carbamazepine
Trade name: tegretol
Approved
Mar 11, 1968
Carbamazepine is an analgesic, anti-epileptic agent that is FDA approved for the treatment of epilepsy, trigeminal neuralgia. It appears to act by reducing polysynaptic responses and blocking the post-tetanic potentiation. It depresses thalamic potential and bulbar and polysynaptic reflexes, including the linguomandibular reflex in cats. Commonly reported side effects of carbamazepine include: dizziness, drowsiness, nausea, ataxia, and vomiting. Carbamazepine is a potent inducer of hepatic CYP1A2, 2B6, 2C9/19, and 3A4 and may reduce plasma concentrations of concomitant medications mainly metabolized by CYP1A2, 2B6, 2C9/19, and 3A4 through induction of their metabolism, like Boceprevir, Cyclophosphamide, Aripiprazole, Tacrolimus, Temsirolimus and others. — NCATS
Clinical trial activity
124 trials · 150 clinical orgs · 43 marketing orgs
Earliest trial started Sep 1, 1990 (NCT00000217)
Timeline
1960s
1980s
- Aug 14, 1986
Inwood Laboratories — Marketing Organization
- Jul 24, 1987
Pliva — Marketing Organization
- Nov 9, 1987
Actavis — Marketing Organization
- Feb 1, 1988
Jubilant Innovation Ltd. — Marketing Organization
1990s
2000s
- Jul 5, 2001
Torrent Pharmaceuticals Limited — Marketing Organization
- Feb 27, 2002
Apotex — Marketing Organization
- Jun 5, 2002
Wockhardt — Marketing Organization
- Jun 5, 2002
Chartwell Pharmaceuticals — Marketing Organization
- Dec 10, 2004
Validus Pharmaceuticals — NDA Secondary Org
- Jan 1, 2005
Earliest Phase 1 Sponsor(trial)
2010s
- May 20, 2011
Nostrum Laboratories — Marketing Organization
- May 20, 2011
Mylan — Marketing Organization
- Sep 20, 2012
Teva — Marketing Organization
- Jun 21, 2013
Sun Pharmaceuticals — Marketing Organization
- Oct 7, 2016
Lundbeck — NDA Secondary Org
- Feb 7, 2019
Zydus Discovery DMCC — Marketing Organization
2020s
- Apr 15, 2020
Umedica Labs Pvt Ltd — Marketing Organization
- Apr 24, 2020
Unique Pharmaceuticals Ltd, India — Marketing Organization
- Apr 13, 2021
Shijiazhuang Pharma Group (CSPC) — Marketing Organization
- Aug 16, 2021
Vgyaan — Marketing Organization
- Aug 16, 2021
Apicore — Marketing Organization
- Sep 30, 2021
Anbison Lab — Marketing Organization
- Mar 31, 2022
Zhejiang Jiuzhou Pharmaceutical Co., Ltd. — Marketing Organization
- Aug 22, 2022
Unichem — Marketing Organization
- Oct 6, 2022
Novitium Pharma — Marketing Organization
- Oct 6, 2022
Ani Pharmaceuticals — Marketing Organization
- Dec 2, 2022
RiconPharma — Marketing Organization
- Dec 2, 2022
Novast Labs — Marketing Organization
- Dec 2, 2022
Ingenus Pharmaceuticals — Marketing Organization
- Mar 2, 2023
Sciecure Pharma Inc — Marketing Organization
- Mar 24, 2023
Ajanta Pharma Ltd — Marketing Organization
- Sep 22, 2023
Amneal Pharmaceuticals — Marketing Organization
- Feb 16, 2024
Bionpharma Inc — Marketing Organization
- Oct 22, 2024
Osmotica Pharmaceutical — Marketing Organization
- Jan 14, 2025
Alkem Labs Ltd — Marketing Organization
- Jan 16, 2025
Yichang Humanwell Pharmaceutical Co.,Ltd — Marketing Organization
- Apr 16, 2025
Alembic — Marketing Organization
Indications
Approved for
Studied for
- Alcoholism · Phase 4
- alpha 1-Antitrypsin Deficiency · Phase 2
- Anxiety Disorders · Phase 3
- Asthma · Phase 4
- Astrocytoma · Phase 1
