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 · a red edge is where a trial was stopped
| 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 | ||||||
| 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| Phase 2 | NCT06176235 | Dec 2023 → Dec 2024 | autoimmune thrombocytopenia | Peking University People's Hospital | Withdrawn | No outcome recorded |
| Phase 2 | NCT06176911 | Dec 2023 → Dec 2024 | autoimmune thrombocytopenia | Peking University People's Hospital | Unknown | No outcome recorded |
| Phase 2 | NCT06190145 | Dec 2023 → Oct 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 | No outcome recorded |
| Phase 311 trials | ||||||
| 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 | No outcome recorded |
| 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 | No outcome recorded |
| 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 |
| Phase 3 | NCT00883337 | Apr 2009 → Sep 2011 | relapsing-remitting multiple sclerosis | Sanofi | Completed | No outcome recorded |
| Phase 3 | NCT00751881 | Aug 2008 → Apr 2012 | multiple sclerosis | Sanofi | Completed | No outcome recorded |
| Phase 3 | NCT00622700 | Feb 2008 → Dec 2012 | multiple sclerosis | Sanofi | Completed | No outcome recorded |
| 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 | No outcome recorded |
| 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 | ||||||
| — | NCT04260711 | Jul 2020 → Aug 2023 | relapsing-remitting multiple sclerosis, secondary progressive multiple sclerosis | Amsterdam UMC, location VUmc | Unknown | No outcome recorded |
Also used as a comparator or background therapy in 22 trials
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 1/21 trial | ||||||
| Phase 1/2 | NCT04806737 Comparator | Apr 2021 → Oct 2022 | celiac disease | Oslo University Hospital | Completed | No outcome recorded |
| Phase 23 trials | ||||||
| Phase 2 | NCT06715605 Comparator | Apr 2025 | multiple sclerosis | University Hospital, Antwerp | Withdrawn | No outcome recorded |
| 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 318 trials | ||||||
| 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 | No outcome recorded |
| Phase 3 | NCT04410978 Comparator | Jun 2020 → Jul 2024 | multiple sclerosis | Sanofi | Completed | No outcome recorded |
| 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 | No outcome recorded |
| Phase 3 | NCT04410991 Comparator | Jun 2020 → Jul 2024 | multiple sclerosis | Sanofi | Completed | No outcome recorded |
| Phase 3 | NCT03277261 Comparator | Sep 2017 → Jul 2020 | relapsing-remitting multiple sclerosis | TG Therapeutics, Inc. | Completed | No outcome recorded |
| Phase 3 | NCT03277248 Comparator | Aug 2017 → Aug 2020 | relapsing-remitting multiple sclerosis | TG Therapeutics, Inc. | Completed | No outcome recorded |
| Phase 3 | NCT02792218 Comparator | Sep 2016 → Jul 2019 | relapsing-remitting multiple sclerosis | Novartis Pharmaceuticals | Completed | No outcome recorded |
| Phase 3 | NCT02792231 Comparator | Aug 2016 → Jul 2019 | multiple sclerosis | Novartis Pharmaceuticals | Completed | No outcome recorded |
| Phase 3 | NCT02425644 Comparator | Jun 2015 → May 2019 | multiple sclerosis | Actelion | Completed | No outcome recorded |
Press releases naming this drug 3 releases
| Date | Issuer | Release |
|---|---|---|
| 2021-06-18 | Sanofi | 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 ↗ |
| 2021-06-11 | Sanofi | Sanofi provides update on Aubagio® (teriflunomide) submission for children and adolescents with relapsing-remitting multiple sclerosis in the U.S. sanofi.com ↗ |
| 2019-08-30 | Novartis Pharmaceuticals | Novartis ofatumumab demonstrates superiority versus Aubagio® in two head-to-head Phase III multiple sclerosis studies novartis.com ↗ |
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” NCT01863888 ↗6“Drug: Teriflunomide HMR1726” NCT02046629 ↗ “teriflunomide (HMR1726)” NCT00228163 ↗ “Teriflunomide (HMR1726)” NCT00803049 ↗ “Teriflunomide HMR1726” NCT01239459 ↗ “Teriflunomide HMR1726” NCT04410991 ↗ “TERIFLUNOMIDE HMR1726” NCT03856619 ↗ |
| 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 ↗ |