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Country of origin : China
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pp-221

Tablets

Dossier type
CTD
Dossier status
Under development
Country of origin
China
GMP approvals
China
Comments
Indication: Autosomal dominant polycystic kidney disease (ADPKD) — rapidly progressive; renal oedema Clinical stage: Phase 2 — Phase 2 randomised double-blind placebo-controlled RCT for ADPKD ongoing (NCT06800651); Phase 2 dose-finding for renal oedema (NCT06670534) Modality: Small molecule (novel selective arginine vasopressin V2 receptor antagonist — NCE) Mechanism / Target: Selective vasopressin V2 receptor (V2R) antagonist; blocks vasopressin-stimulated cAMP production in renal collecting duct principal cells; reduces fluid-driven cyst formation and growth in ADPKD; long-residence-time V2R binding (claimed property improving duration of cAMP suppression vs. tolvaptan); potent aquaretic for renal oedema management Route / form: Oral tablet Differentiation: Novel V2R antagonist NCE distinct from tolvaptan; Phase 2 double-blind RCT for ADPKD (NCT06800651) and Phase 2 renal oedema study (NCT06670534) ongoing;
Manufacturer #39357

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