CLINICAL TRIALS PROFILE FOR GILENYA

All Clinical Trials for Gilenya

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT00670449 ↗	An Extension Study of the Efficacy and Safety of Fingolimod (FTY720) in Patients With Relapsing Multiple Sclerosis	Completed	Mitsubishi Tanabe Pharma Corporation	Phase 2	2008-04-01	This study was an extension study of NCT00537082. This study was designed to evaluate the efficacy and safety of long-term administration of 0.5 mg or 1.25 mg of fingolimod (FTY720) to relapsing multiple sclerosis.
NCT00670449 ↗	An Extension Study of the Efficacy and Safety of Fingolimod (FTY720) in Patients With Relapsing Multiple Sclerosis	Completed	Novartis	Phase 2	2008-04-01	This study was an extension study of NCT00537082. This study was designed to evaluate the efficacy and safety of long-term administration of 0.5 mg or 1.25 mg of fingolimod (FTY720) to relapsing multiple sclerosis.
NCT01285479 ↗	The Gilenya Pregnancy Registry	Recruiting	Novartis Pharmaceuticals		2011-10-15	The purpose of the Multi-National Gilenya Pregnancy Exposure Registry in Multiple Sclerosis (MS) is to continuously monitor, evaluate, and assess for major and minor teratogenic effects in the offspring of women exposed to Gilenya before (up to 8 weeks before last menstrual period) and during pregnancy in routine clinical practice. The overall aim is to collect and evaluate data on maternal, fetal, and infant outcomes and compare it with reference populations.
NCT01466114 ↗	Estriol Treatment in Multiple Sclerosis (MS): Effect on Cognition	Recruiting	Synthetic Biologics (formerly Adeona Pharmaceuticals)	Phase 2	2011-10-01	Approximately 50% of people diagnosed with Multiple Sclerosis (MS) will develop problems with cognition. Currently, there are no FDA-approved treatments targeting cognitive function in Multiple Sclerosis. This trial will ascertain whether treatment with an estrogen pill, used in combination with standard MS anti-inflammatory drugs, can improve cognitive testing as compared to treatment with a placebo pill in combination with standard anti-inflammatory drugs in women with MS.
NCT01466114 ↗	Estriol Treatment in Multiple Sclerosis (MS): Effect on Cognition	Recruiting	University of California, Los Angeles	Phase 2	2011-10-01	Approximately 50% of people diagnosed with Multiple Sclerosis (MS) will develop problems with cognition. Currently, there are no FDA-approved treatments targeting cognitive function in Multiple Sclerosis. This trial will ascertain whether treatment with an estrogen pill, used in combination with standard MS anti-inflammatory drugs, can improve cognitive testing as compared to treatment with a placebo pill in combination with standard anti-inflammatory drugs in women with MS.
NCT01534182 ↗	Evaluation of Patient Reported Outcomes in RRMS Patients Candidates for MS Therapy Change and Transitioned to Fingolimod 0.5 mg (EPOC)	Completed	Novartis Pharmaceuticals	Phase 4	2012-01-01	A 6-month, Randomized, Active Comparator, Open-label, Multi-Center Study to Evaluate Patient Outcomes, Safety and Tolerability of (fingolimod) 0.5 mg/day in Patients with Relapsing Remitting Multiple Sclerosis who are candidates for MS therapy change from Previous Disease Modifying Therapy.

Clinical Trial Conditions for Gilenya

Condition Name

Condition Name for Gilenya
Intervention	Trials
Multiple Sclerosis	9
Relapsing Remitting Multiple Sclerosis	5
Stroke	2
Relapsing-Remitting Multiple Sclerosis	2

Condition MeSH

Condition MeSH for Gilenya
Intervention	Trials
Multiple Sclerosis	20
Sclerosis	19
Multiple Sclerosis, Relapsing-Remitting	12
Ischemic Stroke	2

Clinical Trial Locations for Gilenya

Trials by Country

Trials by Country for Gilenya
Location	Trials
United States	83
Canada	12
China	10
Brazil	8
Italy	8

Trials by US State

Trials by US State for Gilenya
Location	Trials
Texas	6
California	5
Colorado	5
Ohio	4
Iowa	3

Clinical Trial Progress for Gilenya

Clinical Trial Phase

Clinical Trial Phase for Gilenya
Clinical Trial Phase	Trials
Phase 4	11
Phase 3	1
Phase 2/Phase 3	1

Clinical Trial Status

Clinical Trial Status for Gilenya
Clinical Trial Phase	Trials
Completed	14
Recruiting	6
Terminated	6

Clinical Trial Sponsors for Gilenya

Sponsor Name

Sponsor Name for Gilenya
Sponsor	Trials
Novartis Pharmaceuticals	8
Novartis	5
Shaoxing People's Hospital	2

Sponsor Type

Sponsor Type for Gilenya
Sponsor	Trials
Other	43
Industry	20
NIH	2

Clinical Trials, Market Analysis, and Projections for Gilenya

Introduction

Gilenya (fingolimod) is a groundbreaking oral disease-modifying therapy (DMT) approved for the treatment of relapsing forms of multiple sclerosis (MS). Here, we will delve into the latest clinical trial updates, market analysis, and projections for this significant medication.

Clinical Trial Updates

Efficacy in Relapsing-Remitting MS

Clinical trials have consistently demonstrated the efficacy of Gilenya in treating relapsing-remitting MS. The phase III FREEDOMS and FREEDOMS II studies showed that Gilenya significantly reduced the annualized relapse rate (ARR) by 54% compared to placebo and by 52% compared to interferon beta-1a IM (Avonex)[1][5].

