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Apremilast Oral Tablet
Apremilast Oral Tablet, developed by Professor Mikkel Østergaard, is a marketed drug with a key composition patent expiring in 2028. The drug's primary strength lies in its established market presence and patent protection, which helps maintain its competitive edge. The primary risk is the patent expiry in 2028, which could lead to increased competition from generics.
At a glance
| Generic name | Apremilast Oral Tablet |
|---|---|
| Also known as | Otzela, CC-10004 |
| Sponsor | Professor Mikkel Østergaard |
| Modality | Small molecule |
| Phase | FDA-approved |
Approved indications
Common side effects
Key clinical trials
- I-SPY COVID-19 TRIAL: An Adaptive Platform Trial for Critically Ill Patients (PHASE2)
- Randomized Double Blind Controlled Trial Comparing the Safety and Efficacy of Apremilast Versus Placebo in Severe Forms of Recurrent Aphthous Stomatitis (PHASE3)
- 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) (PHASE3)
- A Study to Assess the Efficacy and Safety of Apremilast in Japanese Pediatric Participants With Moderate to Severe Plaque Psoriasis (PHASE3)
- A Study in Patients With Moderate to Severe Plaque Psoriasis to Evaluate the Efficacy and Safety of ESK-001 (PHASE3)
- A Study to Evaluate the Efficacy and Safety of ESK-001 in Patients With Moderate to Severe Plaque Psoriasis (PHASE3)
- A Study of Apremilast in Children With Oral Ulcers Associated With Behçet's Disease or Juvenile Psoriatic Arthritis (PHASE3)
- A Study of Apremilast in Pediatric Participants in Children With Mild to Moderate Plaque Psoriasis (PHASE3)
Primary sources
Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.
| Source | Used for |
|---|---|
| ClinicalTrials.gov | Trial enrolment, design, endpoints, results |
Competitive intelligence
For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:
- Apremilast Oral Tablet CI brief — competitive landscape report
- Apremilast Oral Tablet updates RSS · CI watch RSS
- Professor Mikkel Østergaard portfolio CI