Drugs / Ozanimod
Ozanimod
also known as
RPC1063 · OZA · ozanimod HCl · OZANIMOD HYDROCHLORIDE · RPC-1063 HCL · RPC-1063 HYDROCHLORIDE · Zeposia · Zeposia (ozanimod)
Small molecule targets S1PR1, S1PR5
Regulatory milestones approvals, filings & regulatory actions · 8 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Filed ulcerative colitis 2 milestones | |||||
| Filed | US (FDA) | Zeposia | ulcerative colitis | 2021-02-01 | “FDA has accepted its supplemental New Drug Application (sNDA) for Zeposia ® (ozanimod) for the treatment of adults with moderately to severely active ulcerative colitis (UC).” bms.com ↗ |
| Filed | EU (EMA) | Zeposia | ulcerative colitis | 2020-12-28 | “EMA has validated its Marketing Authorization Application (MAA) for Zeposia (ozanimod) for the treatment of adults with moderately to severely active ulcerative colitis (UC).” bms.com ↗ |
| Approved Indication not stated 5 milestones | |||||
| Label expansions (2) | US (FDA) | ZEPOSIA | — | 2021-05-27 – 2024-08-30 | fda.gov ↗ |
| Approved | EU (EMA) | Zeposia | — | 2020-05-20 | europa.eu ↗ |
| Approved | US (FDA) | ZEPOSIA | — | 2020-03-25 | fda.gov ↗ |
| Filed | EU (EMA) | — | — | 2019-11-20 | “regulatory filings of luspatercept and ozanimod in the U.S. and Europe.” bms.com ↗ |
| Filed | US (FDA) | — | — | 2019-11-20 | “regulatory filings of luspatercept and ozanimod in the U.S. and Europe.” bms.com ↗ |
Trials 36
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 110 trials | ||||||
| Phase 1 | NCT04978298 | Jul 2021 → Feb 2023 | — | Celgene Corporation | Completed | No outcome recorded |
| Phase 1 | NCT04639115 | Dec 2020 → Apr 2022 | liver disorder | Celgene Corporation | Completed | No outcome recorded |
| Phase 1 | NCT04528290 | Oct 2020 → May 2021 | — | Celgene Corporation | Completed | No outcome recorded |
| Phase 1 | NCT04211558 | Aug → Sep 2020 | — | Celgene Corporation | Completed | No outcome recorded |
| Phase 1 | NCT04149678 | Oct → Nov 2019 | — | Celgene Corporation | Completed | No outcome recorded |
| Phase 1 | NCT03694119 | Jul 2018 → Jan 2019 | — | Celgene Corporation | Completed | No outcome recorded |
| Phase 1 | NCT03644576 | Jul → Sep 2018 | — | Celgene Corporation | Completed | No outcome recorded |
| Phase 1 | NCT03624959 | Jun → Aug 2018 | — | Celgene Corporation | Completed | No outcome recorded |
| Phase 1 | NCT02994381 | Oct → Nov 2016 | — | Celgene Corporation | Completed | No outcome recorded |
| Phase 1 | NCT02797015 | Jun 2016 → Oct 2017 | multiple sclerosis | Celgene Corporation | Completed | No outcome recorded |
| Phase 24 trials · 1 met primary | ||||||
| Phase 2 | NCT06862960 | Jul 2025 → Jun 2027 expected | Alzheimer disease | ChenXiaoChun | Not yet recruiting | No outcome recorded |
| Phase 2 | NCT04405102 | Sep 2020 → Mar 2022 | COVID-19 | Centre de Recherche de l'Institut Universitaire de Cardiologie et de Pneumologie de Quebec | Terminated | No outcome recorded Stop: Enrollment |
| Phase 2 | NCT02531113 | Oct 2015 → Sep 2019 | Crohn disease | Celgene Corporation | Completed | No outcome recorded |
| Phase 2 | NCT01647516 | Dec 2012 → Mar 2015 | ulcerative colitis | Celgene Corporation | Completed | Met primary |
| Phase 2/33 trials · 1 met primary | ||||||
| Phase 2/3 | NCT05470985 | Aug 2023 → Sep 2024 | Crohn disease | Bristol-Myers Squibb | Terminated | No outcome recorded Stop: Business |
| Phase 2/3 | NCT05076175 | May 2022 → Jul 2032 expected | ulcerative colitis | Bristol-Myers Squibb | Recruiting | No outcome recorded |
| Phase 2/3 | NCT01628393 | Sep 2012 → Apr 2014 | multiple sclerosis | Celgene Corporation | Completed | Met primary |
| Phase 313 trials · 4 met primary · 2 missed | ||||||
