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6 Diseases |  |
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17 News |  |
- || Review, Journal: Sphingosine 1-Phosphate Receptor Modulators for Multiple Sclerosis. (Pubmed Central) - Jan 11, 2022
Other second-generation selective S1PR modulators that have been tested for MS, with statistically significant data from phase II and phase III clinical studies, include ponesimod (ACT-128800), ceralifimod (ONO-4641), and amiselimod (MT-1303). This review covers the available data about the mechanisms of action, pharmacodynamics and kinetics, efficacy, safety, and tolerability of the various S1PR modulators for patients with relapsing-remitting, secondary progressive, and, for fingolimod, primary progressive MS.
- | ceralifimod (ONO 4641) / Ono Pharma
Preclinical, Journal: Preventive and Therapeutic Efficacy of ONO-4641, a Selective Agonist for Sphingosine 1-Phosphate Receptor 1 and 5, in Preclinical Models of Type 1 Diabetes Mellitus. (Pubmed Central) - Sep 29, 2021
Histopathological analysis demonstrated that insulin-positive areas in the islets of mice administered 0.03 and 0.1 mg/kg ONO-4641 showed a tendency of high values although they were not significantly different from the Control group, which was treated with vehicle. These observations suggest ONO-4641 may delay the onset and progression of type 1 diabetes mellitus.
- | ceralifimod (ONO 4641) / Ono Pharma
Preclinical, Journal: Sphingosine 1-phosphate Receptor Modulator ONO-4641 Regulates Trafficking of T Lymphocytes and Hematopoietic Stem Cells and Alleviates Immune-Mediated Aplastic Anemia in a Mouse Model. (Pubmed Central) - May 1, 2021
Significance Statement ONO-4641 is a second-generation sphingosine 1-phosphate (S1P) receptor modulator selective for S1P receptors 1 and 5. In this study, we demonstrated that ONO-4641 regulates the trafficking of T lymphocytes along with hematopoietic stem and progenitor cells leading to alleviation of pancytopenia and destruction of bone marrow in a bone marrow failure-induced mouse model mimicking human aplastic anemia.
- | ceralifimod (ONO 4641) / Ono Pharma
Trial termination, Trial primary completion date: DreaMS: Phase 2 Extension Trial in Patients With Relapsing-Remitting Multiple Sclerosis (RRMS) (clinicaltrials.gov) - Jul 17, 2015
P2, N=343, Terminated, Sponsor: EMD Serono
Active, not recruiting --> Terminated | Trial primary completion date: Jun 2016 --> Dec 2014; Merck has decided to not pursue phase 3 development of ceralifimod (ONO-4641). The decision was not related to any safety and efficacy findings
- ||||| Rebif (human IFN-β-1a) / EMD Serono
Trial initiation date: Study which compares the effectiveness and safety of a not yet approved drug called ONO-4641 versus an approved drug called interferon beta 1a (active comparator) in patients with multiple sclerosis. The study is double-blind (that is when neither the patient nor the investigator know which of the 2 drugs the patient is receiving). Patients will be randomly assigned (like the flip of a coin) to receive the study drug (two different doses) or the comparator. (EUDRACT) - Apr 14, 2014
P3, N=1176, Ongoing, Sponsor: Merck KGaA
The decision was not related to any safety and efficacy findings Initiation date: Mar 2014 --> Mar 2014
- |||||||||| Rebif (human IFN-β-1a) / EMD Serono
New P3 trial: Study which compares the effectiveness and safety of a not yet approved drug called ONO-4641 versus an approved drug called interferon beta 1a (active comparator) in patients with multiple sclerosis. The study is double-blind (that is when neither the patient nor the investigator know which of the 2 drugs the patient is receiving). Patients will be randomly assigned (like the flip of a coin) to receive the study drug (two different doses) or the comparator. (EUDRACT) - Feb 19, 2014
P3, N=1176, Ongoing, Sponsor: Merck KGaA
- ||| ceralifimod (ONO 4641) / Ono Pharma
Enrollment closed: DreaMS: Phase 2 Extension Trial in Patients With Relapsing-Remitting Multiple Sclerosis (RRMS) (clinicaltrials.gov) - May 22, 2012
P2, N=343, Active, not recruiting, Sponsor: EMD Serono
Initiation date: Mar 2014 --> Mar 2014 Enrolling by invitation --> Active, not recruiting
- |||| ceralifimod (ONO 4641) / Ono Pharma
Trial completion: DreaMS: A Study of the Safety and Efficacy of ONO-4641 in Patients With Relapsing-Remitting Multiple Sclerosis (clinicaltrials.gov) - Feb 2, 2012
P2, N=407, Completed, Sponsor: Ono Pharma USA Inc
Enrolling by invitation --> Active, not recruiting Active, not recruiting --> Completed