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Drug

Pregabalin

Approved · FDA / EMA
Emerging researchLate-stage developmentCooling momentum
Also known as (S)-3-Isobutyl GABA, 3-Isobutyl GABA, Bonqat, Lyrica+2 more

(S)-3-Isobutyl GABA, 3-Isobutyl GABA, Bonqat, Lyrica, Pregabalina, Prégabaline.

RxNorm187832ChEMBLCHEMBL1059UNII55JG375S6M
6
Research papers
11
Active clinical trials
20
Regulatory events
Latest activity
beta

Recent clinical, regulatory, research and industry developments relating to this drug.

A Multicenter, Randomized, Double-blind, Double-dummy, Parallel-controlled Phase II Clinical Study Evaluating the Efficacy and Safety of Y-4 Tablets in Chinese Patients With Postherpetic Neuralgia, Compared With Pregabalin Capsules

Clinical trial2026-07-31Primary completion · ClinicalTrials.gov

Label change: PREGABALIN (ANDA211687)

Regulatory2026-07-17FDA

Label change: PREGABALIN (ANDA209357)

Regulatory2026-07-14FDA

Comparing the Efficacy and Safety of Pregabalin Monotherapy Versus Other Neuromodulatory Drugs (Mirogabalin) in the Treatment of Fibromyalgia: A Multicenter Clinical Study

Clinical trial2026-06-25Results expected Q2 2027 · ClinicalTrials.gov

Label change: PREGABALIN (ANDA205321)

Regulatory2026-06-23FDA

A Phase 3, Randomized, Double-blind, Placebo- and Active-Controlled Study of the Efficacy and Safety of Suzetrigine in Subjects With Pain Associated With Diabetic Peripheral Neuropathy

Clinical trial2026-06-15Results expected Q2 2027 · ClinicalTrials.gov

Effect of Preoperative Pregabalin on Optic Nerve Sheath Diameter as a Surrogate for Intracranial Pressure in Elective Craniotomy Patients.

Clinical trial2026-06-08Results expected Q4 2026 · ClinicalTrials.gov

Approval: PREGABALIN (ANDA219593)

Regulatory2026-04-30FDA

Pregabalin versus placebo in postoperative pain relief of patients' status post photorefractive keratectomy: a double-masked, randomized, prospective study.

Research2014-06-10Journal of ocular pharmacology and therapeutics : the official journal of the Association for Ocular Pharmacology and Therapeutics

Cerebrospinal fluid neurotransmitter changes during the perioperative period in patients undergoing total knee replacement: a randomized trial.

Research2011-12-09Anesthesia and analgesia

Effect of the α2δ ligand, pregabalin, on colonic sensory and motor functions in healthy adults.

Research2011-05-19American journal of physiology. Gastrointestinal and liver physiology

Effects of pregabalin on heart rate variability in patients with painful diabetic neuropathy.

Research2011-04-01Journal of clinical psychopharmacology

Profile

Identifiers & mechanism

Canonical identifiers, marketed brand names and mechanism, resolved across RxNorm, ChEMBL and ATC.

Canonical name
Pregabalin
Aliases & brands
(S)-3-Isobutyl GABA3-Isobutyl GABABonqatLyricaPregabalinaPrégabaline
RxNorm CUI
187832
ChEMBL ID
CHEMBL1059
UNII
55JG375S6M
Regulatory jurisdictions
fdamhraema

Regulatory timeline

20 events

The complete regulatory record, grouped by authority — approvals, safety advisories and label changes. Each authority shows its most recent events; expand one to read its full history.

Earliest approval
2004-07-05
Latest approval
2026-04-30
Authorities
FDA · EMA · MHRA
Total events
20
fdaU.S. Food and Drug Administration· 11 events
2026-07-17Label change
Label change: PREGABALIN (ANDA211687)
Evidence ↗
2026-07-14Label change
Label change: PREGABALIN (ANDA209357)
Evidence ↗
2026-06-23Label change
Label change: PREGABALIN (ANDA205321)
Evidence ↗
emaEuropean Medicines Agency· 7 events
2023-10-04Market withdrawalMarket
Market withdrawal: Pregabalin Sandoz GmbH (EMA)
Indication: Epilepsy Pregabalin Sandoz GmbH is indicated as adjunctive therapy in adults with partial seizures with or without secondary generalisation. Generalised Anxiety Disorder… Show full indication

Epilepsy Pregabalin Sandoz GmbH is indicated as adjunctive therapy in adults with partial seizures with or without secondary generalisation. Generalised Anxiety Disorder Pregabalin Sandoz GmbH is indicated for the treatment of Generalised Anxiety Disorder (GAD) in adults.

