Clinical Trials

Numerous clinical trials spanning Early Phase 1 to Phase 4 evaluate carbamazepine across completed, active, recruiting, and not yet recruiting statuses. Sponsored by pharmaceutical leaders and academic medical centers, these studies investigate neurological conditions such as focal epilepsy and trigeminal neuralgia, substance-related disorders, and pharmacokinetics in healthy participants and patients with advanced non-small cell lung cancer.

NCT Number Recruitment Conditions Sponsor/Collaborators Start Date Phases
NCT07673549 NOT_YET_RECRUITING
Idiopathic Trigeminal Neuralgia
Beijing Tiantan Hospital
2026-08-31
NCT03307863 SUSPENDED
Contraception; Drug Interactions
University of Sao Paulo
2017-11-01 PHASE4
NCT07750730 NOT_YET_RECRUITING
Trigeminal Neuralgia (TN)
Beijing Hospital of Traditional Chinese Medicine
2026-08-31
NCT07369622 NOT_YET_RECRUITING
Gout Initiating Urate-loweringUrate-lowering Therapy; Gout Arthritis; Gout and Hyperuricemia
Haiphong University of Medicine and Pharmacy
2026-01-20 PHASE4
NCT07395024 ACTIVE_NOT_RECRUITING
Healthy Volunteer
Astellas Pharma Global Development, Inc.
2026-02-03 PHASE1
NCT07781631 NOT_YET_RECRUITING
Healthy
Boehringer Ingelheim
2026-09-10 PHASE1
NCT07766369 NOT_YET_RECRUITING
Healthy Volunteers
Eisai Inc.
2026-08-12 PHASE1
NCT07446400 RECRUITING
Healthy Volunteers
Otsuka Pharmaceutical Development & Commercialization, Inc.
2026-03-31 PHASE1
NCT07775261 NOT_YET_RECRUITING
Healthy Participants
H. Lundbeck A/S
2026-08-27 PHASE1
NCT07570082 COMPLETED
Healthy Volunteers
Crinetics Pharmaceuticals Inc.
2026-05-28 PHASE1
NCT06909162 COMPLETED
Healthy Participants
Incyte Corporation
2025-05-05 PHASE1
NCT07449390 COMPLETED
Healthy Participants
Acesion Pharma
2026-04-01 PHASE1
NCT07279233 COMPLETED
Healthy; Volunteer
SpringWorks Therapeutics, Inc., a healthcare company of Merck KGaA, Darmstadt, Germany
2025-12-15 PHASE1
NCT07198035 COMPLETED
Healthy Adults
Pfizer
2025-09-18 PHASE1
NCT07252453 ACTIVE_NOT_RECRUITING
Trigeminal Neuralgia
Abbasi Shaheed Hospital
2025-05-20
NCT07100964 COMPLETED
Healthy
Boehringer Ingelheim
2025-08-11 PHASE1
NCT06547164 COMPLETED
Healthy Participants
AstraZeneca
2024-08-27 PHASE1
NCT06965881 TERMINATED
Tuberous Sclerosis Complex (TSC); Focal Cortical Dysplasia; Other Neurological Disorders
GRIN Therapeutics, Inc.
2025-05-08 PHASE1
NCT06672900 ACTIVE_NOT_RECRUITING
Healthy Volunteer
Aligos Therapeutics
2025-01-09 PHASE1
NCT06847464 COMPLETED
RSV Infection; Drug Drug Interaction (DDI)
Enanta Pharmaceuticals, Inc
2025-01-27 PHASE1
NCT06914869 COMPLETED
Healthy Participants
X4 Pharmaceuticals
2025-02-18 PHASE1
NCT06897683 COMPLETED
Healthy Adults
Pfizer
2025-03-21 PHASE1
NCT06751017 COMPLETED
COVID-19
Shionogi
2024-12-17 PHASE1
NCT06671405 COMPLETED
Dyslipidaemia
AstraZeneca
2024-09-25 PHASE1
NCT06633419 COMPLETED
Healthy
Merck Sharp & Dohme LLC
2024-12-18 PHASE1
NCT06596668 COMPLETED
Healthy
Merck Sharp & Dohme LLC
2024-10-02 PHASE1
NCT06357260 UNKNOWN
Trigeminal Neuralgia
Postgraduate Institute of Dental Sciences Rohtak
2024-04-01
NCT06849219 ACTIVE_NOT_RECRUITING
Trigeminal Neuralgia
Jinnah Postgraduate Medical Centre
2024-09-21 PHASE4
NCT06646042 COMPLETED
Healthy
Pfizer
2024-10-28 PHASE1
NCT06370728 COMPLETED
Healthy
