You're using a free limited version of DrugPatentWatch: Upgrade for Complete Access

Last Updated: February 17, 2025

CLINICAL TRIALS PROFILE FOR RILUTEK


✉ Email this page to a colleague

« Back to Dashboard


All Clinical Trials for Rilutek

Trial ID Title Status Sponsor Phase Start Date Summary
NCT00026052 ↗ Riluzole to Treat Major Depression Completed National Institute of Mental Health (NIMH) Phase 2 2001-11-01 This study will examine the safety and effectiveness of the drug riluzole (Rilutek® (Registered Trademark)) for short-term treatment of depression symptoms, such as depressed mood, psychomotor retardation, and excessive sleeping. Despite the availability of a wide range of antidepressant drugs, studies indicate that 30 to 40 percent of patients with major depression do not respond to first-line antidepressant treatment with drugs such as fluoxetine, upropion, venlafaxine and others. Riluzole, which is approved by the Food and Drug Administration (FDA) for amyotrophic lateral sclerosis (ALS), causes chemical changes in the brain that may also have antidepressant properties. Patients between 18 and 70 years of age with major depressive disorder without psychotic features may be eligible for this 2-stage 7-week study. Candidates will be screened with a medical history and physical examination, including an electrocardiogram (EKG), blood and urine tests, and a psychiatric evaluation. A blood or urine sample will be tested for illegal drugs.Women of childbearing potential will have a pregnancy test. Participants will complete stage 1 of the study, which lasts 1 week, and may then continue with stage 2 for an additional 6 weeks. At the start of the study, patients will be tapered off all psychiatric medicines and will begin treatment with a placebo (a sugar pill formulated to look like the active drug). At some point, they will be switched from placebo to riluzole. In addition, participants will undergo the following procedures: - Physical examination and electrocardiograms (EKG) at the beginning and end of the study, with vital signs (temperature, blood pressure and heart rate) checked daily - Weekly 1-hour interviews consisting of psychiatric and psychomotor rating scales to assess treatment response - Weekly blood tests to measure blood levels of riluzole and evaluate drug side effects At the end of the study, participants' psychiatric status will be reassessed and appropriate long-term psychiatric treatment arranged. Patients, ages 18 to 70 with a diagnosis of major depression without psychotic features, will in this pilot study (single arm, single blind) receive riluzole (50-200 mg/day) for a period of 6 weeks. Acute efficacy will be determined by demonstrating a greater response rate using specified criteria. Approximately 25 patients will enter the study to obtain 22 subjects who complete the 6 weeks of acute riluzole treatment. Therefore, if 7/22 patients or greater have greater than 50% improvement on the primary efficacy measure, then based on statistically guidelines from the Optimal Two Stage Design for Clinical Trials, a controlled trial would be indicated to scientifically confirm the signal observed in the single arm trial.
NCT00047723 ↗ Minocycline to Treat Amyotrophic Lateral Sclerosis Completed National Institute of Neurological Disorders and Stroke (NINDS) Phase 3 2003-01-01 The purpose of this trial is to test the safety, tolerability, and effectiveness of minocycline compared to placebo in patients with amyotrophic lateral sclerosis (ALS).
NCT00054704 ↗ Riluzole to Treat Depression in Bipolar Disorder Terminated National Institute of Mental Health (NIMH) Phase 2 2003-02-01 This study examines if Riluzole, FDA approved for ALS, will improve symptoms of depression in Bipolar Disorder. Purpose: This study will examine the safety and effectiveness of riluzole (Rilutek trademark) for short-term treatment of depression symptoms, such as depressed mood, psychomotor retardation, and excessive sleeping in patients with bipolar disease. Riluzole is approved by the Food and Drug Administration (FDA) to treat amyotrophic lateral sclerosis (ALS, also known as Lou Gehrig's disease). Preliminary findings of a study using riluzole to treat acute depression in patients with unipolar depression indicate that it may have antidepressant properties in some patients. Patients between 18 and 70 years of age with bipolar I or II disorder without psychosis may be eligible for this 8-week study. Candidates must be currently depressed, must have had at least one previous major depressive episode, and must have failed to improve with prior treatment with at least one antidepressant. They will be screened with a medical history, physical examination, electrocardiogram (EKG), blood and urine tests, and psychiatric evaluation. A blood or urine sample will be analyzed for illegal drugs. Women of childbearing potential will have a pregnancy test. Participants will begin an 8-week course of treatment, starting with a placebo (a sugar pill formulated to look like the active drug) and, at some point, switching to riluzole. In addition to drug treatment, participants will undergo the following procedures: Physical examination and electrocardiogram (EKG) at the beginning and end of the study; Weekly check of vital signs (temperature, blood pressure and heart rate); Weekly 1-hour interviews consisting of psychiatric and psychomotor rating scales to assess treatment response; Weekly blood tests to measure blood levels of riluzole and evaluate drug side effects. At the end of the study, participants' psychiatric status will be reassessed and appropriate long-term psychiatric treatment arranged. Atendemos pacientes de habla hispana. We enroll eligible participants locally and from around the country. Travel arrangements are provided and costs covered by the National Institute of Mental Health (NIMH). (Arrangements vary by distance and by specific study.) After completing the study participants receive short-term follow-up care while transitioning back to a provider.
NCT00251303 ↗ Riluzole to Treat Child and Adolescent Obsessive-Compulsive Disorder With or Without Autism Spectrum Disorders Completed National Institute of Mental Health (NIMH) Phase 2 2005-08-01 This study will examine the effectiveness of riluzole for treating Obsessive-Compulsive Disorder in Youth, Including those with Autism Spectrum Disorders.
NCT00353665 ↗ Memantine for Disability in Amyotrophic Lateral Sclerosis (MEDALS) Completed H. Lundbeck A/S Phase 2/Phase 3 2005-07-01 The purpose of this trial is to study the effect of Memantine (uncompetitive, moderate affinity, NMDA receptor antagonist that binds to the NMDA receptor channel, and regulates the calcium influx into the neurons), a drug used to treat Alzheimer´s disease, on the progression of Amyotrophic Lateral Sclerosis (ALS). Memantine is added to riluzole (the single drug approved to treat ALS).
>Trial ID >Title >Status >Phase >Start Date >Summary