| Phase 3 | NCT06408259 | Apr 2025 → Apr 2031 expected | relapsing-remitting multiple sclerosis | Bristol-Myers Squibb | Recruiting | No outcome recorded |
| Phase 3 | NCT05644665 | Dec 2022 → Mar 2025 | ulcerative colitis | Bristol-Myers Squibb | Terminated | No outcome recorded Stop: Business |
| Phase 3 | NCT04140305 | Jan 2020 → May 2025 | multiple sclerosis | Celgene Corporation | Terminated | No outcome recorded Stop: Business |
| Phase 3 | NCT03915769 | Jun 2019 → Sep 2025 | ulcerative colitis | Celgene Corporation | Completed | No outcome recorded |
| Phase 3 | NCT03467958 | Aug 2018 → Oct 2024 | Crohn disease | Celgene Corporation | Terminated | No outcome recorded Stop: Business |
| Phase 3 | NCT03464097 | Jun 2018 → Oct 2024 | Crohn disease | Celgene Corporation | Terminated | Missed primary Stop: Business |
| Phase 3 | NCT03440385 | Mar 2018 → Nov 2023 | Crohn disease | Celgene Corporation | Completed | Missed primary |
| Phase 3 | NCT03440372 | Feb 2018 → Oct 2024 | Crohn disease | Celgene Corporation | Terminated | Met primary Stop: Business |
| Phase 3 | NCT02531126 | Dec 2015 → Dec 2024 | ulcerative colitis | Celgene Corporation | Completed | No outcome recorded |
| Phase 3 | NCT02576717 | Oct 2015 → Jan 2023 | multiple sclerosis | Celgene Corporation | Completed | No outcome recorded |
| Phase 3 | NCT02435992 | Jun 2015 → Mar 2020 | ulcerative colitis | Celgene Corporation | Completed | Met primary |
| Phase 3 | NCT02294058 | Dec 2014 → Dec 2016 | multiple sclerosis | Celgene Corporation | Completed | Met primary |
| Phase 3 | NCT02047734 | Dec 2013 → Mar 2017 | relapsing-remitting multiple sclerosis | Celgene Corporation | Completed | Met primary |
| Phase 46 trials | ||||||
| Phase 4 | NCT06188637 | Aug 2024 → Mar 2026 | ulcerative colitis | Geert D'Haens | Withdrawn | No outcome recorded Stop: Business |
| Phase 4 | NCT06529406 | Jul 2024 → Aug 2028 expected | relapsing-remitting multiple sclerosis | University of Colorado, Denver | Recruiting | No outcome recorded |
| Phase 4 | NCT06334094 | Jun 2024 → Mar 2028 | multiple sclerosis | The University of Texas at Dallas | Withdrawn | No outcome recorded Stop: Business |
| Phase 4 | NCT05777902 | Jan 2023 → Apr 2024 | multiple sclerosis | Santa Lucia Foundation IRCCS | Terminated | No outcome recorded |
| Phase 4 | NCT05369832 | Dec 2022 → Jan 2025 | ulcerative colitis | Bristol-Myers Squibb | Terminated | No outcome recorded Stop: Business |
| Phase 4 | NCT03535298 | Jan 2019 → Jul 2027 expected | relapsing-remitting multiple sclerosis | The Cleveland Clinic | Active not recruiting | No outcome recorded |
| Comparator or background therapy2 trials | ||||||
| Phase 1 | NCT05001152 Background | Sep 2021 | — | Bristol-Myers Squibb | Completed | No outcome recorded |
| Phase 2 | NCT06715605 Comparator | Apr 2025 | multiple sclerosis | University Hospital, Antwerp | Withdrawn | No outcome recorded Stop: Business |
News releases announcing trial results or a regulatory action · 22
| Date | Issuer | Release |
|---|---|---|
| 2024-09-18 | Bristol-Myers Squibb | Results New Long-Term Zeposia (ozanimod) Data Demonstrate Durable Efficacy and Consistent Safety in Relapsing Forms of Multiple Sclerosis bms.com ↗
These findings showed that patients receiving continuous Zeposia treatment for up to five years experienced low and stable rates of whole brain volume (WBV) loss through Month 60 (annualized least squares mean [LSM] % change from parent trial baseline: RADIANCE, −0.27; SUNBEAM, −0.35). |
| 2024-03-28 | Bristol-Myers Squibb | Results Bristol Myers Squibb Provides Update on the First Phase 3 YELLOWSTONE Trial Evaluating Oral Zeposia (ozanimod) in Patients with Moderate to Severe Active Crohn’s Disease bms.com ↗
The study did not meet its primary endpoint of clinical remission at Week 12. |
