Gilenya

(Fingolimod)

ApprovedSmall molecule

Fingolimod is used to treat multiple sclerosis (MS), a disease where the immune system attacks the nervous system. It helps reduce relapses and slow the progression of disability by modifying how immune cells behave.[2] Gilenya is currently approved and in use across 11 indications[4].[1]

Gilenya is one of 280 small molecule programs targeting Lung Cancer. It is currently in Approved.

Indications

Total Trials

Active Trials

279

Competitors

FDA Application

NDA/BLA/ANDA regulatory filings

Patents

Pipeline

Status by Indication[4][1]

Indication

Lung CancerRecruiting

Anaplastic AstrocytomaApproved

Type 2 Diabetes MellitusActive, not recruiting

Relapsing-Remitting Multiple SclerosisTerminated

Primary Progressive Multiple SclerosisActive, not recruiting

Multiple SclerosisCompleted

AsthmaApproved

Relapsing Multiple SclerosisNot yet recruiting

UveitisApproved

Renal InsufficiencyApproved

Lung CancerPhase 2

Recruiting

Anaplastic AstrocytomaApproved

Approved

Type 2 Diabetes MellitusApproved

Active, not recruiting

Relapsing-Remitting Multiple SclerosisApproved

Terminated

Primary Progressive Multiple SclerosisApproved

Active, not recruiting

Multiple SclerosisApproved

Completed

AsthmaApproved

Approved

Relapsing Multiple SclerosisPreclinical

Not yet recruiting

UveitisApproved

Approved

Renal InsufficiencyApproved

Approved

Showing 10 of 11 indications

Competition

Competitive Landscape

199 competitors in Lung Cancer

#DrugCompanyPhaseTrials

Imfinzi

AstraZeneca

Phase 3

25 2

Tagrisso

AstraZeneca

Phase 3

17 3

Beyfortus

BeiGene

Phase 3

10 4

Gilenya

Novartis

Approved

1 5

Abraxane

Bristol-Myers Squibb

Phase 3

7 6

Imjudo

AstraZeneca

Phase 3

6 7

Tecentriq

Roche

Phase 3

6 8

Zepzelca

Jazz Pharmaceuticals

Phase 3

3 9

Ilaris

Novartis

Phase 3

2 10

Verzenio

Eli Lilly

Phase 3

Ranked by pipeline maturity and clinical activity. Current drug highlighted in teal.

Timeline

Expected Milestones

Q3 2027

ApprovedActive, not recruiting

Multiple Sclerosis

NCT04480853

Q1 2028

ApprovedRecruiting

Diabetes Mellitus, Type 2

NCT05307731

Q2 2028

Phase 2Recruiting

Lung Cancer

NCT06424067

Q3 2029

Phase 3Active, not recruiting

Relapsing-Remitting Multiple Sclerosis

NCT05123703

Clinical

Trials by Indication[1]

Multiple Sclerosis18 trials

Long-term Effect of Fingolimod on Circulating Immunocompetent Mononuclear Cells in Patients With Multiple Sclerosis

Terminated·HHeinrich-Heine University, Duesseldorf·Phase 4·NCT01755871·8 enrolled

Evaluation of Patient Retention of Fingolimod vs. Currently Approved Disease Modifying Therapy in Patients With Relapsing Remitting Multiple Sclerosis.

Completed· Novartis logo

Novartis·Phase 4·NCT01623596·881 enrolled

Examining the Risk of Skin Cancer in Multiple Sclerosis Patients Using Fingolimod: a Population-Based Study

Completed·UUniversity of British Columbia··NCT06705608·4,000 enrolled

Show 15 more trials

A Study of Immune Phenotype Biomarkers in Patients With Relapsing Multiple Sclerosis (RMS) After Treatment With 0.5mg Fingolimod

Completed· Novartis logo

Novartis·Phase 4·NCT03257358·382 enrolled

A Study to Learn About the Safety of Diroximel Fumarate (DRF) and Dimethyl Fumarate (DMF) and Their Effects on Relapses in Pediatric Participants With Relapsing Forms of Multiple Sclerosis (RMS)

Not yet recruiting· Biogen logo

Biogen·Phase 3·NCT07483632·185 enrolled

Fingolimod Versus Dimethyl-fumarate in Multiple Sclerosis

Terminated·FFondazione I.R.C.C.S. Istituto Neurologico Carlo Besta·Phase 4·NCT03345940·55 enrolled

