{
  "as_of": "2026-11-06",
  "title": "Polycystic Kidney Disease (ADPKD) Drug Landscape",
  "assets": [
    {
      "section": "approved",
      "asset": "JYNARQUE(tolvaptan)",
      "company": "Otsuka",
      "country": "Japan",
      "mechanism": "Vasopressin V2 receptor antagonist",
      "route": "Oral",
      "stage": "Approved",
      "indication": "Rapidly progressing ADPKD",
      "trials": [],
      "deal": "—",
      "latest": "First US generic launched (Lupin, 180-day exclusivity)",
      "date": "2025-05-13",
      "sources": [
        "https://lupin.com/US/media/lupin-launches-tolvaptan-tablets-in-the-u-s-with-180-day-exclusivity"
      ],
      "asia": true,
      "source_records": [
        {
          "url": "https://lupin.com/US/media/lupin-launches-tolvaptan-tablets-in-the-u-s-with-180-day-exclusivity",
          "date": "2025-05-13",
          "date_kind": "publication",
          "accessed_at": "2026-11-06",
          "provenance": "Claude review 2026-11-06; task corrections"
        }
      ]
    },
    {
      "section": "pipeline",
      "asset": "farabursen(RGLS8429)",
      "company": "Novartis (acquired Regulus)",
      "country": "Switzerland",
      "mechanism": "miR-17 oligonucleotide",
      "route": "Subcutaneous",
      "stage": "Phase 1b completed",
      "indication": "ADPKD",
      "trials": [
        "NCT05521191"
      ],
      "deal": "Novartis acquired Regulus in 2025: $7 per share in cash plus a $7-per-share CVR on approval; up to about $1.7 billion",
      "latest": "Phase 1b multiple-ascending-dose study completed at acquisition",
      "date": "2025-04-30",
      "sources": [
        "https://www.sec.gov/Archives/edgar/data/1505512/000119312525105845/d873263dex991.htm",
        "https://www.pharmaceutical-technology.com/news/novartis-regulus-renal-disease/",
        "https://clinicaltrials.gov/study/NCT05521191"
      ],
      "asia": false,
      "source_records": [
        {
          "url": "https://www.sec.gov/Archives/edgar/data/1505512/000119312525105845/d873263dex991.htm",
          "date": "2025-04-30",
          "date_kind": "publication",
          "accessed_at": "2026-11-06",
          "provenance": "Claude review 2026-11-06; task corrections"
        },
        {
          "url": "https://www.pharmaceutical-technology.com/news/novartis-regulus-renal-disease/",
          "date": "2025-05-01",
          "date_kind": "publication",
          "accessed_at": "2026-11-06",
          "provenance": "Claude review 2026-11-06; task corrections"
        },
        {
          "url": "https://clinicaltrials.gov/study/NCT05521191",
          "date": "2025-06-03",
          "date_kind": "last_update",
          "accessed_at": "2026-11-06",
          "provenance": "ClinicalTrials.gov API v2 lastUpdatePostDateStruct; verified 2026-11-06"
        }
      ]
    },
    {
      "section": "pipeline",
      "asset": "VX-407",
      "company": "Vertex",
      "country": "United States",
      "mechanism": "small-molecule PC1 folding corrector",
      "route": "Oral",
      "stage": "Phase 2a",
      "indication": "ADPKD with specific PKD1 variants",
      "trials": [
        "NCT07161037"
      ],
      "deal": "—",
      "latest": "Phase 2a enrollment completed",
      "date": "2026-09-21",
      "sources": [
        "https://clinicaltrials.gov/study/NCT07161037",
        "https://www.vrtx.com/our-science/pipeline/autosomal-dominant-polycystic-kidney-disease"
      ],
      "asia": false,
      "source_records": [
        {
          "url": "https://clinicaltrials.gov/study/NCT07161037",
          "date": "2026-09-21",
          "date_kind": "last_update",
          "accessed_at": "2026-11-06",
          "provenance": "ClinicalTrials.gov API v2 lastUpdatePostDateStruct; verified 2026-11-06"
        },
        {
          "url": "https://www.vrtx.com/our-science/pipeline/autosomal-dominant-polycystic-kidney-disease",
          "date": "Not found",
          "date_kind": "undated",
          "accessed_at": "2026-11-06",
          "provenance": "Publication date not established; accessed date recorded separately"
        }
      ]
    },
    {
      "section": "pipeline",
      "asset": "ABBV-CLS-628",