| 2024-02-29 | Bristol-Myers Squibb | Results Bristol Myers Squibb Announces New Data from the Long-Term DAYBREAK Study Reinforcing Efficacy and Safety of Zeposia (ozanimod) in Patients with Relapsing Forms of Multiple Sclerosis bms.com ↗
In the DAYBREAK long-term extension study, treatment with Zeposia demonstrated a low annualized relapse rate of 0.098. |
| 2023-10-11 | Bristol-Myers Squibb | Results Bristol Myers Squibb Presents New Zeposia (ozanimod) Data on Long-Term Disease Progression and Cognition in Patients with Relapsing Forms of Multiple Sclerosis bms.com ↗
Bristol Myers Squibb (NYSE: BMY) today announced new data showing that after eight years of follow-up, 76% of patients treated with Zeposia for relapsing multiple sclerosis (RMS) were free of six-month confirmed disability progression (CDP). |
| 2022-10-26 | Bristol-Myers Squibb | Results New Zeposia (ozanimod) Data Highlight COVID-19 Outcomes and Preservation of Long-Term Cognitive Function from Separate Analyses in Patients with Relapsing Forms of Multiple Sclerosis bms.com ↗
Bristol Myers Squibb (NYSE: BMY) today announced new retrospective analyses on serologic responses and clinical outcomes with COVID-19 vaccination in participants treated with Zeposia (ozanimod) from the ongoing Phase 3 DAYBREAK open-label extension (OLE) study in relapsing multiple sclerosis (MS). |
| 2022-10-24 | Bristol-Myers Squibb | Results New Data Presented at the American College of Gastroenterology Annual Scientific Meeting Demonstrate Continuous Zeposia (ozanimod) Treatment Prevents Disease Relapse Over One Year in 86.1% of Patients Who Respond at the End of the Induction Period bms.com ↗
After achieving a clinical response at the end of the induction period, 86.1% of patients who remained on Zeposia showed no disease relapse at Week 52 (Kaplan-Meier [KM] estimates of no disease relapse at Week 52: Zeposia / Zeposia , 86.1%; Zeposia /placebo, 62.6%). |
| 2022-06-24 | Bristol-Myers Squibb | Results New Data Highlight Immune Response to COVID-19 Vaccines in Individuals with Relapsing Forms of Multiple Sclerosis Treated with Zeposia (ozanimod) bms.com ↗
For participants who showed no evidence of recent COVID-19 infection, results showed seroconversion occurred in 100% (80/80) and 62% (18/29) of fully vaccinated mRNA and non-mRNA vaccine recipients, respectively. |
| 2022-06-24 | Bristol-Myers Squibb | Results Bristol Myers Squibb Presents New Data Showing Effect of Early Zeposia (ozanimod) Treatment in Improving and Preserving Cognitive Function in People With Relapsing Multiple Sclerosis bms.com ↗
Zeposia was well tolerated, with more than 80% of people staying on therapy through 48 months |
| 2022-02-17 | Bristol-Myers Squibb | Results Bristol Myers Squibb Presents Interim Results from Long-Term Study Reinforcing Maintenance of Response and Safety Profile of Zeposia (ozanimod) in Patients with Moderately to Severely Active Ulcerative Colitis bms.com ↗
Findings show that the percentage of patients achieving clinical remission, clinical response, endoscopic improvement and corticosteroid-free remission was maintained through Week 142. |
| 2021-11-23 | Bristol-Myers Squibb | Regulatory Bristol Myers Squibb Receives European Commission Approval of Zeposia (ozanimod) for use in Adults with Moderately to Severely Active Ulcerative Colitis bms.com ↗
Bristol Myers Squibb (NYSE:BMY) today announced the European Commission has granted a Marketing Authorization for Zeposia (ozanimod) for the treatment of adults with moderately to severely active ulcerative colitis (UC) who have had an inadequate response, lost response, or were intolerant to either conventional therapy or a biologic agent. |
