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 90 small molecule programs targeting Low back pain. It is currently in Approved.

Indications

Total Trials

Active Trials

Competitors

FDA Applications

NDA/BLA/ANDA regulatory filings

Patents

Pipeline

Status by Indication[4][1]

Indication

Low Back PainActive, not recruiting

Muscle CrampActive, not recruiting

Breast CancerActive, not recruiting

Minimally Invasive Surgical ProceduresNot yet recruiting

Low Back PainApproved

Active, not recruiting

Muscle CrampPhase 3

Active, not recruiting

Breast CancerPhase 2

Active, not recruiting

Minimally Invasive Surgical ProceduresApproved

Not yet recruiting

Competition

Competitive Landscape

2828 competitors in Breast Cancer

#DrugCompanyPhaseTrials

Amrix

TTonix Pharmaceuticals, Inc.

Approved

1 2

Avastin

BBio-Thera Solutions

Preclinical

153 3

Nolvadex

SSan Diego Pacific Oncology & Hematology Associates

Preclinical

78 4

Gemzar

GGynecologic Oncology Group

Preclinical

22 5

DATROWAY

Daiichi Sankyo

Preclinical

4 6

Voltaren

Novartis

Preclinical

1 7

Lupron

EEastern Cooperative Oncology Group

Preclinical

5 8

MS Contin

HHikma Pharmaceuticals LLC

Preclinical

3 9

Zinecard

CChildren's Oncology Group

Preclinical

2 10

Tricor

JJagotec

Preclinical

Ranked by pipeline maturity and clinical activity. Current drug highlighted in teal.

Timeline

Expected Milestones

Q4 2026

Phase 2/3Recruiting

Adjuvant Treatment

NCT07404397

ApprovedNot yet recruiting

Minimally Invasive Surgical Procedures

NCT07664956

Q3 2027

Recruiting

Infants

NCT03511118

Clinical

Trials by Indication[1]

Adult2 trials

Comparative Pharmacokinetics and Safety of TNX-102 SL Tablets and Cyclobenzaprine Oral Tablet in Healthy Adults

Completed·TTonix Pharmaceuticals, Inc.·Phase 1·NCT01689259·24 enrolled

Comparative Pharmacokinetics and Safety of 3 Different Formulations of TNX-102 2.8 mg SL Tablets and Cyclobenzaprine 5 mg Oral Tablet in Healthy Adults

Completed·TTonix Pharmaceuticals, Inc.·Phase 1·NCT01889173·24 enrolled

Pain Control1 trial

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

Terminated·AApsen Farmaceutica S.A.·Phase 3·NCT03127592·140 enrolled

Efficacy and Safety1 trial

Efficacy and Safety of the Combination of Ketoprofen and Cyclobenzaprine in Osteomuscular Treatment

Completed·EEMS·Phase 3·NCT03025113·416 enrolled

Breast Cancer1 trial

Pilot Study of Cyclobenzaprine for Treatment of Sleep Disturbance in Aromatase Inhibitor-treated Breast Cancer Patients

Terminated·LLynn Henry·Phase 2·NCT01921296·2 enrolled

Muscle Cramp1 trial

Cyclobenzaprine in Muscle Cramps With Liver Cirrhosis

Unknown status·TTanta University·Phase 3·NCT02642861·200 enrolled

10 more indications

Infants1 trial

Pharmacokinetics and Safety of Commonly Used Drugs in Lactating Women and Breastfed Infants

Recruiting·—··NCT03511118·1,600 enrolled

Medication1 trial

Medication Effects on Periurethral Sensation,Urethral Sphincter Activity and Pressure Flow Parameters

Completed·UUniversity of Alabama at Birmingham·N/A·NCT01028014·56 enrolled

Low back pain1 trial

A Randomized Study of Three Medication Regimens for Acute Low Back Pain

Completed·MMontefiore Medical Center·Phase 4·NCT01587274·323 enrolled

Surgery1 trial

Use of Cyclobenzaprine After Vaginal Surgery

Completed·EEndeavor Health·N/A·NCT01081990·63 enrolled

Intravenous1 trial

Comparative Bioavailability of Sublingual TNX-102, Oral and Intravenous Cyclobenzaprine in Healthy Adults

Completed·TTonix Pharmaceuticals, Inc.·Phase 1·NCT01634412·24 enrolled

Driving1 trial

Driving Simulation to Assess Non-Sedative Effects of Tolperisone

Completed·NNeurana Pharmaceuticals, Inc.·Phase 1·NCT03353922·35 enrolled

Ankle Surgery1 trial

Opiate Free Multimodal Pain Pathway in Elective Foot and Ankle Surgery: A Prospective Study

Completed·PPrisma Health-Midlands··NCT04771741·72 enrolled

Clinical Trial1 trial

Comparison of Ibuprofen, Cyclobenzaprine, or Both for Acute Cervical Strain: A Randomized Clinical Trial

Completed·SStony Brook University·Phase 2·NCT00790270·61 enrolled

Adjuvant Treatment1 trial

Comparing Adjuvant Treatments for High Tone Pelvic Floor Dysfunction

Recruiting·UUniversity of Michigan·Phase 2/3·NCT07404397·60 enrolled

Minimally Invasive Surgical Procedures1 trial

Cyclobenzaprine for Postoperative Pain in Minimally Invasive Hysterectomy: A Randomized Controlled Trial

Not yet recruiting·CChristiana Care Health Services·Approved·NCT07664956·36 enrolled

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]
ClinicalTrials.gov — 16 trial records for Cyclobenzaprine. U.S. National Library of Medicine, National Institutes of Health.
[2]
MedlinePlus Drug Information — Amrix drug information. U.S. National Library of Medicine, National Institutes of Health.
[3]
ChEMBL — Cyclobenzaprine compound record. European Bioinformatics Institute (EMBL-EBI).
[4]
Open Targets Platform — Drug–disease associations for Cyclobenzaprine. EMBL-EBI & Wellcome Sanger Institute.
[5]
OpenFDA — FDA approval records (NDA NDA219428). U.S. Food & Drug Administration.
[6]
FDA Orange Book — Patent and exclusivity data for Amrix. U.S. Food & Drug Administration.
[7]
SEC EDGAR — Tonix Pharmaceuticals, Inc. company filings. U.S. Securities and Exchange Commission.

Details

Drug Info

Quick Facts

Modality: Small molecule[3]
Highest Phase: Approved[1]
Company: TTonix Pharmaceuticals, Inc.

Patent Landscape[6]

Patent Cliff

Mar 14, 2034

Earliest patent expiration — generic entry possible after this date

Patent #Expires

10117936Mar 14, 2034

10864175Mar 14, 2034

9636408Mar 14, 2034

9956188Mar 14, 2034

Amrix

Status by Indication[4][1]

Competitive Landscape

Expected Milestones

Q4 2026

Q3 2027

Trials by Indication[1]

Adult2 trials

Pain Control1 trial

Efficacy and Safety1 trial

Breast Cancer1 trial

Muscle Cramp1 trial

Infants1 trial

Medication1 trial

Low back pain1 trial

Surgery1 trial

Intravenous1 trial

Driving1 trial

Ankle Surgery1 trial

Clinical Trial1 trial

Adjuvant Treatment1 trial

Minimally Invasive Surgical Procedures1 trial

FDA Approval Timeline[5]

References

Drug Info

Quick Facts

Patent Landscape[6]

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