Data updated: Jun 28, 2026
OZANIMOD · SYNTHON BV
Trial Activity: Declining 4 active trials
Immunology
Development Insights
Celgene conducting 18 trials (64%)
12 indications explored (Broad Platform)
→ healthy volunteers (6 trials)
→ crohn disease (5 trials)
→ colitis, ulcerative (3 trials)
Details
- Status
- None (Tentative Approval)
- First Approved
- N/A
- Routes
- N/A
- Dosage Forms
- CAPSULE
OZANIMOD Approval History
No approval records found
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Clinical Trial Registry
27 trials| Trial | Sponsor ID | Phase | Status | Title |
|---|---|---|---|---|
| NCT05076175 | IM047-001 2023-509248-86 | Ph 2, Ph 3 | recruiting | A Study Investigating Oral Ozanimod (RPC1063) in Pediatric Participants With Moderate to Severe Active Ulcerative Colitis |
| NCT06408259 | IM047-050 2022-501332-42, U1111-1281-5433 | Ph 3 | recruiting | Study to Evaluate the Effectiveness and Safety of Ozanimod Compared to Fingolimod in Children and Adolescents With Relapsing Remitting Multiple Sclerosis |
| NCT05369832 results posted | IM047-029 | Ph 4 | terminated | An Open-label Study of Ozanimod in Moderate to Severe Ulcerative Colitis in Clinical Practice |
| NCT03440372 results posted | RPC01-3201 U1111-1203-7225, 2017-004292-31 | Ph 3 | terminated | Induction Study #1 of Oral Ozanimod as Induction Therapy for Moderately to Severely Active Crohn's Disease |
| NCT03915769 | RPC01-3103 U1111-1230-3228 | Ph 3 | completed | To Evaluate Efficacy and Long-term Safety of Ozanimod in Japanese Subjects With Moderately to Severely Active Ulcerative Colitis |
| NCT03464097 results posted | RPC01-3203 U1111-1203-8002, 2023-510426-33 | Ph 3 | terminated | A Placebo-Controlled Study of Oral Ozanimod as Maintenance Therapy for Moderately to Severely Active Crohn's Disease |
| NCT06529406 COAST | 23-1686 | Ph 4 | recruiting | Prospective Evaluation of Sequencing From antiCD-20 Therapies to Ozanimod |
| NCT03467958 results posted | RPC01-3204 U1111-1203-8203, 2017-004295-55 | Ph 3 | terminated | An Extension Study of Oral Ozanimod for Moderately to Severely Active Crohn's Disease |
| NCT06862960 | 2024XHYG0025 | Ph 2 | not yet recruiting | Ozanimod in Patients With Alzheimer's Disease |
| NCT05470985 results posted | IM047-023 2021-005019-30 | Ph 2, Ph 3 | terminated | A Study to Evaluate the Efficacy, Safety, and Drug Levels of Oral Ozanimod in Pediatric Participants With Moderately to Severely Active Crohn's Disease With an Inadequate Response to Conventional Therapy |
| NCT05644665 | IM047-010 | Ph 3 | terminated | A Study to Evaluate Efficacy and Long-term Safety of Oral Ozanimod in Chinese Participants With Moderately to Severely Active Ulcerative Colitis (UC) |
| NCT03440385 results posted | RPC01-3202 U1111-1203-7949, 2017-004293-33 | Ph 3 | completed | Induction Study #2 of Oral Ozanimod as Induction Therapy for Moderately to Severely Active Crohn's Disease |
| NCT06334094 | IRB-23-486 IM047-1054 | Ph 4 | withdrawn | Assessing the Cognitive Benefits of Ozanimod and Their Brain-Biomarkers in MS |
| NCT04405102 COZI | 2021-3474 | Ph 2 | terminated | COVID-19 Ozanimod Intervention Study |
| NCT04978298 | RPC-1063-CP-005 | Ph 1 | completed | Study to Evaluate the Pressor Effect of Oral Tyramine During Ozanimod Treatment in Healthy Adult Participants |
| NCT05001152 | IM047-013 | Ph 1 | completed | Taste Assessment of Ozanimod |
| NCT04639115 | RPC-1063-CP-004 U1111-1257-6851 | Ph 1 | completed | A Phase 1, Multicenter, Open-Label Study to Evaluate the Effect of Mild or Moderate Hepatic Impairment on the Multiple-Dose Pharmacokinetics of Ozanimod |
