Skip to content

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.

  • Cyclobenzaprine for Postoperative Pain in Minimally Invasive Hysterectomy

    NCT07664956 · start 2026-07-01

    Registered record
    Registry ID
    NCT07664956
    Conditions
    Minimally Invasive Surgical Procedures; Abnormal Uterine Bleeding, Unspecified; Adenomyosis of Uterus; Fibroid Uterus; Chronic Pelvic Pain; Endometriosis; Menorrhagia; Endometritis; Adnexal Diseases
    Interventions
    Cyclobenzaprine
    Study type
    INTERVENTIONAL
    Phase
    Phase 4
    Registry status
    Not yet recruiting
    Start
    2026-07-01
    Completion
    2026-12-01
    Enrolment
    36

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

    ConditionMinimally Invasive Surgical Procedures; Abnormal Uterine Bleeding, Unspecified; Adenomyosis of Uterus; Fibroid Uterus +5 more
    InterventionCyclobenzaprine
    PhasePhase 4
    Registry statusNot yet recruiting
  • A Study to Evaluate TNX-102 SL Monotherapy Versus Placebo in Participants With Major Depressive Disorder (MDD)

    NCT07621237 · start 2026-06

    Registered record
    Registry ID
    NCT07621237
    Conditions
    Major Depressive Episode (MDE); Major Depressive Disorder (MDD); Depression
    Interventions
    TNX-102 SL; Placebo sublingual tablet
    Study type
    INTERVENTIONAL
    Phase
    Phase 2
    Registry status
    Recruiting
    Start
    2026-06
    Completion
    2028-02
    Enrolment
    360

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

    ConditionMajor Depressive Episode (MDE); Major Depressive Disorder (MDD); Depression
    InterventionTNX-102 SL; Placebo sublingual tablet
    PhasePhase 2
    Registry statusRecruiting
  • Fixed-dose Combination of Etoricoxib + Cyclobenzaprine for Pain Relief After Third Molar Extraction in Brazil

    NCT05683574 · start 2026-05-30

    Registered record
    Registry ID
    NCT05683574
    Conditions
    Third Molar Extraction
    Interventions
    FDC of etoricoxib + cyclobenzaprine + etoricoxib placebo; etoricoxib 90 mg (Arcoxia®) +FDC placebo; cyclobenzaprine hydrochloride + etoricoxib placebo
    Study type
    INTERVENTIONAL
    Phase
    Phase 3
    Registry status
    Withdrawn
    Start
    2026-05-30
    Completion
    2028-02-28
    Enrolment
    0

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

    ConditionThird Molar Extraction
    InterventionFDC of etoricoxib + cyclobenzaprine + etoricoxib placebo; etoricoxib 90 mg (Arcoxia®) +FDC placebo; cyclobenzaprine hydrochloride + etoricoxib placebo
    PhasePhase 3
    Registry statusWithdrawn
  • A Phase 1, Open-Label, Parallel-Group, Single-Dose Study To Compare The Pharmakokinetics Of TNX-102 SL (Cyclobenzaprine Hydrochloride Sublingual Tablet) In Non-Elderly Versus Elderly Participants

    NCT07413367 · start 2025-12-09

    Registered record
    Registry ID
    NCT07413367
    Conditions
    Pharmakokinetic; Open Label; Phase 1
    Interventions
    TNX-102 SL Tablet
    Study type
    INTERVENTIONAL
    Phase
    Phase 1
    Registry status
    Active not recruiting
    Start
    2025-12-09
    Completion
    2026-02-10
    Enrolment
    50

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

    ConditionPharmakokinetic; Open Label; Phase 1
    InterventionTNX-102 SL Tablet
    PhasePhase 1
    Registry statusActive not recruiting
  • A Comparative Study of EMG Biofeedback and Pharmacotherapy for the Treatment of Masticatory Muscle Hyperactivity in Bruxism Patients

    NCT06894472 · start 2025-03-26

    Registered record
    Registry ID
    NCT06894472
    Conditions
    Bruxism
    Interventions
    Electromyography biofeedback; Pharmacotherapy
    Study type
    INTERVENTIONAL
    Phase
    Not applicable
    Registry status
    Not yet recruiting
    Start
    2025-03-26
    Completion
    2025-05-01
    Enrolment
    30

