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Last Updated: February 7, 2025

CLINICAL TRIALS PROFILE FOR SERVISONE


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505(b)(2) Clinical Trials for Servisone

This table shows clinical trials for potential 505(b)(2) applications. See the next table for all clinical trials
Trial Type Trial ID Title Status Sponsor Phase Start Date Summary
OTC NCT03742258 ↗ Combination Chemotherapy and TAK-659 as Front-Line Treatment in Treating Patients With High-Risk Diffuse Large B Cell Lymphoma Active, not recruiting National Cancer Institute (NCI) Phase 1 2019-03-13 The purpose of this research study is to evaluate a new investigational drug, TAK-659, given in combination with standard chemotherapy, for the treatment of Diffuse Large B-cell Lymphoma (DLBCL). ?Investigational? means that TAK-659 has not been approved by the United States Food and Drug Administration (FDA) for use as a prescription or over-the-counter medication to treat a certain condition. The primary purpose of this study is to find the appropriate and safe dose of the study drug to be used in combination with standard chemotherapy for the treatment of your disease and to determine how well the drug works in treating the disease. Other objectives include measuring the amount of the study drug in the body at different times after taking the study drug. Participation in the study is expected to last for up to 3 years after receiving the last dose of the study drug. Patients will receive the study treatment for up to 18 weeks, as long as they are benefitting.
OTC NCT03742258 ↗ Combination Chemotherapy and TAK-659 as Front-Line Treatment in Treating Patients With High-Risk Diffuse Large B Cell Lymphoma Active, not recruiting Northwestern University Phase 1 2019-03-13 The purpose of this research study is to evaluate a new investigational drug, TAK-659, given in combination with standard chemotherapy, for the treatment of Diffuse Large B-cell Lymphoma (DLBCL). ?Investigational? means that TAK-659 has not been approved by the United States Food and Drug Administration (FDA) for use as a prescription or over-the-counter medication to treat a certain condition. The primary purpose of this study is to find the appropriate and safe dose of the study drug to be used in combination with standard chemotherapy for the treatment of your disease and to determine how well the drug works in treating the disease. Other objectives include measuring the amount of the study drug in the body at different times after taking the study drug. Participation in the study is expected to last for up to 3 years after receiving the last dose of the study drug. Patients will receive the study treatment for up to 18 weeks, as long as they are benefitting.
>Trial Type >Trial ID >Title >Status >Phase >Start Date >Summary

