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Cyclobenzaprine Hydrochloride

FDA-approved product (tablet, oral), marketed as Amrix, Cyclobenzaprine Hydrochloride, Flexeril and 1 more.

Registered studies
50+
Lab records
0
Pathogens at ≥40%
1 of 4

Chemical structure

Chemical structure of Cyclobenzaprine Hydrochloride
A drawing shows what the molecule is, not what it does.

Existing / approved use

Documented · FDA, WHO, ChEMBL

Approved for

  • Cerebral palsy
  • Muscle spasm
  • Myalgia
  • Spasticity
  • Spinal cord disease

Indications ChEMBL records as approved, from FDA and DailyMed labels. Label ↗

WHO therapeutic group
Other centrally acting agents
Anti-infective classification
Not classified as an anti-infective.

Repurposing investigation

This medicine is being investigated here for AI-predicted antimicrobial activity against M. tuberculosis. It was surfaced computationally for further investigation; it is not an established treatment for this infection.

AI-predicted activity

AI prediction · nothing measured
  • MRSA11.0% AI-predicted activityBelow the ≥40% mark this site uses to surface candidates.
  • E. coli18.6% AI-predicted activityBelow the ≥40% mark this site uses to surface candidates.
  • K. pneumoniae11.6% AI-predicted activityBelow the ≥40% mark this site uses to surface candidates.
  • M. tuberculosis54.8% AI-predicted activityAt or above the ≥40% mark this site uses to surface candidates.

A model’s estimate of laboratory activity against each pathogen species. It is not clinical effectiveness.

Evidence

Clinical and experimental

Documented evidence

Clinical

50+registered studies name this medicine, for any condition. The registry search keeps the first 50, so there may be more. See them below.

Experimental

No evidence found

No laboratory measurement against the four pathogens in the ChEMBL records loaded here.

Docking

Computational · nothing measured

Dihydrofolate reductase ↗ (E. coli)

-8.5 kcal/mol

0better fit →-12

KPC-2 carbapenemase ↗ (K. pneumoniae)

-6.6 kcal/mol

0better fit →-12

Enoyl-ACP reductase (InhA) ↗ (M. tuberculosis)

-6.6 kcal/mol

0better fit →-12

Dihydrofolate reductase ↗ (MRSA)

-7.7 kcal/mol

0better fit →-12

AutoDock Vina, one experimentally solved protein per pathogen. This project’s screening target is -7.0 kcal/mol, its own mark rather than a universal cutoff. A docking score is a structural hypothesis, not proof of binding, and requires experimental validation.

Other medicines to investigate

AI prediction · nothing measured

Other repurposing candidates: approved medicines besides Cyclobenzaprine Hydrochloride with AI-predicted activity ≥40% against the chosen pathogen, leaving out existing antimicrobials. They are computational candidates for further investigation, not alternatives and not recommendations.

Sorted by AI-predicted activity, high to low. The order is not a ranking of which medicine is better.

Registered studies

A registration describes a study; it does not establish a positive result.

  • Dose-Proportionality and Food Effect Study of TNX-102 SL

    NCT04164719 · start 2019-10-14

    Registered record
    Registry ID
    NCT04164719
    Conditions
    Healthy Subjects
    Interventions
    TNX-102 SL
    Study type
    INTERVENTIONAL
    Phase
    Phase 1
    Registry status
    Completed
    Start
    2019-10-14
    Completion
    2019-12-24
    Enrolment
    16

    As stored from ClinicalTrials.gov. Registration describes a study; it does not mean the study worked.

    ConditionHealthy Subjects
    InterventionTNX-102 SL
    PhasePhase 1
    Registry statusCompleted
  • A Phase 3 Study to Evaluate the Efficacy and Safety of TNX-102 SL in Participants With PTSD

    NCT03841773 · start 2019-03-07

    Registered record
    Registry ID
    NCT03841773
    Conditions
    PTSD
    Interventions
    TNX-102 SL; Placebo SL Tablets
    Study type
    INTERVENTIONAL
    Phase
    Phase 3
    Registry status
    Terminated
    Start
    2019-03-07
    Completion
    2020-04-24
    Enrolment
    192

    As stored from ClinicalTrials.gov. Registration describes a study; it does not mean the study worked.

