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Drug ReportsCyclobenzaprine
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
Therapeutic Areas
Therapeutic Area
MeSH
infectionsD007239
musculoskeletal diseasesD009140
nervous system diseasesD009422
signs and symptoms pathological conditionsD013568
psychological phenomenaD011579
musculoskeletal and neural physiological phenomenaD055687
Trade Name
FDA
EMA
Amrix, Cyclobenzaprine (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
AMRIXTevaN-021777 RX2007-02-01
2 products, RLD, RS
Show 1 discontinued
Labels
FDA
EMA
Brand Name
Status
Last Update
amrixNew Drug Application2024-04-30
cyclo/gaba 10/300 packANDA2016-06-22
cyclo/magunapproved drug other2010-03-05
cyclo/mag 10mg/200mgunapproved drug other2010-02-17
cyclobenzaprineANDA2024-09-20
cyclobenzaprine cyclobenzaprine hydrochlorideANDA2023-04-17
cyclobenzaprine hciANDA2019-04-02
cyclobenzaprine hci cyclobenzaprine hclANDA2023-06-06
cyclobenzaprine hci cyclobenzaprine hcl cyclobenzprine hclANDA2019-04-04
cyclobenzaprine hclNDA authorized generic2023-03-31
Show 13 more
Agency Specific
FDA
EMA
No data
Patent Expiration
No data
ATC Codes
M: Musculo-skeletal system drugs
— M03: Muscle relaxants
— M03B: Muscle relaxants, centrally acting agents
— M03BX: Other centrally acting agents in atc
— M03BX08: Cyclobenzaprine
HCPCS
No data
Clinical
Clinical Trials
58 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 syndromesD009209EFO_1001054——182212
FibromyalgiaD005356EFO_0005687M79.1—182212
Low back painD017116HP_0003419M54.5——3227
PainD010146EFO_0003843R52—11215
Back painD001416HP_0003418M54——1214
SpasmD013035—M62.83——2114
Postoperative painD010149—G89.18———213
Muscle crampD009120HP_0003394———11—2
SyndromeD013577—————1—1
Somatoform disordersD013001—F45———1—1
Show 9 more
Indications Phases 3
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Post-traumatic stress disordersD013313EFO_0001358F43.1—44——8
Migraine disordersD008881EFO_0003821G43——1—12
Musculoskeletal painD059352————2——2
Muscular diseasesD009135HP_0003198G72.9——2——2
Nervous system diseasesD009422—G00-G99——2——2
Rheumatic diseasesD012216—M79.0——2——2
Musculoskeletal diseasesD009140————2——2
Neuromuscular diseasesD009468EFO_1001902G70.9——2——2
Collagen diseasesD003095————2——2
Acute painD059787—R52——1——1
Show 3 more
Indications Phases 2
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
DiseaseD004194EFO_0000408R69—2——13
Sprains and strainsD013180———1———1
Sleep initiation and maintenance disordersD007319—F51.01—1———1
DyssomniasD020920———1———1
ParasomniasD020447—G47.5—1———1
Covid-19D000086382———1———1
InfectionsD007239EFO_0000544——1———1
Communicable diseasesD003141———1———1
Post-acute covid-19 syndromeD000094024———1———1
Stress fracturesD015775—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———15
DepressionD003863—F33.91———12
SleepinessD000077260—R40.01————1
Driving under the influenceD000066448——1————1
Indications Without Phase
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
HeadacheD006261HP_0002315R51————11
ArthritisD001168HP_0001369M05-M14————11
TendinopathyD052256EFO_1001434M77.9————11
SynovitisD013585EFO_0008997M67.5————11
RadiculopathyD011843—M54.1————11
GoutD006073EFO_0004274M10————11
Ankle fracturesD064386—S82.5————11
BunionD000071378—M21.61————11
Hammer toe syndromeD037801EFO_1001336M21.53————11
Tailor's bunionD050489—M21.62————11
Show 5 more
Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
Drug common nameCyclobenzaprine
INNcyclobenzaprine
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)Loading
Structure (InChI/SMILES or Protein Sequence)
CN(C)CCC=C1c2ccccc2C=Cc2ccccc21
Identifiers
PDB—
CAS-ID303-53-7
RxCUI—
ChEMBL IDCHEMBL669
ChEBI ID3996
PubChem CID2895
DrugBankDB00924
UNII ID69O5WQQ5TI (ChemIDplus, GSRS)
Target
No data
Variants
No data
Financial
Revenue by drug
$
€
£
â‚£
Amrix – Cephalon
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Estimated US medical usage
Cyclobenzaprine
Total medical expenditures per year (USD, in millions)
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Number of persons purchased
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Number of purchases
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Refill frequency
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Price per prescription (USD)
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Trends
PubMed Central
Top Terms for Disease or Syndrome:
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Additional graphs summarizing 1,773 documents
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Safety
Black-box Warning
Black-box warning for: Lisinopril
Adverse Events
Top Adverse Reactions
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11,483 adverse events reported
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