Eli Lilly and Company
2024-05-06 PHASE1
NCT07304453 COMPLETED
Trigeminal Neuralgia; Neuropathic Pain
Karbala University
2024-01-07 PHASE2
NCT03689114 COMPLETED
Epilepsies, Partial
Mario Negri Institute for Pharmacological Research
2021-05-10 PHASE4
NCT06345794 COMPLETED
Healthy
DICE Therapeutics, Inc., a wholly owned subsidiary of Eli Lilly and Company
2024-04-03 PHASE1
NCT05419180 COMPLETED
Pharmacoresistant Focal Epilepsies
Biocodex
2022-10-13 PHASE4
NCT06348888 COMPLETED
Advanced Non-small Cell Lung Cancer; EGFR Mutation; HER2 Mutation; Healthy Volunteers
Bayer
2024-04-10 PHASE1
NCT06173596 COMPLETED
Healthy
Alexion Pharmaceuticals, Inc.
2024-01-10 PHASE1
NCT05840952 COMPLETED
COVID-19
Aligos Therapeutics
2023-07-04 PHASE1
NCT06071442 COMPLETED
Healthy Participants
Alexion Pharmaceuticals, Inc.
2024-01-17 PHASE1
NCT06357260 Not yet recruiting
Trigeminal Neuralgia
Postgraduate Institute of Dental Sciences Rohtak
2024-04 Not Applicable
NCT06348888 Recruiting
Advanced Non-small Cell Lung Cancer|EGFR Mutation|HER2 Mutation|Healthy Volunteers
Bayer
2024-04-10 Phase 1
NCT06028464 COMPLETED
Healthy
Boehringer Ingelheim
2023-09-11 PHASE1
NCT05965219 COMPLETED
Healthy Volunteers
Cerevel Therapeutics, LLC
2023-08-15 PHASE1
NCT05932303 COMPLETED
Healthy Participants
Bristol-Myers Squibb
2023-07-12 PHASE1
NCT06005688 COMPLETED
Healthy Participants
Pfizer
2023-08-18 PHASE1
NCT05748236 UNKNOWN
Focal Epilepsy
Dhaka Medical College
2022-11-01 PHASE4
NCT05994807 COMPLETED
Healthy Volunteers
DICE Therapeutics, Inc., a wholly owned subsidiary of Eli Lilly and Company
2023-08-08 PHASE1
NCT05860933 COMPLETED
Healthy
Eli Lilly and Company
2023-05-08 PHASE1
NCT06005688 Completed
Healthy Participants
Pfizer|Arvinas Estrogen Receptor Inc.
2023-08-18 Phase 1
NCT05824143 COMPLETED
Healthy Participants
Cerevel Therapeutics, LLC
2023-04-17 PHASE1
NCT05860933 Completed
Healthy
Eli Lilly and Company|Loxo Oncology Inc.
2023-05-08 Phase 1
NCT05552196 COMPLETED
Healthy
Janssen Pharmaceutica N.V., Belgium
2022-10-18 PHASE1
NCT06316362 COMPLETED
Acute Poisoning
Alexandria University
2022-01-01 PHASE2
NCT05581823 COMPLETED
Parkinson Disease
Cerevel Therapeutics, LLC
2022-10-19 PHASE1
NCT05594602 COMPLETED
COVID-19
Enanta Pharmaceuticals, Inc
2022-10-06 PHASE1
NCT07542847 COMPLETED
Healthy Volunteers
Otsuka Pharmaceutical Development & Commercialization, Inc.
2022-09-19 PHASE1
NCT05486949 COMPLETED
Healthy Subjects
Dizal Pharmaceuticals
2022-07-27 PHASE1
NCT05248945 COMPLETED
Healthy
Merck Healthcare KGaA, Darmstadt, Germany, an affiliate of Merck KGaA, Darmstadt, Germany
2022-01-13 PHASE1
NCT04923659 ACTIVE_NOT_RECRUITING
Low Intensity Focussed Ultrasound
University Health Network, Toronto
2021-05-25 EARLY_PHASE1
NCT04330248 COMPLETED
Healthy
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
2020-03-31 PHASE1
NCT05418582 COMPLETED
Healthy Subjects
Dizal Pharmaceuticals
2022-01-25 PHASE1
NCT05213481 COMPLETED
Healthy
Merck Healthcare KGaA, Darmstadt, Germany, an affiliate of Merck KGaA, Darmstadt, Germany
2021-12-15 PHASE1
NCT05205447 TERMINATED
Healthy
Eli Lilly and Company
2022-01-05 PHASE1
NCT04840888 COMPLETED
Healthy
Eli Lilly and Company
2021-04-26 PHASE1
NCT04996199 UNKNOWN
Trigeminal Neuralgia
Postgraduate Institute of Dental Sciences Rohtak
