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

  • USAubagio · Approved2012-09-12 Source
  • EU/EEAAubagio · Authorised2013-08-26 Source
  • EU/EEATeriflunomide Viatris (previously Teriflunomide Mylan) · Authorised · Generic2022-11-09 Source
  • EU/EEATeriflunomide Accord · Authorised · Generic2022-11-09 Source

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.

44,980 reports in total, 19,534 marked serious.

  • Alopecia6,076
  • Multiple sclerosis relapse5,230
  • Fatigue4,765
  • Diarrhoea4,759
  • Fall3,342
  • Hypoaesthesia3,172
  • Headache3,005
  • Drug ineffective2,821
  • Paraesthesia2,814
  • Nausea2,750

Trials

Key trials

Large trials with a reported result on their main goal.

  • TERIS

    Completed · Phase 3 · Early (CIS/RIS) · Main goal met

  • TERIKIDS

    Completed · Phase 3 · Relapsing MS · Main goal not met

  • TERACLES

    Terminated · Phase 3 · Relapsing MS · Stopped: safety

  • TENERE

    Completed · Phase 3 · Relapsing MS · Main goal not met

  • TOWER

    Completed · Phase 3 · Relapsing MS · Main goal met

  • TOPIC

    Completed · Phase 3 · Early (CIS/RIS) · Main goal met

  • Teriflunomide, phase 3

    Completed · Phase 3 · Relapsing MS · Not an efficacy test

  • TEMSO

    Completed · Phase 3 · Relapsing and progressive · Main goal met

Running now

  • DESIRE MS

    Recruiting · Phase 3 · Relapsing and progressive · ongoing

  • TWINS

    Not yet recruiting · Phase 3 · Relapsing MS · ongoing

  • FENhance 2

    Running, not recruiting · Phase 3 · Relapsing MS · ongoing

  • FENhance

    Running, not recruiting · Phase 3 · Relapsing MS · ongoing

  • STOP-I-SEP

    Running, not recruiting · Phase 3 · Progressive MS · ongoing

  • TERIPET

    Running, not recruiting · Phase 4 · Progressive MS · ongoing

Other trials (29)

Completed small trials, dose-finding studies and trials in other diseases.

  • TDM-MS

    Status unknown · Phase 4 · MS (type not specified) · no_result_found

  • TERIFIN

    Completed · Phase 4 · MS (type not specified) · no_result_found

  • Teriflunomide, phase 4

    Completed · Phase 4 · MS (type not specified) · no_result_found

  • STATURE

    Status unknown · MS (type not specified) · no_result_found

  • TERI-PK

    Completed · Phase 4 · Relapsing MS · result_in_paper_unread

  • Teriflunomide, phase 4

    Completed · Phase 4 · Relapsing MS · result_in_paper_unread

  • SAFE

    Completed · Phase 4 · Relapsing MS · no_result_found

  • Dimethyl fumarate

    Completed · MS (type not specified) · result_in_paper_unread

  • Teriflunomide

    Completed · Relapsing MS · no_result_found

  • nd

    Terminated · Phase 4 · Relapsing MS · stopped_other

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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Assembled by software from public sources and not checked by people. Each record links to its source. Report an error