TheraRadar
Data updated: May 26, 2026

PREGABALIN

Pain Approved 2019-07-19

Pregabalin capsules are indicated for: Management of neuropathic pain associated with diabetic peripheral neuropathy Management of postherpetic neuralgia Adjunctive therapy for the treatment of partial-onset seizures in patients 1 month of age and older Management of fibromyalgia Management of neuropathic pain associated with spinal cord injury Pregabalin capsules are indicated for: Neuropathic pain associated with diabetic peripheral neuropathy (DPN) Postherpetic neuralgia (PHN) Adjunctive ther...

Source: FDA Label • Aurobindo Pharma
Jump to: Indications Approvals Trials Competitors Safety Patents
37
Indications
--
Phase 3 Trials
6
Years on Market

Details

Status
Prescription
First Approved
2019-07-19
Routes
ORAL
Dosage Forms
CAPSULE, TABLET, EXTENDED RELEASE, SOLUTION

Companies

Aurobindo Pharma ESKAYEF CHANGZHOU PHARM Dr. Reddy's RENATA Apotex PHARMOBEDIENT AIPING PHARM INC FOURRTS LABS UNICHEM WATSON LABS INC CADILA PHARMS LTD HETERO LABS LTD III TORRENT ALKEM LABS LTD ALVOGEN MSN SCIEGEN PHARMS EPIC PHARMA LLC ZYDUS PHARMS STRIDES PHARMA YILING Teva Novartis REGCON HOLDINGS RISING CREEKWOOD PHARMS Lupin NOVEL LABS INC MACLEODS PHARMS LTD AMNEAL PHARMS CO Sun Pharma CHARTWELL RX RUBICON RESEARCH PATRIN ALEMBIC PRINSTON INC JUBILANT GENERICS INVAGEN PHARMS Cipla ADAPTIS
Active Ingredient: PREGABALIN

PREGABALIN Approval History

2020
2021
2022
2023
2024
2025
2026
Original
New Indication
New Form
Label Update
857 FDA actions from 2019 to 2026
Apr 2026 ORIGINAL
Update
Mar 2026 SUPPL
Label · Labeling
Feb 2026 ORIGINAL
Update

What PREGABALIN Treats

37 FDA approvals

Originally approved for its first indication in 2019 . Covers 37 distinct patient populations.