    ConditionPTSD
    InterventionTNX-102 SL; Placebo SL Tablets
    PhasePhase 3
    Registry statusTerminated
  • Pharmacokinetics and Safety of Commonly Used Drugs in Lactating Women and Breastfed Infants

    NCT03511118 · start 2018-10-04

    Registered record
    Registry ID
    NCT03511118
    Conditions
    Lactating Women on Select DOI; Breastfed Infants of Mothers on Select DOI
    Interventions
    Tranexamic acid (TXA); labetalol; metformin; nifedipine; clindamycin; oxycodone; azithromycin; escitalopram; sertraline; ondansetron; Ciprofloxacin; Doxycycline; Levofloxacin; Methylphenidate; Sumatriptan; Citalopram; Cyclobenzaprine; Furosemide; Gabapentin; Hydrochlorothiazide; Hydroxyurea; Rosuvastatin; Topiramate; Trazodone; Valganciclovir; Venlafaxine; Verapamil; Remdesivir; Anakinra; Tocilizumab; Fluvoxamine; Amoxicillin; Bupropion; Duloxetine; Hydrocodone; Levetiracetam; Paroxetine; Buprenorphine
    Study type
    OBSERVATIONAL
    Phase
    Not recorded
    Registry status
    Recruiting
    Start
    2018-10-04
    Completion
    2028-07-31
    Enrolment
    1,600

    As stored from ClinicalTrials.gov. Registration describes a study; it does not mean the study worked.

    ConditionLactating Women on Select DOI; Breastfed Infants of Mothers on Select DOI
    InterventionTranexamic acid (TXA); labetalol; metformin; nifedipine +34 more
    PhaseNot recorded
    Registry statusRecruiting
  • Cyclobenzaprine in Muscle Cramps With Liver Cirrhosis

    NCT02642861 · start 2018-10

    Registered record
    Registry ID
    NCT02642861
    Conditions
    Liver Cirrhosis
    Interventions
    Cyclobenzaprine; Calcium Carbonate
    Study type
    INTERVENTIONAL
    Phase
    Phase 3
    Registry status
    Unknown
    Start
    2018-10
    Completion
    2019-12
    Enrolment
    200

    As stored from ClinicalTrials.gov. Registration describes a study; it does not mean the study worked.

    ConditionLiver Cirrhosis
    InterventionCyclobenzaprine; Calcium Carbonate
    PhasePhase 3
    Registry statusUnknown
  • A 40-week Study to Evaluate TNX-102 SL 5.6 mg Taken Daily at Bedtime in Patients With PTSD

    NCT03508700 · start 2018-04-19

    Registered record
    Registry ID
    NCT03508700
    Conditions
    PTSD
    Interventions
    TNX-102 SL 5.6 mg
    Study type
    INTERVENTIONAL
    Phase
    Phase 3
    Registry status
    Completed
    Start
    2018-04-19
    Completion
    2019-09-30
    Enrolment
    93

    As stored from ClinicalTrials.gov. Registration describes a study; it does not mean the study worked.

    ConditionPTSD
    InterventionTNX-102 SL 5.6 mg
    PhasePhase 3
    Registry statusCompleted
  • Efficacy and Safety of the Combination of Ketoprofen and Cyclobenzaprine in Osteomuscular Treatment

    NCT03025113 · start 2018-03-08

    Registered record
    Registry ID
    NCT03025113
    Conditions
    Musculoskeletal Pain
    Interventions
    ketoprofen and cyclobenzaprine association; Cyclobenzaprine
    Study type
    INTERVENTIONAL
    Phase
    Phase 3
    Registry status
    Completed
    Start
    2018-03-08
    Completion
    2020-03-27
    Enrolment
    416

    As stored from ClinicalTrials.gov. Registration describes a study; it does not mean the study worked.

