Drug Profile


Alternative Names: Adempas; BAY-32521; BAY-63-2521

Latest Information Update: 10 Oct 2017

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At a glance

  • Originator Bayer
  • Class 2 ring heterocyclic compounds; Carbamates; Fluorobenzenes; Pyrazoles; Pyridines; Pyrimidines; Small molecules; Vascular disorder therapies
  • Mechanism of Action Guanylate cyclase stimulants
  • Orphan Drug Status

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

    Yes - Systemic scleroderma; Pulmonary hypertension; Pulmonary arterial hypertension
  • New Molecular Entity Yes

Highest Development Phases

  • Marketed Pulmonary arterial hypertension; Pulmonary hypertension
  • Phase II Cystic fibrosis; Raynaud's disease; Systemic scleroderma

Most Recent Events

  • 10 Oct 2017 Bayer terminates phase II trial in Cystic fibrosis in USA, Canada, Germany, the Netherlands, United Kingdom, Belgium, France, Greece and Italy, based on multiple factors, including the design of part 2 is no longer appropriate (NCT02170025)
  • 01 Dec 2016 Bayer completes a phase III trial for Pulmonary Hypertension in the US, Canada, the UK, Belgium, Czech Republic, France, Germany, Italy and Switzerland (NCT02007629)
  • 01 Oct 2016 Bayer completes a phase I trial for pharmacokinetic interaction trial for Pulmonary hypertension (In patients with HIV infections) in USA (NCT02556268)
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