ruxolitinib
ruxolitinib: sourced relationships with 1 company · 128 clinical trials tracked · 2 FDA decisions.
ruxolitinib evidence translation
What we can confirm
2 FDA records · 128 tracked trials
What it means
What to watch
Prepared research question
How could ruxolitinib → INCY affect its developer, and what evidence supports the link?
Traceable citations · Unknowns marked
See linked entities and source evidence8 indications · 6 study sponsors
Related indications
Dated Pipeline Records (1)
| Company | Dated record stage |
|---|---|
| Incyte Corp. (INCY) Reported 2021-09-21 · Current development: unknownSource | Approved |
Clinical Trial Registry Records (128)showing 10 most recent
Ruxolitinib for Chuvash Polycythemia
Phase Ib/II Study Of Revumenib As Monotherapy Or In Combination With Jak Inhibitors In Patients With Myelofibrosis
Primary endpoint: Dose limiting toxicity (DLT)
A Randomized Open Label Trial Comparing Momelotinib vs Dose-Adjusted Ruxolitinib For Treatment-Naive, Cytopenic Myelofibrosis
Primary endpoint: To estimate and compare the proportion of participants achieving a dual response [SVR35] and transfusion independence response from red blood cell transfusions.
A Phase 2/3, Randomized, Open-label, Active-comparator-controlled, Parallel-group, Multicenter Study to Evaluate the Safety and Efficacy of Bomedemstat (MK-3543) Versus Best Available Therapy in Participants With Polycythemia Vera Who Have an Inadequate Response to or Are Intolerant to Hydroxyurea
Primary endpoint: Clinicohematologic Response (CHR) Rate
A Phase 1/1b Study Evaluating the Safety, Pharmacokinetics, and Preliminary Efficacy of Mutant Calreticulin Targeted Antibodies, Administered Alone or in Combination With Ruxolitinib, in Participants With CALR-mutant Myeloproliferative Neoplasms
Primary endpoint: To evaluate the safety and tolerability of DMR-001 & determine the MTD, RDE(s), and/or recommended Phase 2 dose(s) in participants with CALR-mutant MPNs, when administered as monotherapy or in combination with ruxolitinib
Ruxolitinib for Immune Effector Cell Associated Hemophagocytic Lymphohistiocytosis-like Syndrome (RISE)
Primary endpoint: Number of Participants with Clinical Response
A Phase 2 Study of Belumosudil Combined With Ruxolitinib as Second Line Therapy to Treat Chronic Graft Versus Host Disease (cGvHD) After Steroid Failure (BELRUX)
Primary endpoint: Efficacy will be assessed using overall response rate (ORR) as per the NIH cGvHD Consensus Response Criteria at 24 weeks of combination treatment. Tolerability and safety will be assessed by the incidence and severity of adverse events (AEs)
Ruxolitinib-Enhanced Conditioning for Pediatric and Young Adult Patients With Symptomatic Sickle Cell Disease Undergoing Haploidentical Hematopoietic Cell Transplantation
Primary endpoint: Event Free Survival
Study of JAK Inhibition in Stem-Like Prostate Cancer (JASPER): A Phase 1b/2a Multicenter Study of Ruxolitinib and Enzalutamide in Castration Resistant Prostate Cancer
Primary endpoint: Dose-limiting toxicity (DLT)
A Phase 3, Randomized, Double-blind, Active-control Study of Pelabresib (DAK539) and Ruxolitinib vs. Placebo and Ruxolitinib in Adult Patients With Myelofibrosis Who Are JAK Inhibitor Naive
Primary endpoint: Number of Participants with Splenic Response (SVR35) by Central Radiology Reads at Week 24 in participants with baseline total symptom score (TSS) ≥ 25
FDA Decisions2 records
Frequently asked questions
Which companies have sourced relationships with ruxolitinib?
ruxolitinib has dated SEC/FDA relationship records for Incyte Corp..
How many clinical trials involve ruxolitinib?
BioSniper tracks 128 clinical trials involving ruxolitinib.
What is ruxolitinib's latest FDA decision?
The most recent tracked FDA decision for ruxolitinib is Approval for 1 INDICATIONS AND USAGE OPZELURA is a Janus kinase (JAK) inhibitor indicated for: the topical short-term and non-continuous chronic treatment of mild to moderate atopic dermatitis in non-immunocompromised adult and pediatric patients 2 years of age and older whose disease is not adequately controlled with topical prescription therapies or when those therapies are not advisable. ( 1.1 ) the topical treatment of nonsegmental vitiligo in adult and pediatric patients 12 years of age and older. ( 1.2 ) Limitations of Use Use of OPZELURA in combination with therapeutic biologics, other JAK inhibitors or potent immunosuppressants such as azathioprine or cyclosporine is not recommended. ( 1.3 ) 1.1 Atopic Dermatitis OPZELURA is indicated for the topical short-term and non-continuous chronic treatment of mild to moderate atopic dermatitis in non-immunocompromised adult and pediatric patients 2 years of age and older whose disease is not adequately controlled with topical prescription therapies or when those therapies are not advisable. 1.2 Nonsegmental Vitiligo OPZELURA is indicated for the topical treatment of nonsegmental vitiligo in adult and pediatric patients 12 years of age and older. 1.3 Limitations of Use Use of OPZELURA in combination with therapeutic biologics, other Janus kinase (JAK) inhibitors, or potent immunosuppressants such as azathioprine or cyclosporine is not recommended., dated September 21, 2021.