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CLINICAL TRIALS PROFILE FOR RADICAVA ORS

All Clinical Trials for radicava ors

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT03272503 ↗	A Clinical Trial of Pimozide in Patients With Amyotrophic Lateral Sclerosis (ALS)	Recruiting	ALS Canada	Phase 2	2017-10-27	This study will look at whether Pimozide may help to slow the progression of Amyotrophic Lateral Sclerosis. 100 people from several Canadian centres with ALS who have provided their consent will be randomly assigned into one of 2 groups. The first group will receive a dose of up to 2mg of Pimozide per day and the second group will receive placebo (lactose tablets). Subjects will be assigned randomly (like by a flip of a coin) to receive either Pimozide 2 mg per day or placebo tablets. There will be a fifty-fifty chance of receiving Pimozide or placebo. Participants will be on study medication up to 22 weeks, and on study up to 26 weeks. There are 8 clinic visits and 1 phone visit over the course of the Treatment Phase of the study. The second phase which is Observational, is optional with follow-up for up to 5 years from the end of the Treatment Phase.
NCT03272503 ↗	A Clinical Trial of Pimozide in Patients With Amyotrophic Lateral Sclerosis (ALS)	Recruiting	Brain Canada	Phase 2	2017-10-27	This study will look at whether Pimozide may help to slow the progression of Amyotrophic Lateral Sclerosis. 100 people from several Canadian centres with ALS who have provided their consent will be randomly assigned into one of 2 groups. The first group will receive a dose of up to 2mg of Pimozide per day and the second group will receive placebo (lactose tablets). Subjects will be assigned randomly (like by a flip of a coin) to receive either Pimozide 2 mg per day or placebo tablets. There will be a fifty-fifty chance of receiving Pimozide or placebo. Participants will be on study medication up to 22 weeks, and on study up to 26 weeks. There are 8 clinic visits and 1 phone visit over the course of the Treatment Phase of the study. The second phase which is Observational, is optional with follow-up for up to 5 years from the end of the Treatment Phase.
NCT03272503 ↗	A Clinical Trial of Pimozide in Patients With Amyotrophic Lateral Sclerosis (ALS)	Recruiting	University of Calgary	Phase 2	2017-10-27	This study will look at whether Pimozide may help to slow the progression of Amyotrophic Lateral Sclerosis. 100 people from several Canadian centres with ALS who have provided their consent will be randomly assigned into one of 2 groups. The first group will receive a dose of up to 2mg of Pimozide per day and the second group will receive placebo (lactose tablets). Subjects will be assigned randomly (like by a flip of a coin) to receive either Pimozide 2 mg per day or placebo tablets. There will be a fifty-fifty chance of receiving Pimozide or placebo. Participants will be on study medication up to 22 weeks, and on study up to 26 weeks. There are 8 clinic visits and 1 phone visit over the course of the Treatment Phase of the study. The second phase which is Observational, is optional with follow-up for up to 5 years from the end of the Treatment Phase.
NCT03272802 ↗	Treatment Effect of Edaravone in Patients With Amyotrophic Lateral Sclerosis (ALS)	Unknown status	Isfahan University of Medical Sciences	Phase 2/Phase 3	2017-03-16	Amyotrophic Lateral Sclerosis (ALS) is a neurodegenerative disease that causes the death of 30,000 affected individual every year. Complex nature and unknown pathogenesis of this disease are 2 major reasons for failure of therapeutic interventions. Edaravone is a free radical scavenger that slows down functional decline and prevents from disease progression in ALS patients. FDA newly approved this drug in these patients (2017/5/5). In this study, investigators aimed to assess the treatment effect of this newly approved drug in patients with ALS in a representative Iranian population.

