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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Therapeutic Areas
Therapeutic Area | MeSH |
|---|---|
| infections | D007239 |
| neoplasms | D009369 |
| musculoskeletal diseases | D009140 |
| stomatognathic diseases | D009057 |
| nervous system diseases | D009422 |
| urogenital diseases | D000091642 |
| cardiovascular diseases | D002318 |
| hereditary congenital and neonatal diseases and abnormalities | D009358 |
| immune system diseases | D007154 |
| signs and symptoms pathological conditions | D013568 |
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Trade Name
FDA
EMA
Fleqsuvy, Gablofen, Lioresal, Lyvispah, Ozobax (generic drugs available since 1988-07-21, discontinued: Kemstro)
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 |
|---|---|---|---|---|
| LIORESAL | Amneal Pharmaceuticals | N-020075 RX | 1992-06-17 | 3 products, RLD, RS |
| LYVISPAH | Amneal Pharmaceuticals | N-215422 RX | 2021-11-22 | 3 products, RLD, RS |
| FLEQSUVY | Azurity | N-215602 RX | 2022-02-04 | 1 products, RLD, RS |
| OZOBAX | Metacel Pharmaceuticals | N-208193 RX | 2019-09-18 | 1 products, RLD, RS |
| GABLOFEN | Piramal Critical Care | N-022462 RX | 2010-11-19 | 4 products, RLD, RS |
Show 2 discontinued
Indications
FDA
EMA
Indication | Ontology | MeSH | ICD-10 |
|---|---|---|---|
| cerebral palsy | — | D002547 | G80 |
| hiccup | — | D006606 | R06.6 |
| huntington disease | Orphanet_399 | D006816 | G10 |
| intractable pain | — | D010148 | — |
| multiple sclerosis | EFO_0003885 | D009103 | G35 |
| muscle spasticity | HP_0001257 | D009128 | — |
| neurogenic urinary bladder | HP_0000011 | D001750 | N31 |
| spinal cord injuries | EFO_1001919 | D013119 | — |
| spinal cord ischemia | EFO_1001426 | D020760 | — |
| spinal cord neoplasms | EFO_0003828 | D013120 | C72.0 |
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Agency Specific
FDA
EMA
No data
Clinical
Clinical Trials
141 clinical trials
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Indications Phases 4
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Crohn disease | D003424 | EFO_0000384 | K50 | — | 2 | 10 | 7 | 10 | 29 |
| Lupus nephritis | D008181 | EFO_0005761 | — | 3 | 6 | 1 | 2 | 12 | |
| Ulcerative colitis | D003093 | EFO_0000729 | K51 | — | — | 3 | 3 | 3 | 9 |
| Systemic lupus erythematosus | D008180 | EFO_0002690 | M32 | — | 2 | 4 | 1 | — | 7 |
| Granulomatosis with polyangiitis | D014890 | EFO_0005297 | M31.3 | — | 2 | 5 | 1 | — | 7 |
| Microscopic polyangiitis | D055953 | EFO_1000784 | M31.7 | — | 2 | 4 | 2 | — | 7 |
| Inflammatory bowel diseases | D015212 | EFO_0003767 | 1 | — | — | 1 | 4 | 6 | |
| Vasculitis | D014657 | EFO_0006803 | M31 | — | 2 | 3 | 2 | — | 6 |
| Kidney transplantation | D016030 | 1 | — | 1 | 3 | — | 5 | ||
| Autoimmune hepatitis | D019693 | K75.4 | — | 1 | — | 3 | — | 4 |
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Indications Phases 3
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Anti-neutrophil cytoplasmic antibody-associated vasculitis | D056648 | I77.82 | — | — | 3 | — | 1 | 4 | |
| Neuromyelitis optica | D009471 | EFO_0004256 | G36.0 | — | 2 | 3 | — | — | 3 |
