Drugs / Fingolimod
last change Jul 2026 re-read 2 minutes ago

Fingolimod

Small molecule targets RHOA via inhibition

Developed for
multiple sclerosis · relapsing-remitting multiple sclerosis · ischemic stroke · intracerebral hemorrhage · stroke disorder · amyotrophic lateral sclerosis · anaplastic astrocytoma · asthma
+14 more · brain edema · chemotherapy-induced neuropathy · chronic inflammatory demyelinating polyradiculoneuropathy · COVID-19 · glioblastoma · non-small cell lung carcinoma · optic neuritis · primary progressive multiple sclerosis · Rett syndrome · small cell lung carcinoma · type 2 diabetes mellitus · uveitis · renal fibrosis · schizophrenia
Investigated by
Novartis Pharmaceuticals · Novartis · Tanabe Pharma Corporation · Affiliated Hospital of Jiaxing University · Jinhua Center Hospital · Mayo Clinic
+29 more · National Cancer Institute (NCI) · Second Affiliated Hospital, School of Medicine, Zhejiang University · Shaoxing People's Hospital · Taizhou Hospital · The Second Affiliated Hospital of Jiaxing University · ALS Therapy Development Institute · Biogen · Charite University, Berlin, Germany · First Affiliated Hospital of Fujian Medical University · General Hospital of Shenyang Military Region · Heinrich-Heine University, Duesseldorf · Huizhou Municipal Central Hospital · Huzhou Center Hospital · Jochen Vehoff · Massachusetts General Hospital · Medical University of South Carolina · National Center for Advancing Translational Sciences (NCATS) · NeuroCure Clinical Research Center, Charite, Berlin · Ning Wang, MD., PhD. · Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins · TG Therapeutics, Inc. · Tang-Du Hospital · The Affiliated Hospital of Xuzhou Medical University · The Cleveland Clinic · Tianjin Medical University General Hospital · University Hospital Muenster · University Hospital, Basel, Switzerland · University of Nottingham · Wake Forest University Health Sciences

Regulatory milestones approvals, filings & regulatory actions · 4 recorded

MilestoneJurisdictionBrandIndicationDateSentence it was read from
Label expansions (2) US (FDA) GILENYA 2011-07-20 – 2018-05-11 fda.gov
Approved EU (EMA) Gilenya 2011-03-17 europa.eu
Approved US (FDA) GILENYA 2010-09-21 fda.gov

