Overview
Gabapentin is a structural analogue of the inhibitory neurotransmitter gamma-aminobutyric acid (GABA) that was first approved for use in the United States in 1993. It was originally developed as a novel anti-epileptic for the treatment of certain types of seizures - today it is also widely used to treat neuropathic pain. Gabapentin has some stark advantages as compared with other anti-epileptics, such as a relatively benign adverse effect profile, wide therapeutic index, and lack of appreciable metabolism making it unlikely to participate in pharmacokinetic drug interactions.. It is structurally and functionally related to another GABA derivative, pregabalin.
Indication
In the United States, gabapentin is officially indicated for the treatment of postherpetic neuralgia in adults and for the adjunctive treatment of partial-onset seizures, with or without secondary generalization, in patients 3 years of age and older. In Europe, gabapentin is indicated for adjunctive therapy in the treatment of partial-onset seizures, with or without secondary generalization, in patients 6 years of age and older and as monotherapy in patients 12 years of age and older. It is also used in adults for the treatment of various types of peripheral neuropathic pain, such as painful diabetic neuropathy.
Associated Conditions
- Partial-Onset Seizures
- Peripheral Neuropathic Pain
- Postherpetic Neuralgia
Research Report
Published: Jul 17, 2025
Gabapentin (DB00966): A Comprehensive Pharmacological and Clinical Monograph
Section 1: Drug Identification and Physicochemical Properties
This section establishes the fundamental identity of Gabapentin, providing the chemical and physical data that form the basis for its pharmacological behavior and formulation. A clear understanding of its nomenclature and properties is essential to distinguish it from other agents and to appreciate the scientific basis for its clinical use.
1.1. Nomenclature and Identifiers
To prevent ambiguity in clinical practice and research, Gabapentin is identified by a systematic set of names and registry numbers.
- Common Name: The universally recognized non-proprietary name for the compound is Gabapentin.[1]
- Brand Names: Gabapentin is marketed under several brand names, including Neurontin®, Gralise®, Horizant®, and Gabarone®.[3] It is critical to note that these formulations, particularly the extended-release versions like Gralise® and Horizant®, are not interchangeable due to differing pharmacokinetic profiles and approved indications, a factor that presents a potential source for medication errors.[5]
- Systematic (IUPAC) Name: The formal chemical name according to the International Union of Pure and Applied Chemistry (IUPAC) is 2-[1-(aminomethyl)cyclohexyl]acetic acid.[2]
- Synonyms and Codes: In research and development literature, it may be referred to as 1-(aminomethyl)cyclohexaneacetic acid or by its developmental code, CI-945.[7]
- Registry Identifiers: The compound is cataloged in major chemical and drug databases under the following unique identifiers:
- DrugBank ID: DB00996 [1]
- CAS Number: 60142-96-3 [7]
- Reaxys Registry Number: 2359739 [11]
1.2. Chemical Structure and Formula
The molecular blueprint of Gabapentin defines its interactions with biological systems and its classification as a structural analogue of the neurotransmitter gamma-aminobutyric acid (GABA).[2]
Clinical Trials
Title | Posted | Study ID | Phase | Status | Sponsor |
|---|---|---|---|---|---|
2025/08/20 | Not Applicable | Recruiting | |||
2025/07/02 | Not Applicable | Not yet recruiting | |||
2025/06/13 | Not Applicable | Active, not recruiting | Haroon Muhammad Khalil | ||
2025/05/30 | Phase 4 | Not yet recruiting | |||
2025/05/28 | Phase 3 | Recruiting | |||
2025/03/25 | Not Applicable | Not yet recruiting | University of Medicine and Pharmacy at Ho Chi Minh City | ||
2025/03/21 | Phase 3 | Not yet recruiting | |||
2025/01/17 | Phase 4 | Recruiting | Universidad Europea de Madrid | ||
