| Drug ID: | Drug139 |
|---|---|
| Drug Name: | Ozanimod |
| CID: | 52938427 |
| DrugBank ID: | DB12612 |
| Modality: | Small Molecule |
| Groups: | NULL |
| US Approved: | YES |
| Other Approved: | YES |
| Identifier: | NCT05702879, , NCT05382715, , NCT05369832, , NCT03915769, , NCT05076175, , NCT06126835, , NCT06073873, , NCT01647516, , NCT05644665, , NCT05809583, , NCT06188637, , NCT02435992, , NCT02531126, , NCT02531113 |
| Molecular Formula: | C23H24N4O3 |
| Molecular Weight: | 404.5 g/mol |
| Isomeric SMILES: | CC(C)OC1=C(C=C(C=C1)C2=NC(=NO2)C3=C4CC[C@@H](C4=CC=C3)NCCO)C#N |
| Synonyms: | Ozanimod; 1306760-87-1; RPC1063; RPC-1063; Z80293URPV; Benzonitrile, 5-[3-[(1S)-2,3-dihydro-1-[(2-hydroxyethyl)amino]-1H-inden-4-yl]-1,2,4-oxadiazol-5-yl]-2-(1-methylethoxy)-; RPC 1063; UNII-Z80293URPV; Benzonitrile, 5-(3-((1S)-2,3-dihydro-1-((2-hydroxyethyl)amino)-1H-inden-4-yl)-1,2,4-oxadiazol-5-yl)-2-(1-methylethoxy)-; Ozanimodum |
| Phase 0: | 0 |
| Phase 1: | 12 |
| Phase 2: | 7 |
| Phase 3: | 16 |
| Phase 4: | 7 |
| Description: | NULL |
Molecular Structure
Knowledge Graph
| dtID | CID | Compound Name | Gene ID | Gene Name | Species | PubMed IDs | Action |
|---|---|---|---|---|---|---|---|
| dt1103 | 52938427 | Ozanimod | 276 | AMY1A | Homo sapiens (human) | Agonist | |
| dt1104 | 52938427 | Ozanimod | 1901 | S1PR1 | Homo sapiens (human) | Agonist | |
| dt1105 | 52938427 | Ozanimod | 53637 | S1PR5 | Homo sapiens (human) | Agonist | |
| dt1106 | 52938427 | Ozanimod | 224 | ALDH3A2 | Homo sapiens (human) | Substrate | |
| dt1107 | 52938427 | Ozanimod | 128 | ADH5 | Homo sapiens (human) | Substrate | |
| dt1108 | 52938427 | Ozanimod | 10 | NAT2 | Homo sapiens (human) | Substrate | |
| dt1109 | 52938427 | Ozanimod | 1558 | CYP2C8 | Homo sapiens (human) | Substrate | |
| dt1110 | 52938427 | Ozanimod | 4129 | MAOB | Homo sapiens (human) | Substrate | |
| dt1111 | 52938427 | Ozanimod | 1645 | AKR1C1 | Homo sapiens (human) | Substrate | |
| dt1112 | 52938427 | Ozanimod | 1646 | AKR1C2 | Homo sapiens (human) | Substrate |
- No data available
Phase Distribution
Phase Description
- Phase 0: Exploratory trials to assess drug behavior in humans
- Phase 1: Safety trials to determine safe dosage range
- Phase 2: Efficacy trials to evaluate therapeutic effects
- Phase 3: Large-scale trials to confirm efficacy and safety
- Phase 4: Post-marketing surveillance for long-term safety and efficacy
| Trial ID | Title | Phase | Status | Sponsor | Indications | Interventions | |
|---|---|---|---|---|---|---|---|
| NCT06188637 | Ulcerative Colitis Leukocyte TRAfficking After Treatment With Zeposia: the ULTRAZ Study | PHASE4 | WITHDRAWN | Geert D'Haens | Ulcerative Colitis | DRUG: Ozanimod Oral Capsule | Details |
| NCT05076175 | A Study Investigating Oral Ozanimod (RPC1063) in Pediatric Participants With Moderate to Severe Active Ulcerative Colitis | PHASE2|PHASE3 | RECRUITING | Bristol-Myers Squibb | Colitis, Ulcerative | DRUG: Ozanimod | Details |
| NCT06126835 | A Study to Evaluate the Safety of Ozanimod Exposure During Pregnancy in Women With Ulcerative Colitis and Their Infants | None | ACTIVE_NOT_RECRUITING | Bristol-Myers Squibb | Ulcerative Colitis | DRUG: Ozanimod|DRUG: Conventional therapy|DRUG: A… | Details |
| NCT06073873 | A Post-Marketing Surveillance Study to Assess Safety of Ozanimod in Patients With Moderate to Severe Active UC in Korea | None | RECRUITING | Bristol-Myers Squibb | Ulcerative Colitis | DRUG: Ozanimod | Details |
