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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59 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 |
|---|---|---|---|---|---|---|---|---|---|
| Myofascial pain syndromes | D009209 | EFO_1001054 | — | — | 1 | 8 | — | — | 8 |
| Fibromyalgia | D005356 | EFO_0005687 | M79.1 | — | 1 | 8 | — | — | 8 |
| Post-traumatic stress disorders | D013313 | EFO_0001358 | F43.1 | — | 4 | 4 | — | — | 8 |
| Muscular diseases | D009135 | EFO_0002970 | G72.9 | — | — | 2 | — | — | 2 |
| Nervous system diseases | D009422 | — | G00-G99 | — | — | 2 | — | — | 2 |
| Rheumatic diseases | D012216 | — | M79.0 | — | — | 2 | — | — | 2 |
| Musculoskeletal diseases | D009140 | — | — | — | — | 2 | — | — | 2 |
| Neuromuscular diseases | D009468 | EFO_1001902 | G70.9 | — | — | 2 | — | — | 2 |
| Collagen diseases | D003095 | — | — | — | — | 2 | — | — | 2 |
Indications Phases 2
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Disease | D004194 | EFO_0000408 | R69 | — | 2 | — | — | — | 2 |
| Covid-19 | D000086382 | — | U07.1 | — | 1 | — | — | — | 1 |
| Infections | D007239 | EFO_0000544 | — | — | 1 | — | — | — | 1 |
| Communicable diseases | D003141 | — | — | — | 1 | — | — | — | 1 |
| Post-acute covid-19 syndrome | D000094024 | — | — | — | 1 | — | — | — | 1 |
| Stress fractures | D015775 | — | M84.3 | — | 1 | — | — | — | 1 |
| Traumatic stress disorders acute | D040701 | EFO_0005223 | F43.0 | — | 1 | — | — | — | 1 |
Indications Phases 1
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Healthy volunteers/patients | — | — | — | 3 | — | — | — | — | 3 |
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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Cyclobenzaprine
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Black-box Warning
Black-box warning for: Lisinopril
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12,917 adverse events reported
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