Clinical Trial Conditions for Rilutek

Condition Name

Condition Name for Rilutek
Intervention Trials
Amyotrophic Lateral Sclerosis 8
Amyotrophic Lateral Sclerosis (ALS) 2
Depression 2
Bipolar Disorder 2
[disabled in preview] 0
This preview shows a limited data set
Subscribe for full access, or try a Trial

Condition MeSH

Condition MeSH for Rilutek
Intervention Trials
Sclerosis 11
Motor Neuron Disease 11
Amyotrophic Lateral Sclerosis 11
Depression 7
[disabled in preview] 0
This preview shows a limited data set
Subscribe for full access, or try a Trial

Clinical Trial Locations for Rilutek

Trials by Country

Trials by Country for Rilutek
Location Trials
United States 80
Canada 17
Germany 3
France 3
United Kingdom 3
This preview shows a limited data set
Subscribe for full access, or try a Trial

Trials by US State

Trials by US State for Rilutek
Location Trials
Maryland 8
Massachusetts 4
Ohio 4
New York 4
Kansas 3
This preview shows a limited data set
Subscribe for full access, or try a Trial

Clinical Trial Progress for Rilutek

Clinical Trial Phase

Clinical Trial Phase for Rilutek
Clinical Trial Phase Trials
Phase 4 3
Phase 3 6
Phase 2/Phase 3 4
[disabled in preview] 12
This preview shows a limited data set
Subscribe for full access, or try a Trial

Clinical Trial Status

Clinical Trial Status for Rilutek
Clinical Trial Phase Trials
Completed 21
Recruiting 3
Unknown status 2
[disabled in preview] 4
This preview shows a limited data set
Subscribe for full access, or try a Trial

Clinical Trial Sponsors for Rilutek

Sponsor Name

Sponsor Name for Rilutek
Sponsor Trials
National Institute of Mental Health (NIMH) 4
Stanley Medical Research Institute 2
Yale University 2
[disabled in preview] 4
This preview shows a limited data set
Subscribe for full access, or try a Trial

Sponsor Type

Sponsor Type for Rilutek
Sponsor Trials
Other 36
Industry 10
NIH 7
[disabled in preview] 3
This preview shows a limited data set
Subscribe for full access, or try a Trial

Clinical Trials, Market Analysis, and Projections for Rilutek

Introduction to Rilutek

Rilutek, also known by its generic name Riluzole, is a medication that has been a cornerstone in the treatment of amyotrophic lateral sclerosis (ALS) since its approval in 1995. Here, we will delve into the clinical trials that led to its approval, its current market standing, and future projections.

Clinical Trials and Approval

Rilutek was approved by the U.S. Food and Drug Administration (FDA) based on two pivotal clinical trials. The first trial involved 155 participants, and the second, larger trial included 959 participants. These trials demonstrated a two to three-month survival benefit for patients with ALS who received Riluzole compared to those who received a placebo[1][4].

Key Findings

  • Survival Benefit: Patients receiving Riluzole had an average survival time about 2 months longer than those receiving a placebo over an 18-month period[4].
  • Dosage: The optimal dosage was found to be 100 mg/day, as higher or lower doses did not show additional benefits[4].
  • Side Effects: Common side effects include nausea, asthenia (weakness), and abnormal liver tests[4].