Effect of Treatment With Fingolimod on the Immune Response Following Seasonal Flu Vaccination and Tetanus Booster Injection in Patients With Relapsing Multiple Sclerosis (MS)

Completed· Novartis logo

Novartis·Phase 3·NCT01199861·138 enrolled

Efficacy and Safety of Ofatumumab and Siponimod Compared to Fingolimod in Pediatric Patients With Multiple Sclerosis

Active, not recruiting· Novartis logo

Novartis·Phase 3·NCT04926818·129 enrolled

A 6-month, Randomized, Open-label, Patient OutComes, Safety and Tolerability Study of Fingolimod (FTY720) 0.5 mg/Day vs. Comparator in Patients With Relapsing Forms of Multiple Sclerosis

Completed· Novartis logo

Novartis·Phase 4·NCT01216072·1,053 enrolled

Safety Study in Patients With Multiple Sclerosis Treated Fingolimod or Other Approved Disease-modifying Therapies

Completed· Novartis logo

Novartis··NCT01442194·3,076 enrolled

Disease Control and Safety in Patients With Relapsing Remitting Multiple Sclerosis (RRMS) Switching From Natalizumab to Fingolimod

Terminated· Novartis logo

Novartis·Phase 3·NCT01499667·142 enrolled

Patients With Relapse Remitting Multiple Sclerosis (RRMS): Candidates for MS Therapy Change

Completed· Novartis logo

Novartis·Phase 4·NCT01317004·61 enrolled

Study of Efficacy and Safety of Fingolimod (Gilenya) 0.5 mg in Chinese Patients With Relapsing Multiple Sclerosis (RMS) Patients

Completed· Novartis logo

Novartis·Phase 4·NCT04667949·98 enrolled

An Extension Study of the Efficacy and Safety of Fingolimod (FTY720) in Patients With Relapsing Multiple Sclerosis

Completed· Novartis logo

Novartis·Phase 2·NCT00670449·143 enrolled

Long-term Safety and Tolerability of 0.5 mg Fingolimod in Patients With Relapsing Forms of Multiple Sclerosis

Completed· Novartis logo

Novartis·Phase 3·NCT01201356·4,125 enrolled

A 12-month, Prospective, Multi-center Post-authorization Commitment (PAC) Study Monitoring Safety in Adult Patients With Relapsing-remitting Multiple Sclerosis Newly Initiated on Gilenya (Fingolimod) in Taiwan (SPRING)

Active, not recruiting· Novartis logo

Novartis·Approved·NCT04480853·14 enrolled

Pregnancy Outcomes in Women Exposed to Diroximel Fumarate

Active, not recruiting· Biogen logo

Biogen··NCT05688436·1,178 enrolled

A 2 Year, Double-blind, Randomized, Multicenter, Active-controlled Core Phase to Evaluate Safety & Efficacy of Daily Fingolimod vs Weekly Interferon β-1a im in Pediatric Patients With Multiple Sclerosis and 5 Year Fingolimod Extension Phase

Active, not recruiting· Novartis logo

Novartis·Phase 3·NCT01892722·240 enrolled

Relapsing-Remitting Multiple Sclerosis11 trials

Safety and Effectiveness of Generic Fingolimod (Sphingomod®, Hikma) in Patients With Relapsing-Remitting Multiple Sclerosis in Egypt

Completed·HHikma Pharmaceuticals LLC··NCT05423769·30 enrolled

Evaluating of the Effect of Fingolimod With Fish Oil on Relapsing-Remitting Multiple Sclerosis Patients

Completed·IIsfahan University of Medical Sciences·Phase 2/3·NCT02939079·50 enrolled

Efficacy and Safety of Fingolimod (FTY720) in Patients With Relapsing-remitting Multiple Sclerosis

Completed· Novartis logo

Novartis·Phase 3·NCT00355134·1,083 enrolled

Show 8 more trials

Safety and Tolerability of Fingolimod in Patients With Relapsing-remitting Multiple Sclerosis

Completed· Novartis logo

Novartis·Phase 3·NCT01497262·162 enrolled

Impact of Natalizumab Versus Fingolimod in Relapsing-Remitting Multiple Sclerosis (RRMS) Participants

