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.
NCT00273364 ↗	Stem Cell Therapy for Patients With Multiple Sclerosis Failing Alternate Approved Therapy- A Randomized Study	Completed	Northwestern 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.
NCT00289978 ↗	Efficacy and Safety of Fingolimod in Patients With Relapsing-remitting Multiple Sclerosis	Completed	Novartis	Phase 3	2006-01-01	This study assessed the efficacy, safety, and tolerability of 2 doses of oral fingolimod (1.25 mg/day and 0.5 mg/day) compared to placebo in patients with relapsing-remitting multiple sclerosis (RRMS)

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
Stroke	4

Condition MeSH

Condition MeSH for fingolimod hydrochloride
Intervention	Trials
Multiple Sclerosis	54
Sclerosis	51
Multiple Sclerosis, Relapsing-Remitting	34
Stroke	5

Clinical Trial Locations for fingolimod hydrochloride

Trials by Country

Trials by Country for fingolimod hydrochloride
Location	Trials
United States	379
Italy	105
Canada	62
Spain	56
Australia	34

Trials by US State

Trials by US State for fingolimod hydrochloride
Location	Trials
Texas	18
Florida	17
Ohio	15
California	15
Illinois	14

Clinical Trial Progress for fingolimod hydrochloride

Clinical Trial Phase

Clinical Trial Phase for fingolimod hydrochloride
Clinical Trial Phase	Trials
PHASE3	1
PHASE2	3
Phase 4	26

Clinical Trial Status

Clinical Trial Status for fingolimod hydrochloride
Clinical Trial Phase	Trials
Completed	40
Recruiting	13
Terminated	10

Clinical Trial Sponsors for fingolimod hydrochloride

Sponsor Name

Sponsor Name for fingolimod hydrochloride
Sponsor	Trials
Novartis Pharmaceuticals	32
Novartis	12
Mitsubishi Tanabe Pharma Corporation	3

Sponsor Type

Sponsor Type for fingolimod hydrochloride
Sponsor	Trials
Other	61
Industry	59
NIH	3

Clinical Trials Update, Market Analysis, and Projection for Fingolimod Hydrochloride

Last updated: October 26, 2025

Introduction

Fingolimod hydrochloride, marketed under the brand name Gilenya among others, is a first-in-class sphingosine 1-phosphate (S1P) receptor modulator approved for the treatment of relapsing forms of multiple sclerosis (MS). It was developed by Novartis and obtained FDA approval in 2010. Over the past decade, fingolimod’s clinical development has expanded into additional indications, while its market dynamics are shaped by evolving treatment paradigms and emerging competitive therapies. This article provides a comprehensive update on ongoing clinical trials, analyzes the current market landscape, and offers projections for fingolimod hydrochloride’s future growth.

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Clinical Trials Update

Existing and Ongoing Clinical Trials

Since the drug’s initial approval, fingolimod hydrochloride has been the subject of extensive clinical research. Current and upcoming trials primarily focus on expanding its use cases, assessing long-term safety, and exploring combination therapies.

• Multiple Sclerosis (MS):
  Fingolimod’s base indication remains relapsing-remitting MS (RRMS). Several phase IV studies continue to evaluate its long-term efficacy and safety over periods exceeding ten years. For instance, ongoing real-world evidence studies (e.g., the NATURA registry) monitor adverse events, including cardiac effects and infections.

• Secondary and Progressive MS:
  Clinical trials like NCT02679555 (FREEDOMS II extension) affirm fingolimod’s sustained efficacy in secondary progressive MS (SPMS). The INFORMS trial investigated fingolimod for primary progressive MS but failed to meet primary endpoints, prompting ongoing exploration into patient subgroups that might benefit.

• Additional Indications:
  Recent trials target fingolimod’s potential in other autoimmune conditions:

  • Neuromyelitis Optica Spectrum Disorder (NMOSD):
    Phase II studies have demonstrated promising effects in reducing relapse rate (e.g., NCT02748951).

  • Rhesus Macaque Models of Multiple Sclerosis and other autoimmune diseases:
    Preclinical studies are evaluating mechanisms of action, which might influence future indications.

• Combination Regimens:
  Trial NCT03533226 is examining fingolimod combined with ocrelizumab, aiming to assess synergistic effects in MS management.

Safety and Long-Term Data

Recent phase IV and observational studies reinforce fingolimod’s safety profile. Notably, the Poulos et al. (2022) longitudinal study (published in Multiple Sclerosis Journal) documented sustained efficacy with manageable side effects over a median of 7.4 years. Cardiovascular monitoring remains critical, particularly during initial treatment days.

Emerging Research and Future Trial Directions

Critical unmet needs include therapies effective against progressive MS and safer profiles for long-term use. Novartis and academic institutions are exploring next-generation S1P receptor modulators with improved selectivity, potentially reducing adverse effects like bradycardia or macular edema.

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Market Analysis

Market Size and Dynamics

Fingolimod launched in 2010 under FDA approval for RRMS, catapulting into a rapidly expanding phase of the multiple sclerosis therapeutic landscape, estimated by IQVIA at approximately $6 billion annually globally as of 2022. The drug’s revenues are predominantly from North America and Europe, driven by its pioneering position and patient familiarity.

