Drugs / Riluzole
Riluzole
also known as
Rilutek · BHV-0223 · 2-amino-6-trifluoromethoxybenzothiazole · Exservan · NSC-753433 · NSC-759823 · Rilutek (Registered Trademark) · Riluzol · +5 more
Regulatory milestones approvals, filings & regulatory actions · 4 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Filed amyotrophic lateral sclerosis 28 1 milestone | |||||
| Filed | US (FDA) | Exservan | amyotrophic lateral sclerosis 28 | 2019-04-16 | “has accepted the Company's New Drug Application (NDA) for the investigational product riluzole oral film” aquestive.com ↗ |
| Approved Indication not stated 3 milestones | |||||
| Label expansion | US (FDA) | TIGLUTIK KIT | — | 2019-12-13 | fda.gov ↗ |
| Approved | EU (EMA) | Rilutek | — | 1996-06-10 | europa.eu ↗ |
| Approved | US (FDA) | RILUTEK | — | 1995-12-12 | fda.gov ↗ |
Trials 54
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 03 trials | ||||||
| Phase 0 | NCT06270108 | Nov 2022 → Dec 2024 | treatment-refractory schizophrenia | King's College London | Unknown | No outcome recorded |
| Phase 0 | NCT04630444 | Mar 2017 → Mar 2019 | post-traumatic stress disorder | Mclean Hospital | Completed | No outcome recorded |
| Phase 0 | NCT02081027 | Sep 2013 → Apr 2015 | autism spectrum disorder | Children's Hospital Medical Center, Cincinnati | Completed | No outcome recorded |
| Phase 113 trials · 1 met primary | ||||||
| Phase 1 | NCT07618715 | Jun → Aug 2026 overdue | — | Neurodawn Pharmaceutical Co., Ltd. | Not yet recruiting | No outcome recorded |
| Phase 1 | NCT07093268 | Aug 2025 → Jun 2026 overdue | amyotrophic lateral sclerosis | Brain Trust Bio | Not yet recruiting | No outcome recorded |
| Phase 1 | NCT07013773 | May → Jul 2025 overdue | — | Beijing Tiantan Hospital | Recruiting | No outcome recorded |
| Phase 1 | NCT06935721 | Mar → May 2025 overdue | — | Beijing Tiantan Hospital | Recruiting | No outcome recorded |
| Phase 1 | NCT06935682 | Jan → May 2025 overdue | — | Beijing Tiantan Hospital | Recruiting | No outcome recorded |
| Phase 1 | NCT04761614 | Apr 2021 → Apr 2023 | colorectal carcinoma | Ning Jin | Completed | No outcome recorded |
| Phase 1 | NCT04819438 | Jan → Mar 2021 | — | Cross Research S.A. | Completed | Met primary |
| Phase 1 | NCT03520517 | Feb → Oct 2018 | amyotrophic lateral sclerosis | Biohaven Pharmaceuticals, Inc. | Completed | No outcome recorded |
| Phase 1 | NCT02019940 | Jan 2014 → Jan 2020 | post-traumatic stress disorder | Yale University | Completed | No outcome recorded |
| Phase 1 | NCT01303341 | Feb 2011 → May 2012 overdue | cutaneous melanoma | National Cancer Institute (NCI) | Active not recruiting | No outcome recorded |
| Phase 1 | NCT01018836 | Nov 2009 → Dec 2013 | cancer of unknown primary site, metastatic malignant neoplasm | Rutgers, The State University of New Jersey | Terminated | No outcome recorded Stop: Enrollment |
| Phase 1 | NCT00903214 | May 2009 → Jun 2011 | female breast carcinoma | Barbara Ann Karmanos Cancer Institute | Withdrawn | No outcome recorded Stop: Business |
| Phase 1 | NCT00667901 | Feb 2007 → Oct 2008 | cutaneous melanoma | University of Medicine and Dentistry of New Jersey | Terminated | No outcome recorded Stop: Enrollment |
| Phase 1/21 trial · 1 missed | ||||||
| Phase 1/2 | NCT02155829 | Jul 2013 → Oct 2017 | post-traumatic stress disorder | Uniformed Services University of the Health Sciences | Completed | Missed primary |
