OPZELURA (ruxolitinib phosphate)
OPZELURA is indicated for the treatment of Atopic Dermatitis; Vitiligo.
How OPZELURA Works
Ruxolitinib inhibits JAK1 and JAK2, which are enzymes that mediate the signaling of cytokines and growth factors involved in immune function and hematopoiesis. This signaling pathway involves the recruitment of signal transducers and activators of transcription (STATs) to cytokine receptors. Once activated, STATs localize to the nucleus to modulate gene expression. The specific relevance of inhibiting these individual JAK enzymes to the drug's therapeutic effectiveness is not currently known.
Development Insights
Details
- Status
- Prescription
- First Approved
- 2021-09-21
- Patent Cliff
- 2041
- Routes
- TOPICAL
- Dosage Forms
- CREAM
OPZELURA Approval History
What OPZELURA Treats
2 indicationsOPZELURA is approved for 2 conditions since its original approval in 2021. These indications span multiple therapeutic areas including oncology, immunology, and more.
- Atopic Dermatitis
- Vitiligo
OPZELURA Boxed Warning
SERIOUS INFECTIONS, MORTALITY, MALIGNANCY, MAJOR ADVERSE CARDIOVASCULAR EVENTS, AND THROMBOSIS SERIOUS INFECTIONS Patients treated with oral Janus kinase inhibitors for inflammatory conditions are at risk for developing serious infections that may lead to hospitalization or death [see Warnings and Precautions ( 5.1 ) and Adverse Reactions ( 6.1 )] . Reported infections include: Active tuberculosis, which may present with pulmonary or extrapulmonary disease. Invasive fungal infections, including ...
WARNING: SERIOUS INFECTIONS, MORTALITY, MALIGNANCY, MAJOR ADVERSE CARDIOVASCULAR EVENTS, AND THROMBOSIS SERIOUS INFECTIONS Patients treated with oral Janus kinase inhibitors for inflammatory conditions are at risk for developing serious infections that may lead to hospitalization or death [see Warnings and Precautions ( 5.1 ) and Adverse Reactions ( 6.1 )] . Reported infections include: Active tuberculosis, which may present with pulmonary or extrapulmonary disease. Invasive fungal infections, including cryptococcosis, and pneumocystosis. Bacterial, viral, including herpes zoster, and other infections due to opportunistic pathogens. Avoid use of OPZELURA in patients with an active, serious infection, including localized infections. If a serious infection develops, interrupt OPZELURA until the infection is controlled. The risks and benefits of treatment with OPZELURA should be carefully considered prior to initiating therapy in patients with chronic or recurrent infection. Patients should be closely monitored for the development of signs and symptoms of infection during and after treatment with OPZELURA [see Warnings and Precautions ( 5.1 )] . MORTALITY In a large, randomized, postmarketing safety study in rheumatoid arthritis (RA) patients 50 years of age and older with at least one cardiovascular risk factor comparing an oral JAK inhibitor to tumor necrosis factor (TNF) blocker treatment, a h igher rate of all-cause mortality, including sudden cardiovascular death, was observed with the JAK inhibitor [see Warnings and Precautions ( 5.2 )] . MALIGNANCIES Malignancies were reported in patients treated with OPZELURA. Lymphoma and other malignancies have been observed in patients receiving JAK inhibitors used to treat inflammatory conditions. In RA patients treated with an oral JAK inhibitor, a higher rate of malignancies (excluding non-melanoma skin cancer (NMSC)) was observed when compared with TNF blockers. Patients who are current or past smokers are at additional
OPZELURA Target & Pathway
ProTarget
A member of the JAK family involved in signaling for interferons and several interleukins. JAK1 inhibition is effective in rheumatoid arthritis, atopic dermatitis, and other inflammatory conditions by blocking multiple cytokine pathways.
OPZELURA Competitive Set
ProThree rings of competition based on shared molecular targets and treated indications.
MoA expansion candidates
Same target(s), different indications — where else is this mechanism being explored?
Indication competitors
Same indication, different mechanism — what else might this patient receive?
