Tolvaptan

Drug Profile

Tolvaptan

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

Latest Information Update: 15 Nov 2017

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At a glance

  • Originator Otsuka America Pharmaceutical; Otsuka Pharmaceutical
  • Class Antihypertensives; Benzazepines; Heart failure therapies
  • 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

  • 09 Nov 2017 Registered for Autosomal-dominant polycystic kidney disease in Australia, South Korea, Hong Kong and Switzerland (PO) before November 2017
  • 09 Nov 2017 FDA accepts resubmission of NDA and assigns PDUFA action date of 24/04/2018 for tolvaptan for Autosomal-dominant polycystic kidney disease
  • 04 Nov 2017 Efficacy data from phase III REPRISE trial in Autosomal-dominant polycystic kidney disease released by Otsuka Pharmaceutical
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