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

    ConditionBruxism
    InterventionElectromyography biofeedback; Pharmacotherapy
    PhaseNot applicable
    Registry statusNot yet recruiting
  • Prevention/Reduction of ASRs and PTSD to Sustain Civilian Performance With Sublingual Cyclobenzaprine HCl (TNX-102 SL)

    NCT06636786 · start 2025-03-25

    Registered record
    Registry ID
    NCT06636786
    Conditions
    Acute Stress Reaction; Acute Stress Disorder; Neurocognitive Function; Post-traumatic Stress
    Interventions
    Cyclobenzaprine HCl; Placebo
    Study type
    INTERVENTIONAL
    Phase
    Phase 2
    Registry status
    Recruiting
    Start
    2025-03-25
    Completion
    2026-09
    Enrolment
    180

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

    ConditionAcute Stress Reaction; Acute Stress Disorder; Neurocognitive Function; Post-traumatic Stress
    InterventionCyclobenzaprine HCl; Placebo
    PhasePhase 2
    Registry statusRecruiting
  • Safety and Efficacy Study of TNX-102 SL in Participants With PTSD

    NCT05372887 · start 2022-10-14

    Registered record
    Registry ID
    NCT05372887
    Conditions
    PTSD
    Interventions
    TNX-102 SL; Placebo
    Study type
    INTERVENTIONAL
    Phase
    Phase 2
    Registry status
    Withdrawn
    Start
    2022-10-14
    Completion
    2022-11-08
    Enrolment
    0

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

    ConditionPTSD
    InterventionTNX-102 SL; Placebo
    PhasePhase 2
    Registry statusWithdrawn
  • A Phase 3 Study to Evaluate the Efficacy and Safety of TNX-102 SL Taken Daily in Patients With Fibromyalgia

    NCT05273749 · start 2022-04-06

    Registered record
    Registry ID
    NCT05273749
    Conditions
    Fibromyalgia
    Interventions
    TNX-102 SL Tablet, 5.6 mg; Placebo SL Tablet
    Study type
    INTERVENTIONAL
    Phase
    Phase 3
    Registry status
    Completed
    Start
    2022-04-06
    Completion
    2023-11-14
    Enrolment
    457

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

    ConditionFibromyalgia
    InterventionTNX-102 SL Tablet, 5.6 mg; Placebo SL Tablet
    PhasePhase 3
    Registry statusCompleted
  • A Single-Dose, Randomized, Open-Label, 2-Way Crossover Study to Evaluate the Dose-Proportionality, Safety, and Tolerability of TNX-102 SL (Cyclobenzaprine HCl Sublingual Tablets) in Healthy Japanese and Chinese Subjects

    NCT07464535 · start 2022-03-18

    Registered record
    Registry ID
    NCT07464535
    Conditions
    Healthy Subjects (HS)
    Interventions
    TNX-102 SL
    Study type
    INTERVENTIONAL
    Phase
    Phase 1
    Registry status
    Completed
    Start
    2022-03-18
    Completion
    2022-04-30
    Enrolment
    20

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

    ConditionHealthy Subjects (HS)
    InterventionTNX-102 SL
    PhasePhase 1
    Registry statusCompleted
  • Opioid Free vs. Standard Perioperative Pain Regimen for Anterior Cervical Discectomy and Fusion (ACDF) Surgery

    NCT04990804 · start 2021-08-01

    Registered record
    Registry ID
    NCT04990804
    Conditions
    Opioid Use; Spinal Diseases; Surgery--Complications; Surgery; Postoperative Pain
    Interventions
    Opioid Analgesic; Opioid-Free Postoperative Pain Regimen
    Study type
    INTERVENTIONAL
    Phase
    Phase 4
    Registry status
    Terminated
    Start
    2021-08-01
    Completion
    2022-02-01
    Enrolment
    8

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

    ConditionOpioid Use; Spinal Diseases; Surgery--Complications; Surgery +1 more
    InterventionOpioid Analgesic; Opioid-Free Postoperative Pain Regimen
    PhasePhase 4
    Registry statusTerminated
  • Multimodal Analgesia Effect on Post Surgical Patient

