Fingolimod

also known as FTY720 · Gilenya · Fingolimod Hydrochloride · Fingolimod (as hydrochloride) · Fingolimod accord · Fingolimod hcl · Fingolimod hydrochlorid · Fingolimod mylan · +6 more

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 · 7 recorded

Milestone	Jurisdiction	Brand	Indication	Date	Sentence it was read from
Filed multiple sclerosis 1 milestone
Filed	Japan (PMDA)	—	multiple sclerosis	2010-12-20	“Application Submitted in Japan for FTY720, a Novel Multiple Sclerosis Treatment” tanabe-pharma.com ↗
Filed pediatric multiple sclerosis 2 milestones
Filed	EU (EMA)	Gilenya	pediatric multiple sclerosis	—	“following the submission of Gilenya for a pediatric MS indication to both FDA and EMA.” novartis.com ↗
Filed	US (FDA)	Gilenya	pediatric multiple sclerosis	—	“following the submission of Gilenya for a pediatric MS indication to both FDA and EMA.” novartis.com ↗
Approved Indication not stated 3 milestones
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

200220032004200520062007200820092010201120122013201420152016201720182019202020212022202320242025202620272028

Phase	Registry id	Dates	Indication	Sponsor	Status	Outcome
Phase 03 trials · 1 missed
Phase 0	NCT04088630	Aug 2020 → Jun 2023	brain edema, intracerebral hemorrhage	Wake Forest University Health Sciences	Completed	Missed primary
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 · 1 missed
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	Missed primary
Phase 215 trials · 3 met primary · 1 missed
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 Stop: Enrollment
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	NCT01757691	Aug 2013 → May 2014	optic neuritis	Novartis Pharmaceuticals	Terminated	No outcome recorded
Phase 2	NCT01786174	Aug 2013 → Sep 2014	amyotrophic lateral sclerosis	Massachusetts General Hospital	Completed	Missed primary
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	NCT00670449	Apr 2008 → Apr 2012	multiple sclerosis	Novartis	Completed	No outcome recorded
Phase 2	NCT00537082	Sep 2007 → Feb 2010	multiple sclerosis	Novartis	Completed	Met primary
Phase 2	NCT00239798	Nov 2004 → Nov 2006	—	Novartis Pharmaceuticals	Completed	Met primary
Phase 2	NCT00333138	May 2003 → Apr 2011	multiple sclerosis	Novartis	Completed	Met primary
Phase 2	NCT00239902	May 2002 → Nov 2004	—	Novartis Pharmaceuticals	Completed	No outcome recorded

Phase 2/33 trials · 2 met primary
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	Met primary Stop: Enrollment
Phase 2/3	NCT00099749	Nov 2003 → Apr 2006	—	Novartis Pharmaceuticals	Completed	Met primary
Phase 322 trials · 4 met primary · 2 missed
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	Met primary
Phase 3	NCT01625182	Dec 2012 → Sep 2016	chronic inflammatory demyelinating polyradiculoneuropathy	Novartis Pharmaceuticals	Completed	Missed primary
Phase 3	NCT01633112	Aug 2012 → Apr 2018	relapsing-remitting multiple sclerosis	Novartis Pharmaceuticals	Terminated	No outcome recorded Stop: Enrollment
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 3	NCT00731692	Jul 2008 → Jun 2015	primary progressive multiple sclerosis	Novartis Pharmaceuticals	Terminated	Missed primary
Phase 3	NCT00662649	Feb 2008 → Jun 2011	multiple sclerosis	Novartis	Completed	No outcome recorded
Phase 3	NCT00355134	Jun 2006 → Jun 2011	multiple sclerosis	Novartis	Completed	Met primary
Phase 3	NCT00340834	May 2006 → Jul 2011	relapsing-remitting multiple sclerosis	Novartis	Completed	Met primary
Phase 3	NCT00289978	Jan 2006 → Jul 2009	relapsing-remitting multiple sclerosis	Novartis	Completed	Met primary
Phase 3	NCT00239876	May → Dec 2005	—	Novartis Pharmaceuticals	Completed	No outcome recorded
Phase 3	NCT00099801	Jan 2005 → Mar 2006	—	Novartis Pharmaceuticals	Completed	No outcome recorded
Phase 3	NCT00239863	May 2004 → May 2006	—	Novartis Pharmaceuticals	Completed	No outcome recorded
Phase 3	NCT00239811	Apr 2004 → May 2006	—	Novartis Pharmaceuticals	Completed	No outcome recorded
Phase 3	NCT00098735	Apr 2004 → Apr 2006	—	Novartis Pharmaceuticals	Completed	No outcome recorded
Phase 3	NCT00099736	May 2003 → Sep 2005	—	Novartis Pharmaceuticals	Completed	Mixed
Phase 3	NCT00239785	Apr 2003 → Apr 2005	—	Novartis Pharmaceuticals	Completed	No outcome recorded

