Tegretol

(Carbamazepine)

ApprovedSmall molecule

Carbamazepine is used to treat seizures in people with epilepsy and to relieve nerve pain. It's also sometimes prescribed to help stabilize mood in people with bipolar disorder.[2] Tegretol is currently approved and in use across 23 indications[4].[1]

Tegretol is one of 606 small molecule programs targeting HIV infection. It is currently in Approved.

Indications

Total Trials

Active Trials

605

Competitors

FDA Applications

NDA/BLA/ANDA regulatory filings

Patents

Pipeline

Status by Indication[4][1]

Indication

HIV InfectionApproved

Neuropathic PainApproved

Bipolar I DisorderActive, not recruiting

Partial EpilepsyActive, not recruiting

Hepatitis B Virus InfectionApproved

Trigeminal NeuralgiaActive, not recruiting

Carpal Tunnel SyndromeActive, not recruiting

Mood DisorderActive, not recruiting

StrokeActive, not recruiting

Photosensitive EpilepsyApproved

HIV InfectionApproved

Approved

Neuropathic PainApproved

Approved

Bipolar I DisorderPhase 3

Active, not recruiting

Partial EpilepsyPhase 3

Active, not recruiting

Hepatitis B Virus InfectionApproved

Approved

Trigeminal NeuralgiaApproved

Active, not recruiting

Carpal Tunnel SyndromePreclinical

Active, not recruiting

Mood DisorderApproved

Active, not recruiting

StrokePhase 3

Active, not recruiting

Photosensitive EpilepsyApproved

Approved

Showing 10 of 23 indications

Competition

Competitive Landscape

1931 competitors in COVID-19

#DrugCompanyPhaseTrials

Tegretol

Novartis

Approved

99 2

Spikevax

Moderna

Preclinical

21 3

Bnt162b2

BioNTech

Preclinical

29 4

COVID-19 Vaccine

Moderna

Preclinical

27 5

Biaxin

AbbVie

Preclinical

2 6

Aldactone

Pfizer

Preclinical

1 7

Nexavar

Bayer

Preclinical

1 8

Stivarga

Bayer

Preclinical

1 9

Aimovig

Amgen

Preclinical

1 10

Singulair

AstraZeneca

Preclinical

Ranked by pipeline maturity and clinical activity. Current drug highlighted in teal.

Timeline

Expected Milestones

Q3 2026

Phase 1Recruiting

Adult

NCT07395024

Q4 2026

Phase 1Active, not recruiting

Study completion

NCT07570082

Clinical

Trials by Indication[1]

Interaction17 trials

A Drug-Drug Interaction Study to Assess the Pharmacokinetics of DC-806 When Orally Administered Alone, When Coadministered With Itraconazole, and When Coadministered With Carbamazepine in Healthy Adult Participants

Completed· Eli Lilly logo

Eli Lilly·Phase 1·NCT05994807·33 enrolled

A Drug-drug Interaction Study of S-892216 Coadministered With Carbamazepime to Healthy Adult Participants

Completed· Shionogi logo

Shionogi·Phase 1·NCT06751017·16 enrolled

A Study to Evaluate the Effect of Food on the Single-Dose Pharmacokinetics and a Drug-Drug Interaction Evaluation of Itraconazole and Carbamazepine on INCB123667 When Administered Orally to Healthy Adult Participants

Recruiting· Incyte logo

Incyte·Phase 1·NCT06909162·51 enrolled

Show 14 more trials

A Multi-part Study of ALG-000184 to Evaluate Safety, Tolerability, Pharmacokinetics and Drug-drug Interaction Potential After Single and Multiple Doses in Healthy Volunteers

Active, not recruiting·AAligos Therapeutics·Phase 1·NCT06672900·24 enrolled

A Drug-Drug Interaction Study of Carbamazepine and Opevesostat (MK-5684) in Healthy Adult Male Participants (MK-5684-012)

Completed· Merck & Co. logo

Merck & Co.·Phase 1·NCT06633419·14 enrolled

Pharmacokinetic Interaction Study Between Eslicarbazepine Acetate and Carbamazepine

Completed·BBial - Portela C S.A.·Phase 1·NCT02284854·43 enrolled

A Drug-Drug Interaction Study to Evaluate the Effects of Itraconazole, Carbamazepine, Quinidine and Fluconazole on the Pharmacokinetics and Safety of EDP-323.

