TERIFLUNOMIDE
TERIFLUNOMIDE is indicated for the treatment of Multiple Sclerosis; Clinically Isolated Syndrome; Relapsing-Remitting Disease; Secondary Progressive Disease.
How TERIFLUNOMIDE Works
Teriflunomide acts by inhibiting dihydroorotate dehydrogenase, which is a mitochondrial enzyme essential for de novo pyrimidine synthesis. By blocking this enzyme, the drug exerts immunomodulatory and anti-inflammatory effects. Although the exact therapeutic process in multiple sclerosis is unknown, it may involve a reduction in the quantity of activated lymphocytes within the central nervous system.
Development Insights
Details
- Status
- Prescription
- First Approved
- 2018-07-27
- Routes
- ORAL
- Dosage Forms
- TABLET
TERIFLUNOMIDE Approval History
What TERIFLUNOMIDE Treats
4 indicationsTERIFLUNOMIDE is approved for 4 conditions since its original approval in 2018. These indications span multiple therapeutic areas including oncology, immunology, and more.
- Multiple Sclerosis
- Clinically Isolated Syndrome
- Relapsing-Remitting Disease
- Secondary Progressive Disease
TERIFLUNOMIDE Boxed Warning
HEPATOTOXICITY and EMBRYOFETAL TOXICITY • Hepatotoxicity: Clinically significant and potentially life-threatening liver injury, including acute liver failure requiring transplant, has been reported in patients treated with teriflunomide tablets in the postmarketing setting [see Warnings and Precautions (5.1) ] . Concomitant use of teriflunomide tablets with other hepatotoxic drugs may increase the risk of severe liver injury. Obtain transaminase and bilirubin levels within 6 months before initia...
WARNING: HEPATOTOXICITY and EMBRYOFETAL TOXICITY • Hepatotoxicity: Clinically significant and potentially life-threatening liver injury, including acute liver failure requiring transplant, has been reported in patients treated with teriflunomide tablets in the postmarketing setting [see Warnings and Precautions (5.1) ] . Concomitant use of teriflunomide tablets with other hepatotoxic drugs may increase the risk of severe liver injury. Obtain transaminase and bilirubin levels within 6 months before initiation of teriflunomide tablets therapy. Monitor ALT levels at least monthly for six months after starting teriflunomide tablets [see Warnings and Precautions (5.1) ]. If drug induced liver injury is suspected, discontinue teriflunomide tablets and start an accelerated elimination procedure with cholestyramine or charcoal [see Warnings and Precautions (5.3) ] . Teriflunomide tablets are contraindicated in patients with severe hepatic impairment [see Contraindications (4) ] . Patients with pre-existing liver disease may be at increased risk of developing elevated serum transaminases when taking teriflunomide tablets. • Embryofetal Toxicity: Teriflunomide tablets are contraindicated for use in pregnant women and in females of reproductive potential who are not using effective contraception because of the potential for fetal harm. Teratogenicity and embryolethality occurred in animals at plasma teriflunomide exposures lower than that in humans. Exclude pregnancy before the start of treatment with teriflunomide tablets in females of reproductive potential. Advise females of reproductive potential to use effective contraception during teriflunomide tablets treatment and during an accelerated drug elimination procedure after teriflunomide tablets treatment. Stop teriflunomide tablets and use an accelerated drug elimination procedure if the patient becomes pregnant [see Contraindications (4) , Warnings and Precautions (5.2 , 5.3) , Use in Specific Populations (8.1 , 8.3) , an
TERIFLUNOMIDE Competitive Set
ProThree rings of competition based on shared molecular targets and treated indications.
Indication competitors
Same indication, different mechanism — what else might this patient receive?
Filters applied: drops same-active-ingredient (505(b)(2) reformulations), route-mismatch (topical vs systemic), and cross-therapeutic-area matches in same-indication rings.
What's emerging in TERIFLUNOMIDE's indications
See all emerging drugs →Phase 3 candidates targeting molecules with no FDA-approved drug, in indications TERIFLUNOMIDE treats. First-in-class if their pivotal trials read out positive.
Drugs Similar to TERIFLUNOMIDE
3 of 20FDA-approved drugs for similar conditions. Compare mechanisms and indications to understand treatment alternatives.
