NDAORALTABLET
Approved
Mar 2014
Lifecycle
Peak
Competitive Pressure
0/100
Clinical Trials
20
Data completeness
5/8 — Partial
OTEZLA (apremilast) by Amgen is phosphodiesterase 4 inhibitors [moa]. Approved for phosphodiesterase 4 inhibitor [epc]. First approved in 2014.
Drug data last refreshed 9h ago · AI intelligence enriched 5d ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
OTEZLA (apremilast) is an oral phosphodiesterase 4 (PDE-4) inhibitor approved in 2014 for inflammatory conditions including psoriasis, psoriatic arthritis, and Behçet's disease. It works by inhibiting PDE-4, increasing intracellular cAMP levels and suppressing pro-inflammatory cytokine production. The drug is administered as an oral tablet with a convenient twice-daily dosing regimen.
Peak8.2 years to LOE
Product is in peak lifecycle stage with extended patent protection through 2034, supporting stable team size and mature commercial operations.
Mechanism of Action
Phosphodiesterase 4 Inhibitors
Pharmacologic Class:
Phosphodiesterase 4 Inhibitor
Indications
Indication data is being enriched from DailyMed and FDA labeling. Check back soon for approved therapeutic uses.
Clinical Trials (20)
Comparison of Otezla to SFA-002 to Placebo in Plaque Psoriasis Patients
Started Jun 2025
125 enrolled
Psoriasis (PsO)
Adherence to Otezla
Started Jun 2025
0Psoriasis
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)
Started Nov 2023
203 enrolled
Plaque Psoriasis
A Study of Apremilast in Pediatric Participants in Children With Mild to Moderate Plaque Psoriasis
Started Oct 2023
51 enrolled
Plaque Psoriasis
A Study of Apremilast in Children With Oral Ulcers Associated With Behçet's Disease or Juvenile Psoriatic Arthritis
Started Mar 2023
48 enrolled
Behçet's DiseaseJuvenile Psoriatic Arthritis
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Data Sources
- Drug label: DailyMed / FDA
- Clinical trials: ClinicalTrials.gov
- Patent data: FDA Orange Book
- Spending data: CMS Medicare
The information on this page is for informational purposes only and should not be used as a substitute for professional medical advice. Drug information is sourced from FDA, DailyMed, and other government databases. Adverse event data from FAERS does not establish causation. Always consult a healthcare professional for medical decisions.