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 | 2024-11-05 |
| gabapentin gabapentin | ANDA | 2013-08-23 |
| gralise | New Drug Application | 2024-07-02 |
| horizant | New Drug Application | 2023-08-29 |
| metformin hydrochloride extended release | ANDA | 2017-08-24 |
| neurontin | New Drug Application | 2024-07-22 |
| 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
527 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 | 8 | 7 | 13 | 35 | 23 | 82 |
| Pain | D010146 | EFO_0003843 | R52 | 2 | 10 | 10 | 15 | 16 | 48 |
| Neuralgia | D009437 | EFO_0009430 | — | 2 | 11 | 9 | 11 | 11 | 43 |
| Syndrome | D013577 | — | — | — | 3 | 8 | 12 | 6 | 29 |
| Restless legs syndrome | D012148 | EFO_0004270 | G25.81 | 4 | 3 | 6 | 8 | 3 | 24 |
| Healthy volunteers/patients | — | — | — | 11 | — | 1 | 1 | 9 | 22 |
| Psychomotor agitation | D011595 | — | — | 1 | 3 | 6 | 7 | 2 | 19 |
| Chronic pain | D059350 | HP_0012532 | — | 1 | 6 | 3 | 2 | 6 | 17 |
| Postherpetic neuralgia | D051474 | — | — | — | 6 | 4 | 3 | 5 | 17 |
| Diabetic neuropathies | D003929 | EFO_1000783 | — | — | 7 | 4 | 8 | — | 16 |
Show 141 more
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 | — | 4 | 10 |
| Myofascial pain syndromes | D009209 | EFO_1001054 | — | — | 1 | 2 | — | 8 | 10 |
| Fibromyalgia | D005356 | EFO_0005687 | M79.1 | — | 1 | 2 | — | 8 | 10 |
| Depression | D003863 | — | F33.9 | — | 2 | 2 | — | 3 | 7 |
| Scoliosis | D012600 | EFO_0004273 | M41 | — | — | 3 | — | 2 | 5 |
| Intervertebral disc displacement | D007405 | EFO_1001800 | — | — | 1 | 1 | — | 2 | 4 |
| Alcohol drinking | D000428 | EFO_0004329 | — | — | 2 | 2 | — | — | 4 |
| Anterior cruciate ligament injuries | D000070598 | — | — | — | 2 | 3 | — | — | 3 |
| Spasm | D013035 | — | M62.83 | — | — | 1 | — | 2 | 3 |
| Depressive disorder | D003866 | EFO_1002014 | F32.A | — | 1 | 1 | — | 1 | 3 |
Show 52 more
Indications Phases 2
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Marijuana abuse | D002189 | EFO_0007191 | F12 | — | 5 | — | — | — | 5 |
| Covid-19 | D000086382 | — | — | — | 1 | — | — | 2 | 3 |
| Nervous system neoplasms | D009423 | — | — | 1 | 2 | — | — | 1 | 3 |
| Psychotic disorders | D011618 | — | F20.81 | 1 | 3 | — | — | — | 3 |
| Bipolar disorder | D001714 | EFO_0000289 | F30.9 | — | 3 | — | — | — | 3 |
| Hiv | D006678 | — | — | — | 1 | — | — | 2 | 3 |
| Male breast neoplasms | D018567 | — | — | — | 1 | — | — | 1 | 2 |
| Central nervous system neoplasms | D016543 | — | — | 1 | 2 | — | — | — | 2 |
| Intractable pain | D010148 | — | — | — | 1 | — | — | 1 | 2 |
| Squamous cell carcinoma | D002294 | — | — | — | 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 |
|---|---|---|---|---|---|---|---|---|---|
| Hypertension | D006973 | EFO_0000537 | I10 | 1 | — | — | — | 2 | 3 |
| Squamous cell carcinoma of head and neck | D000077195 | — | — | 1 | — | — | — | 1 | 2 |
| Critical illness | D016638 | — | — | 1 | — | — | — | 1 | 2 |
| Burns | D002056 | — | T30.0 | 1 | — | — | — | 1 | 2 |
| Refractive errors | D012030 | EFO_0003908 | H52.7 | 1 | — | — | — | — | 1 |
| Stomatitis | D013280 | EFO_1001904 | K12.1 | 1 | — | — | — | — | 1 |
| Spondylosis | D055009 | — | M47 | 1 | — | — | — | — | 1 |
| Pharmacokinetics | D010599 | — | — | 1 | — | — | — | — | 1 |
| Weight loss | D015431 | HP_0001824 | — | 1 | — | — | — | — | 1 |
| Alopecia areata | D000506 | EFO_0004192 | L63 | 1 | — | — | — | — | 1 |
Show 9 more
Indications Without Phase
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Disease | D004194 | EFO_0000408 | R69 | — | — | — | — | 5 | 5 |
| Pancreatic neoplasms | D010190 | EFO_0003860 | C25 | — | — | — | — | 3 | 3 |
| Cardiac surgical procedures | D006348 | — | — | — | — | — | — | 2 | 2 |
| Hysterectomy | D007044 | EFO_0003881 | — | — | — | — | — | 2 | 2 |
| Pathologic constriction | D003251 | — | — | — | — | — | — | 2 | 2 |
| Migraine disorders | D008881 | EFO_0003821 | G43 | — | — | — | — | 2 | 2 |
| Sciatica | D012585 | HP_0011868 | M54.3 | — | — | — | — | 2 | 2 |
| Vulvodynia | D056650 | — | N94.81 | — | — | — | — | 2 | 2 |
| Renal cell carcinoma | D002292 | EFO_0000376 | — | — | — | — | — | 2 | 2 |
| Diabetes mellitus | D003920 | HP_0000819 | E08-E13 | — | — | — | — | 2 | 2 |
Show 84 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
No data
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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Number of persons purchased
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Trends
PubMed Central
Top Terms for Disease or Syndrome:
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Additional graphs summarizing 29,204 documents
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Safety
Black-box Warning
No Black-box warning
Adverse Events
Top Adverse Reactions
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98,414 adverse events reported
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