{
  "meta": {
    "data_length": 1,
    "message": "Indication id ind:fda:trisenox:1 retrieved successfully",
    "request_url": "https://api.moalmanac.org/indications?indication_id=ind%3Afda%3Atrisenox%3A1",
    "status": "success",
    "status_code": 200,
    "timestamp_elapsed": 0.001938,
    "timestamp_received": "2026-11-09T16:14:30.760340Z",
    "timestamp_returned": "2026-11-09T16:14:30.762278Z",
    "trace_id": "8c0901d5-30d2-4813-8f8b-81c50ba35b35"
  },
  "service": {
    "github": "https://github.com/vanallenlab/moalmanac-db",
    "name": "Molecular Oncology Almanac",
    "license": "GPL-2.0",
    "release": "draft",
    "url": "https://moalmanac.org",
    "last_updated": "2026-10-08"
  },
  "data": [
    {
      "id": "ind:fda:trisenox:1",
      "type": "Indication",
      "description": "TRISENOX is an arsenical indicated for induction of remission and consolidation in patients with APL who are refractory to, or have relapsed from, retinoid and anthracycline chemotherapy, and whose APL is characterized by the presence of the t(15;17) translocation or PML/RAR-alpha gene expression.",
      "contributions": [
        {
          "id": "ctrb:vanallenlab:2025-06-26:0",
          "type": "Contribution",
          "description": "Resolving statements mapped to incorrect propositions",
          "date": "2025-06-26",
          "contributor": {
            "id": "agent:user:vanallenlab",
            "type": "Agent",
            "agentType": "contributor",
            "name": "Van Allen lab",
            "description": "Van Allen lab, Dana-Farber Cancer Institute"
          }
        },
        {
          "id": "ctrb:vanallenlab:2024-10-30:0",
          "type": "Contribution",
          "description": "Initial access of FDA approvals",
          "date": "2024-10-30",
          "contributor": {
            "id": "agent:user:vanallenlab",
            "type": "Agent",
            "agentType": "contributor",
            "name": "Van Allen lab",
            "description": "Van Allen lab, Dana-Farber Cancer Institute"
          }
        },
        {
          "id": "ctrb:fda:2000-09-25:0",
          "type": "Contribution",
          "description": "Indication received traditional approval.",
          "date": "2000-09-25",
          "contributor": {
            "id": "agent:org:fda",
            "type": "Agent",
            "agentType": "organization",
            "name": "Food and Drug Administration",
            "description": "Regulatory agency that approves drugs for use in the United States."
          }
        }
      ],
      "reportedIn": [
        {
          "id": "doc:fda:trisenox",
          "type": "Document",
          "documentType": "Regulatory approval",
          "name": "Trisenox (arsenic trioxide) [package insert]. FDA.",
          "title": null,
          "aliases": [],
          "description": "Cephalon, Inc. Trisenox (arsenic trioxide) [package insert]. U.S. Food and Drug Administration website. https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/021248s019lbl.pdf. Revised October 2020. Accessed October 30, 2024.",
          "urls": [
            "https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/021248s019lbl.pdf",
            "https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=021248"
          ],
          "doi": null,
          "pmid": null,
          "extensions": [
            {
              "name": "agent",
              "value": {
                "id": "agent:org:fda",
                "type": "Agent",
                "agentType": "organization",
                "name": "Food and Drug Administration",
                "description": "Regulatory agency that approves drugs for use in the United States."
              },
              "description": "The organization that published this document."
            },
            {
              "name": "company",
              "value": "Cephalon, Inc.",
              "description": "The company that manufactures the cancer drug. Only applicable to market authorization documents."
            },
            {
              "name": "drug_name_brand",
              "value": "Trisenox",
              "description": "The brand name of the cancer drug, per this document. Only applicable to market authorization documents."
            },
            {
              "name": "drug_name_generic",
              "value": "arsenic trioxide",
              "description": "The generic name of the cancer drug, per this document. Only applicable to market authorization documents."
            },
            {
              "name": "first_publication_date",
              "value": null,
              "description": "The publication date for the initial version of this document."
            },
            {
              "name": "publication_date",
              "value": "2020-10-20",
              "description": "The publication date for the document."
            },
            {
              "name": "regulatory_identifier",
              "value": "NDA021248",
              "description": "Identifier assigned by the regulatory agency, such as an FDA application number (e.g. NDA208716, BLA125427) or an EMA product number (e.g. EMEA/H/C/006184)."
            },
            {
              "name": "status",
              "value": "Active",
              "description": "Whether this document is Active or Deprecated within moalmanac-db."
            }
          ]
        },
        {
          "id": "doc:fda:trisenox:2000-09-25",
          "type": "Document",
          "documentType": "Regulatory approval",
          "name": "Trisenox (arsenic trioxide) [package insert]. FDA.",
          "title": null,
          "aliases": [],
          "description": "Cephalon, Inc. Trisenox (arsenic trioxide) [package insert]. U.S. Food and Drug Administration website. https://www.accessdata.fda.gov/drugsatfda_docs/label/2000/21248lbl.pdf. Revised September 2000. Accessed October 6, 2026.",
          "urls": [
            "https://www.accessdata.fda.gov/drugsatfda_docs/label/2000/21248lbl.pdf",
            "https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=021248"
          ],
          "doi": null,
          "pmid": null,
          "extensions": [
            {
              "name": "agent",
              "value": {
                "id": "agent:org:fda",
                "type": "Agent",
                "agentType": "organization",
                "name": "Food and Drug Administration",
                "description": "Regulatory agency that approves drugs for use in the United States."
              },
              "description": "The organization that published this document."
            },
            {
              "name": "company",
              "value": "Cephalon, Inc.",
              "description": "The company that manufactures the cancer drug. Only applicable to market authorization documents."
            },
            {
              "name": "drug_name_brand",
              "value": "Trisenox",
              "description": "The brand name of the cancer drug, per this document. Only applicable to market authorization documents."
            },
            {
              "name": "drug_name_generic",
              "value": "arsenic trioxide",
              "description": "The generic name of the cancer drug, per this document. Only applicable to market authorization documents."
            },
            {
              "name": "first_publication_date",
              "value": null,
              "description": "The publication date for the initial version of this document."
            },
            {
              "name": "publication_date",
              "value": "2000-09-25",
              "description": "The publication date for the document."
            },
            {
              "name": "regulatory_identifier",
              "value": "NDA021248",
              "description": "Identifier assigned by the regulatory agency, such as an FDA application number (e.g. NDA208716, BLA125427) or an EMA product number (e.g. EMEA/H/C/006184)."
            },
            {
              "name": "status",
              "value": "Deprecated",
              "description": "Whether this document is Active or Deprecated within moalmanac-db."
            }
          ]
        }
      ],
      "extensions": [
        {
          "name": "status",
          "value": "Approved",
          "description": "Current approval status."
        },
        {
          "name": "statement description",
          "value": "The U.S. Food and Drug Administration granted approval to arsenic trioxide for the induction of remission and consolidation in patients with acute promyelocytic leukemia (APL) who are refractory to, or have relapsed from, retinoid and anthracycline chemotherapy, and whose APL is characterized by the presence of the t(15;17) translocation or PML/RAR-alpha gene expression.",
          "description": "The description text for all Statements derived from this Indication."
        }
      ]
    }
  ]
}