{
  "last_checked": "2026-10-29",
  "license": "CC BY 4.0. Credit: ProteinIQ, https://proteiniq.io/guides/fda-approved-peptide-drugs",
  "sources": {
    "drugsatfda": "Drugs@FDA data files, release of October 28, 2026",
    "purple_book": "FDA Purple Book October 2026 download",
    "novel_approvals": "CDER Novel Drug Approvals 2015 to 2026 (2026 through October 20)"
  },
  "definition": "2 to 50 amino acid residues, defined sequence, FDA NDA or BLA, one count per active moiety",
  "peptides_approved_ever": 98,
  "marketed_now": 77,
  "excluding_microbial_natural_products": 79,
  "microbial_natural_products": 19,
  "radiolabelled": 7,
  "excluding_natural_products_and_radiolabelled": 72,
  "over_40_residues_now_biologics": [
    "corticorelin ovine triflutate",
    "tesamorelin",
    "lixisenatide",
    "bulevirtide"
  ],
  "at_fda_40_residue_cutoff": 94,
  "insulins_listed_separately": [
    "insulin human",
    "insulin lispro",
    "insulin aspart",
    "insulin glargine",
    "insulin glulisine",
    "insulin detemir",
    "insulin degludec",
    "insulin icodec"
  ],
  "by_decade": {
    "Before 1982": 22,
    "1982 to 1989": 6,
    "1990s": 10,
    "2000s": 18,
    "2010s": 21,
    "2020s": 21
  },
  "by_decade_excluding_natural_products": {
    "Before 1982": 14,
    "1982 to 1989": 5,
    "1990s": 9,
    "2000s": 13,
    "2010s": 19,
    "2020s": 19
  },
  "by_class": {
    "Linear": 40,
    "Cyclic": 29,
    "Lipidated": 13,
    "Radiolabelled": 7,
    "PEGylated": 4,
    "Glycopeptide": 4,
    "Peptide-drug conjugate": 1
  },
  "by_structure": {
    "Linear": 46,
    "Cyclic (disulfide)": 28,
    "Cyclic (head to tail)": 8,
    "Cyclic (lactam)": 7,
    "Cyclic (cross-linked)": 4,
    "Cyclic (lactone)": 3,
    "Cyclic (macrocycle)": 1,
    "Cyclic (thioether)": 1
  },
  "by_origin": {
    "Hormone or hormone analog": 58,
    "Microbial natural product": 19,
    "Designed or display derived": 14,
    "Venom or toxin derived": 7
  },
  "by_therapeutic_area": {
    "Infectious disease": 18,
    "Diagnostic": 16,
    "Endocrinology": 10,
    "Diabetes and obesity": 9,
    "Oncology": 9,
    "Cardiovascular": 6,
    "Immunology and hematology": 6,
    "Reproductive health": 5,
    "Bone and mineral": 4,
    "Rare genetic disease": 4,
    "Kidney disease": 4,
    "Gastrointestinal": 3,
    "Neurology and pain": 2,
    "Dermatology": 1,
    "Respiratory": 1
  },
  "by_route_contains": {
    "Subcutaneous": 37,
    "Intravenous": 32,
    "Intramuscular": 6,
    "Oral": 12,
    "Nasal": 6,
    "Implant": 4,
    "Topical": 2,
    "Ophthalmic": 4
  },
  "by_first_approval_year_2015_on": {
    "2015": {
      "peptides": 0,
      "novel_approvals": 45
    },
    "2016": {
      "peptides": 2,
      "novel_approvals": 22
    },
    "2017": {
      "peptides": 5,
      "novel_approvals": 46
    },
    "2018": {
      "peptides": 1,
      "novel_approvals": 59
    },
    "2019": {
      "peptides": 3,
      "novel_approvals": 48
    },
    "2020": {
      "peptides": 2,
      "novel_approvals": 53
    },
    "2021": {
      "peptides": 6,
      "novel_approvals": 50
    },
    "2022": {
      "peptides": 2,
      "novel_approvals": 37
    },
    "2023": {
      "peptides": 4,
      "novel_approvals": 55
    },
    "2024": {
      "peptides": 1,
      "novel_approvals": 50
    },
    "2025": {
      "peptides": 1,
      "novel_approvals": 46
    },
    "2026": {
      "peptides": 5,
      "novel_approvals": 47
    }
  },
  "share_of_novel_approvals": {
    "2015-2022": {
      "peptides": 21,
      "novel_approvals": 360,
      "percent": 5.8
