Pregabalin clinical trials
Pregabalin is named as an intervention in 27 current clinical trials in our China, Egypt, USA, France, Canada, Israel, UK, Germany, Italy, India, Japan, Belgium and Brazil registers. 22 are recruiting patients now. The most common phase is Not applicable. The sponsor with the most trials is Beijing Tiantan Hospital (8). The most-studied condition is Pregabalin.
Where Pregabalin is approved
All regulators →Of the three regulators tracked here, the first to approve Pregabalin was the EU, on 5 Jul 2004. It is approved in 3 of the 3 regulators tracked here.
From the regulators' own registers: FDA Drugs@FDA, the EMA medicines list and Health Canada's Notice of Compliance database. Dates are the first listed approval of a product containing only this substance; combination products and nationally authorised EU medicines are not counted.
Pregabalin patents and exclusivity
Expiry tracker →Protections still running for marketed products containing Pregabalin, as listed by the regulators. Expired patents and exclusivities, and discontinued products, are not shown.
- 3 listed patents; the last listed expires 2 May 2027 (US 10022447, including a 6-month paediatric extension).
Reproduced from the FDA Orange Book and Purple Book (checked 8 Nov 2026) and the European Commission's Union Register of medicinal products (CC BY 4.0; the EU expiry date is calculated exactly as the Commission's register displays it). Listed patents and dates are as submitted to or published by the regulator and may not reflect litigation, invalidation, settlements, lapsed fees or later extensions. This is not legal advice or a freedom-to-operate opinion, and it does not say when a generic or biosimilar will launch.
What health systems spend on Pregabalin
All medicines →From NHSBSA Prescription Cost Analysis (Open Government Licence v3.0) and CMS State Drug Utilization Data. Both are gross amounts: neither system publishes its discounts or rebates per drug. Products combining several substances are not counted here.
How Pregabalin works
All drug targets →- Voltage-gated calcium channel modulator ModulatorTarget: Voltage-gated calcium channelChEMBL only
- Chronic painPhase 3
- Focal-onset seizurePhase 3
- HeadachePhase 3
- Low back painPhase 3
- PainPhase 3
- PruritusPhase 3
- Sleep disturbancePhase 3
- Alcohol dependencePhase 3
- Burning mouth syndromePhase 3
- Chronic prostatitisPhase 3
Mechanisms and diseases from ChEMBL via the Open Targets Platform (release 26.09), ChEMBL record CHEMBL1059, CC BY-SA 3.0. Targets checked against the IUPHAR/BPS Guide to PHARMACOLOGY (2026.3.1), ligand 5484, CC BY-SA 4.0. Trial phases are not approvals: approved uses are shown from the regulators' own records where we hold them.
Patient leaflets for Pregabalin
The package leaflet is the official guide for patients that comes with every medicine. These links go to the regulators that publish it.
- IEIreland: 106 products on the HPRA listEach product record links to the HPRA, which publishes the leaflet and SmPC.
- EUEuropean Union: Lyrica, Pregabalin Viatris Pharma (previously Pregabalin Pfizer), Pregabalin Accord (generic), Pregabalin Sandoz (generic), Pregabalin Viatris (previously Pregabalin Mylan) (generic), Pregabalin Zentiva (generic)EMA product information: package leaflet and summary of product characteristics in every EU language.
- UKUnited Kingdom: Search MHRA ProductsPatient information leaflets and SmPCs for UK-licensed products.
- USUnited States: Search DailyMedFDA-approved labels, including patient and medication guides.
Leaflets differ between brands and countries; always read the one that comes with your own medicine. This is regulatory information, not medical advice.
Reference identifiers for Pregabalin
- ATC code
- N02BF02
- ChEMBL
- CHEMBL1059
- DrugBank
- DB00230
- PubChem CID
- 25271887
- CAS number
- 148553-50-8
- FDA UNII
- 55JG375S6M
- Wikidata
- Q412174
- Wikipedia
- Pregabalin
Codes that identify this medicine in other databases, from Wikidata (CC0), matched by its ChEMBL ID. The ATC code is the WHO classification of what the medicine is used for.
Trials by status
Trials by phase
Clinical trials of Pregabalin
27 trialsRegisters list studies that are recruiting, about to open, active but closed to enrolment, or enrolling by invitation. The UK and USA registers cover industry-sponsored studies only. Trial titles and statuses are copied from the registry as published.
Pregabalin across our data
Ireland · EU · USThe same active substance in our other registers, matched by its exact name. Each entry links to the register record it comes from.
Licensed in Ireland (HPRA)
106 single-substance products containing Pregabalin on the HPRA medicines list.
- Pregabalin Clonmel 100 mg capsules, hardClonmel Healthcare Ltd · PA0126/290/004 · Marketed
- Pregabalin Clonmel 150 mg capsules, hardClonmel Healthcare Ltd · PA0126/290/005 · Marketed
- Pregabalin Clonmel 200 mg capsules, hardClonmel Healthcare Ltd · PA0126/290/006 · Marketed
- Pregabalin Clonmel 25 mg capsules, hardClonmel Healthcare Ltd · PA0126/290/001 · Marketed
- Pregabalin Clonmel 300 mg capsules, hardClonmel Healthcare Ltd · PA0126/290/008 · Marketed
Supply shortages
No entry for Pregabalin in the EMA, FDA or German BfArM shortage lists we track.
