Drugs / Ozanimod
Ozanimod
also known as
RPC1063 · BMS-986374 · OZA · ozanimod HCl · OZANIMOD HYDROCHLORIDE · RPC-1063 HCL · RPC-1063 HYDROCHLORIDE · Zeposia · +1 more
Small molecule targets S1PR1, S1PR5
Regulatory milestones approvals, filings & regulatory actions · 4 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| 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 ↗ |
Trials 37 · a red edge is where a trial was stopped
| 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 | ||||||
| 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 |
| 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 | No outcome recorded |
| Phase 2/33 trials | ||||||
| Phase 2/3 | NCT05470985 | Aug 2023 → Sep 2024 | Crohn disease | Bristol-Myers Squibb | Terminated | No outcome recorded |
| 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 | No outcome recorded |
| Phase 313 trials | ||||||
| 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 |
| Phase 3 | NCT04140305 | Jan 2020 → May 2025 | multiple sclerosis | Celgene Corporation | Terminated | No outcome recorded |
| 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 |
| Phase 3 | NCT03464097 | Jun 2018 → Oct 2024 | Crohn disease | Celgene Corporation | Terminated | No outcome recorded |
| Phase 3 | NCT03440385 | Mar 2018 → Nov 2023 | Crohn disease | Celgene Corporation | Completed | No outcome recorded |
| Phase 3 | NCT03440372 | Feb 2018 → Oct 2024 | Crohn disease | Celgene Corporation | Terminated | No outcome recorded |
| 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 | No outcome recorded |
| Phase 3 | NCT02294058 | Dec 2014 → Dec 2016 | multiple sclerosis | Celgene Corporation | Completed | No outcome recorded |
| Phase 3 | NCT02047734 | Dec 2013 → Mar 2017 | relapsing-remitting multiple sclerosis | Celgene Corporation | Completed | No outcome recorded |
| Phase 47 trials | ||||||
| Phase 4 | NCT06188637 | Aug 2024 → Mar 2026 | ulcerative colitis | Geert D'Haens | Withdrawn | No outcome recorded |
| 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 |
| Phase 4 | NCT06396039 | May 2024 → Dec 2028 expected | multiple sclerosis | Bristol-Myers Squibb | Active not recruiting | No outcome recorded |
| 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 |
| Phase 4 | NCT03535298 | Jan 2019 → Jul 2027 expected | relapsing-remitting multiple sclerosis | The Cleveland Clinic | Active not recruiting | No outcome recorded |
Also used as a comparator or background therapy in 2 trials
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 11 trial | ||||||
| Phase 1 | NCT05001152 Background | Sep 2021 | — | Bristol-Myers Squibb | Completed | No outcome recorded |
| Phase 21 trial | ||||||
| Phase 2 | NCT06715605 Comparator | Apr 2025 | multiple sclerosis | University Hospital, Antwerp | Withdrawn | No outcome recorded |
Evidence & citations 15 cited values
Every value below carries the sentence it was read from. 42 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 | BMS-986374 | ClinicalTrials.gov intervention name — accepted as the source's own label NCT06396039 ↗ |
| 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 NCT02531126 ↗ |
| 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 ↗ |