| Phase 220 trials · 6 missed | ||||||
| Phase 2 | NCT07275762 | Feb → Jul 2026 overdue | postherpetic neuralgia | Neurodawn Pharmaceutical Co., Ltd. | Recruiting | No outcome recorded |
| Phase 2 | NCT07447050 | Dec 2025 → Dec 2027 expected | breast cancer, colorectal cancer, gastric cancer, head and neck cancer +5 | University of California, Irvine | Recruiting | No outcome recorded |
| Phase 2 | NCT06580002 | Dec 2024 → Jul 2027 expected | Hodgkins lymphoma, brain cancer, breast cancer, colorectal cancer +14 | University of California, Irvine | Recruiting | No outcome recorded |
| Phase 2 | NCT05292209 | Jun 2022 → Oct 2024 overdue | paroxysmal atrial fibrillation | University of Utah | Recruiting | No outcome recorded |
| Phase 2 | NCT03722680 | Oct 2020 → Aug 2024 | chemotherapy-induced neuropathy | UNICANCER | Suspended | No outcome recorded Stop: Business |
| Phase 2 | NCT02859792 | May 2019 → Nov 2023 | spinal cord injury | Assistance Publique Hopitaux De Marseille | Unknown | No outcome recorded |
| Phase 2 | NCT03679975 | Apr → Sep 2018 | amyotrophic lateral sclerosis | Aquestive Therapeutics | Terminated | No outcome recorded |
| Phase 2 | NCT03457753 | Mar 2018 | amyotrophic lateral sclerosis | Aquestive Therapeutics | Withdrawn | No outcome recorded |
| Phase 2 | NCT01910259 | Dec 2014 → Jun 2018 | secondary progressive multiple sclerosis | University College, London | Completed | Missed primary |
| Phase 2 | NCT01703117 | Nov 2013 → May 2020 | Alzheimer disease | Icahn School of Medicine at Mount Sinai | Completed | No outcome recorded |
| Phase 2 | NCT01703039 | Jan 2013 → Jun 2018 | major depressive disorder | Brigham and Women's Hospital | Terminated | Missed primary Stop: Enrollment |
| Phase 2 | NCT01204918 | Jun 2011 → May 2015 | depressive disorder | Yale University | Completed | No outcome recorded |
| Phase 2 | NCT00866840 | Apr 2009 → Jul 2013 | cutaneous melanoma | Rutgers, The State University of New Jersey | Completed | Missed primary |
| Phase 2 | NCT00523718 | Sep 2006 → Aug 2015 | obsessive-compulsive disorder | Yale University | Completed | Missed primary |
| Phase 2 | NCT00251303 | Aug 2005 → Feb 2012 | autism, obsessive-compulsive disorder, specific developmental disorder | National Institute of Mental Health (NIMH) | Completed | Missed primary |
| Phase 2 | NCT00202397 | Jun 2005 → Jun 2008 | cerebellar ataxia, hereditary ataxia, multiple sclerosis | S. Andrea Hospital | Completed | No outcome recorded |
| Phase 2 | NCT00376220 | May 2004 → May 2010 | bipolar depression | Johns Hopkins University | Completed | No outcome recorded |
| Phase 2 | NCT00054704 | Feb 2003 → Dec 2014 | bipolar disorder | National Institute of Mental Health (NIMH) | Terminated | Missed primary |
| Phase 2 | NCT00026052 | Nov 2001 → Apr 2003 | depressive disorder | National Institute of Mental Health (NIMH) | Completed | No outcome recorded |
| Phase 2 | NCT00013624 | Mar 2001 → Mar 2005 | Parkinson disease | National Institute of Neurological Disorders and Stroke (NINDS) | Completed | No outcome recorded |
| Phase 2/34 trials · 1 met primary · 2 missed | ||||||
| Phase 2/3 | NCT03660917 | Jun 2021 → Sep 2025 overdue | autosomal dominant cerebellar ataxia | S. Andrea Hospital | Recruiting | No outcome recorded |