| 2021-10-15 | Bristol-Myers Squibb | Regulatory Bristol Myers Squibb Receives Positive CHMP Opinion for Zeposia (ozanimod) as a Treatment for Adult Patients with Moderately to Severely Active Ulcerative Colitis bms.com ↗ |
| 2021-10-13 | Bristol-Myers Squibb | Results Bristol Myers Squibb Announces Up to Five Years of Data from Long-Term DAYBREAK Study Reinforcing Efficacy and Safety Profile of Zeposia (ozanimod) in Patients with Relapsing Forms of Multiple Sclerosis bms.com ↗
Bristol Myers Squibb (NYSE: BMY) today announced interim results from the Phase 3 open-label extension trial DAYBREAK, demonstrating the long-term efficacy and safety profile of Zeposia (ozanimod) in patients with relapsing forms of multiple sclerosis (MS). |
| 2021-05-27 | Bristol-Myers Squibb | Regulatory U.S. Food and Drug Administration Approves Bristol Myers Squibb’s Zeposia® (ozanimod), an Oral Treatment for Adults with Moderately to Severely Active Ulcerative Colitis bms.com ↗
Bristol Myers Squibb (NYSE:BMY) today announced that the U.S. Food and Drug Administration (FDA) approved Zeposia ® (ozanimod) 0.92 mg for the treatment of adults with moderately to severely active ulcerative colitis (UC), a chronic inflammatory bowel disease (IBD). |
| 2021-05-23 | Bristol-Myers Squibb | Results Bristol Myers Squibb Presents New Data at Digestive Disease Week® on Zeposia (ozanimod) Highlighting Clinical Benefits and Safety Profile in Patients with Ulcerative Colitis bms.com ↗
Long-term treatment with Zeposia showed a safety profile that was consistent with its known safety profile. |
| 2021-02-01 | Bristol-Myers Squibb | Regulatory Bristol Myers Squibb Application for Zeposia® (ozanimod) for the Treatment of Ulcerative Colitis Accepted for Filing with Priority Review by U.S. Food and Drug Administration bms.com ↗
Bristol Myers Squibb (NYSE:BMY) today announced that the U.S. Food and Drug Administration (FDA) has accepted its supplemental New Drug Application (sNDA) for Zeposia ® (ozanimod) for the treatment of adults with moderately to severely active ulcerative colitis (UC). |
| 2020-12-28 | Bristol-Myers Squibb | Regulatory European Medicines Agency Validates Bristol Myers Squibb’s Application for Zeposia (ozanimod) for the Treatment of Ulcerative Colitis bms.com ↗
Bristol Myers Squibb (NYSE:BMY) today announced that the European Medicines Agency (EMA) has validated its Marketing Authorization Application (MAA) for Zeposia (ozanimod) for the treatment of adults with moderately to severely active ulcerative colitis (UC). |
| 2020-10-10 | Bristol-Myers Squibb | Results Bristol Myers Squibb Presents Positive Late-Breaking Data from Phase 3 True North Trial Evaluating Zeposia (ozanimod) in Adult Patients with Moderate to Severe Ulcerative Colitis bms.com ↗
Bristol Myers Squibb (NYSE:BMY) today announced detailed results from True North, a pivotal, placebo-controlled Phase 3 trial evaluating oral Zeposia (ozanimod) as an induction and maintenance therapy in adult patients with moderate to severe ulcerative colitis (UC). |
| 2020-09-01 | Bristol-Myers Squibb | Results Bristol Myers Squibb Announces Interim Results from Long-Term Study Reinforcing Efficacy and Safety Profile of Zeposia (ozanimod) in Patients with Relapsing Forms of Multiple Sclerosis bms.com ↗
Bristol Myers Squibb (NYSE:BMY) today announced interim results from the Phase 3 open-label extension trial DAYBREAK, demonstrating the long-term efficacy and safety profile of Zeposia (ozanimod) in patients with relapsing forms of multiple sclerosis (MS). |
| 2020-06-02 | Bristol-Myers Squibb | Results Bristol Myers Squibb Announces Positive Topline Results from Pivotal Phase 3 True North Trial Evaluating Zeposia (ozanimod) in Patients with Moderate to Severe Ulcerative Colitis bms.com ↗