Completed·EEnanta Pharmaceuticals, Inc·Phase 1·NCT06847464·48 enrolled

Drug-Drug Interaction Potential of Mavorixafor

Completed·XX4 Pharmaceuticals·Phase 1·NCT06914869·38 enrolled

Drug-Drug Interaction Study Between EDP-235, Itraconazole, Carbamazepine and Quinidine in Healthy Subjects.

Completed·EEnanta Pharmaceuticals, Inc·Phase 1·NCT05594602·36 enrolled

A First-in-Human Multi-Part Phase 1 Study in Healthy Volunteers to Evaluate the Safety, Tolerability, Pharmacokinetics, and Drug-Drug Interaction Potential of Single and Multiple Doses of ALG-097558

Completed·AAligos Therapeutics·Phase 1·NCT05840952·90 enrolled

Drug-Drug Interaction Study of Bomedemstat and Carbamazepine in Healthy Adult Participants (MK-3543-020)

Completed· Merck & Co. logo

Merck & Co.·Phase 1·NCT06596668·16 enrolled

Drug-drug Interaction Trial of AP31969 and Carbamazepine or Itraconazole

Not yet recruiting·AAcesion Pharma·Phase 1·NCT07449390·28 enrolled

Potential Drug Interaction Study Between Vemircopan and Rosuvastatin, Metformin, Levonorgestrel/Ethinyl Estradiol-containing Oral Contraceptives, and Carbamazepine

Completed· AstraZeneca logo

AstraZeneca·Phase 1·NCT06071442·60 enrolled

Tepotinib Drug-Drug Interaction Study With Carbamazepine in Healthy Participants

Completed· Merck & Co. logo

Merck & Co.·Phase 1·NCT05213481·18 enrolled

A Drug-Drug Interaction (DDI) Study of Orforglipron With Carbamazepine in Healthy Participants

Completed· Eli Lilly logo

Eli Lilly·Phase 1·NCT06370728·30 enrolled

A Study to Investigate the Potential Pharmacokinetic Interactions Between Phenytoin or Carbamazepine and Telaprevir

Completed· Johnson & Johnson logo

Johnson & Johnson·Phase 1·NCT01635829·24 enrolled

Drug-Drug Interaction Study Assessing Effect of Carbamazepine on PF-07321332 Boosted With Ritonavir

Completed· Pfizer logo

Pfizer·Phase 1·NCT04962230·12 enrolled

Epilepsy11 trials

Changing Agendas on Sleep, Treatment and Learning in Epilepsy

Terminated·KKing's College London·Phase 4·NCT04610879·5 enrolled

A Cross-sectional Study to Investigate the Effect of Topiramate on Bone and Mineral Metabolism in Female Participants With Epilepsy

Completed· Johnson & Johnson logo

Johnson & Johnson··NCT01030094·140 enrolled

Characterization of Epilepsy Patients BEEP 2b

Completed·FFood and Drug Administration (FDA)·Phase 1·NCT02707965·21 enrolled

Show 8 more trials

Study to Assess the Safety and Tolerability of Intravenous Carbamazepine in Adults With Epilepsy

Completed· Lundbeck logo

Lundbeck·Phase 3·NCT01128959·108 enrolled

Evaluating Long Term Safety of Lacosamide (LCM) to Carbamazepine Controlled-release (CBZ-CR); Initial Monotherapy in Epilepsy Subjects 16 Years and Older

Completed· UCB logo

UCB·Phase 3·NCT01465997·551 enrolled

Trial Comparing the Efficacy and Safety of Lacosamide (LCM) to Carbamazepine Controlled-Release (CBZ-CR); Initial Monotherapy in Epilepsy; Subjects Aged 16 and Older

Completed· UCB logo

UCB·Phase 3·NCT01243177·888 enrolled

Levetiracetam Versus Standard Antiepileptic Drugs (Carbamazepine and Valproate) Used as Monotherapy in Patients With Newly Diagnosed Epilepsy

