{
  "data": {
    "id": "thymosin-alpha-1",
    "canonicalName": "Thymosin alpha-1",
    "aliases": [
      "Thymalfasin"
    ],
    "exactForm": "pending",
    "route": "pending",
    "dosageForm": "pending",
    "intendedUse": "human use (unspecified)",
    "productStatus": "Not verified",
    "compoundingStatus": "Not verified",
    "evidenceTier": "50 registered clinical studies",
    "answer": "Thymosin alpha-1 is listed in the CompoundedGuide registry with no verified FDA-approved product. FDA lists Thymosin alpha-1 among bulk drug substances for use in compounding that may present significant safety risks. Thymosin alpha-1 is not on FDA's 503B Bulks List for outsourcing facilities (list checked 2026-07-25). 50 registered ClinicalTrials.gov studies cite Thymosin alpha-1 (18 completed, 11 recruiting, 10 unknown, 5 not yet recruiting, 3 active not recruiting, 2 withdrawn, 1 enrolling by invitation); registration is not evidence of approval, efficacy, or safety. Identity and regulatory status are pending source collection and editorial review. This is not medical advice.",
    "uncertainty": [
      "Exact form, route, and dosage form are not yet resolved.",
      "No FDA-approved product has been verified for this substance.",
      "Trial counts are read from a captured ClinicalTrials.gov response citing 50 specific study records, not from an open search.",
      "503B Bulks List membership was read from the list page captured 2026-07-25; being off that list is not itself a statement that compounding is lawful or unlawful.",
      "The FDA safety-risk listing is reported as published by FDA. CompoundedGuide has not independently assessed the risk, and the listing's exact status and route qualifiers are not yet editorially reviewed.",
      "Compounding status, shortage status, and safety profile are not yet verified.",
      "This is not a medical, legal, or professional endorsement."
    ],
    "lane": "pending",
    "commercialPolicy": "none",
    "reviewedAt": "2026-07-25",
    "sources": [
      {
        "id": "fda_significant_safety_risk",
        "title": "Bulk Drug Substances That May Present Significant Safety Risks",
        "authorityTier": "P0",
        "url": "https://www.fda.gov/drugs/human-drug-compounding/certain-bulk-drug-substances-use-compounding-may-present-significant-safety-risks",
        "retrievedAt": "2026-07-25T19:17:37.709Z"
      },
      {
        "id": "fda_503b_bulks",
        "title": "503B Bulks List and Interim Categories",
        "authorityTier": "P0",
        "url": "https://www.fda.gov/drugs/human-drug-compounding/503b-bulk-drug-substances-list",
        "retrievedAt": "2026-07-25T04:39:37.764Z"
      },
      {
        "id": "clinicaltrials_gov_api",
        "title": "ClinicalTrials.gov API v2",
        "authorityTier": "P0",
        "url": "https://clinicaltrials.gov/api/v2/studies?filter.ids=NCT00001036,NCT00082082,NCT00197860,NCT00291616,NCT00580450,NCT00711620,NCT00911443,NCT01178996,NCT01938820,NCT01943617,NCT02233075,NCT02281266,NCT02366208,NCT02366247,NCT02473406,NCT02535988,NCT02542137,NCT02545751,NCT02646189,NCT02867267,NCT02883595,NCT02906150,NCT03448744,NCT03659578,NCT04320238,NCT04901104,NCT04963712,NCT05086614,NCT05339529,NCT05487469,NCT05658692,NCT05790447,NCT06024356,NCT06056804,NCT06139419,NCT06401447,NCT06552598,NCT06573398,NCT06584006,NCT06598839,NCT06607926,NCT06821100,NCT06829355,NCT06966687,NCT07103395,NCT07103408,NCT07277439,NCT07342322,NCT07644897,NCT07675980&pageSize=50&countTotal=true",
        "retrievedAt": "2026-07-25T01:36:55.627Z"
      }
    ],
    "trials": [
      {
        "nctId": "NCT07342322",
        "title": "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",
        "status": "NOT_YET_RECRUITING",
        "phase": "PHASE2",
        "startYear": "2026"
      },
      {
        "nctId": "NCT07103395",
        "title": "A Study Evaluating Neoadjuvant Chemotherapy, Concurrent Chemoradiotherapy Combined With Dual Immune Checkpoint Blockade in Patients With Locally Advanced Non-Small Cell Lung Cancer",
        "status": "RECRUITING",
        "phase": "PHASE2",
        "startYear": "2026"
      },
      {
        "nctId": "NCT07675980",
