Cyclobenzaprine

Generic Name: Cyclobenzaprine

Brand Names: Amrix, Fexmid, Flexeril

Drug Type: Small Molecule

Chemical Formula: C_₂₀H_₂₁N

CAS Number: 303-53-7

Unique Ingredient Identifier: 69O5WQQ5TI

Background: Cyclobenzaprine, a centrally-acting muscle relaxant, was first synthesized in 1961 and has been available for human use since 1977. It was initially studied for use as antidepressant given its structural similarity to tricyclic antidepressants - it differs from Amitriptyline by only a single double bond. Since its approval, it has remained relatively popular as an adjunctive, short-term treatment for acute skeletal muscle spasms secondary to musculoskeletal injury.

Indication: 用于缓解与急性疼痛的肌肉骨骼疾病相关的肌肉痉挛（作为休息和物理治疗的辅助药）。但环苯扎林对脑、脊髓疾病或儿童脑性瘫痪引起的痉挛无效。

Associated Conditions: Muscle Spasms

Clinical Trials

Prevention/Reduction of ASRs and PTSD to Sustain Civilian Performance With Sublingual Cyclobenzaprine HCl (TNX-102 SL)

Phase 2

Recruiting

Conditions: Acute Stress Reaction
Acute Stress Disorder
Neurocognitive Function
Post-traumatic Stress

Interventions: Drug: Cyclobenzaprine HCl
Drug: Placebo

First Posted Date: 2024-10-15

Last Posted Date: 2025-03-30

Lead Sponsor: University of North Carolina, Chapel Hill

Target Recruit Count: 180

Registration Number: NCT06636786

Locations: 🇺🇸
Indiana University, Indianapolis, Indiana, United States
🇺🇸
University of Kansas Medical Center, Kansas City, Kansas, United States
🇺🇸
University of Massachusetts Chan Medical School (Umass Memorial Medical Center), Worcester, Massachusetts, United States

and more 3 locations

Fixed-dose Combination of Etoricoxib + Cyclobenzaprine for Pain Relief After Third Molar Extraction in Brazil

Phase 3

Withdrawn

Conditions: Third Molar Extraction

Interventions: Drug: cyclobenzaprine hydrochloride + etoricoxib placebo
Drug: etoricoxib 90 mg (Arcoxia®) +FDC placebo
Drug: FDC of etoricoxib + cyclobenzaprine + etoricoxib placebo

First Posted Date: 2023-01-13

Last Posted Date: 2024-02-28

Lead Sponsor: Eurofarma Laboratorios S.A.

Registration Number: NCT05683574

Locations: 🇧🇷
Eurofarma Laboratorios S.A, São Paulo, SP, Brazil

A Phase 2 Study to Evaluate the Efficacy and Safety of TNX-102 SL in Patients With Multi-Site Pain Associated With Post-Acute Sequelae of SARS-CoV-2 Infection

Phase 2

Completed

Conditions: Post-Acute Sequelae of SARS-CoV-2 (PASC) Infection
COVID-19
Long COVID
Long Haul COVID

Interventions: Drug: TNX-102 SL
Drug: Placebo SL Tablet

First Posted Date: 2022-07-25

Last Posted Date: 2024-11-26

Lead Sponsor: Tonix Pharmaceuticals, Inc.

Target Recruit Count: 63

Registration Number: NCT05472090

Locations: 🇺🇸
Accel Research-Birmingham Clinical Research Unit, Birmingham, Alabama, United States
🇺🇸
Tonix Clinical Site, McKinney, Texas, United States

Safety and Efficacy Study of TNX-102 SL in Participants With PTSD

Phase 2

Withdrawn

Conditions: PTSD

Interventions: Drug: TNX-102 SL
Drug: Placebo

First Posted Date: 2022-05-13

Last Posted Date: 2023-12-11

Lead Sponsor: Tonix Pharmaceuticals, Inc.

Registration Number: NCT05372887

Locations: 🇰🇪
Centre for Clinical Research at KEMRI-Nairobi, Nairobi, Kenya
🇰🇪
Aga Khan University Clinical Research Unit, Nairobi, Kenya
🇰🇪
Moi University Clinical Research Centre, Nairobi, Kenya