Completed· UCB logo

UCB·Phase 3·NCT00175903·1,701 enrolled

Effect of Anti-epileptic Drugs on Etonogestrel-releasing Implant Pharmacokinetics in Women With Epilepsy

Suspended·UUniversity of Sao Paulo·Phase 4·NCT03307863·69 enrolled

A Study of the Pharmacokinetics (PK) and Safety of IV Carbamazepine Relative to Oral Carbamazepine in Adults With Epilepsy

Completed· Lundbeck logo

Lundbeck·Phase 1·NCT01079351·98 enrolled

Prediction of Childhood Epilepsy Outcome in Bangladesh

Completed·IInstitute of Child Health·N/A·NCT00381537·92 enrolled

Second-Line Treatment Choice for Epilepsy

Unknown status·DDutch Epilepsy Clinics Foundation·N/A·NCT00208520·60 enrolled

CAR10 trials

A Study to Understand the Effects of Carbamazepine on How Vepdegestrant is Processed in Healthy Participants

Completed· Pfizer logo

Pfizer·Phase 1·NCT06005688·12 enrolled

A Study of the Effects of Itraconazole or Carbamazepine on LY3537982 in Healthy Participants

Completed· Eli Lilly logo

Eli Lilly·Phase 1·NCT05860933·30 enrolled

A Study to Assess the Effect of Multiple Doses of Itraconazole, Gemfibrozil, or Carbamazepine on BMS-986278 in Healthy Participants

Completed· Bristol-Myers Squibb logo

Bristol-Myers Squibb·Phase 1·NCT05932303·47 enrolled

Show 7 more trials

Crossover Study of Neuropsychological Effects of Lacosamide and Carbamazepine Immediate Release in Healthy Subjects

Completed· UCB logo

UCB·Phase 1·NCT01530022·60 enrolled

A Study in Healthy Men to Test Whether Carbamazepine Influences the Amount of Zongertinib in the Blood

Completed· Boehringer Ingelheim logo

Boehringer Ingelheim·Phase 1·NCT06028464·16 enrolled

DDI Study of Evobrutinib and Carbamazepine

Completed· Merck & Co. logo

Merck & Co.·Phase 1·NCT05248945·14 enrolled

A Study in Healthy Men to Test Whether Carbamazepine Influences the Amount of Nerandomilast in the Blood

Completed· Boehringer Ingelheim logo

Boehringer Ingelheim·Phase 1·NCT07100964·16 enrolled

A Study to Learn if Multiple Doses of the Study Medicine Called Carbamazepine Changes How the Body Processes the Other Study Medicine PF-07248144

Recruiting· Pfizer logo

Pfizer·Phase 1·NCT07198035·12 enrolled

Study of the Effects of Itraconazole and Carbamazepine on LY3410738 in Healthy Participants

Terminated· Eli Lilly logo

Eli Lilly·Phase 1·NCT05205447·27 enrolled

Carbamazapine for Inherited Erythromelalgia Patients With NaV1.7 Mutations

Completed·VVA Connecticut Healthcare System·Phase 4·NCT02214615·2 enrolled

Adult8 trials

Study to Evaluate the Effects of Cytochrome P450 (CYP) 3A4 Inducer Carbamazepine on Tavapadon Pharmacokinetics in Healthy Adult Participants

Completed·CCerevel Therapeutics, LLC·Phase 1·NCT05581823·16 enrolled

A Study of Steady-state Carbamazepine on the Single-dose of Erdafitinib Tablets in Healthy Adult Participants

Completed· Johnson & Johnson Pharmaceutical Research & Development, L.L.C. logo

Johnson & Johnson Pharmaceutical Research & Development, L.L.C.·Phase 1·NCT04330248·15 enrolled

A Study of Ponesimod in Healthy Adult Participants

Completed· Johnson & Johnson logo

Johnson & Johnson·Phase 1·NCT05552196·28 enrolled

Show 5 more trials

Comparison of the Cognitive and Behavioral Effects of Eslicarbazepine Acetate and Carbamazepine in Healthy Adults

Completed·SStanford University·Phase 4·NCT02912364·46 enrolled

Open-label Trial to Evaluate the Effect Carbamazepine on Darigabat Pharmacokinetics in Healthy Adult Participants

