | WITHDRAWN | 0 |
| [NCT03659578](https://clinicaltrials.gov/study/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 |
| [NCT06573398](https://clinicaltrials.gov/study/NCT06573398) | Radiotherapy With Sequential Chemotherapy Combined With PD-1 Inhibitor and Thymalfasin for BRPC | Carcinoma, Pancreatic Ductal | Phase 2 | NOT_YET_RECRUITING | 20 |
| [NCT02646189](https://clinicaltrials.gov/study/NCT02646189) | Therapeutic Safety and Efficacy of REP 2139 (REP 9AC') in HBV Infected Patients | Hepatitis B, Chronic | Phase 2 | COMPLETED | 12 |
| [NCT02366208](https://clinicaltrials.gov/study/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 |
| [NCT07103395](https://clinicaltrials.gov/study/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 | 56 |
| [NCT02787447](https://clinicaltrials.gov/study/NCT02787447) | Radiotherapy Combined With Thymosin for Metastatic NSCLC Patients Who Showed Stable Disease After First Line TKI Therapy | Lung Adenocarcinoma | Phase 2 | UNKNOWN | 46 |
| [NCT04428008](https://clinicaltrials.gov/study/NCT04428008) | Thymosin Alpha 1 to Prevent COVID-19 Infection in Renal Dialysis Patients | COVID-19 | Phase 2 | COMPLETED | 189 |
| [NCT01943617](https://clinicaltrials.gov/study/NCT01943617) | Optimized Treatment and Regression of HBV-induced Compensated Liver Cirrhosis | Liver Cirrhosis | Phase 4 | COMPLETED | 606 |
| [NCT06461910](https://clinicaltrials.gov/study/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 | 30 |
| [NCT00039962](https://clinicaltrials.gov/study/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 |
| [NCT06552598](https://clinicaltrials.gov/study/NCT06552598) | The Safety, Tolerability, and Efficacy of KD01 in Gynecologic Malignancies | Cervical Cancer, Gynecologic Malignancies | Phase 1 | RECRUITING | 97 |
| [NCT00001036](https://clinicaltrials.gov/study/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 |
| [NCT02976740](https://clinicaltrials.gov/study/NCT02976740) | SBRT Combination With rhGM-CSF and Tα1 for Stage IV NSCLC Patients Who Failed in Second-line Chemotherapy | Lung Cancer Metastatic | Phase 2 | UNKNOWN | 48 |
| [NCT00911443](https://clinicaltrials.gov/study/NCT00911443) | Thymosin Alpha 1, Interferon Alpha, or Both, in Combination With Dacarbazine in Patients With Malignant Melanoma | Malignant Melanoma | Phase 2 | COMPLETED | 488 |
| [NCT00291616](https://clinicaltrials.gov/study/NCT00291616) | Efficacy Study of Thymosin alpha1 & Pegylated Interferon-alpha2a to Treat Chronic Hepatitis B | Chronic Hepatitis B | Phase 4 | COMPLETED | 52 |
| [NCT06829355](https://clinicaltrials.gov/study/NCT06829355) | "Thymalfasin Immunotherapy Study with Triple Regimen in Advanced MSS/pMMR Colorectal Cancer" | MCRC | Phase 2 | RECRUITING | 52 |
| [NCT06584006](https://clinicaltrials.gov/study/NCT06584006) | Thymalfasin and Recombinant Human IL-2 Injections in Treating Lymphocytopenia for Patients With Malignant Hematological Tumors | Hematological Malignancy, Lymphocytopenia | Phase 2 | RECRUITING | 50 |
| [NCT06966687](https://clinicaltrials.gov/study/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](https://clinicaltrials.gov/study/NCT02535988) | Abscopal Effect for Metastatic Colorectal Cancer | Colorectal Cancer, Metastatic Colorectal Cancer | Phase 2 | WITHDRAWN | 0 |
| [NCT07103408](https://clinicaltrials.gov/study/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](https://clinicaltrials.gov/study/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 | 75 |
| [NCT02366247](https://clinicaltrials.gov/study/NCT02366247) | Phase Ⅲ Trial for Combination Treatment of PEG-Tα1 and Adefovir for HBeAg-positive Chronic Hepatitis B | Hepatitis B, Chronic | Phase 3 | UNKNOWN | 463 |
| [NCT05339529](https://clinicaltrials.gov/study/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 | 330 |
| [NCT02906163](https://clinicaltrials.gov/study/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 | UNKNOWN | 188 |
| [NCT02233075](https://clinicaltrials.gov/study/NCT02233075) | REP 2139-Ca / Pegasys™ Combination Therapy in Hepatitis B / Hepatitis D Co-infection | Chronic HBV Infection (HBeAg Negative) | Phase 2 | COMPLETED | 12 |
| [NCT00040027](https://clinicaltrials.gov/study/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 |
| [NCT02281266](https://clinicaltrials.gov/study/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 | UNKNOWN | 360 |
| [NCT07675980](https://clinicaltrials.gov/study/NCT07675980) | Thymosin-α1 for Recurrent Implantation Failure | Recurrent Implantation Faliure | Phase 3 | RECRUITING | 136 |
| [NCT02473406](https://clinicaltrials.gov/study/NCT02473406) | Thymosin Alpha 1 in the Prevention of Pancreatic Infection Following Acute Necrotizing Pancreatitis | Pancreatitis, Acute Necrotizing | Phase 4 | COMPLETED | 508 |
| [NCT07644897](https://clinicaltrials.gov/study/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 | 55 |
| [NCT07277439](https://clinicaltrials.gov/study/NCT07277439) | Phase II Trial of Neoadjuvant Thymalfasin, PD-1 Inhibitor, and Chemoradiotherapy for cStage III GEJ Adenocarcinoma | Gastric Cancer | Phase 2 | RECRUITING | 48 |
| [NCT06401447](https://clinicaltrials.gov/study/NCT06401447) | TPF Concurrent Chemo-radiotherapy Plus Immunotherapy for Local Advanced Esophageal Squamous Cell Carcinoma | Esophageal Squamous Cell Carcinoma | Not phased | ACTIVE_NOT_RECRUITING | 50 |
| [NCT02883595](https://clinicaltrials.gov/study/NCT02883595) | Efficacy of Thymosin Alpha 1 on Improving Monocyte Function for Sepsis | Sepsis | Phase 4 | COMPLETED | 20 |
| [NCT03448744](https://clinicaltrials.gov/study/NCT03448744) | Efficacy and Safety of Combination Therapy of Thymalfasin and Entecavir in HBeAg-positive ETV-experienced Patients | Chronic Hepatitis b | Phase 4 | UNKNOWN | 240 |
| [NCT00197860](https://clinicaltrials.gov/study/NCT00197860) | Dendritic Cell Based Therapy of Renal Cell Carcinoma | Advanced Renal Cell Carcinoma | Phase 2 | COMPLETED | 40 |
| [NCT06607926](https://clinicaltrials.gov/study/NCT06607926) | Neoadjuvant With Tα1 Plus Immuno-chemotherapy for Resectable NSCLC | Resectable Non-Small-Cell Lung Cancer | Not phased | NOT_YET_RECRUITING | 40 |

## Common questions

**How many human trials does Thymosin α1 have?**
63, each listed above with a link to its original record.

**Is Thymosin α1 FDA approved?**
No. It is not approved by the FDA for any indication.

**Where does this data come from?**
ClinicalTrials.gov. We count interventional human studies only. Every trial
links to its original record.

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*Automated aggregation from public registries. Not medical advice. No physician
has reviewed this page. Source: https://www.whatsactuallyknown.com/compounds/thymosin-alpha-1*