| NCT01647516 | Efficacy and Safety Study of Ozanimod in Ulcerative Colitis | PHASE2 | COMPLETED | Celgene | Ulcerative Colitis | DRUG: Ozanimod|DRUG: Placebo | Details |
| NCT05644665 | A Study to Evaluate Efficacy and Long-term Safety of Oral Ozanimod in Chinese Participants With Moderately to Severely Active Ulcerative Colitis (UC) | PHASE3 | TERMINATED | Bristol-Myers Squibb | Ulcerative Colitis | DRUG: Ozanimod|DRUG: Placebo | Details |
| NCT05809583 | Define Predictors of Response to Ozanimod in UC Discovering Biomarkers in the Management of Ulcerative Colitis | None | UNKNOWN | Beth Israel Deaconess Medical Center | Ulcerative Colitis | DRUG: Ozanimod | Details |
| EUCTR2016-003073-18-GB | A Phase I, Single-Centre, Single Dose Oral Excretion Balance Study of [14C]-RPC1063 in Healthy Male Adults - ADME study of [14C]-RPC1063 in healthy male subjects (QCL117686) | PHASE1 | Not Recruiting | Celgene International II S鈭氣€爎l | The drug is a potential treatment for adult patie… | Product Name: [14C]-RPC1063 Solution (0.1 mg/mL) … | Details |
| NCT05702879 | Combined Microbiota and Metabolic Signature in Ulcerative Colitis Predicts Anti-Inflammatory Therapy Success | None | RECRUITING | Insel Gruppe AG, University Hospital Bern | Ulcerative Colitis | DRUG: Ozanimod|DRUG: TNF Inhibitor|DRUG: Steroids… | Details |
| NCT05953402 | A Study of Ozanimod in Pregnant Women With Ulcerative Colitis and Their Offspring | None | NOT_YET_RECRUITING | Bristol-Myers Squibb | Ulcerative Colitis | None | Details |
| NCT05382715 | A Study to Evaluate the Utilization, Effectiveness, and Quality of Life of Ozanimod in Participants With Ulcerative Colitis | None | RECRUITING | Bristol-Myers Squibb | Colitis, Ulcerative | DRUG: Ozanimod | Details |
| NCT05369832 | An Open-label Study of Ozanimod in Moderate to Severe Ulcerative Colitis in Clinical Practice | PHASE4 | ACTIVE_NOT_RECRUITING | Bristol-Myers Squibb | Colitis, Ulcerative | DRUG: Ozanimod | Details |
| NCT06311123 | Understanding Ozanimod's MOA Via Mass Cytometry in Ulcerative Colitis | None | RECRUITING | University of California, San Diego | Ulcerative Colitis|Ulcerative Colitis Chronic Mod… | None | Details |
| NCT03915769 | To Evaluate Efficacy and Long-term Safety of Ozanimod in Japanese Subjects With Moderately to Severely Active Ulcerative Colitis | PHASE3 | ACTIVE_NOT_RECRUITING | Celgene | Colitis, Ulcerative | DRUG: Ozanimod|OTHER: Placebo | Details |
| NCT02435992 | Safety and Efficacy Trial of RPC1063 for Moderate to Severe Ulcerative Colitis | PHASE3 | COMPLETED | Celgene | Ulcerative Colitis | DRUG: RPC1063|DRUG: Placebo | Details |
| NCT02531126 | An Extension Study of RPC1063 as Therapy for Moderate to Severe Ulcerative Colitis | PHASE3 | COMPLETED | Celgene | Ulcerative Colitis | DRUG: RPC1063 | Details |
| NCT02531113 | Efficacy and Safety Trial of RPC1063 for Moderate to Severe Crohn's Disease | PHASE2 | COMPLETED | Celgene | Crohn's Disease | DRUG: RPC1063 | Details |
| NCT04624230 | Evaluation of Oral Tofacitinib in Children Aged 2 to 17 Years Old Suffering From Moderate to Severe Ulcerative Colitis | PHASE3 | RECRUITING | Pfizer | Ulcerative Colitis | DRUG: tofacitinib | Details |
| NCT06651281 | Extension Study of Long-term Safety and Efficacy of Tulisokibart in Participants With Crohn's Disease or Ulcerative Colitis (MK-7240-011) | PHASE3 | RECRUITING | Merck Sharp & Dohme LLC | Crohn Disease|Colitis, Ulcerative | DRUG: Tulisokibart|DRUG: Placebo to tulisokibart | Details |
