OTEZLA XR
LaunchNDAORALTABLET, EXTENDED RELEASE
Approved
Aug 2025
Lifecycle
Launch
Competitive Pressure
0/100
Clinical Trials
57
Data completeness
3/8 — Basic
Drug data last refreshed 20h ago · AI intelligence enriched 2w ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
OTEZLA XR is an extended-release oral formulation of apremilast, a small-molecule phosphodiesterase-4 (PDE-4) inhibitor approved by the FDA on August 29, 2025. The drug's mechanism and approved indications are not publicly detailed in this dataset, but apremilast is clinically used for inflammatory conditions including psoriasis, psoriatic arthritis, and behçet's disease. The XR formulation likely offers improved dosing convenience and potentially better tolerability compared to the immediate-release version.
Launch16.1 years to LOE
As a recently launched product with no reported competitive pressure, the brand team is in growth-building mode with immediate opportunity for field expansion and market development roles.
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 (57)
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
Apremilast Pediatric Study in Children With Active Juvenile Psoriatic Arthritis
Started Mar 2022
60 enrolled
Active Juvenile 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.