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Dexmedetomidine - Hospira/Orion/Recro Pharma

Drug Profile

Dexmedetomidine - Hospira/Orion/Recro Pharma

Alternative Names: DA 9501; DEX-IN; DEX-SL; DEX-TD; Dexdor; Dexmedetomidine hydrochloride; MPV-1440; Precedex; Primadex

Latest Information Update: 01 Jul 2019

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At a glance

  • Originator Orion
  • Developer Hospira; Maruishi Pharmaceutical; Orion; Recro Pharma; Turku University Hospital
  • Class Anxiolytics; Behavioural disorder therapies; Hypnosedatives; Imidazoles; Non-opioid analgesics; Small molecules
  • Mechanism of Action Alpha 2 adrenergic receptor agonists
  • Orphan Drug Status

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

  • New Molecular Entity Yes

Highest Development Phases

  • Marketed Sedation
  • Phase II Cancer pain; Pain
  • Phase I/II Subarachnoid haemorrhage
  • Discontinued Delirium; Postoperative pain

Most Recent Events

  • 05 Oct 2018 Phase-III clinical trials in Sedation (In adolescents) in Russia (IV) (EudraCT2018-003063-64)
  • 29 Jun 2018 CHMP recommended change in terms of the MAA for Sedation in the European Union
  • 24 Jun 2018 Biomarkers information updated
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