CLINICAL TRIALS PROFILE FOR TEGRETOL

All Clinical Trials for TEGRETOL

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT00000441 ↗	Drug Therapy for Alcohol Detoxification	Completed	National Institute on Alcohol Abuse and Alcoholism (NIAAA)	Phase 4	1969-12-31	This project will provide relevant clinical information for primary care practitioners treating alcohol withdrawal syndrome in outpatient settings. This double-blind, placebo- controlled clinical trial will compare the effectiveness of lorazepam (Ativan) and carbamazepine (Tegretol) in alcoholics who meet the criteria for a diagnosis of uncomplicated alcohol withdrawal syndrome. Participants are randomized to five days of treatment with a 1-week posttreatment followup.
NCT00005951 ↗	Irinotecan Plus Temozolomide in Treating Patients With Recurrent Primary Malignant Glioma	Completed	National Cancer Institute (NCI)	Phase 1	2000-08-01	RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug may kill more tumor cells. PURPOSE: Phase I trial to study the effectiveness of irinotecan plus temozolomide in treating patients who have recurrent primary malignant glioma.
NCT00005951 ↗	Irinotecan Plus Temozolomide in Treating Patients With Recurrent Primary Malignant Glioma	Completed	Duke University	Phase 1	2000-08-01	RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug may kill more tumor cells. PURPOSE: Phase I trial to study the effectiveness of irinotecan plus temozolomide in treating patients who have recurrent primary malignant glioma.
NCT00006395 ↗	Drug Interaction Study of Tegretol (Carbamazepine) and St. John's Wort in Normal Volunteers	Completed	National Institutes of Health Clinical Center (CC)	Phase 4	2000-10-01	St. John's Wort is a popular dietary supplement that many patients-including those with epilepsy or seizures-take in addition to their regular medicines to elevate mood or relieve stress. Preliminary research indicates that this supplement can speed the metabolism of the anti-seizure drug Tegretol, causing reduced blood levels of the drug. Patients who take Tegretol to control their seizures may have more frequent seizures if the blood level of the drug drops too low. A recent study shows that this effect is not seen when Tegretol is taken for at least 3 weeks. The present study will examine whether there is a medically important drug interaction between St. John's wort and Tegretol when Tegretol is taken for 1 day. Normal healthy volunteers between 21 and 65 years old who are not taking medicines that can affect the metabolism of drugs in the liver and have not used St. John's wort for at least 30 days may be eligible for this 25-day study. Participants will take a 400-mg dose of Tegretol after fasting overnight. Blood samples will be drawn the next day during a 12-hour clinic stay at the following intervals: just before the Tegretol dose and at 1, 2, 4, 6, 8, 10, 24, 34, 48 and 72 hours after the dose. A catheter will be placed in the vein to prevent the need for multiple needle sticks until after the 10-hour sample. After completing the blood sampling, participants will take 300 mg of St. John's wort 3 times a day with meals for 2 weeks. After 2 weeks, another fasting dose of Tegretol will be given and the 72-hour blood study will be repeated. This study may provide information important for the care of patients with epilepsy who take both Tegretol and St. John's Wort.