| NCT04528290 | RPC-1063-CP-003 U1111-1256-5078 | Ph 1 | completed | A Study to Evaluate the Relative Bioavailability of a Pediatric Granule Formulation of Ozanimod in Healthy Adult Subjects |
| NCT01647516 Touchstone results posted | RPC01-202 | Ph 2 | completed | Efficacy and Safety Study of Ozanimod in Ulcerative Colitis |
| NCT04211558 | RPC-1063-CP-002 U1111-1244-6464 | Ph 1 | completed | A Study to Evaluate the Pharmacokinetics of Single Oral Doses of Ozanimod in Healthy Adult Chinese Subjects |
| NCT01628393 RADIANCE results posted | RPC01-201-PartA 2012-002714-40 | Ph 2, Ph 3 | completed | Efficacy and Safety Study of Ozanimod (RPC1063) in Relapsing Multiple Sclerosis Patients |
| NCT02047734 RADIANCE results posted | RPC01-201-PartB 2012-002714-40 | Ph 3 | completed | Efficacy and Safety Study of Ozanimod in Relapsing Multiple Sclerosis |
| NCT02294058 SUNBEAM results posted | RPC01-301 2014-002320-27 | Ph 3 | completed | Study of Ozanimod (RPC1063) in Relapsing Multiple Sclerosis (MS) |
| NCT04149678 | RPC-1063-CP-001 U1111-1239-1156 | Ph 1 | completed | Drug Interaction Study of the Effect on Cyclosporine on Ozanimod and Major Active Metabolites |
| NCT03694119 | RPC01-1913 U1111-1218-6630 | Ph 1 | completed | Drug-drug Interaction Study of Ozanimod With Tyramine to Evaluate the Effect on Pressor Response |
| NCT03644576 | RPC01-1914 U1111-1215-6267 | Ph 1 | completed | Drug-drug Interaction Study of Ozanimod With Pseudoephedrine to Evaluate the Effect on Blood Pressure and Heart Rate |
| NCT03624959 | RPC01-1912 U1111-1215-6965 | Ph 1 | completed | Drug-drug Interaction Study of Ozanimod With Inhibitor or Inducer of CYP2C8 and/or CYP3A |
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Pro Active Pipeline
Ongoing clinical trials by development phase
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Pro Key Completed Trials
Completed studies with published results, ranked by significance
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Trial Timeline
Full development history with FDA approval milestones
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Understanding FDA Approval Types
| Count | Type | What it means |
|---|---|---|
| - | ORIG | Original approval - drug first enters market |
| - | SUPPL - Efficacy | New indication (new disease/condition approved) |
| - | SUPPL - Labeling | Label text changes (warnings, dosing updates) |
| - | SUPPL - Manufacturing | Production changes (new facility) |
| - | SUPPL - Chemistry | Formulation changes (new dosage strength) |
Green lines in the timeline show ORIG and Efficacy approvals - the clinically meaningful milestones.
OZANIMOD FDA Label Details
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Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.
How We Calculate These Metrics
Trial Activity Stage
Measures the current development activity pattern based on trial phases, status, and trends. Important: This measures R&D activity, not commercial lifecycle.
Trial statuses: "Active" means recruiting or ongoing. "Completed" means reached planned endpoint. "Terminated" means stopped early—often due to safety, efficacy, or business reasons.
- Growth: High proportion of early-phase trials (Phase 1/2), active development
- Expansion: Significant Phase 3 activity, approaching or pursuing approvals
- Mature: Substantial Phase 4 post-marketing studies
- Stable: Mixed phase distribution, steady development
- Declining: Low active trial ratio, reduced R&D investment