True North met both primary endpoints, demonstrating highly statistically significant (p-value < 0.0001) results for induction of clinical remission at Week 10 and in maintenance at Week 52. |
| 2020-05-27 | Bristol-Myers Squibb | Regulatory Bristol Myers Squibb Receives European Commission Approval for Zeposia (ozanimod) for the Treatment of Adult Patients with Relapsing Remitting Multiple Sclerosis with Active Disease bms.com ↗
Bristol Myers Squibb (NYSE:BMY) today announced that the European Commission (EC) has approved Zeposia (ozanimod) for the treatment of adult patients with relapsing remitting multiple sclerosis (RRMS) with active disease as defined by clinical or imaging features. |
| 2020-03-27 | Bristol-Myers Squibb | Regulatory Bristol Myers Squibb Receives Positive CHMP Opinion Recommending Approval of ZEPOSIA® (ozanimod) for the Treatment of Adult Patients with Relapsing Remitting Multiple Sclerosis with Active Disease bms.com ↗
Bristol Myers Squibb (NYSE:BMY) today announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency has adopted a positive opinion for ZEPOSIA ® (ozanimod) for the treatment of adult patients with relapsing remitting multiple sclerosis (RRMS) with active disease as defined by clinical or imaging features. |
| 2020-03-26 | Bristol-Myers Squibb | Regulatory U.S. Food and Drug Administration Approves Bristol Myers Squibb’s ZEPOSIA® (ozanimod), a New Oral Treatment for Relapsing Forms of Multiple Sclerosis bms.com ↗
Bristol-Myers Squibb Company (NYSE: BMY) today announced that the U.S. Food and Drug Administration (FDA) approved ZEPOSIA ® (ozanimod) 0.92 mg for the treatment of adults with relapsing forms of multiple sclerosis (RMS), including clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease. |
All press releases naming this drug 26 releases
Evidence & citations 14 cited values
Every value below carries the sentence it was read from. 41 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | Ozanimod | “Standard-of-care on first-line treatment such as interferon-beta, glatiramer acetate, teriflunomide, dimethylfumarate, ponesimod and ozanimod.” NCT06715605 ↗32“Study Describing Cognitive Processing Speed Changes in Relapsing Multiple Sclerosis Subjects Treated With Ozanimod (RPC-1063)” NCT04140305 ↗ “RPC1063 (Ozanimod)” NCT02435992 ↗ “Zeposia (ozanimod)” NCT03535298 ↗ |
| Known as | OZA | “Is it feasible to administer an SRL therapy, here ozanimod (OZA), to acutely ill patients infected with SARS-CoV-2?” PMID 37898184 ↗ Oct 2023 |
| Known as | ozanimod HCl | “daily ozanimod 0.92 mg (equivalent to ozanimod HCl 1 mg) or placebo for 12 weeks during induction.” PMID 36208720 ↗ Oct 2022 |
| Known as | OZANIMOD HYDROCHLORIDE | ChEMBL registry synonym — accepted as the source's own label CHEMBL3707247 ↗ |
| Known as | RPC-1063 HCL | ChEMBL registry synonym — accepted as the source's own label CHEMBL3707247 ↗ |
| Known as | RPC-1063 HYDROCHLORIDE | ChEMBL registry synonym — accepted as the source's own label CHEMBL3707247 ↗ |
| Known as | RPC1063 | ClinicalTrials.gov intervention name — accepted as the source's own label NCT02576717 ↗ |
| Known as | Zeposia | ChEMBL registry synonym — accepted as the source's own label CHEMBL3707247 ↗ |
| Known as | Zeposia (ozanimod) | “Zeposia (ozanimod)” NCT03535298 ↗ |
| Action | Activate | “activates the sphingosine 1-phosphate 1 receptor (S1P1) and the S1P 5 receptor (S1P5)” NCT03915769 ↗ |
| Modality | Small molecule | “Ozanimod as a novel oral small molecule therapy” PMID 36208720 ↗ Oct 2022 |
| Route | Oral | “Oral capsule taken once a day” NCT01628393 ↗ |
| Target | S1PR1 | “Sphingosine 1-phosphate receptor Edg-1 modulator” CHEMBL3707247 ↗ |
| Target | S1PR5 | “Sphingosine 1-phosphate receptor 5 modulator” CHEMBL3707247 ↗ |