Evidence ↗
2015-08-28Approval
Approval: Pregabalin Accord (EMA)
Indication: Epilepsy Pregabalin Accord is indicated as adjunctive therapy in adults with partial seizures with or without secondary generalisation. Generalised Anxiety Disorder Pregabalin… Show full indication

Epilepsy Pregabalin Accord is indicated as adjunctive therapy in adults with partial seizures with or without secondary generalisation. Generalised Anxiety Disorder Pregabalin Accord is indicated for the treatment of Generalised Anxiety Disorder (GAD) in adults.

Evidence ↗
2015-07-17Approval
Approval: Pregabalin Zentiva (EMA)
Indication: Neuropathic pain Pregabalin Zentiva is indicated for the treatment of peripheral and central neuropathic pain in adults. Epilepsy Pregabalin Zentiva is indicated as adjunctive… Show full indication

Neuropathic pain Pregabalin Zentiva is indicated for the treatment of peripheral and central neuropathic pain in adults. Epilepsy Pregabalin Zentiva is indicated as adjunctive therapy in adults with partial seizures with or without secondary generalisation. Generalised anxiety disorder Pregabalin Zentiva is indicated for the treatment of generalised anxiety disorder (GAD) in adults.

Evidence ↗
mhraMedicines and Healthcare products Regulatory Agency· 2 events
2022-04-19Safety communicationSafety
Drug Safety Update: Pregabalin (Lyrica): findings of safety study on risks during pregnancy
Evidence ↗
2021-02-18Safety communicationSafety
Drug Safety Update: Pregabalin (Lyrica): reports of severe respiratory depression
Evidence ↗

Data from the U.S. Food and Drug Administration (U.S. Food and Drug Administration), public domain (CC0).

Contains information from the European Medicines Agency (European Medicines Agency), © EMA, reused under CC BY 4.0.

Contains public sector information from the Medicines and Healthcare products Regulatory Agency (MHRA) licensed under the Open Government Licence (OGL v3).

Clinical trials

183 trials

The current development programme across all trial phases — status mix, phase distribution and the late-stage studies shaping the evidence base.

Development programme
CLINICALTRIALS.GOV · LIVE REGISTRY
183
registered trials across all phases
LATEST COMPLETION 2024
11
Active studies
10
Recruiting
136
Late-stage (III+)
121
Completed
51
Discontinued
PHASE DISTRIBUTIONn = 183
Early Phase 13Phase 112Phase 1 / 24Phase 228Phase 2 / 37Phase 349Phase 452Phase N / A28

Late-stage studies

Phase III+ trials still open or recently active — where late-stage evidence is being generated.

A 2x2 Factorial, Randomized, Open-label Trial to Evaluate Neuromodulators and Cough Control Therapy in Patients With Refractory or Unexplained Chronic Cough (FORTITUDE)

Not yet recruitingPH IVMcMaster Universityn=1242029

Pregabalin Versus Dexmedetomidine for Delirium Treatment After Coronary Artery Bypass Grafting: A Randomized Double-Blind Trial

RecruitingPH IVTanta Universityn=702026

Efficacy of Different Doses of Pregabalin as a Multimodal Analgesic Agent in Postoperative Pain Control After Total Knee Arthroplasty - A Randomized Controlled Trial

CompletedPH IVThammasat Universityn=822024

Evaluating the Efficacy and Safety of Pregabalin in Total Knee Arthroplasty Patients With Central Sensitization

TerminatedPH IVUniversity of Iowan=202024

Combined Effect of Pregabalin and Oxycodone, and Lacosamide and Oxycodone, on Breathing: an Exploratory Study in Healthy Volunteers (The Polo Study)

CompletedPH IVLeiden University Medical Centern=242024

Recent completions

Trials that read out recently, adding to the completed evidence base.

