Drugs / Teriflunomide
Teriflunomide
also known as
HMR1726 · Aubagio · A77 1726 · Aubagio (teriflunomide) · Leflunomide related compound b · Leflunomide related compound b rs · Teriflunomida · Teriflunomide accord · +1 more
Small molecule targets DHODH via inhibition
Regulatory milestones approvals, filings & regulatory actions · 5 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Label expansions (3) | US (FDA) | AUBAGIO | — | 2014-10-17 – 2021-04-30 | fda.gov ↗ |
| Approved | EU (EMA) | Aubagio | — | 2013-08-26 | europa.eu ↗ |
| Approved | US (FDA) | AUBAGIO | — | 2012-09-12 | fda.gov ↗ |
Trials 32
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 13 trials | ||||||
| Phase 1 | NCT02263547 | Mar 2015 → Jun 2016 | — | Derrick Scott Robertson | Terminated | No outcome recorded |
| Phase 1 | NCT02046629 | May → Jul 2014 | multiple sclerosis | Sanofi | Completed | No outcome recorded |
| Phase 1 | NCT01239459 | Nov 2010 → Feb 2011 | impaired renal function disease | Sanofi | Completed | No outcome recorded |
| Phase 1/21 trial | ||||||
| Phase 1/2 | NCT04799288 | Sep 2021 → Dec 2027 expected | — | National Institute of Neurological Disorders and Stroke (NINDS) | Recruiting | No outcome recorded |
| Phase 210 trials · 1 met primary | ||||||
| Phase 2 | NCT07065968 | Aug 2025 → Sep 2027 expected | autoimmune thrombocytopenia | Peking University People's Hospital | Recruiting | No outcome recorded |
| Phase 2 | NCT06176235 | Dec 2023 → Dec 2024 | autoimmune thrombocytopenia | Peking University People's Hospital | Withdrawn | No outcome recorded Stop: Enrollment |
| Phase 2 | NCT06190145 | Dec 2023 → Oct 2024 | autoimmune thrombocytopenia | Peking University People's Hospital | Unknown | No outcome recorded |
| Phase 2 | NCT06176911 | Dec 2023 → Dec 2024 | autoimmune thrombocytopenia | Peking University People's Hospital | Unknown | No outcome recorded |
| Phase 2 | NCT01403376 | Sep 2011 → Jan 2012 | multiple sclerosis | Sanofi | Completed | No outcome recorded |
| Phase 2 | NCT00811395 | Oct 2007 → Apr 2010 | multiple sclerosis | Sanofi | Completed | No outcome recorded |
| Phase 2 | NCT00489489 | May 2007 → Jun 2009 | multiple sclerosis | Sanofi | Completed | No outcome recorded |
| Phase 2 | NCT00475865 | Apr 2007 → Oct 2009 | multiple sclerosis | Sanofi | Completed | No outcome recorded |
| Phase 2 | NCT00228163 | Jan 2002 → Jan 2015 | multiple sclerosis | Sanofi | Completed | No outcome recorded |
| Phase 2 | NCT01487096 | Apr 2001 → Mar 2003 | multiple sclerosis | Sanofi | Completed | Met primary |
| Phase 311 trials · 4 met primary · 2 missed | ||||||
| Phase 3 | NCT07189325 | Jun 2026 → Jun 2031 expected | relapsing-remitting multiple sclerosis | University Hospital, Montpellier | Recruiting | No outcome recorded |
| Phase 3 | NCT03122652 | Sep 2017 → Feb 2019 | multiple sclerosis | Centre Hospitalier Universitaire de Nice | Completed | Met primary |
| Phase 3 | NCT02587195 | Dec 2015 → Aug 2020 | multiple sclerosis | Centre Hospitalier Universitaire de Nice | Completed | No outcome recorded |
| Phase 3 | NCT02201108 | Jul 2014 → Oct 2019 | multiple sclerosis | Genzyme, a Sanofi Company | Completed | Missed primary |
| Phase 3 | NCT01863888 | Oct 2013 → Jan 2015 | multiple sclerosis | Sanofi | Completed | No outcome recorded |
| Phase 3 | NCT01252355 | Jan 2011 → Apr 2013 | multiple sclerosis | Sanofi | Terminated | No outcome recorded Stop: Business |
| Phase 3 | NCT00883337 | Apr 2009 → Sep 2011 | relapsing-remitting multiple sclerosis | Sanofi | Completed | Missed primary |
| Phase 3 | NCT00751881 | Aug 2008 → Apr 2012 | multiple sclerosis | Sanofi | Completed | Met primary |
| Phase 3 | NCT00622700 | Feb 2008 → Dec 2012 | multiple sclerosis | Sanofi | Completed | Met primary |
| Phase 3 | NCT00803049 | Oct 2006 → Dec 2015 | multiple sclerosis | Sanofi | Completed | No outcome recorded |
| Phase 3 | NCT00134563 | Sep 2004 → Jul 2010 | multiple sclerosis | Sanofi | Completed | Met primary |
| Phase 46 trials | ||||||
