Drug Profile


Alternative Names: Aerosolized KL4 surfactant; Aerosurf; ATI-01; ATI-02; DSC-104; DSC-105; KL-4 lung surfactant; KL4 pulmonary surfactant; KL4 surfactant; Lucinactant; Surfaxin; Surfaxin LS

Latest Information Update: 29 Aug 2017

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At a glance

  • Originator The Scripps Research Institute
  • Developer Discovery Laboratories; University of Pennsylvania; Windtree Therapeutics
  • Class Amino acids; Peptides; Surfactants
  • Mechanism of Action Cell membrane permeability enhancers
  • Orphan Drug Status

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

    Yes - Bronchopulmonary dysplasia; Neonatal respiratory distress syndrome; Acute lung injury; Adult respiratory distress syndrome; Meconium aspiration syndrome; Cystic fibrosis
  • New Molecular Entity Yes
  • Available For Licensing Yes

Highest Development Phases

  • Phase II Neonatal respiratory distress syndrome
  • Preclinical Acute lung injury; Chronic obstructive pulmonary disease; Lung disorders; Reperfusion injury
  • No development reported Adult respiratory distress syndrome; Bronchopulmonary dysplasia; Cystic fibrosis
  • Discontinued Asthma; Meconium aspiration syndrome; Otitis media; Respiratory insufficiency; Rhinitis; Sinusitis

Most Recent Events

  • 17 Aug 2017 Discovery Laboratories terminates a phase IIa trial based upon the sponsor decision to terminate after 3 dosing groups for Neonatal respiratory distress syndrome in USA, Canada, Chile and Poland (Inhalation) (NCT02528318)
  • 29 Jun 2017 Top-line efficacy and adverse events data from a phase IIb trial in Neonatal respiratory distress syndrome released by Windtree Therapeutics
  • 12 Jun 2017 Windtree grants Lee's Pharmaceutical Holdings exclusive license to manufacture KL4 surfactant in China for use in non-aerosol surfactant products
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