Conditions studied with Pregabalin
40 conditionsAll 40 conditions
| Condition (as registered) | Trials |
|---|---|
| Pregabalin | 12 |
| Fibromyalgia | 7 |
| Pain | 6 |
| Diabetic Peripheral Neuropathic Pain | 3 |
| Healthy Male and Female Subjects | 2 |
| Duloxetine | 2 |
| Neuropathic Pain | 2 |
| Dexmedetomidine | 2 |
| Diabetic Pruritus | 1 |
| Efficacy of Pregabalin in Controlling Diabetic Pruritus Severity | 1 |
| Venlafaxine | 1 |
| Mirogabalin | 1 |
| Postherpetic Neuralgia ( PHN ) | 1 |
| Postherpetic Neuralgia | 1 |
| Y-4 | 1 |
| Lumbar Radiculopathy | 1 |
| Lumbar Disc Herniation | 1 |
| Lumbar Disc Disease | 1 |
| Early-stage Breast Cancer | 1 |
| Estrogen-receptor-positive Breast Cancer | 1 |
| Cough | 1 |
| Refractory Chronic Cough | 1 |
| Unexplained Chronic Cough | 1 |
| Cough Hypersensitivity Syndrome | 1 |
| Spinal Cord Injuries | 1 |
| Spinal Cord Diseases | 1 |
| Painful Peripheral Neuropathy | 1 |
| Diabetic Peripheral Neuropathic Pain (DPN) | 1 |
| Chemotherapy Induced Peripheral Neuropathy (CIPN) | 1 |
| Idiopathic Peripheral Neuropathy | 1 |
| Delirium Treatment | 1 |
| Coronary Artery Bypass Grafting | 1 |
| Oral | 1 |
| Melatonin | 1 |
| Postoperative Pain | 1 |
| Amantadine | 1 |
| Mastectomy | 1 |
| Optic Nerve Sheath Diameter Measurement | 1 |
| Intracranial Pressure Changes | 1 |
| Post Operative Pain, Acute | 1 |
Sponsors
lead sponsor per trial+ 2 more sponsors in the trial list above.
By country register
A trial with sites in more than one country appears in each of those registers.
Related compounds
Questions about Pregabalin trials
How many clinical trials are testing Pregabalin?
27 current trials in our China, Egypt, USA, France, Canada, Israel, UK, Germany, Italy, India, Japan, Belgium and Brazil registers name Pregabalin as a drug or biological intervention, as of the registry sync on 10 November 2026. Completed and withdrawn studies are not counted.
Are Pregabalin trials recruiting patients?
Yes. 22 of the 27 trials are recruiting: 11 with sites in China, 4 with sites in Egypt, 2 with sites in USA, 1 with sites in France, 1 with sites in Canada, 2 with sites in Israel, 1 with sites in UK, 1 with sites in Germany, 1 with sites in Italy, 1 with sites in India, 1 with sites in Japan, 1 with sites in Belgium and 1 with sites in Brazil. Eligibility and site contacts are on each trial's record. Only the study team can confirm whether a patient is eligible.
Who sponsors Pregabalin clinical trials?
Beijing Tiantan Hospital (8), Vertex Pharmaceuticals Incorporated (2), Neurodawn Pharmaceutical Co., Ltd (2) and Tanta University (2), among 17 lead sponsors in total. The number in brackets is how many trials each organisation leads.
Is Pregabalin licensed in Ireland?
Yes. The HPRA medicines list includes 106 single-substance products containing Pregabalin, for example Pregabalin Clonmel 100 mg capsules, hard (Clonmel Healthcare Ltd). A licence does not mean a product is currently marketed or reimbursed; see each product's record.
Is there a Pregabalin shortage?
Not in the lists we track: Pregabalin has no entry in the EMA, FDA or German BfArM shortage registers as of their latest sync.
Where does this information come from?
Every trial, status, phase and sponsor on this page is copied from public ClinicalTrials.gov records by a daily sync. Nothing here describes how Pregabalin works or whether it is effective, and it is not medical advice.
How this page is built
Everything on this page is copied from public ClinicalTrials.gov registry records — it is not written from memory, and nothing here describes how Pregabalin works or whether it is effective. Each trial links to its own record so you can check it yourself.
- ClinicalTrials.gov (U.S. National Library of Medicine) ↗ Trial IDs, titles, intervention names and synonyms, phase, overall status, lead sponsor and conditions for every trial on this page
This page is built automatically: a daily sync job reads the registry records behind our country trial registers, collects every trial that lists Pregabalin (or a registered synonym) as a drug or biological intervention, and tabulates the registry fields directly. Placebos and generic comparators are excluded. There is no AI drafting and no per-compound editorial pass, and the page has not been clinically reviewed. The “last verified” date above is the timestamp of that sync, not a review date. Our general editorial approach is described in our editorial standards and corrections policy. The ClinicalTrials.gov data on this page was last retrieved on 10 Nov 2026. How every register is built: methodology · fixes we have made: corrections log.