Wednesday, July 8, 2026

Drug profile · INN

gabapentin

gabapentin (APX-GABAPENTIN) is a voltage-gated calcium channel modulator. Associated with Viatris Pharmaceuticals Co.,. Route of administration: oral. Current US regulatory status: approved.

FDA: approved TGA: approved
US status approved
Patents linked 2
Pipeline programs 13
News articles 0
Drug details — gabapentin
US status
approved
Class
Route
ORAL
Patents
2
Programs
13
Data quality
0.89

Quick answer

gabapentin (APX-GABAPENTIN) is a voltage-gated calcium channel modulator. Associated with Viatris Pharmaceuticals Co.,. Route of administration: oral. Current US regulatory status: approved.

Key facts

INN gabapentin
Brand APX-GABAPENTIN
Mechanism Voltage-gated calcium channel modulator
Target Voltage-gated calcium channel
Route ORAL
Formulation CAPSULE

Mechanism of action

Voltage-gated calcium channel modulator

Primary target: Voltage-gated calcium channel

Approval history

Authority Status Date
FDA approved
TGA approved

Pipeline programs

  1. Gabapentin Phase 3 · BRIGHT MINDS BIOSCIENCES · Drug Dependence
  2. Gabapentin 300mg Phase 3 · BRIGHT MINDS BIOSCIENCES · Alcohol Drinking
  3. gabapentin Phase 3 · Pfizer · Epilepsies, Partial
  4. Gabapentin Phase 2 · Lxo Ireland Designated · Sickle Cell Disease
  5. Gabapentin Phase 2 · BRIGHT MINDS BIOSCIENCES · Pain
  6. Gabapentin Phase 2 · BRIGHT MINDS BIOSCIENCES · Benzodiazepine Dependence
  7. Ramelteon and gabapentin Phase 2 · Takeda · Sleep Initiation and Maintenance Disorders
  8. Gabapentin Approved · United Therapeutics Europe · Peripheral Nerve Disorder Associated With Repair of Hernia

Related & competitor drugs

  1. pregabalin Nervous system (N02)
  2. bepridil hydrochloride Voltage-gated calcium channel blocker
  3. gabapentin enacarbil Voltage-gated calcium channel modulator
  4. gabapentin encarbil Voltage-gated calcium channel modulator
  1. EP 3364975

    KOMBINATIONEN VON TRAZODON UND GABAPENTIN ZUR BEHANDLUNG VON SCHMERZEN

    Expires Tue Aug 24 2038 00:00:00 GMT+0000 (Coordinated Universal Time)

    granted
  2. US 6531509

    Stable gabapentin containing more than 20 ppm of chlorine ion

    Expires Mon Mar 06 2023 00:00:00 GMT+0000 (Coordinated Universal Time)

    expired

Frequently asked questions

What is gabapentin?

gabapentin (APX-GABAPENTIN) is a voltage-gated calcium channel modulator. Associated with Viatris Pharmaceuticals Co.,. Route of administration: oral. Current US regulatory status: approved.

What is the brand name for gabapentin?

APX-GABAPENTIN is a marketed brand name for gabapentin. Check FDA Drugs@FDA for the current US label holder and prescribing information.

What is the US approval status of gabapentin?

gabapentin has approved status in the United States according to our Drugs@FDA-derived records. Verify on the official FDA label before clinical or commercial decisions.