A Randomized, Double-Blind, Placebo-Controlled Crossover Study to Evaluate the Pharmacodynamic Effects of Pregabalin in Healthy Male Adults

CompletedPH ILatigo Biotherapeuticsn=202024

Oral Premedication With Tapentadol Versus Pregabalin for Acute Postoperative Pain in Lower Limb Surgery Under Neuraxial Anesthesia: A Pilot Randomized Controlled Trial

CompletedN/AISSSTE Hospital Regional "Gral. Ignacio Zaragoza"n=462024

Perioperative Pregabalin as Part of a Multimodal Treatment Plan for Ureteral Stent Symptoms After Ureteroscopy: a Randomized Controlled Trial

CompletedPH II/IIIUniversity of Missouri-Columbian=1182024

An Interventional Randomized, Double-blind, Placebo and Active Comparator-controlled, Four-way Crossover Trial Investigating the Analgesic Properties of a Single Oral Dose of Lu AG06474 in Healthy Participants

CompletedPH IH. Lundbeck A/Sn=262024

Efficacy of Different Doses of Pregabalin as a Multimodal Analgesic Agent in Postoperative Pain Control After Total Knee Arthroplasty - A Randomized Controlled Trial

CompletedPH IVThammasat Universityn=822024

Combined Effect of Pregabalin and Oxycodone, and Lacosamide and Oxycodone, on Breathing: an Exploratory Study in Healthy Volunteers (The Polo Study)

CompletedPH IVLeiden University Medical Centern=242024

Research activity

6 papers

Key research shaping understanding of this drug, combining the latest publications with the most influential evidence.

Publications over time
20102014
Most influential

Perioperative oral pregabalin reduces chronic pain after total knee arthroplasty: a prospective, randomized, controlled trial.

Anesthesia and analgesia · 2010 · 276 cites

Cerebrospinal fluid neurotransmitter changes during the perioperative period in patients undergoing total knee replacement: a randomized trial.

Anesthesia and analgesia · 2012 · 22 cites

An enhanced bunionectomy model as a potential tool for early decision-making in the development of new analgesics.

Advances in therapy · 2010 · 20 cites

Effects of pregabalin on heart rate variability in patients with painful diabetic neuropathy.

Journal of clinical psychopharmacology · 2011 · 15 cites

Effect of the α2δ ligand, pregabalin, on colonic sensory and motor functions in healthy adults.

American journal of physiology. Gastrointestinal and liver physiology · 2011 · 14 cites

Pregabalin versus placebo in postoperative pain relief of patients' status post photorefractive keratectomy: a double-masked, randomized, prospective study.

Journal of ocular pharmacology and therapeutics : the official journal of the Association for Ocular Pharmacology and Therapeutics · 2014 · 7 cites
Recent papers

Pregabalin versus placebo in postoperative pain relief of patients' status post photorefractive keratectomy: a double-masked, randomized, prospective study.

Journal of ocular pharmacology and therapeutics : the official journal of the Association for Ocular Pharmacology and Therapeutics · 2014 · 7 cites

Cerebrospinal fluid neurotransmitter changes during the perioperative period in patients undergoing total knee replacement: a randomized trial.

Anesthesia and analgesia · 2012 · 22 cites

Effects of pregabalin on heart rate variability in patients with painful diabetic neuropathy.

Journal of clinical psychopharmacology · 2011 · 15 cites

Effect of the α2δ ligand, pregabalin, on colonic sensory and motor functions in healthy adults.

American journal of physiology. Gastrointestinal and liver physiology · 2011 · 14 cites

Perioperative oral pregabalin reduces chronic pain after total knee arthroplasty: a prospective, randomized, controlled trial.

Anesthesia and analgesia · 2010 · 276 cites

An enhanced bunionectomy model as a potential tool for early decision-making in the development of new analgesics.

Advances in therapy · 2010 · 20 cites
Major research themes2
Arthroplasty, Replacement, Knee1Photorefractive Keratectomy1
Journals, researchers & institutions
Top journals
  • Anesthesia and analgesia2
  • Advances in therapy1
  • American journal of physiology. Gastrointestinal and liver physiology1
  • Journal of clinical psychopharmacology1
  • Journal of ocular pharmacology and therapeutics : the official journal of the Association for Ocular Pharmacology and Therapeutics1
Leading researchers
  • Buvanendran A2
  • Della Valle CJ2
  • Kroin JS2
  • Moric M2
  • Tuman KJ2
  • Beals C1
  • Burton D1
  • Busciglio I1
Leading institutions
free-text, unnormalised
  • Rush University Medical Center2
  • Clinical Enteric Neuroscience Translational and Epidemiological Research1
  • Duke University Medical Center1
  • Wilford Hall Medical Center (WHMC)1
References & data sources
  • RxNorm (U.S. National Library of Medicine) — drug identity
  • ChEMBL (EMBL-EBI) & UniProt — pharmacology and targets
  • Europe PMC — research literature
  • ClinicalTrials.gov — clinical trials
  • Regulatory event sources are credited in the Regulatory Timeline above.