{"id":"cyclobenzaprine-hydrochloride-2","safety":{"commonSideEffects":[{"rate":"29","effect":"Drowsiness"},{"rate":"11","effect":"Dizziness"},{"rate":"21","effect":"Dry mouth"},{"rate":"6","effect":"Fatigue"},{"rate":null,"effect":"Headache"}]},"_chembl":null,"_dailymed":null,"mechanism":{"_ai_source":"anthropic-haiku","explanation":"Cyclobenzaprine works primarily through central nervous system depression, acting on the brainstem to reduce motor neuron activity and muscle tone. It is structurally related to tricyclic antidepressants and may have some noradrenergic activity. The drug is used to relieve muscle spasms associated with acute musculoskeletal conditions.","oneSentence":"Cyclobenzaprine is a centrally acting muscle relaxant that reduces muscle tension by depressing activity in the brainstem.","_ai_confidence":"medium"},"_scrapedAt":"2026-03-28T03:30:17.394Z","_scrapedBy":"cloudflare-swarm","_wikipedia":null,"indications":{"approved":[{"name":"Acute musculoskeletal pain and muscle spasms (topical formulation in Phase 2)"}]},"trialDetails":[{"nctId":"NCT07464535","phase":"PHASE1","title":"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","status":"COMPLETED","sponsor":"Tonix Pharmaceuticals, Inc.","startDate":"2022-03-18","conditions":"Healthy Subjects (HS)","enrollment":20},{"nctId":"NCT07404397","phase":"PHASE2, PHASE3","title":"Comparing Adjuvant Treatments for High Tone Pelvic Floor Dysfunction","status":"RECRUITING","sponsor":"University of Michigan","startDate":"2026-02-18","conditions":"High Tone Pelvic Floor Dysfunction","enrollment":60},{"nctId":"NCT03511118","phase":"","title":"Pharmacokinetics and Safety of Commonly Used Drugs in Lactating Women and Breastfed Infants","status":"RECRUITING","sponsor":"Duke University","startDate":"2018-10-04","conditions":"Lactating Women on Select DOI, Breastfed Infants of Mothers on Select DOI","enrollment":1600},{"nctId":"NCT04240626","phase":"PHASE4","title":"Multimodal Analgesia Effect on Post Surgical Patient","status":"ACTIVE_NOT_RECRUITING","sponsor":"University of California, Davis","startDate":"2021-01-20","conditions":"Obesity, Morbid, Surgery, Bariatric Surgery Candidate","enrollment":60},{"nctId":"NCT06636786","phase":"PHASE2","title":"Prevention/Reduction of ASRs and PTSD to Sustain Civilian Performance With Sublingual Cyclobenzaprine HCl (TNX-102 SL)","status":"RECRUITING","sponsor":"University of North Carolina, Chapel Hill","startDate":"2025-03-25","conditions":"Acute Stress Reaction, Acute Stress Disorder, Neurocognitive Function","enrollment":180},{"nctId":"NCT06894472","phase":"NA","title":"A Comparative Study of EMG Biofeedback and Pharmacotherapy for the Treatment of Masticatory Muscle Hyperactivity in Bruxism Patients","status":"NOT_YET_RECRUITING","sponsor":"Beni-Suef University","startDate":"2025-03-26","conditions":"Bruxism","enrollment":30},{"nctId":"NCT03110575","phase":"PHASE3","title":"12-Week Open-Label Extension Study of TNX-102 SL in PTSD Patients","status":"TERMINATED","sponsor":"Tonix Pharmaceuticals, Inc.","startDate":"2017-06-20","conditions":"PTSD","enrollment":190},{"nctId":"NCT03841773","phase":"PHASE3","title":"A Phase 3 Study to Evaluate the Efficacy and Safety of TNX-102 SL in Participants With PTSD","status":"TERMINATED","sponsor":"Tonix Pharmaceuticals, Inc.","startDate":"2019-03-07","conditions":"PTSD","enrollment":192},{"nctId":"NCT03508700","phase":"PHASE3","title":"A 40-week Study to Evaluate TNX-102 SL 5.6 mg Taken Daily at Bedtime in Patients With PTSD","status":"COMPLETED","sponsor":"Tonix Pharmaceuticals, Inc.","startDate":"2018-04-19","conditions":"PTSD","enrollment":93},{"nctId":"NCT05273749","phase":"PHASE3","title":"A Phase 3 Study to Evaluate the Efficacy and Safety of TNX-102 SL Taken Daily in Patients With Fibromyalgia","status":"COMPLETED","sponsor":"Tonix Pharmaceuticals, Inc.","startDate":"2022-04-06","conditions":"Fibromyalgia","enrollment":457},{"nctId":"NCT03062540","phase":"PHASE3","title":"Safety and Efficacy Study of