Terminated· Biogen logo

Biogen·Phase 4·NCT02342704·111 enrolled

Combination of Antidepressants and Fingolimod Relapsing-remitting Multiple Sclerosis (RRMS) Patients With Depression

Terminated· Novartis logo

Novartis·Phase 4·NCT01436643·54 enrolled

Efficacy and Safety of Fingolimod in Patients With Relapsing-remitting Multiple Sclerosis

Completed· Novartis logo

Novartis·Phase 3·NCT00289978·1,272 enrolled

Efficacy and Safety of Fingolimod in Patients With Relapsing-remitting Multiple Sclerosis With Optional Extension Phase

Completed· Novartis logo

Novartis·Phase 3·NCT00340834·1,292 enrolled

Long-term Efficacy and Safety of Fingolimod (FTY720) in Patients With Relapsing-remitting Multiple Sclerosis

Completed· Novartis logo

Novartis·Phase 3·NCT00662649·920 enrolled

Biomarker Study After Initiation of Treatment With Fingolimod (FTY720) in Patients With Relapsing-remitting Multiple Sclerosis

Completed· Novartis logo

Novartis·Phase 4·NCT01310166·447 enrolled

A Phase III Multicenter, Randomized, Double-blind, Double-dummy Study to Evaluate Safety and Efficacy of Ocrelizumab in Comparison With Fingolimod in Children and Adolescents With Relapsing-remitting Multiple Sclerosis

Active, not recruiting· Roche logo

Roche·Phase 3·NCT05123703·188 enrolled

Outcome3 trials

Evaluation of Patient Reported Outcomes in RRMS Patients Candidates for MS Therapy Change and Transitioned to Fingolimod 0.5 mg (EPOC)

Completed· Novartis logo

Novartis·Phase 4·NCT01534182·298 enrolled

Impact of Fingolimod Adherence on Outcomes

Completed· Novartis logo

Novartis··NCT05141669·694 enrolled

A 12 -Month, Open-label, Multi-center Study to Explore the Health Outcomes of FTY720

Completed· Novartis logo

Novartis·Phase 4·NCT01578330·42 enrolled

Ischemic stroke3 trials

Fingolimod in Endovascular Treatment of Ischemic Stroke

Unknown status·—·Phase 2·NCT04629872·30 enrolled

Combinating Fingolimod With Alteplase Bridging With Mechanical Thrombectomy in Acute Ischemic Stroke

Withdrawn·SSecond Affiliated Hospital, School of Medicine, Zhejiang University·Phase 2·NCT02956200

Combinating Fingolimod With Alteplase Bridging With Thrombectomy in Acute Ischemic Stroke

Unknown status·SSecond Affiliated Hospital, School of Medicine, Zhejiang University·Phase 2·NCT04675762·118 enrolled

Oral2 trials

Oral Bio-equivalence Study

Completed·AAlembic Pharmaceuticals Ltd.·Phase 1·NCT05145621·26 enrolled

Relationship Between Oral DMT Burden and Adherence in MS

Enrolling by invitation·MMonash University··NCT04676204·323 enrolled

25 more indications

Stroke2 trials

Revascularization Pretreated With Fingolimod in Acute Stroke

Unknown status·TThe Affiliated Hospital of Xuzhou Medical University·N/A·NCT04718064·20 enrolled

Efficacy and Safety of FTY720 for Acute Stroke

Completed·TTianjin Medical University General Hospital·Phase 2·NCT02002390·22 enrolled

Safety and Efficacy2 trials

Safety and Efficacy of Fingolimod in MS Patients in China

Withdrawn· Novartis logo

Novartis·Phase 3·NCT01941004

MS Study Evaluating Safety and Efficacy of Two Doses of Fingolimod Versus Copaxone

Terminated· Novartis logo

Novartis·Phase 3·NCT01633112·1,064 enrolled

Intracerebral Hemorrhage2 trials

Fingolimod as a Treatment of Cerebral Edema After Intracerebral Hemorrhage

Completed·WWake Forest University Health Sciences·Phase 1·NCT04088630·28 enrolled

