Zanaflex

(Tizanidine)

ApprovedSmall molecule

Zanaflex is a small molecule that works as Adrenergic Receptor Alpha-2 Agonist.[2] It is being used across 11 indications, with its most advanced program in Approved.[1]

Zanaflex is one of 279 small molecule programs targeting Low back pain. It is currently in Approved.

Indications

Total Trials

Active Trials

278

Competitors

FDA Applications

NDA/BLA/ANDA regulatory filings

Patents

Pipeline

Status by Indication[3][1]

Indication

Low Back PainActive, not recruiting

SpasticityApproved

StrokeActive, not recruiting

Urinary RetentionActive, not recruiting

CognitionActive, not recruiting

Chronic PainActive, not recruiting

Total Knee ArthroplastyActive, not recruiting

Muscle CrampActive, not recruiting

MelanomaApproved

Multiple SclerosisActive, not recruiting

Low Back PainApproved

Active, not recruiting

SpasticityApproved

Approved

StrokePhase 1

Active, not recruiting

Urinary RetentionPhase 3

Active, not recruiting

CognitionApproved

Active, not recruiting

Chronic PainPhase 2

Active, not recruiting

Total Knee ArthroplastyPreclinical

Active, not recruiting

Muscle CrampApproved

Active, not recruiting

MelanomaApproved

Approved

Multiple SclerosisPhase 1/Phase 2

Active, not recruiting

Competition

Competitive Landscape

947 competitors in Melanoma

#DrugCompanyPhaseTrials

Zanaflex

LLegacy Health System

Approved

19 2

Lenvima

Eisai

Phase 3

9 3

Imjudo

AstraZeneca

Phase 3

2 4

GSK 257049

GSK

Phase 3

1 5

Actimmune

HHorizon Therapeutics Ireland DAC

Phase 3

—6

Carboplatin/paclitaxel

AstraZeneca

Phase 3

1 7

Vusolimogene Oderparepvec

YYana Najjar

Phase 3

1 8

Zelboraf

CConrado Roberto Hoffmann Filho

Preclinical

39 9

Isolated Limb Perfusion

MMemorial Sloan Kettering Cancer Center

Phase 3

2 10

Intron a

Merck & Co.

Preclinical

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

Timeline

Expected Milestones

Q3 2026

Post-ApprovalActive, not recruiting

Shoulder Arthroplasty

NCT05488847

Q3 2028

Phase 3Recruiting

Spine Surgery

NCT06027099

Q3 2029

Phase 1Recruiting

Stroke

NCT06666673

Clinical

Trials by Indication[1]

Spine Surgery1 trial

CARES-Spine (Comprehensive Analgesic, Recovery, and Education Support for Spine Surgery) Trial

Recruiting·SStanford University·Phase 3·NCT06027099·375 enrolled

Women1 trial

A Study to Define the ECG Effects of Tizanidine Compared to Placebo and the Positive Control, Moxifloxacin, in Healthy Men and Women Using a Blinded ECG Evaluator: A Thorough ECG Trial

Completed·AAcorda Therapeutics·Phase 2·NCT01839279·136 enrolled

Pain1 trial

Tizanidine and Pain After Herniorrhaphy

Completed·—·Phase 4·NCT02016443·30 enrolled

Low back pain1 trial

Ibuprofen Plus Metaxolone, Tizanidine, or Baclofen for Low Back Pain

Completed·MMontefiore Medical Center·Phase 4·NCT03068897·320 enrolled

Shoulder Arthroplasty1 trial

Opioid-Free Pain Protocol After Shoulder Arthroplasty

Active, not recruiting·HHenry Ford Health System·Phase 4·NCT05488847·83 enrolled

13 more indications

Urinary retention1 trial

Effect of Tizanidine on Postoperative Urinary Retention After Sacrospinous Suspension

Completed·EEndeavor Health·Phase 3·NCT06258785·20 enrolled

Chronic pain1 trial

Gabapentin and Tizanidine for Insomnia in Chronic Pain

Completed·UUniversity of California, San Diego·Phase 2·NCT04429347·9 enrolled

Fed1 trial

Bioequivalence Study of Tizanidine HCl 4mg Tablets of Dr.Reddy's Under Fed Conditions

Completed·—·Phase 1·NCT01065987·24 enrolled

Fasting Conditions1 trial

Bioequivalence Study of Tizanidine HCl Tablets 4 mg of Dr.Reddys Under Fasting Conditions

