TheraRadar
Data updated: May 26, 2026

TIGLUTIK KIT (riluzole)

CNS Approved 2018-09-05

TIGLUTIK is indicated for the treatment of amyotrophic lateral sclerosis (ALS).

Source: FDA Label • ITALFARMACO SA
Jump to: Indications Approvals Trials Competitors Safety Patents
2
Indications
--
Phase 3 Trials
7
Years on Market

Details

Status
Prescription
First Approved
2018-09-05
Patent Cliff
2029

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Routes
ORAL
Dosage Forms
SUSPENSION

Companies

ITALFARMACO SA
Active Ingredient: RILUZOLE

TIGLUTIK KIT Approval History

2019
2020
2021
2022
2023
2024
2025
2026
Original
New Indication
New Form
Label Update
4 FDA actions from 2018 to 2025 · 1 indication expansions
Sep 2025 SUPPL
Label · Labeling
FDA Letter Label
May 2020 SUPPL
Label · Labeling
FDA Letter Label
Dec 2019 SUPPL
Efficacy
FDA Letter Label

What TIGLUTIK KIT Treats

2 FDA approvals

Originally approved for its first indication in 2018 . Covers 2 distinct patient populations.

  • Other (2)
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Clinical Trial Registry

34 trials
Trial Sponsor ID Phase Status Title
NCT04745299 ALSummit NEURONATA-R_ALS301 Ph 3 completed Evaluation the Efficacy and Safety of Mutiple Lenzumestrocel (Neuronata-R® Inj.) Treatment in Patients With ALS
NCT01303341 NCI-2011-02597 NCI-2011-02597, CDR0000695355 Ph 1 active not recruiting Riluzole and Sorafenib Tosylate in Treating Patients With Advanced Solid Tumors or Melanoma
NCT07447050 STUDY00000370 UCI 25-48 Ph 2 recruiting Riluzole For Preventing Cognitive Dysfunction in Ca Pts Receiving Chemo (REFOCUS): Pilot Trial
NCT07414212 NADALS-001-ALS NADALS-001-ALS-2021 2024-519857-13-00 Ph 1, Ph 2 recruiting Evaluation of the Combined Therapy of EH-301 and N-acetylcysteine Together With Riluzole in Amyotrophic Lateral Sclerosis (ALS)
NCT03039673 MIROCALS H2020/PHRC-N/2014/GB-01 2015-005347-14 Ph 2 completed MIROCALS: Modifying Immune Response and OutComes in ALS
NCT03127267 AB19001 Ph 3 recruiting Efficacy and Safety of Masitinib Versus Placebo in the Treatment of ALS Patients
NCT01661855 RILISE RILISE-07-2013 Ph 2 completed A Pilot Study of Riluzole Versus Placebo in the Treatment of Children and Adolescents With ASD
NCT06580002 4994 UCI 24-05 Ph 2 recruiting Repurposing Riluzole for Cancer-Related Cognitive Impairment: A Pilot Trial
NCT03722680 RILUZOX-01 UC-0106/1712 2017-002320-25 Ph 2 suspended Effectiveness Assessment of Riluzole in the Prevention of Oxaliplatin-induced Peripheral Neuropathy.
NCT04761614 OSU-20096 NCI-2021-00018 Ph 1 completed Riluzole in Combination With mFOLFOX6 and Bevacizumab in Treating Patients With Metastatic Colorectal Cancer
NCT03660917 AIFA-2016-02365063 Ph 2, Ph 3 recruiting Riluzole in Patients With Spinocerebellar Ataxia Type 7
NCT06676423 NEURONATA-ALSHT122 Ph 1 completed Evaluate the Safety of Neuronata-R® Inj. Suspended With HypoTHermosol® FRS (HTS-FRS) in Patients With ALS
NCT00866840 results posted 0220080280 P30CA072720, CINJ-090802 Ph 2 completed Riluzole in Treating Patients With Stage III or Stage IV Melanoma That Cannot Be Removed by Surgery
NCT02588677 AB10015 Ph 2, Ph 3 completed Masitinib in Combination With Riluzole for the Treatment of Patients Suffering From Amyotrophic Lateral Sclerosis (ALS)
NCT02238626 IBU-ALS-1201 results posted MN-166-ALS-1201 Ph 2 completed Ibudilast (MN-166) in Subjects With Amyotrophic Lateral Sclerosis (ALS)
NCT01703117 results posted GCO 18-0623 APE-0792 Ph 2 completed Riluzole in Mild Alzheimer's Disease
NCT03347344 ATRIL P160927J 2017-001481-23 Ph 3 completed Clinical Trial With Riluzole in Spinocerebellar Ataxia Type 2 (ATRIL)
NCT02155829 results posted 380797 Ph 1, Ph 2 completed Safety Study of Riluzole to Treat Post-traumatic Stress Disorder (PTSD)
NCT01597518 RISCIS SPN-12-001 Ph 2, Ph 3 terminated Riluzole in Spinal Cord Injury Study
NCT02796755 results posted IRB00086271 Ph 4 completed Effects of Riluzole on CNS Glutamate and Fatigue in Breast Cancer Survivors With High Inflammation
NCT02019940 results posted 1308012549 Ph 1 completed A Pilot Study Of Riluzole In Patients With Post Traumatic Stress Disorder (PTSD)
NCT01709149 results posted CY 4026 Ph 2 completed Study of Safety, Tolerability & Efficacy of CK-2017357 in Amyotrophic Lateral Sclerosis (ALS)
NCT01910259 MS-SMART 12/0219 Ph 2 completed MS-SMART: Multiple Sclerosis-Secondary Progressive Multi-Arm Randomisation Trial
NCT01204918 results posted 0903004917 137889 Ph 2 completed Efficacy and Tolerability of Riluzole in Treatment Resistant Depression
NCT00868166 MITOTARGET results posted WN29853 EudraCT Number:2008-007320-25, TRO19622 CL E Q 1015-1 Ph 3 completed Safety and Efficacy of TRO19622 as add-on Therapy to Riluzole Versus Placebo in Treatment of Patients Suffering From ALS
NCT01703039 RAPID results posted 2012P001841 Ph 2 terminated Riluzole Augmentation Pilot in Depression (RAPID) Trial
NCT01257828 CSM-Protect SPN-10-001 Ph 3 completed Efficacy of Riluzole in Surgical Treatment for Cervical Spondylotic Myelopathy (CSM-Protect)
NCT01018056 results posted NA_00023969 R34MH085844 Ph 4 completed Developing New Treatments for Tourette Syndrome: Therapeutic Trials With Modulators of Glutamatergic Neurotransmission
NCT00805493 results posted 090042 09-M-0042 Ph 2 terminated Double-Blind Placebo-Controlled Trial of Riluzole in Pediatric Bipolar Disorder
NCT00895752 results posted 0809-11 Ph 4 completed Riluzole in Fragile X Syndrome
NCT01104649 FARM7KAJM7 Ph 2, Ph 3 completed Efficacy of Riluzole in Hereditary Cerebellar Ataxia
NCT01018836 050808 CDR0000660044, P30CA072720 Ph 1 terminated Riluzole and Whole-Brain Radiation Therapy in Treating Patients With Brain Metastases
NCT00903214 CDR0000641180 P30CA022453, WSU-2008-120 Ph 1 withdrawn Riluzole in Women With Stage I, Stage II, or Stage IIIA Breast Cancer
NCT00818389 results posted U01NS049640 3U01NS049640-04S1 Ph 2, Ph 3 terminated Study to Investigate the Safety and Efficacy of Lithium in Volunteers With Amyotrophic Lateral Sclerosis (ALS)
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Active Pipeline