NCT00108069 ↗	Tamoxifen and Bortezomib to Treat Recurrent Brain Tumors	Completed	National Cancer Institute (NCI)	Phase 2	2005-04-01	This study will determine whether the drugs tamoxifen and bortezomib can delay tumor growth in patients with recurrent glioma (malignant brain tumor). Tamoxifen may work by interfering with the internal signaling needed for the cancer to grow. Bortezomib may also interfere with tumor growth processes. Laboratory studies show that low doses of bortezomib significantly enhance glioma cell death when used with tamoxifen. Patients 18 years of age and older with glioma whose tumor does not respond to standard medical treatment and who are not taking enzyme-inducing anti-seizure medications such as Dilantin, phenobarbitol, or Tegretol, may be eligible for this study. Candidates are screened with a physical examination, blood tests, and magnetic resonance imaging (MRI) or computed tomography (CT). MRI and CT scans produce images of the brain that can show if the brain tumor is growing (see below). Participants receive treatment in 6-week cycles for up to 1 year. (The treatment duration may be extended in some patients who continue to tolerate the drug and show no signs of tumor growth after 1 year.) During each cycle, patients take six tamoxifen tablets twice a day every day and receive bortezomib by infusion into a vein on days 3, 6, 10, 13, 24, 27, 31 and 34. Treatment may continue as long as the tumor does not grow and the patient does not develop unacceptable side effects. In addition to drug treatment, patients undergo the following tests and procedures: - Periodic routine blood tests. - MRI or CT scan of the head before starting each new cycle. MRI uses a magnetic field and radio waves to produce images of body tissues and organs. CT uses x-rays to provide 3-dimensional views of the part of the body being studied. For both procedures, the patient lies on a table that slides into the cylindrical scanner. - Blood test to measure levels of bortezomib. Blood is drawn before the bortezomib infusion on days 3 and 24, and 4 hours after the infusion on day 24 of the first treatment cycle only. - Dynamic MRI with spectroscopy or positron emission tomography (PET). Patients may be asked to undergo one of these tests, which help distinguish live tumor from dying tumor. The experience of dynamic MRI with spectroscopy is the same as standard MRI and is done at the same time as the standard procedure (see above). PET uses a radioactive substance to show cellular activity in specific tissues of the body. The patient is given an injection of a sugar solution in which a radioactive isotope has been attached to the sugar molecule. A special camera detects the radiation emitted by the radioisotope, and the resulting images show how much glucose is being used in various parts of the body. Because rapidly growing cells, such as tumors, take up and use more glucose than normal cells do, this test can be used to show active tumors. - Drug diary. Patients maintain a calendar to record when they take their study drugs and what side effects they develop.
NCT00441142 ↗	Zactima With Temodar During Radiation Treatment for Newly Diagnosed Stage IV Brain Tumors	Completed	Beth Israel Deaconess Medical Center	Phase 1/Phase 2	2007-05-25	Phase I: The purpose of this research study is to determine the safety of the combination treatment of ZD6474 (Vandetanib) with the standard therapy for glioblastomas and gliosarcomas, temozolomide (Temodar) and radiation therapy. This agent is investigational for the treatment of glioblastomas. We will determine the highest dose of ZD6474 (Vandetanib) that can be given safely when combined with temozolomide (Temodar) and radiation therapy. Phase II: The purpose of this research study is to determine the efficacy of the combination treatment of ZD6474 (Vandetanib) with the standard therapy for glioblastomas and gliosarcomas, temozolomide (Temodar) and radiation therapy. This agent is investigational for the treatment of glioblastomas. All subjects participating in this research study must NOT be taking a certain type of anti-seizure medication called enzyme inducing anticonvulsant drugs. These drugs include (but are not limited to) the following medications: Dilantin, Tegretol, Phenobarbital and trileptal.

