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AboutPricing
Drug ReportsPregabalin
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
Therapeutic Areas
Therapeutic Area
MeSH
musculoskeletal diseasesD009140
nervous system diseasesD009422
signs and symptoms pathological conditionsD013568
wounds and injuriesD014947
mental disordersD001523
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)
Pregabalin
Tradename
Company
Number
Date
Products
LYRICAUpjohnN-021446 RX2004-12-30
8 products, RLD, RS
LYRICAUpjohnN-022488 RX2010-01-04
1 products, RLD, RS
LYRICA CRUpjohnN-209501 RX2017-10-11
3 products, RLD, RS
Labels
FDA
EMA
Brand Name
Status
Last Update
lyricaNew Drug Application2025-04-15
lyrica crNew Drug Application2025-04-09
pregabalinANDA2025-12-22
pregabalin capsules, cvANDA2025-12-22
pregabalin extended releaseANDA2022-09-19
Indications
FDA
EMA
Indication
Ontology
MeSH
ICD-10
spinal cord injuriesEFO_1001919D013119—
postherpetic neuralgia—D051474—
fibromyalgiaEFO_0005687D005356M79.1
seizures—D012640G40.4
Agency Specific
FDA
EMA
No data
Patent Expiration
Patent
Expires
Flag
FDA Information
Pregabalin, Lyrica Cr, Upjohn
89456202026-11-02DPU-2136, U-2137
91445592026-11-02DP
100224472026-11-02U-2136, U-2137
ATC Codes
N: Nervous system drugs
— N02: Analgesics
— N02B: Other analgesics and antipyretics in atc
— N02BF: Gabapentinoids, analgesics and antipyretics
— N02BF02: Pregabalin
HCPCS
No data
Clinical
Clinical Trials
598 clinical trials
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Indications Phases 4
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
NeuralgiaD009437EFO_0009430—71123163187
PainD010146EFO_0003843R5251629102581
Postoperative painD010149—G89.1851121271976
Diabetic neuropathiesD003929EFO_1000783—2242015461
FibromyalgiaD005356EFO_0005687M79.1241982758
Healthy volunteers/patients———33——3137
Postherpetic neuralgiaD051474——2668729
EpilepsyD004827EFO_0000474G40.912127627
Chronic painD059350———4331424
Partial epilepsiesD004828EFO_0004263—12127—21
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Indications Phases 3
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Breast neoplasmsD001943EFO_0003869C50—42—28
HerniaD006547—K40-K46——2—24
Hiv infectionsD015658EFO_0000764B20——4——4
Sleep wake disordersD012893—G471—1—24
DementiaD003704EFO_0003862F03—12——2
Urologic diseasesD014570—N39.9——1—12
Bone fracturesD050723EFO_0003931T14.81—1——2
Spinal fusionD013123————1—12
Chronic pancreatitisD050500EFO_0000342K86.1—11—12
Inguinal herniaD006552HP_0000023K40——2——2
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Indications Phases 2
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
NauseaD009325—R11.0—2——13
Small fiber neuropathyD000071075——11——13
Narcotic-related disordersD000079524———1——12
VomitingD014839—R11.1—1——12
Conscious sedationD016292———1——12
Patient complianceD010349———1———1
ComplianceD003187———1———1
LymphomaD008223—C85.9—1———1
MucositisD052016EFO_1001898——1———1
Dental pinsD003772———1———1
Show 27 more
Indications Phases 1
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Multiple fracturesD000069076——1————1
Marijuana abuseD002189EFO_0007191F121————1
Refractive errorsD012030HP_0000483H52.71————1
Tobacco use disorderD014029—F171————1
Pain thresholdD017288——1————1
Radiation injuriesD011832—T661————1
CystitisD003556EFO_1000025N301————1
Indications Without Phase
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Cancer painD000072716—G89.3————33
Ganglion cystsD045888—M67.4————22
Anesthesia and analgesiaD000760——————22
Depressive disorderD003866EFO_1002014F32.A————22
Trigeminal neuralgiaD014277EFO_1001219G50.0————22
Systemic sclerodermaD012595EFO_0000717M34————11
Localized sclerodermaD012594EFO_1001361L94.0————11
Diffuse sclerodermaD045743EFO_0000404—————11
ArthroplastyD001178——————11
Gynecologic surgical proceduresD013509——————11
Show 46 more
Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
Drug common namePregabalin
INNpregabalin
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 classgabamimetics
Image (chem structure or protein)Loading
Structure (InChI/SMILES or Protein Sequence)
CC(C)C[C@H](CN)CC(=O)O
Identifiers
PDB—
CAS-ID148553-50-8
RxCUI—
ChEMBL IDCHEMBL1059
ChEBI ID64356
PubChem CID5486971
DrugBankDB00230
UNII ID55JG375S6M (ChemIDplus, GSRS)
Target
No data
Variants
No data
Financial
Revenue by drug
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Lyrica – Viatris
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Lyrica – Pfizer
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Estimated US medical usage
Pregabalin
Total medical expenditures per year (USD, in millions)
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Number of persons purchased
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Trends
PubMed Central
Top Terms for Disease or Syndrome:
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Additional graphs summarizing 21,058 documents
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Safety
Black-box Warning
No Black-box warning
Adverse Events
Top Adverse Reactions
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166,813 adverse events reported
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