Insulin glargine (Insulin U300) - Sanofi

Drug Profile

Insulin glargine (Insulin U300) - Sanofi

Alternative Names: Gla-300; HOE901-U300; Insulin glargine U300; Insulin U300; LantusXR; Toujeo; Toujeo Max SoloStar; Toujeo SoloSTAR

Latest Information Update: 02 Apr 2018

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At a glance

  • Originator Sanofi
  • Class Antihyperglycaemics; Insulins; Pancreatic hormones
  • Mechanism of Action Insulin receptor agonists; Ornithine decarboxylase stimulants; Phosphokinase stimulants; Protein tyrosine kinase stimulants
  • 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 1 diabetes mellitus; Type 2 diabetes mellitus

Most Recent Events

  • 27 Mar 2018 The US FDA approves Toujeo® (insulin glargine 300 U/mL) Max SoloStar® pen for Diabetes mellitus
  • 11 Nov 2016 Interim pharmacodynamics and pharmacokinetics data from a phase II trial in Type 1 diabetes mellitus released by Sanofi
  • 01 Nov 2016 Sanofi completes a phase III trial for Type-2 diabetes mellitus in United Kingdom, Germany and Austria (NCT02585674; EudraCT2014-004533-13)
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