| Phase 2/3 | NCT03017508 | Jan 2017 → Dec 2019 | social phobia | Yale University | Completed | Missed primary |
| Phase 2/3 | NCT01597518 | Oct 2013 → Oct 2020 | spinal cord injury | AOSpine North America Research Network | Terminated | Missed primary Stop: Enrollment |
| Phase 2/3 | NCT01104649 | Apr 2010 → Feb 2014 | cerebellar ataxia | S. Andrea Hospital | Completed | Met primary |
| Phase 34 trials · 3 missed | ||||||
| Phase 3 | NCT03347344 | Jan 2018 → Dec 2020 | spinocerebellar ataxia type 2 | Assistance Publique - Hôpitaux de Paris | Completed | Missed primary |
| Phase 3 | NCT01257828 | Mar 2012 → Dec 2017 | spondylosis, cervical | AOSpine North America Research Network | Completed | Missed primary |
| Phase 3 | NCT00211224 | Apr 2000 → Nov 2004 | multiple system atrophy, progressive supranuclear palsy | King's College London | Terminated | Missed primary |
| Phase 3 | NCT00277602 | Nov 1999 → Jul 2004 | Huntington disease | Sanofi | Completed | No outcome recorded |
| Phase 45 trials · 2 missed | ||||||
| Phase 4 | NCT02796755 | Apr 2016 → Oct 2019 | — | Emory University | Completed | No outcome recorded |
| Phase 4 | NCT01018056 | Nov 2009 → Sep 2013 | Tourette syndrome | Johns Hopkins University | Completed | No outcome recorded |
| Phase 4 | NCT00895752 | Apr 2009 → Jul 2010 | fragile X syndrome | Indiana University | Completed | Missed primary |
| Phase 4 | NCT00419003 | Dec 2006 → Jul 2008 | major depressive disorder | Baylor College of Medicine | Completed | Missed primary |
| Phase 4 | NCT00542412 | Jan 2001 → Dec 2004 | amyotrophic lateral sclerosis | Sanofi | Completed | No outcome recorded |
| Phase not applicable3 trials | ||||||
| — | NCT02136823 | Jun 2009 → May 2015 | spinal cord injury | Shirley Ryan AbilityLab | Unknown | No outcome recorded |
| — | NCT00544544 | Jun 2007 → Jun 2009 | bipolar depression | Mclean Hospital | Completed | No outcome recorded |
| — | NCT00375050 | May 2002 → Aug 2006 | schizoaffective disorder, schizophrenia | Yale University | Completed | No outcome recorded |
| Phase not stated1 trial | ||||||
| — | NCT03537807 | — | amyotrophic lateral sclerosis | Biohaven Pharmaceuticals, Inc. | No longer available | No outcome recorded |
| Comparator or background therapy27 trials | ||||||
| Phase 0 | NCT04454840 Comparator | May 2016 → May 2019 | amyotrophic lateral sclerosis | Peking University Third Hospital | Completed | No outcome recorded |
| Phase 1 | NCT06676423 Background | Nov 2022 → Nov 2023 | amyotrophic lateral sclerosis | Corestemchemon, Inc. | Completed | No outcome recorded |
| Phase 1/2 | NCT07414212 Background | Nov 2025 → Nov 2026 expected | amyotrophic lateral sclerosis | Biogipuzkoa Health Research Institute | Recruiting | No outcome recorded |
| Phase 1/2 | NCT04326283 Comparator | Apr 2020 → Apr 2023 | amyotrophic lateral sclerosis | Genuv Inc. | Terminated | No outcome recorded |
| Phase 2 | NCT07834450 Background | Oct 2026 → Oct 2028 expected | amyotrophic lateral sclerosis | Huashan Hospital | Not yet recruiting | No outcome recorded |
| Phase 2 | NCT07142291 Background | Nov 2025 → Mar 2027 expected | amyotrophic lateral sclerosis | PhenoNet, Inc. | Recruiting | No outcome recorded |
| Phase 2 | NCT05508074 Background | Dec 2022 → Nov 2024 | amyotrophic lateral sclerosis | InFlectis BioScience | Completed | Met primary |