Trials 71 · started per year

today
US approved 2010
EU approved 2011
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200220032004200520062007200820092010201120122013201420152016201720182019202020212022202320242025202620272028
PhaseRegistry idDatesIndicationSponsorStatusOutcome
Phase 03 trials
Phase 0 NCT04088630 Aug 2020 → Jun 2023 brain edema, intracerebral hemorrhage Wake Forest University Health Sciences Completed No outcome recorded
Phase 0 NCT03943498 May 2019 → Dec 2020 chemotherapy-induced neuropathy Mayo Clinic Completed No outcome recorded
Phase 0 NCT02490930 Jul 2015 → Sep 2017 anaplastic astrocytoma, glioblastoma Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins Completed No outcome recorded
Phase 13 trials
Phase 1 NCT03941743 Dec 2019 → Jun 2020 breast carcinoma Mayo Clinic Completed No outcome recorded
Phase 1 NCT00731523 Jul → Aug 2008 impaired renal function disease Novartis Completed No outcome recorded
Phase 1 NCT00416845 Oct 2006 → Mar 2007 Novartis Completed No outcome recorded
Phase 1/22 trials
Phase 1/2 NCT06087965 Oct 2023 → Jun 2025 intracerebral hemorrhage Tang-Du Hospital Unknown No outcome recorded
Phase 1/2 NCT02061137 Aug 2013 → Apr 2018 Rett syndrome University Hospital, Basel, Switzerland Completed No outcome recorded
Phase 215 trials
Phase 2 NCT06424067 May 2025 → May 2027 expected non-small cell lung carcinoma, small cell lung carcinoma Medical University of South Carolina Recruiting No outcome recorded
Phase 2 NCT04675762 Jan 2021 → Dec 2025 ischemic stroke Second Affiliated Hospital, School of Medicine, Zhejiang University Unknown No outcome recorded
Phase 2 NCT04629872 Nov 2020 → Dec 2022 stroke disorder Ning Wang, MD., PhD. Unknown No outcome recorded
Phase 2 NCT04280588 Feb → Jul 2020 COVID-19 First Affiliated Hospital of Fujian Medical University Withdrawn No outcome recorded
Phase 2 NCT02956200 Nov 2016 → Oct 2018 ischemic stroke Second Affiliated Hospital, School of Medicine, Zhejiang University Withdrawn No outcome recorded
Phase 2 NCT01791192 Nov 2013 → Oct 2014 uveitis Novartis Pharmaceuticals Withdrawn No outcome recorded
Phase 2 NCT01786174 Aug 2013 → Sep 2014 amyotrophic lateral sclerosis Massachusetts General Hospital Completed No outcome recorded
Phase 2 NCT01757691 Aug 2013 → May 2014 optic neuritis Novartis Pharmaceuticals Terminated No outcome recorded
Phase 2 NCT02002390 Oct 2012 → Oct 2014 ischemic stroke Tianjin Medical University General Hospital Completed No outcome recorded
Phase 2 NCT00785083 Sep 2008 → Feb 2009 asthma Novartis Completed No outcome recorded
Phase 2/33 trials
Phase 2/3 NCT07220252 Jul 2026 → Jan 2030 expected multiple sclerosis TG Therapeutics, Inc. Recruiting No outcome recorded
Phase 2/3 NCT01647880 Jul 2013 → Apr 2016 multiple sclerosis Charite University, Berlin, Germany Terminated No outcome recorded
Phase 2/3 NCT00099749 Nov 2003 → Apr 2006 Novartis Pharmaceuticals Completed No outcome recorded
Phase 322 trials
Phase 3 NCT07483632 Nov 2026 → Jul 2034 expected multiple sclerosis Biogen Not yet recruiting No outcome recorded
Phase 3 NCT01941004 Jun 2014 → May 2017 relapsing-remitting multiple sclerosis Novartis Pharmaceuticals Withdrawn No outcome recorded
Phase 3 NCT01892722 Jul 2013 → Jul 2017 overdue multiple sclerosis Novartis Pharmaceuticals Active not recruiting No outcome recorded
Phase 3 NCT01625182 Dec 2012 → Sep 2016 chronic inflammatory demyelinating polyradiculoneuropathy Novartis Pharmaceuticals Completed No outcome recorded
Phase 3 NCT01633112 Aug 2012 → Apr 2018 relapsing-remitting multiple sclerosis Novartis Pharmaceuticals Terminated No outcome recorded
Phase 3 NCT01497262 Feb 2012 → Apr 2014 multiple sclerosis Novartis Pharmaceuticals Completed No outcome recorded
Phase 3 NCT01499667 Sep 2011 → Nov 2012 relapsing-remitting multiple sclerosis Novartis Pharmaceuticals Terminated No outcome recorded
Phase 3 NCT01201356 Sep 2010 → Oct 2018 multiple sclerosis Novartis Pharmaceuticals Completed No outcome recorded
Phase 3 NCT01199861 Aug 2010 → May 2011 multiple sclerosis Novartis Completed No outcome recorded
Phase 3 NCT01127750 May 2010 → Oct 2011 multiple sclerosis Novartis Completed No outcome recorded
Phase 422 trials
Phase 4 NCT05307731 Mar 2022 → Mar 2026 overdue type 2 diabetes mellitus General Hospital of Shenyang Military Region Recruiting No outcome recorded
Phase 4 NCT04667949 Feb 2021 → Mar 2025 multiple sclerosis Novartis Pharmaceuticals Completed No outcome recorded
Phase 4 NCT04480853 Oct 2020 → Sep 2027 expected multiple sclerosis Novartis Pharmaceuticals Recruiting No outcome recorded
Phase 4 NCT03535298 Jan 2019 → Jul 2027 expected relapsing-remitting multiple sclerosis The Cleveland Clinic Active not recruiting No outcome recorded
Phase 4 NCT03257358 Sep 2017 → Mar 2019 multiple sclerosis Novartis Pharmaceuticals Completed No outcome recorded
Phase 4 NCT02575365 Feb 2016 → Jan 2017 Novartis Pharmaceuticals Terminated No outcome recorded
Phase 4 NCT02373098 Mar 2015 → Jan 2017 relapsing-remitting multiple sclerosis Novartis Pharmaceuticals Completed No outcome recorded
Phase 4 NCT02232061 Sep 2014 → Jan 2020 multiple sclerosis Novartis Pharmaceuticals Completed No outcome recorded
Phase 4 NCT02325440 Mar 2014 → Apr 2016 relapsing-remitting multiple sclerosis University Hospital Muenster Unknown No outcome recorded
Phase 4 NCT02048072 Jul 2013 → Jun 2015 dysautonomia, multiple sclerosis Jochen Vehoff Completed No outcome recorded
Phase not applicable1 trial
NCT04718064 Feb → Oct 2021 stroke disorder The Affiliated Hospital of Xuzhou Medical University Unknown No outcome recorded
Also used as a comparator or background therapy in 15 trials
PhaseRegistry idDatesIndicationSponsorStatusOutcome
Phase 12 trials
Phase 1 NCT05145621 Comparator Oct 2015 → Jan 2016 Alembic Pharmaceuticals Ltd. Completed No outcome recorded
Phase 1 NCT02193217 Comparator ? → Dec 2014 relapsing-remitting multiple sclerosis Tanabe Pharma Corporation Completed No outcome recorded
Phase 23 trials
Phase 2 NCT05285878 Comparator Jul 2022 → Jun 2027 expected chronic kidney disease, chronic transplant rejection, renal fibrosis The Methodist Hospital Research Institute Enrolling by invitation No outcome recorded
Phase 2 NCT01779700 Comparator Jan 2013 → Aug 2016 schizophrenia Indiana University Completed No outcome recorded
Phase 2 NCT00273364 Comparator Nov 2005 → Jan 2017 multiple sclerosis Northwestern University Completed No outcome recorded
Phase 2/31 trial
Phase 2/3 NCT02939079 Background Apr 2015 → Sep 2016 multiple sclerosis Isfahan University of Medical Sciences Completed No outcome recorded
Phase 33 trials
Phase 3 NCT06408259 Comparator Apr 2025 → Apr 2031 expected relapsing-remitting multiple sclerosis Bristol-Myers Squibb Recruiting No outcome recorded
Phase 3 NCT05123703 Comparator May 2022 → Jun 2025 overdue relapsing-remitting multiple sclerosis Hoffmann-La Roche Active not recruiting No outcome recorded
Phase 3 NCT04926818 Comparator Oct 2021 → Mar 2026 overdue multiple sclerosis Novartis Pharmaceuticals Active not recruiting No outcome recorded
Phase 46 trials
Phase 4 NCT02769689 Background Jun 2019 → Jun 2024 multiple sclerosis University Hospital, Clermont-Ferrand Unknown No outcome recorded
Phase 4 NCT03345940 Comparator Apr 2017 → Oct 2019 relapsing-remitting multiple sclerosis Fondazione I.R.C.C.S. Istituto Neurologico Carlo Besta Terminated No outcome recorded
Phase 4 NCT02720107 Background May → Nov 2016 relapsing-remitting multiple sclerosis Novartis Pharmaceuticals Completed No outcome recorded
Phase 4 NCT02342704 Comparator Nov 2014 → May 2016 relapsing-remitting multiple sclerosis Biogen Terminated No outcome recorded
Phase 4 NCT01705236 Background Aug 2012 → Feb 2019 relapsing-remitting multiple sclerosis Novartis Pharmaceuticals Completed No outcome recorded