        "title": "Thymosin-α1 for Recurrent Implantation Failure",
        "status": "RECRUITING",
        "phase": "PHASE2/PHASE3",
        "startYear": "2026"
      },
      {
        "nctId": "NCT07277439",
        "title": "Phase II Trial of Neoadjuvant Thymalfasin, PD-1 Inhibitor, and Chemoradiotherapy for cStage III GEJ Adenocarcinoma",
        "status": "RECRUITING",
        "phase": "PHASE2",
        "startYear": "2025"
      },
      {
        "nctId": "NCT07103408",
        "title": "A Study Evaluating Concurrent Chemoradiotherapy Combined With Dual Immune Checkpoint Blockade for Limited-stage Small Cell Lung Cancer",
        "status": "NOT_YET_RECRUITING",
        "phase": "PHASE2",
        "startYear": "2025"
      },
      {
        "nctId": "NCT06829355",
        "title": "\"Thymalfasin Immunotherapy Study with Triple Regimen in Advanced MSS/pMMR Colorectal Cancer\"",
        "status": "RECRUITING",
        "phase": "PHASE2",
        "startYear": "2025"
      },
      {
        "nctId": "NCT06966687",
        "title": "Protective Effect of Ulinastatin and Thymosin α1 Against Negative Immune Dysregulation and Organ Dysfunction After Acute Aortic Dissection Surgery (PANDA XI)",
        "status": "ENROLLING_BY_INVITATION",
        "phase": "NA",
        "startYear": "2025"
      },
      {
        "nctId": "NCT06573398",
        "title": "Radiotherapy With Sequential Chemotherapy Combined With PD-1 Inhibitor and Thymalfasin for BRPC",
        "status": "NOT_YET_RECRUITING",
        "phase": "PHASE2",
        "startYear": "2024"
      },
      {
        "nctId": "NCT06821100",
        "title": "Thymalfasin (Thymosin Alpha 1; Ta1) as an Enhancer of Vaccine Response Among Older Adults Receiving Booster Doses of COVID-19 Vaccine",
        "status": "RECRUITING",
        "phase": "PHASE1",
        "startYear": "2024"
      },
      {
        "nctId": "NCT06056804",
        "title": "Neoadjuvant Chemoradiotherapy Combined With PD-1 Inhibitor and Thymalfasin for pMMR/MSS Locally Advanced Mid-low Rectal Cancer",
        "status": "ACTIVE_NOT_RECRUITING",
        "phase": "PHASE2",
        "startYear": "2024"
      },
      {
        "nctId": "NCT06598839",
        "title": "Immuno-effect of Tα1 for Stage I NSCLC",
        "status": "RECRUITING",
        "phase": "NA",
        "startYear": "2024"
      },
      {
        "nctId": "NCT06607926",
        "title": "Neoadjuvant With Tα1 Plus Immuno-chemotherapy for Resectable NSCLC",
        "status": "NOT_YET_RECRUITING",
        "phase": "NA",
        "startYear": "2024"
      },
      {
        "nctId": "NCT06552598",
        "title": "The Safety, Tolerability, and Efficacy of KD01 in Gynecologic Malignancies",
        "status": "RECRUITING",
        "phase": "PHASE1",
        "startYear": "2024"
      },
      {
        "nctId": "NCT06584006",
        "title": "Thymalfasin and Recombinant Human IL-2 Injections in Treating Lymphocytopenia for Patients With Malignant Hematological Tumors",
        "status": "RECRUITING",
        "phase": "PHASE2",
        "startYear": "2024"
      },
      {
        "nctId": "NCT07644897",
        "title": "Thymosin Alpha 1 Combined With Anti-PD-1 Monoclonal Antibody in Elderly Patients With Advanced Melanoma",
        "status": "RECRUITING",
        "phase": "PHASE2",
        "startYear": "2023"
      },
      {
        "nctId": "NCT06139419",
        "title": "The Impact of Thymosin α-1 on the Efficacy of Concurrent Chemoradiotherapy Followed by Immunotherpay Consolidation for Locally Advanced NSCLC",
        "status": "ACTIVE_NOT_RECRUITING",
        "phase": "PHASE2",
        "startYear": "2023"
      },
      {
        "nctId": "NCT06401447",
        "title": "TPF Concurrent Chemo-radiotherapy Plus Immunotherapy for Local Advanced Esophageal Squamous Cell Carcinoma",
        "status": "ACTIVE_NOT_RECRUITING",
        "phase": "NA",
        "startYear": "2023"
      },
      {
        "nctId": "NCT06024356",
        "title": "Neoadjuvant Chemoradiotherapy Combined With PD-1 Inhibitor and Thymalfasin for Locally Advanced Mid-low Rectal Cancer",
        "status": "COMPLETED",
        "phase": "",