| Phase 2 | NCT03039673 Background | Jun 2017 → Jul 2021 | amyotrophic lateral sclerosis | Nîmes University Hospital | Completed | No outcome recorded |
| Phase 2 | NCT02238626 Background | Sep 2014 → Aug 2017 | amyotrophic lateral sclerosis | MediciNova | Completed | No outcome recorded |
| Phase 2 | NCT01661855 Comparator | Sep 2013 → Sep 2015 | autism spectrum disorder | Holland Bloorview Kids Rehabilitation Hospital | Completed | No outcome recorded |
| Phase 2 | NCT01709149 Background | Oct 2012 → Mar 2014 | amyotrophic lateral sclerosis | Cytokinetics | Completed | Missed primary |
| Phase 2 | NCT01486849 Background | Nov 2011 → Mar 2012 | amyotrophic lateral sclerosis | Cytokinetics | Completed | No outcome recorded |
| Phase 2 | NCT00805493 Comparator | Nov 2008 → Jun 2012 | anxiety disorder, bipolar depression | National Institute of Mental Health (NIMH) | Terminated | No outcome recorded Stop: Enrollment |
| Phase 2 | NCT00501943 Comparator | Jul 2006 → Oct 2012 | multiple sclerosis | University of California, San Francisco | Completed | No outcome recorded |
| Phase 2/3 | NCT04950933 Comparator | Jun 2020 → Dec 2021 | amyotrophic lateral sclerosis | Peking University Third Hospital | Unknown | No outcome recorded |
| Phase 2/3 | NCT03272802 Background | Mar 2017 → Mar 2019 | neuromuscular disease | Isfahan University of Medical Sciences | Unknown | No outcome recorded |
| Phase 2/3 | NCT02588677 Background | Apr 2013 → Dec 2016 | amyotrophic lateral sclerosis | AB Science | Completed | No outcome recorded |
| Phase 2/3 | NCT00818389 Comparator | Jan → Oct 2009 | amyotrophic lateral sclerosis | Massachusetts General Hospital | Terminated | No outcome recorded |
| Phase 2/3 | NCT00774423 Comparator | Jan 2006 → Sep 2011 | spinal muscular atrophy | Assistance Publique - Hôpitaux de Paris | Completed | No outcome recorded |
| Phase 2/3 | NCT00353665 Background | Jul 2005 → Jun 2008 | amyotrophic lateral sclerosis | University of Lisbon | Completed | No outcome recorded |
| Phase 3 | NCT07174492 Background | Jan 2026 → Dec 2028 expected | amyotrophic lateral sclerosis | AB Science | Not yet recruiting | No outcome recorded |
| Phase 3 | NCT04745299 Background | Feb 2021 → Oct 2024 | amyotrophic lateral sclerosis | Corestemchemon, Inc. | Completed | No outcome recorded |
| Phase 3 | NCT03127267 Background | Feb 2021 → Dec 2027 expected | amyotrophic lateral sclerosis | AB Science | Recruiting | No outcome recorded |
| Phase 3 | NCT00868166 Background | Apr 2009 → Sep 2011 | amyotrophic lateral sclerosis | Hoffmann-La Roche | Completed | Missed primary |
| Phase 4 | NCT00283309 Comparator | Nov 2005 → Apr 2007 | — | University of Texas Southwestern Medical Center | Terminated | No outcome recorded Stop: Enrollment |
| — | NCT04518540 Background | Sep 2020 → Sep 2022 | amyotrophic lateral sclerosis | Second Affiliated Hospital, School of Medicine, Zhejiang University | Unknown | No outcome recorded |
| — | NCT02645461 Background | Jan 2014 → Jun 2015 | amyotrophic lateral sclerosis | University of Roma La Sapienza | Completed | No outcome recorded |
News releases announcing trial results or a regulatory action · 11
| Date | Issuer | Release |
|---|---|---|
| 2024-03-25 | Brain Trust Bio | Regulatory Brain Trust Bio Receives Approval for Patient Trials Targeting ALS and other CNS Diseases with Continuous Intrathecal Drug Delivery Method braintrustbio.com ↗
