Clinical Trials

Numerous clinical trials evaluate teriflunomide across Phase 1 through Phase 4, focusing primarily on relapsing-remitting multiple sclerosis and related neuroinflammatory disorders, as well as HTLV-1 associated myelopathy/tropical spastic paraparesis and populations with renal impairment. Encompassing varied recruitment statuses ranging from active and completed to terminated, these studies are supported by pharmaceutical sponsors such as Sanofi and TG Therapeutics, alongside academic or governmental entities including the National Institute of Neurological Disorders and Stroke.

NCT Number Recruitment Conditions Sponsor/Collaborators Start Date Phases
NCT07189325 RECRUITING
Relapsing-Remitting Multiple Sclerosis (RRMS); Anti-CD20 Therapy
University Hospital, Montpellier
 2026-06-15 PHASE3
NCT06372145 ACTIVE_NOT_RECRUITING
Relapsing Multiple Sclerosis; Secondary Progressive Multiple Sclerosis; Progressive Relapsing Multiple Sclerosis
Sanofi
 2024-04-16 PHASE3
NCT04799288 RECRUITING
HAM/TSP
National Institute of Neurological Disorders and Stroke (NINDS)
 2021-09-24 PHASE1; PHASE2
NCT07065968 RECRUITING
Immune Thrombocytopenia (ITP)
Peking University People's Hospital
 2025-08-19 PHASE2
NCT06141473 ACTIVE_NOT_RECRUITING
Multiple Sclerosis
Sanofi
 2023-12-13 PHASE3
NCT03500328 ACTIVE_NOT_RECRUITING
Multiple Sclerosis, Relapsing-Remitting
Johns Hopkins University
 2018-05-02
NCT05156281 ACTIVE_NOT_RECRUITING
Relapsing Multiple Sclerosis
Novartis Pharmaceuticals
 2021-12-13 PHASE3
NCT05147220 ACTIVE_NOT_RECRUITING
Relapsing Multiple Sclerosis
Novartis Pharmaceuticals
 2021-12-16 PHASE3
NCT04586010 ACTIVE_NOT_RECRUITING
Relapsing Multiple Sclerosis
Hoffmann-La Roche
 2021-03-17 PHASE3
NCT04586023 ACTIVE_NOT_RECRUITING
Relapsing Multiple Sclerosis
Hoffmann-La Roche
 2021-03-24 PHASE3
NCT06176911 UNKNOWN
Immune Thrombocytopenia
Peking University People's Hospital
 2023-12-05 PHASE2
NCT06176235 WITHDRAWN
Immune Thrombocytopenia
Peking University People's Hospital
 2023-12-19 PHASE2
NCT06190145 UNKNOWN
Immune Thrombocytopenia
Peking University People's Hospital
 2023-12-05 PHASE2
NCT04410991 COMPLETED
Relapsing Multiple Sclerosis
Sanofi
 2020-06-11 PHASE3
NCT04410978 COMPLETED
Relapsing Multiple Sclerosis
Sanofi
 2020-06-30 PHASE3
NCT04338022 TERMINATED
Relapsing Multiple Sclerosis
Merck Healthcare KGaA, Darmstadt, Germany, an affiliate of Merck KGaA, Darmstadt, Germany
 2020-06-12 PHASE3
NCT04338061 TERMINATED
Relapsing Multiple Sclerosis
Merck Healthcare KGaA, Darmstadt, Germany, an affiliate of Merck KGaA, Darmstadt, Germany
 2020-07-02 PHASE3
NCT04806737 COMPLETED
Celiac Disease
Oslo University Hospital
 2021-04-16 PHASE1; PHASE2
NCT05385744 COMPLETED
Multiple Sclerosis
Biocad
 2021-04-05 PHASE3
NCT03856619 COMPLETED
Relapsing Multiple Sclerosis
Sanofi
 2019-03-27 PHASE4
NCT05075499 UNKNOWN
Multiple Sclerosis
Sheba Medical Center
 2021-03-20
NCT04799288 Recruiting
HAM/TSP
National Institute of Neurological Disorders and Stroke (NINDS)|National Institutes of Health Clinical Center (CC)
 2021-09-24 Phase 1|Phase 2
NCT04410965 COMPLETED
Multiple Sclerosis
Sanofi
 2020-05-20 PHASE4
NCT01970410 COMPLETED
Multiple Sclerosis
Providence Health & Services
 2013-10 PHASE4
NCT04129736 COMPLETED
Multiple Sclerosis, Pharmacokinetics
Jan Lycke
 2019-10-10 PHASE4
NCT02587195 COMPLETED
Multiple Sclerosis
Centre Hospitalier Universitaire de Nice
 2015-12-18 PHASE3
NCT03277248 COMPLETED
Relapsing Multiple Sclerosis (RMS)
TG Therapeutics, Inc.
 2017-08-25 PHASE3
NCT03277261 COMPLETED
Relapsing Multiple Sclerosis (RMS)
TG Therapeutics, Inc.
 2017-09-19 PHASE3
NCT04056897 COMPLETED
Multiple Sclerosis
Biocad
 2019-06-07 PHASE2
NCT02201108 COMPLETED
Multiple Sclerosis
Genzyme, a Sanofi Company
 2014-07-16 PHASE3
NCT04129736 Completed
Multiple Sclerosis Pharmacokinetics
Jan Lycke|Sahlgrenska University Hospital Sweden
 2019-10-10 Phase 4
NCT02792231 COMPLETED
Relapsing Multiple Scelrosis
Novartis Pharmaceuticals
 2016-08-26 PHASE3
NCT02792218 COMPLETED
Relapsing Multiple Sclerosis
Novartis Pharmaceuticals
 2016-09-20 PHASE3
NCT02425644 COMPLETED
Multiple Sclerosis
Actelion
 2015-06-04 PHASE3
NCT03122652 COMPLETED
Multiple Sclerosis
Centre Hospitalier Universitaire de Nice
 2017-09-25 PHASE3
NCT03526224 Completed
Tecfidera|Teriflunomide
University at Buffalo
 2018-06-14 --
NCT03561402 Completed
Multiple Sclerosis Relapsing-Remitting
McGill University
 2016-12-01 --
NCT02263547 TERMINATED
Teriflunomide Elimination; Healthy Volunteers
Derrick Scott Robertson
 2015-03 PHASE1
NCT02833714 Terminated
RELAPSING REMITTING MULTIPLE SCLEROSIS
University of North Carolina Chapel Hill|Genzyme a Sanofi Company
 2016-01 --
NCT00803049 COMPLETED
Multiple Sclerosis
Sanofi
 2006-10 PHASE3
NCT01895335 COMPLETED
Multiple Sclerosis
Sanofi
 2013-06 PHASE4
NCT01863888 COMPLETED
Multiple Sclerosis
Sanofi
 2013-10 PHASE3
NCT00228163 COMPLETED
Multiple Sclerosis
Sanofi
 2002-01 PHASE2
NCT02046629 COMPLETED
Multiple Sclerosis
Sanofi
 2014-05 PHASE1
NCT01252355 TERMINATED
Multiple Sclerosis Relapse
Sanofi
 2011-01 PHASE3
NCT00622700 COMPLETED
Multiple Sclerosis
Sanofi
 2008-02 PHASE3
NCT00751881 COMPLETED
Multiple Sclerosis
Sanofi
 2008-08 PHASE3
NCT01403376 COMPLETED
Multiple Sclerosis
Sanofi
 2011-09 PHASE2
NCT00883337 COMPLETED
Multiple Sclerosis
Sanofi
 2009-04 PHASE3
NCT01239459 COMPLETED
Renal Impairment
Sanofi
 2010-11 PHASE1
NCT00134563 COMPLETED
Multiple Sclerosis
Sanofi
 2004-09 PHASE3
NCT00811395 COMPLETED
Multiple Sclerosis
Sanofi
 2007-10 PHASE2
NCT00475865 COMPLETED
Multiple Sclerosis
Sanofi
 2007-04 PHASE2
NCT00489489 COMPLETED
Multiple Sclerosis
Sanofi
 2007-05 PHASE2
NCT01487096 COMPLETED
Multiple Sclerosis
Sanofi
 2001-04 PHASE2

