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Placebo-Apremilast
Apremilast is a phosphodiesterase-4 (PDE-4) inhibitor that reduces inflammatory mediator production by increasing intracellular cAMP levels.
Apremilast is a phosphodiesterase-4 (PDE-4) inhibitor that reduces inflammatory mediator production by increasing intracellular cAMP levels. Used for Plaque psoriasis, Psoriatic arthritis, Ankylosing spondylitis.
At a glance
| Generic name | Placebo-Apremilast |
|---|---|
| Also known as | Otezla, CC-10004 |
| Sponsor | Amgen |
| Drug class | Phosphodiesterase-4 (PDE-4) inhibitor |
| Target | PDE-4 |
| Modality | Small molecule |
| Therapeutic area | Immunology |
| Phase | FDA-approved |
Mechanism of action
By inhibiting PDE-4, apremilast prevents the breakdown of cyclic adenosine monophosphate (cAMP), leading to elevated intracellular cAMP levels in immune cells. This suppresses the production of pro-inflammatory cytokines such as TNF-α, IL-2, and IL-17, while promoting anti-inflammatory mediators, thereby reducing systemic inflammation.
Approved indications
- Plaque psoriasis
- Psoriatic arthritis
- Ankylosing spondylitis
- Behçet's disease-associated oral ulcers
Common side effects
- Diarrhea
- Nausea
- Headache
- Upper respiratory tract infection
- Vomiting
Key clinical trials
- Repigmentation Using Apremilast and Phototherapy In Diffuse VITILIGO (PHASE2)
- Human Laboratory Study of Apremilast for Alcohol Use Disorder (PHASE2)
- Randomized Double Blind Controlled Trial Comparing the Safety and Efficacy of Apremilast Versus Placebo in Severe Forms of Recurrent Aphthous Stomatitis (PHASE3)
- Apremilast Pediatric Study in Children With Active Juvenile Psoriatic Arthritis (PHASE3)
- 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 Study in Patients With Moderate to Severe Plaque Psoriasis to Evaluate the Efficacy and Safety of ESK-001 (PHASE3)
- A Study to Evaluate the Efficacy and Safety of ESK-001 in Patients 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:
- Placebo-Apremilast CI brief — competitive landscape report
- Placebo-Apremilast updates RSS · CI watch RSS
- Amgen portfolio CI