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Mannitol inhalation - Pharmaxis

Drug Profile

Mannitol inhalation - Pharmaxis

Alternative Names: Bronchitol; Mannitol dry powder for inhalation - Pharmaxis; Precision spray‐dried mannitol

Latest Information Update: 26 Jun 2019

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At a glance

  • Originator Royal Prince Alfred Hospital
  • Developer Pharmaxis
  • Class Anti-inflammatories; Antiallergics; Antibronchitics; Antifibrotics; Mucolytics; Small molecules; Sugar alcohols
  • Mechanism of Action Osmotic diuretics
  • Orphan Drug Status

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

    Yes - Bronchiectasis; Cystic fibrosis
  • New Molecular Entity No
  • Available For Licensing Yes - Bronchiectasis; Cystic fibrosis

Highest Development Phases

  • Marketed Cystic fibrosis
  • Discontinued Allergic rhinitis; Bronchiectasis; Sinusitis

Most Recent Events

  • 28 Oct 2019 Pharmaxis expects a decision from the US FDA regarding approval inhaled mannitol for Cystic fibrosis in second quarter 2020
  • 20 Jun 2019 Cheisi receives complete response letter from the US FDA for mannitol in Cystic fibrosis (In adults)
  • 13 Jun 2019 Pharmaxis's inhalation formulation mannitol licensed to EffRx Pharmaceuticals in Switzerland
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