Completed·CCerevel Therapeutics, LLC·Phase 1·NCT05824143·13 enrolled

A Study to Learn How Fluconazole, Carbamazepine and Itraconazole Affect How the Body Processes ASP3082 in Healthy Adults

Recruiting· Astellas logo

Astellas·Phase 1·NCT07395024·54 enrolled

A Study to Assess LY4100511 (DC-853) in Healthy Adult Participants

Completed· Eli Lilly logo

Eli Lilly·Phase 1·NCT06345794·50 enrolled

Effects of TPV/r on the Pharmacokinetics of Carbamazepine in Healthy Adult Volunteers

Completed· Boehringer Ingelheim logo

Boehringer Ingelheim·Phase 1·NCT02253849·28 enrolled

Trigeminal Neuralgia5 trials

Comparison b/w Carbamazepine vs Oxcarbazepine in Treatment of Trigeminal Neuralgia

Active, not recruiting·—·N/A·NCT07252453·122 enrolled

Pregabalin as an add-on Therapy to Carbamazepine in Trigeminal Neuralgia Patients

Recruiting·PPostgraduate Institute of Dental Sciences Rohtak·N/A·NCT06357260·50 enrolled

Comparision Efficacy of Carbamazepine & Oxcarbazepine in the Treatment of Trigeminal Neuralgia- a Randomised Clinical Trial

Unknown status·PPostgraduate Institute of Dental Sciences Rohtak·Phase 4·NCT04996199·132 enrolled

Show 2 more trials

Symptomatic Trigeminal Neuralgia Attributed to Multiple Sclerosis - a Prospective Study in 60 Patients

Completed·—··NCT04371575·60 enrolled

Comparison of Oxcarbazepine Versus Carbamazepine in the Management of Trigeminal Neuralgia

Active, not recruiting·JJinnah Postgraduate Medical Centre·Phase 4·NCT06849219·122 enrolled

37 more indications

Seizure4 trials

Assessing The Long-Term Safety And To Explore The Long-Term Efficacy Of Zonisamide As Monotherapy In Newly Diagnosed Partial Seizures

Completed· Eisai logo

Eisai·Phase 3·NCT00848549·295 enrolled

Effect of Carbamazepine and Oxcarbazepine on Serum Neuron-specific Enolase and S100B in Focal Seizures

Completed·—·Phase 4·NCT02705768·90 enrolled

Open-label, Randomized, Active-controlled Study of LEV Used as Monotherapy in Patients With Partial-Onset Seizures

Completed· UCB logo

UCB·Phase 3·NCT01954121·436 enrolled

Show 1 more trial

Does Gabapentin and Lamotriginel Have Significantly Fewer Side-effects While Providing Equal or Better Seizure Control Than the Current Drug Choice, Carbamazepine, for the Treatment of Seizures in the Elderly.

Completed·UUS Department of Veterans Affairs·Phase 3·NCT00007670·720 enrolled

Bipolar I Disorder3 trials

Efficacy and Safety of Olanzapine in the Extended Treatment for Manic or Mixed Episode of Bipolar I Disorder

Completed· Eli Lilly logo

Eli Lilly·Phase 3·NCT00266630·139 enrolled

Efficacy and Safety of SPD417 in Treatment of Manic Symptoms in Adults With Bipolar I Disorder

Completed·VValidus Pharmaceuticals·Phase 3·NCT00150553·102 enrolled

Safety of SPD417 Combined With Other Psychotropic Medications in the Treatment of Bipolar I Disorder

Completed·VValidus Pharmaceuticals·Phase 3·NCT00150605·50 enrolled

Cocaine Dependence2 trials

Carbamazepine Treatment for Cocaine Dependence - 5

Completed·UUniversity of Pennsylvania·Phase 2·NCT00000191

Carbamazepine Treatment of Cocaine Dependence - 1

Completed·MMedical University of South Carolina·Phase 2·NCT00000242

Asthma2 trials

Study of Efficacy of Carbamazepine in Therapy of Patients With Moderate Persistent and Severe Bronchial Asthma

