OTEZLA XR
LaunchNDAORALTABLET, EXTENDED RELEASE
Approved
Aug 2025
Lifecycle
Launch
Competitive Pressure
0/100
Clinical Trials
23
Data completeness
3/8 — Basic
Drug data last refreshed 6h 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 approved by the FDA in August 2025. The parent compound targets inflammatory and immunomodulatory pathways, though specific approved indications are not yet disclosed in this dataset. This XR formulation represents a lifecycle extension strategy for Amgen's existing OTEZLA franchise.
Growth15.9 years to LOE
Recent launch phase with zero competitive pressure creates an immediate demand for sales force, market access, and brand management roles to capture market share during the critical post-approval window.
Mechanism of Action
Mechanism of action data is being enriched from DailyMed and FDA sources. Check back soon for updated drug intelligence.
Indications
Indication data is being enriched from DailyMed and FDA labeling. Check back soon for approved therapeutic uses.
Clinical Trials (23)
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
Molecular Effects of Apremilast in the Synovium of Psoriatic Arthritis Patients
Started Nov 2020
19 enrolled
Psoriatic Arthritis
Apremilast 30 mg Twice Daily (BID) Combined With Dupilumab
Started Aug 2020
10 enrolled
Atopic Dermatitis
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.