NDAORALTABLET
Approved
Aug 2025
Lifecycle
Growth
Competitive Pressure
0/100
Clinical Trials
20
Data completeness
6/8 — Strong
OTEZLA (apremilast) by Amgen is phosphodiesterase 4 inhibitors [moa]. Approved for phosphodiesterase 4 inhibitor [epc]. First approved in 2025.
Drug data last refreshed 7h 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 by the FDA on August 29, 2025. It modulates immune response by inhibiting PDE-4, thereby reducing inflammatory cytokine production. The drug is used to treat inflammatory conditions where PDE-4 inhibition provides therapeutic benefit.
$0.364MPart D
Growth15.7 years to LOEEarly-stage growth product with modest current penetration; commercial teams should expect ramp-up in promotional activities and market development over the next 2-3 years.
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.