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Last Updated: April 27, 2025

CLINICAL TRIALS PROFILE FOR OXCARBAZEPINE


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All Clinical Trials for OXCARBAZEPINE

Trial IDTitleStatusSponsorPhaseStart DateSummary
NCT00068770 ↗ Celecoxib in Patients With Newly Diagnosed GBM Who Are Receiving Anticonvulsant Drugs and Undergoing RT Terminated National Cancer Institute (NCI) Phase 2 2003-10-01 RATIONALE: Celecoxib may stop the growth of tumor cells by blocking the enzymes necessary for their growth. It is not yet known whether the effectiveness of celecoxib in treating glioblastoma multiforme is decreased in patients who are receiving anticonvulsant drugs and undergoing radiation therapy. PURPOSE: Phase II trial to study the effectiveness of celecoxib in treating patients who are receiving anticonvulsant drugs and undergoing radiation therapy for newly diagnosed glioblastoma multiforme.
NCT00068770 ↗ Celecoxib in Patients With Newly Diagnosed GBM Who Are Receiving Anticonvulsant Drugs and Undergoing RT Terminated Sidney Kimmel Comprehensive Cancer Center Phase 2 2003-10-01 RATIONALE: Celecoxib may stop the growth of tumor cells by blocking the enzymes necessary for their growth. It is not yet known whether the effectiveness of celecoxib in treating glioblastoma multiforme is decreased in patients who are receiving anticonvulsant drugs and undergoing radiation therapy. PURPOSE: Phase II trial to study the effectiveness of celecoxib in treating patients who are receiving anticonvulsant drugs and undergoing radiation therapy for newly diagnosed glioblastoma multiforme.
NCT00050947 ↗ Pediatric Epilepsy Study Completed Novartis Pharmaceuticals Phase 3 2002-07-01 This study will evaluate the safety and effectiveness of oxcarbazepine (Trileptal) as monotherapy in the treatment of partial seizures in pediatric patients 1 month to 3 years of age.
NCT00050934 ↗ Pediatric Epilepsy Study Completed Novartis Pharmaceuticals Phase 3 2002-06-01 This study will evaluate the safety and effectiveness of oxcarbazepine (Trileptal) as add-on therapy in the treatment of partial seizures in pediatric patients 1 month to 3 years of age.
>Trial ID>Title>Status>Phase>Start Date>Summary
Showing 1 to 4 of 4 entries

Clinical Trial Conditions for OXCARBAZEPINE

Condition Name

13554002468101214EpilepsyHealthySeizuresBipolar Disorder[disabled in preview]
Condition Name for OXCARBAZEPINE
Intervention Trials
Epilepsy 13
Healthy 5
Seizures 5
Bipolar Disorder 4
[disabled in preview] 0
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Condition MeSH

21131160-20246810121416182022EpilepsySeizuresEpilepsies, PartialNeuralgia[disabled in preview]
Condition MeSH for OXCARBAZEPINE
Intervention Trials
Epilepsy 21
Seizures 13
Epilepsies, Partial 11
Neuralgia 6
[disabled in preview] 0
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Clinical Trial Locations for OXCARBAZEPINE

Trials by Country

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Trials by Country for OXCARBAZEPINE
Location Trials
United States 139
Japan 34
Mexico 17
Germany 11
Canada 10
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Trials by US State

+
Trials by US State for OXCARBAZEPINE
Location Trials
Texas 8
New York 8
Georgia 8
Pennsylvania 7
Florida 7
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Clinical Trial Progress for OXCARBAZEPINE

Clinical Trial Phase

56.1%24.4%9.8%9.8%04681012141618202224Phase 4Phase 3Phase 2/Phase 3[disabled in preview]
Clinical Trial Phase for OXCARBAZEPINE
Clinical Trial Phase Trials
Phase 4 23
Phase 3 10
Phase 2/Phase 3 4
[disabled in preview] 4
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Clinical Trial Status

80.7%8.8%5.3%5.3%005101520253035404550CompletedTerminatedNot yet recruiting[disabled in preview]
Clinical Trial Status for OXCARBAZEPINE
Clinical Trial Phase Trials
Completed 46
Terminated 5
Not yet recruiting 3
[disabled in preview] 3
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Clinical Trial Sponsors for OXCARBAZEPINE

Sponsor Name

trials011223344556Novartis PharmaceuticalsRoxane LaboratoriesNovartis[disabled in preview]
Sponsor Name for OXCARBAZEPINE
Sponsor Trials
Novartis Pharmaceuticals 5
Roxane Laboratories 5
Novartis 5
[disabled in preview] 3
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Sponsor Type

59.8%37.3%00102030405060OtherIndustryNIH[disabled in preview]
Sponsor Type for OXCARBAZEPINE
Sponsor Trials
Other 61
Industry 38
NIH 2
[disabled in preview] 1
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Oxcarbazepine: Clinical Trials, Market Analysis, and Projections

Introduction to Oxcarbazepine

Oxcarbazepine is an anticonvulsant medication primarily used in the treatment of epilepsy, particularly for partial seizures. It is also sometimes prescribed off-label for bipolar disorder to stabilize mood swings. Here, we will delve into the current state of clinical trials, market analysis, and future projections for oxcarbazepine.

Clinical Trials Update

Ongoing and Completed Trials

Clinical trials for oxcarbazepine are continuously being conducted to evaluate its efficacy, safety, and optimal dosing regimens. The European Union Clinical Trials Register provides detailed information on protocol and results of various trials involving oxcarbazepine[4].

