CLINICAL TRIALS PROFILE FOR VIDAZA

All Clinical Trials for Vidaza

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT00101179 ↗	MS-275 and Azacitidine in Treating Patients With Myelodysplastic Syndromes, Chronic Myelomonocytic Leukemia, or Acute Myeloid Leukemia	Completed	National Cancer Institute (NCI)	Phase 1	2004-11-03	MS-275 may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Drugs used in chemotherapy, such as azacitidine, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Giving MS-275 together with azacitidine may kill more cancer cells. This phase I trial is studying the side effects and best dose of MS-275 when given together with azacitidine in treating patients with myelodysplastic syndromes, chronic myelomonocytic leukemia, or acute myeloid leukemia.
NCT00118287 ↗	Azacitidine and Etanercept in Treating Patients With Myelodysplastic Syndromes	Completed	National Cancer Institute (NCI)	Phase 1/Phase 2	2005-04-01	This phase I/II trial studies how well giving azacitidine together with etanercept works in treating patients with myelodysplastic syndromes (MDS). Drugs used in chemotherapy, such as azacitidine, works in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Chemoprotective drugs, such as etanercept, may protect normal cells from the side effects of chemotherapy
NCT00118287 ↗	Azacitidine and Etanercept in Treating Patients With Myelodysplastic Syndromes	Completed	Fred Hutchinson Cancer Research Center	Phase 1/Phase 2	2005-04-01	This phase I/II trial studies how well giving azacitidine together with etanercept works in treating patients with myelodysplastic syndromes (MDS). Drugs used in chemotherapy, such as azacitidine, works in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Chemoprotective drugs, such as etanercept, may protect normal cells from the side effects of chemotherapy
NCT00118287 ↗	Azacitidine and Etanercept in Treating Patients With Myelodysplastic Syndromes	Completed	Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium	Phase 1/Phase 2	2005-04-01	This phase I/II trial studies how well giving azacitidine together with etanercept works in treating patients with myelodysplastic syndromes (MDS). Drugs used in chemotherapy, such as azacitidine, works in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Chemoprotective drugs, such as etanercept, may protect normal cells from the side effects of chemotherapy
NCT00313586 ↗	Azacitidine With or Without Entinostat in Treating Patients With Myelodysplastic Syndromes, Chronic Myelomonocytic Leukemia, or Acute Myeloid Leukemia	Completed	National Cancer Institute (NCI)	Phase 2	2006-08-01	This randomized phase II trial studies azacitidine with or without entinostat to see how well they work compared to azacitidine alone in treating patients with myelodysplastic syndromes, chronic myelomonocytic leukemia, or acute myeloid leukemia. Drugs used in chemotherapy, such as azacitidine, work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Entinostat may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Giving azacitidine together with entinostat may work better in treating patients with myelodysplastic syndromes, chronic myelomonocytic leukemia, or acute myeloid leukemia.

Clinical Trial Conditions for Vidaza

Condition Name

Condition Name for Vidaza
Intervention	Trials
Acute Myeloid Leukemia	66
Myelodysplastic Syndrome	54
Leukemia	33
Myelodysplastic Syndromes	27

Condition MeSH

Condition MeSH for Vidaza
Intervention	Trials
Leukemia	140
Myelodysplastic Syndromes	133
Preleukemia	124
Leukemia, Myeloid, Acute	123

Clinical Trial Locations for Vidaza

Trials by Country

Trials by Country for Vidaza
Location	Trials
United States	791
Canada	41
France	39
Germany	35
Australia	26

Trials by US State

Trials by US State for Vidaza
Location	Trials
Texas	102
California	46
New York	44
Ohio	39
Illinois	37

Clinical Trial Progress for Vidaza

Clinical Trial Phase

Clinical Trial Phase for Vidaza
Clinical Trial Phase	Trials
Phase 4	1
Phase 3	8
Phase 2/Phase 3	2

Clinical Trial Status

Clinical Trial Status for Vidaza
Clinical Trial Phase	Trials
Completed	94
Recruiting	49
Terminated	40

Clinical Trial Sponsors for Vidaza

Sponsor Name

Sponsor Name for Vidaza
Sponsor	Trials
National Cancer Institute (NCI)	77
M.D. Anderson Cancer Center	54
Celgene Corporation	46

Sponsor Type

Sponsor Type for Vidaza
Sponsor	Trials
Other	201
Industry	186
NIH	77

Vidaza (Azacitidine): Clinical Trials Update, Market Analysis, and Projections

Introduction to Vidaza (Azacitidine)

Vidaza, also known as azacitidine, is a hypomethylating agent used in the treatment of various hematological malignancies. It is approved for the treatment of adult patients with intermediate-2 and high-risk myelodysplastic syndromes (MDS), chronic myelomonocytic leukemia (CMML), and acute myeloid leukemia (AML) under specific conditions[5].

Clinical Trials Update

Ongoing and Recent Trials

Vidaza has been extensively studied in various clinical trials to evaluate its efficacy and safety in different patient populations.

• Combination Therapies: A notable trial, the VIOLA trial, investigated the combination of azacitidine and lenalidomide for patients with AML or MDS that had relapsed after a stem cell transplant. This phase 1 trial found the combination to be safe and effective, with some patients achieving complete remission. However, larger trials are needed to confirm these findings[1].