TNX-102 SL in Patients With Military-related PTSD","status":"TERMINATED","sponsor":"Tonix Pharmaceuticals, Inc.","startDate":"2017-03-27","conditions":"PTSD","enrollment":358},{"nctId":"NCT05683574","phase":"PHASE3","title":"Fixed-dose Combination of Etoricoxib + Cyclobenzaprine for Pain Relief After Third Molar Extraction in Brazil","status":"WITHDRAWN","sponsor":"Eurofarma Laboratorios S.A.","startDate":"2026-05-30","conditions":"Third Molar Extraction","enrollment":""},{"nctId":"NCT04990804","phase":"PHASE4","title":"Opioid Free vs. Standard Perioperative Pain Regimen for Anterior Cervical Discectomy and Fusion (ACDF) Surgery","status":"TERMINATED","sponsor":"Vanderbilt University Medical Center","startDate":"2021-08-01","conditions":"Opioid Use, Spinal Diseases, Surgery--Complications","enrollment":8},{"nctId":"NCT04508621","phase":"PHASE3","title":"A Phase 3 Study To Evaluate The Efficacy And Safety Of TNX-102 SL In Patients With Fibromyalgia","status":"COMPLETED","sponsor":"Tonix Pharmaceuticals, Inc.","startDate":"2020-07-22","conditions":"Fibromyalgia","enrollment":514},{"nctId":"NCT05372887","phase":"PHASE2","title":"Safety and Efficacy Study of TNX-102 SL in Participants With PTSD","status":"WITHDRAWN","sponsor":"Tonix Pharmaceuticals, Inc.","startDate":"2022-10-14","conditions":"PTSD","enrollment":""},{"nctId":"NCT04771741","phase":"","title":"Opiate Free Multimodal Pain Pathway in Elective Foot and Ankle Surgery: A Prospective Study","status":"COMPLETED","sponsor":"Prisma Health-Midlands","startDate":"2020-12-01","conditions":"Bunion of Unspecified Foot, Bunionette of Unspecified Foot, Hammertoe","enrollment":72},{"nctId":"NCT03127592","phase":"PHASE3","title":"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","status":"TERMINATED","sponsor":"Apsen Farmaceutica S.A.","startDate":"2020-10-05","conditions":"Pain, Acute","enrollment":140},{"nctId":"NCT04172831","phase":"PHASE3","title":"A Study To Evaluate The Efficacy And Safety Of TNX-102 SL In Patients With Fibromyalgia","status":"COMPLETED","sponsor":"Tonix Pharmaceuticals, Inc.","startDate":"2019-12-09","conditions":"Fibromyalgia","enrollment":503},{"nctId":"NCT03025113","phase":"PHASE3","title":"Efficacy and Safety of the Combination of Ketoprofen and Cyclobenzaprine in Osteomuscular Treatment","status":"COMPLETED","sponsor":"EMS","startDate":"2018-03-08","conditions":"Musculoskeletal Pain","enrollment":416},{"nctId":"NCT04704297","phase":"PHASE4","title":"Trigger Point Injection for Myofascial Pain Syndrome in the Low Back: A Randomized Controlled Trial","status":"RECRUITING","sponsor":"Madigan Army Medical Center","startDate":"2020-12-28","conditions":"Low Back Pain, Myofascial Pain Syndrome Lower Back","enrollment":180},{"nctId":"NCT02862977","phase":"PHASE3","title":"Efficacy and Safety of the Combination of Ketoprofen and Cyclobenzaprine and Caffeine in Osteomuscular Treatment","status":"COMPLETED","sponsor":"EMS","startDate":"2017-11-10","conditions":"Musculoskeletal Pain","enrollment":414},{"nctId":"NCT04164719","phase":"PHASE1","title":"Dose-Proportionality and Food Effect Study of TNX-102 SL","status":"COMPLETED","sponsor":"Tonix Pharmaceuticals, Inc.","startDate":"2019-10-14","conditions":"Healthy Subjects","enrollment":16},{"nctId":"NCT03168022","phase":"PHASE1","title":"Bioequivalence Study of TNX-102 SL 2.8 mg Sublingual Tablets From Two Manufacturers.","status":"COMPLETED","sponsor":"Tonix Pharmaceuticals, Inc.","startDate":"2015-12-16","conditions":"Healthy Adults","enrollment":43},{"nctId":"NCT00386243","phase":"NA","title":"Evaluation of Stepped Care for Chronic Pain in Iraq/Afghanistan Veterans (ESCAPE)","status":"COMPLETED","sponsor":"VA Office of Research and Development","startDate":"2007-12","conditions":"Low Back Pain, Pain, Pain, Intractable","enrollment":242},{"nctId":"NCT02497066","phase":"PHASE3","title":"Efficacy Study Comparing Compounded Topical Pain Creams vs. Placebo for Treating Pain Symptoms","status":"COMPLETED","sponsor":"Walter Reed National