Completed·—·Phase 1·NCT01146028·42 enrolled

Cognition1 trial

Assess the Effect of Metaxalone 640 mg (M640) Compared to Tizanidine 8 mg on Truck Driving Ability and Cognition

Completed·PPrimus Pharmaceuticals·Phase 4·NCT06382662·20 enrolled

Thyroid1 trial

Tizanidine and Superficial Cervical Block on Pain After Thyroidectomy

Completed·—·Phase 4·NCT02725359·60 enrolled

Malignancies1 trial

A Study on the Effect of Vemurafenib on the Pharmacokinetics of a Single Dose of Tizanidine in Patients With BRAFV600 Mutation-Positive Metastatic Malignancies

Completed· Roche logo

Roche·Phase 1·NCT01844674·18 enrolled

Analgesic Efficacy1 trial

Comparison of Analgesic Efficacy of Intrathecal Levobupivacaine With and Without Oral Tizanidine in Lower Limb Surgeries: A Prospective Randomized Study

Completed·—·Phase 4·NCT07310628·64 enrolled

Stroke1 trial

Effect of Neural Constraints on Movement in Stroke

Recruiting·NNorthwestern University·Phase 1·NCT06666673·64 enrolled

Mastectomy1 trial

Bi-level Erector Spinae Plane Block and Pre-emptive Oral Tizanidine for Analgesia After Mastectomy Surgery

Completed·MMansoura University·N/A·NCT07022353·90 enrolled

Total Knee Arthroplasty1 trial

Addition of Muscle Relaxants in a Multimodal Analgesic Regimen for Analgesia After Primary Total Knee Arthroplasty

Unknown status·RRothman Institute Orthopaedics·N/A·NCT04574791·240 enrolled

Multiple Sclerosis1 trial

Study of Nighttime Dosing of Sublingual Tizanidine (12 mg) in Multiple Sclerosis (MS) Patients With Significant Spasticity

Completed· Teva logo

Teva·Phase 1/2·NCT00358293·20 enrolled

Unspecified2 trials

Tizanidine and Acoustic Reflex

Recruiting·—·N/A·NCT07309354·45 enrolled

One Year Extension Study To Protocol C2/5/TZ:MS-05

Terminated· Teva logo

Teva·Phase 1/2·NCT00464958·10 enrolled

Regulatory

FDA Approval Timeline[4]

Feb 4, 2000

ZANAFLEX

NDA NDA020397

Aug 29, 2002

ZANAFLEX

NDA NDA021447

Dec 12, 2024

ONTRALFY

NDA NDA216190

Sources

References

[1]
ClinicalTrials.gov — 19 trial records for Tizanidine. U.S. National Library of Medicine, National Institutes of Health.
[2]
ChEMBL — Tizanidine compound record. European Bioinformatics Institute (EMBL-EBI).
[3]
Open Targets Platform — Drug–disease associations for Tizanidine. EMBL-EBI & Wellcome Sanger Institute.
[4]
OpenFDA — FDA approval records (NDA NDA216190). U.S. Food & Drug Administration.
[5]
FDA Orange Book — Patent and exclusivity data for Zanaflex. U.S. Food & Drug Administration.
[6]
SEC EDGAR — Legacy Health System company filings. U.S. Securities and Exchange Commission.

Details

Drug Info

Quick Facts

Mechanism of Action: Adrenergic Receptor Alpha-2 Agonist[2]
Modality: Small molecule[2]
Highest Phase: Approved[1]
Company: LLegacy Health System

Patent Landscape[5]

Patent Cliff

May 7, 2042

Earliest patent expiration — generic entry possible after this date

Patent #Expires

12263158May 7, 2042

12042484May 7, 2042

Zanaflex

Status by Indication[3][1]

Competitive Landscape

Expected Milestones

Q3 2026

Q3 2028

Q3 2029

Trials by Indication[1]

Spine Surgery1 trial

Women1 trial

Pain1 trial

Low back pain1 trial

Shoulder Arthroplasty1 trial

Urinary retention1 trial

Chronic pain1 trial

Fed1 trial

Fasting Conditions1 trial

Cognition1 trial

Thyroid1 trial

Malignancies1 trial

Analgesic Efficacy1 trial

Stroke1 trial

Mastectomy1 trial

Total Knee Arthroplasty1 trial

Multiple Sclerosis1 trial

Unspecified2 trials

FDA Approval Timeline[4]

References

Drug Info

Quick Facts

Patent Landscape[5]

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