All Clinical Trials for Servisone

Trial ID Title Status Sponsor Phase Start Date Summary
NCT00025259 ↗ Chemotherapy With or Without Additional Chemotherapy and/or Radiation Therapy in Treating Children With Newly Diagnosed Hodgkin's Disease Completed National Cancer Institute (NCI) Phase 3 2002-09-01 This randomized phase III trial is studying different chemotherapy regimens given with or without radiation therapy to compare how well they work in treating children with newly diagnosed Hodgkin's disease. Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. Giving the drugs in different combinations may kill more cancer cells. Radiation therapy uses high-energy x-rays to damage cancer cells. It is not yet known if chemotherapy is more effective with or without additional chemotherapy and/or radiation therapy in treating Hodgkin's disease.
NCT00025259 ↗ Chemotherapy With or Without Additional Chemotherapy and/or Radiation Therapy in Treating Children With Newly Diagnosed Hodgkin's Disease Completed Children's Oncology Group Phase 3 2002-09-01 This randomized phase III trial is studying different chemotherapy regimens given with or without radiation therapy to compare how well they work in treating children with newly diagnosed Hodgkin's disease. Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. Giving the drugs in different combinations may kill more cancer cells. Radiation therapy uses high-energy x-rays to damage cancer cells. It is not yet known if chemotherapy is more effective with or without additional chemotherapy and/or radiation therapy in treating Hodgkin's disease.
NCT00075725 ↗ Dexamethasone Compared With Prednisone During Induction Therapy and Methotrexate With or Without Leucovorin During Maintenance Therapy in Treating Patients With Newly Diagnosed High-Risk Acute Lymphoblastic Leukemia Completed National Cancer Institute (NCI) Phase 3 2003-12-29 This randomized phase III trial is studying dexamethasone to see how well it works compared to prednisone during induction therapy. This trial is also studying methotrexate and leucovorin calcium to see how well they work compared to methotrexate alone during maintenance therapy in treating patients with newly diagnosed acute lymphoblastic leukemia (ALL). Drugs used in chemotherapy, such as dexamethasone, prednisone, methotrexate, and leucovorin calcium, work in different ways to stop cancer cells from dividing so they stop growing or die. Giving more than one drug may kill more cancer cells. It is not yet known which combination chemotherapy regimen is more effective in treating acute lymphoblastic leukemia.
NCT00075725 ↗ Dexamethasone Compared With Prednisone During Induction Therapy and Methotrexate With or Without Leucovorin During Maintenance Therapy in Treating Patients With Newly Diagnosed High-Risk Acute Lymphoblastic Leukemia Completed Children's Oncology Group Phase 3 2003-12-29 This randomized phase III trial is studying dexamethasone to see how well it works compared to prednisone during induction therapy. This trial is also studying methotrexate and leucovorin calcium to see how well they work compared to methotrexate alone during maintenance therapy in treating patients with newly diagnosed acute lymphoblastic leukemia (ALL). Drugs used in chemotherapy, such as dexamethasone, prednisone, methotrexate, and leucovorin calcium, work in different ways to stop cancer cells from dividing so they stop growing or die. Giving more than one drug may kill more cancer cells. It is not yet known which combination chemotherapy regimen is more effective in treating acute lymphoblastic leukemia.
NCT00390793 ↗ Combination Chemotherapy and Dasatinib in Treating Participants With Philadelphia Positive or BCR-ABL Positive Acute Lymphoblastic Leukemia. Active, not recruiting Bristol-Myers Squibb Phase 2 2006-09-28 This phase II trial studies how well combination chemotherapy and dasatinib works in treating participants with Philadelphia-positive or B-cell receptor-ABL positive acute lymphoblastic leukemia. Drugs used in chemotherapy, such as cyclophosphamide, vincristine, doxorubicin, dexamethasone, methotrexate, and cytarabine, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Dasatinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Giving chemotherapy in combination with dasatinib may work better in treating participants with Philadelphia-positive or BCR-ABL positive acute lymphoblastic leukemia.
NCT00390793 ↗ Combination Chemotherapy and Dasatinib in Treating Participants With Philadelphia Positive or BCR-ABL Positive Acute Lymphoblastic Leukemia. Active, not recruiting National Cancer Institute (NCI) Phase 2 2006-09-28 This phase II trial studies how well combination chemotherapy and dasatinib works in treating participants with Philadelphia-positive or B-cell receptor-ABL positive acute lymphoblastic leukemia. Drugs used in chemotherapy, such as cyclophosphamide, vincristine, doxorubicin, dexamethasone, methotrexate, and cytarabine, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Dasatinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Giving chemotherapy in combination with dasatinib may work better in treating participants with Philadelphia-positive or BCR-ABL positive acute lymphoblastic leukemia.
NCT00390793 ↗ Combination Chemotherapy and Dasatinib in Treating Participants With Philadelphia Positive or BCR-ABL Positive Acute Lymphoblastic Leukemia. Active, not recruiting M.D. Anderson Cancer Center Phase 2 2006-09-28 This phase II trial studies how well combination chemotherapy and dasatinib works in treating participants with Philadelphia-positive or B-cell receptor-ABL positive acute lymphoblastic leukemia. Drugs used in chemotherapy, such as cyclophosphamide, vincristine, doxorubicin, dexamethasone, methotrexate, and cytarabine, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Dasatinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Giving chemotherapy in combination with dasatinib may work better in treating participants with Philadelphia-positive or BCR-ABL positive acute lymphoblastic leukemia.
>Trial ID >Title >Status >Phase >Start Date >Summary

