Roflumilast

Drug Profile

Roflumilast

Alternative Names: APTA-2217; B 9302-107; BY 217; BYK 20869; Daliresp; Daxas; IN-ALR 01; Libertek

Latest Information Update: 03 Jan 2017

Price : $50

At a glance

  • Originator Nycomed
  • Developer Actavis; Mitsubishi Tanabe Pharma Corporation; Nycomed; Takeda; Takeda Pharmaceuticals International GmbH
  • Class Aminopyridines; Antiallergics; Antiasthmatics; Benzamides; Cyclopropanes; Small molecules
  • Mechanism of Action Type 4 cyclic nucleotide phosphodiesterase inhibitors
  • Orphan Drug Status

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

    No
  • On Fast track

    Fast track status is assigned by the US FDA so therapies with the potential to address unmet needs can move faster through development.

    No
  • New Molecular Entity Yes

Highest Development Phases

  • Marketed Chronic obstructive pulmonary disease
  • No development reported Alzheimer's disease; Asthma; Atopic dermatitis; Non-alcoholic steatohepatitis; Plaque psoriasis; Schizophrenia; Type 2 diabetes mellitus

Most Recent Events

  • 03 Sep 2016 Adverse events data from a phase-III trial in Chronic obstructive pulmonary disease presented at the 26th Annual Congress of the European Respiratory Society (ERS-2016)
  • 15 Mar 2016 Biomarkers information updated
  • 01 Feb 2016 Takeda completes a phase III trial for Chronic obstructive pulmonary disease in Denmark, Germany, Poland, Sweden and the United Kingdom (NCT01509677)
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