Phase 422 trials · 1 met primary · 2 missed
Phase 4	NCT05307731	Mar 2022 → Mar 2028 expected	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 Stop: Enrollment
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 4	NCT01621269	Jun 2013 → Jun 2014	multiple sclerosis	Novartis Pharmaceuticals	Withdrawn	No outcome recorded
Phase 4	NCT01755871	Jan 2013 → Jan 2016	relapsing-remitting multiple sclerosis	Heinrich-Heine University, Duesseldorf	Terminated	No outcome recorded Stop: Enrollment
Phase 4	NCT01578330	Oct 2012 → Apr 2015	relapsing-remitting multiple sclerosis	Novartis Pharmaceuticals	Completed	No outcome recorded
Phase 4	NCT01623596	Jun 2012 → Jul 2015	relapsing-remitting multiple sclerosis	Novartis Pharmaceuticals	Completed	No outcome recorded
Phase 4	NCT01585298	Apr 2012 → Dec 2016	multiple sclerosis	Novartis Pharmaceuticals	Completed	No outcome recorded
Phase 4	NCT01534182	Jan 2012 → Jun 2013	relapsing-remitting multiple sclerosis	Novartis Pharmaceuticals	Completed	No outcome recorded
Phase 4	NCT01498887	Dec 2011 → Dec 2015	relapsing-remitting multiple sclerosis	Novartis Pharmaceuticals	Completed	Missed primary
Phase 4	NCT01420055	Aug 2011 → Jun 2013	relapsing-remitting multiple sclerosis	Novartis Pharmaceuticals	Completed	No outcome recorded
Phase 4	NCT01317004	May 2011 → Jun 2014	relapsing-remitting multiple sclerosis	Novartis Pharmaceuticals	Completed	No outcome recorded
Phase 4	NCT01333501	May 2011 → Sep 2015	multiple sclerosis	Novartis Pharmaceuticals	Completed	Missed primary
Phase 4	NCT01310166	Feb 2011 → Jul 2012	relapsing-remitting multiple sclerosis	Novartis Pharmaceuticals	Completed	No outcome recorded
Phase 4	NCT01216072	Aug 2010 → Aug 2012	multiple sclerosis	Novartis Pharmaceuticals	Completed	Met primary

Phase not applicable1 trial
—	NCT04718064	Feb → Oct 2021	stroke disorder	The Affiliated Hospital of Xuzhou Medical University	Unknown	No outcome recorded
Comparator or background therapy15 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 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 2/3	NCT02939079 Background	Apr 2015 → Sep 2016	multiple sclerosis	Isfahan University of Medical Sciences	Completed	No outcome recorded
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	Met primary
Phase 3	NCT04926818 Comparator	Oct 2021 → Mar 2026 overdue	multiple sclerosis	Novartis Pharmaceuticals	Active not recruiting	No outcome recorded
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 Stop: Enrollment
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 Stop: Business
Phase 4	NCT01705236 Background	Aug 2012 → Feb 2019	relapsing-remitting multiple sclerosis	Novartis Pharmaceuticals	Completed	No outcome recorded
Phase 4	NCT01436643 Background	Nov 2011 → Sep 2013	depressive disorder, relapsing-remitting multiple sclerosis	Novartis Pharmaceuticals	Terminated	No outcome recorded Stop: Enrollment