Completed·CCentre of Chinese Medicine, Georgia·Phase 4·NCT00153296·68 enrolled

Antiepileptic Drug Carbamazepine in Treatment of Bronchial Asthma

Completed·CCentre of Chinese Medicine, Georgia·Phase 4·NCT00207428·65 enrolled

Drug Interactions2 trials

A Study to Evaluate Potential Drug Interactions Between ALXN2080 and Itraconazole, Fluconazole & Carbamazepine in Healthy Adults

Completed· AstraZeneca logo

AstraZeneca·Phase 1·NCT06173596·60 enrolled

An Open-label Study in Healthy Participants to Evaluate AZD0780 as an Object or Precipitant of CYP3A4-mediated Drug-drug Interactions

Completed· AstraZeneca logo

AstraZeneca·Phase 1·NCT06671405·59 enrolled

Drug2 trials

Premenstrual Dysphoric Disorder and Antiepileptic Drugs

Completed·—··NCT00612235·80 enrolled

A Study to Learn About How Itraconazole and Carbamazepine Affect the Level of BAY2927088 in the Blood When These Drugs Are Taken Together by Healthy Participants

Completed· Bayer logo

Bayer·Phase 1·NCT06348888·30 enrolled

Efficacy and Safety2 trials

Comparative Study of Zonisamide and Carbamazepine as an Initial Monotherapy: Efficacy and Safety Evaluation

Completed· Eisai logo

Eisai·Phase 4·NCT01127256·200 enrolled

The Efficacy and Safety of Low Dose Combination of LTG and VPA Compared to CBZ Monotherapy

Completed·YYonsei University·Phase 4·NCT00807989·207 enrolled

Midazolam1 trial

A Study to Investigate the Pharmacokinetics of Midazolam After Repeated Doses of Camizestrant (AZD9833) and to Investigate the Pharmacokinetics of Camizestrant When Administered Alone and in Combination With Carbamazepine in Healthy Post-Menopausal Female Participants

Completed· AstraZeneca logo

AstraZeneca·Phase 1·NCT06547164·40 enrolled

Mood Disorder1 trial

Cost- Effectiveness and Quality of Life Assessment in Mood Disorder

Completed·FFederal University of Rio Grande do Sul·Phase 4·NCT02870283·107 enrolled

Drug Abuse1 trial

Pharmacotherapy and Intensive Treatment of Drug Abuse - 1

Completed·UUniversity of Kansas·Phase 2·NCT00000217

Carpal Tunnel Syndrome1 trial

Compare the Efficacy of Acupuncture Therapy and Carbamazepine Oral Dosage in Patients With Carpal Tunnel Syndrome by Multiple Excitability Test

Unknown status·TTaipei Medical University WanFang Hospital·N/A·NCT00952432·80 enrolled

Pediatrics1 trial

Population Pharmacokinetics of Antiepileptic in Pediatrics

Completed·AAssistance Publique - Hôpitaux de Paris··NCT03196466·753 enrolled

Pomalidomide1 trial

A Phase 1 Open-Label Study to Evaluate the Effect of CYP450 and P-gp Inhibition and Induction on the Pharmacokinetics of Pomalidomide (CC-4047) in Healthy Male Subjects

Completed· Bristol-Myers Squibb logo

Bristol-Myers Squibb·Phase 1·NCT01707407·32 enrolled

Bipolar 1 Disorder1 trial

DB/Maintenance of Equetro (Carbamazepine) in Children With Acute Manic or Mixed Bipolar 1 Disorder

Terminated·VValidus Pharmaceuticals·Phase 4·NCT02623504·17 enrolled

Elderly Patients1 trial

Study on the Treatment of Elderly Patients With Older and Newer Antiepileptic Drugs

Completed·JJohannes Gutenberg University Mainz·Phase 4·NCT00438451·361 enrolled

Trial1 trial

Photosensitivity Proof of Concept Trial

Completed·TThe Epilepsy Study Consortium·Phase 2·NCT00894010·6 enrolled

Cognitive Function1 trial

Lamotrigine Cognitive Function Study in Adult Untreated Epilepsies

Completed·KKorean Epilepsy Society·Phase 4·NCT00896987·121 enrolled

Pediatric1 trial

The Young Adult and Pediatric Bipolar Study

Completed·VValidus Pharmaceuticals·Phase 4·NCT00350857·161 enrolled

Drug Therapy1 trial

Drug Therapy for Alcohol Detoxification

Completed·NNational Institute on Alcohol Abuse and Alcoholism (NIAAA)·Phase 4·NCT00000441

