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
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 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 |
Show 3 discontinued
Labels
FDA
EMA
Brand Name | Status | Last Update |
|---|---|---|
| baclofen | ANDA | 2024-02-08 |
| baclofen (intrathecal) | ANDA | 2023-11-08 |
| fleqsuvy | New Drug Application | 2023-02-27 |
| gablofen | New Drug Application | 2022-12-24 |
| kemstro | 2006-01-04 | |
| lioresal | New Drug Application | 2016-10-07 |
| lioresal (baclofen) | New Drug Application | 2022-12-14 |
| lyvispah | New Drug Application | 2023-04-20 |
| ozobax | New Drug Application | 2023-10-17 |
Indications
FDA
EMA
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Agency Specific
FDA
EMA
No data
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
140 clinical trials
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Indications Phases 4
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Alcoholism | D000437 | EFO_0003829 | F10.1 | 2 | 8 | 6 | 4 | 3 | 20 |
| Cerebral palsy | D002547 | — | G80 | 1 | 2 | 1 | 3 | 4 | 10 |
| Gastroesophageal reflux | D005764 | EFO_0003948 | K21 | 1 | 3 | 1 | 1 | 3 | 9 |
| Muscle spasticity | D009128 | HP_0001257 | — | — | 2 | 1 | 2 | 1 | 6 |
| Pain | D010146 | EFO_0003843 | R52 | — | — | 2 | 2 | — | 4 |
| Alcohol withdrawal delirium | D000430 | EFO_1000800 | — | — | 1 | — | 1 | 2 | 4 |
| Stroke | D020521 | EFO_0000712 | I63.9 | — | — | — | 1 | 1 | 2 |
| Hemiplegia | D006429 | HP_0011099 | G81.0 | — | — | — | 1 | — | 1 |
| Overactive urinary bladder | D053201 | EFO_1000781 | N32.81 | — | — | — | 1 | — | 1 |
| Lower urinary tract symptoms | D059411 | EFO_0008008 | — | — | — | — | 1 | — | 1 |
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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 | 5 | — | 3 | 9 |
| Fragile x syndrome | D005600 | — | Q99.2 | 1 | 2 | 1 | — | — | 4 |
| Charcot-marie-tooth disease | D002607 | EFO_0004148 | G60.0 | — | — | 2 | — | — | 2 |
| Analgesia | D000698 | — | — | — | 1 | 1 | — | — | 1 |
| Acute pain | D059787 | — | R52 | — | 1 | 1 | — | — | 1 |
| Knee osteoarthritis | D020370 | EFO_0004616 | M17 | — | 1 | 1 | — | — | 1 |
| Female genital diseases | D005831 | EFO_0009549 | N85 | — | 1 | 1 | — | — | 1 |
| Leukemia | D007938 | — | C95 | — | — | 1 | — | — | 1 |
| Myelodysplastic syndromes | D009190 | — | D46 | — | — | 1 | — | — | 1 |
| Neoplasms | D009369 | — | C80 | — | — | 1 | — | — | 1 |
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Indications Phases 2
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Spinal cord injuries | D013119 | EFO_1001919 | — | 1 | 1 | — | — | 3 | 5 |
| Autism spectrum disorder | D000067877 | HP_0000729 | F84.0 | — | 3 | — | — | 2 | 5 |
| Cocaine-related disorders | D019970 | — | F14 | — | 4 | — | — | — | 4 |
| Liver cirrhosis | D008103 | EFO_0001422 | K74.0 | — | 1 | — | — | 3 | 4 |
| Tobacco use disorder | D014029 | — | F17 | — | 3 | — | — | — | 3 |
| Traumatic brain injuries | D000070642 | — | S06 | — | 1 | — | — | 2 | 3 |
| Alcohol drinking | D000428 | EFO_0004329 | — | — | 1 | — | — | 1 | 2 |
| Alzheimer disease | D000544 | EFO_0000249 | F03 | — | 2 | — | — | — | 2 |
| Muscle cramp | D009120 | HP_0003394 | — | — | 1 | — | — | 1 | 2 |
| Marijuana abuse | D002189 | EFO_0007191 | F12 | — | 2 | — | — | — | 2 |
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Indications Phases 1
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Healthy volunteers/patients | — | — | — | 5 | — | — | — | 1 | 6 |
| Osteoarthritis | D010003 | EFO_0002506 | M15-M19 | 1 | — | — | — | — | 1 |
| Substance-related disorders | D019966 | EFO_0003890 | F13 | 1 | — | — | — | — | 1 |
| Neonatal abstinence syndrome | D009357 | EFO_0005799 | P96.1 | 1 | — | — | — | — | 1 |
| Autistic disorder | D001321 | HP_0000717 | F84.0 | 1 | — | — | — | — | 1 |
| Cheyne-stokes respiration | D002639 | — | R06.3 | 1 | — | — | — | — | 1 |
| Ataxia telangiectasia | D001260 | Orphanet_100 | G11.3 | 1 | — | — | — | — | 1 |
| Pharmacokinetics | D010599 | — | — | 1 | — | — | — | — | 1 |
Indications Without Phase
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Migraine disorders | D008881 | EFO_0003821 | G43 | — | — | — | — | 1 | 1 |
| Headache | D006261 | HP_0002315 | R51 | — | — | — | — | 1 | 1 |
| Arthritis | D001168 | HP_0001369 | M05-M14 | — | — | — | — | 1 | 1 |
| Tendinopathy | D052256 | EFO_1001434 | M77.9 | — | — | — | — | 1 | 1 |
| Synovitis | D013585 | EFO_0008997 | M67.5 | — | — | — | — | 1 | 1 |
| Spasm | D013035 | — | M62.83 | — | — | — | — | 1 | 1 |
| Radiculopathy | D011843 | — | M54.1 | — | — | — | — | 1 | 1 |
| Gout | D006073 | EFO_0004274 | M10 | — | — | — | — | 1 | 1 |
| Feeding and eating disorders | D001068 | — | F50 | — | — | — | — | 1 | 1 |
| Bulimia nervosa | D052018 | EFO_0005204 | F50.2 | — | — | — | — | 1 | 1 |
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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
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
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Financial
Revenue by drug
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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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Trends
PubMed Central
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Additional graphs summarizing 14,423 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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34,944 adverse events reported
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