Drugs / Tizanidine
Tizanidine
also known as
Zanaflex · Sirdalud · Tizanidine HCl · tizanidine hydrochloride · AN-021 · DS 103-282 · Sirdalud mr · TIZ · +3 more
Regulatory milestones approvals, filings & regulatory actions · 1 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Approved | US (FDA) | ZANAFLEX | — | 1996-11-27 | fda.gov ↗ |
Trials 28
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 03 trials | ||||||
| Phase 0 | NCT06274021 | Mar 2024 → Dec 2025 | spinal cord injury | University of Mississippi Medical Center | Unknown | No outcome recorded |
| Phase 0 | NCT05789173 | Oct 2023 → Aug 2026 overdue | — | Indiana University | Recruiting | No outcome recorded |
| Phase 0 | NCT05852093 | Jun 2023 → Jun 2026 overdue | rotator cuff syndrome | Second Affiliated Hospital, School of Medicine, Zhejiang University | Not yet recruiting | No outcome recorded |
| Phase 14 trials | ||||||
| Phase 1 | NCT01844674 | Sep 2013 → Aug 2014 | melanoma | Hoffmann-La Roche | Completed | No outcome recorded |
| Phase 1 | NCT01405950 | May 2011 → Mar 2012 | spastic cerebral palsy | Acorda Therapeutics | Terminated | No outcome recorded |
| Phase 1 | NCT01068847 | Feb 2010 → Oct 2012 | drug dependence | University of Arkansas | Completed | No outcome recorded |
| Phase 1 | NCT00287157 | Dec 2006 → May 2007 | traumatic brain injury | Teva GTC | Completed | No outcome recorded |
| Phase 1/22 trials | ||||||
| Phase 1/2 | NCT00464958 | Jan → Dec 2008 | multiple sclerosis | Teva GTC | Terminated | No outcome recorded Stop: Business |
| Phase 1/2 | NCT00358293 | Dec 2006 → Feb 2007 | — | Teva GTC | Completed | No outcome recorded |
| Phase 23 trials | ||||||
| Phase 2 | NCT07766837 | Aug 2026 → Jul 2028 expected | — | Hartford Hospital | Recruiting | No outcome recorded |
| Phase 2 | NCT04429347 | Jul 2020 → Dec 2024 | chronic pain syndrome, insomnia | University of California, San Diego | Completed | No outcome recorded |
| Phase 2 | NCT01839279 | Apr 2013 → Feb 2014 | — | Acorda Therapeutics | Completed | No outcome recorded |
| Phase 36 trials | ||||||
| Phase 3 | NCT06027099 | Dec 2024 → Jan 2028 expected | chronic pain syndrome, opioid abuse | Stanford University | Recruiting | No outcome recorded |
| Phase 3 | NCT06863662 | Sep 2024 → Sep 2025 | — | Laboratorios Silanes S.A. de C.V. | Completed | No outcome recorded |
| Phase 3 | NCT06258785 | Sep 2024 → Sep 2025 | urinary bladder disorder | Endeavor Health | Completed | No outcome recorded |
| Phase 3 | NCT05484349 | Jun 2023 → Dec 2025 overdue | migraine with aura, migraine without aura | Second Affiliated Hospital, School of Medicine, Zhejiang University | Recruiting | No outcome recorded |
| Phase 3 | NCT01979510 | Nov 2013 → May 2014 | — | Merck Sharp & Dohme LLC | Withdrawn | No outcome recorded |
| Phase 3 | NCT00047580 | Jun → Sep 2002 | multiple sclerosis, spinal cord injury, stroke disorder | Elan Pharmaceuticals | Completed | No outcome recorded |
| Phase 46 trials · 1 met primary | ||||||
| Phase 4 | NCT06113211 | Oct 2024 → Sep 2026 overdue | disease of bone structure, substance-related disorder | Henry Ford Health System | Recruiting | No outcome recorded |
| Phase 4 | NCT06303076 | Sep 2024 → Sep 2026 overdue | major depressive disorder | Sultan Qaboos University | Not yet recruiting | No outcome recorded |
| Phase 4 | NCT07310628 | Aug 2022 → Jul 2025 | chronic pain syndrome | All India Institute of Medical Sciences | Completed | No outcome recorded |
| Phase 4 | NCT02725359 | Apr → Dec 2016 | — | Ataturk University | Completed | No outcome recorded |
| Phase 4 | NCT02016443 | Nov 2013 → Jun 2014 | — | Diskapi Teaching and Research Hospital | Completed | No outcome recorded |
| Phase 4 | NCT00430196 | Dec 2003 → Sep 2006 | — | Icahn School of Medicine at Mount Sinai | Completed | Met primary |
| Phase not applicable4 trials | ||||||
| — | NCT07800364 | Mar → Sep 2026 overdue | — | Tanta University | Recruiting | No outcome recorded |
| — | NCT07382921 | Jan → May 2026 overdue | fibromyalgia | Beijing Tiantan Hospital | Not yet recruiting | No outcome recorded |
| — | NCT07309354 | Jul 2025 → Apr 2026 | hearing disorder | Uşak University | Completed | No outcome recorded |
| — | NCT04574791 | Sep 2020 → Sep 2021 | — | Rothman Institute Orthopaedics | Unknown | No outcome recorded |
| Comparator or background therapy11 trials | ||||||
| Phase 0 | NCT06666673 Comparator | Aug 2024 → Jun 2029 expected | stroke disorder | Northwestern University | Recruiting | No outcome recorded |
