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Last Updated: February 7, 2025

CLINICAL TRIALS PROFILE FOR RUXOLITINIB PHOSPHATE


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All Clinical Trials for Ruxolitinib Phosphate

Trial ID Title Status Sponsor Phase Start Date Summary
NCT00778700 ↗ A Dose Ranging Study of the Effect of Ruxolitinib Phosphate Cream When Applied to Patients With Plaque Psoriasis Completed Incyte Corporation Phase 2 2008-10-01 The study will be a double-blind, randomized, vehicle-controlled study with application of ruxolitinib phosphate cream or vehicle in patients with stable plaque psoriasis. Application will be QD for 12 weeks without occlusive dressings. There will be 4 treatments of 50 subjects each.
NCT00820950 ↗ A Study of Ruxolitinib Phosphate Cream When Applied to Patients With Plaque Psoriasis Completed Incyte Corporation Phase 2 2007-05-01 The study is comprised of two parts. The first portion of this study will be a double-blind, Sponsor-unblinded, vehicle-controlled study with application of ruxolitinib or vehicle to paired lesions at least 15 cm apart in patients with active but stable plaque psoriasis. Part 2 of the study is a double-blind, sponsor unblinded, comparison of ruxolitinib with two FDA approved products in patients with active but stable plaque psoriasis.
NCT01164163 ↗ INCB18424 in Treating Young Patients With Relapsed or Refractory Solid Tumor, Leukemia, or Myeloproliferative Disease Completed National Cancer Institute (NCI) Phase 1 2010-09-01 RATIONALE: INCB18424 (Ruxolitinib) may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. PURPOSE: This phase 1 clinical trial is studying the side effects and best dose of INCB18424 in treating young patients with relapsed or refractory solid tumor, leukemia, or myeloproliferative disease.
NCT01164163 ↗ INCB18424 in Treating Young Patients With Relapsed or Refractory Solid Tumor, Leukemia, or Myeloproliferative Disease Completed Children's Oncology Group Phase 1 2010-09-01 RATIONALE: INCB18424 (Ruxolitinib) may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. PURPOSE: This phase 1 clinical trial is studying the side effects and best dose of INCB18424 in treating young patients with relapsed or refractory solid tumor, leukemia, or myeloproliferative disease.
NCT01431209 ↗ Ruxolitinib Phosphate in Treating Patients With Relapsed or Refractory Diffuse Large B-Cell or Peripheral T-Cell Non-Hodgkin Lymphoma After Donor Stem Cell Transplant Completed Incyte Corporation Phase 2 2011-08-01 This phase II trial studies how well ruxolitinib phosphate works in treating patients with diffuse large B-cell or peripheral T-cell non-Hodgkin lymphoma that has returned (relapsed) or that does not respond to treatment (refractory) after donor stem cell transplant. Ruxolitinib phosphate may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth.
>Trial ID >Title >Status >Phase >Start Date >Summary

Clinical Trial Conditions for Ruxolitinib Phosphate

Condition Name

Condition Name for Ruxolitinib Phosphate
Intervention Trials
Primary Myelofibrosis 5
Leukemia 5
Secondary Myelofibrosis 4
Acute Myeloid Leukemia 2
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Condition MeSH

Condition MeSH for Ruxolitinib Phosphate
Intervention Trials
Leukemia 11
Leukemia, Myeloid 7
Leukemia, Lymphoid 5
Neoplasms 5
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Clinical Trial Locations for Ruxolitinib Phosphate

Trials by Country

Trials by Country for Ruxolitinib Phosphate
Location Trials
United States 189
Canada 5
China 1
Germany 1
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Trials by US State

Trials by US State for Ruxolitinib Phosphate
Location Trials
Texas 14
California 11
Oregon 8
Minnesota 8
Michigan 7
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Clinical Trial Progress for Ruxolitinib Phosphate

Clinical Trial Phase

Clinical Trial Phase for Ruxolitinib Phosphate
Clinical Trial Phase Trials
Phase 4 1
Phase 2 16
Phase 1/Phase 2 2
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Clinical Trial Status

Clinical Trial Status for Ruxolitinib Phosphate
Clinical Trial Phase Trials
Completed 13
Recruiting 8
Active, not recruiting 3
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Clinical Trial Sponsors for Ruxolitinib Phosphate

Sponsor Name

Sponsor Name for Ruxolitinib Phosphate
Sponsor Trials
National Cancer Institute (NCI) 19
Incyte Corporation 13
M.D. Anderson Cancer Center 5
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Sponsor Type

Sponsor Type for Ruxolitinib Phosphate
Sponsor Trials
Other 23
NIH 20
Industry 13
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Ruxolitinib Phosphate: Clinical Trials, Market Analysis, and Projections

Introduction to Ruxolitinib Phosphate

Ruxolitinib phosphate is a Janus kinase (JAK) inhibitor, specifically targeting JAK1 and JAK2, and is used in the treatment of various hematological disorders. Here, we will delve into the current status of clinical trials, market analysis, and future projections for this drug.

Clinical Trials Update

Ongoing and Completed Trials

Ruxolitinib phosphate is being studied in several clinical trials to expand its therapeutic applications. One notable trial is the Phase I/II study (NCT02713386) that investigates the combination of ruxolitinib phosphate with paclitaxel and carboplatin in treating patients with stage III-IV epithelial ovarian, fallopian tube, or primary peritoneal cancer. This trial aims to determine the side effects and the optimal dose of ruxolitinib phosphate when used in conjunction with these chemotherapy agents[1].