Clinical Trial Conditions for TEGRETOL

Condition Name

Condition Name for TEGRETOL
Intervention	Trials
Epilepsy	5
Gliosarcoma	3
Glioblastoma	2
Healthy	2

Condition MeSH

Condition MeSH for TEGRETOL
Intervention	Trials
Epilepsy	7
Glioma	4
Gliosarcoma	3
Glioblastoma	3

Clinical Trial Locations for TEGRETOL

Trials by Country

Trials by Country for TEGRETOL
Location	Trials
United States	14
Korea, Republic of	2
China	2
Indonesia	2
Belgium	2

Trials by US State

Trials by US State for TEGRETOL
Location	Trials
North Carolina	4
Maryland	2
Massachusetts	1
South Carolina	1
California	1

Clinical Trial Progress for TEGRETOL

Clinical Trial Phase

Clinical Trial Phase for TEGRETOL
Clinical Trial Phase	Trials
Phase 4	13
Phase 3	1
Phase 2	2

Clinical Trial Status

Clinical Trial Status for TEGRETOL
Clinical Trial Phase	Trials
Completed	19
Recruiting	3
Withdrawn	1

Clinical Trial Sponsors for TEGRETOL

Sponsor Name

Sponsor Name for TEGRETOL
Sponsor	Trials
Duke University	3
National Cancer Institute (NCI)	2
University Health Network, Toronto	1

Sponsor Type

Sponsor Type for TEGRETOL
Sponsor	Trials
Other	23
Industry	11
NIH	4

Clinical Trials Update, Market Analysis, and Projection for Tegretol

Last updated: October 28, 2025

Introduction

Tegretol (carbamazepine), developed by Novartis, remains a cornerstone in the management of epilepsy and certain neuropathic pain conditions. Since its approval in the 1960s, Tegretol has accrued a robust clinical profile and a significant market share. This report synthesizes recent clinical trial data, evaluates market dynamics, and offers projections for Tegretol, guiding stakeholders on current trends and future potential.

Clinical Trials Update

Recent Clinical Trials and Research Insights

While Tegretol is an established medication, ongoing clinical research continues to refine its application spectrum and safety profile.

• Epilepsy Management Trials: Recent studies focus on carbamazepine's efficacy for various epilepsy subtypes. A 2022 randomized controlled trial published in Epilepsia examined its long-term efficacy in partial seizures, confirming sustained seizure control with manageable adverse effects [1].

• Neuropathic Pain and Trigeminal Neuralgia: Multiple trials investigate carbamazepine as third-line treatment for conditions such as trigeminal neuralgia. A 2021 meta-analysis demonstrated significant pain reduction with acceptable tolerability [2].

• Pharmacogenomics and Safety: Notably, research into pharmacogenomics (e.g., HLA-B*1502 allele testing) enhances safety, particularly for Asian populations at increased risk of Stevens-Johnson syndrome. Clinical guidelines now recommend genetic screening prior to initiation [3].

• Drug-Interaction Studies: Emerging data explore interactions with newer antiepileptic drugs (e.g., levetiracetam, lacosamide). Findings suggest carbamazepine's interaction profile necessitates careful monitoring when co-administered with other CYP450 inducers or inhibitors [4].

Regulatory and Market Access Developments

• Labeling Updates: The FDA in 2020 updated carbamazepine’s labeling to include pharmacogenomic considerations, influencing prescribing practices.

• Generic Competition: The patent expiry period has led to a proliferation of generic formulations, maintaining price competitiveness and accessible treatment options, especially in emerging markets.

Market Analysis

Market Size and Segmentation

As of 2023, the global anticonvulsant market is valued at approximately USD 4.5 billion, with Tegretol occupying a significant segment—estimated at USD 1.2 billion—due to its proven efficacy and widespread use [5].

Key segments include:

• Epilepsy Treatment: Constitutes roughly 65% of Tegretol's sales, given its longstanding status as a first- or second-line therapy worldwide.

• Neuropathic Pain: Accounts for about 20%, especially in treating trigeminal neuralgia and diabetic neuropathy.

• Other Indications: Include bipolar disorder and off-label uses, though these comprise a smaller market share.

Geographical Market Trends

• North America: Maintains the largest market share (~45%), driven by high epilepsy prevalence and robust healthcare infrastructure.

• Europe: Significant demand, driven by national guidelines endorsing carbamazepine as a first-line therapy.

• Asia-Pacific: Fast-growing segment (~25%), fueled by increasing epilepsy diagnosis rates, rising healthcare access, and the availability of generic formulations.

• Emerging Markets: Countries like India and Brazil are seeing increased penetration owing to affordability and expanding healthcare coverage.

Market Drivers

• Established Efficacy and Safety Profile: Long-standing clinical validation sustains clinician confidence.

• Cost-Effectiveness: Generic availability ensures affordability, particularly in low- and middle-income countries.

• Guideline Endorsements: Leading neurological and psychiatric associations continue to recommend carbamazepine, reinforcing its market position.

Challenges and Competitive Landscape

Despite its advantages, Tegretol faces challenges:

• Safety Concerns: Risks of hematologic and dermatologic adverse effects necessitate careful patient screening and monitoring.

• Emergence of Newer AEDs: Medications like levetiracetam and lamotrigine offer better safety profiles, reducing Tegretol’s market share in some regions.

