Tolvaptan

Drug Profile

Tolvaptan

Alternative Names: Jinarc; OPC-156; OPC-41061; Samsca

Latest Information Update: 09 Feb 2017

Price : $50

At a glance

  • Originator Otsuka America Pharmaceutical; Otsuka Pharmaceutical
  • Class Antihypertensives; Benzazepines; Heart failure therapies
  • Mechanism of Action 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
  • On Fast track

    Fast track status is assigned by the US FDA so therapies with the potential to address unmet needs can move faster through development.

    Autosomal dominant polycystic kidney disease
  • New Molecular Entity Yes

Highest Development Phases

  • Marketed Autosomal dominant polycystic kidney disease; Cardiac oedema; Hyponatraemia; Oedema
  • Phase II Renal failure
  • Phase I Unspecified
  • No development reported Ascites

Most Recent Events

  • 01 Jan 2017 Phase-III clinical trials in Hyponatraemia in Japan (PO) (JapicCTI173512)
  • 14 Dec 2016 Otsuka Pharmaceutical plans a phase I trial in Healthy volunteers in Japan (PO, Controlled-release tablet) (NCT02994394)
  • 13 Dec 2016 Investigation in Undefined indication in Japan (PO, Controlled-release tablet) before December 2016
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