Filters applied: drops same-active-ingredient (505(b)(2) reformulations), route-mismatch (topical vs systemic), and cross-therapeutic-area matches in same-indication rings.
What's emerging in OPZELURA's indications
See all emerging drugs →Phase 3 candidates targeting molecules with no FDA-approved drug, in indications OPZELURA treats. First-in-class if their pivotal trials read out positive.
Drugs Similar to OPZELURA
3 of 20FDA-approved drugs for similar conditions. Compare mechanisms and indications to understand treatment alternatives.
Clinical Trial Registry
19 trials| Trial | Sponsor ID | Phase | Status | Title |
|---|---|---|---|---|
| NCT02131584 | 2013-0044 NCI-2014-01465, 2013-0044 | Ph 2 | active not recruiting | Ruxolitinib Phosphate in Reducing Fatigue in Patients With Chronic Lymphocytic Leukemia |
| NCT01787487 | 2012-0737 NCI-2013-00704, 2012-0737 | Ph 2 | completed | Ruxolitinib Phosphate and Azacytidine in Treating Patients With Myelofibrosis or Myelodysplastic Syndrome/Myeloproliferative Neoplasm |
| NCT07317700 | FMF-03 | Ph 3 | recruiting | A Clinical Trial of Flonoltinib Maleate for Intermediate or High-Risk Myelofibrosis |
| NCT03120624 results posted | MC1562 NCI-2017-00615, MC1562 | Ph 1 | active not recruiting | VSV-hIFNbeta-NIS With or Without Ruxolitinib Phosphate in Treating Stage IV or Recurrent Endometrial Cancer |
| NCT07278856 | 25404 NCI-2025-08060, 25404 | Ph 1 | not yet recruiting | Ruxolitinib in Combination With CHOP Chemotherapy for the Treatment of Untreated Nodal T-Follicular Helper Cell Lymphomas |
| NCT06128070 | 23010 NCI-2023-07401, 23010 | Ph 2 | recruiting | Ruxolitinib With Tacrolimus and Methotrexate for the Prevention of Graft Versus Host Disease in Pediatric and Young Adult Patients Undergoing Allogeneic Hematopoietic Cell Transplant for Acute Myeloid Leukemia, Acute Lymphoblastic Leukemia, or Myelodysplastic Syndrome |
| NCT02257138 results posted | 2014-0344 NCI-2014-02299, 2014-0344 | Ph 1, Ph 2 | completed | Ruxolitinib Phosphate and Decitabine in Treating Patients With Relapsed or Refractory or Post Myeloproliferative Acute Myeloid Leukemia |
| NCT02420717 results posted | 2014-0521 NCI-2015-00779, 2014-0521 | Ph 2 | terminated | Ruxolitinib Phosphate or Dasatinib With Chemotherapy in Treating Patients With Relapsed or Refractory Philadelphia Chromosome-Like Acute Lymphoblastic Leukemia |
| NCT02713386 results posted | NRG-GY007 NCI-2016-00203, NRG-GY007 | Ph 1, Ph 2 | completed | Ruxolitinib Phosphate, Paclitaxel, and Carboplatin in Treating Patients With Stage III-IV Epithelial Ovarian, Fallopian Tube, or Primary Peritoneal Cancer |
| NCT03012230 | MC1534 NCI-2016-02057, 15-006282 | Ph 1 | completed | Pembrolizumab and Ruxolitinib Phosphate in Treating Patients With Metastatic Stage IV Triple Negative Breast Cancer |
| NCT02917096 | 16337 NCI-2016-01400, 16337 | Ph 1 | completed | Ruxolitinib Phosphate and Chemotherapy Given Before and After Reduced Intensity Donor Stem Cell Transplant in Treating Patients With Myelofibrosis |
| NCT01431209 results posted | 0283-11-FB NCI-2011-02733, P30CA036727 | Ph 2 | completed | Ruxolitinib Phosphate to Treat Diffuse Large B-Cell or Peripheral T-Cell Non-Hodgkin Lymphoma After Stem Cell Transplant |
| NCT00778700 results posted | INCB 18424-203 | Ph 2 | completed | A Dose Ranging Study of the Effect of Ruxolitinib Phosphate Cream When Applied to Participants With Plaque Psoriasis |
| NCT03041636 results posted | 2015-0570 NCI-2017-00478, 2015-0570 | Ph 2 | completed | Ruxolitinib Phosphate in Treating Patients With Previously Untreated Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma |
