Wednesday, July 8, 2026

Drug profile · INN

pregabalin

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

FDA: approved EMA: approved TGA: approved NMPA: clinical trials Nervous system (N02) N02BF02
US status approved
Patents linked 2
Pipeline programs 17
News articles 0
Drug details — pregabalin
US status
approved
Class
Nervous system (N02)
Route
ORAL
Patents
2
Programs
17
Data quality
0.89

Quick answer

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

Key facts

INN pregabalin
Brand APO-PREGABALIN
Mechanism Voltage-gated calcium channel modulator
Target Voltage-gated calcium channel
Therapeutic class Nervous system (N02)
Route ORAL
Formulation CAPSULE
ATC code N02BF02

Mechanism of action

Voltage-gated calcium channel modulator

Primary target: Voltage-gated calcium channel

Approval history

Authority Status Date
FDA approved
EMA approved
TGA approved
NMPA clinical trials

Pipeline programs

  1. Pregabalin Phase 3 · Chinese Academy of · Herpetic Neuralgia
  2. Pregabalin Dose Level 1 Phase 3 · Pfizer · Partial Onset Seizures
  3. pregabalin Phase 3 · Pfizer · Neuropathy
  4. pregabalin Phase 3 · Pfizer · Partial Seizures
  5. 64407564MMY2006 Phase 2 · Janssen-Cilag International N.V · multiple myeloma
  6. KETOROLAC, PREGABALIN Phase 2 · George Institute for · Estrogen receptor-positive early breast cancer (ER + BC).
  7. Pregabalin Phase 2 · Sun Yat-sen Memorial · Neuropathic Pain
  8. VX24-993-103 Phase 2 · Vertex Pharmaceuticals (Australia) · Pain Associated With Diabetic Peripheral Neuropathy

Related & competitor drugs

  1. aripiprazole Nervous system (N05)
  2. brexpiprazole Nervous system (N05)
  3. brivaracetam Nervous system (N03)
  4. bupivacaine Nervous system (N01)
  5. buprenorphine Nervous system (N07)
  6. caffeine citrate Nervous system (N06)
  1. US 7462737

    Pregabalin free of isobutylglutaric acid and a process for preparation thereof

    Expires Mon Dec 04 2028 00:00:00 GMT+0000 (Coordinated Universal Time)

    granted
  2. US 7417165

    Crystalline forms of pregabalin

    Expires Mon Aug 21 2028 00:00:00 GMT+0000 (Coordinated Universal Time)

    granted

Frequently asked questions

What is pregabalin?

pregabalin (APO-PREGABALIN) 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 pregabalin?

APO-PREGABALIN is a marketed brand name for pregabalin. Check FDA Drugs@FDA for the current US label holder and prescribing information.

What is the US approval status of pregabalin?

pregabalin 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.