Fingolimod clinical trials
Fingolimod is named as an intervention in 8 current clinical trials in our USA, Poland, Spain, Italy, Mexico, Australia, Germany, France, Austria, Turkey, Canada, Brazil, Portugal, Taiwan, UK, India, Belgium, Netherlands, Switzerland, Israel and China registers. 3 are recruiting patients now. The most common phase is Phase 3. The sponsor with the most trials is Novartis Pharmaceuticals (3). The most-studied condition is Multiple Sclerosis.
Where Fingolimod is approved
All regulators →Of the three regulators tracked here, the first to approve Fingolimod was the US, on 21 Sep 2010. It is approved in 3 of the 3 regulators tracked here.
- 3 EU orphan designations, most recently for treatment of hypomyelinating leukodystrophy-18 (22 May 2023, positive)
- 1 EU safety letter (DHPC), latest: periodic safety update report for Gilenya, 10 Nov 2020
From the regulators' own registers: FDA Drugs@FDA, the EMA medicines list and Health Canada's Notice of Compliance database. Dates are the first listed approval of a product containing only this substance; combination products and nationally authorised EU medicines are not counted.
Fingolimod patents and exclusivity
Expiry tracker →Protections still running for marketed products containing Fingolimod, as listed by the regulators. Expired patents and exclusivities, and discontinued products, are not shown.
- 2 listed patents; the last listed expires 30 Sep 2032 (US 9592208, including a 6-month paediatric extension).
Reproduced from the FDA Orange Book and Purple Book (checked 8 Nov 2026) and the European Commission's Union Register of medicinal products (CC BY 4.0; the EU expiry date is calculated exactly as the Commission's register displays it). Listed patents and dates are as submitted to or published by the regulator and may not reflect litigation, invalidation, settlements, lapsed fees or later extensions. This is not legal advice or a freedom-to-operate opinion, and it does not say when a generic or biosimilar will launch.
What health systems spend on Fingolimod
All medicines →From NHSBSA Prescription Cost Analysis (Open Government Licence v3.0) and CMS State Drug Utilization Data. Both are gross amounts: neither system publishes its discounts or rebates per drug. Products combining several substances are not counted here.
How Fingolimod works
All drug targets →- Sphingosine 1-phosphate receptor agonist AgonistTarget: Sphingosine 1-phosphate receptor✓ In ChEMBL and the Guide to Pharmacology
- Kidney transplantPhase 3
Mechanisms and diseases from ChEMBL via the Open Targets Platform (release 26.09), ChEMBL record CHEMBL544665, CC BY-SA 3.0. Targets checked against the IUPHAR/BPS Guide to PHARMACOLOGY (2026.3.1), ligand 2407, CC BY-SA 4.0. Trial phases are not approvals: approved uses are shown from the regulators' own records where we hold them.
NICE appraisals of Fingolimod
All NICE appraisals →NICE, which decides whether the NHS in England should fund new medicines, has published 1 technology appraisal of Fingolimod. 1 is current, and 1 of it recommends it for at least some patients.
| Appraisal | NICE recommendation | Published | Status |
|---|---|---|---|
| Fingolimod for the treatment of highly active relapsing–remitting multiple sclerosis NICE TA254 | Recommended | 25 Apr 2012 | Current |
NICE decisions apply to the NHS in England. In Ireland the HSE decides on reimbursement, advised by the National Centre for Pharmacoeconomics. Titles, categories and dates link to the guidance on nice.org.uk. © NICE 2026 technology appraisal guidance. Available from www.nice.org.uk/guidance. All rights reserved. Subject to Notice of rights. NICE guidance is prepared for the National Health Service in England. All NICE guidance is subject to regular review and may be updated or withdrawn. NICE accepts no responsibility for the use of its content in this product/publication.
Patient leaflets for Fingolimod
The package leaflet is the official guide for patients that comes with every medicine. These links go to the regulators that publish it.
- IEIreland: 13 products on the HPRA listEach product record links to the HPRA, which publishes the leaflet and SmPC.
- EUEuropean Union: Gilenya, Fingolimod Accord (generic), Fingolimod Mylan (generic)EMA product information: package leaflet and summary of product characteristics in every EU language.
- UKUnited Kingdom: Search MHRA ProductsPatient information leaflets and SmPCs for UK-licensed products.
- USUnited States: Search DailyMedFDA-approved labels, including patient and medication guides.
Leaflets differ between brands and countries; always read the one that comes with your own medicine. This is regulatory information, not medical advice.
Reference identifiers for Fingolimod
- ChEMBL
- CHEMBL544665
- PubChem CID
- 57516011
- CAS number
- 162359-56-0
- FDA UNII
- G926EC510T
- Wikidata
- Q27132395
Codes that identify this medicine in other databases, from Wikidata (CC0), matched by its ChEMBL ID. The ATC code is the WHO classification of what the medicine is used for.
Trials by status
Trials by phase
Clinical trials of Fingolimod
8 trialsRegisters list studies that are recruiting, about to open, active but closed to enrolment, or enrolling by invitation. The UK and USA registers cover industry-sponsored studies only. Trial titles and statuses are copied from the registry as published.