| Phase 2 | NCT02887534 Comparator | Nov 2016 → Dec 2017 | — | Sun Pharma Advanced Research Company Limited | Withdrawn | No outcome recorded |
| Phase 3 | NCT07296770 Background | Oct 2026 → Dec 2028 expected | chronic pain syndrome | University of California, San Francisco | Not yet recruiting | No outcome recorded |
| Phase 3 | NCT02934061 Comparator | Oct 2016 → Jan 2017 | — | MDM S.p.A. | Completed | No outcome recorded |
| Phase 3 | NCT02508805 Background | May → Sep 2015 | radiculopathy | Bausch Health Americas, Inc. | Completed | No outcome recorded |
| Phase 4 | NCT06382662 Comparator | Apr → Dec 2024 | cognitive disorder | Primus Pharmaceuticals | Completed | No outcome recorded |
| Phase 4 | NCT05488847 Background | Jun 2022 → Dec 2024 overdue | arthropathy | Henry Ford Health System | Active not recruiting | No outcome recorded |
| Phase 4 | NCT04990804 Background | Aug 2021 → Feb 2022 | spinal cord disorder, substance-related disorder | Vanderbilt University Medical Center | Terminated | No outcome recorded |
| Phase 4 | NCT03068897 Comparator | May 2017 → Jul 2018 | — | Montefiore Medical Center | Completed | No outcome recorded |
| — | NCT07022353 Comparator | Jul → Dec 2025 | female breast carcinoma | Mansoura University | Completed | No outcome recorded |
| — | NCT07025187 Background | Jun → Nov 2025 | headache disorder | Kafrelsheikh University | Completed | No outcome recorded |
News releases announcing trial results or a regulatory action · 1
| Date | Issuer | Release |
|---|---|---|
| 2002-07-03 | Teva Branded Pharmaceutical Products R&D, Inc. | Regulatory Teva Announces Approval of Tizanidine HCl Tablets tevapharm.com ↗
Teva Pharmaceutical Industries Ltd. (Nasdaq: TEVA) announced today that the U. S. Food and Drug Administration has approved the company's ANDA for Tizanidine HCl Tablets, 2 mg and 4 mg. |
All press releases naming this drug 1 release
| Date | Issuer | Release |
|---|---|---|
| 2002-07-03 | Teva Branded Pharmaceutical Products R&D, Inc. | Teva Announces Approval of Tizanidine HCl Tablets tevapharm.com ↗ |
Evidence & citations 15 cited values
Every value below carries the sentence it was read from. 41 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | tizanidine | “Alternative muscle relaxers (Metaxalone 800 mg TID or Tizanidine 2-6 mg TID)” NCT04990804 ↗34“Phase 1b Study of Tizanidine in Pediatric Patients With Cerebral Palsy” NCT01405950 ↗ “Tizanidine: 4, 8, 12 mg oral capsules may possibly be given.” NCT01068847 ↗ “Zanaflex - also know as tizanidine 4mg PO q6hr” NCT06113211 ↗ “tizanidine 6 mg modified release” NCT01979510 ↗ “Tizanidine” NCT07296770 ↗ |
| Known as | AN-021 | ChEMBL registry synonym — accepted as the source's own label CHEMBL1079 ↗ |
| Known as | DS 103-282 | ChEMBL registry synonym — accepted as the source's own label CHEMBL1079 ↗ |
| Known as | Sirdalud | “Sirdalud®” NCT02934061 ↗ |
| Known as | Sirdalud mr | ChEMBL registry synonym — accepted as the source's own label CHEMBL1079 ↗ |
| Known as | TIZ | “Tizanidine (TIZ) (Zanaflex®) is a centrally acting noradrenergic α-2 agonist and a ligand of I3 (non-I1/I2) imidazoline receptors.” NCT06666673 ↗ |
| Known as | Tizanidina | ChEMBL registry synonym — accepted as the source's own label CHEMBL1079 ↗ |
| Known as | Tizanidine (as hydrochloride) | ChEMBL registry synonym — accepted as the source's own label CHEMBL1079 ↗ |
| Known as | Tizanidine HCl | “Oral Tizanidine HCl (12 mg) Versus Novel Sublingual Tizanidine HCl (12 mg)” NCT00358293 ↗1“Tizanidine Hcl 4Mg Tab” NCT06303076 ↗ |
| Known as | tizanidine hydrochloride | “tizanidine hydrochloride capsules versus Zanaflex® (tizanidine hydrochloride tablets)” NCT00047580 ↗ |
| Known as | Tizanidine: Zanaflex | “Tizanidine: Zanaflex” NCT01068847 ↗ |
| Known as | Zanaflex | “tizanidine hydrochloride capsules versus Zanaflex® (tizanidine hydrochloride tablets)” NCT00047580 ↗4“Zanaflex - also know as tizanidine 4mg PO q6hr” NCT06113211 ↗ “as compared to oral tizanidine (Zanaflex)” NCT00287157 ↗ “oral tizanidine (Zanaflex)” NCT00358293 ↗ |
| Action | Activate | “Tizanidine is a centrally acting α2-agonist with muscle relaxant properties.” PMID 26555871 ↗ Mar 2016 |
| Modality | Small molecule | “Tizanidine is an imidazoline derivative and a centrally acting alpha-2 receptor agonist with skeletal muscle relaxant, sedative and anxiolytic properties.” NCT07382921 ↗ |
| Route | Other | “Sublingual tizanidine” NCT00287157 ↗ |