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Last Updated: February 7, 2025

CLINICAL TRIALS PROFILE FOR DACOGEN


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All Clinical Trials for Dacogen

Trial ID Title Status Sponsor Phase Start Date Summary
NCT00002831 ↗ Chemotherapy Plus Peripheral Stem Cell Transplantation in Treating Patients With Chronic Myelogenous or Acute Leukemia Completed National Cancer Institute (NCI) Phase 1/Phase 2 1995-08-01 RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. Combining chemotherapy with peripheral stem cell transplantation may allow the doctor to give higher doses of chemotherapy drugs and kill more cancer cells. PURPOSE: Phase I/II trial to study the effectiveness of high-dose chemotherapy plus peripheral stem cell transplantation in treating patients with chronic myelogenous or acute leukemia.
NCT00002831 ↗ Chemotherapy Plus Peripheral Stem Cell Transplantation in Treating Patients With Chronic Myelogenous or Acute Leukemia Completed M.D. Anderson Cancer Center Phase 1/Phase 2 1995-08-01 RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. Combining chemotherapy with peripheral stem cell transplantation may allow the doctor to give higher doses of chemotherapy drugs and kill more cancer cells. PURPOSE: Phase I/II trial to study the effectiveness of high-dose chemotherapy plus peripheral stem cell transplantation in treating patients with chronic myelogenous or acute leukemia.
NCT00002832 ↗ Decitabine and Peripheral Stem Cell Transplantation in Treating Patients Who Have Relapsed Following Bone Marrow Transplantation for Leukemia, Myelodysplastic Syndrome, or Chronic Myelogenous Leukemia Completed National Cancer Institute (NCI) Phase 1/Phase 2 1995-08-01 RATIONALE: Peripheral stem cell transplantation may be an effective treatment for leukemia, myelodysplastic syndrome, or chronic myelogenous leukemia that has relapsed following bone marrow transplantation. PURPOSE: Phase I/II trial to study the effectiveness of decitabine and peripheral stem cell transplantation in treating patients who have leukemia, myelodysplastic syndrome, or chronic myelogenous leukemia that has relapsed after bone marrow transplantation.
NCT00002832 ↗ Decitabine and Peripheral Stem Cell Transplantation in Treating Patients Who Have Relapsed Following Bone Marrow Transplantation for Leukemia, Myelodysplastic Syndrome, or Chronic Myelogenous Leukemia Completed M.D. Anderson Cancer Center Phase 1/Phase 2 1995-08-01 RATIONALE: Peripheral stem cell transplantation may be an effective treatment for leukemia, myelodysplastic syndrome, or chronic myelogenous leukemia that has relapsed following bone marrow transplantation. PURPOSE: Phase I/II trial to study the effectiveness of decitabine and peripheral stem cell transplantation in treating patients who have leukemia, myelodysplastic syndrome, or chronic myelogenous leukemia that has relapsed after bone marrow transplantation.
NCT00067808 ↗ Study of Three Different Schedules of Low-Dose Decitabine in Myelodysplastic Syndrome (MDS) Completed Eisai Inc. Phase 2 2003-10-01 The goal of this clinical research study is to learn if decitabine (given at 3 different doses) can help to control Myelodysplastic Syndrome (MDS). The safety of these 3 treatments will also be studied.
NCT00067808 ↗ Study of Three Different Schedules of Low-Dose Decitabine in Myelodysplastic Syndrome (MDS) Completed M.D. Anderson Cancer Center Phase 2 2003-10-01 The goal of this clinical research study is to learn if decitabine (given at 3 different doses) can help to control Myelodysplastic Syndrome (MDS). The safety of these 3 treatments will also be studied.
>Trial ID >Title >Status >Phase >Start Date >Summary

Clinical Trial Conditions for Dacogen

Condition Name

Condition Name for Dacogen
Intervention Trials
Acute Myeloid Leukemia 38
Myelodysplastic Syndrome 29
Untreated Adult Acute Myeloid Leukemia 18
Recurrent Acute Myeloid Leukemia 17
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Condition MeSH

Condition MeSH for Dacogen
Intervention Trials
Leukemia 80
Leukemia, Myeloid, Acute 78
Leukemia, Myeloid 75
Myelodysplastic Syndromes 64
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Clinical Trial Locations for Dacogen

Trials by Country

Trials by Country for Dacogen
Location Trials
United States 362
Germany 15
Belgium 12
Canada 9
France 8
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Trials by US State

Trials by US State for Dacogen
Location Trials
Texas 48
Ohio 29
New York 23
California 22
Maryland 14
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Clinical Trial Progress for Dacogen

Clinical Trial Phase

Clinical Trial Phase for Dacogen
Clinical Trial Phase Trials
Phase 4 1
Phase 3 5
Phase 2/Phase 3 4
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Clinical Trial Status

Clinical Trial Status for Dacogen
Clinical Trial Phase Trials
Completed 51
Recruiting 27
Active, not recruiting 20
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Clinical Trial Sponsors for Dacogen

Sponsor Name

Sponsor Name for Dacogen
Sponsor Trials
National Cancer Institute (NCI) 49
M.D. Anderson Cancer Center 34
Eisai Inc. 16
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Sponsor Type

Sponsor Type for Dacogen
Sponsor Trials
Other 130
Industry 71
NIH 50
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Dacogen: Clinical Trials, Market Analysis, and Projections

Introduction to Dacogen

Dacogen, also known as decitabine, is a hypomethylating agent used in the treatment of myelodysplastic syndromes (MDS) and certain forms of leukemia. Here, we will delve into the current clinical trials, market analysis, and future projections for this drug.

