{
  "drugs": [
    {
      "drug": "resmetirom",
      "brand": "Rezdiffra",
      "FDA_approval_date": "2024-03-14",
      "FDA_indication": "Non-cirrhotic NASH/MASH with moderate to advanced fibrosis (F2-F3) in adults",
      "EMA_approval_date": "2025-08-22",
      "EMA_indication": "Non-cirrhotic MASH F2-F3 adults; conditional",
      "MFDS_approval_date": null,
      "MFDS_status": "under_review_2026",
      "PMDA_approval_date": null,
      "AE_warning": "Hepatotoxicity, gallbladder events, drug-drug interactions (statins)",
      "dosing": "80 mg or 100 mg PO once daily based on body weight",
      "label_link_simulated": "https://www.fda.gov/.../rezdiffra"
    },
    {
      "drug": "pegozafermin",
      "FDA_approval_date": null,
      "FDA_status": "phase3_ENLIVEN-2_readout_2026Q1",
      "EMA_approval_date": null,
      "EMA_status": "phase3_pending",
      "MFDS_approval_date": null,
      "MFDS_status": "not_filed",
      "AE_warning": "GI events, injection site reactions",
      "dosing": "30-44 mg SC weekly or biweekly (trial doses)",
      "label_link_simulated": null
    },
    {
      "drug": "efruxifermin",
      "FDA_approval_date": null,
      "FDA_status": "phase3_SYMMETRY_ongoing",
      "EMA_approval_date": null,
      "EMA_status": "phase3_pending",
      "MFDS_approval_date": null,
      "MFDS_status": "not_filed",
      "AE_warning": "GI events, transient ALT elevation",
      "dosing": "28-50 mg SC weekly (trial doses)",
      "label_link_simulated": null
    },
    {
      "drug": "survodutide",
      "FDA_approval_date": null,
      "FDA_status": "phase2_complete_phase3_planned",
      "EMA_approval_date": null,
      "EMA_status": "phase3_planned",
      "MFDS_approval_date": null,
      "MFDS_status": "not_filed",
      "AE_warning": "GI events, hypoglycemia (with insulin)",
      "dosing": "2.4-6 mg SC weekly (trial doses)",
      "label_link_simulated": null
    },
    {
      "drug": "semaglutide",
      "brand": "Ozempic/Wegovy",
      "FDA_approval_date": "2017-12-05",
      "FDA_indication": "T2DM (Ozempic 2017), Obesity (Wegovy 2021); MASH indication under FDA review post-ESSENCE 2024",
      "EMA_approval_date": "2018-02-08",
      "MFDS_approval_date": "2019-02-15",
      "AE_warning": "Pancreatitis, gallbladder events, MTC contraindication",
      "dosing": "0.25-2.4 mg SC weekly (titration)"
    },
    {
      "drug": "tirzepatide",
      "brand": "Mounjaro/Zepbound",
      "FDA_approval_date": "2022-05-13",
      "EMA_approval_date": "2022-09-15",
      "MFDS_approval_date": "2023-06-21",
      "AE_warning": "GI events, pancreatitis, MTC contraindication",
      "dosing": "2.5-15 mg SC weekly (titration)"
    },
    {
      "drug": "pioglitazone",
      "FDA_approval_date": "1999-07-15",
      "EMA_approval_date": "2000-10-13",
      "MFDS_approval_date": "2001-08-30",
      "AE_warning": "Weight gain, edema, fracture risk, bladder cancer signal",
      "dosing": "15-45 mg PO daily"
    },
    {
      "drug": "vitamin_e",
      "FDA_approval_date": null,
      "EMA_approval_date": null,
      "MFDS_approval_date": null,
      "indication": "OTC supplement; off-label MASH adjunct",
      "AE_warning": "Hemorrhagic stroke risk at high dose; prostate cancer signal",
      "dosing": "800 IU PO daily (MASH off-label)"
    },
    {
      "drug": "retatrutide",
      "FDA_approval_date": null,
      "FDA_status": "phase3_TRIUMPH_ongoing",
      "EMA_approval_date": null,
      "MFDS_approval_date": null,
      "AE_warning": "GI events (anticipated)",
      "dosing": "1-12 mg SC weekly (trial doses)"
    }
  ]
}