  • Other (37)
📋

Clinical Trial Registry

154 trials
Trial Sponsor ID Phase Status Title
NCT07275762 Y-4-LC-04 Ph 2 recruiting Y-4 to Treat the Postherpetic Neuralgia
NCT07567924 SIUT-ERC-2024/A-475 Ph 4 active not recruiting Comparison Between Pregabalin and Acetaminophen for the Treatment of Post-Mastectomy Pain Syndrome
NCT03794388 CAPTRANE results posted ICO-A-2018-10 Ph 3 completed Evaluation in the Treatment of Neuropathic Pain Post Breast Surgery
NCT06628908 VX24-548-110 Ph 3 recruiting Evaluation of Efficacy and Safety of Suzetrigine for Pain Associated With Diabetic Peripheral Neuropathy
NCT06614322 STUDY00009806 Ph 2 recruiting SPENDD: Quantitative Sensory Testing and Analgesic Response for Painful Peripheral Neuropathy.
NCT06619860 VX24-993-103 2024-514689-38-01 Ph 2 recruiting Evaluation of Efficacy and Safety of VX-993 for Pain Associated With Diabetic Peripheral Neuropathy
NCT07451431 #5739 Ph 4 recruiting Efficacy and Safety of Mirogabalin in Diabetic Peripheral Neuropathic Pain
NCT05488847 results posted 15592 Ph 4 active not recruiting Opioid-Free Pain Protocol After Shoulder Arthroplasty
NCT04862845 N-39-2021 Ph 1 completed Combination of Duloxetine and Pregabalin to Improve Postoperative Pain
NCT07288528 FORTITUDE FORTITUDE-01 Ph 4 not yet recruiting A 2x2 Factorial, Randomized, Open-label Trial to Evaluate Neuromodulators and Cough Control Therapy in Patients With Refractory or Unexplained Chronic Cough
NCT03216187 PREVENT PREVENT Ph 3 terminated Swiss Multi-centre, Randomized, Placebo Controlled Trial of Pregabalin for Prevention of Persistent Pain in High Risk Patients Undergoing Breast Cancer Surgery
NCT05660538 results posted VX21-548-103 Ph 2 completed Evaluation of Efficacy and Safety of VX-548 for Painful Diabetic Peripheral Neuropathy (DPN)
NCT05640453 35912/10/22 Ph 4 recruiting Pregabalin Versus Dexmedetomidine for Delirium Treatment After Coronary Artery Bypass Grafting
NCT06766916 CRYSTAL SYSKY-2024-1020-02 Ph 2 recruiting Crisugabalin for Radiotherapy-Related Neuropathic Pain
NCT04322305 GABI2 7977 R21AA028371 Ph 2 suspended Pregabalin Trial for the Treatment of Alcohol Use Disorder
NCT03928093 1000060628 Ph 3 completed Pregabalin Treatment for RDEB Pain and Itch
NCT05640479 35913/10/22 Ph 4 completed Pregabalin Versus Dexmedetomidine for Delirium Prevention After Cardiac Surgery
NCT06512155 Sleep disorders-1 Ph 1 completed Improving Perioperative Sleep Disorders
NCT01480765 Reda 007583 2010-024462-21, 11/H0703/7 Ph 4 completed Preventing Pain After Heart Surgery
NCT06367998 PC24MISV0017 Ph 4 not yet recruiting Effect of Pregabalin on Shoulder Pain in Patients With Central Sensitization After Arthroscopic Rotator Cuff Repair
NCT04015908 results posted 121505 Ph 4 completed A Multimodal Analgesia Protocol Adapted for Ambulatory Surgery
NCT06077786 20435A 2023-503987-18-00 Ph 1 completed A Trial Investigating the Pain-relieving Properties of Lu AG06474 in Healthy Adult Participants
NCT05967052 POSTCOVID NIGRIR_001POSTCOVID Ph 2 recruiting Investigation of Treating Chronic Fatigue Syndrome After COVID With Pharmacotherapy (Pregabalin) or Complex Rehabilitation
NCT04766996 results posted STUDY00002021 Ph 4 terminated PROUD Study - Preventing Opioid Use Disorders
NCT05221151 1/2022ANET3-B Ph 4 completed Melatonin vs Pregabalin for Anxiolysis and Sedation
NCT04641273 20887 2020-002066-14 Ph 2 terminated A 2-part Trial to Learn More About How BAY1817080 Works, How Safe it is, and What the Right Dose is for Participants With Diabetic Neuropathic Pain
NCT01801189 results posted H001 Ph 4 completed Preoperative Pain Control in Gastric Bypass Surgery Patients
NCT05370716 CG100651-1-01 Ph 1 completed Drug-Drug Interaction Study of "CG-651" in Healthy Volunteer
NCT04246619 BLOSSOM KCT 11/2017 2017-004341-24 Ph 4 terminated Efficacy of Pregabalin and Duloxetine in Patients With PDPN: the Effect of Pain on Cognitive Function, Sleep and Quality of Life
NCT04495283 results posted CP-NVK009-0005 Ph 2 completed A Phase 2 Study to Evaluate Pregabalin and Acetaminophen Compared to Acetaminophen and Placebo in Subjects Undergoing Bunionectomy
NCT00599638 results posted B0261002 Ph 2 completed A Study To Compare Pregabalin/PF-00489791 Combination Versus Pregabalin Alone In Post-Herpetic Neuralgia
NCT00853229 results posted CCF 08-195 Ph 2 terminated Pregabalin for the Treatment of Vulvodynia
NCT01939366 results posted KF6005/08 2013-000473-68, U1111-1151-4331 Ph 2 completed Cebranopadol Efficacy and Safety in Diabetic Patients Suffering From Chronic Pain Caused by Damage to the Nerves
NCT03472469 MAST results posted HSC-MS-18-0036 KL2TR000370, UL1TR000371 Ph 4 completed MAST Trial: Multi-modal Analgesic Strategies in Trauma
NCT03348735 PELICAN R017007 Ph 4 terminated Localized Neuropathic Pain: Topical Treatment Versus Systemic Treatment
NCT01846182 REGIONS results posted SPLD-016-12F 6125 Ph 2 terminated Research Examining Gulf War Illness in Our Nations Service Members
NCT00991276 results posted A0081185 Ph 3 completed Polysomnography Study Of Pregabalin And Pramipexole Versus Placebo In Patients With Restless Legs Syndrome And Associated Sleep Disturbance
NCT00676403 results posted A0081183 Ph 2 completed Lyrica Dose Response Study With Restless Legs Syndrome (RLS) Patients
NCT01701362 results posted A0081279 2012-003304-12 Ph 3 completed Placebo-controlled Safety and Efficacy Study of Pregabalin in Subjects With Post-traumatic Peripheral Neuropathic Pain
NCT01387607 results posted A0081241 Ph 3 completed A Study For Pregabalin In Patients With Fibromyalgia
NCT01202227 results posted A0081252 Ph 3 completed An Open-Label Long-Term Study Of Pregabalin For The Treatment Of Central Neuropathic Pain
NCT01332149 results posted A0081265 Ph 3 completed Study To Evaluate Efficacy, Safety And Tolerability Of Lyrica In Patients With Painful Diabetic Peripheral Neuropathy
NCT01049217 results posted A0081244 Ph 3 terminated Pregabalin Versus Placebo In The Treatment Of Neuropathic Pain Associated With HIV Neuropathy
NCT00905437 results posted A0081229 Ph 3 terminated Study To Investigate The Effectiveness Of Pregabalin For Management Of Patients Undergoing Total Hip Replacement
NCT01455415 results posted A0081268 2011-002743-10 Ph 3 completed Effect Of Pregabalin Treatment In Patients With Diabetic Nerve Pain Who Currently Use A Non-Steroid Anti-Inflammatory Drug (NSAID) For Another Pain
NCT01474772 results posted A0081269 2011-003266-32 Ph 3 completed Efficacy and Safety Study of Pregabalin in the Treatment of Pain on Walking in Patients With Diabetic Peripheral Neuropathy (DPN)
NCT01020526 results posted A0081231 2010-020300-29 Ph 4 completed Pregabalin In Adolescent Patients With Fibromyalgia
NCT00624780 results posted A0081147 Ph 4 completed Safety and Efficacy Evaluation Of Pregabalin (Lyrica) With Patients With Generalized Anxiety Disorder
NCT01270828 results posted A0081224 2009-016766-86 Ph 3 completed Safety And Efficacy Study Of Once Daily Controlled Release Pregabalin In The Treatment Of Patients With Postherpetic Neuralgia
NCT00631696 results posted A0081104 Ph 4 completed Evaluation Of Sperm Production With Healthy Male Volunteers Receiving Lyrica Or Placebo

