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.
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.

Clinical Trial Conditions for TEGRETOL

Condition Name

Condition Name for TEGRETOL
Intervention	Trials
Epilepsy	5
Gliosarcoma	3
Healthy	2
Focal Epilepsy	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
Belgium	2
Korea, Republic of	2
China	2
Indonesia	2

Trials by US State

Trials by US State for TEGRETOL
Location	Trials
North Carolina	4
Maryland	2
California	1
Connecticut	1
Virginia	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
Unknown status	1

Clinical Trial Sponsors for TEGRETOL

Sponsor Name

Sponsor Name for TEGRETOL
Sponsor	Trials
Duke University	3
National Cancer Institute (NCI)	2
Sunovion	1

Sponsor Type

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

TEGRETOL (carbamazepine) clinical trials update, market analysis, and market projection: pipeline, geographies, and competitor pressure

Last updated: July 26, 2026

TEGRETOL is a long-established brand of carbamazepine. Market value and near-term growth are driven by generic penetration, formulary dynamics for focal seizures and trigeminal neuralgia, and ongoing substitution between branded and generic carbamazepine across the US, EU, and select emerging markets. Clinical activity in carbamazepine is largely incremental (line extensions, bioequivalence, and formulation/PK studies) rather than late-stage pivotal development.

No single, current, comprehensive “clinical trials update” can be produced from the information provided.

What clinical trials are ongoing for TEGRETOL (carbamazepine) right now, and what endpoints are sponsors using?

Answer: Carbamazepine clinical programs in 2024 to 2026 are typically small and focused on (1) bioequivalence for immediate-release or extended-release formulations, (2) pharmacokinetics in defined populations (pediatrics, hepatic impairment, drug-drug interaction cohorts), and (3) safety surveillance rather than new efficacy paradigms.

Which study types dominate today’s carbamazepine evidence base?

• Bioequivalence and formulation comparability (IR vs ER where applicable)
• Pharmacokinetic and drug interaction studies (inducer/inhibitor effect characterization)
• Safety and tolerability observational studies (postmarketing)

What are common clinical endpoints in carbamazepine studies?

• PK: Cmax, Tmax, AUC, half-life, clearance
• Safety: adverse event incidence, discontinuation, lab markers (notably hepatic/hematologic parameters)
• Efficacy endpoints when used: seizure frequency/time to seizure breakthrough, pain score change for trigeminal neuralgia

What is the current TEGRETOL market size, growth rate, and regional demand outlook?

Answer: TEGRETOL competes in a mature, off-patent antiepileptic category with widespread generic availability. Regional demand tracks seizure prevalence, guideline adherence for trigeminal neuralgia, payer formularies, and therapeutic interchange policies. Growth is usually modest and driven by population growth and incremental share shifts, not by new molecule-driven expansion.

US market dynamics

• Formulary pressure strongly favors generics of carbamazepine
• Brand share depends on patient-specific factors (tolerability, switching stability) and payer contracting

EU market dynamics

• EU managed entry and reimbursement policies influence brand retention
• Country-level substitution rules affect brand vs generic mix

Emerging market dynamics

• Lower price ceilings and tendering can rapidly dilute brand economics
• Private payers and neurologist prescribing patterns can support residual brand presence

How does TEGRETOL’s forecast compare with other carbamazepine brands and antiepileptics?

Answer: TEGRETOL’s trajectory is constrained by generic carbamazepine supply and substitution across older antiseizure medicines. Category growth depends more on ongoing antiseizure therapy expansion than on carbamazepine-specific innovation.

Competitive set likely to pressure TEGRETOL share

• Other older antiseizure medicines (OESM) with entrenched generic access
• Newer branded antiseizure medicines where neurologists pursue alternative mechanisms
• Extended-release and generic formulation options that improve dosing convenience

When does TEGRETOL lose exclusivity, and how does that affect generic launch risk?

Answer: TEGRETOL is a legacy product; exclusivity and patent protection for carbamazepine generics in most major markets have long expired. Generic launch risk is typically low because generic carbamazepine is already widely available. The practical risk is ongoing price compression and tender-driven share shifts, not exclusivity expiry.

What still creates IP or regulatory “friction” for entry?

• Specific formulation attributes (if any brand-linked ER or formulation patents exist in a given jurisdiction)
• Pediatric exclusivity-era restrictions in specific markets (rare for this mature compound)
• Manufacturing site regulatory status and product discontinuations that temporarily reduce competitive supply

What is the Orange Book status of TEGRETOL, and which patents cover it?

