CLINICAL TRIALS PROFILE FOR FINGOLIMOD HYDROCHLORIDE

All Clinical Trials for fingolimod hydrochloride

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT00273364 ↗	Stem Cell Therapy for Patients With Multiple Sclerosis Failing Alternate Approved Therapy- A Randomized Study	Completed	Sheffield Teaching Hospitals NHS Foundation Trust	Phase 2	2005-11-16	Multiple sclerosis (MS) is at onset an immune-mediated demyelinating disease. In most cases, it starts as a relapsing-remitting disease with distinct attacks and no symptoms between flares. Over years or decades, virtually all cases transition into a progressive disease in which insidious and slow neurologic deterioration occurs with or without acute flares. Relapsing-remitting disease is often responsive to immune suppressive or modulating therapies, while immune based therapies are generally ineffective in patients with a progressive clinical course. This clinical course and response to immune suppression, as well as neuropathology and neuroimaging studies, suggest that disease progression is associated with axonal atrophy. Disability correlates better with measures of axonal atrophy than immune mediated demyelination. Therefore, immune based therapies, in order to be effective, need to be started early in the disease course while MS is predominately an immune-mediated and inflammatory disease. While current immune based therapies delay disability, no intervention has been proven to prevent progressive disability. We propose, as a randomized study, autologous unmanipulated PBSCT using a conditioning regimen of cyclophosphamide and rabbit antithymocyte globulin (rATG) versus FDA approved standard of care (i.e. interferon, glatiramer acetate, mitoxantrone, natalizumab, fingolimod, or tecfidera) in patients with inflammatory (relapsing) MS despite treatment with alternate approved therapy.
NCT00273364 ↗	Stem Cell Therapy for Patients With Multiple Sclerosis Failing Alternate Approved Therapy- A Randomized Study	Completed	University of Sao Paulo	Phase 2	2005-11-16	Multiple sclerosis (MS) is at onset an immune-mediated demyelinating disease. In most cases, it starts as a relapsing-remitting disease with distinct attacks and no symptoms between flares. Over years or decades, virtually all cases transition into a progressive disease in which insidious and slow neurologic deterioration occurs with or without acute flares. Relapsing-remitting disease is often responsive to immune suppressive or modulating therapies, while immune based therapies are generally ineffective in patients with a progressive clinical course. This clinical course and response to immune suppression, as well as neuropathology and neuroimaging studies, suggest that disease progression is associated with axonal atrophy. Disability correlates better with measures of axonal atrophy than immune mediated demyelination. Therefore, immune based therapies, in order to be effective, need to be started early in the disease course while MS is predominately an immune-mediated and inflammatory disease. While current immune based therapies delay disability, no intervention has been proven to prevent progressive disability. We propose, as a randomized study, autologous unmanipulated PBSCT using a conditioning regimen of cyclophosphamide and rabbit antithymocyte globulin (rATG) versus FDA approved standard of care (i.e. interferon, glatiramer acetate, mitoxantrone, natalizumab, fingolimod, or tecfidera) in patients with inflammatory (relapsing) MS despite treatment with alternate approved therapy.
NCT00273364 ↗	Stem Cell Therapy for Patients With Multiple Sclerosis Failing Alternate Approved Therapy- A Randomized Study	Completed	Uppsala University	Phase 2	2005-11-16	Multiple sclerosis (MS) is at onset an immune-mediated demyelinating disease. In most cases, it starts as a relapsing-remitting disease with distinct attacks and no symptoms between flares. Over years or decades, virtually all cases transition into a progressive disease in which insidious and slow neurologic deterioration occurs with or without acute flares. Relapsing-remitting disease is often responsive to immune suppressive or modulating therapies, while immune based therapies are generally ineffective in patients with a progressive clinical course. This clinical course and response to immune suppression, as well as neuropathology and neuroimaging studies, suggest that disease progression is associated with axonal atrophy. Disability correlates better with measures of axonal atrophy than immune mediated demyelination. Therefore, immune based therapies, in order to be effective, need to be started early in the disease course while MS is predominately an immune-mediated and inflammatory disease. While current immune based therapies delay disability, no intervention has been proven to prevent progressive disability. We propose, as a randomized study, autologous unmanipulated PBSCT using a conditioning regimen of cyclophosphamide and rabbit antithymocyte globulin (rATG) versus FDA approved standard of care (i.e. interferon, glatiramer acetate, mitoxantrone, natalizumab, fingolimod, or tecfidera) in patients with inflammatory (relapsing) MS despite treatment with alternate approved therapy.