Military Medical Center","startDate":"2015-08-05","conditions":"Pain","enrollment":399},{"nctId":"NCT03207828","phase":"NA","title":"Testing Interventions for Patients With Fibromyalgia and Depression","status":"UNKNOWN","sponsor":"Pontificia Universidad Catolica de Chile","startDate":"2017-09-09","conditions":"Fibromyalgia, Depression","enrollment":90},{"nctId":"NCT03443960","phase":"PHASE1","title":"Steady-State Pharmacokinetic Comparison Study of TNX-102 SL 5.6 mg Versus AMRIX® 30 mg ER Capsules","status":"COMPLETED","sponsor":"Tonix Pharmaceuticals, Inc.","startDate":"2018-01-29","conditions":"Healthy Subjects","enrollment":60},{"nctId":"NCT02403687","phase":"","title":"Prospective Analgesic Compound Efficacy (PACE) Study","status":"COMPLETED","sponsor":"Express Specialty Pharmacy","startDate":"2015-06","conditions":"Arthritis, Tendonitis, Gout","enrollment":300},{"nctId":"NCT02642861","phase":"PHASE3","title":"Cyclobenzaprine in Muscle Cramps With Liver Cirrhosis","status":"UNKNOWN","sponsor":"Tanta University","startDate":"2018-10","conditions":"Liver Cirrhosis","enrollment":200},{"nctId":"NCT00913419","phase":"PHASE1","title":"To Demonstrate the Relative Bioavailability of Cyclobenzaprine HCl Tablets","status":"COMPLETED","sponsor":"Sandoz","startDate":"1988-11","conditions":"Depression","enrollment":30},{"nctId":"NCT01587508","phase":"PHASE3","title":"Study Comparing A New Drug Containing The Combination Meloxicam And Cyclobenzaprine In The Treatment Of Acute Lumbago","status":"WITHDRAWN","sponsor":"Eurofarma Laboratorios S.A.","startDate":"2013-05","conditions":"Acute Lumbago","enrollment":""},{"nctId":"NCT01921296","phase":"PHASE2","title":"Pilot Study of Cyclobenzaprine for Treatment of Sleep Disturbance in Aromatase Inhibitor-treated Breast Cancer Patients","status":"TERMINATED","sponsor":"Lynn Henry","startDate":"2013-08","conditions":"Sleep Initiation and Maintenance Disorders, Pain","enrollment":2},{"nctId":"NCT01689259","phase":"PHASE1","title":"Comparative Pharmacokinetics and Safety of TNX-102 SL Tablets and Cyclobenzaprine Oral Tablet in Healthy Adults","status":"COMPLETED","sponsor":"Tonix Pharmaceuticals, Inc.","startDate":"2012-09","conditions":"Healthy Adults","enrollment":24},{"nctId":"NCT01028014","phase":"NA","title":"Medication Effects on Periurethral Sensation,Urethral Sphincter Activity and Pressure Flow Parameters","status":"COMPLETED","sponsor":"University of Alabama at Birmingham","startDate":"2010-04","conditions":"Urethral Sphincter Activity","enrollment":56},{"nctId":"NCT00778037","phase":"NA","title":"Bioequivalence Study of Cyclobenzaprine Hydrochloride 10 mg Tablets, USP Under Fasting Conditions","status":"COMPLETED","sponsor":"Ranbaxy Laboratories Limited","startDate":"2006-09","conditions":"Healthy","enrollment":40}],"_emaApprovals":[],"_faersSignals":[],"_approvalHistory":[],"publicationCount":0,"rwe":[],"genericFilers":[],"relatedDrugs":[],"labelChanges":[],"biosimilarFilings":[],"pricing":[],"formularyStatus":[],"manufacturing":[],"companionDiagnostics":[],"competitors":[],"timeline":[],"patents":[],"ownershipHistory":[],"trials":[],"biosimilars":[],"latestUpdates":[],"references":[],"tags":[],"ecosystem":[],"genericManufacturerList":[],"offLabel":[],"developmentCodes":[],"aliases":["Cyclobenzaprine hydrochloride"],"phase":"phase_2","status":"active","brandName":"Cyclobenzaprine hydrochloride 2%","genericName":"Cyclobenzaprine hydrochloride 2%","companyName":"Express Specialty Pharmacy","companyId":"express-specialty-pharmacy","modality":"Small molecule","firstApprovalDate":"","aiSummary":"Cyclobenzaprine is a centrally acting muscle relaxant that reduces muscle tension by depressing activity in the brainstem. Used for Acute musculoskeletal pain and muscle spasms (topical formulation in Phase 2).","enrichmentLevel":3,"visitCount":0,"trialStats":{"total":0,"withResults":0},"verificationStatus":"verified","dataCompleteness":{"mechanism":true,"indications":true,"safety":true,"trials":true,"score":4}}