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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.

  • A Study to Evaluate eFFIcacy and Safety of Sublingual TNX-102 SL Tablet Taken at Bedtime in Patients With fibRoMyalgia

    NCT02436096 · start 2015-04

    Registered record
    Registry ID
    NCT02436096
    Conditions
    Fibromyalgia; Myofascial Pain Syndromes; Muscular Diseases; Musculoskeletal Diseases; Nervous System Diseases; Neuromuscular Diseases; Rheumatic Diseases
    Interventions
    TNX-102 SL Tablet, 2.8mg; Placebo SL Tablet
    Study type
    INTERVENTIONAL
    Phase
    Phase 3
    Registry status
    Completed
    Start
    2015-04
    Completion
    2016-09
    Enrolment
    519

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

    ConditionFibromyalgia; Myofascial Pain Syndromes; Muscular Diseases; Musculoskeletal Diseases +3 more
    InterventionTNX-102 SL Tablet, 2.8mg; Placebo SL Tablet
    PhasePhase 3
    Registry statusCompleted
  • 12-Month Open-Label Long-term Safety Study of TNX-102 SL Tablets in Fibromyalgia Patients

    NCT02015234 · start 2013-12

    Registered record
    Registry ID
    NCT02015234
    Conditions
    Primary Fibromyalgia
    Interventions
    TNX-102 SL
    Study type
    INTERVENTIONAL
    Phase
    Phase 3
    Registry status
    Completed
    Start
    2013-12
    Completion
    2015-08
    Enrolment
    158

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

    ConditionPrimary Fibromyalgia
    InterventionTNX-102 SL
    PhasePhase 3
    Registry statusCompleted
  • BEdtime Sublingual TNX-102 SL as Fibromyalgia Intervention Therapy (BESTFIT)

    NCT01903265 · start 2013-09

    Registered record
    Registry ID
    NCT01903265
    Conditions
    Primary Fibromyalgia
    Interventions
    TNX-102 SL 2.8mg; Placebo
    Study type
    INTERVENTIONAL
    Phase
    Phase 2 / Phase 3
    Registry status
    Completed
    Start
    2013-09
    Completion
    2014-09
    Enrolment
    205

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

    ConditionPrimary Fibromyalgia
    InterventionTNX-102 SL 2.8mg; Placebo
    PhasePhase 2 / Phase 3
    Registry statusCompleted
  • Pilot Study of Cyclobenzaprine for Treatment of Sleep Disturbance in Aromatase Inhibitor-treated Breast Cancer Patients

    NCT01921296 · start 2013-08

    Registered record
    Registry ID
    NCT01921296
    Conditions
    Sleep Initiation and Maintenance Disorders; Pain
    Interventions
    Cyclobenzaprine
    Study type
    INTERVENTIONAL
    Phase
    Phase 2
    Registry status
    Terminated
    Start
    2013-08
    Completion
    2015-04
    Enrolment
    2

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

    ConditionSleep Initiation and Maintenance Disorders; Pain
    InterventionCyclobenzaprine
    PhasePhase 2
    Registry statusTerminated
  • Comparative Pharmacokinetics and Safety of 3 Different Formulations of TNX-102 2.8 mg SL Tablets and Cyclobenzaprine 5 mg Oral Tablet in Healthy Adults

    NCT01889173 · start 2013-06

    Registered record
    Registry ID
    NCT01889173
    Conditions
    Healthy Adults
    Interventions
    TNX-102 SL Tablets at 2.8 mg; TNX-102-B SL Tablets at 2.8 mg; TNX-102-C SL Tablets at 2.8 mg; Cyclobenzaprine tablets
    Study type
    INTERVENTIONAL
    Phase
    Phase 1
    Registry status
    Completed
    Start
    2013-06
    Completion
    2014-03
    Enrolment
    24