Fingolimod across our data
Ireland · EU · USThe same active substance in our other registers, matched by its exact name. Each entry links to the register record it comes from.
Licensed in Ireland (HPRA)
13 single-substance products containing Fingolimod on the HPRA medicines list.
- Fingolimod 0.5 mg hard capsulesFlynn Pharma Limited · PA1226/017/002 · Marketed
- Fingolimod Clonmel 0.5 mg hard capsulesClonmel Healthcare Ltd · PA0126/319/001 · Marketed
- Fingolimod Krka 0.5 mg hard capsulesKRKA, d.d., Novo mesto · PA1347/101/001 · Marketed
- Fingolimod MSN 0.5 mg hard capsulesMSN Labs Europe Limited · PA23250/007/001 · Marketed
- Fingolimod Teva 0.5 mg hard capsulesNorton Waterford · PA0436/047/001 · Marketed
Supply shortages
- Fingolimod Zentiva 0,5 mg HartkapselnGermany (BfArM) · Production problem · 1 Sep 2026 to 8 Jan 2027
- Fingolimod Zentiva 0,5 mg HartkapselnGermany (BfArM) · Production problem · 1 Sep 2026 to 8 Jan 2027
- Fingolimod PUREN 0,5 mg HartkapselnGermany (BfArM) · Production problem · 1 Jun 2026 to 30 Jan 2027
Recent approvals
- Fingolimod HydrochlorideFDA · 30 Dec 2020 · Generic (ANDA) · Alkem Labs Ltd
- Fingolimod HydrochlorideFDA · 28 Oct 2020 · Generic (ANDA) · Accord Hlthcare
Conditions studied with Fingolimod
6 conditionsSponsors
lead sponsor per trial| Lead sponsor | Trials |
|---|---|
| Novartis Pharmaceuticals | 3 |
| Hoffmann-La Roche | 1 |
| Biogen | 1 |
| TG Therapeutics, Inc | 1 |
| Bristol-Myers Squibb | 1 |
| General Hospital of Shenyang Military Region | 1 |
By country register
A trial with sites in more than one country appears in each of those registers.
Related compounds
Questions about Fingolimod trials
How many clinical trials are testing Fingolimod?
8 current trials in our USA, Poland, Spain, Italy, Mexico, Australia, Germany, France, Austria, Turkey, Canada, Brazil, Portugal, Taiwan, UK, India, Belgium, Netherlands, Switzerland, Israel and China registers name Fingolimod (also registered as FTY720) as a drug or biological intervention, as of the registry sync on 10 November 2026. Completed and withdrawn studies are not counted.
Are Fingolimod trials recruiting patients?
Yes. 3 of the 8 trials are recruiting: 2 with sites in USA, 2 with sites in Poland, 1 with sites in Spain, 1 with sites in Italy, 1 with sites in Mexico, 1 with sites in Australia, 1 with sites in Turkey, 1 with sites in Portugal, 1 with sites in Taiwan and 1 with sites in China. Eligibility and site contacts are on each trial's record. Only the study team can confirm whether a patient is eligible.
Who sponsors Fingolimod clinical trials?
Novartis Pharmaceuticals (3), Hoffmann-La Roche (1), Biogen (1) and TG Therapeutics, Inc (1), among 6 lead sponsors in total. The number in brackets is how many trials each organisation leads.
Is Fingolimod licensed in Ireland?
Yes. The HPRA medicines list includes 13 single-substance products containing Fingolimod, for example Fingolimod 0.5 mg hard capsules (Flynn Pharma Limited). A licence does not mean a product is currently marketed or reimbursed; see each product's record.
Is there a Fingolimod shortage?
The registers we track list 3 entries for Fingolimod: 3 German notices. Shortages are product- and country-specific; check with a pharmacist.
Where does this information come from?
Every trial, status, phase and sponsor on this page is copied from public ClinicalTrials.gov records by a daily sync. Nothing here describes how Fingolimod works or whether it is effective, and it is not medical advice.
How this page is built
Everything on this page is copied from public ClinicalTrials.gov registry records — it is not written from memory, and nothing here describes how Fingolimod works or whether it is effective. Each trial links to its own record so you can check it yourself.
- ClinicalTrials.gov (U.S. National Library of Medicine) ↗ Trial IDs, titles, intervention names and synonyms, phase, overall status, lead sponsor and conditions for every trial on this page
This page is built automatically: a daily sync job reads the registry records behind our country trial registers, collects every trial that lists Fingolimod (or a registered synonym) as a drug or biological intervention, and tabulates the registry fields directly. Placebos and generic comparators are excluded. There is no AI drafting and no per-compound editorial pass, and the page has not been clinically reviewed. The “last verified” date above is the timestamp of that sync, not a review date. Our general editorial approach is described in our editorial standards and corrections policy. The ClinicalTrials.gov data on this page was last retrieved on 10 Nov 2026. How every register is built: methodology · fixes we have made: corrections log.