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Apremilast (CC-10004)
Apremilast inhibits phosphodiesterase 4 (PDE4) to reduce inflammatory cytokine production and modulate immune cell function.
Apremilast inhibits phosphodiesterase 4 (PDE4) to reduce inflammatory cytokine production and modulate immune cell function. Used for Plaque psoriasis, Psoriatic arthritis, Ankylosing spondylitis.
At a glance
| Generic name | Apremilast (CC-10004) |
|---|---|
| Also known as | N-{2-[1-(3-ethoxy-4-methoxyphenyl)-2-(methylsulfonyl)ethyl]-1,3-dioxoisoindolin-4-yl}acetamide (S enantiomer), Otezla |
| Sponsor | Virginia Clinical Research, Inc. |
| Drug class | Phosphodiesterase 4 (PDE4) inhibitor |
| Target | PDE4 |
| Modality | Small molecule |
| Therapeutic area | Immunology |
| Phase | FDA-approved |
Mechanism of action
By inhibiting PDE4, apremilast increases intracellular cAMP levels, which suppresses the production of pro-inflammatory cytokines (TNF-α, IL-2, IL-6, IFN-γ) and enhances anti-inflammatory mediators. This mechanism reduces immune cell activation and inflammatory responses in conditions characterized by excessive immune-mediated inflammation.
Approved indications
- Plaque psoriasis
- Psoriatic arthritis
- Ankylosing spondylitis
- Behçet's disease (oral ulcers)
Common side effects
- Diarrhea
- Nausea
- Headache
- Upper respiratory tract infection
- Vomiting
Key clinical trials
- Human Laboratory Study of Apremilast for Alcohol Use Disorder (PHASE2)
- I-SPY COVID-19 TRIAL: An Adaptive Platform Trial for Critically Ill Patients (PHASE2)
- Apremilast Pediatric Study in Children With Active Juvenile Psoriatic Arthritis (PHASE3)
- Apremilast for Alcohol Use Disorder Treatment in Women and Men (PHASE1)
- Dose-response Study of Apremilast in Women and Men With Alcohol Use Disorder (PHASE2)
- A Study to Investigate Efficacy and Safety of Apremilast 30 mg Twice Daily (BID) in Chinese Participants With Moderate to Severe Plaque-type Psoriasis (PsO) (PHASE3)
- A Long-term Extension Study of Apremilast (CC-10004) in Pediatric Subjects From 6 Through 17 Years of Age With Moderate to Severe Plaque Psoriasis (PHASE3)
- A Study to Assess the Efficacy and Safety of Apremilast in Japanese Pediatric Participants With Moderate to Severe Plaque Psoriasis (PHASE3)
Primary sources
Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.
| Source | Used for |
|---|---|
| ClinicalTrials.gov | Trial enrolment, design, endpoints, results |
Competitive intelligence
For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:
- Apremilast (CC-10004) CI brief — competitive landscape report
- Apremilast (CC-10004) updates RSS · CI watch RSS
- Virginia Clinical Research, Inc. portfolio CI