  • Approval and Efficacy: A significant clinical review by the FDA supported the approval of oxcarbazepine extended-release (XR) tablets, demonstrating efficacy at the 2400mg dose and potential therapeutic benefits starting at 1200mg[1].
  • Safety and Adverse Events: Studies have also focused on the safety profile of oxcarbazepine, highlighting common adverse events such as dizziness, headache, and nausea. Serious adverse events, although rare, include hyponatremia and hematological changes[1].

Market Analysis

Current Market Size and Growth

The oxcarbazepine market has been experiencing steady growth driven by several key factors:

  • Global Market Size: As of 2023, the oxcarbazepine drug market was valued at approximately USD 436 million. It is projected to reach USD 630.9 million by 2030, growing at a CAGR of 6.8% from 2024 to 2030[5].
  • Regional Markets: The market is segmented across North America, Europe, Asia Pacific, Latin America, and the Middle East & Africa. North America and Europe are significant markets due to high prevalence rates of epilepsy and bipolar disorder, while the Asia Pacific region is witnessing growth due to increasing awareness and improving healthcare infrastructure[5].

Market Drivers

Several factors are driving the growth of the oxcarbazepine market:

  • Growing Epilepsy Prevalence: An increase in the incidence of epilepsy worldwide is a major driver, as oxcarbazepine is a primary treatment option for this condition[5].
  • Increasing Awareness and Diagnosis: Greater awareness and diagnosis of epilepsy and other related illnesses are leading to higher demand for the medication[5].
  • Developments in Healthcare Infrastructure: Improvements in healthcare infrastructure, particularly in developing nations, are enhancing access to diagnosis and treatment, thereby boosting market growth[5].
  • Government Financing and Efforts: Government initiatives and financing for epilepsy treatment and awareness campaigns are also contributing to market expansion[5].

Market Projections

Future Growth and Trends

The oxcarbazepine market is expected to continue its growth trajectory due to several trends and factors:

  • Generic Versions: The introduction of generic versions of oxcarbazepine is making the medication more accessible and affordable, which is likely to propel market growth[5].
  • Research & Development: Advances in the science of treating epilepsy may lead to new formulations or applications for oxcarbazepine, further expanding the market[5].
  • Regulatory Environment: Changes in regulatory policies, particularly those related to drug approvals and pricing, will influence market dynamics[5].

Challenges and Limitations

Despite the positive outlook, there are several challenges that could impact the market:

  • Side Effects and Safety Issues: Reports of serious side effects or safety issues could lead to a decline in acceptance or regulatory actions[5].
  • Alternative Therapies: The availability of substitute therapies for the same indications could constrain market expansion[5].
  • Restricted Therapeutic Applications: Oxcarbazepine’s market potential may be limited if it is only authorized for a small number of indications[5].

Types and Applications of Oxcarbazepine

Forms of Oxcarbazepine

Oxcarbazepine is available in various forms to cater to different patient needs:

  • Tablets: The most common form, suitable for oral administration[5].
  • Oral Suspension: Liquid form, particularly useful for children or patients who have difficulty swallowing tablets[5].
  • Injectables: Less common, but used in certain medical settings for intravenous administration[5].

Applications

  • Epilepsy: Primarily used as an anticonvulsant for the treatment of epilepsy, including partial seizures[5].
  • Bipolar Disorder: Sometimes prescribed off-label to help stabilize mood swings in bipolar disorder[5].

Geographic Markets

The oxcarbazepine market is geographically segmented into:

  • North America: Significant market due to high prevalence rates of epilepsy and bipolar disorder[5].
  • Europe: Focus on accessibility and affordability of the drug[5].
  • Asia Pacific: Witnessing growth due to increasing awareness and improving healthcare infrastructure[5].
  • Latin America: Driven by increasing healthcare expenditure and prevalence of epilepsy[5].
  • Middle East & Africa: Smaller market but growing due to improving access to healthcare[5].

Key Takeaways

  • Clinical Trials: Ongoing trials continue to evaluate the efficacy and safety of oxcarbazepine, with significant support for its approval in extended-release formulations.
  • Market Growth: The market is projected to grow at a CAGR of 6.8% from 2024 to 2030, driven by increasing epilepsy prevalence, improving healthcare infrastructure, and government initiatives.
  • Challenges: Despite growth, the market faces challenges such as side effects, alternative therapies, and restricted therapeutic applications.
  • Forms and Applications: Available in tablets, oral suspension, and injectables, primarily used for epilepsy and sometimes for bipolar disorder.

FAQs

What is the primary use of oxcarbazepine?

Oxcarbazepine is primarily used as an anticonvulsant for the treatment of epilepsy, particularly for partial seizures.

What are the common forms of oxcarbazepine?

Oxcarbazepine is available in tablet, oral suspension, and injectable forms.

What is the projected market size of oxcarbazepine by 2030?

The oxcarbazepine drug market is projected to reach USD 630.9 million by 2030.

What are the key drivers of the oxcarbazepine market?

Key drivers include growing epilepsy prevalence, increasing awareness and diagnosis, developments in healthcare infrastructure, and government financing and efforts.

What are some potential challenges for the oxcarbazepine market?

Challenges include side effects and safety issues, alternative therapies, restricted therapeutic applications, and regulatory obstacles.

Sources

  1. FDA: Oxcarbazepine 202810 Clinical PREA - FDA
  2. OpenPR: Oxcarbazepine Market Projected to Witness Huge Growth
  3. Cognitive Market Research: Oxcarbazepine Drug Market Report 2024 (Global Edition)
  4. European Union Clinical Trials Register: Search for Oxcarbazepine - Clinical Trials register
  5. Verified Market Research: Oxcarbazepine Drug Market Size & Forecast

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