Clinical Trial Conditions for Servisone

Condition Name

Condition Name for Servisone
Intervention Trials
Acute Lymphoblastic Leukemia 14
Untreated Adult Acute Lymphoblastic Leukemia 9
Leukemia 9
B Acute Lymphoblastic Leukemia 9
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Condition MeSH

Condition MeSH for Servisone
Intervention Trials
Lymphoma 36
Leukemia 33
Precursor Cell Lymphoblastic Leukemia-Lymphoma 32
Leukemia, Lymphoid 32
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Clinical Trial Locations for Servisone

Trials by Country

Trials by Country for Servisone
Location Trials
Canada 74
Australia 28
New Zealand 13
Puerto Rico 7
Israel 4
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Trials by US State

Trials by US State for Servisone
Location Trials
Texas 50
California 38
Washington 37
Illinois 34
Ohio 33
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Clinical Trial Progress for Servisone

Clinical Trial Phase

Clinical Trial Phase for Servisone
Clinical Trial Phase Trials
Phase 3 17
Phase 2/Phase 3 3
Phase 2 47
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Clinical Trial Status

Clinical Trial Status for Servisone
Clinical Trial Phase Trials
Recruiting 37
Active, not recruiting 22
Not yet recruiting 12
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Clinical Trial Sponsors for Servisone

Sponsor Name

Sponsor Name for Servisone
Sponsor Trials
National Cancer Institute (NCI) 77
M.D. Anderson Cancer Center 23
University of Washington 8
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Sponsor Type

Sponsor Type for Servisone
Sponsor Trials
Other 81
NIH 78
Industry 28
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Clinical Trials, Market Analysis, and Projections for Servier's Drugs: A Comprehensive Overview

Introduction

Servier, a global pharmaceutical company, is actively involved in various clinical trials and market endeavors, particularly in the realms of oncology, cardiovascular diseases, and neuropsychiatric disorders. This article will delve into the current state of Servier's clinical trials, market analysis, and future projections for their drugs.

Clinical Trials Overview

Ongoing and Recent Trials

Servier is conducting a multitude of clinical trials across different therapeutic areas. Here are some notable examples:

  • Oncology: Servier is involved in several Phase 1 and Phase 3 trials for cancer treatments. For instance, the "SPLFIO-174" trial is a Phase 1b/2 study evaluating the safety and efficacy of select immunotherapy combinations in participants with advanced non-small cell lung cancer[1].
  • Neuropsychiatric Diseases: The "S221237-176" trial is a Phase 1 comparative pharmacokinetic study of three prolonged release formulations and one immediate release formulation of S221237, targeting neuropsychiatric diseases[1].
  • Cardiovascular Diseases: The "CL3-06593-018" trial assesses the clinical efficacy and safety of a combination of perindopril, indapamide, and amlodipine in patients with cardiovascular diseases[1].

Impact of COVID-19

The COVID-19 pandemic has significantly influenced the clinical trial landscape. Many companies, including Servier, have adapted by investing in virtual clinical trials and accelerating research on COVID-19 treatments. This shift has been driven by the urgent need for effective therapies and the challenges posed by traditional trial methodologies during the pandemic[3].

Market Analysis

Global Drug Delivery Systems Market

The global drug delivery systems market, which is relevant to Servier's product portfolio, was valued at USD 42.71 billion in 2023 and is projected to reach USD 63.38 billion by 2032, growing at a CAGR of 4.0% from 2024 to 2032[2].

Regional Market Dynamics

  • North America: This region dominated the market in 2023 with a value of USD 17.33 billion. The demand is driven by increased hospital admissions and the rise in COVID-19 vaccination drives[2].
  • Europe: Europe held the second-largest market share and is expected to register a significant CAGR during the forecast period, driven by the adoption of advanced drug delivery devices[2].
  • Asia Pacific: This region is expected to record the highest CAGR due to a large patient population, growing healthcare expenditure, and increasing COVID-19 vaccination efforts[2].

Targeted Drug Delivery Market

The targeted drug delivery market, another area of interest for Servier, was valued at USD 6,960 million in 2021 and is projected to reach USD 26,468 million by 2030, growing at a CAGR of 16% from 2021 to 2030[5].