    ConditionMusculoskeletal Pain
    Interventionketoprofen and cyclobenzaprine association; Cyclobenzaprine
    PhasePhase 3
    Registry statusCompleted
  • Steady-State Pharmacokinetic Comparison Study of TNX-102 SL 5.6 mg Versus AMRIX® 30 mg ER Capsules

    NCT03443960 · start 2018-01-29

    Registered record
    Registry ID
    NCT03443960
    Conditions
    Healthy Subjects
    Interventions
    TNX-102 SL 5.6 mg; Amrix 30 mg
    Study type
    INTERVENTIONAL
    Phase
    Phase 1
    Registry status
    Completed
    Start
    2018-01-29
    Completion
    2018-04-09
    Enrolment
    60

    As stored from ClinicalTrials.gov. Registration describes a study; it does not mean the study worked.

    ConditionHealthy Subjects
    InterventionTNX-102 SL 5.6 mg; Amrix 30 mg
    PhasePhase 1
    Registry statusCompleted
  • Efficacy and Safety of the Combination of Ketoprofen and Cyclobenzaprine and Caffeine in Osteomuscular Treatment

    NCT02862977 · start 2017-11-10

    Registered record
    Registry ID
    NCT02862977
    Conditions
    Musculoskeletal Pain
    Interventions
    ketoprofen and cyclobenzaprine association with caffeine; Cyclobenzaprine with caffeine
    Study type
    INTERVENTIONAL
    Phase
    Phase 3
    Registry status
    Completed
    Start
    2017-11-10
    Completion
    2019-12-20
    Enrolment
    414

    As stored from ClinicalTrials.gov. Registration describes a study; it does not mean the study worked.

    ConditionMusculoskeletal Pain
    Interventionketoprofen and cyclobenzaprine association with caffeine; Cyclobenzaprine with caffeine
    PhasePhase 3
    Registry statusCompleted
  • Testing Interventions for Patients With Fibromyalgia and Depression

    NCT03207828 · start 2017-09-09

    Registered record
    Registry ID
    NCT03207828
    Conditions
    Fibromyalgia; Depression
    Interventions
    Behavioral activation; Usual care
    Study type
    INTERVENTIONAL
    Phase
    Not applicable
    Registry status
    Unknown
    Start
    2017-09-09
    Completion
    2019-05-31
    Enrolment
    90

    As stored from ClinicalTrials.gov. Registration describes a study; it does not mean the study worked.

    ConditionFibromyalgia; Depression
    InterventionBehavioral activation; Usual care
    PhaseNot applicable
    Registry statusUnknown
  • Cyclobenzaprine HCl Extended Release 15 mg Versus Placebo in Treatment of Cervical and/or Lower Back Pain Due to Muscle Spasms of Local Origin

    NCT02814565 · start 2016-10-12

    Registered record
    Registry ID
    NCT02814565
    Conditions
    Neck Pain; Back Pain; Spasm
    Interventions
    Cyclobenzaprine HCl; Placebo
    Study type
    INTERVENTIONAL
    Phase
    Phase 3
    Registry status
    Completed
    Start
    2016-10-12
    Completion
    2017-03-14
    Enrolment
    180

    As stored from ClinicalTrials.gov. Registration describes a study; it does not mean the study worked.

    ConditionNeck Pain; Back Pain; Spasm
    InterventionCyclobenzaprine HCl; Placebo
    PhasePhase 3
    Registry statusCompleted
  • Repeat of: A Study to Evaluate Efficacy and Safety of Sublingual TNX-102 SL Tablet Taken at Bedtime in Patients With Fibromyalgia

    NCT02829814 · start 2016-07-22

    Registered record
    Registry ID
    NCT02829814
    Conditions
    Fibromyalgia; Myofascial Pain Syndromes; Muscular Diseases; Nervous System Diseases; Neuromuscular Diseases; Rheumatic Diseases; Musculoskeletal Diseases
    Interventions
    TNX-102 SL Tablet, 2.8 mg; Placebo SL Tablet
    Study type
    INTERVENTIONAL
    Phase
    Phase 3
    Registry status
    Terminated
    Start
    2016-07-22
    Completion
    2016-09-13
    Enrolment
    51

    As stored from ClinicalTrials.gov. Registration describes a study; it does not mean the study worked.

