{
  "data": {
    "id": "tb-500",
    "canonicalName": "TB-500",
    "aliases": [
      "Thymosin beta-4 fragment"
    ],
    "exactForm": "pending",
    "route": "pending",
    "dosageForm": "pending",
    "intendedUse": "human use (unspecified)",
    "productStatus": "Not verified",
    "compoundingStatus": "Not verified",
    "evidenceTier": "18 registered clinical studies",
    "answer": "TB-500 is listed in the CompoundedGuide registry with no verified FDA-approved product. FDA lists TB-500 among bulk drug substances for use in compounding that may present significant safety risks. TB-500 is not on FDA's 503B Bulks List for outsourcing facilities (list checked 2026-07-25). 18 registered ClinicalTrials.gov studies cite TB-500 (11 completed, 2 recruiting, 2 terminated, 2 withdrawn, 1 not yet recruiting); registration is not evidence of approval, efficacy, or safety.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 18 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": "2026-07-25T19:17:37.464Z"
      },
      {
        "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": "2026-07-25T04:39:36.923Z"
      },
      {
        "id": "clinicaltrials_gov_api",
        "title": "ClinicalTrials.gov API v2",
        "authorityTier": "P0",
        "url": "https://clinicaltrials.gov/api/v2/studies?filter.ids=NCT00311766,NCT00382174,NCT00598871,NCT00743769,NCT00832091,NCT01311518,NCT01387347,NCT01393132,NCT02597803,NCT02974907,NCT03937882,NCT04555824,NCT04555850,NCT05485818,NCT05555589,NCT05984134,NCT07487363,NCT07586865&pageSize=50&countTotal=true",
        "retrievedAt": "2026-07-25T01:36:53.883Z"
      }
    ],
    "trials": [
      {
        "nctId": "NCT07586865",
        "title": "Recombinant Human Thymosin Beta 4 for Injection(NL005) for Acute Myocardial Infarction",
        "status": "NOT_YET_RECRUITING",
        "phase": "PHASE2",
        "startYear": "2026"
      },
      {
        "nctId": "NCT07487363",
        "title": "TB-500 (Thymosin Beta 4 17-23 Fragment) for Cardiovascular Biomarkers in Stable ASCVD",
        "status": "RECRUITING",
        "phase": "PHASE1/PHASE2",
        "startYear": "2026"
      },
      {
        "nctId": "NCT05555589",
        "title": "Assessment of the Safety and Efficacy of 0.1% RGN-259 Ophthalmic Solution for the Treatment of NK: SEER-2",
        "status": "RECRUITING",
        "phase": "PHASE3",
        "startYear": "2023"
      },
      {
        "nctId": "NCT05984134",
        "title": "Efficacy and Safety Study of Thymosin Beta 4 in Patients With Acute Myocardial Infarction",
        "status": "COMPLETED",
        "phase": "PHASE2",
        "startYear": "2022"
      },
      {
        "nctId": "NCT05485818",
        "title": "Safety and Efficacy Study of Thymosin Beta 4 in Patients With Acute Myocardial Infarction.Infarction",
        "status": "COMPLETED",
        "phase": "PHASE2",
        "startYear": "2020"
      },
      {
        "nctId": "NCT01311518",
        "title": "A Study of the Safety and Efficacy of Injectable Thymosin Beta 4 for Treating Acute Myocardial Infarction",
        "status": "WITHDRAWN",
        "phase": "PHASE2",
        "startYear": "2019"
      },
      {
        "nctId": "NCT03937882",
        "title": "Assessment of the Safety and Efficacy of RGN-259 Ophthalmic Solutions for Dry Eye Syndrome: ARISE-3",
        "status": "COMPLETED",
        "phase": "PHASE3",
        "startYear": "2019"
      },
      {
        "nctId": "NCT04555850",
        "title": "A Phase 1b Study of Thymosin Beta 4 in Healthy Volunteers",
        "status": "COMPLETED",
        "phase": "PHASE1",
        "startYear": "2018"
      },
      {
        "nctId": "NCT04555824",
        "title": "A Phase 1a Study of Thymosin Beta 4 in Healthy Volunteers",
        "status": "COMPLETED",
        "phase": "PHASE1",
        "startYear": "2017"
      },
      {
        "nctId": "NCT02974907",
        "title": "Assessment of the Safety and Efficacy of RGN-259 Ophthalmic Solutions for Dry Eye Syndrome : ARISE-2",
        "status": "COMPLETED",
        "phase": "PHASE3",
        "startYear": "2016"
      },
      {
        "nctId": "NCT02597803",
        "title": "Assessment of the Safety and Efficacy of RGN-259 Ophthalmic Solutions for Dry Eye Syndrome: ARISE-1",
        "status": "COMPLETED",
        "phase": "PHASE2/PHASE3",
        "startYear": "2015"
      },
      {
        "nctId": "NCT01393132",
        "title": "Comparative Study of Thymosin Beta 4 Eye Drops vs. Vehicle in the Treatment of Severe Dry Eye",
        "status": "COMPLETED",
        "phase": "PHASE2",
        "startYear": "2011"
      },
      {
        "nctId": "NCT01387347",
        "title": "Safety and Efficacy of Thymosin Beta 4 Ophthalmic Solution in Patients With Dry Eye",
        "status": "COMPLETED",
        "phase": "PHASE2",
        "startYear": "2011"
      },
      {
        "nctId": "NCT00743769",
        "title": "A Phase 1 Safety Study of the Intravenous Administration of Thymosin Beta in Healthy Volunteers",
        "status": "WITHDRAWN",
        "phase": "PHASE1",
        "startYear": "2008"
      },
      {
        "nctId": "NCT00598871",
        "title": "A Phase 2 Study of the Safety and Efficacy of Thymosin Beta 4 for Treating Corneal Wounds",
        "status": "TERMINATED",
        "phase": "PHASE2",
        "startYear": "2007"
      },
      {
        "nctId": "NCT00311766",
        "title": "A Phase 2 Study on Effect of Thymosin Beta 4 on Wound Healing in Patients With Epidermolysis Bullosa",
        "status": "TERMINATED",
        "phase": "PHASE2",
        "startYear": "2006"
      },
      {
        "nctId": "NCT00382174",
        "title": "Study of Thymosin Beta 4 in Patients With Pressure Ulcers",
        "status": "COMPLETED",
        "phase": "PHASE2",
        "startYear": "2006"
      },
      {
        "nctId": "NCT00832091",
        "title": "Study of Thymosin Beta 4 in Patients With Venous Stasis Ulcers",
        "status": "COMPLETED",
        "phase": "PHASE2",
        "startYear": "2006"
      }
    ],
    "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"
      ]
    }
  }
}