Disease Type Segmentation

  • Cardiovascular Diseases: This segment dominated the market in 2021 with a 21% market share, driven by the lack of effective public health initiatives to eliminate cardiovascular risk factors[5].

Market Projections

Growth Drivers

Several factors are expected to drive the growth of the markets relevant to Servier's drugs:

  • Rising Prevalence of Chronic Diseases: The increasing incidence of chronic diseases such as cancer, cardiovascular diseases, and diabetes is a significant driver for both the drug delivery systems and targeted drug delivery markets[2][5].
  • Technological Advancements: The development of advanced drug delivery systems, including sensor-embedded devices and metered-dose inhalers, is expected to boost market growth[2].
  • Research and Development: Increased R&D activities and the introduction of new products by key players are crucial for market expansion[2][5].

Key Players and Competitive Landscape

Servier operates in a competitive landscape alongside major players such as BD, Baxter International Inc., Gerresheimer AG, and West Pharmaceutical Services Inc. in the drug delivery systems market. In the targeted drug delivery market, key players include AstraZeneca plc., Pfizer, Inc., Novartis AG, and Johnson and Johnson Services Inc.[2][5].

Future Outlook

Emerging Trends

  • Personalized Medicine: The globalization of clinical trials and the penetration of personalized medicine are expected to positively impact the market growth[3].
  • Virtual Clinical Trials: The adoption of virtual clinical trials is likely to continue, driven by the efficiency and cost-effectiveness they offer compared to traditional trials[3].

Regulatory Environment

Clinical trials and drug approvals are heavily regulated. Servier must navigate these regulatory landscapes to ensure timely approvals for their drugs. For instance, Phase III trials, which account for a significant portion of the clinical trials market, require extensive regulatory compliance and often involve a large number of patients and longer treatment periods[3].

Key Takeaways

  • Servier's Clinical Trials: Servier is actively engaged in various clinical trials across oncology, neuropsychiatric diseases, and cardiovascular diseases.
  • Market Growth: The global drug delivery systems and targeted drug delivery markets are expected to grow significantly, driven by rising chronic disease prevalence, technological advancements, and increased R&D.
  • Regional Dynamics: North America and Europe are key markets, with Asia Pacific expected to show the highest CAGR in the coming years.
  • Competitive Landscape: Servier competes with major pharmaceutical and medical device companies, emphasizing the need for innovative products and strong R&D.

FAQs

What is the current state of Servier's clinical trials in oncology?

Servier is conducting several clinical trials in oncology, including Phase 1 and Phase 3 studies. For example, the "SPLFIO-174" trial is evaluating immunotherapy combinations in advanced non-small cell lung cancer[1].

How has the COVID-19 pandemic impacted clinical trials?

The COVID-19 pandemic has accelerated the adoption of virtual clinical trials and increased investment in novel drug development, particularly for COVID-19 treatments[3].

What is the projected growth of the global drug delivery systems market?

The global drug delivery systems market is projected to grow from USD 42.71 billion in 2023 to USD 63.38 billion by 2032, at a CAGR of 4.0% from 2024 to 2032[2].

Which region is expected to show the highest CAGR in the targeted drug delivery market?

The Asia Pacific region is expected to record the highest CAGR in the targeted drug delivery market due to a large patient population and increasing healthcare expenditure[5].

What are the key drivers for the growth of the targeted drug delivery market?

The key drivers include the rising prevalence of chronic diseases, increased R&D activities, and the adoption of inorganic growth strategies by key players[5].

Sources

  1. Servier Clinical Trials: Find Clinical Trials - Servier.
  2. Drug Delivery Systems Market: Fortune Business Insights - Drug Delivery Systems Market Size, Share | Global Report [2032].
  3. Clinical Trials Market: Grand View Research - Clinical Trials Market Size, Share And Growth Report, 2030.
  4. NIH Clinical Trials: National Institutes of Health - In the News | NIH Clinical Research Trials You.
  5. Targeted Drug Delivery Market: Spherical Insights - Targeted Drug Delivery Market Growth, Share, Report to 2030.

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