| 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: A First-in-Class Sphingosine 1-Phosphate Receptor Modulator for the T…
PMID: 34423657
Year: 2022
Relationship Type:
Treatment
Score: 6.5
OBJECTIVE: To review the pharmacological and clinical profile of ozanimod in the treatment of ulcerative colitis (UC). DATA SOURCES: A PubMed search …
An Overview of the Efficacy and Safety of Ozanimod for the Treatment of Relapsi…
PMID: 34007159
Year: 2021
Relationship Type:
Treatment
Score: 6.5
Multiple sclerosis (MS) is a complex disease of the central nervous system that can cause permanent disability in young adults. A large armamentarium…
Long-Term Efficacy and Safety of Ozanimod in Moderately to Severely Active Ulce…
PMID: 33438008
Year: 2021
Relationship Type:
Treatment
Score: 6.5
BACKGROUND AND AIMS: This analysis examined the long-term safety and efficacy of ozanimod in patients with moderately to severely active ulcerative c…
Ozanimod induction therapy for patients with moderate to severe Crohn's disease…
PMID: 32553149
Year: 2020
Relationship Type:
Treatment
Score: 6.5
BACKGROUND: Although treatment of Crohn's disease has improved with development of tumour necrosis factor antagonists, fewer than 50% of patients hav…
Cardiac Safety of Ozanimod, a Novel Sphingosine-1-Phosphate Receptor Modulator:…
PMID: 28783871
Year: 2018
Relationship Type:
Association
Score: 6.3
Ozanimod is a novel, selective, oral sphingosine-1-phosphate (1 and 5) receptor modulator in development for multiple sclerosis and inflammatory bowe…