Showing 50 of 154 trials

🔬

Active Pipeline

Pro

Ongoing clinical trials by development phase

Loading...
⭐

Key Completed Trials

Pro

Completed studies with published results, ranked by significance

Loading...
📊

Trial Timeline

ClinicalTrials.gov ↗ Pro

Full development history with FDA approval milestones

|
Loading...
Understanding FDA Approval Types
Count Type What it means
- ORIG Original approval - drug first enters market
- SUPPL - Efficacy New indication (new disease/condition approved)
- SUPPL - Labeling Label text changes (warnings, dosing updates)
- SUPPL - Manufacturing Production changes (new facility)
- SUPPL - Chemistry Formulation changes (new dosage strength)

Green lines in the timeline show ORIG and Efficacy approvals - the clinically meaningful milestones.

PREGABALIN FDA Label Details

Indications & Usage

Pregabalin capsules are indicated for: Management of neuropathic pain associated with diabetic peripheral neuropathy Management of postherpetic neuralgia Adjunctive therapy for the treatment of partial-onset seizures in patients 1 month of age and older Management of fibromyalgia Management of neuropathic pain associated with spinal cord injury Pregabalin capsules are indicated for: Neuropathic pain associated with diabetic peripheral neuropathy (DPN) Postherpetic neuralgia (PHN) Adjunctive therapy for the treatment of partial-onset seizures in patients 1 month of age and older Fibromyalgia Ne...

Looking for the branded version?

LYRICA CR

Full clinical data, patents, trials, and competitive landscape for pregabalin.

See LYRICA CR

Data Sources

FDA Approval: ANDA205321 → Label: DailyMed → Trials: ClinicalTrials.gov →

Data sourced from official FDA and NIH databases. Click links to verify on original sources.