| NCT04985968 | The Efficacy and Safety of Cobitolimod in Participants With Moderate to Severe Active Left-Sided Ulcerative Colitis | PHASE3 | TERMINATED | InDex Pharmaceuticals | Ulcerative Colitis | DRUG: Cobitolimod 250 mg|DRUG: Cobitolimod 500 mg… | Details |
| Disease ID | Disease Name | Definition | Category | Related Drugs | Mechanism | |
|---|---|---|---|---|---|---|
| No data available | ||||||
| Strategy ID | Therapeutic Strategy | Synonyms | Related Drugs | Mechanism | |
|---|---|---|---|---|---|
| S05 | Angiogenesis | cell proliferation; vascular permeability | ozanimod | The bioactive lipid S1P has been shown to activate NF-κB an… | Details |
| S07 | Blockade of cytokine | Cytokine signalling | apremilast; roflumilast; filgotinib; tofacitinib; ABT494; ABT-874; ustekinumab; isankizumab; LY-2525623; AMG139; MEDI2079; guselkumab | Various T-cell subsets, their differentiation pathways and … | Details |
Ozanimod (RPC1063) is a potent sphingosine-1-phosphate receptor-1 (S1P1 ) and r…
PMID: 26990079
Year: 2016
Relationship Type:
Treatment
Score: 9.3
BACKGROUND AND PURPOSE: Sphingosine1-phosphate (S1P) receptors mediate multiple events including lymphocyte trafficking, cardiac function, and endoth…
Ozanimod Induction and Maintenance Treatment for Ulcerative Colitis
PMID: 27144850
Year: 2016
Relationship Type:
Treatment
Score: 7.3
BACKGROUND: Ozanimod (RPC1063) is an oral agonist of the sphingosine-1-phosphate receptor subtypes 1 and 5 that induces peripheral lymphocyte sequest…
Matching-adjusted indirect comparisons of efficacy outcomes between etrasimod a…
PMID: 39989343
Year: 2025
Relationship Type:
Treatment
Score: 6.5
Aim: Etrasimod and ozanimod are selective sphingosine 1-phosphate receptor modulators targeting the S1P(1,4,5), and S1P(1,5) receptors, respectively,…
Impact of Prior Biologic Exposure on Ozanimod Efficacy and Safety in the Phase …
PMID: 39773524
Year: 2025
Relationship Type:
Treatment
Score: 6.5
INTRODUCTION: Patients with ulcerative colitis (UC) and prior biologic failure may have reduced or delayed efficacy with subsequent advanced therapie…
Comparative Effectiveness of Ozanimod and Vedolizumab as First-Line Advanced Th…
PMID: 39478367
Year: 2025
Relationship Type:
Treatment
Score: 6.5
INTRODUCTION: There is limited real-world evidence comparing the effectiveness of ozanimod to vedolizumab as first-line advanced therapies in patient…
Concomitant Administration of Ozanimod and Serotonergic Antidepressants in Pati…
PMID: 39018016
Year: 2025
Relationship Type:
Treatment
Score: 6.5
BACKGROUND: Ozanimod, approved for the treatment of moderately to severely active ulcerative colitis (UC) and relapsing multiple sclerosis (RMS), is …
Real World Clinical Effectiveness and Safety of Ozanimod in the Treatment of Ul…
PMID: 38087126
Year: 2024
Relationship Type:
Treatment
Score: 6.5
BACKGROUND: Ozanimod is a first-in-class Sphingosine-1-phosphate (S1P) receptor modulator approved for the treatment of moderately to severely active…
Cardiovascular Safety of Ozanimod in Patients With Ulcerative Colitis: True Nor…
PMID: 38040274
Year: 2024
Relationship Type:
Treatment
Score: 6.5
BACKGROUND & AIMS: Evaluating cardiovascular safety of sphingosine 1-phosphate (S1P) receptor modulators is warranted due to S1P receptor expression …