Single Dose1 trial

A Study on The Effect of Multiple Dose Carbamazepine on Single Dose Pharmacokinetics of RO4917838 in Healthy Volunteers

Completed· Roche logo

Roche·Phase 1·NCT01365403·16 enrolled

Bipolar Disorder1 trial

Longitudinal Comparative Effectiveness of Bipolar Disorder Therapies

Terminated·UUniversity of New Mexico··NCT02893371·1,037,352 enrolled

Transcranial Magnetic Stimulation1 trial

Effects of Lacosamide on Human Motor Cortex Excitability: a Transcranial Magnetic Stimulation Study

Completed·UUniversity of Kiel·N/A·NCT01382017·18 enrolled

Women1 trial

A Study to Learn What Happens to Elinzanetant in the Body When Taken With or Without Carbamazepine, and How Safe it is in Healthy Men and Women Aged 18 to 60 Years.

Completed· Bayer logo

Bayer·Phase 1·NCT05028608·16 enrolled

Metformin1 trial

A Trial to Evaluate the Effects of Itraconazole and Carbamazepine on the Pharmacokinetics of Emraclidine and of Emraclidine on the Pharmacokinetics of Metformin in Healthy Adult Participants

Completed·CCerevel Therapeutics, LLC·Phase 1·NCT05965219·60 enrolled

Methotrexate1 trial

A Trial to Examine the Interaction of Repinatrabit With Ethinyl Estradiol/Norethindrone, Metformin,Carbamazepine, Rosuvastatin, and Methotrexate When Administered Together

Not yet recruiting· Otsuka logo

Otsuka·Phase 1·NCT07446400·48 enrolled

Diabetic Neuropathy1 trial

Efficacy and Tolerability of Carbamazepine CR in Diabetic Neuropathy Pain

Completed· Novartis logo

Novartis·Phase 4·NCT01089855·123 enrolled

Female1 trial

A Study of LY3484356 in Healthy Female Participants

Completed· Eli Lilly logo

Eli Lilly·Phase 1·NCT04840888·82 enrolled

Stroke1 trial

Levetiracetam Versus Carbamazepine in Post-Stroke Late Onset Crisis

Unknown status·SScienze Neurologiche Ospedaliere·Phase 3·NCT00542802·630 enrolled

Ultrasound1 trial

Pharmacological Mechanisms of Low-intensity Focused Ultrasound for Motor Cortex Neuroplasticity

Active, not recruiting·UUniversity Health Network, Toronto·Phase 1·NCT04923659·20 enrolled

Partial Epilepsy1 trial

A Double-blind Study to Compare the Efficacy and Safety of Zonisamide and Carbamazepine as Monotherapy, in Newly Diagnosed Partial Epilepsy

Completed· Eisai logo

Eisai·Phase 3·NCT00477295·583 enrolled

Brain Injury1 trial

Carbamazepine for the Treatment of Chronic Post-Traumatic Brain Injury Irritability and Aggression

Completed·WWake Forest University Health Sciences·N/A·NCT00621751·70 enrolled

Olanzapine1 trial

Olanzapine Plus Carbamazepine in the Treatment of Bipolar I Mania

Completed· Eli Lilly logo

Eli Lilly·Phase 4·NCT00190892·120 enrolled

Treatment1 trial

Pharmacotherapy and Intensive Treatment - 2

Completed·NNational Institute on Drug Abuse (NIDA)·Phase 4·NCT00000218·353 enrolled

Infantile Spasms1 trial

Phase II Randomized Study of Early Surgery Vs Multiple Sequential Antiepileptic Drug Therapy for Infantile Spasms Refractory to Standard Treatment

Completed·NNational Center for Research Resources (NCRR)·Phase 2·NCT00004758·30 enrolled

Chemotherapy-induced nausea and vomiting1 trial

Efficacy and Safety Evaluation of Carbamazepine for Prevention of Chemotherapy-induced Nausea and Vomiting