Press releases naming this drug 18 releases

DateIssuerRelease
2022-09-21 Novartis Pharmaceuticals Novartis plans to petition the U.S. Supreme Court to uphold validity of the Gilenya® (fingolimod) dosing regimen patent novartis.com
2022-06-21 Novartis Pharmaceuticals Novartis plans to petition the U.S. Court of Appeals for the Federal Circuit for further review to uphold validity of the Gilenya® (fingolimod) dosing regimen patent novartis.com
2022-01-04 Novartis Pharmaceuticals Novartis announces U.S. Court of Appeals for the Federal Circuit (CAFC) upholds validity of Gilenya® (fingolimod) dosage regimen patent novartis.com
2020-08-17 Novartis Pharmaceuticals Novartis announces US District Court for the District of Delaware upholds validity of Gilenya® (fingolimod) dosage regimen patent novartis.com
2019-07-19 Novartis Pharmaceuticals Novartis key multiple sclerosis product Gilenya® approved in China novartis.com
2019-05-10 Novartis Pharmaceuticals Novartis data at AAN show Gilenya® is the first and only disease-modifying therapy with proven superiority versus glatiramer acetate in relapsing remitting MS novartis.com
2018-11-29 Novartis Pharmaceuticals Novartis announces EU approval of Gilenya® for children and adolescents with MS, making it the first and only oral disease-modifying treatment for these patients in Europe novartis.com
2018-10-10 Novartis Pharmaceuticals Novartis announces new data from the first direct head-to-head trial to demonstrate superior efficacy of Gilenya® over Copaxone® in patients with relapsing remitting multiple sclerosis novartis.com
2018-09-21 Novartis Pharmaceuticals Novartis receives positive CHMP opinion for Gilenya® for the treatment of children and adolescents with MS, marking a major medical advance for young MS patients in Europe novartis.com
2018-09-12 Novartis Pharmaceuticals Novartis announces NEJM publication of landmark PARADIGMS study demonstrating significant benefit of Gilenya® in children and adolescents with MS novartis.com
2018-05-12 Novartis Pharmaceuticals Novartis announces FDA approval of Gilenya® as the first disease-modifying therapy for pediatric relapsing multiple sclerosis novartis.com
2017-10-28 Novartis Pharmaceuticals Novartis PARADIGMS data show children and adolescents with MS had an 82% lower relapse rate with Gilenya® vs. interferon beta-1a novartis.com

