Gabapentin
Gabapentin, Gralise, Neurontin (gabapentin) is a small molecule pharmaceutical. Gabapentin was first approved as Neurontin on 1993-12-30. It is used to treat bipolar disorder, epilepsy, partial epilepsies, phobic disorders, and postherpetic neuralgia in the USA. It is known to target potassium voltage-gated channel subfamily KQT member 3 and potassium voltage-gated channel subfamily KQT member 5.
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Commercial
Therapeutic Areas
Trade Name
FDA
EMA
Gralise, Neurontin (generic drugs available since 2003-09-12)
Drug Products
FDA
EMA
New Drug Application (NDA)
New Drug Application (NDA)
Abbreviated New Drug Application (ANDA)
Abbreviated New Drug Application (ANDA)
Labels
FDA
EMA
Brand Name | Status | Last Update |
|---|---|---|
| cyclo/gaba 10/300 pack | ANDA | 2016-06-22 |
| fanatrex | unapproved drug other | 2016-01-07 |
| gaba 300-ezs | unapproved drug other | 2020-11-16 |
| gabapentin | ANDA | 2024-01-31 |
| gabapentin gabapentin | ANDA | 2013-08-23 |
| gralise | New Drug Application | 2021-10-01 |
| horizant | New Drug Application | 2023-08-29 |
| metformin hydrochloride extended release | ANDA | 2017-08-24 |
| neurontin | New Drug Application | 2022-07-12 |
| neurotin | ANDA | 2021-07-28 |
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Indications
FDA
EMA
Agency Specific
FDA
EMA
No data
Patent Expiration
Patent | Expires | Flag | FDA Information |
|---|---|---|---|
| Gabapentin, Gralise, Almatica | |||
| 7438927 | 2024-02-26 | U-1114 | |
HCPCS
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Clinical
Clinical Trials
516 clinical trials
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Indications Phases 4
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Postoperative pain | D010149 | — | G89.18 | 7 | 4 | 10 | 28 | 14 | 60 |
| Pain | D010146 | EFO_0003843 | R52 | 2 | 5 | 7 | 15 | 15 | 42 |
| Healthy volunteers/patients | — | — | — | 11 | — | 1 | 1 | 9 | 22 |
| Restless legs syndrome | D012148 | EFO_0004270 | G25.81 | 3 | 3 | 6 | 6 | 3 | 21 |
| Neuralgia | D009437 | EFO_0009430 | — | 1 | 4 | 1 | 5 | 6 | 17 |
| Sleep initiation and maintenance disorders | D007319 | — | F51.01 | 1 | 4 | 8 | 1 | 2 | 16 |
| Diabetic neuropathies | D003929 | EFO_1000783 | — | — | 7 | 4 | 8 | — | 16 |
| Hot flashes | D019584 | — | — | — | 2 | 7 | 1 | 5 | 15 |
| Chronic pain | D059350 | HP_0012532 | — | — | 4 | 3 | 1 | 4 | 12 |
| Alcoholism | D000437 | EFO_0003829 | F10.1 | — | 8 | 3 | 1 | 2 | 12 |
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Indications Phases 3
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Breast neoplasms | D001943 | EFO_0003869 | C50 | — | 3 | 4 | — | 3 | 9 |
| Fibromyalgia | D005356 | EFO_0005687 | M79.1 | — | 1 | 2 | — | 7 | 9 |
| Neoplasms | D009369 | — | C80 | — | 3 | 1 | — | 2 | 6 |
| Substance-related disorders | D019966 | EFO_0003890 | F13 | 1 | 3 | 2 | — | 1 | 5 |
| Depression | D003863 | — | F33.9 | — | 1 | 1 | — | 3 | 5 |
| Scoliosis | D012600 | EFO_0004273 | M41 | — | — | 3 | — | 1 | 4 |
| Postoperative complications | D011183 | — | — | — | 1 | 1 | — | 1 | 3 |
| Anxiety disorders | D001008 | EFO_0006788 | F41.1 | — | 1 | 1 | — | 1 | 3 |
| Menopause | D008593 | EFO_0003922 | N95 | — | 1 | 1 | — | 1 | 3 |
| Tinnitus | D014012 | HP_0000360 | H93.1 | — | 3 | 1 | — | — | 3 |
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Indications Phases 2
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Intervertebral disc displacement | D007405 | EFO_1001800 | — | — | 1 | — | — | 2 | 3 |
| Bipolar disorder | D001714 | EFO_0000289 | F30.9 | — | 3 | — | — | — | 3 |
| Hiv | D006678 | — | O98.7 | — | 1 | — | — | 2 | 3 |
| Covid-19 | D000086382 | — | U07.1 | — | 1 | — | — | 1 | 2 |
| Male breast neoplasms | D018567 | — | — | — | 1 | — | — | 1 | 2 |
| Central nervous system neoplasms | D016543 | — | — | 1 | 2 | — | — | — | 2 |
| Cocaine-related disorders | D019970 | — | F14 | — | 2 | — | — | — | 2 |
