Drug

Apremilast

Approved · EMA

Emerging researchLate-stage developmentSteady momentum

Also known as Otezla, Apremilastum.

RxNorm1492727 ChEMBLCHEMBL514800UNIIUP7QBP99PN

Research papers

Active clinical trials

Regulatory events

Latest activity

beta

Recent clinical, regulatory, research and industry developments relating to this drug.

A Phase 3, Multicenter, Double-blind, Randomized, Placebo-controlled, Parallel Group Study, Followed by an Active Treatment Phase to Evaluate the Efficacy and Safety of Apremilast in Children From 2 to Less Than 18 Years of Age With Active Oral Ulcers Associated With Behçet's Disease (BEAN)

Clinical trial2026-07-24Results expected Q1 2030 · ClinicalTrials.gov

[18F]PF-06445974 to Image PDE4B in Major Depressive Disorder Using PET

Clinical trial2026-07-02Results expected Q4 2028 · ClinicalTrials.gov

Comparison of Efficacy of Methotrexate vs Apremilast in Moderate to Severe Plaque Psoriasis

Clinical trial2026-06-25Primary completion · ClinicalTrials.gov

Phase 2 Study of Apremilast in Women and Men With Alcohol Use Disorder

Clinical trial2026-06-08Results expected Q3 2030 · ClinicalTrials.gov

Apremilast for the Treatment of Refractory Erythema Multiforme

Clinical trial2026-06-03Results posted · ClinicalTrials.gov

Approval: Apremilast Accord (EMA)

Regulatory2024-04-19EMA

Effect of baseline disease severity on achievement of treatment target with apremilast: results from a pooled analysis.

Research2021-08-23Journal of the European Academy of Dermatology and Venereology : JEADV

A multicentre open-label study of apremilast in palmoplantar pustulosis (APLANTUS).

Research2021-06-24Journal of the European Academy of Dermatology and Venereology : JEADV

Pharmacokinetics and safety of apremilast in pediatric patients with moderate to severe plaque psoriasis: Results from a phase 2 open-label study.

Research2019-08-10Journal of the American Academy of Dermatology

Drug Safety Update: Apremilast (Otezla ▼): risk of suicidal thoughts and behaviour

Regulatory2017-01-19MHRA

Approval: Otezla (EMA)

Regulatory2015-01-15EMA

Efficacy, tolerability, and pharmacodynamics of apremilast in recalcitrant plaque psoriasis: a phase II open-label study.

Research2013-08-01Journal of drugs in dermatology : JDD

Profile

Identifiers & mechanism

Canonical identifiers, marketed brand names and mechanism, resolved across RxNorm, ChEMBL and ATC.

Canonical name

Apremilast

Aliases & brands

OtezlaApremilastum

RxNorm CUI

1492727

ChEMBL ID

CHEMBL514800

UNII

UP7QBP99PN

Regulatory jurisdictions

emamhra

Regulatory timeline

3 events

The complete regulatory record, grouped by authority — approvals, safety advisories and label changes. Each authority shows its most recent events; expand one to read its full history.

Earliest approval

2015-01-15

Latest approval

2024-04-19

Authorities

EMA · MHRA

Total events

emaEuropean Medicines Agency· 2 events

2024-04-19Approval

Approval: Apremilast Accord (EMA)

Indication: Psoriatic arthritis Apremilast Accord, alone or in combination with Disease Modifying Antirheumatic Drugs (DMARDs), is indicated for the treatment of active psoriatic arthritis… Show full indication

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.

Evidence ↗

2015-01-15Approval

Approval: Otezla (EMA)

Indication: Psoriatic arthritisOtezla, alone or in combination with Disease Modifying Antirheumatic Drugs (DMARDs), is indicated for the treatment of active psoriatic arthritis (PsA) in adult… Show full indication

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.

Evidence ↗

mhraMedicines and Healthcare products Regulatory Agency· 1 event

2017-01-19Safety communicationSafety

Drug Safety Update: Apremilast (Otezla ▼): risk of suicidal thoughts and behaviour

Evidence ↗

Contains information from the European Medicines Agency (European Medicines Agency), © EMA, reused under CC BY 4.0.

Contains public sector information from the Medicines and Healthcare products Regulatory Agency (MHRA) licensed under the Open Government Licence (OGL v3).