Clinical Trial Conditions for radicava ors

Condition Name

Condition Name for radicava ors
Intervention	Trials
ALS	1
Amyotrophic Lateral Sclerosis	1
Healthy	1
Healthy Adult Subjects	1

Condition MeSH

Condition MeSH for radicava ors
Intervention	Trials
Sclerosis	2
Motor Neuron Disease	2
Amyotrophic Lateral Sclerosis	2
Liver Diseases	1

Clinical Trial Locations for radicava ors

Trials by Country

Trials by Country for radicava ors
Location	Trials
Canada	4
Iran, Islamic Republic of	1
Slovakia	1
Hungary	1
Czechia	1

Trials by US State

Trials by US State for radicava ors
Location	Trials
Texas	1

Clinical Trial Progress for radicava ors

Clinical Trial Phase

Clinical Trial Phase for radicava ors
Clinical Trial Phase	Trials
Phase 2/Phase 3	1
Phase 2	1
Phase 1	2

Clinical Trial Status

Clinical Trial Status for radicava ors
Clinical Trial Phase	Trials
Completed	2
Recruiting	1
Unknown status	1

Clinical Trial Sponsors for radicava ors

Sponsor Name

Sponsor Name for radicava ors
Sponsor	Trials
Mitsubishi Tanabe Pharma Corporation	1
Auzone Biological Technology Pty Ltd	1
ALS Canada	1

Sponsor Type

Sponsor Type for radicava ors
Sponsor	Trials
Other	4
Industry	2

Radicava ors Market Analysis and Financial Projection

Radicava ORS: Clinical Trials, Market Analysis, and Projections

Introduction to Radicava ORS

Radicava ORS, an oral suspension formulation of edaravone, has been a significant development in the treatment of amyotrophic lateral sclerosis (ALS). Here, we will delve into the recent clinical trial updates, market analysis, and projections for this drug.

Clinical Trial Updates

Efficacy and Survival Benefits

Recent analyses presented at the Northeast Amyotrophic Lateral Sclerosis Consortium (NEALS) 2024 annual meeting have shown promising results for Radicava ORS. These studies compared the outcomes of patients treated with Radicava ORS against historical controls from the PRO-ACT database. The results indicated that Radicava ORS significantly slowed the decline in physical function and improved survival outcomes. Over nearly three years of follow-up (35 months), only 13.8% of patients given Radicava ORS died, compared to 32.9% of those in the control group, translating to a 66% lower risk of death and an additional 7.3 months of survival[1][4].

Long-Term Function and Survival

The Phase 3b extension study (MT-1186-A04) further reinforced the efficacy and safety of the FDA-approved on/off regimen of Radicava ORS. This study, which continued testing the drug for an additional 48 weeks, showed no new safety concerns and demonstrated that Radicava ORS was well-tolerated. The analysis also highlighted a significant slowing of functional decline and improved survival outcomes compared to the PRO-ACT placebo group[1][4].

Real-World Analysis

A real-world study presented at the European Network to Cure Amyotrophic Lateral Sclerosis (ENCALS) 2024 meeting evaluated treatment patterns, clinical outcomes, and survival of patients treated with Radicava ± riluzole versus those treated with riluzole alone. This study found an additional survival benefit of 3.2 months for individuals treated with Radicava ± riluzole compared to those treated with riluzole alone[3].

Market Analysis

Sales and Revenue Projections

The approval of Radicava ORS in the United States in May 2022 and in Japan in December 2022 has led to a significant increase in sales. After a decline in sales of the IV formulation due to generic competition in Japan, the introduction of Radicava ORS has revitalized the market. Projected revenues for Radicava ORS are expected to reach USD 900 million by 2034 across major markets, according to DelveInsight[2].

Market Position

Radicava ORS has emerged as a leading contender in the ALS treatment market, particularly after the setback with RELYVRIO. The drug's innovative oral formulation has been recognized by the FDA with Orphan Drug Exclusivity, further solidifying its market position. The drug is now approved and marketed in several countries, including Canada, Switzerland, Indonesia, Thailand, Malaysia, and Brazil[2][5].

