Overview
Pregabalin is structurally similar to gamma-aminobutyric acid (GABA) - an inhibitory neurotransmitter. It may be used to manage neuropathic pain, postherpetic neuralgia, and fibromyalgia among other conditions. Although as per the FDA Label the mechanism of action has not been definitively defined, there is evidence that pregabalin exerts its effects by binding to the α2δ subunit of voltage-dependent calcium channels. Pregabalin is marketed by Pfizer under the trade name Lyrica and Lyrica Cr (extended release). It may have dependence liability if misused but the risk appears to be highest in patients with current or past substance use disorders.
Indication
Pregabalin is indicated for the management of neuropathic pain associated with diabetic peripheral neuropathy, postherpetic neuralgia, fibromyalgia, neuropathic pain associated with spinal cord injury, and as adjunctive therapy for the treatment of partial-onset seizures in patients 1 month of age and older.
Associated Conditions
- Diabetic Peripheral Neuropathic Pain (DPN)
- Epilepsies
- Fibromyalgia
- Generalized Anxiety Disorder
- Neuropathic Pain
- Partial-Onset Seizures
- Peripheral Neuropathic Pain
- Peripheral neuropathy
- Postherpetic Neuralgia
Clinical Trials
Title | Posted | Study ID | Phase | Status | Sponsor |
|---|---|---|---|---|---|
2025/05/13 | Not Applicable | Recruiting | CMH Kharian Medical College | ||
2025/04/20 | Phase 1 | Recruiting | Beijing Tiantan Hospital | ||
2025/02/18 | Not Applicable | Recruiting | |||
2025/01/24 | Phase 4 | Not yet recruiting | Post Graduate Institute of Medical Education and Research, Chandigarh | ||
2025/01/09 | Phase 2 | Recruiting | |||
2024/12/04 | Phase 3 | Not yet recruiting | Eurofarma Laboratorios S.A. | ||
2024/10/08 | Phase 3 | Recruiting | |||
2024/10/01 | Phase 2 | Recruiting | |||
2024/09/26 | Phase 2 | Not yet recruiting | |||
2024/09/19 | Early Phase 1 | Completed | Latigo Biotherapeutics |
FDA Drug Approvals
Approved Product | Manufacturer | NDC Code | Route | Strength | Effective Date |
|---|---|---|---|---|---|
| Major Pharmaceuticals | 0904-6992 | ORAL | 50 mg in 1 1 | 4/5/2021 | |
| Medsource Pharmaceuticals | 45865-106 | ORAL | 50 mg in 1 1 | 2/26/2024 | |
| STAT Rx USA LLC | 16590-503 | ORAL | 50 mg in 1 1 | 2/8/2013 | |
| Tris Pharma Inc | 27808-238 | ORAL | 150 mg in 1 1 | 1/21/2022 | |
| Cadila Pharmaceuticals Limited | 71209-036 | ORAL | 150 mg in 1 1 | 5/5/2023 | |
| Sun Pharmaceutical Industries, Inc. | 63304-049 | ORAL | 330 mg in 1 1 | 12/20/2022 | |
| Aurobindo Pharma Limited | 65862-759 | ORAL | 50 mg in 1 1 | 2/12/2024 | |
| Viatris Specialty LLC | 58151-238 | ORAL | 75 mg in 1 1 | 12/20/2023 | |
| ApotexCorp | 60505-3797 | ORAL | 150 mg in 1 1 | 1/17/2024 | |
| CELLTRION USA, INC. | 72606-007 | ORAL | 100 mg in 1 1 | 3/31/2020 |
EMA Drug Approvals
Approved Product | Authorization Holder | Status | Issued Date |
|---|---|---|---|
Authorised | 8/28/2015 | ||