- Bariatric Surgery · Phase 4
- Bone Diseases, Metabolic · Phase 4
- Carcinoma, Non-Small-Cell Lung · Phase 1
- Cocaine-Related Disorders · Phase 4
- Contraception · Phase 4
- COVID-19 · Phase 1
- Dementia · Phase 3
- Depression · Phase 3
- Drug Interactions · Phase 4
- Drug-Related Side Effects and Adverse Reactions · Phase 2
- Drug Resistant Epilepsy · Phase 4
- Drugs, Generic · Phase 1
- Dyslipidemias · Phase 1
- Epilepsies, Partial · Phase 4
- Epilepsy, Reflex · Phase 2
- Epilepsy, Rolandic · Phase 4
- Erb-b2 Receptor Tyrosine Kinases · Phase 1
- Erythromelalgia · Phase 4
- Fasting · Phase 1
- Glioblastoma · Phase 1
- Glioma · Phase 4
- Gliosarcoma · Phase 1
- Healthy Volunteers · Phase 1
- Hepatitis B · Phase 1
- HIV · Phase 1
- HIV Infections · Phase 2
- Intellectual Disability · Phase 4
- Liver Cirrhosis · Phase 2
- Mania · Phase 4
- Metabolic Clearance Rate · Phase 4
- Mutation · Phase 1
- Neuralgia · Phase 4
- Oligodendroglioma · Phase 1
- Osteoporosis · Phase 4
- Parkinson Disease · Phase 1
- Pharmacology, Clinical · Phase 1
- Psychophysiologic Disorders · Phase 3
- Respiratory Syncytial Virus Infections · Phase 1
- Schizophrenia · Phase 3
- Spasms, Infantile · Phase 2
- Stroke · Phase 3
- Substance-Related Disorders · Phase 4
- Ultrasonography · Early Phase 1
- Vasomotor System · Phase 1
- Wuchereria bancrofti · Phase 1
Mechanism of action
- Sodium channel alpha subunitBLOCKER
Sodium channel alpha subunit blocker
- Sodium channel protein type 1 subunit alpha (SCN1A) ↗
- Sodium channel protein type 5 subunit alpha (SCN5A) ↗
- Sodium channel protein type 4 subunit alpha (SCN4A) ↗
- Sodium channel protein type 7 subunit alpha (SCN7A) ↗
- Sodium channel protein type 2 subunit alpha (SCN2A) ↗
- Sodium channel protein type 9 subunit alpha (SCN9A) ↗
- Sodium channel protein type 3 subunit alpha (SCN3A) ↗
- Sodium channel protein type 11 subunit alpha (SCN11A) ↗
- Sodium channel protein type 8 subunit alpha (SCN8A) ↗
- Sodium channel protein type 10 subunit alpha (SCN10A) ↗
- Sodium channel protein type I alpha subunit
- Sodium channel protein type V alpha subunit
- Sodium channel protein type IV alpha subunit
- Sodium channel protein type VII alpha subunit
- Sodium channel protein type IX alpha subunit
- Sodium channel protein type II alpha subunit
- Sodium channel protein type III alpha subunit
- Sodium channel protein type XI alpha subunit
- Sodium channel protein type VIII alpha subunit
- Sodium channel protein type X alpha subunit
- Sodium channel alpha subunits; brain (Types I, II, III)
Approval history
- approvedPriority reviewMar 11, 1968
Chemistry & pharmacology
SMILES
NC(=O)N1C2=CC=CC=C2C=CC3=CC=CC=C13- Mol. weight
- 236.2686 g/mol
- Lipinski Ro5
- Pass
- Rule of 3
- No
- Chirality
- Achiral Molecule
- Inorganic
- No
- Polymer
- No
- Delivery
- Oral, Parenteral
- Availability
- Prescription Only
Oral
Yes
Parenteral
Yes
Topical
No
Sources
- WikipediaCarbamazepine ↗
- NCATS33CM23913M ↗
- ChEMBLCHEMBL108 ↗
Also known as
- 5-carbamoyl-5h-dibenz(b,f)azepine
- 5-carbamoyl-5h-dibenz(b,f)azepine
- 5-carbamoyl-5h-dibenz[b,f]azepine
- 5-carbamoyl-5h-dibenz[b,f]azepine
- 5-carbamoyl-5h-dibenzo(b,f)azepine
- 5-carbamoyl-5h-dibenzo(b,f)azepine
- 5-carbamyl-5h-dibenzo(b,f)azepine
- 5-carbamyl-5h-dibenzo(b,f)azepine
- 5h-dibenz(b,f)azepine-5-carboxamide
