Last reviewed · How we verify
Otezla (APREMILAST)
Apremilast inhibits PDE4, increasing intracellular cAMP levels, but the exact therapeutic mechanism is unclear.
At a glance
| Generic name | APREMILAST |
|---|---|
| Sponsor | Amgen |
| Drug class | Phosphodiesterase 4 Inhibitor [EPC] |
| Target | PDE4 |
| Modality | Small molecule |
| Therapeutic area | Immunology |
| Phase | FDA-approved |
| First approval | 2014 |
| Annual revenue | 2100 |
Mechanism of action
Apremilast works by inhibiting PDE4, which is an enzyme that breaks down cAMP. By blocking PDE4, apremilast increases the levels of cAMP inside cells. However, it is not fully understood how this leads to the drug's therapeutic effects.
Approved indications
- Behçet's disease affecting oral mucosa
- Plaque psoriasis
- Psoriasis with arthropathy
Common side effects
- Diarrhea
- Nausea
- Upper respiratory tract infection
- Headache
- Vomiting
- Abdominal pain
- Nasopharyngitis
- Frequent bowel movement
- Gastroesophageal reflux disease
- Dyspepsia
- Weight decrease
- Decreased appetite
Key clinical trials
- Repigmentation Using Apremilast and Phototherapy In Diffuse VITILIGO (PHASE2)
- Human Laboratory Study of Apremilast for Alcohol Use Disorder (PHASE2)
- Effect of Anti-Psoriatic Biologics on Risk of Anogenital Warts (CONDYPSO)
- I-SPY COVID-19 TRIAL: An Adaptive Platform Trial for Critically Ill Patients (PHASE2)
- Evaluation the Topical Apremilast Nanoformulation in Treatment of Localized Plaque Psoriasis (NA)
- Methotrexate Versus Apremilast for Pruritus in Psoriasis (PHASE4)
- Randomized Double Blind Controlled Trial Comparing the Safety and Efficacy of Apremilast Versus Placebo in Severe Forms of Recurrent Aphthous Stomatitis (PHASE3)
- Apremilast and Adalimumab in Psoriatic Arthritis Patients (NA)
Patents
| Patent | Expiry | Type |
|---|---|---|
| 9872854 | 2034-05-29 | Method of Use |
| 7427638*PED | 2028-08-16 | Compound |
| 9872854*PED | 2034-11-29 | Compound |
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 |
|---|---|
| FDA label | Mechanism, indications, dosing, boxed warnings, drug interactions |
| ClinicalTrials.gov | Trial enrolment, design, endpoints, results |
| FDA Orange Book | Patents + exclusivity |
| SEC EDGAR | Revenue + earnings |