        "startYear": "2023"
      },
      {
        "nctId": "NCT05790447",
        "title": "Thymalfasin-based PRaG Mode for Advanced Refractory Solid Tumors",
        "status": "UNKNOWN",
        "phase": "PHASE2",
        "startYear": "2023"
      },
      {
        "nctId": "NCT05339529",
        "title": "Protective Effect of Thymosin Α1 Against Negative Immune Dysregulation and Organ Dysfunction After Acute Aortic Dissection Surgery (PANDA II)",
        "status": "RECRUITING",
        "phase": "NA",
        "startYear": "2022"
      },
      {
        "nctId": "NCT05487469",
        "title": "Thymosin α1 Use in Rheumatic Heart Disease Patients Undergoing Cardiac Surgery on Cardiopulmonary Bypass",
        "status": "UNKNOWN",
        "phase": "NA",
        "startYear": "2022"
      },
      {
        "nctId": "NCT05658692",
        "title": "Platform Adaptive Embedded Trial for Acute Respiratory Distress Syndrome",
        "status": "UNKNOWN",
        "phase": "PHASE4",
        "startYear": "2022"
      },
      {
        "nctId": "NCT04963712",
        "title": "Zadaxin and HIV-positive Patients With Immune Reconstitution Disorder",
        "status": "COMPLETED",
        "phase": "EARLY_PHASE1",
        "startYear": "2021"
      },
      {
        "nctId": "NCT04901104",
        "title": "Long-term Prognosis of Patients With Sepsis After Immunotherapy",
        "status": "NOT_YET_RECRUITING",
        "phase": "",
        "startYear": "2021"
      },
      {
        "nctId": "NCT05086614",
        "title": "Thymosin-alpha 1 for Adjuvant Treatment After Radical Resection of High-risk Stage II and III Colorectal Cancer",
        "status": "RECRUITING",
        "phase": "PHASE3",
        "startYear": "2021"
      },
      {
        "nctId": "NCT04320238",
        "title": "Experimental Trial of rhIFNα Nasal Drops to Prevent 2019-nCOV in Medical Staff",
        "status": "UNKNOWN",
        "phase": "PHASE3",
        "startYear": "2020"
      },
      {
        "nctId": "NCT02473406",
        "title": "Thymosin Alpha 1 in the Prevention of Pancreatic Infection Following Acute Necrotizing Pancreatitis",
        "status": "COMPLETED",
        "phase": "PHASE4",
        "startYear": "2018"
      },
      {
        "nctId": "NCT03659578",
        "title": "Study of Thymosin α1 to Reduce Acute Pneumonia For Bulky None-small Cell Lung Cancer",
        "status": "COMPLETED",
        "phase": "PHASE2",
        "startYear": "2018"
      },
      {
        "nctId": "NCT03448744",
        "title": "Efficacy and Safety of Combination Therapy of Thymalfasin and Entecavir in HBeAg-positive ETV-experienced Patients",
        "status": "UNKNOWN",
        "phase": "PHASE4",
        "startYear": "2017"
      },
      {
        "nctId": "NCT02883595",
        "title": "Efficacy of Thymosin Alpha 1 on Improving Monocyte Function for Sepsis",
        "status": "COMPLETED",
        "phase": "PHASE4",
        "startYear": "2016"
      },
      {
        "nctId": "NCT02906150",
        "title": "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",
        "status": "UNKNOWN",
        "phase": "PHASE2",
        "startYear": "2016"
      },
      {
        "nctId": "NCT02545751",
        "title": "SBRT Combined With Thymalfasin for Metastatic Esophageal Cancer",
        "status": "UNKNOWN",
        "phase": "PHASE2",
        "startYear": "2016"
      },
      {
        "nctId": "NCT02867267",
        "title": "The Efficacy and Safety of Ta1 for Sepsis",
        "status": "COMPLETED",
        "phase": "PHASE3",
        "startYear": "2016"
      },
      {
        "nctId": "NCT02542137",
        "title": "Abscopal Effect for Metastatic Small Cell Lung Cancer",
        "status": "WITHDRAWN",
        "phase": "PHASE2",
        "startYear": "2015"
      },
      {
        "nctId": "NCT02535988",
        "title": "Abscopal Effect for Metastatic Colorectal Cancer",
        "status": "WITHDRAWN",
        "phase": "PHASE2",
        "startYear": "2015"
      },
      {
        "nctId": "NCT02281266",
        "title": "Thymalfasin Adjuvant Therapy in Hepatitis B Virus (HBV)-Related Hepatocellular Carcinoma (HCC) After Curative Resection",