| Phase 4 | NCT04410965 | May 2020 → Jul 2021 | multiple sclerosis | Sanofi | Completed | No outcome recorded |
| Phase 4 | NCT04129736 | Oct 2019 → Mar 2021 | — | Jan Lycke | Completed | No outcome recorded |
| Phase 4 | NCT03856619 | Mar 2019 → May 2022 | multiple sclerosis | Sanofi | Completed | No outcome recorded |
| Phase 4 | NCT03535298 | Jan 2019 → Jul 2027 expected | relapsing-remitting multiple sclerosis | The Cleveland Clinic | Active not recruiting | No outcome recorded |
| Phase 4 | NCT01970410 | Oct 2013 → Apr 2021 | multiple sclerosis | Providence Health & Services | Completed | No outcome recorded |
| Phase 4 | NCT01895335 | Jun 2013 → Nov 2015 | multiple sclerosis | Sanofi | Completed | No outcome recorded |
| Phase not applicable1 trial · 1 missed | ||||||
| — | NCT04260711 | Jul 2020 → Aug 2023 | relapsing-remitting multiple sclerosis, secondary progressive multiple sclerosis | Amsterdam UMC, location VUmc | Unknown | Missed primary |
| Comparator or background therapy22 trials | ||||||
| Phase 1/2 | NCT04806737 Comparator | Apr 2021 → Oct 2022 | celiac disease | Oslo University Hospital | Completed | No outcome recorded |
| Phase 2 | NCT06715605 Comparator | Apr 2025 | multiple sclerosis | University Hospital, Antwerp | Withdrawn | No outcome recorded Stop: Business |
| Phase 2 | NCT04056897 Comparator | Jun 2019 → Jul 2020 | multiple sclerosis | Biocad | Completed | No outcome recorded |
| Phase 2 | NCT00273364 Comparator | Nov 2005 → Jan 2017 | multiple sclerosis | Northwestern University | Completed | No outcome recorded |
| Phase 3 | NCT06663189 Comparator | Jan 2025 → Jan 2027 expected | relapsing-remitting multiple sclerosis | University Hospital, Strasbourg, France | Not yet recruiting | No outcome recorded |
| Phase 3 | NCT06372145 Comparator | Apr 2024 → Apr 2029 expected | progressive relapsing multiple sclerosis, secondary progressive multiple sclerosis | Sanofi | Active not recruiting | No outcome recorded |
| Phase 3 | NCT06141473 Comparator | Dec 2023 → May 2027 expected | multiple sclerosis | Sanofi | Active not recruiting | No outcome recorded |
| Phase 3 | NCT05147220 Comparator | Dec 2021 → Jul 2026 overdue | multiple sclerosis | Novartis Pharmaceuticals | Active not recruiting | No outcome recorded |
| Phase 3 | NCT05156281 Comparator | Dec 2021 → Jul 2026 overdue | multiple sclerosis | Novartis Pharmaceuticals | Active not recruiting | No outcome recorded |
| Phase 3 | NCT04788615 Comparator | Jul 2021 → Nov 2025 | multiple sclerosis | Novartis Pharmaceuticals | Completed | No outcome recorded |
| Phase 3 | NCT05385744 Comparator | Apr 2021 → Sep 2022 | multiple sclerosis | Biocad | Completed | No outcome recorded |
| Phase 3 | NCT04586023 Comparator | Mar 2021 → Sep 2025 overdue | multiple sclerosis | Hoffmann-La Roche | Active not recruiting | No outcome recorded |
| Phase 3 | NCT04586010 Comparator | Mar 2021 → Jan 2026 overdue | multiple sclerosis | Hoffmann-La Roche | Active not recruiting | No outcome recorded |
| Phase 3 | NCT04338061 Comparator | Jul 2020 → Oct 2023 | multiple sclerosis | Merck Healthcare KGaA, Darmstadt, Germany, an affiliate of Merck KGaA, Darmstadt, Germany | Terminated | Missed primary |
| Phase 3 | NCT04410978 Comparator | Jun 2020 → Jul 2024 | multiple sclerosis | Sanofi | Completed | Missed primary |
| Phase 3 | NCT04338022 Comparator | Jun 2020 → Oct 2023 | relapsing-remitting multiple sclerosis | Merck Healthcare KGaA, Darmstadt, Germany, an affiliate of Merck KGaA, Darmstadt, Germany | Terminated | Missed primary |
| Phase 3 | NCT04410991 Comparator | Jun 2020 → Jul 2024 | multiple sclerosis | Sanofi | Completed | Missed primary |
| Phase 3 | NCT03277261 Comparator | Sep 2017 → Jul 2020 | relapsing-remitting multiple sclerosis | TG Therapeutics, Inc. | Completed | Met primary |
| Phase 3 | NCT03277248 Comparator | Aug 2017 → Aug 2020 | relapsing-remitting multiple sclerosis | TG Therapeutics, Inc. | Completed | Met primary |
