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Tolvaptan - Otsuka Pharmaceutical

Drug Profile

Tolvaptan - Otsuka Pharmaceutical

Alternative Names: Jinarc; Jynarque; OPC 61815; OPC-156; OPC-41061; Samsca; Samsca granules 1%

Latest Information Update: 08 Feb 2019

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At a glance

  • Originator Otsuka America Pharmaceutical; Otsuka Pharmaceutical
  • Class Antihypertensives; Benzazepines; Heart failure therapies; 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; 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
  • Phase I Unspecified
  • Clinical Phase Unknown Cystinuria

Most Recent Events

  • 05 Dec 2018 Otsuka Pharmaceutical completes a phase III trial in Autosomal dominant polycystic kidney disease in USA, Argentina, Australia, Belgium, Canada, Czech Republic, Denmark, Germany, Hungary, Israel, Italy, Netherlands, Norway, Poland, Romania, Russia, South Africa, Spain, Sweden and United Kingdom (PO) (NCT02251275)
  • 01 Dec 2018 Otsuka America Pharmaceutical completes a clinical trial in Cystinuria (In children, In adolescents, In adults) in USA (PO) (NCT02538016)
  • 01 Dec 2018 Phase-III clinical trials in Heart failure (In the elderly, In adults) in Japan (IV) (JapicCTI184234)
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