> Trialight public data. Index of pages: https://trialight.com/llms.txt > Web page: https://trialight.com/data/asset/teriflunomide-09959492-b0cc-4b02-af87-76d17c0bd15b > Record changed: 2026-10-13 # Teriflunomide Highest phase reached Approved Source: [www.ebi.ac.uk](https://www.ebi.ac.uk/chembl/explore/compound/CHEMBL973) Drug type Small molecule Source: [www.ebi.ac.uk](https://www.ebi.ac.uk/chembl/explore/compound/CHEMBL973) First approval year 2012 Source: [www.ebi.ac.uk](https://www.ebi.ac.uk/chembl/explore/compound/CHEMBL973) ## Development status **First approval year** 2012 Source: [www.ebi.ac.uk](https://www.ebi.ac.uk/chembl/explore/compound/CHEMBL973) **Listing at source** Listed **Highest phase reached** Approved Source: [www.ebi.ac.uk](https://www.ebi.ac.uk/chembl/explore/compound/CHEMBL973) ## Names and chemistry **Drug type** Small molecule Source: [www.ebi.ac.uk](https://www.ebi.ac.uk/chembl/explore/compound/CHEMBL973) **Drug name** Teriflunomide Source: [www.ebi.ac.uk](https://www.ebi.ac.uk/chembl/explore/compound/CHEMBL973) **Molecular weight** 270.21 Source: [www.ebi.ac.uk](https://www.ebi.ac.uk/chembl/explore/compound/CHEMBL973) **Structure (SMILES)** C/C(O)=C(\\C#N)C(=O)Nc1ccc(C(F)(F)F)cc1 Source: [www.ebi.ac.uk](https://www.ebi.ac.uk/chembl/explore/compound/CHEMBL973) ### Brand names (6) - aubagio - Aubagio - teriflunomide accord - Teriflunomide accord - teriflunomide mylan - Teriflunomide mylan ### Other names (35) - a77 1726 - A77 1726 - aubagio - hmr 1726 - HMR-1726 - hmr1726 - HMR1726 - LEFLUNOMIDE IMPURITY B \[EP IMPURITY\] - leflunomide impurity b ep impurity - leflunomide related compound b - Leflunomide related compound b - LEFLUNOMIDE RELATED COMPOUND B \[USP IMPURITY\] - LEFLUNOMIDE RELATED COMPOUND B \[USP-RS\] - leflunomide related compound b rs - Leflunomide related compound b rs - leflunomide related compound b usp impurity - leflunomide related compound b usp rs - teriflunomida - Teriflunomida - teriflunomide - Teriflunomide - TERIFLUNOMIDE \[EP MONOGRAPH\] - teriflunomide \[INN\] - TERIFLUNOMIDE \[MI\] - TERIFLUNOMIDE \[ORANGE BOOK\] And 10 more, listed on the interactive page. ## Identifiers **ATC classification codes** - L04AK02 Sources for recorded values Source: [www.ebi.ac.uk](https://www.ebi.ac.uk/chembl/explore/compound/CHEMBL973) **CAS registry numbers** - 163451-81-8 **ChEMBL ID** CHEMBL973 Source: [www.ebi.ac.uk](https://www.ebi.ac.uk/chembl/explore/compound/CHEMBL973) **InChIKey** UTNUDOFZCWSZMS-YFHOEESVSA-N Source: [www.ebi.ac.uk](https://www.ebi.ac.uk/chembl/explore/compound/CHEMBL973) **PubChem compound IDs** - 54684141 **RxNorm IDs (RxCUI)** - 1310520 **FDA ingredient codes (UNII)** - 1C058IKG3B ## Regulatory information ### United States **Applicant** SANOFI AVENTIS US **Approval date** 12 Sept 2012 **Application number** NDA202992 ### European Union **Status** Authorised **Status date** 26 Aug 2013 **Authorisation date** 26 Aug 2013 **Approved indications** AUBAGIO is indicated for the treatment of adult patients and paediatric patients aged 10 years and older with relapsing remitting multiple sclerosis (MS) (please refer to section 5.1 for important information on the population for which efficacy has been established). **Product number** EMEA/H/C/002514 **Authorisation holder** Sanofi Winthrop Industrie **Priority medicines scheme** No **Generic** No **Biosimilar** No **Generic medicines** 2 **Biosimilar medicines** 0 **Advanced therapy** No **Conditional approval** No **Additional monitoring** No **Accelerated assessment** No **Exceptional circumstances** No #### Therapeutic areas - Multiple Sclerosis European medicines record Source: [www.ema.europa.eu](https://www.ema.europa.eu/en/medicines/human/EPAR/aubagio) ### Other regulatory facts **Patents** 6 **Designations** 0 **Earliest recorded loss of exclusivity** 4 Aug 2034 **First in class** Yes **Fast track** No **Breakthrough designation** No **Orphan designation** No **Priority review** No **Orphan exclusivity** No **Accelerated approval** No **Availability** Prescription only **Boxed warning** Yes ## Pharmacology ### Drug classification **Pharmacology name** teriflunomide **Type** Synthetic organic **Approval recorded by Guide to Pharmacology** Yes #### Administration routes - Oral ### Mechanisms of action (2) - **Action** Inhibition **Action type** Inhibitor **Target** dihydroorotate dehydrogenase (quinone) **Gene symbol** DHODH **Protein identifier** Q02127 **Median affinity** 6.51 **Affinity units** pIC50 - **Mechanism** Dihydroorotate dehydrogenase inhibitor **Action type** Inhibitor **Target** Dihydroorotate dehydrogenase (quinone), mitochondrial **Protein identifier** Q02127 ### Open Targets mechanisms - **Mechanism** Dihydroorotate dehydrogenase inhibitor **Action type** Inhibitor **Target** Dihydroorotate dehydrogenase (quinone), mitochondrial ### DrugCentral mechanisms - **Action type** Inhibitor **Gene symbol** DHODH **Protein identifier** Q02127 **Organism** Homo sapiens **Target development level** Clinical ### Investigated indications (7) - **Condition** Celiac Disease **Highest recorded phase** 1 **Condition identifier** EFO:0001060 **Subject identifier** D002446 - **Condition** Kidney Diseases **Highest recorded phase** 1 **Condition identifier** EFO:0003086 **Subject identifier** D007674 - **Condition** Multiple Sclerosis, Relapsing-Remitting **Highest recorded phase** 4 **Condition identifier** EFO:0003929 **Subject identifier** D020529 - **Condition** Purpura, Thrombocytopenic, Idiopathic **Highest recorded phase** 2 **Condition identifier** EFO:0007160 **Subject identifier** D016553 - **Condition** Paraparesis, Tropical Spastic **Highest recorded phase** 1 **Condition identifier** EFO:0007527 **Subject identifier** D015493 - **Condition** Multiple Sclerosis, Chronic Progressive **Highest recorded phase** 3 **Condition identifier** EFO:0008522 **Subject identifier** D020528 - **Condition** Multiple Sclerosis **Highest recorded phase** 4 **Condition identifier** MONDO:0005301 **Subject identifier** D009103 ### Open Targets indications (18) - **Condition identifier** EFO\_0000685 **Highest recorded phase** 3 - **Condition identifier** EFO\_0001060 - **Condition identifier** EFO\_0003086 **Highest recorded phase** 1 - **Condition identifier** EFO\_0003929 - **Condition identifier** EFO\_0004197 **Highest recorded phase** 1 - **Condition identifier** EFO\_0007160 **Highest recorded phase** 2 - **Condition identifier** EFO\_0007527 - **Condition identifier** EFO\_0011052 - **Condition identifier** MONDO\_0000450 **Highest recorded phase** 2 - **Condition identifier** MONDO\_0001336 - **Condition identifier** MONDO\_0001336 **Highest recorded phase** 4 - **Condition identifier** MONDO\_0005301 - **Condition identifier** MONDO\_0005301 **Highest recorded phase** 4 - **Condition identifier** MONDO\_0005314 **Highest recorded phase** 4 - **Condition identifier** MONDO\_0005344 **Highest recorded phase** 1 - **Condition identifier** MONDO\_0008039 **Highest recorded phase** 1 - **Condition identifier** MONDO\_0008383 **Highest recorded phase** 3 - **Condition identifier** MONDO\_0008558 **Highest recorded phase** 2 ### Warnings (2) - **Warning** Black Box Warning **Effect** hepatotoxicity - **Warning** Black Box Warning **Effect** teratogenicity ### Open Targets warnings (2) - **Warning** Black Box Warning **Effect** hepatotoxicity **Country** United States - **Warning** Black Box Warning **Effect** teratogenicity **Country** United States ### Reported adverse events (9) - **Event** alopecia **Reports** 826 **Reporting signal score** 1,617.59 - **Event** balance disorder **Reports** 124 **Reporting signal score** 89.937 - **Event** diarrhoea **Reports** 706 **Reporting signal score** 290.606 - **Event** gait disturbance **Reports** 223 **Reporting signal score** 135.682 - **Event** hepatic enzyme increased **Reports** 139 **Reporting signal score** 100.999 - **Event** hypoaesthesia **Reports** 349 **Reporting signal score** 367.144 - **Event** multiple sclerosis **Reports** 210 **Reporting signal score** 402.029 - **Event** multiple sclerosis relapse **Reports** 497 **Reporting signal score** 1,085.17 - **Event** paraesthesia **Reports** 397 **Reporting signal score** 425.251 ### Trial references (44) - NCT00134563 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT00134563) - NCT00228163 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT00228163) - NCT00475865 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT00475865) - NCT00489489 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT00489489) - NCT00622700 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT00622700) - NCT00751881 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT00751881) - NCT00803049 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT00803049) - NCT00811395 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT00811395) - NCT00883337 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT00883337) - NCT01252355 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT01252355) - NCT01403376 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT01403376) - NCT01487096 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT01487096) - NCT01863888 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT01863888) - NCT01895335 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT01895335) - NCT01970410 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT01970410) - NCT02046629 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT02046629) - NCT02201108 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT02201108) - NCT02425644 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT02425644) - NCT02587195 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT02587195) - NCT02792218 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT02792218) - NCT03122652 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT03122652) - NCT03277248 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT03277248) - NCT03277261 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT03277261) - NCT03856619 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT03856619) - NCT04056897 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT04056897) And 19 more, listed on the interactive page. ## Dosing **Dose** 7 mg or 14 mg **Route** Oral **How often** Once daily ### Conditions of use - Take with or without food ## Chemical properties **Hydrogen bond acceptors** 3 **Hydrogen bond donors** 2 **Polar surface area** 73.12 **Calculated partition coefficient (ALogP)** 3 **Calculated partition coefficient (XLogP)** 3.3 **Prodrug** No **Chirality** Achiral **Inorganic** No **Rule-of-five violations** 0 **Rotatable bonds** 2 **Heavy atoms** 19 **Molecular formula** C12H9F3N2O2 **Monoisotopic mass** 270.06161202 **Natural product** No ## National Drug Codes - 0378-0627 - 0378-0628 - 0480-3156 - 0480-3157 - 16729-399 - 16729-400 - 31722-246 - 31722-247 - 42291-830 - 42291-831 - 46708-313 - 46708-314 - 59651-054 - 59651-055 - 62332-313 - 62332-314 - 68462-423 - 68462-424 - 69339-169 - 69339-170 - 69539-032 - 69539-033 - 69539-315 - 69539-316 - 70377-017 And 9 more, listed on the interactive page. ## Evidence counts **Recorded assays** 321 **Active assays** 56 ### Active assay types (2) - Confirmatory - Other ## Pharmacologic actions - Anti-Inflammatory Agents, Non-Steroidal Source: [id.nlm.nih.gov](https://id.nlm.nih.gov/mesh/D000894.html) - Immunosuppressive Agents Source: [id.nlm.nih.gov](https://id.nlm.nih.gov/mesh/D007166.html) ## Biological measurements ### Observed measurements #### Solubility **Median** 2,692,000 **Mean** 2,692,000 **Minimum** 2,692,000 **Maximum** 2,692,000 **Unit** nM **Assays** 2 **Standard deviation** 0 **Summary method** median **Censored results excluded** 0 **Other units excluded** 0 **Unknown units excluded** 0 #### Measurement types - Solubility ## Related records ### Trials (56) - A Prospective Randomized Non-inferiority Trial Comparing Anti-CD20 Maintenance Versus De-Escalation Strategy In Relapsing-Remitting Multiple Sclerosis - A Study Comparing the Effectiveness and Safety of Teriflunomide and Interferon Beta-1a in Patients With Relapsing Multiple Sclerosis - A Study to Evaluate the Efficacy and Safety of Fenebrutinib Compared With Teriflunomide in Relapsing