Amrix
(Cyclobenzaprine)ApprovedSmall molecule
This medication helps relax muscles by affecting the brain and nervous system, and is used to treat muscle spasms or tightness.[2] Amrix is currently approved and in use across 4 indications[4].[1]
Amrix is one of 82 small molecule programs targeting Minimally Invasive Surgical Procedures. It is currently in Approved.
4
Indications
16
Total Trials
3
Active Trials
81
Competitors
3
FDA Applications
NDA/BLA/ANDA regulatory filings
4
Patents
Pipeline
Status by Indication[4][1]
Indication
Competition
Competitive Landscape
56 competitors in Low Back Pain
#DrugCompanyPhaseTrials
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Voltaren
NovartisApproved
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KKenvue Brands
Approved
Toradol
RocheApproved
Lioresal
NovartisApproved
Celebrex
PPhiladelphia Eye Associates
Approved
Oxycontin
PProtega
Approved
Nucynta
CCollegium Pharmaceutical, Inc.
Approved
Zometa
PfizerApproved
Ranked by pipeline maturity and clinical activity. Current drug highlighted in teal.
Timeline
Expected Milestones
Clinical
Trials by Indication[1]
Adult2 trials
Medication1 trial
Efficacy and Safety1 trial
10 more indications
Clinical Trial1 trial
Intravenous1 trial
Ankle Surgery1 trial
Breast Cancer1 trial
Pain, Acute1 trial
Lactating Women on Select DOI1 trial
Regulatory
FDA Approval Timeline[5]
Jan 1, 1982
FLEXERIL
NDA NDA017821
Feb 1, 2007
AMRIX
NDA NDA021777
Aug 15, 2025
TONMYA
NDA NDA219428
Sources
References
- [1]
- [2]MedlinePlus Drug Information — Amrix drug information. U.S. National Library of Medicine, National Institutes of Health.
- [3]
- [4]Open Targets Platform — Drug–disease associations for Cyclobenzaprine. EMBL-EBI & Wellcome Sanger Institute.
- [5]
- [6]FDA Orange Book — Patent and exclusivity data for Amrix. U.S. Food & Drug Administration.
- [7]
Details
Drug Info
Quick Facts
- Modality
- Small molecule[3]
- Highest Phase
- Approved[1]
- Company
- TTonix Pharmaceuticals, Inc.