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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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 | 2025-12-05 |
| gabapentin gabapentin | ANDA | 2013-08-23 |
| gabarone | ANDA | 2024-12-23 |
| gralise | New Drug Application | 2025-05-01 |
| 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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Clinical
Clinical Trials
556 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 | 15 | 35 | 21 | 80 |
| Pain | D010146 | EFO_0003843 | R52 | 3 | 11 | 11 | 20 | 19 | 60 |
| Neuralgia | D009437 | EFO_0009430 | — | 2 | 12 | 7 | 10 | 11 | 41 |
| Restless legs syndrome | D012148 | EFO_0004270 | G25.81 | 4 | 4 | 7 | 8 | 3 | 26 |
| Chronic pain | D059350 | — | — | 1 | 7 | 4 | 3 | 8 | 22 |
| Healthy volunteers/patients | — | — | — | 11 | — | 1 | 1 | 9 | 22 |
| Postherpetic neuralgia | D051474 | — | — | — | 6 | 4 | 3 | 7 | 19 |
| Syndrome | D013577 | — | — | — | 3 | 7 | 4 | 4 | 18 |
| Agnosia | D000377 | EFO_0007136 | F88 | 1 | 2 | 2 | 9 | 3 | 17 |
| Sleep initiation and maintenance disorders | D007319 | — | F51.01 | 1 | 4 | 8 | 1 | 2 | 16 |
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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 | — | 4 | 10 |
| Fibromyalgia | D005356 | EFO_0005687 | M79.1 | — | 1 | 2 | — | 8 | 10 |
| Depression | D003863 | — | F33.9 | — | 2 | 2 | — | 4 | 8 |
| Myofascial pain syndromes | D009209 | EFO_1001054 | — | — | 1 | 1 | — | 6 | 7 |
| Alcohol drinking | D000428 | EFO_0004329 | — | — | 3 | 1 | — | — | 4 |
| Anterior cruciate ligament injuries | D000070598 | — | — | — | 2 | 3 | — | — | 3 |
| Squamous cell carcinoma of head and neck | D000077195 | — | — | 1 | — | 1 | — | 1 | 3 |
| Emergence delirium | D000071257 | — | — | — | — | 2 | — | 1 | 3 |
| Mood disorders | D019964 | EFO_0004247 | F30-F39 | — | 1 | 1 | — | 1 | 3 |
| Diabetes mellitus | D003920 | EFO_0000400 | E08-E13 | — | — | 1 | — | 2 | 3 |
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Indications Phases 2
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Covid-19 | D000086382 | — | U07.1 | — | 1 | — | — | 2 | 3 |
| Glioblastoma | D005909 | EFO_0000515 | — | 2 | 3 | — | — | — | 3 |
| Migraine disorders | D008881 | EFO_0003821 | G43 | — | 1 | — | — | 2 | 3 |
| Psychotic disorders | D011618 | — | F20.81 | 1 | 3 | — | — | — | 3 |
| Marijuana abuse | D002189 | EFO_0007191 | F12 | — | 3 | — | — | — | 3 |
| Bipolar disorder | D001714 | EFO_0000289 | F30.9 | — | 3 | — | — | — | 3 |
| Hiv | D006678 | — | O98.7 | — | 1 | — | — | 2 | 3 |
| Male breast neoplasms | D018567 | — | — | — | 1 | — | — | 1 | 2 |
| Central nervous system neoplasms | D016543 | — | — | 1 | 2 | — | — | — | 2 |
| Gliosarcoma | D018316 | — | — | 1 | 2 | — | — | — | 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 |
| Burns | D002056 | — | T30.0 | 1 | — | — | — | 1 | 2 |
| Refractive errors | D012030 | HP_0000483 | H52.7 | 1 | — | — | — | — | 1 |
| Stomatitis | D013280 | EFO_1001904 | K12.1 | 1 | — | — | — | — | 1 |
| Spondylosis | D055009 | — | M47 | 1 | — | — | — | — | 1 |
| Pharmacokinetics | D010599 | — | — | 1 | — | — | — | — | 1 |
| Weight loss | D015431 | — | — | 1 | — | — | — | — | 1 |
| Autistic disorder | D001321 | EFO_0003758 | F84.0 | 1 | — | — | — | — | 1 |
| Pervasive child development disorders | D002659 | EFO_0003756 | F84 | 1 | — | — | — | — | 1 |
| Alopecia areata | D000506 | EFO_0004192 | L63 | 1 | — | — | — | — | 1 |
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Indications Without Phase
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Disease | D004194 | EFO_0000408 | R69 | — | — | — | — | 3 | 3 |
| Pancreatic neoplasms | D010190 | EFO_0003860 | C25 | — | — | — | — | 3 | 3 |
| Cardiac surgical procedures | D006348 | — | — | — | — | — | — | 2 | 2 |
| Hysterectomy | D007044 | EFO_0003881 | — | — | — | — | — | 2 | 2 |
| Sciatica | D012585 | — | M54.3 | — | — | — | — | 2 | 2 |
| Herpes simplex | D006561 | — | B00 | — | — | — | — | 2 | 2 |
| Vulvodynia | D056650 | — | N94.81 | — | — | — | — | 2 | 2 |
| Renal cell carcinoma | D002292 | EFO_0000376 | — | — | — | — | — | 2 | 2 |
| Pancreatitis | D010195 | EFO_0000278 | K85 | — | — | — | — | 2 | 2 |
| Kidney neoplasms | D007680 | EFO_0003865 | C64 | — | — | — | — | 2 | 2 |
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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
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Safety
Black-box Warning
No Black-box warning
Adverse Events
Top Adverse Reactions
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106,445 adverse events reported
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