Zanaflex

(Tizanidine)

ApprovedSmall molecule

Zanaflex is a small molecule that works as Adrenergic Receptor Alpha-2 Agonist.[2] It is being used across 12 indications, with its most advanced program in Approved.[1]

Zanaflex is one of 192 small molecule programs targeting Muscle Cramp. It is currently in Approved.

Indications

Total Trials

Active Trials

191

Competitors

FDA Applications

NDA/BLA/ANDA regulatory filings

Patents

Pipeline

Status by Indication[3][1]

Indication

Muscle CrampActive, not recruiting

MelanomaApproved

SpasticityApproved

Low Back PainActive, not recruiting

CognitionActive, not recruiting

Total Knee ArthroplastyActive, not recruiting

Post OperativeNot yet recruiting

Spinal Cord InjuriesActive, not recruiting

PreoperativeRecruiting

Spine SurgeryRecruiting

Muscle CrampApproved

Active, not recruiting

MelanomaApproved

Approved

SpasticityApproved

Approved

Low Back PainApproved

Active, not recruiting

CognitionApproved

Active, not recruiting

Total Knee ArthroplastyPreclinical

Active, not recruiting

Post OperativePhase 2

Not yet recruiting

Spinal Cord InjuriesPreclinical

Active, not recruiting

PreoperativePreclinical

Recruiting

Spine SurgeryPhase 3

Recruiting

Showing 10 of 11 indications

Competition

Competitive Landscape

191 competitors in Melanoma

#DrugCompanyPhaseTrials

Zanaflex

LLegacy Health System

Approved

22 2

Mekinist

Novartis

Phase 3

45 3

Cotellic

Roche

Phase 3

21 4

Zelboraf

CConrado Roberto Hoffmann Filho

Phase 3

39 5

Taxol

Teva

Phase 3

13 6

Tecentriq

Roche

Phase 3

11 7

Proleukin

IIovance Biotherapeutics, Inc.

Phase 3

28 8

Lenvima

Eisai

Phase 3

9 9

Libtayo

Regeneron

Phase 3

6 10

Intron a

Merck & Co.

Phase 3

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

Timeline

Expected Milestones

Q3 2027

PreclinicalActive, not recruiting

Spinal Cord Injuries

NCT07792616

Q3 2028

Phase 3Recruiting

Spine Surgery

NCT06027099

Phase 2Not yet recruiting

Post Operative

NCT07766837

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

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

Chronic pain1 trial

Gabapentin and Tizanidine for Insomnia in Chronic Pain

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

16 more indications

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

Shoulder Arthroplasty1 trial

Opioid-Free Pain Protocol After Shoulder Arthroplasty

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

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

Thyroid1 trial

Tizanidine and Superficial Cervical Block on Pain After Thyroidectomy

Completed·—·Phase 4·NCT02725359·60 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

Urinary retention1 trial

Effect of Tizanidine on Postoperative Urinary Retention After Sacrospinous Suspension

Completed·EEndeavor Health·Phase 3·NCT06258785·20 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

Cognitive impairment1 trial

Assessment of the Effect of Metaxalone 640 mg (M640) on Truck Driving Ability and Cognition Compared to Tizanidine 8 mg: A Prospective, Single-blind, Within-subject Pilot Study

Completed·PPrimus Pharmaceuticals·Approved·NCT06382662·20 enrolled

Preoperative1 trial

The Effect of Preoperative Administration of Oral Tizanidine on the Postoperative Pain and Sleep Quality in Patients Undergoing Lower Limb Orthopedic Surgery: A Randomized Placebo Controlled Study

Recruiting·TTanta University·Preclinical·NCT07800364·68 enrolled

Spinal Cord Injuries1 trial

Electrical Neuromodulation for Modifying Spinal Network Involved in Spasticity

Active, not recruiting·UUniversity of Mississippi Medical Center·Preclinical·NCT07792616·12 enrolled

Stroke1 trial

Effect of Neural Constraints on Movement in Stroke

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

Post Operative1 trial

Postoperative Tizanidine Use in Pelvic Reconstructive Surgery: A Pilot Study

Not yet recruiting·HHartford Hospital·Phase 2·NCT07766837·186 enrolled

Unspecified2 trials

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

Terminated· Teva logo

Teva·Phase 1/2·NCT00464958·10 enrolled

Tizanidine and Acoustic Reflex

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

Regulatory

FDA Approval Timeline[4]

Sep 2, 1997

ZANAFLEX

NDA NDA020397

Sep 2, 1997

ZANAFLEX

NDA NDA020397

Oct 23, 1997

ZANAFLEX

NDA NDA020397

Jun 15, 1999

ZANAFLEX

NDA NDA020397

Feb 4, 2000

ZANAFLEX

NDA NDA020397

Feb 4, 2000

ZANAFLEX

NDA NDA020397

Jun 26, 2000

ZANAFLEX

NDA NDA020397

Aug 21, 2000

ZANAFLEX

NDA NDA020397

Dec 7, 2000

ZANAFLEX

NDA NDA020397

Mar 20, 2001

ZANAFLEX

NDA NDA020397

Aug 21, 2001

ZANAFLEX

NDA NDA020397

Aug 22, 2001

ZANAFLEX

NDA NDA020397

Apr 10, 2002

ZANAFLEX

NDA NDA020397

May 17, 2002

ZANAFLEX

NDA NDA020397

Aug 29, 2002

ZANAFLEX

NDA NDA021447

Aug 29, 2002

ZANAFLEX

NDA NDA021447

Nov 27, 2002

ZANAFLEX

NDA NDA020397

Jul 28, 2006

ZANAFLEX

NDA NDA020397

Jul 28, 2006

ZANAFLEX

NDA NDA021447

Mar 8, 2013

ZANAFLEX

NDA NDA021447

Mar 19, 2013

ZANAFLEX

NDA NDA020397

Nov 7, 2013

ZANAFLEX

NDA NDA021447

Nov 7, 2013

ZANAFLEX

NDA NDA020397

Aug 29, 2014

ZANAFLEX

NDA NDA021447

May 27, 2016

ZANAFLEX

NDA NDA020397

May 27, 2020

TIZANIDINE HYDROCHLORIDE

NDA ANDA213798

Dec 18, 2020

ZANAFLEX

NDA NDA021447

May 31, 2024

ZANAFLEX

NDA NDA020397

Nov 22, 2024

ZANAFLEX

NDA NDA021447

Nov 22, 2024

ZANAFLEX

NDA NDA020397

Dec 12, 2024

ONTRALFY

NDA NDA216190

Sources

References

[1]
ClinicalTrials.gov — 22 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 2027

Q3 2028

Q3 2029

Trials by Indication[1]

Spine Surgery1 trial

Pain1 trial

Low back pain1 trial

Chronic pain1 trial

Women1 trial

Fed1 trial

Fasting Conditions1 trial

Shoulder Arthroplasty1 trial

Total Knee Arthroplasty1 trial

Multiple Sclerosis1 trial

Mastectomy1 trial

Thyroid1 trial

Analgesic Efficacy1 trial

Urinary retention1 trial

Malignancies1 trial

Cognitive impairment1 trial

Preoperative1 trial

Spinal Cord Injuries1 trial

Stroke1 trial

Post Operative1 trial

Unspecified2 trials

FDA Approval Timeline[4]

References

Drug Info

Quick Facts

Patent Landscape[5]

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