Fingolimod in Minimal Invasive Treatment of Intracerebral Hemorrhage

Unknown status·TTang-Du Hospital·Phase 1/2·NCT06087965·40 enrolled

Lung Cancer1 trial

Phase 2 Study of Fingolimod in Lung Cancers

Recruiting·MMedical University of South Carolina·Phase 2·NCT06424067·38 enrolled

Schizophrenia1 trial

Fingolimod in Schizophrenia Patients

Completed·IIndiana University·Phase 2·NCT01779700·40 enrolled

Neuropathy1 trial

Fingolimod in Treating Patients With Chemotherapy-Induced Neuropathy

Completed·MMayo Clinic·Phase 1·NCT03943498·2 enrolled

AIN1 trial

ENGYNE Exploring Gilenya in Patients With Neutralizing Antibodies Against Interferon

Withdrawn· Novartis logo

Novartis·Phase 4·NCT01621269

Breast Cancer1 trial

Fingolimod in Preventing Paclitaxel-Associated Neuropathy in Patients With Breast Cancer

Completed·MMayo Clinic·Phase 1·NCT03941743·2 enrolled

Cardiac1 trial

A Phase 1 Study to Explore the Cardiac Pharmacodynamics of MT-1303

Completed· Tanabe Pharma Corporation logo

Tanabe Pharma Corporation·Phase 1·NCT02193217·81 enrolled

Pregnancy1 trial

The Gilenya Pregnancy Registry

Completed· Novartis logo

Novartis··NCT01285479·312 enrolled

Glioma1 trial

A Safety Study of Fingolimod With Radiation and Temozolomide in Newly Diagnosed High Grade Glioma

Completed·SSidney Kimmel Comprehensive Cancer Center at Johns Hopkins·Phase 1·NCT02490930·5 enrolled

Kidney Transplant1 trial

Fingolimod for the Abrogation of Interstitial Fibrosis and Tubular Atrophy Following Kidney Transplantation

Enrolling by invitation·TThe Methodist Hospital Research Institute·Phase 2·NCT05285878·20 enrolled

Treatment1 trial

A 3-year Multi-center Study to Describe Changes of OCT Parameters Under Treatment With Gilenya®

Completed· Novartis logo

Novartis·Phase 4·NCT01705236·87 enrolled

Optic Neuritis1 trial

Fingolimod (FTY720) in Acute Demyelinating Optic Neuritis (ADON)

Terminated· Novartis logo

Novartis·Phase 2·NCT01757691·2 enrolled

Renal Impairment1 trial

Pharmacokinetics (PK) and Metabolism of FTY720 in Patients With Severe Renal Impairment and Healthy Matched Subjects.

Completed· Novartis logo

Novartis·Phase 1·NCT00731523·18 enrolled

Rett syndrome1 trial

Study to Assess Safety and Efficacy of Fingolimod in Children With Rett Syndrome

Completed·UUniversity Hospital, Basel, Switzerland·Phase 1/2·NCT02061137·6 enrolled

Efficacy1 trial

Efficacy of Fingolimod in de Novo Patients Versus Fingolimod in Patients Previously Treated With a First Line Disease Modifying Therapy

Completed· Novartis logo

Novartis·Phase 4·NCT01498887·347 enrolled

COVID-191 trial

Fingolimod in COVID-19

Withdrawn·FFirst Affiliated Hospital of Fujian Medical University·Phase 2·NCT04280588

Chronic Inflammatory Demyelinating Polyradiculoneuropathy1 trial

Evaluate Efficacy and Safety of Fingolimod 0.5 mg Orally Once Daily Versus Placebo in Chronic Inflammatory Demyelinating Polyradiculoneuropathy Patients.

Completed· Novartis logo

Novartis·Phase 3·NCT01625182·106 enrolled

Immune Function1 trial

Study to Assess Immune Function and MRI Disease Activity in RRMS Patients When Switching From Natalizumab to Gilenya

Unknown status·UUniversity Hospital Muenster·Phase 4·NCT02325440·15 enrolled

Cardiovascular1 trial

Long-term, Open-label, Multicenter Study Assessing Long-term Cardiovascular Risks

Completed· Novartis logo

Novartis·Phase 4·NCT02232061·6 enrolled

Relapsing Multiple Sclerosis1 trial

Ublituximab in Pediatric Participants With Relapsing Forms of Multiple Sclerosis (RMS)

Recruiting·TTG Therapeutics, Inc.·Preclinical·NCT07220252·240 enrolled

Multiple Sclerosis, Relapsing-Remitting1 trial

A Phase 3, Multicenter, Double-blind, Active-controlled Study to Evaluate the Efficacy, Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Oral Ozanimod Compared to Oral Fingolimod in Children and Adolescents With Relapsing Remitting Multiple Sclerosis

