NDATOPICALCREAMPriority Review
Approved
Sep 2021
Lifecycle
Peak
Competitive Pressure
0/100
Clinical Trials
20
Data completeness
4/8 — Partial
Priority Review
Drug data last refreshed 12h ago · AI intelligence enriched 1w ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
OPZELURA (ruxolitinib) is a topical JAK inhibitor cream approved for atopic dermatitis, a chronic inflammatory skin condition. It works by selectively inhibiting Janus kinase (JAK) signaling to reduce immune-mediated inflammation at the site of application. This represents the first topical JAK inhibitor approved for dermatological use.
$76MPart D
Peak14.6 years to LOEThe product is in peak commercial phase with solid Part D uptake (33,784 claims in 2023), indicating stable demand and likely a mature brand team focused on market defense and lifecycle extension.
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 (20)
Belumosudil Versus Ruxolitinib for Steroid-Refractory or Breakthrough Hepatic cGVHD
Started Oct 2026
170 enrolled
Hematopoietic Stem Cell Transplantation (HSCT)cGVHDHepatic cGVHD+2 more
A Study to Compare Elritercept to Placebo in Adults With Myelofibrosis and Anemia Who Are Taking Ruxolitinib
Started Sep 2026
324 enrolled
MyelofibrosisAnemia
Topical Ruxolitinib in the Treatment of Adults With Pyoderma Gangrenosum
Started Sep 2026
12 enrolled
Pyoderma Gangrenosum
Comparing Momelotinib and Ruxolitinib in People With Untreated Myelofibrosis and Low Blood Cell Counts
Started Aug 2026
268 enrolled
MyelofibrosisMyelofibrosis (MF)
Tolerability of Ropeginterferon Alfa-2b Add-on to Ongoing Ruxolitinib Therapy in Myelofibrosis (RopeRux in Myelofibrosis)
Started Aug 2026
15 enrolled
Myelofibrosis
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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.