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Drug ReportsBaclofen
Baclofen
Baclofen, Fleqsuvy, Gablofen, Lioresal, Lyvispah, Ozobax (baclofen) is a small molecule pharmaceutical. Baclofen was first approved as Lioresal on 1982-01-01. It is used to treat cerebral palsy, hiccup, huntington disease, intractable pain, and multiple sclerosis amongst others in the USA. It is known to target gamma-aminobutyric acid type B receptor subunit 1.
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Commercial
Therapeutic Areas
Therapeutic Area
MeSH
infectionsD007239
neoplasmsD009369
musculoskeletal diseasesD009140
stomatognathic diseasesD009057
nervous system diseasesD009422
urogenital diseasesD000091642
cardiovascular diseasesD002318
hereditary congenital and neonatal diseases and abnormalitiesD009358
immune system diseasesD007154
signs and symptoms pathological conditionsD013568
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Trade Name
FDA
EMA
Baclofen, Fleqsuvy, Gablofen, Lioresal, Ozobax (discontinued: Baclofen, Kemstro, Lioresal, Lyvispah, Ozobax)
Drug Products
FDA
EMA
New Drug Application (NDA)
New Drug Application (NDA)
Abbreviated New Drug Application (ANDA)
Abbreviated New Drug Application (ANDA)
Baclofen
Tradename
Company
Number
Date
Products
LIORESALAmneal PharmaceuticalsN-020075 RX1992-06-17
3 products, RLD, RS
FLEQSUVYAzurityN-215602 RX2022-02-04
1 products, RLD, RS
OZOBAX DSMetacel PharmaceuticalsN-208193 RX2023-10-12
1 products, RLD, RS
GABLOFENPiramal Critical CareN-022462 RX2010-11-19
4 products, RLD, RS
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Labels
FDA
EMA
Brand Name
Status
Last Update
baclofenANDA2025-10-03
baclofen (intrathecal)ANDA2023-11-08
baclofen baclofenANDA2025-02-05
fleqsuvyNew Drug Application2024-05-16
gablofenNew Drug Application2025-09-23
kemstro2006-01-04
lioresalNew Drug Application2016-10-07
lioresal (baclofen)New Drug Application2022-12-14
lyvispahNew Drug Application2023-04-23
ozobaxNew Drug Application2023-10-17
Indications
FDA
EMA
Indication
Ontology
MeSH
ICD-10
multiple sclerosisEFO_0003885D009103G35
spinal cord injuriesEFO_1001919D013119—
spinal cord neoplasmsEFO_0003828D013120C72.0
hiccup—D006606R06.6
neurogenic urinary bladderHP_0000011D001750N31
muscle spasticity—D009128—
cerebral palsy—D002547G80
spinal cord ischemiaEFO_1001426D020760—
trigeminal neuralgiaEFO_1001219D014277G50.0
huntington diseaseOrphanet_399D006816G10
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Agency Specific
FDA
EMA
No data
Patent Expiration
Patent
Expires
Flag
FDA Information
Baclofen, Lyvispah, Amneal
114911252041-09-29DPU-3488, U-3489
118502252041-09-29DPU-3488, U-3489
107922622039-07-29DPU-3263
116541242039-07-29DP
Baclofen, Ozobax, Metacel Pharms Llc
106105022039-08-30U-2779
Baclofen, Fleqsuvy, Azurity
113246962037-09-29DP
114462462037-09-08U-3433
ATC Codes
M: Musculo-skeletal system drugs
— M03: Muscle relaxants
— M03B: Muscle relaxants, centrally acting agents
— M03BX: Other centrally acting agents in atc
— M03BX01: Baclofen
HCPCS
Code
Description
J0475
Injection, baclofen, 10 mg
J0476
Injection, baclofen, 50 mcg for intrathecal trial
Clinical
Clinical Trials
141 clinical trials
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Indications Phases 4
No data
Indications Phases 3
No data
Indications Phases 2
No data
Indications Phases 1
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Healthy volunteers/patients———1————1
Indications Without Phase
No data
Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
Drug common nameBaclofen
INNbaclofen
Description
Baclofen is a monocarboxylic acid that is butanoic acid substituted by an amino group at position 4 and a 4-chlorophenyl group at position 3. It acts as a central nervous system depressant, GABA agonist and muscle relaxant. It has a role as a muscle relaxant, a central nervous system depressant and a GABA agonist. It is a monocarboxylic acid, a primary amino compound, a member of monochlorobenzenes and a gamma-amino acid. It is a tautomer of a baclofen zwitterion.
Classification
Small molecule
Drug class—
Image (chem structure or protein)Loading
Structure (InChI/SMILES or Protein Sequence)
NCC(CC(=O)O)c1ccc(Cl)cc1
Identifiers
PDB—
CAS-ID1134-47-0
RxCUI—
ChEMBL IDCHEMBL701
ChEBI ID2972
PubChem CID2284
DrugBankDB00181
UNII IDH789N3FKE8 (ChemIDplus, GSRS)
Target
Agency Approved
No data
Alternate
GABBR1
GABBR1
Organism
Homo sapiens
Gene name
GABBR1
Gene synonyms
GPRC3A
NCBI Gene ID
2550
Protein name
gamma-aminobutyric acid type B receptor subunit 1
Protein synonyms
GABA-B receptor, R1 subunit, gamma-aminobutyric acid (GABA) B receptor, 1, seven transmembrane helix receptor
Uniprot ID
Q9UQQ0
Mouse ortholog
Gabbr1 (54393)
gamma-aminobutyric acid type B receptor subunit 1 (Q9WV18)
Variants
No data
Financial
Revenue by drug
$
€
£
â‚£
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Estimated US medical usage
Baclofen
Total medical expenditures per year (USD, in millions)
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Number of persons purchased
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Number of purchases
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Tabular view
Trends
PubMed Central
Top Terms for Disease or Syndrome:
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Additional graphs summarizing 16,482 documents
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Safety
Black-box Warning
Black-box warning for: Baclofen (intrathecal), Gablofen, Lioresal, Lioresal (baclofen)
Adverse Events
Top Adverse Reactions
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41,677 adverse events reported
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