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Last Updated: February 11, 2025

CLINICAL TRIALS PROFILE FOR CLADRIBINE


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All Clinical Trials for Cladribine

Trial ID Title Status Sponsor Phase Start Date Summary
NCT00002805 ↗ Combination Chemotherapy in Treating Patients With Acute Myeloid Leukemia or Myelodysplastic Syndrome Completed National Cancer Institute (NCI) Phase 2 1997-08-01 RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. Combining more than one drug may kill more cancer cells. PURPOSE: Phase II trial to study the effectiveness of combination chemotherapy in treating patients with acute myeloid leukemia or myelodysplastic syndrome in first relapse or who did not achieve first remission.
NCT00002805 ↗ Combination Chemotherapy in Treating Patients With Acute Myeloid Leukemia or Myelodysplastic Syndrome Completed Children's Oncology Group Phase 2 1997-08-01 RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. Combining more than one drug may kill more cancer cells. PURPOSE: Phase II trial to study the effectiveness of combination chemotherapy in treating patients with acute myeloid leukemia or myelodysplastic syndrome in first relapse or who did not achieve first remission.
NCT00002833 ↗ Peripheral Stem Cell Transplantation Plus Filgrastim in Treating Patients With Acute or Chronic Myelogenous Leukemia Completed National Cancer Institute (NCI) Phase 2 1994-10-01 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. Colony stimulating factors such as filgrastim may increase the number of immune cells found in bone marrow or peripheral blood and may help a person's immune system recover from the side effects of chemotherapy. PURPOSE: Phase II trial to study the effectiveness of peripheral stem cell transplantation plus filgrastim in treating patients who have acute or chronic myelogenous leukemia.
>Trial ID >Title >Status >Phase >Start Date >Summary

Clinical Trial Conditions for Cladribine

Condition Name

Condition Name for Cladribine
Intervention Trials
Acute Myeloid Leukemia 27
Leukemia 19
Multiple Sclerosis 13
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Condition MeSH

Condition MeSH for Cladribine
Intervention Trials
Leukemia 78
Leukemia, Myeloid 52
Leukemia, Myeloid, Acute 52
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Clinical Trial Locations for Cladribine

Trials by Country

Trials by Country for Cladribine
Location Trials
United States 240
China 38
Canada 18
Germany 16
Poland 14
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Trials by US State

Trials by US State for Cladribine
Location Trials
Texas 22
Washington 16
Maryland 10
California 10
New York 10
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Clinical Trial Progress for Cladribine

Clinical Trial Phase

Clinical Trial Phase for Cladribine
Clinical Trial Phase Trials
Phase 4 11
Phase 3 16
Phase 2/Phase 3 7
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Clinical Trial Status

Clinical Trial Status for Cladribine
Clinical Trial Phase Trials
Recruiting 50
Completed 43
Unknown status 13
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Clinical Trial Sponsors for Cladribine

Sponsor Name

Sponsor Name for Cladribine
Sponsor Trials
National Cancer Institute (NCI) 33
M.D. Anderson Cancer Center 16
EMD Serono 8
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Sponsor Type

Sponsor Type for Cladribine
Sponsor Trials
Other 195
Industry 46
NIH 34
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Clinical Trials, Market Analysis, and Projections for Cladribine

Introduction to Cladribine

Cladribine, a chlorinated purine nucleoside analog, is a significant drug in the treatment of multiple sclerosis (MS) and certain hematological cancers. It has been approved in over 75 countries, including the United States and Europe, for various indications, particularly for highly active forms of relapsing-remitting MS and hairy cell leukemia[1][2][5].

Current Clinical Trials

Sublingual Cladribine Formulation

BioNxt Solutions Inc. is at the forefront of developing a novel sublingual formulation of cladribine, known as BNT23001. This new formulation is designed to offer an easier mode of administration, especially for patients with swallowing difficulties (dysphagia), a common symptom in MS patients.

  • Upcoming Clinical Trial: BioNxt plans to launch a pilot clinical trial in the second half of 2025 to compare the safety and efficacy of the sublingual cladribine formulation (BNT23001) with the existing tablet formulation, Mavenclad. The trial aims to determine if the sublingual formulation achieves comparable bioequivalence to Mavenclad[4].
  • Preclinical Success: In the first half of 2024, BioNxt reported positive results from animal toxicity and pharmacokinetics (PK) studies. These studies showed zero adverse clinical abnormalities and demonstrated highly comparable rapid absorption and bioequivalence between the sublingual product and the name-brand reference drug[1][5].

Market Analysis

Market Size and Growth

The global Multiple Sclerosis drug market, where cladribine is a key player, is projected to top USD 41 billion by 2033. This growth is driven by several factors:

  • Increasing MS Prevalence: The growing prevalence of MS, particularly in North America and Europe, is a significant driver. Approximately 2.3 million people worldwide live with MS, with the highest prevalence in these regions[1][2][5].
  • Expanding Geriatric Population: An aging population also contributes to the increased demand for MS treatments, as the incidence of MS tends to rise with age[2].