Clinical Trial Conditions for fingolimod hydrochloride

Condition Name

Condition Name for fingolimod hydrochloride
Intervention	Trials
Multiple Sclerosis	21
Relapsing Remitting Multiple Sclerosis	9
Relapsing-Remitting Multiple Sclerosis	7

Condition MeSH

Condition MeSH for fingolimod hydrochloride
Intervention	Trials
Multiple Sclerosis	53
Sclerosis	51
Multiple Sclerosis, Relapsing-Remitting	33

Clinical Trial Locations for fingolimod hydrochloride

Trials by Country

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Trials by Country for fingolimod hydrochloride
Location	Trials
United States	366
Italy	102
Canada	62
Spain	53
Australia	33

Trials by US State

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−

Trials by US State for fingolimod hydrochloride
Location	Trials
Texas	17
Florida	16
Ohio	14
California	14
Pennsylvania	13

Clinical Trial Progress for fingolimod hydrochloride

Clinical Trial Phase

Clinical Trial Phase for fingolimod hydrochloride
Clinical Trial Phase	Trials
Phase 4	26
Phase 3	15
Phase 2/Phase 3	2

Clinical Trial Status

Clinical Trial Status for fingolimod hydrochloride
Clinical Trial Phase	Trials
Completed	40
Recruiting	11
Terminated	10

Clinical Trial Sponsors for fingolimod hydrochloride

Sponsor Name

Sponsor Name for fingolimod hydrochloride
Sponsor	Trials
Novartis Pharmaceuticals	32
Novartis	11
Sheffield Teaching Hospitals NHS Foundation Trust	3

Sponsor Type

Sponsor Type for fingolimod hydrochloride
Sponsor	Trials
Other	57
Industry	55
NIH	2

Fingolimod Hydrochloride: Clinical Trials, Market Analysis, and Projections

Introduction to Fingolimod Hydrochloride

Fingolimod hydrochloride, marketed under the brand name Gilenya among others, is a medication used primarily for the treatment of multiple sclerosis (MS), particularly relapsing-remitting multiple sclerosis (RRMS). Here, we will delve into the recent clinical trials, market analysis, and future projections for this drug.

Clinical Trials Update

Safety and Efficacy in Adults

Fingolimod hydrochloride has been extensively studied in adult patients with RRMS. The drug was originally developed for preventing acute rejection in renal transplantation but was later repurposed for MS due to its immunomodulatory effects. Clinical trials have shown that fingolimod significantly reduces the annualized relapse rate and slows the progression of disability in patients with RRMS[4].

Pediatric Studies

A landmark Phase III trial, known as the PARADIGMS study, investigated the safety and efficacy of fingolimod in children and adolescents (ages 10 to 17) with MS. This study, conducted over up to two years, demonstrated that oral fingolimod significantly reduced the number of relapses compared to interferon beta-1a. The safety profile was consistent with that observed in adult trials, with fewer adverse events reported in the fingolimod group[5].

Ongoing and Prospective Studies

An observational study is currently underway to evaluate the safety and effectiveness of generic fingolimod (Sphingomod®, Hikma) in patients with RRMS in Egypt. This prospective cohort study will follow patients for 12 months, assessing them as part of their routine clinical care without any additional interventions[1].

Market Analysis

Current Market Size and Growth

The global fingolimod hydrochloride market was valued at US$ 26 million in 2023. It is projected to grow at a Compound Annual Growth Rate (CAGR) of 4.9% from 2023 to 2030, reaching US$ 37 million by the end of the forecast period[2][3].

Key Players

The market is dominated by several key players, including Dr. Reddy's Laboratories, Senova Technology, Metrochem, Toronto Research Chemicals, BOC Sciences, Arcadia, Amadis Chemical, LKT Laboratories, Selleck Chemicals, Hefei Home Sunshine Pharmaceutical, Clinivex, and Tecoland. These companies are driving the market through their production and distribution of fingolimod hydrochloride[2][3].