2025/01/16 | Phase 4 | Recruiting | Universidad Europea de Madrid | ||
2024/11/26 | Phase 1 | Not yet recruiting |
FDA Drug Approvals
Approved Product | Manufacturer | NDC Code | Route | Strength | Effective Date |
|---|---|---|---|---|---|
| Ascent Pharmaceuticals, Inc | 43602-470 | ORAL | 300 mg in 1 1 | 5/11/2021 | |
| RedPharm Drug, Inc. | 67296-1536 | ORAL | 300 mg in 1 1 | 1/21/2022 | |
| Aphena Pharma Solutions - Tennessee, LLC | 71610-442 | ORAL | 800 mg in 1 1 | 12/8/2021 | |
| Asclemed USA, Inc. | 76420-015 | ORAL | 300 mg in 1 1 | 10/12/2022 | |
| DIRECT RX | 61919-661 | ORAL | 100 mg in 1 1 | 4/11/2019 | |
| St. Mary's Medical Park Pharmacy | 60760-741 | ORAL | 300 mg in 1 1 | 12/29/2020 | |
| Zhejiang Yongtai Pharmaceutical Co., Ltd. | 69434-043 | ORAL | 300 mg in 1 1 | 2/9/2021 | |
| Asclemed USA, Inc. | 76420-235 | ORAL | 600 mg in 1 1 | 7/7/2022 | |
| Radha Pharmaceuticals, Inc. | 77771-178 | ORAL | 800 mg in 1 1 | 11/9/2023 | |
| DIRECT RX | 61919-350 | ORAL | 800 mg in 1 1 | 4/11/2019 |
EMA Drug Approvals
Approved Product | Authorization Holder | Status | Issued Date |
|---|---|---|---|
| No EMA approvals found for this drug. | |||
HSA Drug Approvals
Approved Product | Manufacturer | Approval Number | Dosage Form | Strength | Approval Date |
|---|---|---|---|---|---|
| Gabapentin Sandoz Capsules 400mg | SIN13678P | CAPSULE | 400mg | 7/20/2009 | |
| PMS-GABAPENTIN CAPSULE 100 mg | SIN12638P | CAPSULE | 100 mg | 1/14/2005 | |
| ALPENTIN CAPSULE 300MG | SIN16697P | CAPSULE | 300 mg | 2/15/2023 | |
| GABAPIN 300-GABAPENTIN CAPSULES USP 300 MG | SIN16293P | CAPSULE, GELATIN COATED | 300 mg | 7/30/2021 | |
| ALPENTIN CAPSULE 100MG | SIN16698P | CAPSULE | 100 mg | 2/15/2023 | |
| NEURONTIN CAPSULE 300 mg | SIN08303P | CAPSULE | 300 mg | 8/25/1995 | |
| NEURONTIN CAPSULE 400 mg | SIN08302P | CAPSULE | 400 mg | 8/25/1995 | |
| NEURAN CAPSULE 300MG | SIN15230P | CAPSULE | 300mg | 5/2/2017 | |
| APO-GABAPENTIN CAPSULES 300mg | SIN14277P | CAPSULE | 300mg | 12/14/2012 | |
| Apo-Gabapentin 400mg Capsules | SIN13548P | CAPSULE | 400mg | 9/3/2008 |
NMPA Drug Approvals
Approved Product | Company | Approval Number | Drug Type | Dosage Form | Approval Date |
|---|---|---|---|---|---|
| No NMPA approvals found for this drug. | |||||
PPB Drug Approvals
Approved Product | Registration No. | Company | Licence No. | Strength | Registration Date |
|---|---|---|---|---|---|
| NEUCORD 100 CAPSULES 100MG | N/A | N/A | N/A | 2/7/2025 | |
| VULTIN 100 CAP 100MG | N/A | N/A | N/A | 7/9/2010 | |
| NEUCORD 400 CAPSULES 400MG | N/A | N/A | N/A | 2/7/2025 | |
| NEUCORD 300 CAPSULES 300MG | N/A | N/A | N/A | 2/7/2025 | |
| GAPATIN CAP 300MG | N/A | N/A | N/A | 2/8/2010 |
TGA Drug Approvals
Approved Product | ARTG ID | Sponsor | Registration Type | Status | Registration Date |
|---|---|---|---|---|---|
| GABAPENTIN MLPL gabapentin 400 mg capsule blister pack | 272669 | Medicine | A | 4/28/2017 | |
| APO-GABAPENTIN gabapentin 800mg tablets bottle | 131505 | Medicine | A | 9/6/2007 | |
| GABACOR gabapentin 400 mg capsule blister pack | 204485 | Medicine | A | 2/6/2014 | |
| APX-GABAPENTIN gabapentin 400 mg capsule blister pack | 335739 | Medicine | A | 7/2/2020 | |
| GABAPENTIN-STR gabapentin 300 mg capsule blister pack | 335746 | Medicine | A | 7/2/2020 | |
| GAPENTIN gabapentin 400mg capsule blister pack (new formulation) | 107498 | Medicine | A | 7/4/2005 | |
| ALKEM GABAPEN gabapentin 100 mg capsule blister pack | 204495 | Medicine | A | 2/6/2014 | |
| IPCA-GABAPENTIN gabapentin 300 mg capsules blister pack | 263797 | Medicine | A | 12/19/2016 | |
| Gabapentin 400 mg capsules bulk EU | 267143 | Medicine | A | 1/13/2016 | |
| GABAPENTIN ASTRON gabapentin 600 mg tablet blister pack | 306884 | Medicine | A | 9/14/2018 |
Health Canada Drug Approvals
Approved Product | Company | DIN | Dosage Form | Strength | Market Date |
|---|---|---|---|---|---|
| GABAPENTIN | omni laboratories division, warner-lambert canada inc. | 02238673 | Capsule - Oral | 400 MG / CAP | N/A |
