NDAORALSOLUTION
Approved
Mar 2000
Lifecycle
LOE Approaching
Competitive Pressure
30/100
Clinical Trials
20
Data completeness
3/8 — Basic
NEURONTIN (gabapentin) by Viatris (2) is unknown. First approved in 2000.
Drug data last refreshed 9h ago · AI intelligence enriched 1w ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
NEURONTIN (gabapentin) is an oral small-molecule anticonvulsant approved in 2000 with an unknown mechanism of action, though it binds to the α2δ subunit of voltage-activated calcium channels. It is indicated for neuropathic pain conditions and seizure management. The drug's mechanism remains incompletely understood despite decades of clinical use.
LOE Approaching
As LOE approaches, expect brand protection initiatives and cost-containment focus; team may consolidate around key accounts and managed care.
Mechanism of Action
unknown. Gabapentin is structurally related to the neurotransmitter gamma-aminobutyric acid (GABA) but has no effect on GABA binding, uptake, or degradation. In vitro studies have shown that gabapentin binds with high-affinity to the α2δ subunit of voltage-activated calcium channels; however, the…
Indications
Indication data is being enriched from DailyMed and FDA labeling. Check back soon for approved therapeutic uses.
Clinical Trials (20)
High-dose Prophylactic Gabapentin (HOPE) vs. Placebo to Prevent Opioid Use for Oral Mucositis Pain During Concurrent Chemoradiation for Head and Neck Cancer
Started Jun 2025
228 enrolled
Head and Neck Squamous Cell CarcinomaStage I Head and Neck Cutaneous Squamous Cell Carcinoma AJCC v8Stage II Head and Neck Cutaneous Squamous Cell Carcinoma AJCC v8+2 more
A Study on Ketoprofen Lysine Salt (KLS) + Gabapentin (GABA) vs KLS to Investigate Their Pharmacodynamic in Healthy Males
Started Feb 2021
141 enrolled
No Condition
A Study of Oral Dosing of Gabapentin Enacarbil in Japanese Restless Legs Syndrome Patients
Started Mar 2017
375 enrolled
Restless Legs Syndrome (RLS)
Efficacy of Gabapentin vs. Placebo for Adjuvant Pain Control Following Acute Rib Fractures
Started Oct 2016
100 enrolled
Acute Pain
Prospective, Cross Over Gabapentin vs Amitriptyline Study on Patients Suffering From Masticatory Muscle Pain
Started Feb 2015
50 enrolled
Myofacial Pain
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Data Sources
- Drug label: DailyMed / FDA
- Clinical trials: ClinicalTrials.gov
- Patent data: FDA Orange Book
- Spending data: CMS Medicare
The information on this page is for informational purposes only and should not be used as a substitute for professional medical advice. Drug information is sourced from FDA, DailyMed, and other government databases. Adverse event data from FAERS does not establish causation. Always consult a healthcare professional for medical decisions.