Unknown status·FFaculdade de Medicina do ABC·Phase 2·NCT01581918·43 enrolled

Tics1 trial

A Study of the Effect of Carbamazepine on the Pharmacokinetics of RO4917523 in Healthy Volunteers

Completed· Roche logo

Roche·Phase 1·NCT01629368·16 enrolled

Unspecified2 trials

Pharmacovigilance in Gerontopsychiatric Patients

Terminated·HHannover Medical School·Phase 3·NCT02374567·407 enrolled

A Phase 1, Open-Label, Two-Cohort Study to Assess the Effect of a Strong CYP3A4 Inducer on the Pharmacokinetics of Atumelnant and the Effect of Atumelnant on the Pharmacokinetics of CYP3A4, P-gp, and MATE1/2-K Substrates in Healthy Participants

Active, not recruiting·CCrinetics Pharmaceuticals Inc.·Phase 1·NCT07570082·46 enrolled

Regulatory

FDA Approval Timeline[5]

Jan 1, 1982

TEGRETOL

NDA NDA018281

Jan 1, 1982

TEGRETOL

NDA NDA016608

Dec 18, 1987

TEGRETOL

NDA NDA018927

Mar 25, 1996

TEGRETOL-XR

NDA NDA020234

Sep 30, 1997

CARBATROL

NDA NDA020712

Dec 10, 2004

EQUETRO

NDA NDA021710

Oct 7, 2016

CARNEXIV

NDA NDA206030

Sources

References

[1]
ClinicalTrials.gov — 99 trial records for Carbamazepine. U.S. National Library of Medicine, National Institutes of Health.
[2]
MedlinePlus Drug Information — Tegretol drug information. U.S. National Library of Medicine, National Institutes of Health.
[3]
ChEMBL — Carbamazepine compound record. European Bioinformatics Institute (EMBL-EBI).
[4]
Open Targets Platform — Drug–disease associations for Carbamazepine. EMBL-EBI & Wellcome Sanger Institute.
[5]
OpenFDA — FDA approval records (NDA NDA206030). U.S. Food & Drug Administration.
[6]
FDA Orange Book — Patent and exclusivity data for Tegretol. U.S. Food & Drug Administration.
[7]
SEC EDGAR — Novartis company filings. U.S. Securities and Exchange Commission.

Details

Drug Info

Quick Facts

Mechanism of Action: Sodium Channel Alpha Subunit Blocker[3]
Modality: Small molecule[3]
Highest Phase: Approved[1]
Company: Novartis

Patent Landscape[6]

Patent Cliff

Nov 10, 2028

Earliest patent expiration — generic entry possible after this date

Patent #Expires

9629797Nov 10, 2028

9770407Nov 10, 2028

7635773Mar 13, 2029

9493582Feb 27, 2033

11529357Jan 31, 2040

Tegretol

Status by Indication[4][1]

Competitive Landscape

Expected Milestones

Q3 2026

Q4 2026

Trials by Indication[1]

Interaction17 trials

Epilepsy11 trials

CAR10 trials

Adult8 trials

Trigeminal Neuralgia5 trials

Seizure4 trials

Bipolar I Disorder3 trials

Cocaine Dependence2 trials

Asthma2 trials

Drug Interactions2 trials

Drug2 trials

Efficacy and Safety2 trials

Midazolam1 trial

Mood Disorder1 trial

Drug Abuse1 trial

Carpal Tunnel Syndrome1 trial

Pediatrics1 trial

Pomalidomide1 trial

Bipolar 1 Disorder1 trial

Elderly Patients1 trial

Trial1 trial

Cognitive Function1 trial

Pediatric1 trial

Drug Therapy1 trial

Single Dose1 trial

Bipolar Disorder1 trial

Transcranial Magnetic Stimulation1 trial

Women1 trial

Metformin1 trial

Methotrexate1 trial

Diabetic Neuropathy1 trial

Female1 trial

Stroke1 trial

Ultrasound1 trial

Partial Epilepsy1 trial

Brain Injury1 trial

Olanzapine1 trial

Treatment1 trial

Infantile Spasms1 trial

Chemotherapy-induced nausea and vomiting1 trial

Tics1 trial

Unspecified2 trials

FDA Approval Timeline[5]

References

Drug Info

Quick Facts

Patent Landscape[6]

Related News