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
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Trade Name
FDA
EMA
Baclofen, Fleqsuvy, Gablofen, Lioresal, Lyvispah, Ozobax (discontinued: Baclofen, Kemstro, Lioresal, 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 |
|---|---|---|---|---|
| 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 DS | Metacel Pharmaceuticals | N-208193 RX | 2023-10-12 | 1 products, RLD, RS |
| GABLOFEN | Piramal Critical Care | N-022462 RX | 2010-11-19 | 4 products, RLD, RS |
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Labels
FDA
EMA
Brand Name | Status | Last Update |
|---|---|---|
| baclofen | ANDA | 2025-02-06 |
| baclofen (intrathecal) | ANDA | 2023-11-08 |
| baclofen baclofen | ANDA | 2025-02-05 |
| fleqsuvy | New Drug Application | 2024-05-16 |
| gablofen | New Drug Application | 2024-12-04 |
| kemstro | 2006-01-04 | |
| lioresal | New Drug Application | 2016-10-07 |
| lioresal (baclofen) | New Drug Application | 2022-12-14 |
| lyvispah | New Drug Application | 2023-04-23 |
| ozobax | New Drug Application | 2023-10-17 |
Indications
FDA
EMA
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Agency Specific
FDA
EMA
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Patent Expiration
Patent | Expires | Flag | FDA Information |
|---|---|---|---|
| Baclofen, Lyvispah, Amneal | |||
| 11491125 | 2041-09-29 | DP | U-3488, U-3489 |
| 11850225 | 2041-09-29 | DP | U-3488, U-3489 |
| 10792262 | 2039-07-29 | DP | U-3263 |
| 11654124 | 2039-07-29 | DP | |
| Baclofen, Ozobax, Metacel Pharms Llc | |||
| 10610502 | 2039-08-30 | U-2779 | |
| Baclofen, Fleqsuvy, Azurity | |||
| 11324696 | 2037-09-29 | DP | |
| 11446246 | 2037-09-08 | U-3433 | |
Clinical
Clinical Trials
144 clinical trials
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Indications Phases 4
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Indications Phases 3
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Multiple sclerosis | D009103 | EFO_0003885 | G35 | — | — | 1 | — | — | 1 |
| Sclerosis | D012598 | — | — | — | — | 1 | — | — | 1 |
Indications Phases 2
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Indications Phases 1
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Indications Without Phase
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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
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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
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Financial
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Estimated US medical usage
Baclofen
Total medical expenditures per year (USD, in millions)
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Trends
PubMed Central
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Additional graphs summarizing 15,523 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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40,468 adverse events reported
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