{
  "last_checked": "2026-10-29",
  "license": "CC BY 4.0. Credit: ProteinIQ, https://proteiniq.io/guides/approved-oligonucleotide-drugs",
  "sources": {
    "fda": "Drugs@FDA data files dated October 28, 2026",
    "ema": "EMA medicines report generated October 29, 2026",
    "pmda": "PMDA List of Approved Drugs April 2004 to February 2026; FY2026 approval list to September 16, 2026"
  },
  "fda": {
    "approved_ever": 25,
    "by_year": {
      "1998": 1,
      "2004": 1,
      "2013": 1,
      "2016": 2,
      "2018": 2,
      "2019": 2,
      "2020": 2,
      "2021": 2,
      "2022": 1,
      "2023": 4,
      "2024": 2,
      "2025": 3,
      "2026": 2
    },
    "by_class": {
      "RNase H antisense": 9,
      "siRNA": 8,
      "Splice-switching antisense": 5,
      "Aptamer": 2,
      "Other": 1
    },
    "by_delivery": {
      "Unconjugated": 11,
      "GalNAc conjugate": 10,
      "PEGylated": 2,
      "Lipid nanoparticle": 1,
      "Lipid conjugate": 1
    },
    "marketed": 21,
    "discontinued": [
      "Vitravene",
      "Macugen",
      "Kynamro",
      "Tegsedi"
    ],
    "through_2025": 23,
    "class_by_year": {
      "1998": {
        "RNase H antisense": 1
      },
      "2004": {
        "Aptamer": 1
      },
      "2013": {
        "RNase H antisense": 1
      },
      "2016": {
        "Splice-switching antisense": 2
      },
      "2018": {
        "siRNA": 1,
        "RNase H antisense": 1
      },
      "2019": {
        "siRNA": 1,
        "Splice-switching antisense": 1
      },
      "2020": {
        "Splice-switching antisense": 1,
        "siRNA": 1
      },
      "2021": {
        "siRNA": 1,
        "Splice-switching antisense": 1
      },
      "2022": {
        "siRNA": 1
      },
      "2023": {
        "RNase H antisense": 2,
        "Aptamer": 1,
        "siRNA": 1
      },
      "2024": {
        "Other": 1,
        "RNase H antisense": 1
      },
      "2025": {
        "siRNA": 2,
        "RNase H antisense": 1
      },
      "2026": {
        "RNase H antisense": 2
      }
    },
    "by_route": {
      "Subcutaneous": 13,
      "Intravenous": 6,
      "Intravitreal": 3,
      "Intrathecal": 3
    },
    "delivery_by_period": {
      "1998-2017": {
        "Unconjugated": 4,
        "PEGylated": 1
      },
      "2018-2021": {
        "Unconjugated": 4,
        "GalNAc conjugate": 3,
        "Lipid nanoparticle": 1
      },
      "2022-2026": {
        "GalNAc conjugate": 7,
        "Unconjugated": 3,
        "PEGylated": 1,
        "Lipid conjugate": 1
      }
    },
    "galnac_share_of_approvals_since_2019": "10 of 18"
  },
  "ema": {
    "approved_ever": 16,
    "by_year": {
      "1999": 1,
      "2006": 1,
      "2017": 1,
      "2018": 2,
      "2019": 1,
      "2020": 3,
      "2022": 1,
      "2024": 1,
      "2025": 3,
      "2026": 2
    },
    "by_class": {
      "RNase H antisense": 7,
      "siRNA": 6,
      "Aptamer": 1,
      "Splice-switching antisense": 1,
      "Other": 1
    },
    "by_delivery": {
      "GalNAc conjugate": 8,
      "Unconjugated": 5,
      "PEGylated": 1,
      "Lipid nanoparticle": 1,
      "Lipid conjugate": 1
    },
    "currently_authorised": 14
  },
  "pmda": {
    "approved_ever": 10,
    "by_year": {
      "2008": 1,
      "2017": 1,
      "2019": 1,
      "2020": 1,
      "2021": 1,
      "2022": 1,
      "2023": 1,
      "2024": 1,
      "2025": 1,
      "2026": 1
    },
    "by_class": {
      "siRNA": 4,
      "Aptamer": 2,
      "Splice-switching antisense": 2,
      "RNase H antisense": 2
    },
    "by_delivery": {
      "Unconjugated": 4,
      "GalNAc conjugate": 3,
      "PEGylated": 2,
      "Lipid nanoparticle": 1
    }
  },
  "worldwide_fda_ema_pmda": {
    "approved_ever": 26,
    "marketed_somewhere": 23,
    "by_class": {
      "RNase H antisense": 10,
      "siRNA": 8,
      "Splice-switching antisense": 5,
      "Aptamer": 2,
      "Other": 1
    },
    "by_delivery": {
      "Unconjugated": 12,
      "GalNAc conjugate": 10,
      "PEGylated": 2,
      "Lipid nanoparticle": 1,
      "Lipid conjugate": 1
    },
    "by_route": {
      "Subcutaneous": 14,
      "Intravenous": 6,
      "Intravitreal": 3,
      "Intrathecal": 3
    },
    "by_first_agency": {
      "FDA": 20,
      "EMA": 4,
      "PMDA": 2
    },
    "not_fda_approved": [
      "volanesorsen"
    ],
    "all_three_agencies": [
      "pegaptanib",
      "nusinersen",
      "patisiran",
      "givosiran",
      "inclisiran",
      "vutrisiran",
      "tofersen"
    ]
  },
  "related_not_counted": {
    "Defitelio": "Polydisperse oligonucleotide mixture"
  }
}