Ozmosi | Fingolimod Drug Profile
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Fingolimod

Alternative Names: fingolimod, gilenya, fty720, fingolimob, fty 720, tascenso odt
Clinical Status: Inactive
Latest Update: 2026-02-17
Latest Update Note: Clinical Trial Update

Product Description

Fingolimod (FTY720, Gilenya) was the first US Food and Drug Administration-approved oral therapy for relapsing forms of multiple sclerosis (MS).  (Sourced from: https://pubmed.ncbi.nlm.nih.gov/30625282/)

Mechanisms of Action: S1P1 Modulator

Novel Mechanism: No

Modality: Small Molecule

Route of Administration: Oral

FDA Designation: *

Approval Status: Approved

Approved Countries: Argentina | Australia | Austria | Belgium | Bosnia | Brazil | Bulgaria | Canada | Chile | Colombia | Croatia | Cyprus | Czech | Denmark | Ecuador | Egypt | Estonia | European Medicines Agency | Finland | France | Germany | Greece | Hong Kong | Hungary | Iceland | India | Indonesia | Ireland | Israel | Italy | Japan | Jordan | Korea | Latvia | Lebanon | Lithuania | Luxembourg | Malaysia | Malta | Mexico | Netherlands | New Zealand | Norway | Peru | Philippines | Poland | Portugal | Romania | Russia | Saudi Arabia | Serbia | Singapore | Slovakia | Slovenia | South Africa | Spain | Sri Lanka | Sweden | Switzerland | Taiwan | Thailand | Tunisia | Turkey | Ukraine | United Arab Emirates | United Kingdom | United States | Uruguay | Venezuela

Approved Indications: None

Known Adverse Events: None

Company: Novartis
Company Location: Europe
Company Founding Year: 1996
Additional Commercial Interests: None

Clinical Description

Map of Global Clinical Trials for Fingolimod

Countries in Clinic: Australia, China, France, Germany, Romania, Slovakia, Spain

Active Clinical Trial Count: 3

Recent & Upcoming Milestones

Highest Development Phases

Phase 3: Multiple Sclerosis

Trial ID

Trial

Phase

Trial Status

Disease

Primary Completion Date

Probability of Success

Latest Trial Update Date

Data Updated

2023-507556-68-00

CFTY720D2311

P3

Active, not recruiting

Multiple Sclerosis

2029-07-12

2025-05-02

Treatments

CTR20161017

CTR20161017

P1

Recruiting

Multiple Sclerosis

None

2025-04-29

ACTRN12618002016213

ACTRN12618002016213

P1

Not yet recruiting

Multiple Sclerosis

None

2026-02-15

Treatments