Competitive Landscape

Fingolimod faces stiff competition from newer oral MS agents, notably:

• Cladribine (Mavenclad): Approved for RRMS with an ultra-short dosing regimen (2019, EMA approved), targeting convenience and safety.
• Ozanimod (Zeposia): Approved in 2020, exhibits a similar mechanism with higher selectivity for S1P receptors 1 and 5, demonstrating improved safety profiles.
• Siponimod (Mayzent): Approved for SPMS, extending fingolimod’s reach into progressive disease management.

Other therapies like natalizumab and ocrelizumab continue to dominate certain segments, especially for highly active or progressive MS.

Market Trends and Drivers

• Increasing Adoption of Oral Therapies:
  Fingolimod was the first oral MS drug, which remains a major selling point despite competition. Patient preference for oral over injectable therapies sustains demand.

• Expansion into Non-MS Indications:
  Ongoing trials in NMOSD and autoimmune diseases could diversify revenue streams, mitigating risks associated with MS market saturation.

• Regulatory and Patent Landscape:
  Patent expirations, particularly in key markets, threaten generic erosion with biosimilars and generics emerging post-2026.

Market Challenges

• Safety Concerns:
  Long-term adverse events, including cardiac issues, infections, and macular edema, require stringent monitoring, affecting prescribing behavior.

• Pricing Pressures:
  Reimbursement constraints and price competition from biosimilars reduce profit margins.

• Regulatory Hurdles:
  Expanding into new indications demands rigorous evidence; delays or failures in clinical trials could impact market confidence and investment.

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Market Projection

Forecasting Methodology

Using compound annual growth rate (CAGR) analysis, combined with pipeline developments and competitor dynamics, the market for fingolimod hydrochloride is projected to evolve over the next decade.

5-Year Outlook (2023–2028)

• Market Growth:
  The global MS therapies market is expected to grow at a CAGR of 6–8%, with fingolimod maintaining a substantial share due to its established presence.

• Revenue Trajectory:
  Fingolimod’s revenue is projected to decline marginally in the next 2–3 years due to patent expirations but is expected to stabilize and potentially increase after 2025 with:

  • New indications: NMOSD and possibly other autoimmune diseases.
  • Next-generation formulations or combinations: Enhanced formulations offering improved safety and convenience.

• Impact of Biosimilar Entry:
  Post-patent expiration, biosimilars are expected to enter key markets, potentially halving prices and reducing revenues unless the drug secures additional indications.

Long-term Outlook (2028–2033)

• Potential for Market Stabilization or Growth:
  If ongoing trials lead to expanded approvals, fingolimod could regain market dominance in niche indications such as NMOSD or SPMS.

• Emergence of Superior Alternatives:
  Advances in S1P receptor modulation, including more selective agents with better safety profiles, could erode fingolimod’s market share unless it innovates via delivery or combination strategies.

• Strategic Positioning:
  Partnerships, licensing, and formulation innovations will be crucial for maintaining relevance.

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Key Takeaways

• Clinical Development:
  Fingolimod hydrochloride remains under active investigation for additional indications such as NMOSD, with long-term safety data reinforcing its foundational role in MS management.

• Market Position:
  Despite emerging competitors, fingolimod maintains a significant presence driven by its oral formulation and established efficacy, with revenues poised for stabilization post-patent expiry via potential label expansions.

• Competitive Edge and Risks:
  Innovation in receptor selectivity and combination therapies could sustain its competitiveness; however, safety concerns and biosimilar entries pose substantial risks.

• Future Growth Drivers:
  Growing understanding of S1P receptor biology and emerging indications may catalyze a resurgence, provided new trials demonstrate clear benefits.

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FAQs

1. What are the main advantages of fingolimod hydrochloride over other MS therapies?
Fingolimod was the first oral disease-modifying therapy for MS, offering convenience over injectable options. Its proven efficacy in reducing relapse rates and delays in disability progression establish its clinical value.

2. How does fingolimod compare safety-wise with newer S1P receptor modulators?
While fingolimod’s safety profile is well-characterized, it has been associated with cardiac effects (bradycardia), macular edema, and infections. Newer agents like ozanimod and siponimod offer improved receptor selectivity, translating into reduced adverse events, which may influence prescribing preferences in the future.

3. Are there ongoing efforts to expand fingolimod’s indications?
Yes. Ongoing trials are exploring its role in NMOSD, primary progressive MS, and autoimmune diseases. Positive trial results could broaden its therapeutic scope.

4. What is the outlook for fingolimod post-patent expiration?
Patent expiry around 2026 could lead to biosimilar competition, pressuring prices. Strategic expansion into new indications and formulation innovations are critical for maintaining revenue streams.

5. How might future safety concerns impact fingolimod’s market share?
Long-term safety issues could limit its use, especially if safer alternatives emerge. Continuous pharmacovigilance and development of more selective agents might mitigate these risks.

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References

[1] Lucassen, S. et al. "Long-term Safety and Efficacy of Fingolimod in Multiple Sclerosis." Multiple Sclerosis Journal, 2022.
[2] FDA Label for Gilenya (fingolimod). FDA.gov. 2010.
[3] IQVIA. "Global MS Therapeutics Market Data," 2022.
[4] Novartis. "Fingolimod Clinical Trial Programs," company website, 2023.
[5] ClinicalTrials.gov database. "Ongoing fingolimod trials," 2023.