        "status": "UNKNOWN",
        "phase": "PHASE4",
        "startYear": "2015"
      },
      {
        "nctId": "NCT02233075",
        "title": "REP 2139-Ca / Pegasys™ Combination Therapy in Hepatitis B / Hepatitis D Co-infection",
        "status": "COMPLETED",
        "phase": "PHASE2",
        "startYear": "2014"
      },
      {
        "nctId": "NCT01943617",
        "title": "Optimized Treatment and Regression of HBV-induced Compensated Liver Cirrhosis",
        "status": "COMPLETED",
        "phase": "PHASE4",
        "startYear": "2013"
      },
      {
        "nctId": "NCT01938820",
        "title": "Optimized Treatment and Regression of HBV-induced Early Cirrhosis",
        "status": "COMPLETED",
        "phase": "PHASE4",
        "startYear": "2013"
      },
      {
        "nctId": "NCT02366247",
        "title": "Phase Ⅲ Trial for Combination Treatment of PEG-Tα1 and Adefovir for HBeAg-positive Chronic Hepatitis B",
        "status": "UNKNOWN",
        "phase": "PHASE3",
        "startYear": "2013"
      },
      {
        "nctId": "NCT02366208",
        "title": "Phase II Trial for Combination Treatment of PEG-Tα1 and Adefovir for HBeAg Positive Chronic Hepatitis B",
        "status": "COMPLETED",
        "phase": "PHASE2",
        "startYear": "2011"
      },
      {
        "nctId": "NCT02646189",
        "title": "Therapeutic Safety and Efficacy of REP 2139 (REP 9AC') in HBV Infected Patients",
        "status": "COMPLETED",
        "phase": "PHASE1/PHASE2",
        "startYear": "2011"
      },
      {
        "nctId": "NCT00711620",
        "title": "Efficacy of Thymosin alpha1 for Severe Sepsis",
        "status": "COMPLETED",
        "phase": "NA",
        "startYear": "2008"
      },
      {
        "nctId": "NCT00580450",
        "title": "Thymosin Alfa 1 in Recipients of Allogeneic Hematopoietic Transplantation for Hematological Malignancies",
        "status": "UNKNOWN",
        "phase": "PHASE1/PHASE2",
        "startYear": "2007"
      },
      {
        "nctId": "NCT00291616",
        "title": "Efficacy Study of Thymosin alpha1 & Pegylated Interferon-alpha2a to Treat Chronic Hepatitis B",
        "status": "COMPLETED",
        "phase": "PHASE4",
        "startYear": "2005"
      },
      {
        "nctId": "NCT00197860",
        "title": "Dendritic Cell Based Therapy of Renal Cell Carcinoma",
        "status": "COMPLETED",
        "phase": "PHASE1/PHASE2",
        "startYear": "2004"
      },
      {
        "nctId": "NCT01178996",
        "title": "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.",
        "status": "COMPLETED",
        "phase": "PHASE3",
        "startYear": "2004"
      },
      {
        "nctId": "NCT00911443",
        "title": "Thymosin Alpha 1, Interferon Alpha, or Both, in Combination With Dacarbazine in Patients With Malignant Melanoma",
        "status": "COMPLETED",
        "phase": "PHASE2",
        "startYear": "2002"
      },
      {
        "nctId": "NCT00001036",
        "title": "The Safety and Effectiveness of a Type of Interleukin-2 Plus Zidovudine Plus Thymosin in HIV-Positive Patients With and Without Symptoms of Infection",
        "status": "COMPLETED",
        "phase": "PHASE1",
        "startYear": ""
      },
      {
        "nctId": "NCT00082082",
        "title": "A Trial of Thymalfasin in Adult Patients With Hepatocellular Carcinoma",
        "status": "COMPLETED",
        "phase": "PHASE2",
        "startYear": ""
      }
    ],
    "pendingResources": {
      "identity": [
        "FDA/NCATS GSRS or equivalent canonical identity source"
      ],
      "product_status": [
        "Drugs@FDA, Purple Book, Orange Book, DailyMed, or applicable primary FDA record"
      ],
      "compounding_status": [
        "FDA 503A/503B pages, Federal Register, docket, or applicable final/interim policy"
      ],
      "safety": [
        "FDA safety communication, warning, recall, FAERS signal context, or explicit absence statement"
      ],
      "evidence": [
        "ClinicalTrials.gov and PubMed/primary publication search"
      ],
      "state_or_facility": [
        "State board or FDA facility record when relevant"
      ]
    }
  }
}