      "company": "AbbVie/Calico",
      "country": "United States",
      "mechanism": "anti-PAPP-A monoclonal antibody",
      "route": "Intravenous",
      "stage": "Phase 2",
      "indication": "ADPKD",
      "trials": [
        "NCT06902558"
      ],
      "deal": "—",
      "latest": "ANCHOR Phase 2 recruiting",
      "date": "2026-10-06",
      "sources": [
        "https://clinicaltrials.gov/study/NCT06902558",
        "https://www.calicolabs.com/clinical-trial-autosomal-dominant-polycystic-kidney-disease/"
      ],
      "asia": false,
      "source_records": [
        {
          "url": "https://clinicaltrials.gov/study/NCT06902558",
          "date": "2026-10-06",
          "date_kind": "last_update",
          "accessed_at": "2026-11-06",
          "provenance": "ClinicalTrials.gov API v2 lastUpdatePostDateStruct; verified 2026-11-06"
        },
        {
          "url": "https://www.calicolabs.com/clinical-trial-autosomal-dominant-polycystic-kidney-disease/",
          "date": "Not found",
          "date_kind": "undated",
          "accessed_at": "2026-11-06",
          "provenance": "Publication date not established; accessed date recorded separately"
        }
      ]
    },
    {
      "section": "pipeline",
      "asset": "AZD1613",
      "company": "AstraZeneca",
      "country": "United Kingdom",
      "mechanism": "Not disclosed",
      "route": "Injection",
      "stage": "Phase 1",
      "indication": "ADPKD",
      "trials": [
        "NCT07228364"
      ],
      "deal": "—",
      "latest": "Phase 1 multiple-ascending-dose study in ADPKD (including China)",
      "date": "2026-10-13",
      "sources": [
        "https://clinicaltrials.gov/study/NCT07228364"
      ],
      "asia": false,
      "source_records": [
        {
          "url": "https://clinicaltrials.gov/study/NCT07228364",
          "date": "2026-10-13",
          "date_kind": "last_update",
          "accessed_at": "2026-11-06",
          "provenance": "ClinicalTrials.gov API v2 lastUpdatePostDateStruct; verified 2026-11-06"
        }
      ]
    },
    {
      "section": "pipeline",
      "asset": "GSK4771261",
      "company": "GSK",
      "country": "United Kingdom",
      "mechanism": "Not disclosed",
      "route": "—",
      "stage": "Phase 1",
      "indication": "ADPKD",
      "trials": [
        "NCT06734234"
      ],
      "deal": "—",
      "latest": "Phase 1a/b in healthy participants and ADPKD patients",
      "date": "2026-07-30",
      "sources": [
        "https://clinicaltrials.gov/study/NCT06734234"
      ],
      "asia": false,
      "source_records": [
        {
          "url": "https://clinicaltrials.gov/study/NCT06734234",
          "date": "2026-07-30",
          "date_kind": "last_update",
          "accessed_at": "2026-11-06",
          "provenance": "ClinicalTrials.gov API v2 lastUpdatePostDateStruct; verified 2026-11-06"
        }
      ]
    },
    {
      "section": "pipeline",
      "asset": "PYC-003",
      "company": "PYC Therapeutics",
      "country": "Australia",
      "mechanism": "Peptide-conjugated PMO antisense oligonucleotide",
      "route": "Intravenous",
      "stage": "Phase 1",
      "indication": "ADPKD",
      "trials": [
        "NCT06714006"
      ],
      "deal": "—",
      "latest": "Phase 1 (Australia, Hong Kong, New Zealand)",
      "date": "2026-07-27",
      "sources": [
        "https://clinicaltrials.gov/study/NCT06714006"
      ],
      "asia": false,
      "source_records": [
        {
          "url": "https://clinicaltrials.gov/study/NCT06714006",
          "date": "2026-07-27",
          "date_kind": "last_update",
          "accessed_at": "2026-11-06",
          "provenance": "ClinicalTrials.gov API v2 lastUpdatePostDateStruct; verified 2026-11-06"
        }
      ]
    },
    {
      "section": "pipeline",
      "asset": "JMKX003142",
      "company": "Jemincare",
      "country": "China",
      "mechanism": "Vasopressin V2 receptor antagonist",
      "route": "Oral",
      "stage": "Phase 2",
      "indication": "Rapidly progressing ADPKD",
      "trials": [
        "NCT06800651"
      ],
      "deal": "—",
      "latest": "Phase 2 recruiting in China, with supporting Phase 1 studies",