Clinical Trials and Efficacy

Phase III and Phase II Trials

The efficacy of Dacogen has been established through several clinical trials, notably the Phase III study D-0007 and the Phase II study DACO-020. In the D-0007 trial, patients received an inpatient dosing regimen of 15 mg/m² body surface area, administered intravenously over three hours, every eight hours for three consecutive days, repeated every six weeks. This study showed an overall response rate (ORR) of 17% in patients receiving Dacogen, with a median duration of response of 288 days and a median time to response of 93 days[3].

The DACO-020 trial supported the outpatient dosing regimen, where patients received 20 mg/m² body surface area, administered intravenously over one hour, once daily for five days, repeated every four weeks. This study reported an ORR of 16% with a median duration of response of 443 days and a median time to response of 162 days[3].

Safety Profile

The clinical safety of Dacogen was evaluated in these studies, highlighting common adverse effects such as neutropenia, thrombocytopenia, and the potential for fetal harm. These risks are outlined in the Serious Warnings and Precautions section of the Product Monograph for Dacogen[3].

Ongoing and Future Trials

In addition to the pivotal trials, there are ongoing clinical trials exploring the use of decitabine in combination with other therapies. For example, a phase II trial is investigating the safety and effectiveness of weekly low-dose decitabine and venetoclax for the treatment of myelodysplastic syndrome and acute myeloid leukemia[1].

Market Analysis

Current Market Size and Growth

The global myelodysplastic syndrome drug market, which includes Dacogen, was valued at USD 2.39 billion in 2022. This market is expected to grow significantly, reaching USD 5.79 billion by 2032 at a compound annual growth rate (CAGR) of 9.5%[5].

Market Segmentation

The market is segmented by drug type, with hypomethylating agents like Dacogen and Vidaza being key players. By route of administration, the market includes intravenous, subcutaneous, and oral routes. Geographically, North America holds the largest market share, but the Asia-Pacific region is projected to experience the fastest growth over the forecast period[5].

Key Players and Competitive Landscape

Celgene/Bristol-Myers Squibb’s Azacitidine currently holds the largest market share among first-line drugs for MDS, but Dacogen, along with other medications like Vidaza, remains a significant competitor. Other major players in the market include Otsuka Pharmaceutical Co. Ltd, Amgen Inc., and Takeda Pharmaceutical Company Ltd[5].

Market Projections

Growth Drivers

The growth of the MDS drug market, including Dacogen, is driven by several factors:

  • Increasing Prevalence: The rising incidence of myelodysplastic syndromes, particularly in aging populations.
  • Advancements in Therapies: New targeted therapies and immunotherapies, such as Rigosertib and SL-401, are expanding treatment options.
  • Healthcare Infrastructure: Growing healthcare investments in emerging economies like Brazil, India, and China are boosting market growth[5].

Regional Outlook

North America is expected to continue dominating the market due to high R&D investments and sophisticated healthcare infrastructure. However, the Asia-Pacific region is anticipated to grow rapidly due to increasing healthcare investments and a rising geriatric population[5].

Future Outlook

Emerging Trends

The market is expected to benefit from the expansion of existing drug labels for new indications and the introduction of new targeted therapies. For instance, late-stage clinical trials for medications like luspatercept and Aranesp, which help in growing the blood’s RBC count and reducing the need for frequent blood transfusions, are promising[5].

Challenges and Opportunities

While the market faces challenges such as low awareness and treatment stoppage due to side effects, it also presents significant opportunities. The growing need for effective treatments in emerging markets and the continuous development of novel therapies are key drivers for future growth.

Key Takeaways

  • Clinical Efficacy: Dacogen has demonstrated efficacy in treating MDS through Phase III and Phase II trials.
  • Market Growth: The global MDS drug market is projected to grow at a CAGR of 9.5% from 2022 to 2032.
  • Competitive Landscape: Dacogen competes with other hypomethylating agents, with Celgene/Bristol-Myers Squibb’s Azacitidine currently leading the market.
  • Regional Growth: North America dominates the market, but the Asia-Pacific region is expected to experience rapid growth.

FAQs

What is the current market size of the myelodysplastic syndrome drug market?

The global myelodysplastic syndrome drug market was valued at USD 2.39 billion in 2022[5].

What is the projected growth rate of the myelodysplastic syndrome drug market?

The market is expected to grow at a CAGR of 9.5% from 2022 to 2032[5].

Which regions are expected to drive the growth of the myelodysplastic syndrome drug market?

North America currently dominates the market, but the Asia-Pacific region is projected to experience the fastest growth over the forecast period[5].

What are the major drivers of the myelodysplastic syndrome drug market?

The market is driven by the increasing prevalence of MDS, advancements in therapies, and growing healthcare investments in emerging economies[5].

Who are the key players in the myelodysplastic syndrome drug market?

Key players include Celgene Corporation, Otsuka Pharmaceutical Co. Ltd, Amgen Inc., and Takeda Pharmaceutical Company Ltd[5].

Sources

  1. National Cancer Institute. Clinical Trials Using Decitabine.
  2. Business Wire. Global Leukemia Therapeutics Market to Reach $2.6 Billion by 2025.
  3. Health Canada. Summary Basis of Decision for Dacogen.
  4. National Cancer Institute. Clinical Trials Using Decitabine and Cedazuridine.
  5. Market.us. Myelodysplastic Syndrome Drug Market Size | CAGR of 9.5%.

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