• Frontline Treatment Options: Real-world data and numerous trials have shown that azacitidine remains a standard of care for higher-risk MDS, with a median overall survival of 14-18 months and an overall response rate of 40%-50%. Despite this, several randomized controlled trials have failed to improve outcomes significantly, highlighting the need for better trial designs and endpoints[4].

• Emerging Combinations: Recent studies have shown promising results with azacitidine combined with other agents such as venetoclax, sabatolimab, and magrolimab. These combinations are currently under investigation in large, placebo-controlled, double-blind studies with overall survival as a primary endpoint[4].

Phase and Status

Vidaza is involved in a multitude of clinical trials across various phases. Here are some recent examples:

• Phase 1 Trials: Several phase 1 trials are ongoing, including those sponsored by institutions like the City of Hope Medical Center and the Therapeutic Advances in Childhood Leukemia Consortium[5].

• Phase 1/Phase 2 Trials: These trials are designed to evaluate the safety and efficacy of azacitidine in combination with other therapies or in different patient populations[5].

Market Analysis

Current Market Size

As of 2022, the global market size for myelodysplastic syndrome (MDS) drugs, which includes Vidaza, was estimated at USD 2.3 billion. This market is projected to expand at a compound annual growth rate (CAGR) of 9.5% until 2032[3].

Market Dynamics

• Demand for Hypomethylating Agents: The approval and widespread use of Vidaza and Dacogen have significantly increased the demand for hypomethylating agents. This demand is expected to continue growing due to novel treatments, easy availability, and accessibility in major countries[3].

• Competitive Landscape: The MDS drug market is competitive, with several other treatments available. However, Vidaza remains a key player due to its established efficacy and safety profile.

Financial Projections

• Revenue Growth: The market for MDS drugs, including Vidaza, is expected to grow substantially. By 2032, the market is projected to expand significantly, driven by the increasing incidence of MDS and the adoption of new treatments[3].

• Patent and Market Exclusivity: Vidaza's patent status and market exclusivity play a crucial role in its financial trajectory. Although the drug's original patents may have expired, its market presence remains strong due to its established brand and ongoing clinical trials[5].

Market Projections

Global Sales

The global sales of Vidaza are expected to continue growing as the drug remains a standard treatment option for MDS and other related conditions. Here are some key projections:

• CAGR: The MDS drug market, which includes Vidaza, is projected to grow at a CAGR of 9.5% until 2032[3].

• Market Share: Vidaza is likely to maintain a significant market share due to its established position and ongoing research into combination therapies.

Regional Growth

The growth of Vidaza sales will vary by region:

• Global Expansion: The global MDS drug market is expected to see significant growth, driven by increasing demand in major countries and emerging markets[3].

• Regional Variations: While the US and European markets will continue to be significant, the fastest growth is anticipated in regions like China, where there is a growing need for effective treatments for hematological malignancies[2].

Key Takeaways

• Clinical Trials: Vidaza continues to be evaluated in various clinical trials, including combination therapies that show promising results.
• Market Growth: The global MDS drug market, including Vidaza, is projected to grow at a CAGR of 9.5% until 2032.
• Market Dynamics: The demand for hypomethylating agents like Vidaza is driven by their efficacy, safety, and increasing accessibility.
• Financial Projections: Vidaza's revenue is expected to grow as it remains a standard treatment option and new combination therapies are developed.

FAQs

What is Vidaza used for?

Vidaza (azacitidine) is used for the treatment of adult patients with intermediate-2 and high-risk myelodysplastic syndromes (MDS), chronic myelomonocytic leukemia (CMML), and acute myeloid leukemia (AML) under specific conditions[5].

What are the common side effects of Vidaza?

Common side effects of Vidaza include infections, serious blood infections (sepsis), and fever caused by a drop in white blood cell count. In some cases, it can also increase the risk of graft-versus-host disease (GVHD) when used after a stem cell transplant[1].

Is Vidaza effective in combination therapies?

Yes, Vidaza has shown promising results in combination with other agents such as lenalidomide, venetoclax, sabatolimab, and magrolimab. These combinations are currently under investigation in various clinical trials[1][4].

What is the projected market growth for Vidaza?

The global MDS drug market, which includes Vidaza, is projected to grow at a CAGR of 9.5% until 2032[3].

Are there any ongoing clinical trials for Vidaza?

Yes, Vidaza is involved in numerous ongoing clinical trials across various phases, including phase 1 and phase 1/phase 2 trials, to evaluate its safety and efficacy in different patient populations and combination therapies[5].

Sources

1. Cancer Research UK: A trial of azacitidine and lenalidomide for acute myeloid leukaemia or myelodysplasia that has come back after a stem cell transplant.
2. Drug Development: NSCLC MARKET - Global Drug Forecast & Market Analysis to 2025.
3. Market.US: Myelodysplastic Syndrome Drug Market Size | CAGR of 9.5%.
4. ASH Publications: Frontline treatment options for higher-risk MDS: can we move past azacitidine?
5. Drug Patent Watch: VIDAZA Drug Patent Profile.