2021-09-18 PHASE4
NCT05028608 COMPLETED
Vasomotor Symptoms as a Sex Hormone-dependent Disorder in Women and Men
Bayer
2021-09-06 PHASE1
NCT04962230 COMPLETED
Healthy Participant
Pfizer
2021-07-15 PHASE1
NCT04783753 COMPLETED
Hepatitis B
Enanta Pharmaceuticals, Inc
2020-11-05 PHASE1
NCT04784000 COMPLETED
Healthy Volunteer Study
Atea Pharmaceuticals, Inc.
2021-03-01 PHASE1
NCT03580317 COMPLETED
Trigeminal Neuralgia
Zhejiang Chinese Medical University
2018-07-12
NCT04610879 TERMINATED
Rolandic Epilepsy
King's College London
2019-08-02 PHASE4
NCT04967326 COMPLETED
Epilepsy
Gia Dinh People Hospital
2016-01-01 PHASE4
NCT03161509 TERMINATED
Bariatric Surgery Candidate
Rambam Health Care Campus
2017-07-01 PHASE4
NCT02623504 TERMINATED
Bipolar Disorder
Validus Pharmaceuticals
2016-10-24 PHASE4
NCT02707965 COMPLETED
Epilepsy
Food and Drug Administration (FDA)
2017-06-08 PHASE1
NCT02912364 COMPLETED
Epilepsy
Stanford University
2016-07 PHASE4
NCT02374567 TERMINATED
Dementia; Depression; Schizophrenia; Psychosomatic Disorders; Anxiety Disorders
Hannover Medical School
2015-01 PHASE3
NCT02705768 COMPLETED
Seizures, Focal
All India Institute of Medical Sciences, Bhubaneswar
2016-04 PHASE4
NCT01379469 TERMINATED
Alpha-1-antitrypsin Deficiency; Liver Cirrhosis
Washington University School of Medicine
2012-01 PHASE2
NCT01465997 COMPLETED
Epilepsy; Monotherapy
UCB BIOSCIENCES GmbH
2012-05 PHASE3
NCT02214615 COMPLETED
Erythromelalgia
VA Connecticut Healthcare System
2014-04 PHASE4
NCT01954121 COMPLETED
Epilepsy; Partial Seizures
UCB Pharma SA
2013-09 PHASE3
NCT01243177 COMPLETED
Epilepsy; Monotherapy
UCB BIOSCIENCES GmbH
2011-04 PHASE3
NCT02870283 COMPLETED
Bipolar Disorder
Federal University of Rio Grande do Sul
2010-05 PHASE4
NCT02132897 COMPLETED
Bio-equivalence Study; Fed Conditions
Center for Clinical Pharmacology Research Bdbeq S.A.
2014-05 PHASE1
NCT01530022 COMPLETED
Healthy
UCB Pharma
2012-05 PHASE1
NCT01967771 COMPLETED
Infection, Human Immunodeficiency Virus
ViiV Healthcare
2013-10 PHASE1
NCT02208492 COMPLETED
Focal Epilepsy
Yonsei University
2011-09 PHASE4
NCT00621751 COMPLETED
Traumatic Brain Injury
Wake Forest University Health Sciences
2008-02
NCT01375374 TERMINATED
Epilepsy, Partial
UCB Pharma
2011-07 PHASE3
NCT01128959 COMPLETED
Epilepsy
Lundbeck LLC
2010-06 PHASE3
NCT01707407 COMPLETED
Pharmacology, Clinical; Healthy
Celgene
2012-09-01 PHASE1
NCT01629368 COMPLETED
Healthy Volunteer
Hoffmann-La Roche
2012-06 PHASE1
NCT01635829 COMPLETED
Healthy Participants
Janssen Infectious Diseases BVBA
2012-05 PHASE1
NCT01382017 COMPLETED
Healthy Male Volunteers
University of Kiel
2011-06
NCT00976794 COMPLETED
Bipolar I Disorder
University of Sao Paulo
2009-01 PHASE4
NCT00807989 COMPLETED
Epilepsy
Yonsei University
2008-03 PHASE4
NCT01581918 UNKNOWN
Chemotherapy-induced Nausea and Vomiting
Faculdade de Medicina do ABC
2011-12 PHASE2
NCT01365403 COMPLETED
Healthy Volunteer
Hoffmann-La Roche
2011-04 PHASE1
NCT00848549 COMPLETED
Epilepsy
Eisai Inc.
2008-10 PHASE3
NCT00894010 COMPLETED
Photosensitive Epilepsy
The Epilepsy Study Consortium
2009-05 PHASE2
NCT00952432 UNKNOWN
Carpal Tunnel Syndrome; Multiple Excitability Test
Taipei Medical University WanFang Hospital
2009-05
NCT00477295 COMPLETED
Epilepsy
Eisai Inc.