Evidence & citations 19 cited values

Every value below carries the sentence it was read from. 93 sources stand behind the page.

FieldValueCited text
Known as fingolimod “Standard treatment with a conventional drug is the treatment with one of the following drugs: Avonex (interferon beta 1a), Betaseron (interferon beta 1b), Copaxone (glatiramer...” NCT00273364
70

“Patients with acute unilateral ON, occurring as a clinically isolated syndrome or MS relapse, were randomized to 6 months of treatment with 0.5 mg oral fingolimod or...” PMID 32126977 Mar 2020

Fingolimod (FTY720) has previously shown clinical efficacy in phase II/III studies of predominantly Caucasian populations with multiple sclerosis (MS).” PMID 22354739 Feb 2012

“Evaluation of the Autonomic Nervous System During First-dosing With 0.5mg of Fingolimod (Gilenya) in Patients With Relapsing-remitting MS” NCT02048072

Fingolimod (FTY720) is a new oral immunomodulating agent under evaluation for the treatment of relapsing multiple sclerosis.” PMID 16971719 Sep 2006

“The patients of this group were treated with Fingolimod 0.5mg per day, in addition to guideline based treatment.” NCT05307731

Fingolimod, an oral sphingosine 1-phosphate receptor modulator, is effective in relapse-onset multiple sclerosis” PMID 26827074 Jan 2016

“Between Natalizumab and Fingolimod Treatments in Patients With Multiple Sclerosis” NCT02769689

Fingolimod 0.5 mg by mouth once daily for 7 days.” NCT01585298

“Gilenya (fingolimod)” NCT03535298

NCT04667949

NCT03941743

NCT05123703

NCT02373098

NCT01216072

NCT01310166

NCT01420055

NCT01199861

NCT02325440

NCT03943498

NCT01633112

NCT05285878

NCT01757691

NCT01621269

NCT07220252

NCT01892722

NCT00731523

NCT02342704

NCT01534182

NCT02002390

NCT04088630

NCT04718064

NCT01578330

NCT01705236

NCT01499667

NCT01498887

NCT01497262

NCT06087965

NCT05145621

NCT02720107

NCT01436643

NCT00355134

NCT04675762

NCT06408259

NCT00662649

NCT03345940

NCT01755871

NCT00670449

NCT02575365

NCT00289978

NCT02956200

NCT03257358

NCT02490930

NCT02193217

NCT04629872

NCT07483632

NCT04926818

NCT01317004

NCT01201356

NCT04280588

NCT01623596

NCT01333501

NCT06424067

NCT01779700

NCT04480853

NCT02232061

NCT00340834

NCT02061137

NCT01941004

NCT02939079

NCT01625182

Known as Fingolimod (as hydrochloride) ChEMBL registry synonym — accepted as the source's own label CHEMBL314854
Known as Fingolimod accord ChEMBL registry synonym — accepted as the source's own label CHEMBL314854
Known as Fingolimod hcl ChEMBL registry synonym — accepted as the source's own label CHEMBL314854
Known as Fingolimod hydrochlorid ChEMBL registry synonym — accepted as the source's own label CHEMBL314854
Known as Fingolimod Hydrochloride “Drug: Fingolimod HydrochlorideNCT03941743
1

“Drug: Fingolimod HydrochlorideNCT03943498

Known as Fingolimod mylan ChEMBL registry synonym — accepted as the source's own label CHEMBL314854
Known as FTY “Leukocyte sequestration is an established therapeutic concept in multiple sclerosis (MS) as represented by the trafficking drugs natalizumab (NAT) and fingolimod (FTY).” PMID 30050529 Jul 2018
Known as FTY-720 HYDROCHLORIDE ChEMBL registry synonym — accepted as the source's own label CHEMBL314854
Known as FTY720 “METHODS: This multicenter, double-blind, Phase IIb, randomized study evaluated the safety and efficacy of 5 mg FTY720 (n=87; Group 1) vs. 2.5 mg FTY720 (n=90; Group 2) vs....” PMID 17984842 Oct 2007
26

