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About Ruxolitinib Phosphate
Ruxolitinib phosphate is the phosphate salt form of ruxolitinib. The medication treats intermediate or high-risk myelofibrosis, a disease that primarily affects the bone marrow in older adults.
Ruxolitinib phosphate is also prescribed for polycythemia vera when patients have a poor response or intolerance to hydroxyurea, and steroid-refractory acute graft-versus-host disease.
Ruxolitinib Phosphate Clinical Studies?
Clinical studies conducted for ruxolitinib phosphate include:
Ruxolitinib versus standard therapy for the treatment of polycythemia vera
This study compared the safety and effectiveness of ruxolitinib to hydroxyurea – a standard treatment for polycythemia vera. Results from the study suggest that ruxolitinib is a superior treatment in reducing spleen volume, achieving hematocrit control, and improving symptoms of polycythemia vera. Further, ruxolitinib was shown to have a higher rate of symptom score reduction and complete hematologic remission.
Ruxolitinib for the treatment of steroid-refractory acute GVHD (REACH1): a multicenter, open-label phase 2 trial
This phase 2 study examined the safety and effectiveness of ruxolitinib for treating steroid-refractory acute graft-versus-host disease (aGVHD) – a condition that can occur after allogeneic hematopoietic cell transplantation (HCT) where healthy donor stem cells are transplanted into patients with damaged or abnormal bone marrow.
In the study, 71 patients received oral ruxolitinib. Participants started treatment at 5 mg twice daily (including corticosteroids) until treatment failure, unacceptable toxicity, or death. On day 28, 54.9% had an overall response, 26.8% had a complete response, and the best overall response rate during the study was 73.2%. Researchers concluded that ruxolitinib demonstrated efficacy and safety in treating steroid-refractory aGVHD.
A double-blind, placebo-controlled trial of ruxolitinib for myelofibrosis
The double-blind clinical trial compared twice-daily oral ruxolitinib to placebo in patients with intermediate-2 or high-risk myelofibrosis. The study’s primary endpoint was the proportion of participants with a spleen volume reduction of 35% or more at 24 weeks. Ruxolitinib exhibited significantly superior performance to the placebo, where 41.9% of patients receiving ruxolitinib achieved the primary endpoint compared to only 0.7% receiving the placebo. Further, 67.0% of patients receiving ruxolitinib maintained their response for at least 48 weeks with significant symptom improvement and a better survival rate. The study concluded that treatment with ruxolitinib significantly benefits myelofibrosis patients by improving symptoms, reducing spleen size, and increasing the patient’s survival rate.
Efficacy and safety of ruxolitinib cream for the treatment of atopic dermatitis: Results from 2 phase 3, randomized, double-blind studies
This phase 3 study evaluated the safety and effectiveness of ruxolitinib (RUX) cream in patients with atopic dermatitis (eczema). Patients with an affected body surface area of 3%-20% and over the age of 12 were recruited for two studies. They were randomized to receive twice-daily 0.75% RUX cream, 1.5% RUX cream, or a vehicle cream for eight weeks.
Results showed that patients achieved success with 0.75% RUX cream (50.0%) and 1.5% RUX cream (53.8%) compared to the vehicle (15.1%). The findings additionally showed significant reductions in itch symptoms within 12 hours of the first application of 1.5% RUX cream when compared to the placebo.
How Ruxolitinib Phosphate Works
Ruxolitinib falls under the category of Janus kinase inhibitors (JAK inhibitors). In pharmacology, an inhibitor either blocks or interferes with the activity of a specific enzyme, receptor, or other biological target.
The inhibitor works by binding to the target molecule and preventing it from functioning normally. Depending on the type of inhibitor, this activity may be irreversible.
Ruxolitinib phosphate primarily targets the JAK1 and JAK2 inhibitors associated with myelofibrosis. Both JAK1 and JAK2 recruit signal transducers (molecules that are involved with signal transmission from the cell’s external to the internal environment) and activators of transcription (STATs) to cytokine receptors, ultimately affecting gene expression and mitigating the signaling disturbances associated with myelofibrosis.
Ruxolitinib also treats polycythemia vera by targeting JAK1 and JAK2.
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Frequently Asked Questions
Ruxolitinib is the active pharmaceutical ingredient (API) while ruxolitinib phosphate is the specific salt form of the drug used to formulate the end product.
Medications are often administered in a salt form to increase their stability, absorption, and/or solubility. The salt form of ruxolitinib is typically created by combining the phosphate counter-ion to create ruxolitinib phosphate.
EU-based MedicaPharma supplies high-quality ruxolitinib phosphate to pharmacies, hospitals, research, and educational institutions. Click here for a free quote.
GMP (Good Manufacturing Practices) and GDP (Good Distribution Practices) are quality assurance systems essential to the safety of products produced by the pharmaceutical industry. GMP guidelines typically cover the manufacturing processes while GDP governs how the products are transported and delivered.