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

    ConditionHealthy Adults
    InterventionTNX-102 SL Tablets at 2.8 mg; TNX-102-B SL Tablets at 2.8 mg; TNX-102-C SL Tablets at 2.8 mg; Cyclobenzaprine tablets
    PhasePhase 1
    Registry statusCompleted
  • Study Comparing A New Drug Containing The Combination Meloxicam And Cyclobenzaprine In The Treatment Of Acute Lumbago

    NCT01587508 · start 2013-05

    Registered record
    Registry ID
    NCT01587508
    Conditions
    Acute Lumbago
    Interventions
    meloxicam/cyclobenzaprine hydrochloride; meloxicam - Movatec®; cyclobenzaprine - Miosan®
    Study type
    INTERVENTIONAL
    Phase
    Phase 3
    Registry status
    Withdrawn
    Start
    2013-05
    Completion
    2013-05
    Enrolment
    0

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

    ConditionAcute Lumbago
    Interventionmeloxicam/cyclobenzaprine hydrochloride; meloxicam - Movatec®; cyclobenzaprine - Miosan®
    PhasePhase 3
    Registry statusWithdrawn
  • Comparative Pharmacokinetics and Safety of TNX-102 SL Tablets and Cyclobenzaprine Oral Tablet in Healthy Adults

    NCT01689259 · start 2012-09

    Registered record
    Registry ID
    NCT01689259
    Conditions
    Healthy Adults
    Interventions
    SL TNX-102 at 2.4 mg; SL TNX-102 at 4.8 mg; SL TNX-102-A at 2.4 mg; Cyclobenzaprine tablets
    Study type
    INTERVENTIONAL
    Phase
    Phase 1
    Registry status
    Completed
    Start
    2012-09
    Completion
    2014-03
    Enrolment
    24

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

    ConditionHealthy Adults
    InterventionSL TNX-102 at 2.4 mg; SL TNX-102 at 4.8 mg; SL TNX-102-A at 2.4 mg; Cyclobenzaprine tablets
    PhasePhase 1
    Registry statusCompleted
  • Comparative Bioavailability of Sublingual TNX-102, Oral and Intravenous Cyclobenzaprine in Healthy Adults

    NCT01634412 · start 2012-06

    Registered record
    Registry ID
    NCT01634412
    Conditions
    Healthy Adults
    Interventions
    SL TNX-102 2.4 mg at pH 3.5; SL TNX-102 2.4 mg at pH 7.1; Cyclobenzaprine Tablet; Cyclobenzaprine IV
    Study type
    INTERVENTIONAL
    Phase
    Phase 1
    Registry status
    Completed
    Start
    2012-06
    Completion
    2014-01
    Enrolment
    24

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

    ConditionHealthy Adults
    InterventionSL TNX-102 2.4 mg at pH 3.5; SL TNX-102 2.4 mg at pH 7.1; Cyclobenzaprine Tablet; Cyclobenzaprine IV
    PhasePhase 1
    Registry statusCompleted
  • A Randomized Study of Three Medication Regimens for Acute Low Back Pain

    NCT01587274 · start 2012-04

    Registered record
    Registry ID
    NCT01587274
    Conditions
    Acute Low Back Pain
    Interventions
    Naproxen; Cyclobenzaprine; Oxycodone/ acetaminophen
    Study type
    INTERVENTIONAL
    Phase
    Phase 4
    Registry status
    Completed
    Start
    2012-04
    Completion
    2014-12
    Enrolment
    323

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

    ConditionAcute Low Back Pain
    InterventionNaproxen; Cyclobenzaprine; Oxycodone/ acetaminophen
    PhasePhase 4
    Registry statusCompleted
  • Analysis of the Effects of the Osteopathic Manipulative Treatment in Carriers of Temporomandibular Disorders