P031 Impact of Prior Biologic Exposure on Response to Ozanimod for Moderate-to-…
PMID: 37461950
Year: 2021
Relationship Type:
Treatment
Score: 6.5
BACKGROUND: Ozanimod, an oral sphingosine 1-phosphate (S1P) receptor modulator selectively targeting S1P1 and S1P5, demonstrated superior efficacy an…
Clinician's Guide to Using Ozanimod for the Treatment of Ulcerative Colitis
PMID: 37436357
Year: 2023
Relationship Type:
Treatment
Score: 6.5
The emergence of advanced therapies [eg, biologics, Janus kinase inhibitors] over the past few decades has revolutionised the treatment of ulcerative…
In vitro assessment of the binding and functional responses of ozanimod and its…
PMID: 36470447
Year: 2023
Relationship Type:
Treatment
Score: 6.5
Ozanimod is approved in multiple countries for the treatment of adults with either relapsing multiple sclerosis or moderately to severely active ulce…
Ozanimod as a novel oral small molecule therapy for the treatment of Crohn's di…
PMID: 36208720
Year: 2022
Relationship Type:
Treatment
Score: 6.5
BACKGROUND: Ozanimod, an oral sphingosine 1-phosphate receptor modulator currently approved for the treatment of moderately to severely active ulcera…
A Literature Review of Ozanimod Therapy in Inflammatory Bowel Disease: From Con…
PMID: 36106049
Year: 2022
Relationship Type:
Treatment
Score: 6.5
Inflammatory bowel disease (IBD), namely Ulcerative Colitis (UC) and Crohn's Disease (CD), is believed to be due to a dysregulation of the innate imm…
Ozanimod: A Review in Ulcerative Colitis
PMID: 35994200
Year: 2022
Relationship Type:
Treatment
Score: 6.5
Ozanimod (Zeposia((R))) is the first sphingosine-1-phosphate receptor (S1PR) modulator to be approved for the treatment of adults with moderately to …
Ozanimod Maintenance Therapy After Cyclosporine Induction in Acute Severe Ulcer…
PMID: 35919406
Year: 2022
Relationship Type:
Treatment
Score: 6.5
Ozanimod has recently received US Food and Drug Administration approval for moderate-to-severe ulcerative colitis. Treatment of acute severe colitis …
Update on ozanimod for ulcerative colitis
PMID: 35851870
Year: 2022
Relationship Type:
Treatment
Score: 6.5
Treating moderate to severe ulcerative colitis (UC) has been enriched by the increasing number of drugs available for this disease. However, failure …
An overview of ozanimod as a therapeutic option for adults with moderate-to-sev…
PMID: 35503955
Year: 2022
Relationship Type:
Treatment
Score: 6.5
INTRODUCTION: Ulcerative colitis (UC) is a chronic inflammatory condition of the gastrointestinal tract involving a dysregulated immune response. Sph…
A critical review of ozanimod for the treatment of adults with moderately to se…
PMID: 35400292
Year: 2022
Relationship Type:
Treatment
Score: 6.5
INTRODUCTION: Ozanimod is a sphingosine-1-phosphate (S1P) modulator that inhibits lymphocyte trafficking from lymph nodes to the circulation. It is a…
Ozanimod in the Treatment of Ulcerative Colitis: Initial Real-World Data From a…
PMID: 35381385
Year: 2023
Relationship Type:
Treatment
Score: 6.5
Ulcerative colitis (UC) is a chronic inflammatory condition affecting the colon and rectum. Long-term therapy is generally required to achieve and ma…
Ozanimod as Induction and Maintenance Therapy for Ulcerative Colitis
PMID: 34587385
Year: 2021
Relationship Type:
Treatment
Score: 6.5
BACKGROUND: Ozanimod, a selective sphingosine-1-phosphate receptor modulator, is under investigation for the treatment of inflammatory bowel disease.…