| Phase 3 | NCT02792218 Comparator | Sep 2016 → Jul 2019 | relapsing-remitting multiple sclerosis | Novartis Pharmaceuticals | Completed | Met primary |
| Phase 3 | NCT02792231 Comparator | Aug 2016 → Jul 2019 | multiple sclerosis | Novartis Pharmaceuticals | Completed | Met primary |
| Phase 3 | NCT02425644 Comparator | Jun 2015 → May 2019 | multiple sclerosis | Actelion | Completed | Met primary |
News releases announcing trial results or a regulatory action · 14
| Date | Issuer | Release |
|---|---|---|
| 2025-04-08 | Sanofi | Results Press Release: Tolebrutinib phase 3 data published in NEJM demonstrate benefit on disability progression in multiple sclerosis sanofi.com ↗
The GEMINI 1 and 2 results did not show superiority on the primary endpoint of reducing annualized relapse rate (ARR) over teriflunomide. |
| 2024-09-20 | Sanofi | Results Press Release: Tolebrutinib demonstrated a 31% delay in time to onset of confirmed disability progression in non-relapsing secondary progressive multiple sclerosis phase 3 study sanofi.com ↗
Both studies did not meet their primary endpoints of statistically significant improvement in annualized relapse rates (ARR) compared to Aubagio. |
| 2021-10-13 | Janssen Research & Development, LLC | Results New Subgroup Analysis of the Phase 3 OPTIMUM Study Demonstrates the Benefits of PONVORYTM (ponesimod) Over teriflunomide in Early Disease Multiple Sclerosis jnj.com ↗ |
| 2021-06-18 | Sanofi | Regulatory European Commission approves Aubagio® (teriflunomide) as the first oral MS therapy for first-line treatment of children and adolescents living with relapsing-remitting multiple sclerosis sanofi.com ↗
The European Commission (EC) has approved Aubagio ® (teriflunomide) for the treatment of pediatric patients 10 to 17 years of age with relapsing-remitting multiple sclerosis (RRMS). |
| 2021-06-11 | Sanofi | Regulatory Sanofi provides update on Aubagio® (teriflunomide) submission for children and adolescents with relapsing-remitting multiple sclerosis in the U.S. sanofi.com ↗
The U.S. Food and Drug Administration (FDA) issued a Complete Response Letter regarding the supplemental New Drug Application for Aubagio ® (teriflunomide) for children and adolescents 10 to 17 years of age with relapsing forms of multiple sclerosis. |
| 2019-09-11 | Janssen Research & Development, LLC | Results New Head-to-Head Phase 3 Study Data Show Ponesimod Superiority Versus Aubagio® (teriflunomide) 14 mg in Adults with Relapsing Multiple Sclerosis (MS) jnj.com ↗
Notably, we saw superiority of the investigational agent ponesimod when compared to teriflunomide across the primary and most secondary endpoints. |
| 2019-09-11 | Janssen Research & Development, LLC | Results New Head-to-Head Phase 3 Study Data Show Ponesimod Superiority Versus Aubagio® (teriflunomide) 14 mg in Adults with Relapsing Multiple Sclerosis (MS) jnj.com ↗
New Head-to-Head Phase 3 Study Data Show Ponesimod Superiority Versus Aubagio® (teriflunomide) 14 mg in Adults with Relapsing Multiple Sclerosis (MS) |
| 2019-09-11 | Idorsia Pharmaceuticals Ltd. | Results Janssen reports new head-to-head Phase 3 study data show ponesimod superiority versus Aubagio (teriflunomide) 14 mg in adults with relapsing multiple sclerosis idorsia.com ↗ |
| 2019-08-30 | Novartis Pharmaceuticals | Results Novartis ofatumumab demonstrates superiority versus Aubagio® in two head-to-head Phase III multiple sclerosis studies novartis.com ↗
In both head-to-head studies, ofatumumab demonstrated superiority over Aubagio ® * (teriflunomide) in patients with relapsing forms of multiple sclerosis (RMS)[1]. |
| 2019-07-25 | Janssen Research & Development, LLC | Results Janssen reports positive top-line Phase 3 results for ponesimod in adults with relapsing multiple sclerosis jnj.com ↗
The study met its primary and most secondary endpoints. |
| 2019-04-01 | Alembic Pharmaceuticals Ltd. | Regulatory 22nd April, 2019, Vadodara, India alembicpharmaceuticals.com ↗