Another area of research involves the use of ruxolitinib phosphate in treating myeloproliferative neoplasms and graft-versus-host disease (GVHD). Although the FDA issued a complete response letter for the extended-release formulation of ruxolitinib, indicating additional requirements for approval, the drug remains a focus of ongoing research[4].

Mechanism of Action

Ruxolitinib phosphate works by inhibiting the JAK1 and JAK2 enzymes, which are crucial for the signaling of cytokines involved in the proliferation and survival of cells. By blocking these enzymes, ruxolitinib phosphate can reduce the growth of tumor cells and alleviate symptoms associated with myeloproliferative neoplasms[3].

Approved Uses

Current Indications

Ruxolitinib phosphate is FDA-approved for the treatment of:

  • Myelofibrosis: Intermediate or high-risk primary myelofibrosis, post-polycythemia vera myelofibrosis, and post-essential thrombocythemia myelofibrosis.
  • Polycythemia Vera: In patients who are resistant to or intolerant of hydroxyurea[3].

Market Analysis

Market Size and Growth

The global ruxolitinib phosphate market has experienced significant growth in recent years and is projected to continue this trend. The market is segmented by type (5.0 mg/tablet, 10.0 mg/tablet, and other), application (hospital, clinic, and other), and geographical regions (North America, Europe, Asia-Pacific, South America, and Middle-East and Africa)[2].

Regional Market Projections

  • North America: The market is expected to grow from an estimated value in 2022 to a higher value by 2028, at a compound annual growth rate (CAGR) during the forecast period.
  • Asia-Pacific: Similar growth is anticipated, with the market increasing from an estimated value in 2022 to a higher value by 2028, at a CAGR during the forecast period[5].

Market Drivers and Challenges

The market growth is driven by increasing awareness and diagnosis of myeloproliferative neoplasms, the efficacy of ruxolitinib phosphate in treating these conditions, and ongoing research into new indications. However, challenges include regulatory hurdles, such as the FDA's complete response letter for the extended-release formulation, and competition from other JAK inhibitors[2][4].

Market Projections

Forecast Period

The global ruxolitinib phosphate market is projected to expand significantly from 2023 to 2031. The market size is expected to increase in value, driven by the growing demand for effective treatments for myeloproliferative neoplasms and other potential indications[2].

Key Market Segments

  • Hospital Segment: This segment is expected to grow substantially, driven by the increasing use of ruxolitinib phosphate in hospital settings for the treatment of various hematological disorders.
  • Geographical Expansion: The market is expected to see significant growth in regions like North America, Europe, and Asia-Pacific, due to improved healthcare infrastructure and increasing awareness of the drug's benefits[5].

Expert Insights and Statistics

Market Growth Statistics

"The ruxolitinib phosphate market has witnessed swift and substantial growth in recent years, and the outlook remains positive with projections indicating a sustained and significant expansion from 2023 to 2031," according to market research reports[2].

Industry Expert Views

"While we are disappointed that the FDA issued a complete response letter for ruxolitinib extended-release tablets, we remain committed to advancing care for people with myeloproliferative neoplasms and GVHD," said a spokesperson from Incyte, highlighting the ongoing commitment to research and development[4].

Key Takeaways

  • Clinical Trials: Ruxolitinib phosphate is being studied in various clinical trials, including a Phase I/II trial for ovarian cancer.
  • Approved Uses: The drug is approved for treating myelofibrosis and polycythemia vera.
  • Market Growth: The global market is projected to grow significantly from 2023 to 2031, driven by increasing demand and expanding indications.
  • Regional Projections: North America, Europe, and Asia-Pacific are expected to be key regions for market growth.
  • Challenges: Regulatory hurdles and competition from other JAK inhibitors are challenges to market growth.

FAQs

What is ruxolitinib phosphate used for?

Ruxolitinib phosphate is used to treat myelofibrosis and polycythemia vera. It is also being studied for other potential indications, including ovarian cancer.

What is the mechanism of action of ruxolitinib phosphate?

Ruxolitinib phosphate works by inhibiting the JAK1 and JAK2 enzymes, which are involved in the signaling of cytokines that promote cell growth and survival.

What is the current market size and growth projection for ruxolitinib phosphate?

The global market for ruxolitinib phosphate is projected to grow significantly from 2023 to 2031, with substantial growth expected in regions like North America, Europe, and Asia-Pacific.

What are the key drivers of the ruxolitinib phosphate market?

The market is driven by increasing awareness and diagnosis of myeloproliferative neoplasms, the efficacy of ruxolitinib phosphate, and ongoing research into new indications.

What challenges does the ruxolitinib phosphate market face?

The market faces challenges such as regulatory hurdles, including the FDA's complete response letter for the extended-release formulation, and competition from other JAK inhibitors.

Sources

  1. UChicago Medicine: Ruxolitinib Phosphate, Paclitaxel, and Carboplatin in Treating Patients With Stage III-IV Epithelial Ovarian, Fallopian Tube, or Primary Peritoneal Cancer.
  2. Market Research Intellect: Global Ruxolitinib Phosphate Market Size, Trends and Projections.
  3. National Cancer Institute: Ruxolitinib Phosphate.
  4. Incyte: Incyte Provides Regulatory Update on Ruxolitinib Extended-Release Tablets.
  5. Valuates Reports: Global Ruxolitinib Phosphate Market Research Report 2022.

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