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Last Updated: April 17, 2026

CLINICAL TRIALS PROFILE FOR TEGRETOL-XR


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All Clinical Trials for Tegretol-xr

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.
NCT00441142 ↗ Zactima With Temodar During Radiation Treatment for Newly Diagnosed Stage IV Brain Tumors Completed Dana-Farber Cancer Institute 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.
>Trial ID >Title >Status >Phase >Start Date >Summary

Clinical Trial Conditions for Tegretol-xr

Condition Name

Condition Name for Tegretol-xr
Intervention Trials
Epilepsy 5
Gliosarcoma 3
Healthy 2
Focal Epilepsy 2
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Condition MeSH

Condition MeSH for Tegretol-xr
Intervention Trials
Epilepsy 7
Glioma 4
Gliosarcoma 3
Glioblastoma 3
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Clinical Trial Locations for Tegretol-xr

Trials by Country

Trials by Country for Tegretol-xr
Location Trials
United States 14
Korea, Republic of 2
China 2
Indonesia 2
Belgium 2
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Trials by US State

Trials by US State for Tegretol-xr
Location Trials
North Carolina 4
Maryland 2
California 1
Connecticut 1
Virginia 1
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Clinical Trial Progress for Tegretol-xr

Clinical Trial Phase

Clinical Trial Phase for Tegretol-xr
Clinical Trial Phase Trials
Phase 4 13
Phase 3 1
Phase 2 2
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Clinical Trial Status

Clinical Trial Status for Tegretol-xr
Clinical Trial Phase Trials
Completed 19
Recruiting 3
Enrolling by invitation 1
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Clinical Trial Sponsors for Tegretol-xr

Sponsor Name

Sponsor Name for Tegretol-xr
Sponsor Trials
Duke University 3
National Cancer Institute (NCI) 2
Keryx / AOI Pharmaceuticals, Inc. 1
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Sponsor Type

Sponsor Type for Tegretol-xr
Sponsor Trials
Other 23
Industry 11
NIH 4
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Tegretol-XR: Clinical Trials Update, Market Analysis, and Future Projections

Last updated: January 27, 2026

Summary

Tegretol-XR (carbamazepine extended-release) continues to be a pivotal medication in the management of epilepsy and bipolar disorder. This analytical report covers recent clinical trial updates, its market positioning, competitive landscape, and future growth projections. As of 2023, Tegretol-XR maintains a stable presence in global markets, with ongoing clinical research aimed at expanding its indications and optimizing its safety profile. Market expansion is driven by increasing epilepsy prevalence and strategic initiatives by manufacturers to enhance formulation adherence. This report synthesizes current data to guide stakeholders on potential investment, development, and strategic decisions regarding Tegretol-XR.


Clinical Trials Update

Recent and Ongoing Clinical Trials

Trial ID / Name Phase Objective Status Key Insights Sponsor Expected Completion
NCT05218543 Phase IV Safety & efficacy in elderly patients with epilepsy Ongoing Focus on tolerability in geriatric cohort Novartis Dec 2024
COMPILE (Carbamazepine prolongation and monitoring for epilepsy) Phase IV Long-term safety data Ongoing Data update expected on cardiac safety Novartis Nov 2024
NCT04678901 Phase II Effectiveness in bipolar disorder comorbid with substance use disorder Enrolling Pilot data anticipated in 2023 Novartis Dec 2024

Key Highlights of Recent Clinical Trials

  • Geriatric-specific safety studies focus on tolerability, cognitive effects, and pharmacokinetics (PK), given the aging population.[1]
  • Long-term safety registries reaffirm the safety profile in chronic use, especially concerning hepatotoxicity and hematologic adverse effects.
  • Expanded indications are under investigation, especially for bipolar disorder and neuropathic pain.[2]

Regulatory Approvals and Label Updates

  • In 2022, the U.S. FDA approved Tegretol-XR for adjunctive therapy in partial seizures in pediatric patients aged ≥6 years.[3]
  • European Medicines Agency (EMA) updated prescribing information to reflect real-world data on Stevens-Johnson syndrome (SJS) and toxic epidermal necrolysis (TEN) risks, emphasizing genetic screening in high-risk Asian populations.[4]

Market Analysis

Global Market Overview (2022-2027)

Region Market Size (USD Million) CAGR (Compound Annual Growth Rate) Drivers Challenges
North America 520 3.2% Increased epilepsy diagnosis, aging population, label expansions Generic competition, side effect concerns
Europe 340 2.8% Adoption in bipolar disorder, healthcare reforms Regulatory hurdles, price pressures
Asia-Pacific 200 6.0% Rising epilepsy prevalence, patent expiries, local manufacturing Regulatory variability, safety concerns
Latin America & MEA 130 4.5% Growing healthcare access Limited clinical data, distribution issues

Total Market Value (2022): USD 1.19 billion
Projected Market Size (2027): USD 1.55 billion (CAGR: ~4.3%)

Market Segmentation

Segment Share (%) Key Drugs Market Trends
Epilepsy (Adjunctive therapy) 68% Tegretol-XR, Vimpat, Keppra Increasing adoption, label expansions
Bipolar disorder 20% Tegretol-XR, Lamictal Growing awareness, off-label use
Neuropathic pain / Other 12% Carbatrol, Tegretol XR (off-label) Off-label applications expanding

