Apremilast - Celgene

Drug Profile

Apremilast - Celgene

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

Latest Information Update: 06 Jul 2018

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At a glance

  • Originator Celgene Corporation
  • Developer Baylor Research Institute; Celgene Corporation; Erasmus MC
  • Class Acetamides; Anti-inflammatories; Antineoplastics; Antipsoriatics; Isoindoles; Phthalimides; Skin disorder therapies; 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.

    Yes - Ulcerative colitis
  • 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; Hidradenitis suppurativa; Ulcerative colitis
  • No development reported Rheumatoid arthritis
  • Discontinued Asthma; Cancer; Crohn's disease

Most Recent Events

  • 13 Jun 2018 Efficacy, adverse events and pharmacokinetics data from the phase III RELIEF trial in Behcet's disease presented at the 19th Annual Congress of the European League Against Rheumatism (EULAR-2018)
  • 19 Feb 2018 Phase-III clinical trials in Behcet's syndrome in Lebanon, South Korea, Italy, Israel, Greece, Germany, Japan, France, USA (PO) after December 2014
  • 19 Feb 2018 Celgene plans to submit supplemental New Drug Applications (sNDA) to US FDA for the treatment of active Behçet’s Disease with oral ulcers in the U.S. in the second half of 2018
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