Mechanism of Action

Riluzole works by reducing the level of glutamate, an amino acid that acts as a neurotransmitter in the brain and spinal cord. It blocks the release of glutamate from nerve terminals, which is beneficial since elevated levels of glutamate are associated with ALS[1].

Market Analysis

Current Market Size

The global Rilutek market was valued at US$ 40 million in 2023. This market is anticipated to decline slightly, reaching US$ 38 million by 2030, with a compound annual growth rate (CAGR) of -1.2% during the forecast period from 2024 to 2030[2].

Market Segments

  • By Type: The market includes different formulations of Riluzole, such as film-coated, liquid suspension, and tablets[2].
  • By Application: The primary applications are in hospitals and pharmacies[2].
  • Key Players: Major players in the Rilutek market include Sanofi, Mylan Pharma, Apotex, Glemark Generics, Covis Pharma, Sun Pharma, Lunan Pharma, and Italfarmaco[2].

Market Projections

Global ALS Treatment Market

The broader amyotrophic lateral sclerosis treatment market, of which Rilutek is a part, is expected to grow significantly. The global ALS treatment market was valued at $662.3 million in 2022 and is projected to reach $1,038.94 million by 2032, growing at a CAGR of 4.6% during the forecast period[3].

Riluzole Segment

Despite the emergence of new treatments, the Riluzole segment is expected to remain dominant due to its widespread adoption and availability from various key players. However, the market share of Riluzole may be impacted by the introduction of newer drugs like Edaravone (Radicava) and Relyvrio (sodium phenylbutyrate and taurursodiol)[3][5].

Factors Influencing Market Growth

  • Emerging Markets: The growth in untapped emerging markets, driven by improved healthcare expenditure and increased awareness about ALS, is expected to boost the demand for ALS treatments[3].
  • New Drug Approvals: Recent approvals of drugs like Edaravone and Relyvrio are set to positively impact the market growth. For instance, Edaravone is expected to show a high growth rate due to its applicability and higher cost[3][5].
  • Pipeline Molecules: Strong pipeline molecules such as AB-1010 (masitinib), Methycobal (mecobalamin), Arimoclomol, and CK-2017357 (CK-357, tirasemtiv) will also contribute to the market growth during the forecast period[5].

Challenges and Limitations

  • Patent Expiry: The patent expiry of Rilutek in 2013 has negatively impacted the market growth, leading to a decline in revenue[5].
  • Late-Stage Efficacy: Rilutek has not been shown to be effective in the late stages of ALS, which limits its therapeutic benefits[4].

Conclusion

Rilutek remains a crucial drug in the treatment of ALS, despite the emergence of new therapies. While its market size is expected to decline slightly, the broader ALS treatment market is poised for significant growth driven by new drug approvals, increased awareness, and expanding healthcare expenditure in emerging markets.

Key Takeaways

  • Clinical Trials: Rilutek was approved based on trials showing a 2-3 month survival benefit.
  • Market Size: The global Rilutek market is valued at US$ 40 million in 2023 and is expected to reach US$ 38 million by 2030.
  • Market Growth: The broader ALS treatment market is projected to grow to $1,038.94 million by 2032.
  • New Drugs: Recent approvals of Edaravone and Relyvrio are expected to impact the market positively.
  • Challenges: Patent expiry and limited efficacy in late-stage ALS are challenges for Rilutek.

FAQs

Q: What is the primary mechanism of action of Rilutek? A: Rilutek works by reducing the level of glutamate in the brain and spinal cord by blocking its release from nerve terminals[1].

Q: What were the key findings of the clinical trials that led to the approval of Rilutek? A: The trials showed a 2-3 month survival benefit for patients with ALS who received Riluzole compared to those who received a placebo[1][4].

Q: What is the current market size of Rilutek and its projected growth? A: The global Rilutek market was valued at US$ 40 million in 2023 and is expected to reach US$ 38 million by 2030, with a CAGR of -1.2%[2].

Q: Which other drugs are approved for the treatment of ALS? A: Besides Rilutek, Edaravone (Radicava) and Relyvrio (sodium phenylbutyrate and taurursodiol) are also approved for ALS treatment[1][3].

Q: What are the common side effects of Rilutek? A: Common side effects include nausea, asthenia (weakness), and abnormal liver tests[4].

Sources

  1. Approved Drugs for ALS Progression - ALS News
  2. Global Rilutek Market Research Report 2024 - Valuates Reports
  3. Amyotrophic Lateral Sclerosis Treatment Market Forecast - 2032 - Allied Market Research
  4. Rilutek | European Medicines Agency (EMA)
  5. Global $306 Million Amyotrophic Lateral Sclerosis Treatment Market - Business Wire

More… ↓

⤷  Try for Free

Make Better Decisions: Try a trial or see plans & pricing

Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.