Lyrica(pregabalin)
Lyrica, Pregabalin (pregabalin) is a small molecule pharmaceutical. Pregabalin was first approved as Lyrica on 2004-07-05. It is used to treat fibromyalgia, postherpetic neuralgia, seizures, and spinal cord injuries in the USA. It has been approved in Europe to treat anxiety disorders, epilepsy, and neuralgia.
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Commercial
Trade Name
FDA
EMA
Lyrica, Pregabalin (discontinued: Pregabalin)
Drug Products
FDA
EMA
New Drug Application (NDA)
New Drug Application (NDA)
Abbreviated New Drug Application (ANDA)
Abbreviated New Drug Application (ANDA)
Labels
FDA
EMA
Brand Name | Status | Last Update |
|---|---|---|
| lyrica | New Drug Application | 2023-12-20 |
| lyrica cr | New Drug Application | 2024-03-19 |
| pregabalin | ANDA | 2025-01-13 |
| pregabalin capsules, cv | ANDA | 2022-03-16 |
| pregabalin extended release | ANDA | 2022-09-19 |
Indications
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EMA
Agency Specific
FDA
EMA
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HCPCS
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Clinical
Clinical Trials
574 clinical trials
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Indications Phases 4
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Neuralgia | D009437 | EFO_0009430 | — | 1 | — | 14 | 7 | 10 | 32 |
| Seizures | D012640 | HP_0002069 | G40.4 | 1 | 1 | 12 | 5 | 1 | 19 |
| Myofascial pain syndromes | D009209 | EFO_1001054 | — | 1 | — | 13 | 2 | 3 | 19 |
| Fibromyalgia | D005356 | EFO_0005687 | M79.1 | 1 | — | 13 | 2 | 3 | 19 |
| Peripheral nervous system diseases | D010523 | HP_0009830 | G64 | — | — | 10 | 5 | 1 | 16 |
| Epilepsy | D004827 | EFO_0000474 | G40.9 | 1 | 1 | 8 | 4 | 3 | 16 |
| Healthy volunteers/patients | — | — | — | 13 | — | — | 1 | — | 14 |
| Diabetic neuropathies | D003929 | EFO_1000783 | — | — | — | 8 | 5 | 1 | 14 |
| Partial epilepsies | D004828 | EFO_0004263 | — | 1 | 1 | 6 | 3 | — | 10 |
| Pain | D010146 | EFO_0003843 | R52 | — | — | 5 | 2 | 2 | 9 |
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Indications Phases 3
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Restless legs syndrome | D012148 | EFO_0004270 | G25.81 | — | 1 | 3 | — | — | 4 |
| Psychomotor agitation | D011595 | — | — | — | 1 | 3 | — | — | 4 |
| Syndrome | D013577 | — | — | — | 1 | 3 | — | — | 4 |
| Postoperative pain | D010149 | — | G89.18 | — | — | 3 | — | — | 3 |
| Spinal cord injuries | D013119 | EFO_1001919 | — | — | — | 2 | — | 1 | 3 |
| Hiv infections | D015658 | EFO_0000764 | B20 | — | — | 3 | — | — | 3 |
| Osteoarthritis | D010003 | EFO_0002506 | M15-M19 | — | — | 1 | — | — | 1 |
| Depression | D003863 | — | F33.9 | — | — | 1 | — | — | 1 |
| Spinal cord diseases | D013118 | HP_0002196 | G95.9 | — | — | 1 | — | — | 1 |
| Sleep wake disorders | D012893 | — | G47 | — | — | 1 | — | — | 1 |
Show 6 more
Indications Phases 2
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Dental anxiety | D016854 | — | — | — | 1 | — | — | — | 1 |
Indications Phases 1
No data
Indications Without Phase
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Neck pain | D019547 | HP_0030833 | M54.2 | — | — | — | — | 1 | 1 |
| Somatoform disorders | D013001 | — | F45 | — | — | — | — | 1 | 1 |
| Pharmacovigilance | D060735 | — | — | — | — | — | — | 1 | 1 |
Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
| Drug common name | Pregabalin |
| INN | pregabalin |
| Description | Pregabalin is a gamma-amino acid that is gamma-aminobutyric acid (GABA) carrying an isobutyl substitutent at the beta-position (the S-enantiomer). It binds with high affinity to the alpha2-delta site (an auxiliary subunit of voltage-gated calcium channels) in central nervous system tissues. It has a role as an anticonvulsant and a calcium channel blocker. It derives from a gamma-aminobutyric acid. Pregabalin is a 3-isobutyl derivative of gamma-amino butyric acid (GABA) with anti-convulsant, anti-epileptic, anxiolytic, and analgesic activities. Although the exact mechanism of action is unknown, pregabalin selectively binds to alpha2delta (A2D) subunits of presynaptic voltage-dependent calcium channels (VDCCs) located in the central nervous system (CNS). Binding of pregabalin to VDCC A2D subunits prevents calcium influx and the subsequent calcium-dependent release of various neurotransmitters, including glutamate, norepinephrine, serotonin, dopamine, and substance P, from the presynaptic nerve terminals of hyperexcited neurons; synaptic transmission is inhibited and neuronal excitability is diminished. Pregabalin does not bind directly to GABA-A or GABA-B receptors and does not alter GABA uptake or degradation. |
| Classification | Small molecule |
| Drug class | gabamimetics |
| Image (chem structure or protein) |  |
| Structure (InChI/SMILES or Protein Sequence) | CC(C)C[C@H](CN)CC(=O)O |
Identifiers
| PDB | — |
| CAS-ID | 148553-50-8 |
| RxCUI | — |
| ChEMBL ID | CHEMBL1059 |
| ChEBI ID | 64356 |
| PubChem CID | 5486971 |
| DrugBank | DB00230 |
| UNII ID | 55JG375S6M (ChemIDplus, GSRS) |
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Financial
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Pregabalin
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Safety
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163,053 adverse events reported
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