    NCT04240626 · start 2021-01-20

    Registered record
    Registry ID
    NCT04240626
    Conditions
    Obesity, Morbid; Surgery; Bariatric Surgery Candidate
    Interventions
    Neurontin; Dilaudid Injectable Product; Marcaine Injectable Product; Oxycodone Hydrochloride; Hycet 7.5Mg-325Mg/15Ml Solution; Zofran Injection; Scopolamine patch; Ativan; Flexeril Oral Product; Tylenol Suspension
    Study type
    INTERVENTIONAL
    Phase
    Phase 4
    Registry status
    Completed
    Start
    2021-01-20
    Completion
    2025-06-24
    Enrolment
    60

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

    ConditionObesity, Morbid; Surgery; Bariatric Surgery Candidate
    InterventionNeurontin; Dilaudid Injectable Product; Marcaine Injectable Product; Oxycodone Hydrochloride +6 more
    PhasePhase 4
    Registry statusCompleted
  • Trigger Point Injection for Myofascial Pain Syndrome in the Low Back: A Randomized Controlled Trial

    NCT04704297 · start 2020-12-28

    Registered record
    Registry ID
    NCT04704297
    Conditions
    Low Back Pain; Myofascial Pain Syndrome Lower Back
    Interventions
    Treatment of Myofascial Pain Syndrome in the low back. This intervention will be based on outcomes of the medications listed below.; Evaluation of functional ability using a patient centered functional score known as the Modified Oswestry Disability Index (MODI). The intervention will be based on outcomes of medications below.; Following up with participants 60-72 hours after treatment in the Emergency Department. This intervention will be based on outcomes of the medications listed below.
    Study type
    INTERVENTIONAL
    Phase
    Phase 4
    Registry status
    Recruiting
    Start
    2020-12-28
    Completion
    2022-07-01
    Enrolment
    180

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

    ConditionLow Back Pain; Myofascial Pain Syndrome Lower Back
    InterventionTreatment of Myofascial Pain Syndrome in the low back. This intervention will be based on outcomes of the medications listed below.; Evaluation of functional ability using a patient centered functional score known as the Modified Oswestry Disability Index (MODI). The intervention will be based on outcomes of medications below.; Following up with participants 60-72 hours after treatment in the Emergency Department. This intervention will be based on outcomes of the medications listed below.
    PhasePhase 4
    Registry statusRecruiting
  • Phase III Efficacy and Tolerability Trial of the Fixed Dose Combination of Etodolac 400 mg and Cyclobenzaprine 10 mg Versus Isolated Active Substances in Pain Control After Impacted Third Molar Extraction

    NCT03127592 · start 2020-10-05

    Registered record
    Registry ID
    NCT03127592
    Conditions
    Pain, Acute
    Interventions
    Fixed Dose Combination; Etodolac; Cyclobenzaprine
    Study type
    INTERVENTIONAL
    Phase
    Phase 3
    Registry status
    Terminated
    Start
    2020-10-05
    Completion
    2022-07-26
    Enrolment
    140

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

    ConditionPain, Acute
    InterventionFixed Dose Combination; Etodolac; Cyclobenzaprine
    PhasePhase 3
    Registry statusTerminated
  • A Phase 3 Study To Evaluate The Efficacy And Safety Of TNX-102 SL In Patients With Fibromyalgia

    NCT04508621 · start 2020-07-22

    Registered record
    Registry ID
    NCT04508621
    Conditions
    Fibromyalgia
    Interventions
    TNX-102 SL; Placebo SL Tablet
    Study type
    INTERVENTIONAL
    Phase
    Phase 3
    Registry status
    Completed
    Start
    2020-07-22
    Completion
    2021-11-01
    Enrolment
    514

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

    ConditionFibromyalgia
    InterventionTNX-102 SL; Placebo SL Tablet
    PhasePhase 3
    Registry statusCompleted
  • A Study To Evaluate The Efficacy And Safety Of TNX-102 SL In Patients With Fibromyalgia

    NCT04172831 · start 2019-12-09

    Registered record
    Registry ID
    NCT04172831
    Conditions
    Fibromyalgia
    Interventions
    TNX-102 SL; Placebo SL Tablet
    Study type
    INTERVENTIONAL
    Phase
    Phase 3
    Registry status
    Completed
    Start
    2019-12-09
    Completion
    2020-10-29
    Enrolment
    503

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

    ConditionFibromyalgia
    InterventionTNX-102 SL; Placebo SL Tablet
    PhasePhase 3
    Registry statusCompleted