2007-05 PHASE3
NCT00438451 COMPLETED
Focal Epilepsy
Johannes Gutenberg University Mainz
2007-01 PHASE4
NCT01089855 COMPLETED
Neuropathic Pain
Novartis
2009-12 PHASE4
NCT02284854 COMPLETED
Epilepsy
Bial - Portela C S.A.
2009-07 PHASE1
NCT00294892 COMPLETED
HIV Infections
Radboud University Medical Center
2006-02 PHASE2
NCT00542802 UNKNOWN
Epileptic Seizures; Stroke
Scienze Neurologiche Ospedaliere
2007-09 PHASE3
NCT01127256 COMPLETED
Epilepsy
Eisai Korea Inc.
2006-05-31 PHASE4
NCT00266630 COMPLETED
Manic or Mixed Episode Associated With Bipolar I Disorder
Eli Lilly and Company
2005-11 PHASE3
NCT01079351 COMPLETED
Epilepsy
Lundbeck LLC
2007-04 PHASE1
NCT00896987 COMPLETED
Epilepsy
Korean Epilepsy Society
2006-05 PHASE4
NCT00913107 COMPLETED
Trigeminal Neuralgia
University of Malaya
2007-09 PHASE2; PHASE3
NCT00175903 COMPLETED
Epilepsy
UCB Pharma
2005-02 PHASE3
NCT00350857 COMPLETED
Bipolar I Disorder
Validus Pharmaceuticals
2006-07 PHASE4
NCT00181870 COMPLETED
Bipolar Disorder; Mania
Massachusetts General Hospital
2005-07 PHASE4
NCT00203567 COMPLETED
Bipolar Depression
Tuscaloosa Research & Education Advancement Corporation
2005-08 PHASE4
NCT00260247 COMPLETED
Metabolic Clearance Rate
Odense University Hospital
2005-04 PHASE4
NCT02253849 COMPLETED
Healthy
Boehringer Ingelheim
2005-11 PHASE1
NCT00150787 COMPLETED
Epilepsy, Tonic-clonic
UCB Pharma
2003-07 PHASE3
NCT00150735 COMPLETED
Generalized Epilepsy
UCB Pharma
2002-06 PHASE3
NCT00000242 COMPLETED
Cocaine-Related Disorders; Substance-Related Disorders
Medical University of South Carolina
1992-10-01 PHASE2
NCT00000217 COMPLETED
Cocaine-Related Disorders; Substance-Related Disorders
University of Kansas
1990-09 PHASE2
NCT00000191 COMPLETED
Cocaine-Related Disorders
University of Pennsylvania
1991-01 PHASE2
NCT00208520 UNKNOWN
Adults With Tonic Clonic Seizures and/or Partial Seizures
Dutch Epilepsy Clinics Foundation
2003-07
NCT00150605 COMPLETED
Bipolar Disorder
Validus Pharmaceuticals
2005-02 PHASE3
NCT00000441 COMPLETED
Alcoholism
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
PHASE4
NCT00216567 COMPLETED
Epilepsy, Rolandic
Janssen Korea, Ltd., Korea
2002-12 PHASE4
NCT00381537 COMPLETED
Epilepsy
Institute of Child Health
NCT00007670 COMPLETED
Seizures
US Department of Veterans Affairs
1998-01 PHASE3
NCT00153296 COMPLETED
Bronchial Asthma
Centre of Chinese Medicine, Georgia
2004-08 PHASE4
NCT00892125 COMPLETED
Schizophrenia; Bipolar Disorder
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
2006-09 PHASE1
NCT00000218 COMPLETED
Cocaine-Related Disorders; Substance-Related Disorders
National Institute on Drug Abuse (NIDA)
PHASE4
NCT00006395 COMPLETED
Healthy
National Institutes of Health Clinical Center (CC)
2000-10 PHASE4
NCT00150553 COMPLETED
Bipolar Disorder
Validus Pharmaceuticals
2005-01 PHASE3
NCT00236717 COMPLETED
Epilepsy; Seizures
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
1997-09 PHASE3
NCT00004758 COMPLETED
Spasms, Infantile; Epilepsy
National Center for Research Resources (NCRR)
1993-11 PHASE2
NCT00325286 UNKNOWN
Bipolar Disorder
Creighton University
2006-05 PHASE4
NCT00190892 COMPLETED
Bipolar Disorder
Eli Lilly and Company
2004-09 PHASE4
NCT00207428 COMPLETED
Bronchial Asthma
Centre of Chinese Medicine, Georgia
1999-08 PHASE4