News releases announcing trial results or a regulatory action · 28

Date	Issuer	Release
2026-04-01	Alembic Pharmaceuticals Ltd.	Regulatory 25th April, 2026 Vadodara, India alembicpharmaceuticals.com ↗ Alembic Pharmaceuticals Limited (Alembic) today announced that it has received final approval from the US Food & Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA) Fingolimod Capsules, 0.5 mg.
2023-01-16	Cycle Pharmaceuticals Ltd.	Regulatory Multiple sclerosis patients in US left without essential patient support program will now receive equivalent backing from Cycle Pharmaceuticals following FDA’s approval of TASCENSO ODT® (fingolimod) cyclepharma.com ↗ We’re thrilled that the FDA has approved TASCENSO ODT for MS patients.
2021-10-13	Biogen	Results New MS PATHS Data at ECTRIMS 2021 Confirm Biogen’s Disease-Modifying Therapies Do Not Reduce Antibody Response to COVID-19 Vaccines in People with Multiple Sclerosis biogen.com ↗ Data from this analysis also suggest that approximately 40 percent of people with MS treated with anti-CD20 and S1P disease-modifying therapies (DMT) mount an antibody response to the COVID-19 vaccine
2021-06-24	Zydus Lifesciences Limited	Regulatory Zydus Cadila receives tentative approval from USFDA for Fingolimod Capsules .25mg zyduslife.com ↗ Zydus Cadila has received tentative approval from the USFDA to market Fingolimod Capsules in the strength of .25 mg (US RLD: Gilenya® Capsules).
2020-10-16	Zydus Lifesciences Limited	Regulatory Zydus Cadila receives final approval from USFDA for Fingolimod Capsules and Verapamil Hydrochloride Injection zyduslife.com ↗ Zydus Cadila has received final approval from the USFDA to market Fingolimod Capsules, 0.5 mg (US RLD: Gilenya® Capsules).
2020-06-19	Glenmark Pharmaceuticals Ltd. India	Regulatory Glenmark Pharmaceuticals receives ANDA approval for Fingolimod Capsules, 0.5 mg glenmarkpharma.com ↗ Glenmark Pharmaceuticals Inc., USA (Glenmark) has been granted final approval by the United States Food & Drug Administration (U.S. FDA) for Fingolimod Capsules, 0.5 mg, the generic version of Gilenya®1 Capsules, 0.5 mg, of Novartis Pharmaceuticals Corporation.
2019-09-13	Novartis Pharmaceuticals	Results New Novartis data show that neuronal and glial filaments, biomarkers of disease activity, have the potential to support decision making in the management of multiple sclerosis (MS) patient novartis.com ↗
2019-09-11	Biogen	Results New Data Presented at ECTRIMS Reinforce Long-term Benefits of TECFIDERA® (dimethyl fumarate) Over 10 Years biogen.com ↗ TECFIDERA demonstrated comparable effectiveness to fingolimod and was less effective than natalizumab and alemtuzumab.
2019-07-19	Novartis Pharmaceuticals	Regulatory Novartis key multiple sclerosis product Gilenya® approved in China novartis.com ↗ Chinese National Medical Products Administration (NMPA) approved Gilenya® for relapsing forms of multiple sclerosis (RMS) for adults and children 10 years and older.
2019-05-10	Novartis Pharmaceuticals	Results 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 ↗ Gilenya showed significant superiority versus glatiramer acetate in other key measures of disease activity, such as brain lesions[1]
2018-11-29	Novartis Pharmaceuticals	Regulatory 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 ↗ Novartis today announced that the European Commission (EC) has approved Gilenya ® (fingolimod) for the treatment of children and adolescents 10 to 17 years old with relapsing-remitting forms of multiple sclerosis (RRMS).
2018-10-10	Novartis Pharmaceuticals	Results 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 ↗ The data show that Gilenya 0.5mg met its primary endpoint of significantly reducing the annualized relapse rate (ARR) compared to Copaxone[1].
2018-09-21	Novartis Pharmaceuticals	Regulatory 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	Results Novartis announces NEJM publication of landmark PARADIGMS study demonstrating significant benefit of Gilenya® in children and adolescents with MS novartis.com ↗ PARADIGMS met the primary endpoint of significantly reducing the rate of relapses when compared to interferon beta-1a intramuscular injections over a period of up to two years[3].
2018-05-12	Novartis Pharmaceuticals	Regulatory Novartis announces FDA approval of Gilenya® as the first disease-modifying therapy for pediatric relapsing multiple sclerosis novartis.com ↗ This approval expands the age range for Gilenya, which was previously approved for patients aged 18 years and older with RMS.