Patient and Healthcare Impact

Patient Demographics and Treatment Duration

Presentations at the 2024 National Association of Specialty Pharmacy (NASP) Annual Meeting provided insights into patient demographics, treatment duration, and progression milestones. These studies highlighted the comprehensive impact of Radicava ORS on both clinical outcomes and healthcare resource utilization. The data drawn from Optum’s de-identified Clinformatics database offered a detailed view of how the drug affects patient care and healthcare resource use[5].

Safety Profile

The safety profile of Radicava ORS has been consistently demonstrated across various studies. A Phase 3, open-label clinical trial involving 185 patients showed that the drug was well-tolerated, with common side effects including fatigue, gait disturbance, headache, and contusion. These findings reinforce the safety and efficacy of Radicava ORS for long-term use in ALS patients[3][4].

Dosage and Administration

On/Off Regimen vs. Once-Daily Dosing

Mitsubishi Tanabe Pharma America (MTPA) conducted a Phase 3b clinical trial (MT-1186-A02) to compare the approved on/off dosing regimen of Radicava ORS against a once-daily dosing schedule. The results from this trial and its extension (MT-1186-A04) supported the continued use of the FDA-approved on/off regimen, showing no significant difference in efficacy and safety between the two dosing schedules[1][4].

Regulatory Approvals and Global Reach

FDA Approvals and Orphan Drug Exclusivity

Radicava ORS was approved by the U.S. FDA in May 2022, and in 2024, it was recognized with Orphan Drug Exclusivity due to its significant contribution to patient care through its innovative oral formulation. The drug has also received marketing authorizations in several other countries, including Canada, Switzerland, Indonesia, Thailand, Malaysia, and Brazil[3][5].

Key Takeaways

• Efficacy and Survival: Radicava ORS significantly slows ALS disease progression and improves survival outcomes compared to historical controls.
• Market Projections: Projected revenues for Radicava ORS are expected to reach USD 900 million by 2034.
• Safety Profile: The drug is well-tolerated with a favorable safety profile, making it suitable for long-term use.
• Global Reach: Radicava ORS is approved and marketed in multiple countries, solidifying its position in the ALS treatment market.
• Regulatory Recognition: The drug has been recognized with Orphan Drug Exclusivity by the FDA.

FAQs

What is Radicava ORS, and how is it administered?

Radicava ORS is an oral suspension formulation of edaravone, administered daily for 14 consecutive days followed by a 14-day drug-free period for the initial treatment cycle, and subsequently for 10 days within a 14-day period followed by a 14-day drug-free period.

What are the key benefits of Radicava ORS in treating ALS?

Radicava ORS slows the decline in physical function and improves survival outcomes for ALS patients, with a significant reduction in the risk of death compared to historical controls.

How does Radicava ORS compare to other ALS treatments?

Radicava ORS has emerged as a leading contender in the ALS treatment market, particularly after the setback with RELYVRIO, and is anticipated to achieve the highest revenue among ALS treatments.

What are the common side effects of Radicava ORS?

Common side effects include fatigue, gait disturbance, headache, and contusion, with the drug being well-tolerated for long-term use.

What is the projected revenue for Radicava ORS by 2034?

Projected revenues for Radicava ORS are expected to reach USD 900 million by 2034 across major markets.

Sources

1. ALS News Today: "Radicava ORS slows ALS disease progression, improves survival"
2. DelveInsight: "Evolving Treatment Landscape of Amyotrophic Lateral Sclerosis"
3. PR Newswire: "Mitsubishi Tanabe Pharma America Presents New Results of Radicava (edaravone) for People Living with ALS at the European Network to Cure Amyotrophic Lateral Sclerosis (ENCALS) 2024 Meeting"
4. Mitsubishi Tanabe Pharma America: "Mitsubishi Tanabe Pharma America Presents New Results of Radicava ORS (edaravone) from a Phase 3b Efficacy and Safety Extension Study and a Clinical Analysis of Multiple Studies at NEALS 2024"
5. Mitsubishi Tanabe Pharma America: "Mitsubishi Tanabe Pharma America to Present Radicava ORS (edaravone) Data at the 2024 National Association of Specialty Pharmacy Annual Meeting"