Last reviewed · How we verify
Cyclobenzaprine HCl
At a glance
| Generic name | Cyclobenzaprine HCl |
|---|---|
| Also known as | TNX-102 SL, Myorix®, AMRIX® |
| Sponsor | University of North Carolina, Chapel Hill |
| Modality | Small molecule |
| Phase | FDA-approved |
Approved indications
Common side effects
- Drowsiness
- Dry Mouth
- Drowsiness
- Dry Mouth
- Fatigue/Tiredness
- Headache
- Dizziness
- Nausea
- Constipation
- Dyspepsia
- Blurred Vision
- Nervousness
Serious adverse events
- Serotonin Syndrome
- Seizures
- Anaphylaxis
- Hepatitis
- Jaundice
- Cholestasis
- Myocardial Infarction
- Stroke
- Paralytic Ileus
- Bone Marrow Depression
Key clinical trials
- 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 (PHASE1)
- Comparing Adjuvant Treatments for High Tone Pelvic Floor Dysfunction (PHASE2, PHASE3)
- 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 (PHASE1)
- Pharmacokinetics and Safety of Commonly Used Drugs in Lactating Women and Breastfed Infants
- Multimodal Analgesia Effect on Post Surgical Patient (PHASE4)
- Prevention/Reduction of ASRs and PTSD to Sustain Civilian Performance With Sublingual Cyclobenzaprine HCl (TNX-102 SL) (PHASE2)
- Multimodal Analgesia vs. Routine Care Pain Management for Lumbar Spine Fusion Surgery: A Prospective Randomized Study (PHASE4)
- A Comparative Study of EMG Biofeedback and Pharmacotherapy for the Treatment of Masticatory Muscle Hyperactivity in Bruxism Patients (NA)
Primary sources
Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.
| Source | Used for |
|---|---|
| ClinicalTrials.gov | Trial enrolment, design, endpoints, results |
Competitive intelligence
For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:
- Cyclobenzaprine HCl CI brief — competitive landscape report
- Cyclobenzaprine HCl updates RSS · CI watch RSS
- University of North Carolina, Chapel Hill portfolio CI