- 5h-dibenz(b,f)azepine-5-carboxamide
- arbil mr
- carabamazepine
- carbagen sr
- carbamazepen
- carbamazepen
- carbamazepen
- carbamazepin
- carbamazepin
- carbamazepin
- carbamazepina
- carbamazepina
- carbamazepine
- carbamazepine
- carbamazepine
- carbamazepine
- carbamazepine
- carbamazepine
- carbamazepine
- carbamazepine
- carbamazepine
- carbamazepine
- carbamazepine
- carbamazépine
- carbamazépine
- carbamazepine anhydrous
- carbamazepine dihydrate
- carbamazepine hydrate
- carbamazepine hydrochloride
- carbamazepine phosphate
- carbamazepine sulfate
- carbamazepine tartrate
- carbamazepinum
- carbamazepinum
- carbamazine
- carbamazine
- carbamazine
- carbamazine
- carbatrol
- carbatrol
- carbazepine
- carbemazepine
- cbz
- cbz
- epimaz
- epimaz ret
- epitol
- epitol
- equetro
- equetro
- g-32883
- g-32883
- sirtal ret
- tegretol
- tegretol
- tegretol
- tegretol
- tegretol chewtab
- tegretol prolonged release
- tegretol xr
- tegretol xr
- tegretol-xr
- tegretol-xr
- teril
- teril
- teril ret
- timonil 200 ret
- timonil 400 ret
Clinical trials
| NCT ID | Phase | Start date | Sponsor(s) |
|---|---|---|---|
| NCT07279233 | Phase 1 | Dec 31, 2025 | SpringWorks Therapeutics, Inc. |
| NCT07198035 | Phase 1 | Sep 18, 2025 | Pfizer |
| NCT07100964 | Phase 1 | Aug 11, 2025 | Boehringer Ingelheim |
| NCT07252453 | N/A | May 20, 2025 | Abbasi Shaheed Hospital |
| NCT06977932 | N/A | May 20, 2025 | Zhejiang University |
| NCT06897683 | Phase 1 | Mar 21, 2025 | Pfizer |
| NCT06914869 | Phase 1 | Feb 18, 2025 | X4 Pharmaceuticals |
| NCT06847464 | Phase 1 | Jan 27, 2025 | Enanta Pharmaceuticals |
| NCT06672900 | Phase 1 | Jan 9, 2025 | Aligos Therapeutics |
| NCT06633419 | Phase 1 | Jan 2, 2025 | Merck |
| NCT06751017 | Phase 1 | Dec 17, 2024 | Shionogi |
| NCT06646042 | Phase 1 | Oct 28, 2024 | Pfizer |
| NCT06596668 | Phase 1 | Oct 2, 2024 | Merck |
| NCT06671405 | Phase 1 | Sep 25, 2024 | AstraZeneca |
| NCT06849219 | Phase 4 | Sep 21, 2024 | Jinnah Postgraduate Medical Centre |
| NCT06547164 | Phase 1 | Aug 27, 2024 | AstraZeneca |
| NCT06370728 | Phase 1 | May 6, 2024 | Eli Lilly |
| NCT06348888 | Phase 1 | Apr 10, 2024 | Bayer |
| NCT06345794 | Phase 1 | Apr 3, 2024 | Eli Lilly |
| NCT06357260 | N/A | Apr 1, 2024 | Pandit Bhagwat Dayal Sharma Post Graduate Institute of Medical Sciences |
Organizations
Research & Development (150)
| Organization | Org type | Trials | As lead sponsor | Phases | Earliest year |
|---|---|---|---|---|---|
| Eli Lilly | For profit | 8 | 8 | 3 | 2004 |
| Hoosier Cancer Research Network | Academic/Hospital | 7 | 5 | 4 | 2005 |
| Department of Veteran Affairs | Government | 6 | 3 | 4 | 1990 |
| Pfizer | For profit | 5 | 5 | 1 | 2021 |
| National Institute on Drug Abuse (NIDA) | Government | 4 | 1 | 2 | 1990 |
| Validus Pharmaceuticals | For profit | 4 | 4 | 2 | 2005 |
| Boehringer Ingelheim | For profit | 3 | 3 | 1 | 2005 |
| Cerevel Therapeutics, LLC | For profit | 3 | 3 | 1 | 2022 |
| Eisai | For profit | 3 | 3 | 2 | 2006 |
| Enanta Pharmaceuticals | For profit | 3 | 3 | 1 | 2020 |
| GlaxoSmithKline | For profit | 3 | 0 | 3 | 2006 |
| Johnson and Johnson | For profit | 3 | 3 | 2 | 1997 |
| Novartis | For profit | 3 | 1 | 2 | 2005 |
| Roche | For profit | 3 | 2 | 1 | 2011 |