Brain Trust Bio (BTB), a leader in the development of treatments for central nervous system (CNS) diseases, has received approval to commence Phase I clinical trials in Australia for its Continuous Intrathecal Drug Delivery Method. |
| 2019-12-04 | MediciNova | Results MediciNova Announces Additional Analyses from Completed Clinical Trial of MN-166 (ibudilast) in ALS Presented at the 30th International Symposium on ALS/MND in Perth, Australia medicinova.com ↗
With riluzole treatment only (without MN-166 treatment), greater disease progression was observed in short ALS history patients. |
| 2019-11-25 | XenoPort, Inc. | Regulatory Aquestive Therapeutics Receives FDA Approval for Exservan™ (riluzole) Oral Film aquestive.com ↗
today announced that Exservan™ (riluzole) Oral Film received early-action approval from the U.S. Food and Drug Administration ( FDA ) for the treatment of amyotrophic lateral sclerosis (ALS), an orphan disease. |
| 2019-04-16 | XenoPort, Inc. | Regulatory Aquestive Therapeutics Announces U.S. Food and Drug Administration (FDA) Acceptance of New Drug Application for Riluzole Oral Film for Treatment of ALS aquestive.com ↗ |
| 2016-03-03 | Portage Biotech | Regulatory Portage’s Biohaven Orphan Drug Designation Request Granted for the Treatment of Spinocerebellar Ataxia portagebiotech.com ↗
Portage Biotech Inc. (“Portage”) (OTC Market: PTGEF, Canadian Securities Exchange: PBT.U), and Biohaven Pharmaceutical Holding Company Limited (Biohaven), are pleased to announce that the Food and Drug Administration (“FDA”) has granted the company’s orphan drug designation request covering BHV-0223 for the treatment of spinocerebellar ataxia. |
| 2016-02-24 | Portage Biotech | Results Portage’s Biohaven Announces Positive Results from Phase I Study with BHV-0223 portagebiotech.com ↗
The final study results confirm that the pharmacokinetic, safety, and tolerability data with sublingual BHV-0223 support advancement of its clinical development. |
| 2015-11-19 | Portage Biotech | Results Portage’s Biohaven Announce Phase I Pharmacokinetic Study Meets Study Objectives and Supports Advancing BHV-0223 and also Appoints a CEO portagebiotech.com ↗ |
| 2015-07-23 | Portage Biotech | Regulatory Portage’s Biohaven Announces IND Filing for BHV-0223 for Phase I Clinical Testing portagebiotech.com ↗
Biohaven has filed an Investigational New Drug (IND) Application with the U.S. Food and Drug Administration (FDA) to conduct clinical testing of BHV-0223. |
| 2010-09-28 | Sun Pharmaceutical Industries, Inc. | Regulatory Sun Pharma announces USFDA tentative approval for generic Rilutek® sunpharma.com ↗ |
| 2003-01-30 | Impax Laboratories, LLC | Regulatory IMPAX Receives FDA Approval for Generic Rilutek amneal.com ↗
Jan. 30, 2003--IMPAX Laboratories, Inc. (NASDAQ:IPXL) today announced that the U.S. Food and Drug Administration (FDA) has granted final approval to the Company's Abbreviated New Drug Application (ANDA) for a generic version of Rilutek® (Riluzole 50mg) tablets. |
| 2002-07-22 | Impax Laboratories, LLC | Regulatory IMPAX Receives Tentative FDA Approval for Generic Rilutek amneal.com ↗
IMPAX Laboratories, Inc. (Nasdaq NM: IPXL) today announced that the U.S. Food and Drug Administration (FDA) has granted tentative approval to the Company's Abbreviated New Drug Application (ANDA) for a generic version of Rilutek® (Riluzole 50mg) tablets. |