“Fingolimod (FTY720) is a new oral immunomodulating agent under evaluation for the treatment of relapsing multiple sclerosis.” PMID 16971719 Sep 2006

FTY720 (Gilenya) is an orally active modulator of four of the five sphingosine-1 phosphate(S1P) receptors.” NCT02061137

“The sphingosine-1-phosphate receptor regulators Fingolimod (FTY720) is an effective immunology modulator” NCT04280588

“Fingolimod, a sphingosine-1-phosphate receptor regulator (FTY720), is an effective immunology modulator.” NCT06087965

“Fingolimod (FTY720, approved as Gilenya™ ) is a sphingosine-1-phosphate (S1P) receptor modulator” NCT01779700

“Treatment With Fingolimod (FTY720) in Patients With Relapsing-remitting Multiple Sclerosis” NCT01310166

“Ophthalmic evaluations in clinical studies of fingolimod (FTY720) in multiple sclerosis.” PMID 23531349 Mar 2013

“Participants received 0.5 mg FTY720 (fingolimod) orally once daily for 12 months.” NCT01498887

“Fingolimod (FTY720)” NCT01625182

“fingolimod (FTY720)” NCT00731523

“Fingolimod, FTY720NCT01578330

NCT00099736

NCT00239811

NCT00239798

NCT00099749

NCT00785083

NCT01791192

NCT00099801

NCT01127750

NCT00239902

NCT00239876

NCT00239863

NCT00537082

NCT00098735

NCT00416845

NCT00239785

Known as FTY720, fingolimod hydrochloride, FTY720, fingolimod hydrochloride,NCT01633112
Known as Gilenia ChEMBL registry synonym — accepted as the source's own label CHEMBL314854
Known as Gilenya “Standard treatment with a conventional drug is the treatment with one of the following drugs: Avonex (interferon beta 1a), Betaseron (interferon beta 1b), Copaxone (glatiramer...” NCT00273364
11

“Patients randomized to fingolimod will also receive fingolimod (Gilenya, Novartis) at a dosage of 0.5 mg once daily, for three consecutive days, with the first dose being given...” NCT04675762

“This is a single-institution, open-labeled study using fingolimod (FTY720/Gilenya) in patients with non-small cell lung cancer (NSCLC) and small cell lung cancer (SCLC)” NCT06424067

“All patients received standard management alone (control participants) or combined with fingolimod (FTY720, Gilenya), 0.5 mg, orally for 3 consecutive days.” PMID 25003359 Sep 2014

“Patients randomized to fingolimod will also receive oral fingolimod (Gilenya, Novartis) at a dosage of 0.5 mg once daily, for three consecutive days” NCT02956200

“Evaluation of the Autonomic Nervous System During First-dosing With 0.5mg of Fingolimod (Gilenya) in Patients With Relapsing-remitting MS” NCT02048072

“early therapeutic intervention with fingolimod (Gilenya ®) after optic neuritis(ON) has a favorable visual outcome” NCT01647880

“FTY720 (Gilenya) is an orally active modulator of four of the five sphingosine-1 phosphate(S1P) receptors.” NCT02061137

“Fingolimod (FTY720, approved as Gilenya™ ) is a sphingosine-1-phosphate (S1P) receptor modulator” NCT01779700

“fingolimod (Gilenya, Novartis) at a dosage of 0.5 mg once daily, for three consecutive days” NCT04718064

“oral fingolimod (Gilenya, Novartis)” NCT04629872

NCT01786174

Known as Gilenya (fingolimod) Gilenya (fingolimod)NCT03535298
Known as Tascenso odt ChEMBL registry synonym — accepted as the source's own label CHEMBL314854
Action Activate “FTY720 acts as 'super agonist' on the S1P receptor on thymocytes and lymphocytes, inducing uncoupling/internalization of that receptor.” NCT02061137
Modality Small molecule “Fingolimod is a small molecule derived from myriocin” NCT06424067
Route Oral “Patients self-administered fingolimod 1.25 mg capsules orally once daily.” NCT00289978
Target RHOA “a sphingosine 1-phosphate receptor modulator and a RhoA inhibitor (2)” NCT05285878