NDAORALSOLUTION
Approved
Mar 2000
Lifecycle
LOE Approaching
Competitive Pressure
30/100
Clinical Trials
20
Data completeness
3/8 — Basic
NEURONTIN (gabapentin) by Viatris is unknown. First approved in 2000.
Drug data last refreshed 16h ago · AI intelligence enriched 1w ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
NEURONTIN (gabapentin) is an oral small-molecule antiepileptic agent with unknown mechanism of action, though it binds the α2δ subunit of voltage-activated calcium channels. The drug is indicated for postherpetic neuralgia and as adjunctive therapy for partial seizures, though off-label use extends to neuropathic pain conditions. Gabapentin's precise therapeutic mechanism remains unclear despite decades of clinical use.
LOE Approaching
As a mature product approaching loss of exclusivity with moderate competitive pressure (30/100), roles will focus on defensive positioning and cost management rather than growth initiatives.
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)
Abuse Potential of Gabapentin Taken Orally Concomitantly With Oxycodone Hydrochloride in Healthy, Non-Drug-Dependent, Recreational Opioid Users
Started Aug 2026
60 enrolled
Healthy, Non-Drug- Dependent, Recreational Opioid Users
Abuse Potential of Oral Gabapentin in Healthy, Non-Drug-Dependent Individuals With Recreational Sedative Drug Use Experience
Started Jun 2026
44 enrolled
Healthy Non-dependent, Recreational Sedative Users
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
Study Evaluating the Abuse Potential of NEURONTIN® in Healthy Non-drug Dependent, Recreational Opioid Users
Started Apr 2021
54 enrolled
Abuse Potential
Evaluating the Abuse Potential of NEURONTIN® When Taken Orally in Healthy Non-drug Dependent Participants With Sedative Drug Abuse Experience
Started Mar 2021
52 enrolled
Abuse Potential
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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.