All press releases naming this drug 28 releases
Evidence & citations 17 cited values
Every value below carries the sentence it was read from. 83 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | riluzole | “This study will evaluate the effects of the drug riluzole on Parkinson's disease symptoms and on dyskinesias (involuntary movements) that develop as a result of long-term...” NCT00013624 ↗79“Y-4 is a new fixed-dose combination drug product containing two active ingredients of pregabalin and riluzole.” NCT07013773 ↗ “Y-4 is a new fixed-dose combination drug product containing two active ingredients of pregabalin and riluzole.” NCT06935682 ↗ “At the same time, the patients will take domestic riluzole tablets 50mg orally, twice a day.” NCT04518540 ↗ “combination of pregabalin and riluzole” NCT07275762 ↗ “one riluzole tablet (50 mg riluzole)” NCT07618715 ↗ “riluzole 40 mg sublingual tablet” NCT03520517 ↗ “Drug: Riluzole” NCT01709149 ↗ |
| Known as | 2-amino-6-trifluoromethoxybenzothiazole | “Riluzole, 2-amino-6-trifluoromethoxybenzothiazole, an anti-glutamatergic drug has been shown to reduce excitotoxicity and confer neuroprotection at the site of injury following...” PMID 26394202 ↗ Sep 2015 |
| Known as | BHV-0223 | ClinicalTrials.gov intervention name — accepted as the source's own label NCT03017508 ↗ |
| Known as | Exservan | ChEMBL registry synonym — accepted as the source's own label CHEMBL744 ↗ |
| Known as | NSC-753433 | ChEMBL registry synonym — accepted as the source's own label CHEMBL744 ↗ |
| Known as | NSC-759823 | ChEMBL registry synonym — accepted as the source's own label CHEMBL744 ↗ |
| Known as | Rilutek | “Riluzole orodispersible film (test): The subjects will be treated with one orodispersible film containing 50 mg of riluzole in two out of the four study periods according to...” NCT04819438 ↗2“Riluzole (Rilutek®) is a benzothiazole drug, market approved, for Amyotrophic Lateral Sclerosis (ALS).” NCT03347344 ↗ “riluzole tablets (Rilutek®)” NCT06935721 ↗ |
| Known as | Rilutek (Registered Trademark) | “This study will examine the safety and effectiveness of the drug riluzole (Rilutek® (Registered Trademark)) for short-term treatment of depression symptoms” NCT00026052 ↗ |
| Known as | Riluzol | ChEMBL registry synonym — accepted as the source's own label CHEMBL744 ↗ |
| Known as | Riluzole zentiva | ChEMBL registry synonym — accepted as the source's own label CHEMBL744 ↗ |
| Known as | RP 54274 | ChEMBL registry synonym — accepted as the source's own label CHEMBL744 ↗ |
| Known as | Teglutik | ChEMBL registry synonym — accepted as the source's own label CHEMBL744 ↗ |
| Known as | Tiglutik | ChEMBL registry synonym — accepted as the source's own label CHEMBL744 ↗ |
| Known as | Tiglutik kit | ChEMBL registry synonym — accepted as the source's own label CHEMBL744 ↗ |
| Action | Inhibit | “Riluzole blocks the action of the chemical messenger glutamate” NCT00013624 ↗ |
| Modality | Small molecule | “Riluzole, a sodium channel blocking benzothiazole anticonvulsant, specifically exerts its neuroprotective effect by helping to maintain neuronal cellular ionic balance and by...” NCT01597518 ↗ |
| Route | Oral | “Patients will take riluzole or placebo (a look-a-like pill with no active ingredient) twice a day” NCT00013624 ↗ |