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Apremilast - Celgene

Drug Profile

Apremilast - Celgene

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

Latest Information Update: 14 Jan 2019

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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 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

  • 07 Jan 2019 Celgene announces intention to submit NDA with label update to the US FDA for scalp Psoriasis in the second quarter of 2019
  • 07 Jan 2019 FDA assigns PDUFA action date of 21/07/2019 for apremilast for Behҫet’s syndrome
  • 17 Dec 2018 Celgene plans the DISCREET phase III trial for Psoriasis in February 2019 (NCT03777436)
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