Authorised | 7/17/2015 | ||
Authorised | 6/19/2015 | ||
Authorised | 7/5/2004 | ||
Authorised | 4/10/2014 | ||
Authorised | 6/24/2015 |
HSA Drug Approvals
Approved Product | Manufacturer | Approval Number | Dosage Form | Strength | Approval Date |
|---|---|---|---|---|---|
| PREGAREDI CAPSULE 150 MG | SIN16761P | CAPSULE | 150mg | 4/18/2023 | |
| REWISCA HARD CAPSULES 150MG | SIN15655P | CAPSULE | 150.00 mg | 4/2/2019 | |
| PREGABALIN MEVON HARD CAPSULES 75 MG | SIN16259P | CAPSULE | 75mg | 7/1/2021 | |
| PREBALIN CAPSULE 75MG | SIN15940P | CAPSULE | 75 mg | 5/15/2020 | |
| REGADEX CAPSULE 75MG | SIN15776P | CAPSULE | 75 mg | 8/14/2019 | |
| PREGABALIN ALVOGEN HARD CAPSULES 25 MG | SIN15485P | CAPSULE | 25.000 mg | 5/17/2018 | |
| BRILLIOR CAPSULE 150mg | SIN14489P | CAPSULE | 150.00mg | 1/16/2014 | |
| PREGABALIN MEVON HARD CAPSULES 25 MG | SIN16260P | CAPSULE | 25mg | 7/1/2021 | |
| MAXGALIN CAPSULE 75 MG | SIN15640P | CAPSULE | 75.000 mg/cap | 2/27/2019 | |
| PREGABALIN SANDOZ CAPSULES 75MG | SIN15359P | CAPSULE | 75mg | 11/10/2017 |
NMPA Drug Approvals
Approved Product | Company | Approval Number | Drug Type | Dosage Form | Approval Date |
|---|---|---|---|---|---|
| No NMPA approvals found for this drug. | |||||
PPB Drug Approvals
Approved Product | Registration No. | Company | Licence No. | Strength | Registration Date |
|---|---|---|---|---|---|
| PREGABALIN ACTAVIS CAPSULES 25MG | N/A | N/A | N/A | 5/27/2019 | |
| PREGATAS 50 CAPSULES 50MG | N/A | N/A | N/A | 7/24/2018 | |
| REWISCA CAPSULES 25MG | N/A | N/A | N/A | 11/20/2020 |
TGA Drug Approvals
Approved Product | ARTG ID | Sponsor | Registration Type | Status | Registration Date |
|---|---|---|---|---|---|
| PREGABALIN LAPL pregabalin 200 mg capsule blister pack | 215701 | Medicine | A | 12/5/2014 | |
| PREGABALIN LAPL pregabalin 300 mg capsule blister pack | 215677 | Medicine | A | 12/5/2014 | |
| PREGABALIN LUPIN pregabalin 25 mg capsule blister pack | 267560 | Medicine | A | 2/14/2017 | |
| PREGACIPLIN pregabalin 50 mg capsule blister | 317765 | Medicine | A | 4/15/2020 | |
| PREGABALIN AMNEAL Pregabalin 150 mg capsules blister pack | 235877 | Medicine | A | 3/23/2016 | |
| PREGABALIN-RZ pregabalin 150 mg capsule blister pack | 263087 | Medicine | A | 12/21/2016 | |
| PREGABALIN INTAS Pregabalin 75 mg capsules blister pack | 235860 | Medicine | A | 3/23/2016 | |
| LYZALON Pregabalin 150 mg capsules bottle pack | 235867 | Medicine | A | 3/23/2016 | |
| LYPRALIN Pregabalin 75 mg capsules bottle pack | 235866 | Medicine | A | 3/23/2016 | |
| LYRILIN pregabalin 150mg capsule blister pack | 205309 | Medicine | A | 2/18/2014 |
Health Canada Drug Approvals
Approved Product | Company | DIN | Dosage Form | Strength | Market Date |
|---|---|---|---|---|---|
| AURO-PREGABALIN | auro pharma inc | 02433893 | Capsule - Oral | 100 MG | N/A |
| M-PREGABALIN | mantra pharma inc | 02541939 | Capsule - Oral | 100 MG | N/A |
