NDAORALTABLET, EXTENDED RELEASE
Approved
Aug 2025
Lifecycle
Growth
Competitive Pressure
0/100
Clinical Trials
43
Data completeness
5/8 — Partial
OTEZLA XR (apremilast) by Amgen is phosphodiesterase 4 inhibitors [moa]. Approved for phosphodiesterase 4 inhibitor [epc]. First approved in 2025.
Drug data last refreshed 1h ago · AI intelligence enriched 6d ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
OTEZLA XR is an extended-release oral formulation of apremilast, a phosphodiesterase 4 (PDE-4) inhibitor that modulates inflammatory and immune responses. It treats inflammatory conditions by reducing production of pro-inflammatory cytokines. The XR formulation represents a lifecycle extension of the original OTEZLA product with improved dosing convenience.
Growth15.7 years to LOE
Early-stage growth product with strong patent protection through 2042 suggests expanding commercial team investment and multi-year career stability for brand and sales professionals.
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 (43)
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
A Study to Assess the Efficacy and Safety of Apremilast in Japanese Pediatric Participants With Moderate to Severe Plaque Psoriasis
Started Jan 2023
17 enrolled
Plaque Psoriasis
A Real-world Observational Study to Compare Effectiveness of Deucravacitinib Vs Apremilast in Adults With Plaque Psoriasis
Started Sep 2022
1,500 enrolled
Psoriasis
Worked on OTEZLA XR at Amgen? Share your interview experience or compensation data (+7 days Pro)
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.