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: None *
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: Multiple Sclerosis
Known Adverse Events: Abdominal Pain | Back Pain | Headache | Pain Unspecified | Sinusitis | Diarrhea | Influenza, Human
Company: Novartis
Company Location: BASEL V8 CH 4056
Company CEO: Vasant Narasimhan
Additonal Commercial Interests: None
Clinical Description
Countries in Clinic: Australia, France, Germany, Romania, Slovakia, Spain
Active Clinical Trial Count: 3
Highest Development Phases
Phase 3: Multiple Sclerosis
Trial |
Phase |
Trial Status |
Disease |
Primary Completion Date |
Probability of Success |
|---|---|---|---|---|---|
| CFTY720D2311 | P3 |
Unknown Status |
Multiple Sclerosis |
2029-07-12 |
|
| 2018-001292-21 | P3 |
Active, not recruiting |
Multiple Sclerosis |
2025-07-04 |
|
| ACTRN12618002016213 | P1 |
Not yet recruiting |
Multiple Sclerosis |
None |