| MAR-GABAPENTIN | marcan pharmaceuticals inc | 02391481 | Capsule - Oral | 300 MG | 1/8/2014 |
| GABAPENTIN | 02403757 | Tablet - Oral | 800 MG | N/A | |
| GABAPENTIN CAPSULES | ranbaxy pharmaceuticals canada inc. | 02332582 | Capsule - Oral | 100 MG | N/A |
| GABAPENTIN | Cobalt Pharmaceuticals Company | 02342677 | Capsule - Oral | 400 MG | N/A |
| AG-GABAPENTIN | angita pharma inc. | 02477920 | Capsule - Oral | 300 MG | 9/28/2018 |
| GABAPENTIN | omni laboratories division, warner-lambert canada inc. | 02238672 | Capsule - Oral | 300 MG / CAP | N/A |
| BIO-GABAPENTIN | biomed pharma | 02450178 | Capsule - Oral | 400 MG | 6/21/2017 |
| GABAPENTIN | omni laboratories division, warner-lambert canada inc. | 02238671 | Capsule - Oral | 100 MG / CAP | N/A |
| IPG-GABAPENTIN | marcan pharmaceuticals inc | 02390957 | Capsule - Oral | 300 MG | N/A |
CIMA AEMPS Drug Approvals
Approved Product | Company | Registration Number | Pharmaceutical Form | Prescription Type | Status |
|---|---|---|---|---|---|
| GABAPENTINA TECNIGEN 400 mg CAPSULAS DURAS EFG | Tecnimede España Industria Farmaceutica S.A. | 70430 | CÁPSULA DURA | Medicamento Sujeto A Prescripción Médica. Tratamiento De Larga Duración | Commercialized |
| GABAPENTINA AUROVITAS 300 MG CAPSULAS DURAS EFG | Aurovitas Spain, S.A.U. | 81533 | CÁPSULA DURA | Medicamento Sujeto A Prescripción Médica. Tratamiento De Larga Duración | Commercialized |
| GABAPENTINA AUROBINDO 800 MG COMPRIMIDOS RECUBIERTOS CON PELICULA EFG | Laboratorios Aurobindo S.L.U. | 76529 | COMPRIMIDO RECUBIERTO CON PELÍCULA | Medicamento Sujeto A Prescripción Médica. Tratamiento De Larga Duración | Not Commercialized |
| GABAPENTINA TECNIGEN 800 mg COMPRIMIDOS RECUBIERTOS CON PELICULA EFG | Tecnimede España Industria Farmaceutica S.A. | 70436 | COMPRIMIDO RECUBIERTO CON PELÍCULA | Medicamento Sujeto A Prescripción Médica. Tratamiento De Larga Duración | Commercialized |
| GABAPENTINA TILLOMED 300 MG CAPSULAS DURAS EFG | Laboratorios Tillomed Spain S.L. | 83334 | CÁPSULA DURA | Medicamento Sujeto A Prescripción Médica. Tratamiento De Larga Duración | Not Commercialized |
| GABAPENTINA CINFA 600 MG COMPRIMIDOS RECUBIERTOS CON PELICULA EFG | Laboratorios Cinfa S.A. | 76215 | COMPRIMIDO RECUBIERTO CON PELÍCULA | Medicamento Sujeto A Prescripción Médica. Tratamiento De Larga Duración | Commercialized |
| GABAPENTINA KERN PHARMA 800 mg COMPRIMIDOS RECUBIERTOS CON PELICULA EFG | 66184 | COMPRIMIDO RECUBIERTO CON PELÍCULA | Medicamento Sujeto A Prescripción Médica. Tratamiento De Larga Duración | Commercialized | |
| GABAPENTINA NORMON 400 mg CAPSULAS DURAS EFG | Laboratorios Normon S.A. | 67153 | CÁPSULA DURA | Medicamento Sujeto A Prescripción Médica. Tratamiento De Larga Duración | Commercialized |
| GABAPENTINA SANDOZ 800 mg COMPRIMIDOS RECUBIERTOS CON PELICULA EFG | Sandoz Farmaceutica S.A. | 74060 | COMPRIMIDO RECUBIERTO CON PELÍCULA | Medicamento Sujeto A Prescripción Médica. Tratamiento De Larga Duración | Commercialized |
| GABAPENTINA ARISTO 400 MG CAPSULAS DURAS EFG | Aristo Pharma Iberia S.L. | 74251 | CÁPSULA DURA | Medicamento Sujeto A Prescripción Médica. Tratamiento De Larga Duración | Not Commercialized |
Philippines FDA Drug Approvals
Approved Product | Company | License Number | Dosage Form | Strength | Approval Date |
|---|---|---|---|---|---|
| No Philippines FDA approvals found for this drug. | |||||
Saudi SFDA Drug Approvals
Approved Product | Company | License Number | Dosage Form | Strength | Approval Date |
|---|---|---|---|---|---|
| No Saudi SFDA approvals found for this drug. | |||||
Malaysia NPRA Drug Approvals
Approved Product | Company | Registration Number | Dosage Form | Strength | Approval Date |
|---|---|---|---|---|---|
| No Malaysia NPRA approvals found for this drug. | |||||
UK EMC Drug Information
Medicine Name | MA Holder | MA Number | Pharmaceutical Form | Active Ingredient | Authorization Date |
|---|---|---|---|---|---|
| No UK EMC drug information found for this drug. | |||||
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