(data from https://clinicaltrials.gov, updated on 2026-06-29)

Check the Carbamazepine product page for in-depth specifications, including solubility, stock solutions, MOA, and working concentrations.

Compliance for Clinical Use

Mechanism and Biochemical Profile

Carbamazepine selectively binds to voltage-gated sodium channels to stabilize their inactivated state, which blocks the persistent influx of sodium ions and dampens high-frequency action potential firing in neurons. This suppression of cellular hyperexcitability effectively attenuates paroxysmal electrical discharges, contributing to its clinical utility in treating conditions such as focal epilepsy and trigeminal neuralgia.

Appendix RUO and cGMP Quality Standards

Quality Dimension RUO (Research Use Only) cGMP (Current Good Manufacturing Practice)
Clinical Applicability Prohibited in human clinical trials or medical diagnostics. Mandatory for human clinical trials (Phase I–III) and therapies.
Regulatory Status Non-regulated grade; exempt from drug manufacturing laws. Legally enforced by health authorities (e.g., FDA, EMA, NMPA).
Facility Environment Unclassified analytical or research laboratories. Validated Cleanrooms (ISO Class 5–8) with continuous monitoring.
Quality Control Basic purity and activity testing. Rigorous safety release testing (Sterility, Endotoxin, Mycoplasma).
Process Validation Basic equipment calibration; no process validation required. Full qualification (IQ/OQ/PQ) and complete batch records.
Quality Assurance Vendor self-declared without required formal QMS. Mandatory QA/QC unit, Change Control, CAPA, and vendor audits.
Regulatory Impact High risk of IND rejection if used as a critical raw material. Required for IND/NDA filings, supported by Drug Master Files (DMF).

Footnotes

Regulatory Note: Governed by FDA (21 CFR Parts 210/211/312), EMA (EudraLex Vol 4), ICH Guidelines (E6/Q7/Q9/Q10), and compendial standards (USP <71>/<85>/<1043>).

Note: Technical data last updated: Sep 1, 2026.