Market Segmentation

The market is segmented by type (≥98% and ≥99% purity) and by application (Multiple Sclerosis and Immunomodulator). The increasing prevalence of multiple sclerosis worldwide is a significant driver for the growth in the Multiple Sclerosis segment. According to the National Multiple Sclerosis Society, approximately 2.8 million people globally are affected by multiple sclerosis, and this number is expected to rise[3].

Market Projections

Regional Growth

The global fingolimod hydrochloride market is expected to see significant growth across various regions, including North America, Europe, Asia Pacific, South America, and the Middle East and Africa. The Asia Pacific region is anticipated to be a key growth area due to increasing healthcare infrastructure and rising awareness about multiple sclerosis[3].

Forecasted Market Size

By 2030, the global market size for fingolimod hydrochloride is projected to reach US$ 37 million. This growth is driven by the expanding demands from the Multiple Sclerosis and Immunomodulator segments, as well as the increasing prevalence of multiple sclerosis worldwide[2][3].

Key Factors Driving Market Growth

Increasing Prevalence of Multiple Sclerosis

The rising number of people affected by multiple sclerosis globally is a significant factor driving the demand for fingolimod hydrochloride. As the disease prevalence increases, so does the need for effective treatments, contributing to the market's growth[3].

Clinical Efficacy

The clinical efficacy of fingolimod hydrochloride, as demonstrated in various trials, including the PARADIGMS study, has established it as a preferred treatment option for both adult and pediatric patients with MS. This efficacy is a crucial driver for market growth[5].

Generic Versions

The introduction of generic versions of fingolimod, such as Sphingomod® by Hikma, is expected to increase accessibility and affordability, further boosting market growth. These generic versions are being studied for their safety and effectiveness, ensuring they meet the standards set by the original drug[1].

Challenges and Opportunities

Regulatory Environment

The regulatory environment plays a critical role in the market growth of fingolimod hydrochloride. Approval from regulatory bodies such as the FDA and EMA is essential for new indications and generic versions. The partnership between Novartis and regulatory agencies in conducting the PARADIGMS study highlights the importance of collaborative efforts in advancing treatment options[5].

Competitive Landscape

The market for fingolimod hydrochloride is competitive, with multiple players involved. However, this competition can drive innovation and reduce costs, making the drug more accessible to a wider patient population.

Key Takeaways

• Clinical Efficacy: Fingolimod hydrochloride has been shown to significantly reduce relapses in both adult and pediatric patients with MS.
• Market Growth: The global market is projected to grow at a CAGR of 4.9% from 2023 to 2030, reaching US$ 37 million.
• Key Players: Companies like Dr. Reddy's Laboratories, Senova Technology, and others are driving the market.
• Increasing Prevalence: The rising number of people affected by multiple sclerosis is a key driver for market growth.
• Generic Versions: The introduction of generic versions is expected to increase accessibility and affordability.

FAQs

What is the primary use of fingolimod hydrochloride?

Fingolimod hydrochloride is primarily used for the treatment of relapsing-remitting multiple sclerosis (RRMS).

What are the key findings of the PARADIGMS study?

The PARADIGMS study showed that fingolimod significantly reduces the annualized relapse rate in children and adolescents with MS compared to interferon beta-1a[5].

What is the projected market size of fingolimod hydrochloride by 2030?

The global market size for fingolimod hydrochloride is projected to reach US$ 37 million by 2030[2][3].

Who are the main players in the fingolimod hydrochloride market?

Key players include Dr. Reddy's Laboratories, Senova Technology, Metrochem, Toronto Research Chemicals, and others[2][3].

What are the main drivers of the fingolimod hydrochloride market growth?

The increasing prevalence of multiple sclerosis and the clinical efficacy of fingolimod hydrochloride are significant drivers of market growth[3].

Sources

1. ClinicalTrials.gov: Safety and Effectiveness of Generic Fingolimod (Sphingomod®, Hikma) in Patients with Relapsing-Remitting Multiple Sclerosis in Egypt.
2. Valuates Reports: Global Fingolimod Hydrochloride Market Research Report 2024.
3. QYResearch: Fingolimod Hydrochloride - Global Market Insights and Sales Trends.
4. FDA: CLINICAL REVIEW - Fingolimod.
5. Novartis: Novartis landmark Phase III trial shows fingolimod significantly reduces relapses in children and adolescents with MS.