Recruiting· Bristol-Myers Squibb logo

Bristol-Myers Squibb·Phase 3·NCT06408259·194 enrolled

Diabetes Mellitus, Type 21 trial

Fingolimod for Type 2 Diabetes Mellitus: a Pilot, Prospective, Randomized, and Open Label Single-center Study

Recruiting·GGeneral Hospital of Shenyang Military Region·Approved·NCT05307731·40 enrolled

Unspecified6 trials

Bioequivalence Study of a Test Capsule Formulation of Fingolimod With the Reference Capsule Formulation of Fingolimod

Completed·AAsofarma S.A.I. y C.·Phase 1·NCT03757338·33 enrolled

Fingolimod -Response According to Coping - Evaluation

Completed· Novartis logo

Novartis·Phase 4·NCT01420055·189 enrolled

Long Term Study of Fingolimod in MS Patients From the FTY Clinical Program

Completed· Novartis logo

Novartis··NCT01281657·64 enrolled

Show 3 more trials

Fingolimod Effect on Cytokine and Chemokine Levels

Completed· Novartis logo

Novartis·Phase 4·NCT02373098·126 enrolled

Fingolimod Versus Interferon Beta 1b in Cognitive Symptoms

Completed· Novartis logo

Novartis·Phase 4·NCT01333501·151 enrolled

Follow up Study of Patients on Fingolimod Who Were Enrolled in the Original Biobank Study (CFTY720DDE01)

Completed· Novartis logo

Novartis·Phase 4·NCT02720107·133 enrolled

Regulatory

FDA Approval Timeline[5]

May 11, 2018

GILENYA

NDA NDA022527

Sources

References

[1]
ClinicalTrials.gov — 70 trial records for Fingolimod. U.S. National Library of Medicine, National Institutes of Health.
[2]
MedlinePlus Drug Information — Gilenya drug information. U.S. National Library of Medicine, National Institutes of Health.
[3]
ChEMBL — Fingolimod compound record. European Bioinformatics Institute (EMBL-EBI).
[4]
Open Targets Platform — Drug–disease associations for Fingolimod. EMBL-EBI & Wellcome Sanger Institute.
[5]
OpenFDA — FDA approval records (NDA NDA022527). U.S. Food & Drug Administration.
[6]
FDA Orange Book — Patent and exclusivity data for Gilenya. U.S. Food & Drug Administration.
[7]
SEC EDGAR — Novartis company filings. U.S. Securities and Exchange Commission.

Details

Drug Info

Quick Facts

Mechanism of Action: Sphingosine 1-Phosphate Receptor Agonist; Sphingosine 1-Phosphate Receptor Binding Agent[3]
Modality: Small molecule[3]
Highest Phase: Approved[1]
Company: Novartis

Patent Landscape[6]

Patent Cliff

Dec 25, 2027

Earliest patent expiration — generic entry possible after this date

Patent #Expires

10543179Dec 25, 2027

9592208Mar 30, 2032

9592208*PEDSep 30, 2032

Gilenya

Status by Indication[4][1]

Competitive Landscape

Expected Milestones

Q3 2027

Q1 2028

Q2 2028

Q3 2029

Trials by Indication[1]

Multiple Sclerosis18 trials

Relapsing-Remitting Multiple Sclerosis11 trials

Outcome3 trials

Ischemic stroke3 trials

Oral2 trials

Stroke2 trials

Safety and Efficacy2 trials

Intracerebral Hemorrhage2 trials

Lung Cancer1 trial

Schizophrenia1 trial

Neuropathy1 trial

AIN1 trial

Breast Cancer1 trial

Cardiac1 trial

Pregnancy1 trial

Glioma1 trial

Kidney Transplant1 trial

Treatment1 trial

Optic Neuritis1 trial

Renal Impairment1 trial

Rett syndrome1 trial

Efficacy1 trial

COVID-191 trial

Chronic Inflammatory Demyelinating Polyradiculoneuropathy1 trial

Immune Function1 trial

Cardiovascular1 trial

Relapsing Multiple Sclerosis1 trial

Multiple Sclerosis, Relapsing-Remitting1 trial

Diabetes Mellitus, Type 21 trial

Unspecified6 trials

FDA Approval Timeline[5]

References

Drug Info

Quick Facts

Patent Landscape[6]

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