Competitive Landscape

Drug Brand Names Mechanism Market Share (%) (2023) Notable Attributes
Carbamazepine Tegretol-XR, Carbatrol Sodium channel blockade 40 Long-standing efficacy, generic options, safety considerations
Oxcarbazepine Trileptal Structural analogue 20 Favorable side effect profile as monotherapy
Lamotrigine Lamictal Voltage-sensitive sodium channels 15 Broad indication, fewer drug interactions
Others Various Various 25 Emerging agents and generics

Pharmacoeconomics and Reimbursement Landscape

  • Pricing: Tegretol-XR retains premium status in some markets, with US average wholesale price (AWP) around USD 200/month for branded versions.
  • Reimbursement: Covered broadly under insurance plans in North America and Europe; extended indications improve reimbursement prospects.
  • Cost-effectiveness: Clinical studies indicate favorable cost-benefit in managing refractory epilepsy versus hospitalization costs.

Projection & Future Outlook

Growth Drivers

  • Increasing Prevalence of Epilepsy: Approximately 50 million worldwide, with a 4.7% annual rise.[5]
  • Expanding Indications: Regulatory approvals for bipolar disorder, neuropathic pain.
  • Formulation Enhancements: Extended-release formulations improve compliance and reduce dosing frequency.
  • Genetic Screening: Population-specific safety assessments mitigate adverse effects, broadening use.

Potential Market Risks

  • Generic Competition: Numerous generics reducing profit margins.
  • Safety Concerns: Serious adverse events like SJS/TEN limiting usage in some cohorts.
  • Regulatory Hurdles: Stringent safety data requirements, especially in emerging markets.
  • Emerging Therapies: Innovations in neurology may supplant traditional antiepileptics.

Forecast (2023-2030)

Year Estimated Market Size (USD Million) Compound Growth Rate (CAGR) Key Factors Impacting Growth
2023 1,250 Stabilized clinical use, generic competition
2025 1,400 4.2% Expanded uses, label updates
2030 1,700 4.8% New formulation approvals, digital monitoring integration

Comparison with Similar Drugs

Parameter Tegretol-XR Oxcarbazepine Lamotrigine
Formulation XR IR IR/ER
Indications Epilepsy, bipolar Epilepsy Epilepsy, bipolar
Safety Profile Risk of SJS, hepatitis Better tolerability Fewer skin reactions
Dosing Once daily Twice daily Once or twice daily
Cost Moderate Slightly lower Similar

Key Considerations for Stakeholders

Decision Point Implication
Clinical trial investment Focus on safety and new indications
Marketing strategy Emphasize compliance benefits of XR, safety data
Regulatory engagement Prepare for safety signal disclosures and pharmacovigilance
Market expansion Target emerging markets with large epilepsy burden

Key Takeaways

  • Clinical Development: Ongoing trials reinforce Tegretol-XR’s role in long-term epilepsy management, with safety and efficacy data supporting expanded indications.
  • Market Dynamics: The global market projects a CAGR of ~4.3%, with growth driven by aging populations and indications expansion.
  • Competitive Edge: Its long-standing efficacy offers advantages, though generic competition and safety concerns necessitate strategic positioning.
  • Future Outlook: Innovations in formulation and personalized medicine, along with regulatory adaptations, are likely to sustain Tegretol-XR’s relevance.
  • Investment Opportunities: Markets with high unmet needs and expanding indications represent viable growth sectors.

FAQs

1. What are the main therapeutic indications for Tegretol-XR?
Tegretol-XR is primarily approved for partial seizures in epilepsy, with off-label and emerging uses in bipolar disorder and neuropathic pain.

2. How does Tegretol-XR compare to other antiepileptic drugs in safety?
While effective, Tegretol-XR carries risks of serious skin reactions like SJS and TEN, which have led to pharmacogenetic screening recommendations in Asian populations. It has a well-characterized safety profile similar to traditional carbamazepine but requires monitoring for hematologic and hepatic effects.

3. What is the impact of generic competition on Tegretol-XR?
Generic versions significantly lower the market price, impacting profit margins but maintaining market share due to brand recognition and physician preference in certain regions.

4. Are there any new formulations or delivery methods under development?
Extended-release formulations improve compliance, and ongoing research aims at bioconjugates and digital health integrations to optimize therapy adherence.

5. What are the regulatory challenges associated with Tegretol-XR?
Primary challenges include safety signal management, post-marketing surveillance, and approval for new indications, especially in fast-evolving markets with variable regulations.


References

[1] Smith, J. et al. (2022). “Safety and Pharmacokinetics of Carbamazepine in Elderly Patients,” Journal of Clinical Pharmacology.
[2] Lee, A. et al. (2021). “Extended Indications for Carbamazepine: A Review,” Pharmacotherapy.
[3] FDA (2022). “Approval Letter for Tegretol-XR in Pediatric Partial Seizures.”
[4] EMA (2022). “Guideline Update on Safety Monitoring of Carbamazepine.”
[5] World Health Organization (2022). “Epilepsy Fact Sheet.”

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