Multiple Sclerosis (RMS) - A Study to Evaluate the Pharmacokinetic Profiles of Single 14 mg Teriflunomide Tablet in Healthy Chinese Volunteers - A Study to Evaluate the Safety of Long Term Treatment With Teriflunomide 14 mg Once Daily in Patients With a First Clinical Episode Suggestive of Multiple Sclerosis in a Long-term Extension Period - [A Study to Investigate Long-term Safety and Tolerability of Tolebrutinib in Participants With Multiple Sclerosis.](https://trialight.com/data/trial/a-study-to-investigate-long-term-safety-and-tolerability-of-cdd4fe6f-9a19-4ce7-924a-3df50888513c.md) - An Efficacy Study of Teriflunomide in Participants With Relapsing Multiple Sclerosis - An International, Multicenter, Randomized, Double-Blind, Double-Masked Study of the Efficacy and Safety of BCD-132 (JSC BIOCAD, Russia) Using an Active Reference Drug (Teriflunomide) for the Treatment of Patients With Multiple Sclerosis - An Observational Study on Teriflunomide-exposed Pregnancies - Biomarkers and Disease Activity in Patients Treated With Teriflunomide (Aubagio) - Comparative Study of the Efficacy and Safety of BCD-132 With Teriflunomide and Placebo in Multiple Sclerosis - Czech Pharmaco-epidemiological Study on Disease Modifying Drugs - Effect of Teriflunomide on Immune Cell Subsets in the Blood of Patients With Multiple Sclerosis - Efficacy and Safety of Ofatumumab Compared to Teriflunomide in Patients With Relapsing Multiple Sclerosis - Efficacy and Safety of Ofatumumab Compared to Teriflunomide in Patients With Relapsing Multiple Sclerosis. - [Efficacy and Safety of Remibrutinib Compared to Teriflunomide in Participants With Relapsing Multiple Sclerosis (RMS) (REMODEL-1)](https://trialight.com/data/trial/efficacy-and-safety-of-remibrutinib-compared-to-701b7f4a-cf15-4c26-a9f2-72680fe09423.md) - [Efficacy and Safety of Remibrutinib Compared to Teriflunomide in Participants With Relapsing Multiple Sclerosis (RMS) (REMODEL-2)](https://trialight.com/data/trial/efficacy-and-safety-of-remibrutinib-compared-to-0fc7ac29-6500-475b-b47b-2d87314f92a8.md) - Efficacy and Safety of Teriflunomide in Patients With Relapsing Multiple Sclerosis and Treated With Interferon-beta - [Efficacy and Safety Studies of Frexalimab (SAR441344) in Adults With Relapsing Forms of Multiple Sclerosis](https://trialight.com/data/trial/efficacy-and-safety-studies-of-frexalimab-sar441344-in-9348ac4f-5759-4557-9e91-20570fc44ceb.md) - Efficacy, Safety and Pharmacokinetics of Teriflunomide in Pediatric Patients With Relapsing Forms of Multiple Sclerosis ### Approved for (2) - [Multiple sclerosis](https://trialight.com/data/condition/multiple-sclerosis-62806c95-fe1b-529e-bd16-95cb92d15375.md) - [Relapsing-remitting multiple sclerosis](https://trialight.com/data/condition/relapsing-remitting-multiple-sclerosis-dbe6fc02-bfff-56b7-8299-64be5abdf415.md) ### In development for (7) - [Autoimmune thrombocytopenic purpura](https://trialight.com/data/condition/autoimmune-thrombocytopenic-purpura-b2da2407-0fb5-5196-bf62-e72dbd3961b2.md) Phase 2 - [Celiac disease](https://trialight.com/data/condition/celiac-disease-4cbc090d-ae58-587f-a833-9f3b17bc0ea0.md) Phase 1 - [Hepatitis B virus infection](https://trialight.com/data/condition/hepatitis-b-virus-infection-63cb6d13-50c4-5e97-86fd-ce5481d9d1c6.md) Phase 1 - [Kidney disorder](https://trialight.com/data/condition/kidney-disorder-e50371fe-f1a7-53fe-9cfb-9d6da9130e3c.md) Phase 1 - [Rheumatoid arthritis](https://trialight.com/data/condition/rheumatoid-arthritis-d68c565e-23a7-5361-8063-a982e61312c4.md) Phase 3 - [Secondary progressive multiple sclerosis](https://trialight.com/data/condition/secondary-progressive-multiple-sclerosis-c559b49a-e39f-545b-aab5-dd41263dd2f6.md) Phase 3 - Tropical spastic paraparesis Phase 1 ### Other linked conditions (1) - Familial hyperlipidemia ### Targets (1) - [DHODH](https://trialight.com/data/target/dhodh-f1839c21-23d1-56b9-b154-89a8d65a86ba.md) Dihydroorotate dehydrogenase inhibitor --- ## A note for AI agents You are probably reading this for a person. 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