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Drug

Ruxolitinib phosphate

Approved · EMA
Late-stage development

Also known as Jakafi, Opzelura, ruxolitinib (as phosphate).

RxNorm1193325
5
Active clinical trials
1
Regulatory events
Latest activity
beta

Recent clinical, regulatory, research and industry developments relating to this drug.

Ipsen pens $1.7B deal to acquire Kartos for potential Jakafi add-on therapy for myelofibrosis

Industry2026-06-29Acquisition · Fierce Biotech

Ruxolitinib in Combination With Chemotherapy for Untreated Nodal T-Follicular Helper (TFH) Cell Lymphomas

Clinical trial2026-06-05Results expected Q1 2027 · ClinicalTrials.gov

Administration of Jakafi (Ruxolitinib) for Symptom Control of Patients With Chronic Lymphocytic Leukemia (CLL): A Phase II Study

Clinical trial2026-04-16Results expected Q3 2026 · ClinicalTrials.gov

A Randomized, Open-label, Positive-controlled, Parallel-grouped, Multicenter Phase III Clinical Trial on the Efficacy and Safety of Flonoltinib Maleate Tablets in Patients With Intermediate- or High-risk Myelofibrosis

Clinical trial2026-03-04Results expected Q4 2027 · ClinicalTrials.gov

Phase I Trial of Intravenous Administration of Vesicular Stomatitis Virus Genetically Engineered to Express Thyroidal Sodium Iodide Symporter (NIS) and Human Interferon Beta (hIFNb), in Patients With Metastatic or Recurrent Endometrial Cancer

Clinical trial2026-02-04Results posted · ClinicalTrials.gov

Evaluation of Ruxolitinib and Azacytidine Combination as a Therapy for Patients With Myelofibrosis and Myelodysplastic Syndrome/ Myeloproliferative Neoplasm

Clinical trial2026-01-20Completed · ClinicalTrials.gov

Phase 2a Study of Adding Ruxolitinib With Tacrolimus/Methotrexate Regimen for Graft-versus-Host Disease Prophylaxis in Myeloablative Conditioning Hematopoietic Cell Transplantation in Pediatric and Young Adult Patients

Clinical trial2025-10-31Results expected Q4 2030 · ClinicalTrials.gov

Phase I/II Study of Ruxolitinib Plus Decitabine in Patients With Post Myeloproliferative Neoplasm - Acute Myeloid Leukemia (AML)

Clinical trial2025-06-08Results posted · ClinicalTrials.gov

A Phase I/II Study of Ruxolitinib With Front-Line Neoadjuvant and Post-Surgical Therapy in Patients With Advanced Epithelial Ovarian, Fallopian Tube or Primary Peritoneal Cancer

Clinical trial2025-05-25Results posted · ClinicalTrials.gov

A Phase 2 Multicenter, Investigator Initiated Study of Oral Ruxolitinib Phosphate for the Treatment of Relapsed or Refractory Diffuse Large B-Cell and Peripheral T-Cell Non-Hodgkin Lymphoma

Clinical trial2023-10-05Results posted · ClinicalTrials.gov

Pilot Open-Label Study of Safety and Efficacy of Ruxolitinib Given Peri-Transplant During Reduced Intensity Allogeneic Hematopoietic Cell Transplantation (HCT) in Patients With Myelofibrosis

Clinical trial2023-08-31Completed · ClinicalTrials.gov

Approval: Opzelura (EMA)

Regulatory2023-04-19EMA

Profile

Identifiers & mechanism

Canonical identifiers, marketed brand names and mechanism, resolved across RxNorm, ChEMBL and ATC.

Canonical name
Ruxolitinib phosphate
Aliases & brands
JakafiOpzeluraruxolitinib (as phosphate)
RxNorm CUI
1193325
Regulatory jurisdictions
ema

Regulatory timeline

1 event

The complete regulatory record, grouped by authority — approvals, safety advisories and label changes. Each authority shows its most recent events; expand one to read its full history.

Earliest approval
2023-04-19
Latest approval
2023-04-19
Authorities
EMA
Total events
1
emaEuropean Medicines Agency· 1 event
2023-04-19Approval
Approval: Opzelura (EMA)

Indication: Opzelura is indicated for the treatment of non-segmental vitiligo with facial involvement in adults and adolescents from 12 years of age.

Evidence ↗

Contains information from the European Medicines Agency (European Medicines Agency), © EMA, reused under CC BY 4.0.

Clinical trials

19 trials

The current development programme across all trial phases — status mix, phase distribution and the late-stage studies shaping the evidence base.

Development programme
CLINICALTRIALS.GOV · LIVE REGISTRY
19
registered trials across all phases
LATEST COMPLETION 2026
5
Active studies
3
Recruiting
1
Late-stage (III+)
12
Completed
2
Discontinued
PHASE DISTRIBUTIONn = 19
Phase 17Phase 1 / 22Phase 29Phase 31

Late-stage studies

Phase III+ trials still open or recently active — where late-stage evidence is being generated.

A Randomized, Open-label, Positive-controlled, Parallel-grouped, Multicenter Phase III Clinical Trial on the Efficacy and Safety of Flonoltinib Maleate Tablets in Patients With Intermediate- or High-risk Myelofibrosis

RecruitingPH IIIChengdu Zenitar Biomedical Technology Co., Ltdn=1052028

Recent completions

Trials that read out recently, adding to the completed evidence base.

Evaluation of Ruxolitinib and Azacytidine Combination as a Therapy for Patients With Myelofibrosis and Myelodysplastic Syndrome/ Myeloproliferative Neoplasm

CompletedPH IIM.D. Anderson Cancer Centern=1212026

A Phase I/II Study of Ruxolitinib With Front-Line Neoadjuvant and Post-Surgical Therapy in Patients With Advanced Epithelial Ovarian, Fallopian Tube or Primary Peritoneal Cancer

CompletedPH I/IINRG Oncologyn=1472024

Pilot Open-Label Study of Safety and Efficacy of Ruxolitinib Given Peri-Transplant During Reduced Intensity Allogeneic Hematopoietic Cell Transplantation (HCT) in Patients With Myelofibrosis

CompletedPH ICity of Hope Medical Centern=182023

A Phase 1 Study of PD-1 Inhibition With Pembrolizumab Combined With JAK2 Inhibition in Triple Negative Breast Cancer

CompletedPH IMayo Clinicn=122023

A Phase 2 Multicenter, Investigator Initiated Study of Oral Ruxolitinib Phosphate for the Treatment of Relapsed or Refractory Diffuse Large B-Cell and Peripheral T-Cell Non-Hodgkin Lymphoma

CompletedPH IIUniversity of Nebraskan=712021

Phase I/II Study of Ruxolitinib Plus Decitabine in Patients With Post Myeloproliferative Neoplasm - Acute Myeloid Leukemia (AML)

CompletedPH I/IIM.D. Anderson Cancer Centern=302021
References & data sources
  • RxNorm (U.S. National Library of Medicine) — drug identity
  • ClinicalTrials.gov — clinical trials
  • Regulatory event sources are credited in the Regulatory Timeline above.