| ACT PREGABALIN | actavis pharma company | 02402963 | Capsule - Oral | 200 MG | N/A |
| APO-PREGABALIN | 02394235 | Capsule - Oral | 25 MG | 6/6/2013 | |
| IPG-PREGABALIN | marcan pharmaceuticals inc | 02416166 | Capsule - Oral | 75 MG | N/A |
| APO-PREGABALIN CAPSULES | 02518988 | Capsule - Oral | 225 MG | N/A | |
| APO-PREGABALIN | 02394278 | Capsule - Oral | 150 MG | 4/22/2013 | |
| APO-PREGABALIN CAPSULES | 02518961 | Capsule - Oral | 150 MG | N/A | |
| TORRENT-PREGABALIN | 02438208 | Capsule - Oral | 300 MG | N/A | |
| TORRENT-PREGABALIN | 02438194 | Capsule - Oral | 225 MG | N/A |
CIMA AEMPS Drug Approvals
Approved Product | Company | Registration Number | Pharmaceutical Form | Prescription Type | Status |
|---|---|---|---|---|---|
| LYRICA 25 MG CAPSULAS DURAS | 04279003 | CÁPSULA DURA | Medicamento Sujeto A Prescripción Médica | Commercialized | |
| LYRICA 150 MG CAPSULAS DURAS | 04279018IP3 | CÁPSULA DURA | Medicamento Sujeto A Prescripción Médica | Commercialized | |
| LYRICA 25 MG CAPSULAS DURAS | 04279005 | CÁPSULA DURA | Medicamento Sujeto A Prescripción Médica | Commercialized | |
| PREGABALINA SUN 300 MG CAPSULAS DURAS EFG | 80292 | CÁPSULA DURA | Medicamento Sujeto A Prescripción Médica | Commercialized | |
| LYRICA 75 MG CAPSULAS DURAS | 04279012IP1 | CÁPSULA DURA | Medicamento Sujeto A Prescripción Médica | Commercialized | |
| LYRICA 150 MG CAPSULAS DURAS | 04279018IP1 | CÁPSULA DURA | Medicamento Sujeto A Prescripción Médica | Commercialized | |
| PREGABALINA STADA GENERICOS 25 MG CAPSULAS DURAS EFG | Stada Genericos S.L. | 79284 | CÁPSULA DURA | Medicamento Sujeto A Prescripción Médica | Not Commercialized |
| PREGABALINA CINFA 50 MG CAPSULAS DURAS EFG | Laboratorios Cinfa S.A. | 85279 | CÁPSULA DURA | Medicamento Sujeto A Prescripción Médica | Commercialized |
| LYRICA 150 MG CAPSULAS DURAS | 04279018IP2 | CÁPSULA DURA | Medicamento Sujeto A Prescripción Médica | Commercialized | |
| PREGABALINA COMBIX 75 MG CAPSULAS DURAS EFG | Laboratorios Combix S.L.U. | 79744 | CÁPSULA DURA | Medicamento Sujeto A Prescripción Médica | Commercialized |
Philippines FDA Drug Approvals
Approved Product | Company | License Number | Dosage Form | Strength | Approval Date |
|---|---|---|---|---|---|
| No Philippines FDA approvals found for this drug. | |||||
Saudi SFDA Drug Approvals
Approved Product | Company | License Number | Dosage Form | Strength | Approval Date |
|---|---|---|---|---|---|
| No Saudi SFDA approvals found for this drug. | |||||
Malaysia NPRA Drug Approvals
Approved Product | Company | Registration Number | Dosage Form | Strength | Approval Date |
|---|---|---|---|---|---|
| No Malaysia NPRA approvals found for this drug. | |||||
UK EMC Drug Information
Medicine Name | MA Holder | MA Number | Pharmaceutical Form | Active Ingredient | Authorization Date |
|---|---|---|---|---|---|
| No UK EMC drug information found for this drug. | |||||
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