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Ongoing clinical trials by development phase

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Key Completed Trials

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Completed studies with published results, ranked by significance

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Trial Timeline

ClinicalTrials.gov ↗ Pro

Full development history with FDA approval milestones

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Understanding FDA Approval Types
Count Type What it means
- ORIG Original approval - drug first enters market
- SUPPL - Efficacy New indication (new disease/condition approved)
- SUPPL - Labeling Label text changes (warnings, dosing updates)
- SUPPL - Manufacturing Production changes (new facility)
- SUPPL - Chemistry Formulation changes (new dosage strength)

Green lines in the timeline show ORIG and Efficacy approvals - the clinically meaningful milestones.

TIGLUTIK KIT FDA Label Details

Indications & Usage

FDA Label (PDF)

TIGLUTIK is indicated for the treatment of amyotrophic lateral sclerosis (ALS). TIGLUTIK is indicated for the treatment of amyotrophic lateral sclerosis (ALS)

View full patent landscape →
1 OB patents · 1 families · 31 international docs across 22 countries

TIGLUTIK KIT Patents & Exclusivity

Latest Patent: Mar 2029

Patents (1 active)

US8765150 Expires Mar 12, 2029
Source: FDA Orange Book

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Deep insights for TIGLUTIK KIT

Revenue Insights

  • • Quarterly revenue tracking
  • • Historical trend analysis

Patent Timeline

  • • Cliff: 2029
  • • 1 active patents

Trial Analysis

  • • Clinical trial tracking
  • • Development stage analysis

Competitive Landscape

  • • Competitor tracking
  • • Same target/indication analysis
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Data Sources

FDA Approval: NDA209080 → Label: DailyMed → Patents: FDA Orange Book → Trials: ClinicalTrials.gov →

Data sourced from official FDA and NIH databases. Click links to verify on original sources.