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fingolimod

Trade name: gilenya

Small moleculeapproved

Approved

Sep 21, 2010

Fingolimod (FTY720) is a sphingosine 1-phosphate receptor modulator indicated and approved for the treatment of relapsing-remitting multiple sclerosis. Fingolimod (trade name Gilenya, Novartis) is metabolized by sphingosine kinase to the active metabolite, fingolimod-phosphate. Fingolimod-phosphate is a sphingosine 1-phosphate receptor modulator, and binds with high affinity to sphingosine 1-phosphate receptors 1, 3, 4, and 5. Fingolimod-phosphate blocks the capacity of lymphocytes to egress from lymph nodes, reducing the number of lymphocytes in peripheral blood. The mechanism by which fingolimod exerts therapeutic effects in multiple sclerosis is unknown, but may involve reduction of lymphocyte migration into the central nervous system. Fingolimod was approved as a first-in-class, orally active drug for relapsing multiple sclerosis in 2010, and its applications in other disease conditions are currently under clinical trials. — NCATS

Clinical trial activity

90 trials · 48 clinical orgs · 23 marketing orgs

Phase 1
16
Phase 2
44
Phase 3
28
Phase 4
28

Earliest trial started May 1, 2002 (NCT00239902)

Timeline

2000s

  1. Jan 1, 2002

    Novartis — Earliest Phase 2 Sponsor(trial)

  2. Jan 1, 2003

    Novartis — Earliest Phase 3 Sponsor(trial)

  3. Jan 1, 2006

    Novartis — Earliest Phase 1 Sponsor(trial)

2010s

  1. Sep 21, 2010

    Novartis — Earliest FDA Approval

  2. Sep 21, 2010

    Novartis — NDA Organization

  3. Dec 29, 2016

    MSN Laboratories — Marketing Organization

  4. Jan 31, 2017

    Strides Pharma Science — Marketing Organization

  5. Mar 14, 2017

    Teva — Marketing Organization

  6. Mar 17, 2017

    Glenmark Pharmaceuticals — Marketing Organization

  7. Mar 22, 2017

    Par Pharmaceuticals — Marketing Organization

  8. Mar 22, 2017

    Accord Research — Marketing Organization

  9. Mar 22, 2017

    Bristol-Myers Squibb — Marketing Organization

  10. Mar 23, 2017

    Alkem Labs Ltd — Marketing Organization

  11. Apr 28, 2017

    Biocon Limited — Marketing Organization

  12. Jul 11, 2017

    Zydus Discovery DMCC — Marketing Organization

  13. Feb 7, 2019

    Aurobindo Pharma — Marketing Organization

  14. Dec 4, 2019

    Sunshine Lake Pharma Co., Ltd. — Marketing Organization

  15. Dec 4, 2019

    Sun Pharmaceuticals — Marketing Organization

2020s

  1. May 18, 2020

    Hetero Labs Ltd — Marketing Organization

  2. Dec 18, 2020

    Apotex — Marketing Organization

  3. Jan 19, 2021

    Mylan — Marketing Organization

  4. Mar 5, 2021

    Dr. Reddy's Laboratories — Marketing Organization

  5. May 11, 2021

    Standard Chem. & Pharm. Co., Ltd. — Marketing Organization

  6. Oct 18, 2021

    Handa Pharmaceuticals — Marketing Organization

  7. Dec 23, 2021

    Cycle Pharmaceuticals Ltd. — Marketing Organization

  8. Sep 7, 2022

    Prinston Inc — Marketing Organization

  9. Dec 9, 2022

    Cycle Pharmaceuticals Ltd. — NDA Secondary Org

  10. May 24, 2023

    Bionpharma Inc — Marketing Organization

Indications

Approved for

Studied for

Mechanism of action

Approval history

  • approvedPriority reviewSep 21, 2010

Chemistry & pharmacology

Loading structure…

SMILES

CCCCCCCCc1ccc(CCC(N)(CO)CO)cc1
Mol. weight
307.48 g/mol
Lipinski Ro5
Pass
Rule of 3
No
Chirality
Achiral Molecule
Inorganic
No
Polymer
No
Delivery
Oral
Availability
Prescription Only

Oral

Yes

Parenteral

No

Topical

No

First in classProdrug

Sources

Also known as

  • fingolimod
  • fingolimod
  • fingolimod
  • fingolimod
  • fingolimod
  • fingolimod
  • fingolimod
  • fingolimod
  • fingolimod
  • fingolimod hcl
  • fingolimod hcl
  • fingolimod hcl
  • fingolimod hydrochloride
  • fingolimod hydrochloride
  • fingolimod hydrochloride
  • fingolimod hydrochloride
  • fingolimod hydrochloride
  • fingolimodum
  • fingolimodum
  • fty-720
  • fty-720
  • fty-720
  • gilenya
  • gilenya
  • gilenya
  • gilenya
  • gilenya
  • gsk618334
  • gsk618334