| Chronic kidney failure | D007676 | EFO_0003884 | N18.6 | 1 | — | 1 | — | 1 | 3 |
| Eosinophilic granuloma | D004803 | C96.6 | — | — | 2 | — | — | 2 | |
| Interstitial lung diseases | D017563 | EFO_0004244 | J84.89 | — | 1 | 1 | — | — | 2 |
| Lung diseases | D008171 | EFO_0003818 | J98.4 | — | 1 | 1 | — | — | 2 |
| Thrombocytopenia | D013921 | HP_0001873 | D69.6 | — | — | 1 | — | — | 1 |
| Eczema | D004485 | HP_0000964 | L30.9 | — | — | 1 | — | — | 1 |
| Systemic vasculitis | D056647 | — | — | 1 | — | — | 1 | ||
| Chronic renal insufficiency | D051436 | N18 | — | — | 1 | — | — | 1 |
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Indications Phases 2
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Pemphigus | D010392 | EFO_1000749 | L10 | — | 2 | — | — | — | 2 |
| Chronic urticaria | D000080223 | L50.8 | 1 | 1 | — | — | — | 1 | |
| Iga vasculitis | D011695 | EFO_1000965 | D69.0 | — | 1 | — | — | — | 1 |
| Sickle cell anemia | D000755 | EFO_0000697 | D57 | — | 1 | — | — | — | 1 |
| Bullous pemphigoid | D010391 | EFO_0007187 | L12 | — | 1 | — | — | — | 1 |
| Mucopolysaccharidosis i | D008059 | E76.0 | 1 | 1 | — | — | — | 1 | |
| Gout | D006073 | EFO_0004274 | M10 | — | 1 | — | — | — | 1 |
| Idiopathic pulmonary fibrosis | D054990 | J84.112 | — | 1 | — | — | — | 1 | |
| Fertilization in vitro | D005307 | — | 1 | — | — | — | 1 | ||
| Intracytoplasmic sperm injections | D020554 | — | 1 | — | — | — | 1 |
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Indications Phases 1
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Therapeutic equivalency | D013810 | 1 | — | — | — | — | 1 |
Indications Without Phase
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Liver diseases | D008107 | EFO_0001421 | K70-K77 | — | — | — | — | 2 | 2 |
| Nephritis | D009393 | N05 | — | — | — | — | 1 | 1 | |
| Hemophilia a | D006467 | EFO_0007267 | D66 | — | — | — | — | 1 | 1 |
| Autoimmune diseases | D001327 | EFO_0000540 | M30-M36 | — | — | — | — | 1 | 1 |
| Nervous system diseases | D009422 | G00-G99 | — | — | — | — | 1 | 1 | |
| Genetic polymorphism | D011110 | — | — | — | — | 1 | 1 |
Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
| Drug common name | BACLOFEN |
| INN | baclofen |
| 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) | |
| Structure (InChI/SMILES or Protein Sequence) | NCC(CC(=O)O)c1ccc(Cl)cc1 |
Identifiers
| PDB | — |
| CAS-ID | 1134-47-0 |
| RxCUI | — |
| ChEMBL ID | CHEMBL701 |
| ChEBI ID | 2972 |
| PubChem CID | 2284 |
| DrugBank | DB00181 |
| UNII ID | H789N3FKE8 (ChemIDplus, GSRS) |
Target
Agency Approved
No data
Alternate
GABBR1
GABBR1
Organism
Homo sapiens
Gene name
GABBR1
Gene synonyms
GPRC3A
NCBI Gene ID
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
Mouse ortholog
Gabbr1 (54393)
gamma-aminobutyric acid type B receptor subunit 1 (Q9WV18)
Variants
Clinical Variant
No data
Financial
No data
Trends
PubMed Central
Top Terms for Disease or Syndrome:
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Safety
Black-box Warning
Black-box warning for: Gablofen, Lioresal (baclofen)
Adverse Events
Top Adverse Reactions
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26,578 adverse events reported
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