| Mood disorders | D019964 | EFO_0004247 | F30-F39 | — | 1 | — | — | 1 | 2 |
| Psychotic disorders | D011618 | — | F20.81 | 1 | 2 | — | — | — | 2 |
| Hiv infections | D015658 | EFO_0000764 | B20 | — | 1 | — | — | 1 | 2 |
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Indications Phases 1
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Refractive errors | D012030 | EFO_0003908 | H52.7 | 1 | — | — | — | — | 1 |
| Stomatitis | D013280 | EFO_1001904 | K12.1 | 1 | — | — | — | — | 1 |
| Squamous cell carcinoma of head and neck | D000077195 | — | — | 1 | — | — | — | — | 1 |
| Pharmacokinetics | D010599 | — | — | 1 | — | — | — | — | 1 |
| Weight loss | D015431 | HP_0001824 | — | 1 | — | — | — | — | 1 |
| Taste disorders | D013651 | — | — | 1 | — | — | — | — | 1 |
Indications Without Phase
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Hypertension | D006973 | EFO_0000537 | I10 | — | — | — | — | 2 | 2 |
| Hysterectomy | D007044 | EFO_0003881 | — | — | — | — | — | 2 | 2 |
| Migraine disorders | D008881 | EFO_0003821 | G43 | — | — | — | — | 2 | 2 |
| Headache | D006261 | HP_0002315 | R51 | — | — | — | — | 2 | 2 |
| Vulvodynia | D056650 | — | N94.81 | — | — | — | — | 2 | 2 |
| Renal cell carcinoma | D002292 | EFO_0000376 | — | — | — | — | — | 2 | 2 |
| Pancreatic neoplasms | D010190 | EFO_0003860 | C25 | — | — | — | — | 2 | 2 |
| Kidney neoplasms | D007680 | EFO_0003865 | C64 | — | — | — | — | 2 | 2 |
| Chronic pancreatitis | D050500 | EFO_0000342 | K86.1 | — | — | — | — | 2 | 2 |
| Pelvic neoplasms | D010386 | — | — | — | — | — | — | 2 | 2 |
Show 64 more
Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
| Drug common name | Gabapentin |
| INN | gabapentin |
| Description | Gabapentin is a gamma-amino acid that is cyclohexane substituted at position 1 by aminomethyl and carboxymethyl groups. Used for treatment of neuropathic pain and restless legs syndrome. It has a role as an anticonvulsant, a calcium channel blocker, an environmental contaminant and a xenobiotic. It is functionally related to a gamma-aminobutyric acid. |
| Classification | Small molecule |
| Drug class | gabamimetics |
| Image (chem structure or protein) |  |
| Structure (InChI/SMILES or Protein Sequence) | NCC1(CC(=O)O)CCCCC1 |
Identifiers
| PDB | — |
| CAS-ID | 60142-96-3 |
| RxCUI | — |
| ChEMBL ID | CHEMBL940 |
| ChEBI ID | 42797 |
| PubChem CID | 3446 |
| DrugBank | DB00996 |
| UNII ID | 6CW7F3G59X (ChemIDplus, GSRS) |
Target
Agency Approved
No data
Alternate
KCNQ3
KCNQ3
KCNQ5
KCNQ5
Organism
Homo sapiens
Gene name
KCNQ3
Gene synonyms
NCBI Gene ID
Protein name
potassium voltage-gated channel subfamily KQT member 3
Protein synonyms
KQT-like 3, Potassium channel subunit alpha KvLQT3, potassium channel, voltage gated KQT-like subfamily Q, member 3, potassium channel, voltage-gated, subfamily Q, member 3, potassium voltage-gated channel, KQT-like subfamily, member 3, Voltage-gated potassium channel subunit Kv7.3
Uniprot ID
Mouse ortholog
Kcnq3 (110862)
potassium voltage-gated channel subfamily KQT member 3 (Q8K3F6)
Variants
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Neurontin – Pfizer
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Gralise – Assertio Therapeutics
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Gralise – Assertio Therapeutics
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Estimated US medical usage
Gabapentin
Total medical expenditures per year (USD, in millions)
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Trends
PubMed Central
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Additional graphs summarizing 27,396 documents
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Safety
Black-box Warning
No Black-box warning
Adverse Events
Top Adverse Reactions
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83,316 adverse events reported
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