Apremilast

Drug Profile

Apremilast

Alternative Names: CC-10004; CC-1004; Otezla

Latest Information Update: 04 Nov 2017

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At a glance

  • Originator Celgene Corporation
  • Developer Baylor Research Institute; Celgene Corporation
  • Class Anti-inflammatories; Antineoplastics; Antipsoriatics; Isoindoles; Phthalimides; Small molecules; Sulfones
  • Mechanism of Action Interleukin 23 inhibitors; Interleukin-10 expression stimulants; Tumour necrosis factor alpha inhibitors; 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
  • New Molecular Entity Yes

Highest Development Phases

  • Marketed Plaque psoriasis; Psoriatic arthritis
  • Preregistration Behcet's syndrome
  • Phase III Ankylosing spondylitis
  • Phase II Atopic dermatitis; Eczema; Ulcerative colitis
  • No development reported Crohn's disease; Rheumatoid arthritis
  • Discontinued Asthma; Cancer

Most Recent Events

  • 04 Nov 2017 No recent reports of development identified for phase-I development in Crohn's-disease in USA (PO, Tablet)
  • 16 Aug 2017 Celgene completes the phase III PALACE-4 trial for Psoriatic arthritis in USA, Australia, Bulgaria, Belgium, Canada, Czech Republic, Estonia, France, Hungary, Italy, South Korea, Lithuania, New Zealand, Poland, Romania, Russia, Taiwan, United Kingdom (NCT01307423)
  • 27 Jul 2017 Celgene intends to submit a supplemental NDA for apremilast (Once-daily) in the second half of 2017
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