Cyclobenzaprine
Amrix, Cyclobenzaprine (cyclobenzaprine) is a small molecule pharmaceutical. Cyclobenzaprine was first approved as Flexeril on 1982-01-01. It is used to treat muscle cramp, muscle rigidity, muscle spasticity, myositis, and pain amongst others in the USA.
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Commercial
Trade Name
FDA
EMA
Amrix, Cyclobenzaprine, Tonmya (discontinued: Cyclobenzaprine, Flexeril)
Drug Products
FDA
EMA
New Drug Application (NDA)
New Drug Application (NDA)
Abbreviated New Drug Application (ANDA)
Abbreviated New Drug Application (ANDA)
Cyclobenzaprine hydrochloride
Tradename | Company | Number | Date | Products |
|---|---|---|---|---|
| AMRIX | Teva | N-021777 RX | 2007-02-01 | 2 products, RLD, RS |
| TONMYA | Tonix Pharmaceuticals | N-219428 RX | 2025-08-15 | 1 products, RLD, RS |
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Labels
FDA
EMA
Brand Name | Status | Last Update |
|---|---|---|
| amrix | New Drug Application | 2024-04-30 |
| cyclo/gaba 10/300 pack | ANDA | 2016-06-22 |
| cyclo/mag | unapproved drug other | 2010-03-05 |
| cyclo/mag 10mg/200mg | unapproved drug other | 2010-02-17 |
| cyclobenzaprine | ANDA | 2024-08-06 |
| cyclobenzaprine cyclobenzaprine hydrochloride | ANDA | 2023-04-17 |
| cyclobenzaprine hci | ANDA | 2019-04-02 |
| cyclobenzaprine hci cyclobenzaprine hcl | ANDA | 2023-06-06 |
| cyclobenzaprine hci cyclobenzaprine hcl cyclobenzprine hcl | ANDA | 2019-04-04 |
| cyclobenzaprine hcl | ANDA | 2025-07-21 |
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Indications
FDA
EMA
Indication | Ontology | MeSH | ICD-10 |
|---|---|---|---|
| myositis | EFO_0000783 | D009220 | G72.49 |
| pain | EFO_0003843 | D010146 | R52 |
| muscle spasticity | — | D009128 | — |
| muscle cramp | — | D009120 | — |
| spasm | — | D013035 | M62.83 |
| tetanus | EFO_0005593 | D013742 | A35 |
| muscle rigidity | — | D009127 | — |
Agency Specific
FDA
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Clinical
Clinical Trials
59 clinical trials
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Indications Phases 4
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Indications Phases 3
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Indications Phases 2
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Indications Phases 1
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Depression | D003863 | — | F33.9 | 1 | — | — | — | — | 1 |
Indications Without Phase
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Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
| Drug common name | Cyclobenzaprine |
| INN | cyclobenzaprine |
| Description | Cyclobenzaprine is 5-Methylidene-5H-dibenzo[a,d]cycloheptene in which one of the hydrogens of the methylidene group is substituted by a 2-(dimethylamino)ethyl group. A centrally acting skeletal muscle relaxant, it is used as its hydrochloride salt in the symptomatic treatment of painful muscle spasm. It has a role as a muscle relaxant, a tranquilizing drug and an antidepressant. It derives from a hydride of a dibenzo[a,d][7]annulene. |
| Classification | Small molecule |
| Drug class | — |
| Image (chem structure or protein) |  |
| Structure (InChI/SMILES or Protein Sequence) | CN(C)CCC=C1c2ccccc2C=Cc2ccccc21 |
Identifiers
| PDB | — |
| CAS-ID | 303-53-7 |
| RxCUI | — |
| ChEMBL ID | CHEMBL669 |
| ChEBI ID | 3996 |
| PubChem CID | 2895 |
| DrugBank | DB00924 |
| UNII ID | 69O5WQQ5TI (ChemIDplus, GSRS) |
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Amrix – Cephalon
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Estimated US medical usage
Cyclobenzaprine
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Trends
PubMed Central
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Additional graphs summarizing 1,988 documents
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Safety
Black-box Warning
Black-box warning for: Lisinopril
Adverse Events
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12,917 adverse events reported
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