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Tolvaptan - Otsuka Pharmaceutical

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Drug Profile

Tolvaptan - Otsuka Pharmaceutical

Alternative Names: Jinarc; Jynarque; OPC 61815; OPC-156; OPC-41061; Samsca; Samsca granules 1%; SAMTASU; Samtasu; Tolvaptan sodium phosphate - Otsuka Pharmaceutical

Latest Information Update: 11 Dec 2025

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At a glance

  • Originator Otsuka America Pharmaceutical; Otsuka Pharmaceutical
  • Class Antihypertensives; Benzazepines; Heart failure therapies; Small molecules; Urologics
  • Mechanism of Action Diuretics; Vasopressin V2 receptor antagonists
  • Orphan Drug Status

    Orphan designation is assigned by a regulatory body to encourage companies to develop drugs for rare diseases.

    Yes - Autosomal dominant polycystic kidney disease; Hyponatraemia; Polycystic kidney disease
  • New Molecular Entity Yes

Highest Development Phases

  • Marketed Autosomal dominant polycystic kidney disease; Cardiac oedema; Hyponatraemia; Oedema
  • Registered Ascites; Heart failure; Renal failure
  • Phase II Benign prostatic hyperplasia
  • No development reported Cystinuria; Unspecified

Most Recent Events

  • 24 Nov 2025 Registered for Cardiac oedema in China (IV) (Otsuka pipeline, November 2025)
  • 24 May 2024 Preregistration for Cardiac oedema in China (IV) (Otsuka Pharmaceutical pipeline; May 2024)
  • 21 Sep 2022 Otsuka Beijing Research Institute completes a phase I pharmacokinetics trial in healthy Chinese male volunteers in China (IV) (NCT05439148)

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