2017-10-28	Novartis Pharmaceuticals	Results Novartis PARADIGMS data show children and adolescents with MS had an 82% lower relapse rate with Gilenya® vs. interferon beta-1a novartis.com ↗ Treatment with oral Gilenya resulted in an 82% reduction in the rate of relapses (annualized relapse rate) over a period of up to two years, compared to interferon beta-1a intramuscular injections (p <0.001)[1].
2017-10-25	Novartis Pharmaceuticals	Results Novartis confirms leadership in multiple sclerosis (MS) with scientific advancements and new data presented at ECTRIMS novartis.com ↗ The safety profile of Gilenya was consistent with that seen in other MS clinical trials[1].
2017-09-05	Novartis Pharmaceuticals	Results Novartis landmark Phase III trial shows fingolimod significantly reduces relapses in children and adolescents with MS novartis.com ↗ Data show that oral fingolimod resulted in a significant and clinically meaningful reduction in the number of relapses (annualized relapse rate) in this patient population over a period of up to two years, compared to interferon beta-1a intramuscular injections[1].
2017-04-24	Novartis Pharmaceuticals	Results Novartis real-world data at AAN confirms benefit of Gilenya® on four key measures of disease activity in relapsing MS novartis.com ↗ Results show that Gilenya impacted four key measures of MS disease activity (relapses, MRI lesions, disability progression and brain shrinkage), in people with relapsing-remitting multiple sclerosis (RRMS) for up to 16 months[1].
2016-09-16	Novartis Pharmaceuticals	Results New Novartis data presented at ECTRIMS show benefit of Gilenya® on patient disability progression at 10 years novartis.com ↗ The study met its primary endpoint of a significantly lower change from baseline at 10 years in patients' Expanded Disability Status Scale (EDSS) score with continuous versus non-continuous Gilenya treatment (0.55 versus 1.21, respectively; p=0.0155).
2016-09-14	Biogen	Results New Data Affirm Strong Efficacy and Well-Characterized Safety Profile of TECFIDERA® in Both Clinical Studies and Real-World Setting biogen.com ↗ TECFIDERA Treatment Significantly Reduced Time to First Relapse vs. Glatiramer Acetate, Interferon β and Teriflunomide and Showed Comparable Efficacy to Fingolimod in Data Analysis from MSBase Registry
2015-10-08	Novartis Pharmaceuticals	Results Long-term efficacy of Gilenya® reinforced by new 'no evidence of disease activity' (NEDA-4) analysis in MS patients over seven years novartis.com ↗ The data showed that in the first year, 27.1% of patients on Gilenya achieved NEDA-4 compared to 9.1% on placebo.
2015-04-21	Novartis Pharmaceuticals	Results Data at AAN showed Gilenya® high efficacy in achieving 'no evidence of disease activity' in previously-treated highly-active MS patients novartis.com ↗ These data showed that previously-treated patients with highly-active relapsing multiple sclerosis (RMS) who were treated with Gilenya ® (fingolimod) had a six-times greater likelihood of achieving 'no evidence of disease activity' across four key measures of disease activity compared to placebo over two years (odds ratio 6.35; 95% CI 3.02-13.35; p<0.0001).
2011-09-26	Tanabe Pharma Corporation	Regulatory Approval for "IMUSERA® Capsules 0.5mg" Japan's First Once-Daily Oral Dosing Multiple Sclerosis Treatment tanabe-pharma.com ↗ Approval for "IMUSERA® Capsules 0.5mg" Japan's First Once-Daily Oral Dosing Multiple Sclerosis Treatment
2011-03-28	Tanabe Pharma Corporation	Regulatory Novartis receives European Commission approval for FTY720, the first oral multiple sclerosis treatment for use in the EU tanabe-pharma.com ↗
2010-12-20	Tanabe Pharma Corporation	Regulatory Application Submitted in Japan for FTY720, a Novel Multiple Sclerosis Treatment tanabe-pharma.com ↗ Application Submitted in Japan for FTY720, a Novel Multiple Sclerosis Treatment
2010-09-28	Tanabe Pharma Corporation	Regulatory Novartis gains NDA approval for FTY720 in the US tanabe-pharma.com ↗
2010-09-22	Biogen	Regulatory Biogen Idec Makes Statement About U.S. FDA Approval of Gilenya™ biogen.com ↗ There has been a desire within the MS community for an oral treatment for a long time, and the approval of Gilenya has made this a reality.

