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 |
Show 1 discontinued
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 |
Show 14 more
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
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Clinical
Clinical Trials
59 clinical trials
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Indications Phases 4
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Myofascial pain syndromes | D009209 | EFO_1001054 | — | — | 1 | 8 | 2 | 2 | 12 |
| Fibromyalgia | D005356 | EFO_0005687 | M79.1 | — | 1 | 8 | 1 | 2 | 11 |
| Low back pain | D017116 | — | M54.5 | — | — | 3 | 2 | 2 | 7 |
| Pain | D010146 | EFO_0003843 | R52 | — | 1 | 1 | 2 | 1 | 5 |
| Spasm | D013035 | — | M62.83 | — | — | 2 | 1 | 1 | 4 |
| Back pain | D001416 | — | M54 | — | — | 1 | 1 | 1 | 3 |
| Postoperative pain | D010149 | — | G89.18 | — | — | — | 2 | 1 | 3 |
| Muscle cramp | D009120 | — | — | — | — | 1 | 1 | — | 2 |
| Emergencies | D004630 | — | — | — | — | — | 1 | — | 1 |
| Morbid obesity | D009767 | EFO_0001074 | — | — | — | — | 1 | — | 1 |
Show 7 more
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 | — | 4 | 4 | — | — | 8 |
| Migraine disorders | D008881 | EFO_0003821 | G43 | — | — | 1 | — | 1 | 2 |
| Musculoskeletal pain | D059352 | — | — | — | — | 2 | — | — | 2 |
| 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 |
| Acute pain | D059787 | — | R52 | — | — | 1 | — | — | 1 |
Show 3 more
Indications Phases 2
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Disease | D004194 | EFO_0000408 | R69 | — | 2 | — | — | 1 | 3 |
| Sprains and strains | D013180 | — | — | — | 1 | — | — | — | 1 |
| Sleep initiation and maintenance disorders | D007319 | — | F51.01 | — | 1 | — | — | — | 1 |
| Dyssomnias | D020920 | — | — | — | 1 | — | — | — | 1 |
| Parasomnias | D020447 | — | G47.5 | — | 1 | — | — | — | 1 |
| 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 |
Show 1 more
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 |
| Sleepiness | D000077260 | — | R40.0 | 1 | — | — | — | — | 1 |
| Driving under the influence | D000066448 | — | — | 1 | — | — | — | — | 1 |
Indications Without Phase
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Headache | D006261 | — | R51 | — | — | — | — | 1 | 1 |
| Arthritis | D001168 | EFO_0005856 | 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 |
| Tailor's bunion | D050489 | — | M21.62 | — | — | — | — | 1 | 1 |
Show 6 more
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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Safety
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12,917 adverse events reported
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