GABAPENTIN

Post-LOE

gabapentin

ANDAORALSOLUTION
Approved
Feb 2011
Lifecycle
Post-LOE
Competitive Pressure
30/100
Clinical Trials
20

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 (1)

Clinical Trials (5)

NCT06992427Phase 3Recruiting

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
NCT03053427Phase 4Completed

A Study of Oral Dosing of Gabapentin Enacarbil in Japanese Restless Legs Syndrome Patients

Started Mar 2017
375 enrolled
Restless Legs Syndrome (RLS)
NCT01981941Phase 4Completed

Post-marketing Study of Gabapentin Enacarbil to Evaluate the Effect in Restless Leg Syndrome (RLS) Patients With Moderate Renal Impairment

Started Nov 2013
19 enrolled
Restless Legs Syndrome (RLS)
NCT01888497Phase 3Completed

Next-Day Residual Effects of Gabapentin, Diphenhydramine and Triazolam on Simulated Driving Performance in Normal Volunteers

Started Jul 2013
59 enrolled
Healthy
NCT05436886N/ACompleted

Bioequivalence Study of Neurogabin-M (Gabapentin 400 mg) Capsule With Parketin (Gabapentin 400 mg) Capsules

Started Jun 2013
Healthy VolunteersBioequivalence Study