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Priya Life Science Compound trial record
Compound · clinical trials

Tizanidine clinical trials

Also listed in trial records as Sirdalud
Source: ClinicalTrials.gov, U.S. National Library of Medicine — the 2 trials in our Egypt register that name Tizanidine as an intervention. Synced 8 Nov 2026
2Current trials
1Recruiting now
2Lead sponsors
1Country register
At a glance

Tizanidine is named as an intervention in 2 current clinical trials in our Egypt register. 1 is recruiting patients now. All registered phases are Not applicable. The sponsor with the most trials is Beni-Suef University (1). The most-studied condition is Airway Management.

Where Tizanidine is approved

All regulators →

Of the three regulators tracked here, the first to approve Tizanidine was the US, on 27 Nov 1996. It is approved in 2 of the 3 regulators tracked here.

USUnited States (FDA)
27 Nov 1996
Zanaflex
NDA020397 on Drugs@FDA
First original NDA/BLA approval
EUEuropean Union (EMA)
No centralised EU authorisation (it may be authorised nationally)
First centralised authorisation
CACanada (Health Canada)
25 Jan 1999
Zanaflex
Notice of Compliance 2089
First new-drug NOC

From the regulators' own registers: FDA Drugs@FDA, the EMA medicines list and Health Canada's Notice of Compliance database. Dates are the first listed approval of a product containing only this substance; combination products and nationally authorised EU medicines are not counted.

Tizanidine patents and exclusivity

Expiry tracker →

Protections still running for marketed products containing Tizanidine, as listed by the regulators. Expired patents and exclusivities, and discontinued products, are not shown.

US FDA Orange Book Zanaflex, Ontralfy
  • 2 listed patents; the last listed expires 7 May 2042 (US 12263158).
See the Orange Book listing for NDA 021447
Patents and exclusivities above are pooled across 3 applications for this substance.

Reproduced from the FDA Orange Book and Purple Book (checked 8 Nov 2026) and the European Commission's Union Register of medicinal products (CC BY 4.0; the EU expiry date is calculated exactly as the Commission's register displays it). Listed patents and dates are as submitted to or published by the regulator and may not reflect litigation, invalidation, settlements, lapsed fees or later extensions. This is not legal advice or a freedom-to-operate opinion, and it does not say when a generic or biosimilar will launch.

What health systems spend on Tizanidine

All medicines →
ENNHS England
£506k
106,660 items dispensed, Sep 2025 to Aug 2026
-31% on the previous 12 months
Net ingredient cost, community prescriptions
USUS Medicaid
$23.4m
2,314,621 prescriptions in 2025 · Tizanidine, tizanidine, Tizanidine Hydrochloride
-3% on 2024
Amount Medicaid reimbursed, before rebates

From NHSBSA Prescription Cost Analysis (Open Government Licence v3.0) and CMS State Drug Utilization Data. Both are gross amounts: neither system publishes its discounts or rebates per drug. Products combining several substances are not counted here.

Patient leaflets for Tizanidine

The package leaflet is the official guide for patients that comes with every medicine. These links go to the regulators that publish it.

Leaflets differ between brands and countries; always read the one that comes with your own medicine. This is regulatory information, not medical advice.

Trials by status

  • Recruiting150%
  • Not yet open150%

Trials by phase

  • Not applicable2100%
01

Clinical trials of Tizanidine

2 trials
StudyPhaseStatusLead sponsorRegisters
The Effect of Preoperative Administration of Oral Tizanidine on the Postoperative Pain and Sleep Quality
NCT07800364 · The Effect of Preoperative Administration of Oral Tizanidine, Post Operative Pain
Not applicable Recruiting Tanta University Egypt
Tizanidine Premedication Versus Placebo for Laryngeal Mask Airway Insertion and Recovery in Adults Undergoing Ambulatory Surgery
NCT07921602 · ClinicalTrials.gov ↗ · Airway Management
Not applicable Not yet open Beni-Suef University Egypt

Registers list studies that are recruiting, about to open, active but closed to enrolment, or enrolling by invitation. The UK and USA registers cover industry-sponsored studies only. Trial titles and statuses are copied from the registry as published.

02

Tizanidine across our data

Ireland · EU · US

The same active substance in our other registers, matched by its exact name. Each entry links to the register record it comes from.

Licensed in Ireland (HPRA)

6 single-substance products containing Tizanidine on the HPRA medicines list.

All 6 Irish products →

Supply shortages

No entry for Tizanidine in the EMA, FDA or German BfArM shortage lists we track.

03

Conditions studied with Tizanidine

3 conditions
Airway Management1The Effect of Preoperative Administration of Oral Tizanidine1Post Operative Pain1
04

Sponsors

lead sponsor per trial
Lead sponsorTrials
Beni-Suef University1
Tanta University1
05

By country register

RegisterTrialsRecruiting
Clinical trials in Egypt21

A trial with sites in more than one country appears in each of those registers.

06

Questions about Tizanidine trials

How many clinical trials are testing Tizanidine?

2 current trials in our Egypt register name Tizanidine as a drug or biological intervention, as of the registry sync on 8 November 2026. Completed and withdrawn studies are not counted.

Are Tizanidine trials recruiting patients?

Yes. 1 of the 2 trials is recruiting: 1 with sites in Egypt. Eligibility and site contacts are on each trial's record. Only the study team can confirm whether a patient is eligible.

Who sponsors Tizanidine clinical trials?

Beni-Suef University (1) and Tanta University (1). The number in brackets is how many trials each organisation leads.

Is Tizanidine licensed in Ireland?

Yes. The HPRA medicines list includes 6 single-substance products containing Tizanidine, for example Zanaflex 2 mg Tablets (Teva Pharma B.V.). A licence does not mean a product is currently marketed or reimbursed; see each product's record.

Is there a Tizanidine shortage?

Not in the lists we track: Tizanidine has no entry in the EMA, FDA or German BfArM shortage registers as of their latest sync.

Where does this information come from?

Every trial, status, phase and sponsor on this page is copied from public ClinicalTrials.gov records by a daily sync. Nothing here describes how Tizanidine works or whether it is effective, and it is not medical advice.

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How this page is built

Everything on this page is copied from public ClinicalTrials.gov registry records — it is not written from memory, and nothing here describes how Tizanidine works or whether it is effective. Each trial links to its own record so you can check it yourself.

This page is built automatically: a daily sync job reads the registry records behind our country trial registers, collects every trial that lists Tizanidine (or a registered synonym) as a drug or biological intervention, and tabulates the registry fields directly. Placebos and generic comparators are excluded. There is no AI drafting and no per-compound editorial pass, and the page has not been clinically reviewed. The “last verified” date above is the timestamp of that sync, not a review date. Our general editorial approach is described in our editorial standards and corrections policy. The ClinicalTrials.gov data on this page was last retrieved on 8 Nov 2026. How every register is built: methodology · fixes we have made: corrections log.

Please verify before you rely on this. This page is general information for life-science and pharmaceutical professionals. It is not medical advice, and it has not been reviewed by a clinician — our editorial team holds life-science qualifications, not clinical ones. It is not exhaustive and may not reflect the most recent label change. Always check the official prescribing information (US Prescribing Information or EU SmPC) and speak to your doctor or pharmacist before acting on anything here. Drugs in the same class are not automatically interchangeable, and approvals, brand names and indications differ between the US, the EU/Ireland (EMA/HPRA) and other regions. Spotted an error? Tell us — we correct promptly and log it.