How it works: Keeping immune cells out of the brain →

Ponvory

EU: Approved in the EU since 2021US: FDA approved 2021

Molecule type
Small molecule
Mechanism (ChEMBL)
Sphingosine 1-phosphate receptor Edg-1 agonist
Targets
Sphingosine 1-phosphate receptor 1
Availability
Authorised in all EU and EEA countries. Reimbursement is decided by each country.

Approvals

  • USPonvory · Approved2021-03-18 Source
  • EU/EEAPonvory · Authorised2021-05-19 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.

430 reports in total, 158 marked serious.

  • Product dose omission issue75
  • Fatigue35
  • Dizziness24
  • Dyspnoea23
  • Headache22
  • Product use issue17
  • Nausea14
  • Covid-1913
  • Drug ineffective13
  • Pain12

Trials

Key trials

Large trials with a reported result on their main goal.

  • OPTIMUM

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

Running now

  • PIONEER

    Ongoing · Phase 3 · Relapsing MS · ongoing

  • Alemtuzumab

    Running, not recruiting · Relapsing MS · ongoing

Other trials (6)

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

  • OPTIMUM-LT

    Completed · Phase 3 · Relapsing and progressive · results_posted_no_test

  • POINT

    Terminated · Phase 3 · Relapsing and progressive · stopped_other

  • POINT

    Terminated · Phase 3 · Relapsing MS

  • Ponesimod, phase 2

    Completed · Phase 2 · Relapsing MS · results_posted_no_test

  • Ponesimod, phase 2

    Completed · Phase 2 · Relapsing MS · Main goal met

  • Ponesimod, phase 2

    Completed · Phase 2 · Relapsing MS

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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