Long-Term Efficacy and Safety

Extension studies from the FREEDOMS and FREEDOMS II trials have reinforced the long-term efficacy and safety profile of Gilenya. Patients who switched from placebo to Gilenya saw a 55% decrease in their ARR, and those on continuous Gilenya treatment had a lower rate of disability progression and remained relapse-free more often than those who switched from placebo[1][3].

No Evidence of Disease Activity (NEDA-4)

A follow-up analysis from the FREEDOMS and FREEDOMS II trials evaluated the proportion of patients achieving NEDA-4 (no relapses, MRI lesions, MS-related brain shrinkage, and disability progression) over seven years. The data showed that 27.1% of patients on Gilenya achieved NEDA-4 in the first year, and this proportion remained high in subsequent years for those on continuous treatment[3].

Brain Volume Loss Reduction

Gilenya has been shown to significantly reduce the rate of brain volume loss, a key indicator of disease progression. In studies involving over 3,600 patients, Gilenya reduced brain volume loss by about one-third compared to interferon beta-1a IM or placebo[5].

Safety Profile

The safety profile of Gilenya has been consistent across various studies. Common adverse events include nasopharyngitis, low lymphocyte counts, upper respiratory tract infections, and influenza. The FIRST study demonstrated a low incidence of first-dose bradycardia and cardiac conduction abnormalities at treatment initiation[1][5].

Market Analysis

Current Market Size

As of 2023, the global market for Gilenya was estimated to be worth US$ 2013 million[2].

Market Projections

The market for Gilenya is forecast to decline to US$ 934.9 million by 2030, with a compound annual growth rate (CAGR) of -8.7% during the forecast period of 2024-2030. This decline could be attributed to various factors, including market competition, patent expirations, and the emergence of new treatments[2].

Key Players

Novartis is the primary player in the Gilenya market, given that Gilenya is a proprietary drug developed and marketed by Novartis Pharmaceuticals[2].

Market Trends and Challenges

Competitive Landscape

The MS treatment market is highly competitive, with several disease-modifying therapies available. The decline in Gilenya's market size could be influenced by the introduction of new oral and injectable treatments that offer similar or improved efficacy and safety profiles[2].

Regulatory Environment

Regulatory actions and changes in healthcare policies can significantly impact the market size and growth of pharmaceutical products. Any unexpected regulatory changes or delays could affect Novartis's expectations regarding Gilenya's market performance[5].

Patient Experience and Adherence

Gilenya has been used to treat approximately 125,000 patients in clinical trials and the post-marketing setting, with over 240,000 years of patient experience. High patient adherence and satisfaction, as indicated by the majority of patients staying on therapy, are crucial for maintaining market share[3].

Future Outlook

Research and Development

Novartis remains committed to researching new treatment options for MS and other neurological conditions. Despite the disappointing results of the INFORMS trial for primary progressive MS, ongoing research and development efforts are expected to yield new treatments and potentially expand Gilenya's indications or improve its formulation[4].

Global Reach

With over 56,000 patients treated worldwide, Gilenya has established a significant global presence. Continued international marketing and distribution efforts will be essential for maintaining its market position[5].

Key Takeaways

• Clinical Efficacy: Gilenya has demonstrated significant reductions in relapse rates and brain volume loss, and has shown long-term efficacy and safety in treating relapsing-remitting MS.
• Market Size: The global market for Gilenya is projected to decline to US$ 934.9 million by 2030.
• Safety Profile: Gilenya's safety profile is consistent with pivotal trials, with common adverse events including nasopharyngitis and low lymphocyte counts.
• Market Trends: The competitive landscape and regulatory environment are key factors influencing Gilenya's market performance.
• Future Outlook: Ongoing research and global distribution efforts are crucial for maintaining and potentially expanding Gilenya's market presence.

FAQs

Q: What is Gilenya used for?

Gilenya (fingolimod) is an oral disease-modifying therapy approved for the treatment of relapsing forms of multiple sclerosis (MS).

Q: What are the key clinical trial findings for Gilenya?

Gilenya has been shown to significantly reduce the annualized relapse rate, brain volume loss, and disability progression in patients with relapsing-remitting MS.

Q: What is the current market size of Gilenya?

As of 2023, the global market for Gilenya was estimated to be worth US$ 2013 million.

Q: What are the projected market trends for Gilenya?

The market for Gilenya is forecast to decline to US$ 934.9 million by 2030, with a CAGR of -8.7% during the forecast period of 2024-2030.

Q: What are the common adverse events associated with Gilenya?

Common adverse events include nasopharyngitis, low lymphocyte counts, upper respiratory tract infections, and influenza.

Sources

1. Novartis Press Release: New extension study data with Novartis drug Gilenya shows patients successfully treated for 7 years with relapsing MS.
2. Valuates Reports: Gilenya - Market, Report Size, Worth, Revenue, Growth, Industry.
3. Novartis Press Release: Long-term efficacy of Gilenya reinforced by new 'no evidence of disease activity' (NEDA-4) analysis in MS patients over seven years.
4. MS Canada: Novartis announces results of phase III clinical trial evaluating the efficacy of the drug Gilenya in the treatment of primary progressive MS.
5. Novartis Press Release: New analysis shows Novartis drug Gilenya significantly reduced rate of brain volume loss across three large phase III studies.

Last updated: 2025-01-07