Clinical Trial Registry
28 trials| Trial | Sponsor ID | Phase | Status | Title |
|---|---|---|---|---|
| NCT06141473 FREXALT | EFC17919 2023-504358-36, U1111-1290-9326 | Ph 3 | active not recruiting | Efficacy and Safety Studies of Frexalimab (SAR441344) in Adults With Relapsing Forms of Multiple Sclerosis |
| NCT05156281 REMODEL-2 | CLOU064C12302 2023-509372-41-00 | Ph 3 | active not recruiting | Efficacy and Safety of Remibrutinib Compared to Teriflunomide in Participants With Relapsing Multiple Sclerosis (RMS) |
| NCT04586023 FENhance 2 | GN42272 2020-001168-28, 2022-502618-95-00 | Ph 3 | active not recruiting | Study to Evaluate the Efficacy and Safety of Fenebrutinib Compared With Teriflunomide in Relapsing Multiple Sclerosis (RMS) |
| NCT04799288 | 210016 21-N-0016 | Ph 1, Ph 2 | recruiting | Teriflunomide in HTLV-1 Associated Myelopathy/Tropical Spastic Paraparesis |
| NCT05147220 REMODEL-1 | CLOU064C12301 2020-005899-36 | Ph 3 | active not recruiting | Efficacy and Safety of Remibrutinib Compared to Teriflunomide in Participants With Relapsing Multiple Sclerosis (RMS) |
| NCT04586010 FENhance | GN41851 2019-004857-10, 2022-502609-14-00 | Ph 3 | active not recruiting | A Study to Evaluate the Efficacy and Safety of Fenebrutinib Compared With Teriflunomide in Relapsing Multiple Sclerosis (RMS) |
| NCT06372145 | LTS17043 2023-503631-18, U1111-1287-6797 | Ph 3 | active not recruiting | A Study to Investigate Long-term Safety and Tolerability of Tolebrutinib in Participants With Multiple Sclerosis. |
| NCT04410965 TERI-PK | BDR16019 U1111-1233-0136 | Ph 4 | completed | Evaluation of the Relationship Between ABCG2 Mutation and Teriflunomide Exposure and Safety in Chinese RMS Patients Treated With Teriflunomide 14 mg Once Daily for 24 Weeks |
| NCT07065968 | TY2025006 | Ph 2 | recruiting | The Efficacy and Safety of Combined Teriflunomide and High-dose Dexamethasone in Newly Diagnosed Primary Immune Thrombocytopenia (TEMPO-2) |
| NCT06176235 | PKU-TFITP-03 | Ph 2 | withdrawn | Teriflunomide Plus High-dose Dexamethasone as First-line Treatment in Newly Diagnosed Primary Immune Thrombocytopenia |
| NCT04410978 GEMINI 1 results posted | EFC16033 U1111-1238-1418, 2020-000637-41 | Ph 3 | completed | Relapsing Forms of Multiple Sclerosis (RMS) Study of Bruton's Tyrosine Kinase (BTK) Inhibitor Tolebrutinib (SAR442168) (GEMINI 1) |
| NCT04338022 results posted | MS200527_0080 2019-004972-20 | Ph 3 | terminated | Study of Evobrutinib in Participants With RMS (evolutionRMS 1) |
| NCT02425644 OPTIMUM results posted | AC-058B301 2012-000540-10 | Ph 3 | completed | Oral Ponesimod Versus Teriflunomide In Relapsing MUltiple Sclerosis |
| NCT04338061 results posted | MS200527_0082 2019-004980-36 | Ph 3 | terminated | Study of Evobrutinib in Participants With RMS (evolutionRMS 2) |
| NCT04056897 | BCD-132-2 | Ph 2 | completed | Comparative Study of the Efficacy and Safety of BCD-132 With Teriflunomide and Placebo in Multiple Sclerosis |
| NCT02201108 TERIKIDS results posted | EFC11759 U1111-1124-0983, 2011-005249-12 | Ph 3 | completed | Efficacy, Safety and Pharmacokinetics of Teriflunomide in Pediatric Patients With Relapsing Forms of Multiple Sclerosis |
| NCT05385744 MIRANTIBUS | BCD-132-4 | Ph 3 | completed | 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 |
| NCT02587195 TERICIS | 15-PP-06 | Ph 3 | completed | 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 |
| NCT01970410 results posted | SWITCH-001 | Ph 4 | completed | MAIN STUDY: SWITCH SUB-STUDY: SWITCH-JCV |
| NCT03277248 ULTIMATE II results posted | TG1101-RMS302 2017-000639-15 | Ph 3 | completed | Study to Assess the Efficacy and Safety of Ublituximab in Participants With Relapsing Forms of Multiple Sclerosis (RMS) |
