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
Gabapentin, Gralise, Neurontin (discontinued: Gabapentin)
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 | 2025-05-27 |
| gabapentin gabapentin | ANDA | 2013-08-23 |
| gabarone | ANDA | 2024-12-23 |
| gralise | New Drug Application | 2024-07-02 |
| horizant | New Drug Application | 2025-04-28 |
| neurontin | New Drug Application | 2025-04-15 |
| therapentin-60 | unapproved drug other | 2011-08-01 |
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HCPCS
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Clinical
Clinical Trials
544 clinical trials
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Indications Phases 4
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Sleep initiation and maintenance disorders | D007319 | — | F51.01 | — | — | 7 | 1 | — | 8 |
| Partial epilepsies | D004828 | EFO_0004263 | — | — | — | 2 | 2 | 2 | 6 |
| Epilepsy | D004827 | EFO_0000474 | G40.9 | — | — | — | 2 | 1 | 3 |
| Seizures | D012640 | — | G40.4 | — | — | 1 | 1 | — | 2 |
| Renal insufficiency | D051437 | — | N19 | — | — | — | 2 | — | 2 |
| Complex partial epilepsy | D017029 | EFO_1000877 | — | — | — | — | 1 | — | 1 |
| Diabetic neuropathies | D003929 | EFO_1000783 | — | — | — | — | 1 | — | 1 |
Indications Phases 3
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Healthy volunteers/patients | — | — | — | 1 | — | 1 | — | — | 2 |
Indications Phases 2
No data
Indications Phases 1
No data
Indications Without Phase
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Neuralgia | D009437 | EFO_0009430 | — | — | — | — | — | 1 | 1 |
| Postherpetic neuralgia | D051474 | — | — | — | — | — | — | 1 | 1 |
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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Financial
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Gralise – Assertio Therapeutics
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Gralise – Assertio Therapeutics
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Neurontin – Pfizer
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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 31,386 documents
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Safety
Black-box Warning
No Black-box warning
Adverse Events
Top Adverse Reactions
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102,987 adverse events reported
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