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Apremilast tablet 20 mg

Phase 3
Amgen Inc. (AMGN)

Phase 3

Development Phase

0

Upcoming Catalysts

0

Historical Events

3

Regulatory Approvals

No Catalysts Found

No catalyst events have been recorded for this drug yet.

Competitive Landscape

0 competitors in Ankylosing Spondyloarthritis

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Drug Information

Target Indication

Ankylosing Spondyloarthritis

Clinical Trial

NCT01583374

Last updated: 1/10/2026

Patent & Exclusivity

No patent data available. Pre-approval drugs may not have Orange Book listings.

Regulatory Approvals
EMAPending

Apremilast Viatris

Treatment of psoriatic arthritis, psoriasis, Behçet’s disease.

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EMA4/19/2024

Apremilast Accord

Psoriatic arthritis Apremilast Accord, alone or in combination with Disease Modifying Antirheumatic Drugs (DMARDs), is indicated for the treatment of active psoriatic arthritis (PsA) in adult patients who have had an inadequate response or who have been intolerant to a prior DMARD therapy (see section 5.1).Psoriasis Apremilast Accord is indicated for the treatment of moderate to severe chronic plaque psoriasis in adult patients who failed to respond to or who have a contraindication to, or are intolerant to other systemic therapy including cyclosporine, methotrexate or psoralen and ultraviolet-A light (PUVA).Behçet’s disease Apremilast Accord is indicated for the treatment of adult patients with oral ulcers associated with Behçet’s disease (BD) who are candidates for systemic therapy.

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EMA1/15/2015

Otezla

Psoriatic arthritisOtezla, alone or in combination with Disease Modifying Antirheumatic Drugs (DMARDs), is indicated for the treatment of active psoriatic arthritis (PsA) in adult patients who have had an inadequate response or who have been intolerant to a prior DMARD therapy. PsoriasisOtezla is indicated for the treatment of moderate to severe chronic plaque psoriasis (PSOR) in adult patients who failed to respond to or who have a contraindication to, or are intolerant to other systemic therapy including cyclosporine, methotrexate or psoralen and ultraviolet-A light (PUVA). Paediatric psoriasisOtezla is indicated for the treatment of moderate to severe plaque psoriasis in children and adolescents from the age of 6 years and weighing at least 20 kg who are candidates for systemic therapy.Behçet’s diseaseOtezla is indicated for the treatment of adult patients with oral ulcers associated with Behçet’s disease (BD) who are candidates for systemic therapy.

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Drug Science
Mechanism of action & safety profile
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