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Dapagliflozin - AstraZeneca

Drug Profile

Dapagliflozin - AstraZeneca

Alternative Names: Andatang; BMS-512148; DAPA; Dapagliflozin propanediol; Farxiga; Forxiga; Oxra

Latest Information Update: 05 Feb 2019

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At a glance

  • Originator Bristol-Myers Squibb
  • Developer AstraZeneca; AstraZeneca KK; Bristol-Myers Squibb; Ono Pharmaceutical; University Medical Center Groningen; Uppsala University
  • Class Antihyperglycaemics; Benzhydryl compounds; Chlorobenzenes; Glucosides; Pyrans; Small molecules
  • Mechanism of Action Sodium-glucose transporter 2 inhibitors
  • Orphan Drug Status

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

    No
  • New Molecular Entity Yes

Highest Development Phases

  • Marketed Type 2 diabetes mellitus
  • Preregistration Type 1 diabetes mellitus
  • Phase III Chronic heart failure; Renal failure
  • Phase II Kidney disorders; Obesity

Most Recent Events

  • 01 Feb 2019 Preregistration for Type 1 diabetes mellitus (Adjunctive treatment) in USA (PO) prior to February 2019
  • 01 Feb 2019 The Committee for Medicinal Products for Human Use of the EMA recommends approval of dapagliflozin for Type 1 diabetes mellitus (Adjunctive treatment) in European Union
  • 22 Nov 2018 AstraZeneca KK and Ono Pharmaceutical completes the phase II DEFENCE trial in Type 2 diabetes mellitus in Japan(UMIN000018754)
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