Ponesimod
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
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.
440 reports in total, 168 marked serious.
- Product dose omission issue76
- Fatigue35
- Dizziness25
- Dyspnoea24
- Headache22
- Product use issue17
- Nausea14
- Covid-1913
- Drug ineffective13
- Pain12
Trials
Key trials
Large trials with a reported result on their main goal.
- Oral Ponesimod Versus Teriflunomide In Relapsing MUltiple Sclerosis
Completed · Phase 3 · Relapsing and progressive · Met its main goal
Running now
- A Clinical Study to Evaluate the Efficacy, Safety, Pharmacokinetics, a
Ongoing · Phase 3 · Relapsing MS · Still running
- A Study to Learn More About The Safety of Diroximel Fumarate (VUMERITY
Running, not recruiting · Relapsing MS · Still running
Other trials (6)
Completed small trials, dose-finding studies and trials in other diseases.
- Long-term Extension to Study AC-058B301 to Investigate Safety, Tolerab
Completed · Phase 3 · Relapsing and progressive · Results posted, not judged
- Clinical Study to Compare the Efficacy and Safety of Ponesimod to Plac
Terminated · Phase 3 · Relapsing and progressive · Stopped
- Clinical study to compare the efficacy and safety of ponesimod to plac
Terminated · Phase 3 · Relapsing MS
- Clinical Study to Investigate the Long-term Safety, Tolerability, and
Completed · Phase 2 · Relapsing MS · Results posted, not judged
- Clinical Study to Evaluate the Efficacy, Safety, and Tolerability of A
Completed · Phase 2 · Relapsing MS · Met its main goal
- Multicenter, randomized, double-blind, placebo-controlled, parallel-gr
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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