      "date": "2025-07-03",
      "sources": [
        "https://clinicaltrials.gov/study/NCT06800651",
        "https://www.dovepress.com/safety-tolerability-pharmacokinetics-and-pharmacodynamics-of-intraveno-peer-reviewed-fulltext-article-DDDT"
      ],
      "asia": true,
      "source_records": [
        {
          "url": "https://clinicaltrials.gov/study/NCT06800651",
          "date": "2025-07-03",
          "date_kind": "last_update",
          "accessed_at": "2026-11-06",
          "provenance": "ClinicalTrials.gov API v2 lastUpdatePostDateStruct; verified 2026-11-06"
        },
        {
          "url": "https://www.dovepress.com/safety-tolerability-pharmacokinetics-and-pharmacodynamics-of-intraveno-peer-reviewed-fulltext-article-DDDT",
          "date": "2026-03-05",
          "date_kind": "publication",
          "accessed_at": "2026-11-06",
          "provenance": "Publisher citation_publication_date meta; verified 2026-11-06"
        }
      ]
    },
    {
      "section": "pipeline",
      "asset": "tamibarotene",
      "company": "Rege Nephro",
      "country": "Japan",
      "mechanism": "Retinoic acid receptor agonist (repurposing)",
      "route": "Oral",
      "stage": "Phase 2a",
      "indication": "ADPKD",
      "trials": [
        "NCT06289998"
      ],
      "deal": "—",
      "latest": "Phase 2a in Japan, 52 weeks",
      "date": "2025-04-04",
      "sources": [
        "https://clinicaltrials.gov/study/NCT06289998"
      ],
      "asia": true,
      "source_records": [
        {
          "url": "https://clinicaltrials.gov/study/NCT06289998",
          "date": "2025-04-04",
          "date_kind": "last_update",
          "accessed_at": "2026-11-06",
          "provenance": "ClinicalTrials.gov API v2 lastUpdatePostDateStruct; verified 2026-11-06"
        }
      ]
    },
    {
      "section": "pipeline",
      "asset": "GV-100",
      "company": "Gilva Therapeutics",
      "country": "Taiwan",
      "mechanism": "Oral selective HDAC6 inhibitor",
      "route": "Oral",
      "stage": "Phase 1",
      "indication": "ADPKD",
      "trials": [
        "NCT07788014"
      ],
      "deal": "—",
      "latest": "Phase 1 single- and multiple-ascending-dose study in healthy volunteers recruiting in Australia (80 planned; started June 2026)",
      "date": "2026-08-26",
      "sources": [
        "https://gilvatherap.com/2026-05-04-%e5%a4%aa%e6%ba%aa%e6%96%b0%e8%97%a5-gv-100-%e6%be%b3%e6%b4%b2%e7%ac%ac%e4%b8%80%e6%9c%9f%e8%87%a8%e5%ba%8a%e8%a9%a6%e9%a9%97%e7%94%b3%e8%ab%8b%e9%80%9a%e9%81%8e%e5%af%a9%e6%9f%a5/",
        "https://clinicaltrials.gov/study/NCT07788014",
        "https://www.bioduro.com/news-resources/company-news/bioduro-congratulates-gilva-therapeutics-on-advancing-gv-100-into-phase-I-clinical-development-in-australia.html"
      ],
      "asia": true,
      "source_records": [
        {
          "url": "https://gilvatherap.com/2026-05-04-%e5%a4%aa%e6%ba%aa%e6%96%b0%e8%97%a5-gv-100-%e6%be%b3%e6%b4%b2%e7%ac%ac%e4%b8%80%e6%9c%9f%e8%87%a8%e5%ba%8a%e8%a9%a6%e9%a9%97%e7%94%b3%e8%ab%8b%e9%80%9a%e9%81%8e%e5%af%a9%e6%9f%a5/",
          "date": "2026-05-04",
          "date_kind": "publication",
          "accessed_at": "2026-11-06",
          "provenance": "Claude review 2026-11-06; task corrections"
        },
        {
          "url": "https://clinicaltrials.gov/study/NCT07788014",
          "date": "2026-08-26",
          "date_kind": "last_update",
          "accessed_at": "2026-11-06",
          "provenance": "ClinicalTrials.gov API v2 lastUpdatePostDateStruct; verified 2026-11-06"
        },
        {
          "url": "https://www.bioduro.com/news-resources/company-news/bioduro-congratulates-gilva-therapeutics-on-advancing-gv-100-into-phase-I-clinical-development-in-australia.html",
          "date": "2026-05-28",
          "date_kind": "publication",
          "accessed_at": "2026-11-06",
          "provenance": "Claude review 2026-11-06; task corrections"
        }
      ]
    },
    {
      "section": "pipeline",
      "asset": "GBP-213",
      "company": "Shanghai Renji Hospital",
      "country": "China",
      "mechanism": "Not disclosed",
      "route": "Subcutaneous",