All press releases naming this drug 39 releases

Date	Issuer	Release
2026-04-01	Alembic Pharmaceuticals Ltd.	25th April, 2026 Vadodara, India alembicpharmaceuticals.com ↗
2023-02-13	Cycle Pharmaceuticals Ltd.	New drug, TASCENSO ODT® (fingolimod), launched to meet the needs of patients in the US left without essential patient support cyclepharma.com ↗
2023-01-16	Cycle Pharmaceuticals Ltd.	Multiple sclerosis patients in US left without essential patient support program will now receive equivalent backing from Cycle Pharmaceuticals following FDA’s approval of TASCENSO ODT® (fingolimod) cyclepharma.com ↗
2022-11-01	Cycle Pharmaceuticals Ltd.	Cycle Pharmaceuticals to launch TASCENSO ODT® (fingolimod) in US in Q1 2023 cyclepharma.com ↗
2022-10-31	Glenmark Pharmaceuticals Ltd. India	Glenmark Pharmaceuticals launches Fingolimod Capsules, 0.5 mg in the US glenmarkpharma.com ↗
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 ↗
2021-10-13	Biogen	New MS PATHS Data at ECTRIMS 2021 Confirm Biogen’s Disease-Modifying Therapies Do Not Reduce Antibody Response to COVID-19 Vaccines in People with Multiple Sclerosis biogen.com ↗
2021-06-24	Zydus Lifesciences Limited	Zydus Cadila receives tentative approval from USFDA for Fingolimod Capsules .25mg zyduslife.com ↗
2020-10-16	Zydus Lifesciences Limited	Zydus Cadila receives final approval from USFDA for Fingolimod Capsules and Verapamil Hydrochloride Injection zyduslife.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 ↗
2020-06-19	Glenmark Pharmaceuticals Ltd. India	Glenmark Pharmaceuticals receives ANDA approval for Fingolimod Capsules, 0.5 mg glenmarkpharma.com ↗
2019-11-08	Pharmascience Inc.	PHARMASCIENCE INC. LANCE LE PMS-FINGOLIMOD POUR LE TRAITEMENT DE LA SCLÉROSE EN PLAQUE (SP) RÉMITTENTE CHEZ L’ADULTE pharmascience.com ↗
2019-10-31	Teva Canada	Teva Canada announces the launch of a Bioequivalent Generic Version of Gilenya®, Teva-Fingolimod Capsulesfor the treatment of Relapsing-Remitting Multiple Sclerosis (MS) tevacanada.com ↗
2019-09-13	Novartis Pharmaceuticals	New Novartis data show that neuronal and glial filaments, biomarkers of disease activity, have the potential to support decision making in the management of multiple sclerosis (MS) patient novartis.com ↗
2019-09-11	Biogen	New Data Presented at ECTRIMS Reinforce Long-term Benefits of TECFIDERA® (dimethyl fumarate) Over 10 Years biogen.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 ↗
2017-10-25	Novartis Pharmaceuticals	Novartis confirms leadership in multiple sclerosis (MS) with scientific advancements and new data presented at ECTRIMS novartis.com ↗
2017-09-05	Novartis Pharmaceuticals	Novartis landmark Phase III trial shows fingolimod significantly reduces relapses in children and adolescents with MS novartis.com ↗
2017-04-24	Novartis Pharmaceuticals	Novartis real-world data at AAN confirms benefit of Gilenya® on four key measures of disease activity in relapsing MS novartis.com ↗
2016-09-16	Novartis Pharmaceuticals	New Novartis data presented at ECTRIMS show benefit of Gilenya® on patient disability progression at 10 years novartis.com ↗
2016-09-14	Biogen	New Data Affirm Strong Efficacy and Well-Characterized Safety Profile of TECFIDERA® in Both Clinical Studies and Real-World Setting biogen.com ↗
2015-10-08	Novartis Pharmaceuticals	Long-term efficacy of Gilenya® reinforced by new 'no evidence of disease activity' (NEDA-4) analysis in MS patients over seven years novartis.com ↗
2015-04-21	Novartis Pharmaceuticals	Data at AAN showed Gilenya® high efficacy in achieving 'no evidence of disease activity' in previously-treated highly-active MS patients novartis.com ↗
2015-04-13	Novartis Pharmaceuticals	Gilenya® data at AAN to highlight Novartis leadership in innovation with new MS assessment methods to benefit patients and physicians novartis.com ↗
2011-09-26	Tanabe Pharma Corporation	Approval for "IMUSERA® Capsules 0.5mg" Japan's First Once-Daily Oral Dosing Multiple Sclerosis Treatment tanabe-pharma.com ↗
2011-03-28	Tanabe Pharma Corporation	Novartis receives European Commission approval for FTY720, the first oral multiple sclerosis treatment for use in the EU tanabe-pharma.com ↗
2010-12-20	Tanabe Pharma Corporation	Application Submitted in Japan for FTY720, a Novel Multiple Sclerosis Treatment tanabe-pharma.com ↗
2010-09-28	Tanabe Pharma Corporation	Novartis gains NDA approval for FTY720 in the US tanabe-pharma.com ↗
2010-09-22	Biogen	Biogen Idec Makes Statement About U.S. FDA Approval of Gilenya™ biogen.com ↗
2004-02-18	Mapi Pharma Ltd.	Mapi Pharma Granted United States Patent Covering the Process for the Preparation of Fingolimod for Multiple Sclerosis mapi-pharma.com ↗

Evidence & citations 19 cited values

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

Field	Value	Cited 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 ↗ NCT00731523 ↗ Show 60 more sources
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 Hydrochloride” NCT03943498 ↗ 1 “Drug: Fingolimod Hydrochloride” NCT03941743 ↗
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)” NCT00731523 ↗ “Fingolimod (FTY720)” NCT01625182 ↗ Show 16 more sources
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 ↗ Show 1 more source
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 ↗