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
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Amrix (generic drugs available since 1989-05-03, discontinued: Flexeril)
Labels
FDA
EMA
Brand Name | Status | Last Update |
|---|---|---|
| amrix | New Drug Application | 2021-08-03 |
| 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 | 2022-04-01 |
| 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 | NDA authorized generic | 2023-03-31 |
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Agency Specific
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Clinical
Clinical Trials
57 clinical trials
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Indications Phases 4
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Fibromyalgia | D005356 | EFO_0005687 | M79.1 | — | 1 | 8 | 1 | 1 | 10 |
| Low back pain | D017116 | HP_0003419 | M54.5 | — | — | 2 | 2 | 2 | 6 |
| Pain | D010146 | EFO_0003843 | R52 | — | 1 | 1 | 2 | 1 | 5 |
| Myofascial pain syndromes | D009209 | EFO_1001054 | — | — | — | 2 | 1 | 1 | 4 |
| Spasm | D013035 | — | M62.83 | — | — | 1 | 1 | 1 | 3 |
| Postoperative pain | D010149 | — | G89.18 | — | — | — | 2 | 1 | 3 |
| Morbid obesity | D009767 | EFO_0001074 | — | — | — | — | 1 | — | 1 |
| Fatigue | D005221 | HP_0012378 | R53.83 | — | — | — | 1 | — | 1 |
| Sleep | D012890 | GO_0030431 | — | — | — | — | 1 | — | 1 |
| Spinal diseases | D013122 | — | M45-M49 | — | — | — | 1 | — | 1 |
Indications Phases 3
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Post-traumatic stress disorders | D013313 | EFO_0001358 | F43.1 | — | 3 | 4 | — | — | 7 |
| Musculoskeletal pain | D059352 | — | — | — | — | 2 | — | — | 2 |
| Muscular diseases | D009135 | HP_0003198 | 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 |
| Acute pain | D059787 | — | R52 | — | — | 1 | — | — | 1 |
| Neck pain | D019547 | HP_0030833 | M54.2 | — | — | 1 | — | — | 1 |
| Back pain | D001416 | HP_0003418 | M54 | — | — | 1 | — | — | 1 |
Show 1 more
Indications Phases 2
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Sleep initiation and maintenance disorders | D007319 | — | F51.01 | — | 1 | — | — | — | 1 |
| Covid-19 | D000086382 | — | U07.1 | — | 1 | — | — | — | 1 |
| Post-acute covid-19 syndrome | D000094024 | — | — | — | 1 | — | — | — | 1 |
Indications Phases 1
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Healthy volunteers/patients | — | — | — | 4 | — | — | — | 1 | 5 |
| Depression | D003863 | — | F33.9 | 1 | — | — | — | 1 | 2 |
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 |
| Radiculopathy | D011843 | — | M54.1 | — | — | — | — | 1 | 1 |
| Gout | D006073 | EFO_0004274 | M10 | — | — | — | — | 1 | 1 |
| Ankle fractures | D064386 | — | S82.5 | — | — | — | — | 1 | 1 |
| Bunion | D000071378 | — | M21.61 | — | — | — | — | 1 | 1 |
| Hammer toe syndrome | D037801 | EFO_1001336 | M21.53 | — | — | — | — | 1 | 1 |
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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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Safety
Black-box Warning
Black-box warning for: Lisinopril
Adverse Events
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9,356 adverse events reported
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