Ozanimod
How it works: Keeping immune cells out of the brain →
Zeposia
EU: Approved in the EU since 2020US: FDA approved 2020
- Other names
- ozanimod hydrochloride
- Molecule type
- Small molecule
- Mechanism (ChEMBL)
- Sphingosine 1-phosphate receptor 5 modulator
- Targets
- Sphingosine 1-phosphate receptor 5
- 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.
8,838 reports in total, 2,582 marked serious.
- Fatigue801
- Multiple sclerosis relapse602
- Drug ineffective564
- Headache535
- Product dose omission issue385
- Dizziness359
- Nausea292
- Colitis ulcerative275
- Diarrhoea273
- Pain260
Trials
Key trials
Large trials with a reported result on their main goal.
- Study of Ozanimod (RPC1063) in Relapsing Multiple Sclerosis (MS)
Completed · Phase 3 · Relapsing MS · Met its main goal
- Efficacy and Safety Study of Ozanimod in Relapsing Multiple Sclerosis
Completed · Phase 3 · Relapsing MS · Met its main goal
- Efficacy and Safety Study of Ozanimod (RPC1063) in Relapsing Multiple
Completed · Phase 2 / Phase 3 · Relapsing MS · Met its main goal
Running now
- Risk of Progressive Multifocal Leukoencephalopathy Among Patients With
Recruiting · MS (type not specified) · Still running
- Study to Evaluate the Effectiveness and Safety of Ozanimod Compared to
Recruiting · Phase 3 · Relapsing MS · Still running
- Prospective Evaluation of Sequencing From antiCD-20 Therapies to Ozani
Recruiting · Phase 4 · Relapsing MS · Still running
- A Study to Assess the Effectiveness and Safety of Ozanimod in Chinese
Running, not recruiting · Phase 4 · Relapsing MS · Still running
- Effect of ozanimod on meningeal inflammation and glial activation in M
Recruiting · Phase 4 · Relapsing MS · Still running
- Effects of ozanimod on myelin dynamics and neurodegeneration in patien
Recruiting · Phase 4 · Relapsing MS · Still running
- A Study to Learn More About The Safety of Diroximel Fumarate (VUMERITY
Running, not recruiting · Relapsing MS · Still running
- A Study to Evaluate the Safety of Ozanimod Exposure During Pregnancy i
Running, not recruiting · MS (type not specified) · Still running
Other trials (12)
Completed small trials, dose-finding studies and trials in other diseases.
- Assessing the Cognitive Benefits of Ozanimod and Their Brain-Biomarker
Withdrawn · Phase 4 · Relapsing MS · Stopped
- Multidimensional Integrated Assessment to Test the Efficacy and Respon
Terminated · Phase 4 · Relapsing MS · Stopped
- Effect of ozanimod on meningeal inflammation and glial activation in M
Moved to EU CTIS registry · Phase 4 · Relapsing MS
- Effects of ozanimod on myelin dynamics and neurodegeneration in patien
Moved to EU CTIS registry · Phase 4 · Relapsing MS
- Multidimensional integrated assessment of neurological and immunologic
Terminated · Phase 4 · Relapsing MS
- Observational Study of the Effect of Ozanimod on Fatigue in Multiple S
Terminated · MS (type not specified) · Stopped
- An Examination of Cognitive Fatigue Using Functional Neuroimaging
Status unknown · Relapsing MS · No results found
- A Study Investigating the Utilization, Effectiveness and Quality of Li
Completed · Relapsing MS · No results found
- Relationship Between Oral DMT Burden and Adherence in MS
Status unknown · MS (type not specified) · No results found
- Study Describing Cognitive Processing Speed Changes in Relapsing Multi
Terminated · Phase 3 · 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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