Market Drivers

  • Diverse Pipeline of Formulations: The availability of novel cladribine formulations, including the sublingual form by BioNxt, is expected to drive market growth. These innovative delivery systems aim to maximize efficacy while minimizing side effects[2].
  • Awareness Campaigns: Augmented awareness campaigns that educate patients about the benefits of early treatment interventions are also boosting the market[2].

Market Restraints

  • Regulatory Challenges: Stringent regulatory processes and high development costs pose significant challenges to the market growth of cladribine drugs[2].
  • Side Effects and Safety Concerns: The drug is associated with side effects such as severe lymphopenia and an increased risk of malignancies, which necessitate careful patient management and monitoring. These safety concerns have historically impacted its approval and usage[3].

Market Opportunities

  • Emerging Markets: Exploring untapped markets in emerging economies could significantly enhance cladribine drug sales. Developing generic versions of cladribine to cater to cost-sensitive markets is another opportunity[2].
  • Regulatory Approvals: Capitalizing on regulatory approvals in underserved regions can expand the market presence of cladribine[2].

Competitive Landscape

Key Players

The cladribine market is dominated by several key players, including:

  • Merck KGaA: Known for its brand Mavenclad, which is a tablet formulation of cladribine approved for relapsing forms of MS[1][2][5].
  • BioNxt Solutions Inc.: Developing a proprietary sublingual cladribine formulation, BNT23001[1][4][5].
  • Other Players: Companies like Abcam plc, Adooq Bioscience, Bio-Techne Corporation, and others are also involved in the research and development of cladribine and related products[2].

Porter’s Five Forces Analysis

The Porter’s Five Forces model provides a comprehensive analysis of the competitive landscape:

  • Threat of New Entrants: The high development costs and stringent regulatory processes act as barriers to new entrants[2].
  • Bargaining Power of Suppliers: The dependence on specific suppliers for raw materials and manufacturing services can influence the bargaining power[2].
  • Bargaining Power of Buyers: Patients and healthcare providers have some bargaining power due to the availability of alternative treatments and the need for cost-effective options[2].
  • Threat of Substitute Products: The emergence of new therapies and treatments for MS and hematological cancers poses a threat to cladribine’s market share[2].
  • Competitive Rivalry Among Existing Competitors: The market is highly competitive, with several players vying for market share through innovative formulations and strategic partnerships[2].

Future Projections

Market Expansion

The cladribine market is expected to expand significantly due to:

  • Innovative Delivery Systems: The development of sublingual and other innovative delivery systems will enhance patient compliance and efficacy[1][4].
  • Regulatory Approvals: Securing patents and regulatory approvals in major jurisdictions will further solidify the market presence of new formulations[4].

Challenges and Opportunities

Despite the growth potential, the market faces challenges such as managing side effects, navigating regulatory hurdles, and competing with emerging therapies. However, opportunities in emerging markets, generic versions, and increased awareness campaigns are expected to drive the market forward[2].

Key Takeaways

  • Clinical Trials: BioNxt is set to launch a clinical trial for its sublingual cladribine formulation in 2025.
  • Market Growth: The global MS drug market is projected to reach USD 41 billion by 2033.
  • Market Drivers: Increasing MS prevalence, expanding geriatric population, and innovative formulations are key drivers.
  • Market Restraints: Regulatory challenges, high development costs, and side effects are significant restraints.
  • Competitive Landscape: Key players include Merck KGaA and BioNxt Solutions Inc., with a highly competitive market environment.

FAQs

What is the current status of BioNxt's sublingual cladribine formulation?

BioNxt's sublingual cladribine formulation, BNT23001, is set to enter clinical trials in the second half of 2025 to compare its safety and efficacy with the existing tablet formulation, Mavenclad[4].

What are the main indications for cladribine?

Cladribine is approved for the treatment of highly active forms of relapsing-remitting multiple sclerosis and certain forms of leukemia, such as hairy cell leukemia[1][2][5].

What are the significant side effects associated with cladribine?

Cladribine is associated with severe lymphopenia and an increased risk of malignancies, which require careful patient monitoring and management[3].

How is the global MS drug market expected to grow?

The global MS drug market is projected to top USD 41 billion by 2033, driven by increasing MS prevalence, an expanding geriatric population, and innovative drug formulations[1][2][5].

What are the key challenges facing the cladribine market?

The market faces challenges such as stringent regulatory processes, high development costs, and potential competition from emerging therapies, as well as managing side effects like severe lymphopenia[2].

Sources

  1. BioNxt Provides Update on Cladribine Program for Multiple Sclerosis, Sublingual Neurodegenerative Disease Patent, and Investor Relations Activities. BioSpace.
  2. Cladribine Drugs Market Size & Share 2025-2030. 360iResearch.
  3. Clinical Pharmacology and Biopharmaceutics Review(s). FDA.
  4. Clinical trial testing sublingual cladribine planned for next year. Multiple Sclerosis News Today.
  5. BioNxt Reports Successful Results From ODF Cladribine PK Study. BioSpace.

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