    ConditionFibromyalgia; Myofascial Pain Syndromes; Muscular Diseases; Nervous System Diseases +3 more
    InterventionTNX-102 SL Tablet, 2.8 mg; Placebo SL Tablet
    PhasePhase 3
    Registry statusTerminated
  • Bioequivalence Study of TNX-102 SL 2.8 mg Sublingual Tablets From Two Manufacturers.

    NCT03168022 · start 2015-12-16

    Registered record
    Registry ID
    NCT03168022
    Conditions
    Healthy Adults
    Interventions
    Treatment A; Treatment B
    Study type
    INTERVENTIONAL
    Phase
    Phase 1
    Registry status
    Completed
    Start
    2015-12-16
    Completion
    2016-01-26
    Enrolment
    43

    As stored from ClinicalTrials.gov. Registration describes a study; it does not mean the study worked.

    ConditionHealthy Adults
    InterventionTreatment A; Treatment B
    PhasePhase 1
    Registry statusCompleted
  • Efficacy Study Comparing Compounded Topical Pain Creams vs. Placebo for Treating Pain Symptoms

    NCT02497066 · start 2015-08-05

    Registered record
    Registry ID
    NCT02497066
    Conditions
    Pain
    Interventions
    Neuropathic pain cream; Nociceptive pain cream; Mixed pain cream
    Study type
    INTERVENTIONAL
    Phase
    Phase 3
    Registry status
    Completed
    Start
    2015-08-05
    Completion
    2018-02-28
    Enrolment
    399

    As stored from ClinicalTrials.gov. Registration describes a study; it does not mean the study worked.

    ConditionPain
    InterventionNeuropathic pain cream; Nociceptive pain cream; Mixed pain cream
    PhasePhase 3
    Registry statusCompleted
  • A 3-Month Open-Label Safety and Efficacy Study of TNX-102 SL Tablets in Fibromyalgia Patients

    NCT02589275 · start 2015-08-04

    Registered record
    Registry ID
    NCT02589275
    Conditions
    Primary Fibromyalgia
    Interventions
    TNX-102 SL Tablet 2.8 mg
    Study type
    INTERVENTIONAL
    Phase
    Phase 3
    Registry status
    Completed
    Start
    2015-08-04
    Completion
    2016-09-28
    Enrolment
    375

    As stored from ClinicalTrials.gov. Registration describes a study; it does not mean the study worked.

    ConditionPrimary Fibromyalgia
    InterventionTNX-102 SL Tablet 2.8 mg
    PhasePhase 3
    Registry statusCompleted
  • Prospective Analgesic Compound Efficacy (PACE) Study

    NCT02403687 · start 2015-06

    Registered record
    Registry ID
    NCT02403687
    Conditions
    Arthritis; Tendonitis; Gout; Radiculopathy; Muscle Spasms; Synovitis; Migraine; Headache
    Interventions
    baclofen 2%; Bupivacaine hydrochloride 1%; Cyclobenzaprine hydrochloride 2%; Diclofenac Sodium 3%; Flurbiprofen 10%; Gabapentin 6%; Ketamine 10%; Lidocaine 2%; Prilocaine 2.5%; Meloxicam 0.09%; Sumatriptan 5%; Tizanidine 0.1%; Topiramate 2.5%; Capsaicin, USP 0.0375%; Menthol, NF 5.00 %
    Study type
    OBSERVATIONAL
    Phase
    Not recorded
    Registry status
    Completed
    Start
    2015-06
    Completion
    2017-02
    Enrolment
    300

    As stored from ClinicalTrials.gov. Registration describes a study; it does not mean the study worked.

    ConditionArthritis; Tendonitis; Gout; Radiculopathy +4 more
    Interventionbaclofen 2%; Bupivacaine hydrochloride 1%; Cyclobenzaprine hydrochloride 2%; Diclofenac Sodium 3% +11 more
    PhaseNot recorded
    Registry statusCompleted