    },
    "2015-2025": {
      "peptides": 27,
      "novel_approvals": 511,
      "percent": 5.3
    },
    "2026_to_date": {
      "peptides": 5,
      "novel_approvals": 47,
      "percent": 10.6
    }
  },
  "glp1_family": [
    {
      "inn": "exenatide",
      "first_brand": "Byetta",
      "first_approval_date": "2005-04-28",
      "residues": 39,
      "counted": "yes",
      "glp1_family": "Peptide GLP-1 receptor agonist",
      "us_status": "Marketed"
    },
    {
      "inn": "liraglutide",
      "first_brand": "Victoza",
      "first_approval_date": "2010-01-25",
      "residues": 31,
      "counted": "yes",
      "glp1_family": "Peptide GLP-1 receptor agonist",
      "us_status": "Marketed"
    },
    {
      "inn": "lixisenatide",
      "first_brand": "Adlyxin",
      "first_approval_date": "2016-07-27",
      "residues": 44,
      "counted": "yes",
      "glp1_family": "Peptide GLP-1 receptor agonist",
      "us_status": "Marketed"
    },
    {
      "inn": "semaglutide",
      "first_brand": "Ozempic",
      "first_approval_date": "2017-12-05",
      "residues": 31,
      "counted": "yes",
      "glp1_family": "Peptide GLP-1 receptor agonist",
      "us_status": "Marketed"
    },
    {
      "inn": "tirzepatide",
      "first_brand": "Mounjaro",
      "first_approval_date": "2022-05-13",
      "residues": 39,
      "counted": "yes",
      "glp1_family": "Peptide GLP-1 receptor agonist (dual GIP/GLP-1)",
      "us_status": "Marketed"
    },
    {
      "inn": "albiglutide",
      "first_brand": "Tanzeum",
      "first_approval_date": "2014-04-15",
      "residues": "",
      "counted": "no",
      "glp1_family": "Fusion protein GLP-1 receptor agonist",
      "us_status": "Discontinued"
    },
    {
      "inn": "dulaglutide",
      "first_brand": "Trulicity",
      "first_approval_date": "2014-09-18",
      "residues": "",
      "counted": "no",
      "glp1_family": "Fusion protein GLP-1 receptor agonist",
      "us_status": "Marketed"
    },
    {
      "inn": "orforglipron",
      "first_brand": "Foundayo",
      "first_approval_date": "2026-04-01",
      "residues": "",
      "counted": "no",
      "glp1_family": "Small-molecule GLP-1 receptor agonist",
      "us_status": "Marketed"
    }
  ],
  "related_not_counted": {
    "insulin human": "Insulin (two chains of 50 to 53 residues; listed separately)",
    "insulin lispro": "Insulin (two chains of 50 to 53 residues; listed separately)",
    "insulin aspart": "Insulin (two chains of 50 to 53 residues; listed separately)",
    "insulin glargine": "Insulin (two chains of 50 to 53 residues; listed separately)",
    "insulin glulisine": "Insulin (two chains of 50 to 53 residues; listed separately)",
    "insulin detemir": "Insulin (two chains of 50 to 53 residues; listed separately)",
    "insulin degludec": "Insulin (two chains of 50 to 53 residues; listed separately)",
    "insulin icodec": "Insulin (two chains of 50 to 53 residues; listed separately)",
    "albiglutide": "GLP-1 fusion protein",
    "dulaglutide": "GLP-1 fusion protein",
    "orforglipron": "Small molecule",
    "bortezomib": "Peptide-derived protease inhibitor",
    "carfilzomib": "Peptide-derived protease inhibitor",
    "ixazomib": "Peptide-derived protease inhibitor",
    "macimorelin": "Peptidomimetic small molecule",
    "glatiramer acetate": "Random amino acid polymer",
    "gallium Ga 68 gozetotide (PSMA-11)": "Urea-based PSMA ligand",
    "lutetium Lu 177 vipivotide tetraxetan (PSMA-617)": "Urea-based PSMA ligand",
    "pegulicianine": "Optical imaging agent with a peptide linker"
  }
}