(data from https://clinicaltrials.gov, updated on 2026-06-23)

Check the Teriflunomide product page for in-depth specifications, including solubility, stock solutions, MOA, and working concentrations.

Compliance for Clinical Use

Mechanism and Biochemical Profile

Teriflunomide selectively binds to and inhibits the mitochondrial enzyme dihydroorotate dehydrogenase, thereby disrupting de novo pyrimidine nucleotide synthesis required for rapidly proliferating lymphocytes. This targeted suppression reduces the activation and expansion of autoreactive T and B cells, which directly underlies its therapeutic efficacy in reducing autoimmune inflammation in relapsing forms of multiple sclerosis.

Appendix RUO and cGMP Quality Standards

Quality Dimension RUO (Research Use Only) cGMP (Current Good Manufacturing Practice)
Clinical Applicability Prohibited in human clinical trials or medical diagnostics. Mandatory for human clinical trials (Phase I–III) and therapies.
Regulatory Status Non-regulated grade; exempt from drug manufacturing laws. Legally enforced by health authorities (e.g., FDA, EMA, NMPA).
Facility Environment Unclassified analytical or research laboratories. Validated Cleanrooms (ISO Class 5–8) with continuous monitoring.
Quality Control Basic purity and activity testing. Rigorous safety release testing (Sterility, Endotoxin, Mycoplasma).
Process Validation Basic equipment calibration; no process validation required. Full qualification (IQ/OQ/PQ) and complete batch records.
Quality Assurance Vendor self-declared without required formal QMS. Mandatory QA/QC unit, Change Control, CAPA, and vendor audits.
Regulatory Impact High risk of IND rejection if used as a critical raw material. Required for IND/NDA filings, supported by Drug Master Files (DMF).

Footnotes

Regulatory Note: Governed by FDA (21 CFR Parts 210/211/312), EMA (EudraLex Vol 4), ICH Guidelines (E6/Q7/Q9/Q10), and compendial standards (USP <71>/<85>/<1043>).

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Note: Technical data last updated: Sep 1, 2026.