| Shire | For profit | 3 | 0 | 1 | 2005 |
| University of London | Academic/Hospital | 3 | 2 | 2 | 2015 |
| Alexion | For profit | 2 | 2 | 1 | 2023 |
| Aligos Therapeutics | For profit | 2 | 2 | 1 | 2023 |
| AstraZeneca | For profit | 2 | 2 | 1 | 2024 |
| Bayer | For profit | 2 | 2 | 1 | 2021 |
Marketing (53)
| Organization | Org type | Relationship | Date |
|---|---|---|---|
| Actavis | For profit | MKTG | Nov 9, 1987 |
| Ajanta Pharma Ltd | For profit | MKTG | Mar 24, 2023 |
| Alembic | For profit | MKTG | Apr 16, 2025 |
| Alkem Labs Ltd | For profit | MKTG | Jan 14, 2025 |
| Amneal Pharmaceuticals | For profit | MKTG | Sep 22, 2023 |
| Amneal Pharmaceuticals | For profit | SYN | Sep 22, 2023 |
| Anbison Lab | For profit | MKTG | Sep 30, 2021 |
| Ani Pharmaceuticals | For profit | MKTG | Oct 6, 2022 |
| Ani Pharmaceuticals | For profit | SYN | May 20, 2011 |
| Apicore | For profit | MKTG | Aug 16, 2021 |
| Apotex | For profit | MKTG | Feb 27, 2002 |
| Apotex | For profit | SYN | Feb 27, 2002 |
| Bionpharma Inc | For profit | MKTG | Feb 16, 2024 |
| Chartwell Pharmaceuticals | For profit | MKTG | Jun 5, 2002 |
| Geigy | For profit | NDA | Mar 11, 1968 |
| Ingenus Pharmaceuticals | For profit | MKTG | Dec 2, 2022 |
| Inwood Laboratories | For profit | MKTG | Aug 14, 1986 |
| Jubilant Innovation Ltd. | For profit | MKTG | Feb 1, 1988 |
| Lundbeck | For profit | NDA2 | Oct 7, 2016 |
| Mylan | For profit | MKTG | May 20, 2011 |
| Nostrum Laboratories | For profit | MKTG | May 20, 2011 |
| Novartis | For profit | NDA2 | Mar 11, 1968 |
| Novast Labs | For profit | MKTG | Dec 2, 2022 |
| Novitium Pharma | For profit | MKTG | Oct 6, 2022 |
| Osmotica Pharmaceutical | For profit | MKTG | Oct 22, 2024 |
| Pliva | For profit | MKTG | Jul 24, 1987 |
| RiconPharma | For profit | MKTG | Dec 2, 2022 |
| Sciecure Pharma Inc | For profit | MKTG | Mar 2, 2023 |
| Shijiazhuang Pharma Group (CSPC) | For profit | MKTG | Apr 13, 2021 |
| Shire | For profit | NDA2 | Sep 30, 1997 |
| Sun Pharmaceuticals | For profit | MKTG | Jun 21, 2013 |
| Takeda | For profit | MKTG | Sep 30, 1997 |
| Takeda | For profit | NDA2 | Sep 30, 1997 |
| Taro Pharmaceuticals | For profit | MKTG | Oct 3, 1996 |
| Taro Pharmaceuticals | For profit | SYN | Sep 20, 2004 |
| Taro Pharmaceuticals | For profit | SYN | Oct 24, 2000 |
| Teva | For profit | SYN | Sep 17, 1986 |
| Teva | For profit | SYN | Sep 20, 2012 |
| Teva | For profit | MKTG | Sep 20, 2012 |
| Torrent Pharmaceuticals Limited | For profit | MKTG | Jul 5, 2001 |
| Torrent Pharmaceuticals Limited | For profit | SYN | Jan 13, 2025 |
| Umedica Labs Pvt Ltd | For profit | MKTG | Apr 15, 2020 |
| Umedica Labs Pvt Ltd | For profit | SYN | Apr 15, 2020 |
| Unichem | For profit | MKTG | Aug 22, 2022 |
| Unique Pharmaceuticals Ltd, India | For profit | MKTG | Apr 24, 2020 |
| Upsher-Smith Laboratories | For profit | MKTG | — |
| Validus Pharmaceuticals | For profit | NDA2 | Dec 10, 2004 |
| Vgyaan | For profit | MKTG | Aug 16, 2021 |
| Warner Chilcott | For profit | MKTG | — |
| Wockhardt | For profit | MKTG | Jun 5, 2002 |
| Yichang Humanwell Pharmaceutical Co.,Ltd | For profit | MKTG | Jan 16, 2025 |
| Zhejiang Jiuzhou Pharmaceutical Co., Ltd. | For profit | MKTG | Mar 31, 2022 |
| Zydus Discovery DMCC | For profit | MKTG | Feb 7, 2019 |