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 5h ago · AI intelligence enriched 1w ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
OPZELURA (ruxolitinib) is a topical JAK1/JAK2 inhibitor cream approved for atopic dermatitis, representing the first topical JAK inhibitor to reach market. It works by inhibiting Janus kinase signaling, a key driver of inflammatory skin disease pathogenesis. The drug is delivered as a non-systemic cream formulation, enabling targeted local immunosuppression with minimal systemic exposure.
$76MPart D
Peak14.9 years to LOEProduct is in peak sales phase with ~$76M in Part D spending and 33,784 claims in 2023; commercial team is likely at full size with stable to growing headcount.
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)
A Study to Compare Elritercept to Placebo in Adults With Myelofibrosis and Anemia Who Are Taking Ruxolitinib
Started Aug 2026
324 enrolled
MyelofibrosisAnemia
Comparing Momelotinib and Ruxolitinib in People With Untreated Myelofibrosis and Low Blood Cell Counts
Started Aug 2026
268 enrolled
MyelofibrosisMyelofibrosis (MF)
Ruxolitinib-Enhanced Haplo HCT for Children and Young Adults With Sickle Cell Disease
Started Jun 2026
24 enrolled
Sickle Cell DiseaseHematopoetic Stem Cell TransplantHaploidentical Hematopoietic Stem Cell Transplant+2 more
Ruxolitinib and Enzalutamide for the Treatment of Metastatic Castration-Resistant Prostate Cancer
Started Jun 2026
20 enrolled
Castration-Resistant Prostate CarcinomaMetastatic Prostate AdenocarcinomaStage IVB Prostate Cancer AJCC v8
Dose-Expansion Study of Low Dose Post-Transplant Cyclophosphamide/Tacrolimus/Ruxolitinib for Graft-versus-Host Disease (GVHD) Prophylaxis in Myeloablative Allogeneic Peripheral Blood Stem Cell Transplantation
Started Jun 2026
124 enrolled
LeukemiaMyelodysplasiaChronic Myelomonocytic Leukemia
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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.