• Regulatory Restrictions: Pharmacogenomic considerations and labeling updates impact prescribing practices.

Market Projection and Future Outlook

Forecast Overview (2023-2030)

The anticonvulsant market is projected to grow at a CAGR of approximately 4.2%, reaching USD 6.1 billion by 2030. Tegretol is expected to maintain a substantial share due to its entrenched clinical use, but its relative market dominance may modestly decline as newer therapies gain traction.

Factors Influencing Future Growth

• Continued Use in Selected Indications: Tegretol remains a first-line choice for trigeminal neuralgia, with clinical guidelines strongly supporting its use.

• Pharmacogenomic Integration: Advances in genetic screening improve safety outcomes, possibly expanding the patient population eligible for Tegretol.

• Generic Market Expansion: Cost competitiveness sustains its use in emerging markets where affordability is crucial.

• Innovation in Formulations: Development of extended-release formulations may enhance tolerability and patient adherence, potentially boosting sales.

• Competitive Dynamics: The rise of newer AEDs with improved safety profiles could cannibalize market share, emphasizing the need for differentiation via combination therapies or novel indications.

Strategic Recommendations

Stakeholders should consider:

• Fostering Pharmacogenomic Innovation: To optimize safety and expand the patient pool.

• Investing in Post-Marketing Surveillance: Continually demonstrating Tegretol’s safety and efficacy.

• Market Penetration in Emerging Economies: Leveraging cost advantages and expanding access.

• Potential for New Indications: Exploring off-label uses in psychiatric and neurological disorders.

Key Takeaways

• Tegretol remains a vital antiepileptic with ongoing research reaffirming its efficacy, especially for partial seizures and trigeminal neuralgia.

• Market-wise, generic formulation proliferation sustains its affordability and accessibility, especially in low- to middle-income nations.

• Regulatory updates emphasizing pharmacogenomics are shaping prescribing practices, promising enhanced safety profiles.

• Despite increasing competition, Tegretol's entrenched position—bolstered by clinical familiarity and cost-effectiveness—supports steady market presence through 2030.

• Market growth will depend on innovation in formulations, safety optimization, and strategic positioning in emerging markets.

FAQs

1. How do recent clinical trials impact the prescribing of Tegretol?
Recent studies affirm Tegretol’s sustained efficacy in epilepsy management and highlight the importance of genetic screening, particularly in Asian populations, to mitigate severe adverse effects. These insights refine patient selection, improving safety and outcomes.

2. What are the primary market challenges facing Tegretol today?
Key challenges include safety concerns, competition from newer AEDs with better tolerability, and regulatory requirements for genetic testing, which might influence prescribing habits and market penetration.

3. How does pharmacogenomics influence Tegretol's market and clinical use?
Genetic testing, notably for the HLA-B*1502 allele, enhances safety by preventing severe skin reactions. Widespread adoption of pharmacogenomic protocols could expand Tegretol’s safe use but requires investment in infrastructure and clinician education.

4. What are the future growth prospects of Tegretol in the global market?
Tegretol’s market is likely to remain stable in the near term, primarily due to its established efficacy and cost advantages. However, growth may be tempered by competition from newer agents, with opportunities in emerging markets and niche indications.

5. Are there upcoming formulations or indications that could revitalize Tegretol’s use?
Development of extended-release formulations could improve tolerability and compliance. Additionally, exploring novel indications, including psychiatric uses, could broaden its clinical applications, supporting sustained demand.

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References

[1] Smith, et al. (2022). Long-term efficacy of carbamazepine in partial epilepsy. Epilepsia.
[2] Lee, et al. (2021). Efficacy of carbamazepine in trigeminal neuralgia: A meta-analysis. Pain Physician.
[3] Johnson, et al. (2020). Pharmacogenomics and safety of carbamazepine. Drug Safety.
[4] Kumar, et al. (2021). Drug interactions of carbamazepine with new AEDs. The Journal of Clinical Pharmacology.
[5] MarketWatch. (2023). Global anticonvulsant market size and trends.