Teriflunomide clinical trials
Teriflunomide is named as an intervention in 7 current clinical trials in our USA, China, Italy, Poland, Mexico, UK, India, Spain, Turkey, Brazil, Denmark, Switzerland, Austria, Germany, France, Portugal, Canada, Netherlands, Belgium, Taiwan, Israel, Czechia, Japan, South Korea, Sweden, Ireland, Norway, Australia and Singapore registers. 1 is recruiting patients now. The most common phase is Phase 3. The sponsor with the most trials is Novartis Pharmaceuticals (2). The most-studied condition is Relapsing Multiple Sclerosis. The EU clinical trials register (CTIS) separately lists 1 authorised or ongoing trial.
Where Teriflunomide is approved
All regulators →Of the three regulators tracked here, the first to approve Teriflunomide was the US, on 12 Sep 2012. It is approved in 3 of the 3 regulators tracked here.
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.
Teriflunomide patents and exclusivity
Expiry tracker →Protections still running for marketed products containing Teriflunomide, as listed by the regulators. Expired patents and exclusivities, and discontinued products, are not shown.
- 3 listed patents; the last listed expires 4 Aug 2034 (US 9186346, 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 Teriflunomide
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 Teriflunomide works
All drug targets →- Dihydroorotate dehydrogenase inhibitor InhibitorTarget: DHODH dihydroorotate dehydrogenase (quinone)✓ In ChEMBL and the Guide to Pharmacology
- Rheumatoid arthritisPhase 3
- Autoimmune thrombocytopenic purpuraPhase 2
- Secondary progressive multiple sclerosisPhase 2
- Celiac diseasePhase 1/2
- Tropical spastic paraparesisPhase 1/2
- Hepatitis B virus infectionPhase 1
Mechanisms and diseases from ChEMBL via the Open Targets Platform (release 26.09), ChEMBL record CHEMBL973, CC BY-SA 3.0. Targets checked against the IUPHAR/BPS Guide to PHARMACOLOGY (2026.3.1), ligand 6844, 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 Teriflunomide
All NICE appraisals →NICE, which decides whether the NHS in England should fund new medicines, has published 1 technology appraisal of Teriflunomide. 1 is current, and 1 of it recommends it for at least some patients.
| Appraisal | NICE recommendation | Published | Status |
|---|---|---|---|
| Teriflunomide for treating relapsing–remitting multiple sclerosis NICE TA303 | Recommended | 22 Jan 2014 Updated 1 Jun 2014 | 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 Teriflunomide
The package leaflet is the official guide for patients that comes with every medicine. These links go to the regulators that publish it.
- IEIreland: 8 products on the HPRA listEach product record links to the HPRA, which publishes the leaflet and SmPC.
- EUEuropean Union: Aubagio, Teriflunomide Accord (generic), Teriflunomide Viatris (previously Teriflunomide 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 Teriflunomide
- ATC code
- L04AA31
- ChEMBL
- CHEMBL973
- DrugBank
- DB08880
- PubChem CID
- 54684141
- CAS number
- 163451-81-8
- FDA UNII
- 1C058IKG3B
- Wikidata
- Q3077133
- Wikipedia
- Teriflunomide
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 Teriflunomide
7 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.
Teriflunomide in the EU trials register (CTIS)
1 trialAuthorised or ongoing trials in the EU Clinical Trials Information System that list a product containing Teriflunomide. Many trials are registered in both CTIS and ClinicalTrials.gov, so these are shown separately rather than added to the count above. Trials with a site in Ireland are listed first.
| Study | Phase | Status | Sponsor | Countries |
|---|---|---|---|---|
|
A Phase 3 extension study to investigate long-term safety and tolerability of frexalimab in participants with multiple sclerosis.
2026-525688-41-00 · CTIS ↗ · Nervous System Diseases
|
Phase 3 | Authorised | Sanofi-Aventis Recherche & Developpement | Hungary, Belgium, Lithuania + 14 more |
Teriflunomide 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)
8 single-substance products containing Teriflunomide on the HPRA medicines list.
- Teriflunomide Clonmel 14 mg film-coated tabletsClonmel Healthcare Ltd · PA0126/375/001 · Marketed
- AUBAGIO 14 mg film-coated tabletsSanofi Winthrop Industrie · EU/1/13/838/001-005
- AUBAGIO 7 mg film-coated tabletsSanofi Winthrop Industrie · EU/1/13/838/006
- Teriflunomide Accord 14 mg film-coated tabletsAccord Healthcare S.L.U. · EU/1/22/1693/001-004
- Teriflunomide Accord 7 mg film-coated tabletsAccord Healthcare S.L.U. · EU/1/22/1693/005-012
Supply shortages
No entry for Teriflunomide in the EMA, FDA or German BfArM shortage lists we track.
Conditions studied with Teriflunomide
5 conditionsSponsors
lead sponsor per trial| Lead sponsor | Trials |
|---|---|
| Novartis Pharmaceuticals | 2 |
| Sanofi | 2 |
| Hoffmann-La Roche | 2 |
| Peking University People's Hospital | 1 |
By country register
A trial with sites in more than one country appears in each of those registers. CTIS does not publish a recruiting flag; its trials may also appear in the registers above.
Related compounds
Questions about Teriflunomide trials
How many clinical trials are testing Teriflunomide?
7 current trials in our USA, China, Italy, Poland, Mexico, UK, India, Spain, Turkey, Brazil, Denmark, Switzerland, Austria, Germany, France, Portugal, Canada, Netherlands, Belgium, Taiwan, Israel, Czechia, Japan, South Korea, Sweden, Ireland, Norway, Australia and Singapore registers name Teriflunomide as a drug or biological intervention, as of the registry sync on 11 November 2026. Completed and withdrawn studies are not counted.
Are Teriflunomide trials recruiting patients?
Yes. 1 of the 7 trials is recruiting: 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 Teriflunomide clinical trials?
Novartis Pharmaceuticals (2), Sanofi (2), Hoffmann-La Roche (2) and Peking University People's Hospital (1). The number in brackets is how many trials each organisation leads.
Are there Teriflunomide clinical trials in Ireland?
Yes. 1 trial in our Ireland register (ClinicalTrials.gov). Some may be the same study registered in both. See the Irish clinical trials register for sites and contacts.
Is Teriflunomide licensed in Ireland?
Yes. The HPRA medicines list includes 8 single-substance products containing Teriflunomide, for example Teriflunomide Clonmel 14 mg film-coated tablets (Clonmel Healthcare Ltd). A licence does not mean a product is currently marketed or reimbursed; see each product's record.
Is there a Teriflunomide shortage?
Not in the lists we track: Teriflunomide has no entry in the EMA, FDA or German BfArM shortage registers as of their latest sync.
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 Teriflunomide 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 Teriflunomide 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 Teriflunomide (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 11 Nov 2026. How every register is built: methodology · fixes we have made: corrections log.