Clinical trials

NCT IDPhaseStart dateSponsor(s)
NCT07220252Phase 2/Phase 3 (Phase 3)Dec 1, 2025TG Therapeutics, Inc.
NCT06408259Phase 3Jan 28, 2025Bristol-Myers Squibb, Celgene
NCT06424067Phase 2Sep 30, 2024Medical University of South Carolina
NCT06087965Phase 1/Phase 2 (Phase 2)Oct 11, 2023People's Liberation Army of China
NCT05285878Phase 2Apr 15, 2022The University of Texas, Dallas
NCT05307731Phase 4Mar 15, 2022People's Liberation Army of China
NCT05123703Phase 3Jan 31, 2022PPD, Roche
NCT04927572Phase 1/Phase 2 (Phase 2)Oct 13, 2021Vyne Therapeutics Inc.
NCT04926818Phase 3Oct 5, 2021Novartis
NCT04667949Phase 4Feb 20, 2021Novartis
NCT04718064N/AFeb 1, 2021Xuzhou Medical University
NCT04675762Phase 2Dec 15, 2020Zhejiang University
NCT04629872Phase 2Nov 12, 2020Fujian Medical University
NCT04480853Phase 4Oct 12, 2020Novartis
NCT04657744Phase 1Aug 10, 2020Genuine Research Center, Egypt, Hikma
NCT04280588Phase 2Feb 22, 2020Fujian Medical University
NCT04088630Early Phase 1 (Phase 1)Nov 30, 2019Wake Forest University
NCT03941743Phase 1May 24, 2019Mayo Clinic, National Cancer Institute (NCI)
NCT03943498Early Phase 1 (Phase 1)May 24, 2019Mayo Clinic, National Cancer Institute (NCI)
NCT03257358Phase 4Sep 19, 2017Novartis
Showing 20 of 90 trials
Page 1 / 5

Organizations

Research & Development (48)

OrganizationOrg typeTrialsAs lead sponsorPhasesEarliest year
NovartisFor profit565342002
Mitsubishi TanabeFor profit5132004
GlaxoSmithKlineFor profit3312007
Fujian Medical UniversityAcademic/Hospital2212020
Mayo ClinicAcademic/Hospital2212019
National Cancer Institute (NCI)Government2012019
People's Liberation Army of ChinaGovernment2222022
Zhejiang UniversityAcademic/Hospital2212016
AlembicFor profit1112015
Algorithme Pharma IncFor profit1012015
ALS Therapy Development InstituteAcademic/Hospital1012013
Asofarma de México S.A de C.V.For profit1112015
BiogenFor profit1112014
Bristol-Myers SquibbFor profit1012025
Cantonal Hospital of St. GallenAcademic/Hospital1112013
CelgeneFor profit1112025
Fondazione I.R.C.C.S. Istituto Neurologico Carlo BestaAcademic/Hospital1112017
Genuine Research Center, EgyptFor profit1112020
Harvard UniversityAcademic/Hospital1112013
HikmaFor profit1012020
48 organizations
Page 1 / 3

Marketing (26)

OrganizationOrg typeRelationshipDate
Accord ResearchFor profitMKTGMar 22, 2017
Accord ResearchFor profitSYNOct 28, 2020
Alkem Labs LtdFor profitMKTGMar 23, 2017
ApotexFor profitMKTGDec 18, 2020
Aurobindo PharmaFor profitMKTGFeb 7, 2019
Biocon LimitedFor profitMKTGApr 28, 2017
Biocon LimitedFor profitSYNDec 4, 2019
Bionpharma IncFor profitMKTGMay 24, 2023
Bristol-Myers SquibbFor profitMKTGMar 22, 2017
Cycle Pharmaceuticals Ltd.For profitMKTGDec 23, 2021
Cycle Pharmaceuticals Ltd.For profitNDA2Dec 9, 2022
Dr. Reddy's LaboratoriesFor profitMKTGMar 5, 2021
Glenmark PharmaceuticalsFor profitMKTGMar 17, 2017
Handa PharmaceuticalsFor profitMKTGOct 18, 2021
Hetero Labs LtdFor profitMKTGMay 18, 2020
MSN LaboratoriesFor profitMKTGDec 29, 2016
MylanFor profitMKTGJan 19, 2021
NovartisFor profitNDASep 21, 2010
Par PharmaceuticalsFor profitMKTGMar 22, 2017
Prinston IncFor profitMKTGSep 7, 2022
Standard Chem. & Pharm. Co., Ltd.For profitMKTGMay 11, 2021
Strides Pharma ScienceFor profitMKTGJan 31, 2017
Sun PharmaceuticalsFor profitMKTGDec 4, 2019
Sunshine Lake Pharma Co., Ltd.For profitMKTGDec 4, 2019
TevaFor profitMKTGMar 14, 2017
Zydus Discovery DMCCFor profitMKTGJul 11, 2017