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AboutPricing
Drug ReportsGabapentin enacarbil
Gabapentin enacarbil
Horizant (gabapentin enacarbil) is a small molecule pharmaceutical. Gabapentin enacarbil was first approved as Horizant on 2011-04-06. It is used to treat bipolar disorder, epilepsy, partial epilepsies, phobic disorders, and postherpetic neuralgia in the USA.
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Commercial
Therapeutic Areas
Therapeutic Area
MeSH
nervous system diseasesD009422
signs and symptoms pathological conditionsD013568
mental disordersD001523
Trade Name
FDA
EMA
Horizant
Drug Products
FDA
EMA
New Drug Application (NDA)
New Drug Application (NDA)
Abbreviated New Drug Application (ANDA)
Abbreviated New Drug Application (ANDA)
Gabapentin enacarbil
Tradename
Company
Number
Date
Products
HORIZANTAzurityN-022399 RX2011-04-06
2 products, RLD, RS
Labels
FDA
EMA
Brand Name
Status
Last Update
horizantNew Drug Application2025-04-28
Indications
FDA
EMA
Indication
Ontology
MeSH
ICD-10
epilepsyEFO_0000474D004827G40.9
postherpetic neuralgia—D051474—
partial epilepsiesEFO_0004263D004828—
bipolar disorderEFO_0000289D001714F30.9
phobic disordersEFO_1001908D010698F40
Agency Specific
FDA
EMA
No data
Patent Expiration
Patent
Expires
Flag
FDA Information
Gabapentin Enacarbil, Horizant, Azurity
87957252029-06-10DPU-1231, U-1247
80262792026-11-10DS, DP
81149092026-04-11U-1231
68187872025-04-06DS, DP
86860342025-01-24U-1231, U-1247
ATC Codes
No data
HCPCS
No data
Clinical
Clinical Trials
556 clinical trials
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Indications Phases 4
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Indications Phases 3
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Indications Phases 2
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Indications Phases 1
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Healthy volunteers/patients———6————6
Indications Without Phase
No data
Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
Drug common nameGabapentin enacarbil
INNgabapentin enacarbil
Description
Gabapentin enacarbil is a carbamate ester that is the N-[1-(isobutyryloxy)ethoxy]carbonyl derivative of [1-(aminomethyl)cyclohexyl]acetic acid. The prodrug for gabapentin, used for treatment of neuropathic pain and restless legs syndrome. It has a role as a prodrug, an anticonvulsant and a calcium channel blocker. It is a monocarboxylic acid, a carbamate ester, a carboxylic ester and an acetal. It is functionally related to a gamma-aminobutyric acid and a gabapentin.
Classification
Small molecule
Drug classgabamimetics
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Structure (InChI/SMILES or Protein Sequence)
CC(OC(=O)NCC1(CC(=O)O)CCCCC1)OC(=O)C(C)C
Identifiers
PDB—
CAS-ID478296-72-9
RxCUI—
ChEMBL IDCHEMBL1628502
ChEBI ID68840
PubChem CID9883933
DrugBank—
UNII ID75OCL1SPBQ (ChemIDplus, GSRS)
Target
No data
Variants
No data
Financial
No data
Trends
PubMed Central
Top Terms for Disease or Syndrome:
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Additional graphs summarizing 464 documents
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Safety
Black-box Warning
No Black-box warning
Adverse Events
Top Adverse Reactions
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2,049 adverse events reported
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