Answer: A complete Orange Book-driven mapping cannot be produced from the information provided in the prompt. A patent-by-patent Orange Book status table (listed patents, expiration, regulatory exclusivities, and paragraph IV tags) requires the underlying Orange Book listing data.

What patent estate strength protects TEGRETOL (carbamazepine): method-of-use, formulation, and manufacturing?

Answer: Carbamazepine is long off primary molecule exclusivity. Any remaining enforceable value is typically tied to secondary IP: formulation-specific patents, method-of-use claims in defined indications/populations, or manufacturing process claims. A “strength” rating (counts, remaining life by jurisdiction, claim scope) cannot be computed without the underlying patent and prosecution record.

Which companies are challenging TEGRETOL via Paragraph IV or authorized generics?

Answer: A Paragraph IV and litigation/settlement update cannot be produced without specific Orange Book entries, ANDA filer identities, and court docket references.

What FDA regulatory pathway governs TEGRETOL generics, and what does that mean for market access?

Answer: Generic carbamazepine products typically use the ANDA pathway referencing the approved reference listed drug. Market access is constrained mainly by bioequivalence requirements, labeling alignment with the reference product, and supply reliability rather than by pathway novelty.

What labeling matters for substitution

• Indications: seizures (where carbamazepine is authorized), trigeminal neuralgia
• Dosing and titration language
• Safety warnings and monitoring language

What clinical safety signals affect prescribing and forecasting for TEGRETOL?

Answer: Carbamazepine safety monitoring influences payer and prescriber tolerance for switching, which can affect brand vs generic stability. Key risk management themes include:

• Hematologic effects and rare severe blood dyscrasias
• Hepatic enzyme elevation and hepatic dysfunction monitoring
• Serious dermatologic reactions risk and hypersensitivity monitoring
• Drug-drug interactions from CYP induction (affecting contraception, anticoagulants, and other antiepileptics)

How does TEGRETOL compare with alternatives for trigeminal neuralgia and focal seizures?

Answer: Carbamazepine is still a common comparator for trigeminal neuralgia due to long track record and guideline inclusion in many settings, but share is diluted by:

• Availability of alternative first-line or second-line agents based on country guidance
• Patient tolerability profiles and interaction burden from enzyme induction
• Uptake of newer antiseizure medicines in focal epilepsy where they are reimbursed

Practical forecasting implication

• Forecast depends on how often neurologists and pain specialists remain on carbamazepine versus switching to alternatives after tolerability events

What market projection is appropriate for TEGRETOL through 2030?

Answer: For a mature, off-patent molecule with broad generic penetration, the appropriate projection framework is:

• Flat-to-low single-digit value CAGR in markets dominated by generics
• Periodic negative pricing pressure from tendering and wholesale channel resets
• Share stabilization only where brand contracting maintains premium positioning or where safety switching issues reduce interchange

A quantified 2030 forecast (revenue and unit growth) cannot be produced from the information provided.

What would be the best-case and base-case scenarios for TEGRETOL revenue?

Answer: Scenarios for legacy antiepileptic brands generally hinge on net selling price (NSP) and share rather than on unit growth:

• Base-case: steady volume, declining NSP, modest market growth
• Best-case: temporary pricing firming from supply constraints and retention of contracted share, partially offset by generic undercutting

Quantified scenario models require market baseline data and country-level net pricing inputs.

Key takeaways

• TEGRETOL is a mature carbamazepine brand with clinical evidence dominated by incremental PK, safety, and bioequivalence rather than new pivotal efficacy programs.
• Market performance is primarily driven by generic substitution, payer formularies, and pricing/tender dynamics.
• Patent-driven generic-entry timing is usually not the dominant variable for carbamazepine brands; the dominant risk is continued price compression and share erosion.
• A fully sourced clinical-trials update and Orange Book patent estate mapping cannot be completed from the information included in the prompt.

FAQs

1. What is the typical FDA generic pathway for carbamazepine tablets and how does it affect availability?
2. Are there any ongoing bioequivalence or formulation studies for carbamazepine extended-release vs immediate-release?
3. How do CYP induction drug-drug interactions influence real-world switching and payer policy for carbamazepine?
4. What role does carbamazepine still play in guidelines for trigeminal neuralgia compared with oxcarbazepine and other agents?
5. How do tender and procurement policies in EU and emerging markets typically impact legacy antiepileptic brand pricing?

References

No sources were provided in the prompt.