Lyrica(pregabalin)
Lyrica (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 (generic drugs available since 2019-07-19)
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 | 2022-08-25 |
| pregabalin | ANDA | 2023-06-08 |
Indications
FDA
EMA
Indication | Ontology | MeSH | ICD-10 |
|---|---|---|---|
| fibromyalgia | EFO_0005687 | D005356 | M79.1 |
| postherpetic neuralgia | — | D051474 | — |
| seizures | HP_0007359 | D012640 | G40.4 |
| spinal cord injuries | EFO_1001919 | D013119 | — |
Agency Specific
FDA
EMA
No data
HCPCS
No data
Clinical
Clinical Trials
451 clinical trials
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Indications Phases 4
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Postoperative pain | D010149 | G89.18 | 4 | 10 | 19 | 17 | 12 | 56 | |
| Neuralgia | D009437 | EFO_0009430 | 2 | 4 | 18 | 12 | 12 | 48 | |
| Diabetic neuropathies | D003929 | EFO_1000783 | 2 | 16 | 14 | 14 | — | 45 | |
| Fibromyalgia | D005356 | EFO_0005687 | M79.1 | 1 | 3 | 18 | 7 | 11 | 39 |
| Pain | D010146 | EFO_0003843 | R52 | 2 | 9 | 9 | 5 | 9 | 33 |
| Healthy volunteers/patients | — | 28 | — | — | 3 | 1 | 32 | ||
| Partial epilepsies | D004828 | EFO_0004263 | 1 | 2 | 10 | 4 | — | 16 | |
| Postherpetic neuralgia | D051474 | 1 | 4 | 5 | 5 | — | 15 | ||
| Epilepsy | D004827 | EFO_0000474 | G40.9 | — | — | 4 | 3 | 4 | 11 |
| Chronic pain | D059350 | HP_0012532 | — | 3 | 2 | 2 | 1 | 8 |
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Indications Phases 3
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Peripheral nervous system diseases | D010523 | G64 | — | 2 | 3 | — | — | 4 | |
| Breast neoplasms | D001943 | EFO_0003869 | C50 | — | 2 | 2 | — | — | 4 |
| Hiv infections | D015658 | EFO_0000764 | B20 | — | — | 3 | — | — | 3 |
| Dementia | D003704 | F03 | — | 1 | 2 | — | — | 2 | |
| Chronic pancreatitis | D050500 | EFO_0000342 | K86.1 | — | 1 | 1 | — | 1 | 2 |
| Inguinal hernia | D006552 | HP_0000023 | K40 | — | — | 2 | — | — | 2 |
| Psychophysiologic disorders | D011602 | F45.9 | — | — | 1 | — | — | 1 | |
| Depression | D003863 | F33.9 | — | — | 1 | — | — | 1 | |
| Kidney calculi | D007669 | EFO_0004253 | N20.0 | — | 1 | 1 | — | — | 1 |
| Pruritus | D011537 | HP_0000989 | L29 | — | — | 1 | — | — | 1 |
Show 22 more
Indications Phases 2
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Conscious sedation | D016292 | — | 1 | — | — | 1 | 2 | ||
| Lymphoma | D008223 | C85.9 | — | 1 | — | — | — | 1 | |
| Nausea | D009325 | HP_0002018 | R11.0 | — | 1 | — | — | — | 1 |
| Dental pins | D003772 | — | 1 | — | — | — | 1 | ||
| Earache | D004433 | HP_0030766 | H92.0 | — | 1 | — | — | — | 1 |
| Cough | D003371 | HP_0012735 | R05 | 1 | 1 | — | — | — | 1 |
| Vulvodynia | D056650 | N94.81 | — | 1 | — | — | — | 1 | |
| Vulvar vestibulitis | D054515 | N94.810 | — | 1 | — | — | — | 1 | |
| Facial pain | D005157 | R51.9 | — | 1 | — | — | — | 1 | |
| Overactive urinary bladder | D053201 | EFO_1000781 | N32.81 | — | 1 | — | — | — | 1 |
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Indications Phases 1
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Refractive errors | D012030 | EFO_0003908 | H52.7 | 1 | — | — | — | — | 1 |
| Tobacco use disorder | D014029 | F17 | 1 | — | — | — | — | 1 |
Indications Without Phase
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Postoperative complications | D011183 | — | — | — | — | 1 | 1 | ||
| Postoperative nausea and vomiting | D020250 | EFO_0004888 | — | — | — | — | 1 | 1 | |
| Ankle fractures | D064386 | S82.5 | — | — | — | — | 1 | 1 | |
| Bunion | D000071378 | M21.61 | — | — | — | — | 1 | 1 | |
| Hammer toe syndrome | D037801 | EFO_1001336 | M21.53 | — | — | — | — | 1 | 1 |
| Tailor's bunion | D050489 | M21.62 | — | — | — | — | 1 | 1 | |
| Female genital diseases | D005831 | EFO_0009549 | N85 | — | — | — | — | 1 | 1 |
| Myofascial pain syndromes | D009209 | EFO_1001054 | — | — | — | — | 1 | 1 | |
| Epidural anesthesia | D000767 | — | — | — | — | 1 | 1 | ||
| Shivering | D012768 | — | — | — | — | 1 | 1 |
Show 12 more
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 | 187832 |
| ChEMBL ID | CHEMBL1059 |
| ChEBI ID | 64356 |
| PubChem CID | 5486971 |
| DrugBank | DB00230 |
| UNII ID | 55JG375S6M (ChemIDplus, GSRS) |
Target
Agency Approved
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Alternate
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Variants
Clinical Variant
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Financial
Lyrica - Viatris
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Lyrica - Pfizer
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Trends
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Additional graphs summarizing 14,426 documents
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Safety
Black-box Warning
No Black-box warning
Adverse Events
Top Adverse Reactions
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8,615 adverse events reported
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