Teriflunomide
How it works: Calming and slowing immune cells →
Aubagio
EU: Approved in the EU since 2013US: FDA approved 2012
- Molecule type
- Small molecule
- Mechanism (ChEMBL)
- Dihydroorotate dehydrogenase inhibitor
- Targets
- Dihydroorotate dehydrogenase (quinone), mitochondrial
- Availability
- Authorised in all EU and EEA countries. Reimbursement is decided by each country.
Approvals
Safety communications
None recorded.
Most-reported side effects (FDA reports)
Reports to the FDA's adverse event system (FAERS) show what people and doctors reported while taking the medicine. They do not prove the medicine caused it, and they are not rates.
45,130 reports in total, 19,644 marked serious.
- Alopecia6,087
- Multiple sclerosis relapse5,245
- Fatigue4,771
- Diarrhoea4,764
- Fall3,354
- Hypoaesthesia3,173
- Headache3,009
- Drug ineffective2,835
- Paraesthesia2,816
- Nausea2,753
Trials
Key trials
Large trials with a reported result on their main goal.
- Randomized, Double-blinded Study of Treatment:Teriflunomide, in Radiol
Completed · Phase 3 · Early (CIS/RIS) · Met its main goal
- Efficacy, Safety and Pharmacokinetics of Teriflunomide in Pediatric Pa
Completed · Phase 3 · Relapsing MS · Missed its main goal
- Efficacy and Safety of Teriflunomide in Patients With Relapsing Multip
Terminated · Phase 3 · Relapsing MS · Stopped: safety
- A Study Comparing the Effectiveness and Safety of Teriflunomide and In
Completed · Phase 3 · Relapsing MS · Missed its main goal
- An Efficacy Study of Teriflunomide in Participants With Relapsing Mult
Completed · Phase 3 · Relapsing MS · Met its main goal
- Phase III Study With Teriflunomide Versus Placebo in Patients With Fir
Completed · Phase 3 · Early (CIS/RIS) · Met its main goal
- Long Term Safety and Efficacy Study of Teriflunomide 7 mg or 14 mg in
Completed · Phase 3 · Relapsing MS · Main goal was not benefit
- Study of Teriflunomide in Reducing the Frequency of Relapses and Accum
Completed · Phase 3 · Relapsing and progressive · Met its main goal
Running now
- A Prospective Randomized Non-inferiority Trial Comparing Anti-CD20 Mai
Recruiting · Phase 3 · Relapsing and progressive · Still running
- Disease Modifying Therapies Withdrawal in Inactive Relapsing-remitting
Not yet recruiting · Phase 3 · Relapsing MS · Still running
- Study to Evaluate the Efficacy and Safety of Fenebrutinib Compared Wit
Running, not recruiting · Phase 3 · Relapsing MS · Still running
- A Study to Evaluate the Efficacy and Safety of Fenebrutinib Compared W
Running, not recruiting · Phase 3 · Relapsing MS · Still running
- Disease Modifying Therapies Withdrawal in Inactive Secondary Progressi
Running, not recruiting · Phase 3 · Progressive MS · Still running
- Effect of Teriflunomide Treatment on Microglial Activation in an MS Pa
Running, not recruiting · Phase 4 · Progressive MS · Still running
Other trials (29)
Completed small trials, dose-finding studies and trials in other diseases.
- Therapeutic Monitoring of Drugs Used in the Treatment of Multiple Scle
Status unknown · Phase 4 · MS (type not specified) · No results found
- Monitoring of drugs used in the treatment of multiple sclerosis
Completed · Phase 4 · MS (type not specified) · No results found
- Peripheral neuropathy as potential side effect in patients with multip
Completed · Phase 4 · MS (type not specified) · No results found
- Relationship Between Oral DMT Burden and Adherence in MS
Status unknown · MS (type not specified) · No results found
- Evaluation of the Relationship Between ABCG2 Mutation and Teriflunomid
Completed · Phase 4 · Relapsing MS · Paper found, not read
- Teriflunomide Concentration in Serum and Cerebrospinal Fluid From Pati
Completed · Phase 4 · Relapsing MS · Paper found, not read
- To Evaluate the Safety and Efficacy of Teriflunomide in Patients With
Completed · Phase 4 · Relapsing MS · No results found
- Teriflunomide Tecfidera LMCE
Completed · MS (type not specified) · Paper found, not read
- Mechanistic Studies of Teriflunomide in RRMS
Completed · Relapsing MS · No results found
- nd
Terminated · Phase 4 · Relapsing MS · Stopped
For information only, not medical advice. Talk to your neurologist before changing treatment.
Hypotheses involving this medicine
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Lab studies
Lab studies in animals or cells. Results in animals often do not hold in people, and these studies never change the status of an idea.
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