| NCT02092324 results posted | IRB00010262 NCI-2014-00633, IRB00010262 | Ph 2 | completed | Ruxolitinib Phosphate in Treating Patients With Chronic Neutrophilic Leukemia or Atypical Chronic Myeloid Leukemia |
| NCT02779283 | IRB00011766 NCI-2016-00083, IRB00011766 | Ph 1 | completed | Personalized Kinase Inhibitor Therapy Combined With Chemotherapy in Treating Patients With Newly Diagnosed Acute Myeloid Leukemia and Acute Lymphoblastic Leukemia |
| NCT01732445 results posted | MC1283 NCI-2012-02201, MC1283 | Ph 2 | completed | Ruxolitinib Phosphate and Danazol in Treating Anemia in Patients With Myelofibrosis |
| NCT02528877 | 14129 NCI-2015-01333, 14129 | Ph 1 | withdrawn | Ruxolitinib Phosphate, Tacrolimus and Sirolimus in Preventing Acute Graft-versus-Host Disease During Reduced Intensity Donor Hematopoietic Cell Transplant in Patients With Myelofibrosis |
| NCT01164163 | ADVL1011 COG-ADVL1011 | Ph 1 | completed | INCB18424 in Treating Young Patients With Relapsed or Refractory Solid Tumor, Leukemia, or Myeloproliferative Disease |
Active Pipeline
Ongoing clinical trials by development phase
Key Completed Trials
Completed studies with published results, ranked by significance
Trial Timeline
Full development history with FDA approval milestones
Understanding FDA Approval Types
| Count | Type | What it means |
|---|---|---|
| - | ORIG | Original approval - drug first enters market |
| - | SUPPL - Efficacy | New indication (new disease/condition approved) |
| - | SUPPL - Labeling | Label text changes (warnings, dosing updates) |
| - | SUPPL - Manufacturing | Production changes (new facility) |
| - | SUPPL - Chemistry | Formulation changes (new dosage strength) |
Green lines in the timeline show ORIG and Efficacy approvals - the clinically meaningful milestones.
OPZELURA FDA Label Details
Indications & Usage
FDA Label (PDF)OPZELURA is indicated for the treatment of Atopic Dermatitis; Vitiligo.
WARNING: SERIOUS INFECTIONS, MORTALITY, MALIGNANCY, MAJOR ADVERSE CARDIOVASCULAR EVENTS, AND THROMBOSIS SERIOUS INFECTIONS Patients treated with oral Janus kinase inhibitors for inflammatory conditions are at risk for developing serious infections that may lead to hospitalization or death [see Warni...
OPZELURA Patents & Exclusivity
Patents (33 active)
Exclusivity
Pro Intelligence Preview
Deep insights for OPZELURA
Revenue Insights
- • Quarterly revenue tracking
- • Historical trend analysis
Patent Timeline
- • Cliff: 2041
- • 39 active patents
Trial Analysis
- • 230 total trials
- • Stage: Stable
Competitive Landscape
- • 20 similar drugs
- • Same target/indication analysis
Full approval history • All patents • Revenue trends • Competitor analysis
Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.
How We Calculate These Metrics
Trial Activity Stage
Measures the current development activity pattern based on trial phases, status, and trends. Important: This measures R&D activity, not commercial lifecycle.
Trial statuses: "Active" means recruiting or ongoing. "Completed" means reached planned endpoint. "Terminated" means stopped early—often due to safety, efficacy, or business reasons.
- Growth: High proportion of early-phase trials (Phase 1/2), active development
- Expansion: Significant Phase 3 activity, approaching or pursuing approvals
- Mature: Substantial Phase 4 post-marketing studies
- Stable: Mixed phase distribution, steady development
- Declining: Low active trial ratio, reduced R&D investment