    NCT02974166 · start 2012-03

    Registered record
    Registry ID
    NCT02974166
    Conditions
    Temporomandibular Disorder
    Interventions
    Conventional Group; Osteopathic Group; Ibuprofen; Cyclobenzaprine Hydrochloride
    Study type
    INTERVENTIONAL
    Phase
    Not applicable
    Registry status
    Completed
    Start
    2012-03
    Completion
    2016-08
    Enrolment
    32

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

    ConditionTemporomandibular Disorder
    InterventionConventional Group; Osteopathic Group; Ibuprofen; Cyclobenzaprine Hydrochloride
    PhaseNot applicable
    Registry statusCompleted
  • A Comparative Bioavailability and Pharmacokinetic Study of TNX-102 2.4 mg and Cyclobenzaprine 5 mg Tablets in Healthy Adults.

    NCT01490788 · start 2011-11-18

    Registered record
    Registry ID
    NCT01490788
    Conditions
    Healthy
    Interventions
    Treatment A; Treatment B; Treatment C
    Study type
    INTERVENTIONAL
    Phase
    Phase 1
    Registry status
    Completed
    Start
    2011-11-18
    Completion
    2011-12-30
    Enrolment
    30

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

    ConditionHealthy
    InterventionTreatment A; Treatment B; Treatment C
    PhasePhase 1
    Registry statusCompleted
  • Efficacy and Safety of Cyclobenzaprine Hydrochloride Extended Release for the Treatment of Chronic Migraine

    NCT01151787 · start 2010-07

    Registered record
    Registry ID
    NCT01151787
    Conditions
    Chronic Migraine
    Interventions
    cyclobenzaprine hydrochloride; placebo
    Study type
    INTERVENTIONAL
    Phase
    Phase 3
    Registry status
    Terminated
    Start
    2010-07
    Completion
    2013-09
    Enrolment
    35

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

    ConditionChronic Migraine
    Interventioncyclobenzaprine hydrochloride; placebo
    PhasePhase 3
    Registry statusTerminated
  • Use of Cyclobenzaprine After Vaginal Surgery

    NCT01081990 · start 2010-04

    Registered record
    Registry ID
    NCT01081990
    Conditions
    Postoperative Pain
    Interventions
    cyclobenzaprine
    Study type
    INTERVENTIONAL
    Phase
    Not applicable
    Registry status
    Completed
    Start
    2010-04
    Completion
    2014-08-01
    Enrolment
    63

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

    ConditionPostoperative Pain
    Interventioncyclobenzaprine
    PhaseNot applicable
    Registry statusCompleted
  • Cyclobenzaprine Extended Release (ER) for Fibromyalgia

    NCT01041495 · start 2009-06

    Registered record
    Registry ID
    NCT01041495
    Conditions
    Fibromyalgia; Pain; Sleep; Fatigue
    Interventions
    cyclobenzaprine ER (AMRIX); placebo
    Study type
    INTERVENTIONAL
    Phase
    Phase 4
    Registry status
    Terminated
    Start
    2009-06
    Completion
    2013-03
    Enrolment
    37

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

    ConditionFibromyalgia; Pain; Sleep; Fatigue
    Interventioncyclobenzaprine ER (AMRIX); placebo
    PhasePhase 4
    Registry statusTerminated
  • Evaluation of Stepped Care for Chronic Pain in Iraq/Afghanistan Veterans (ESCAPE)

    NCT00386243 · start 2007-12

    Registered record
    Registry ID
    NCT00386243
    Conditions
    Low Back Pain; Pain; Pain, Intractable
    Interventions
    Cognitive behavioral therapy; Pain self-management program; Co-Analgesic Therapy; Opioid Analgesics
    Study type
    INTERVENTIONAL
    Phase
    Not applicable
    Registry status
    Completed
    Start
    2007-12
    Completion
    2012-09
    Enrolment
    242

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

    ConditionLow Back Pain; Pain; Pain, Intractable
    InterventionCognitive behavioral therapy; Pain self-management program; Co-Analgesic Therapy; Opioid Analgesics
    PhaseNot applicable
    Registry statusCompleted