Alembic Pharmaceuticals Limited today announced that the company has received approval from the US Food & Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA) Teriflunomide Tablets, 7 mg and 14 mg. |
| 2018-12-01 | Zydus Lifesciences Limited | Regulatory Zydus receives final approval from the USFDA for Teriflunomide Tablets zyduslife.com ↗
Zydus Cadila has received the final approval from the USFDA to market Teriflunomide Tablets (US RLD- AUBAGIO), 7 mg and 14 mg. |
| 2018-11-16 | Glenmark Pharmaceuticals Ltd. India | Regulatory Glenmark receives ANDA approval for Teriflunomide Tablets 7 mg and 14 mg glenmarkpharma.com ↗
Therefore, with this approval, Glenmark is eligible for 180 days of shared generic drug exclusivity for Teriflunomide Tablets, 7 mg and 14 mg. |
| 2017-01-06 | Impax Laboratories, LLC | Regulatory Impax Confirms Patent Challenge Relating to Generic Aubagio® (teriflunomide) Tablets, 14 mg amneal.com ↗
Impax Laboratories, Inc. (NASDAQ: IPXL) today confirmed that it has filed an Abbreviated New Drug Application (ANDA) with the U.S. Food & Drug Administration ( FDA ) containing a paragraph IV certification for a generic version of Aubagio ® (teriflunomide) tablets, 14 mg. |
All press releases naming this drug 18 releases
Evidence & citations 14 cited values
Every value below carries the sentence it was read from. 56 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | teriflunomide | “Standard treatment with a conventional drug is the treatment with one of the following drugs: Avonex (interferon beta 1a), Betaseron (interferon beta 1b), Copaxone (glatiramer...” NCT00273364 ↗53“Standard-of-care on first-line treatment such as interferon-beta, glatiramer acetate, teriflunomide, dimethylfumarate, ponesimod and ozanimod.” NCT06715605 ↗ “Discontinuation of patients' own disease modifying therapy (any of the interferons, glatiramer acetate, dimethylfumarate, teriflunomide)” NCT04260711 ↗ “Interferon-β (IFN-β), glatiramer acetate, dimethyl fumarate, teriflunomide or diroximel fumarate” NCT06663189 ↗ “Teriflunomide 14 mg once a day” NCT04788615 ↗ “Aubagio (teriflunomide)” NCT03535298 ↗ |
| Known as | A77 1726 | ChEMBL registry synonym — accepted as the source's own label CHEMBL973 ↗ |
| Known as | Aubagio | “Standard treatment with a conventional drug is the treatment with one of the following drugs: Avonex (interferon beta 1a), Betaseron (interferon beta 1b), Copaxone (glatiramer...” NCT00273364 ↗4“The study is to evaluate the efficacy and safety of evobrutinib administered orally twice daily versus Teriflunomide (Aubagio®), administered orally once daily in participants...” NCT04338022 ↗ “Teriflunomide (Aubagio®), administered orally once daily” NCT04338061 ↗ “Teriflunomide 14 MG Oral Tablet [Aubagio]” NCT03122652 ↗ “Aubagio®/Teriflunomide” NCT03856619 ↗ |
| Known as | Aubagio (teriflunomide) | “Aubagio (teriflunomide)” NCT03535298 ↗ |
| Known as | HMR1726 | “Drug: Teriflunomide HMR1726” NCT02046629 ↗6“Drug: teriflunomide HMR1726” NCT01863888 ↗ “teriflunomide (HMR1726)” NCT00228163 ↗ “Teriflunomide (HMR1726)” NCT00803049 ↗ “Teriflunomide HMR1726” NCT04410991 ↗ “TERIFLUNOMIDE HMR1726” NCT03856619 ↗ “Teriflunomide HMR1726” NCT01239459 ↗ |
| Known as | Leflunomide related compound b | ChEMBL registry synonym — accepted as the source's own label CHEMBL973 ↗ |
| Known as | Leflunomide related compound b rs | ChEMBL registry synonym — accepted as the source's own label CHEMBL973 ↗ |
| Known as | Teriflunomida | ChEMBL registry synonym — accepted as the source's own label CHEMBL973 ↗ |
| Known as | Teriflunomide accord | ChEMBL registry synonym — accepted as the source's own label CHEMBL973 ↗ |
| Known as | Teriflunomide mylan | ChEMBL registry synonym — accepted as the source's own label CHEMBL973 ↗ |
| Action | Inhibit | “dihydro-orotate dehydrogenase inhibitor” PMID 16567708 ↗ Mar 2006 |
| Modality | Small molecule | — CHEMBL973 ↗ |
| Route | Oral | “Oral administration” NCT00134563 ↗ |
| Target | DHODH | “teriflunomide inhibits dihydroorotate dehydrogenase( DHODH)” NCT01970410 ↗ |