| NCT03277261 ULTIMATE 1 results posted | TG1101-RMS301 2017-000638-75 | Ph 3 | completed | Study to Assess the Efficacy and Safety of Ublituximab in Participants With Relapsing Forms of Multiple Sclerosis (RMS) ( ULTIMATE 1 ) |
| NCT02263547 TERCOL results posted | GZ-2013-11023 | Ph 1 | terminated | Rapid Elimination Procedure of Teriflunomide With Colestipol Hydrochloride |
| NCT00622700 TOPIC results posted | EFC6260 HMR1726D-3005, 2006-001152-12 | Ph 3 | completed | Phase III Study With Teriflunomide Versus Placebo in Patients With First Clinical Symptom of Multiple Sclerosis |
| NCT01895335 TERI-PRO results posted | LPS13567 U1111-1139-8730 | Ph 4 | completed | Using Patient Reported Outcomes (PROs) to Evaluate Teriflunomide Treatment in Relapsing Multiple Sclerosis (RMS) Patients |
| NCT00751881 TOWER results posted | EFC10531 2007-004452-36 | Ph 3 | completed | An Efficacy Study of Teriflunomide in Participants With Relapsing Multiple Sclerosis |
| NCT00883337 TENERE results posted | EFC10891 2008-006226-34 | Ph 3 | completed | A Study Comparing the Effectiveness and Safety of Teriflunomide and Interferon Beta-1a in Patients With Relapsing Multiple Sclerosis |
| NCT01403376 TERIVA results posted | PDY11684 2011-001160-21, U1111-1115-2742 | Ph 2 | completed | Study to Investigate the Immune Response to Influenza Vaccine in Patients With Multiple Sclerosis on Teriflunomide |
| NCT01252355 TERACLES results posted | EFC6058 2010-023172-12, U1111-1115-2414 | Ph 3 | terminated | Efficacy and Safety of Teriflunomide in Patients With Relapsing Multiple Sclerosis and Treated With Interferon-beta |
Active Pipeline
Ongoing clinical trials by development phase
Key Completed Trials
Completed studies with published results, ranked by significance
Trial Timeline
Full development history with FDA approval milestones
Understanding FDA Approval Types
| Count | Type | What it means |
|---|---|---|
| - | ORIG | Original approval - drug first enters market |
| - | SUPPL - Efficacy | New indication (new disease/condition approved) |
| - | SUPPL - Labeling | Label text changes (warnings, dosing updates) |
| - | SUPPL - Manufacturing | Production changes (new facility) |
| - | SUPPL - Chemistry | Formulation changes (new dosage strength) |
Green lines in the timeline show ORIG and Efficacy approvals - the clinically meaningful milestones.
TERIFLUNOMIDE FDA Label Details
Indications & Usage
TERIFLUNOMIDE is indicated for the treatment of Multiple Sclerosis; Clinically Isolated Syndrome; Relapsing-Remitting Disease; Secondary Progressive Disease.
WARNING: HEPATOTOXICITY and EMBRYOFETAL TOXICITY • Hepatotoxicity: Clinically significant and potentially life-threatening liver injury, including acute liver failure requiring transplant, has been reported in patients treated with teriflunomide tablets in the postmarketing setting [see Warnings and...
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AUBAGIO
Full clinical data, patents, trials, and competitive landscape for teriflunomide.
Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.
How We Calculate These Metrics
Trial Activity Stage
Measures the current development activity pattern based on trial phases, status, and trends. Important: This measures R&D activity, not commercial lifecycle.
Trial statuses: "Active" means recruiting or ongoing. "Completed" means reached planned endpoint. "Terminated" means stopped early—often due to safety, efficacy, or business reasons.
- Growth: High proportion of early-phase trials (Phase 1/2), active development
- Expansion: Significant Phase 3 activity, approaching or pursuing approvals
- Mature: Substantial Phase 4 post-marketing studies
- Stable: Mixed phase distribution, steady development
- Declining: Low active trial ratio, reduced R&D investment