      "stage": "Early Phase 1",
      "indication": "ADPKD",
      "trials": [
        "NCT07891364"
      ],
      "deal": "—",
      "latest": "Not yet recruiting",
      "date": "2026-10-23",
      "sources": [
        "https://clinicaltrials.gov/study/NCT07891364"
      ],
      "asia": true,
      "source_records": [
        {
          "url": "https://clinicaltrials.gov/study/NCT07891364",
          "date": "2026-10-23",
          "date_kind": "last_update",
          "accessed_at": "2026-11-06",
          "provenance": "ClinicalTrials.gov API v2 lastUpdatePostDateStruct; verified 2026-11-06"
        }
      ]
    },
    {
      "section": "stopped",
      "asset": "venglustat",
      "company": "Sanofi",
      "country": "France",
      "mechanism": "Glucosylceramide synthase inhibitor",
      "route": "Oral",
      "stage": "Phase 2/3 terminated",
      "indication": "ADPKD",
      "trials": [
        "NCT03523728",
        "NCT04705051"
      ],
      "deal": "—",
      "latest": "STAGED-PKD stopped for futility at interim analysis in 2021",
      "date": "2021-08-03",
      "sources": [
        "https://clinicaltrials.gov/study/NCT03523728",
        "https://clinicaltrials.gov/study/NCT04705051"
      ],
      "asia": false,
      "source_records": [
        {
          "url": "https://clinicaltrials.gov/study/NCT03523728",
          "date": "2023-02-03",
          "date_kind": "last_update",
          "accessed_at": "2026-11-06",
          "provenance": "ClinicalTrials.gov API v2 lastUpdatePostDateStruct; verified 2026-11-06"
        },
        {
          "url": "https://clinicaltrials.gov/study/NCT04705051",
          "date": "2025-09-17",
          "date_kind": "last_update",
          "accessed_at": "2026-11-06",
          "provenance": "ClinicalTrials.gov API v2 lastUpdatePostDateStruct; verified 2026-11-06"
        }
      ]
    },
    {
      "section": "stopped",
      "asset": "bardoxolone methyl",
      "company": "Reata/Biogen",
      "country": "United States",
      "mechanism": "Nrf2 activator",
      "route": "Oral",
      "stage": "Phase 3 terminated",
      "indication": "ADPKD",
      "trials": [
        "NCT03918447"
      ],
      "deal": "—",
      "latest": "FALCON Phase 3 terminated (all CKD programs discontinued)",
      "date": "2025-06-03",
      "sources": [
        "https://clinicaltrials.gov/study/NCT03918447"
      ],
      "asia": false,
      "source_records": [
        {
          "url": "https://clinicaltrials.gov/study/NCT03918447",
          "date": "2025-06-03",
          "date_kind": "last_update",
          "accessed_at": "2026-11-06",
          "provenance": "ClinicalTrials.gov API v2 lastUpdatePostDateStruct; verified 2026-11-06"
        }
      ]
    },
    {
      "section": "stopped",
      "asset": "lixivaptan",
      "company": "Palladio Biosciences",
      "country": "United States",
      "mechanism": "Vasopressin V2 receptor antagonist",
      "route": "Oral",
      "stage": "Phase 3 terminated",
      "indication": "ADPKD",
      "trials": [
        "NCT04064346"
      ],
      "deal": "—",
      "latest": "ACTION Phase 3 terminated (commercial reasons; 12 participants)",
      "date": "2023-02-06",
      "sources": [
        "https://clinicaltrials.gov/study/NCT04064346"
      ],
      "asia": false,
      "source_records": [
        {
          "url": "https://clinicaltrials.gov/study/NCT04064346",
          "date": "2023-02-06",
          "date_kind": "last_update",
          "accessed_at": "2026-11-06",
          "provenance": "ClinicalTrials.gov API v2 lastUpdatePostDateStruct; verified 2026-11-06"
        }
      ]
    }
  ],
  "repurposing": [
    {
      "asset": "dapagliflozin",
      "sponsor": "University of Cologne",
      "stage": "Phase 3",
      "trial": "NCT07280585",
      "name": "STOP-PKD"
    },
    {
      "asset": "metformin XR",
      "sponsor": "University of Queensland",
      "stage": "Phase 3",
      "trial": "NCT04939935",
      "name": "IMPEDE-PKD"
    },
    {
      "asset": "hydrochlorothiazide",
      "sponsor": "UMC Groningen",
      "stage": "Phase 3",
      "trial": "NCT05373264",
      "name": "HYDRO-PROTECT"
    }
  ]
}