| Drug ID: | Drug134 |
|---|---|
| Drug Name: | Etrasimod |
| CID: | 44623998 |
| DrugBank ID: | DB14766 |
| Modality: | Small Molecule |
| Groups: | NULL |
| US Approved: | YES |
| Other Approved: | YES |
| Identifier: | NCT03139032, , NCT06294925, , NCT03950232, , NCT05061446, , NCT04607837, , NCT05287126, , NCT03996369, , NCT06398626, , NCT03945188, , NCT02447302, , NCT04706793, , NCT02536404, , NCT06025227, , NCT04176588 |
| Molecular Formula: | C26H26F3NO3 |
| Molecular Weight: | 457.5 g/mol |
| Isomeric SMILES: | C1CCC(C1)C2=C(C=C(C=C2)COC3=CC4=C(C=C3)NC5=C4CC[C@@H]5CC(=O)O)C(F)(F)F |
| Synonyms: | Etrasimod; 1206123-37-6; APD334; APD-334; Etrasimod [USAN]; etrasimodum; Etrasimod (USAN); Velsipity; 6WH8495MMH; APD-334(FREE ACID) |
| Phase 0: | 0 |
| Phase 1: | 6 |
| Phase 2: | 17 |
| Phase 3: | 8 |
| Phase 4: | 0 |
| Description: | NULL |
Molecular Structure
Knowledge Graph
| dtID | CID | Compound Name | Gene ID | Gene Name | Species | PubMed IDs | Action |
|---|---|---|---|---|---|---|---|
| dt1076 | 44623998 | Etrasimod | 278 | AMY1C | Homo sapiens (human) | Agonist | |
| dt1077 | 44623998 | Etrasimod | 279 | AMY2A | Homo sapiens (human) | Agonist | |
| dt1078 | 44623998 | Etrasimod | 1901 | S1PR1 | Homo sapiens (human) | 25516790 | Sphingosine 1-phosphate receptor edg-1 agonist |
| dt1079 | 44623998 | Etrasimod | 1901 | S1PR1 | Homo sapiens (human) | Agonist | |
| dt1080 | 44623998 | Etrasimod | 275 | AMT | Homo sapiens (human) | Agonist | |
| dt1081 | 44623998 | Etrasimod | 1559 | CYP2C9 | Homo sapiens (human) | None | |
| dt1082 | 44623998 | Etrasimod | 1901 | S1PR1 | Homo sapiens (human) | None | |
| dt1083 | 44623998 | Etrasimod | 53637 | S1PR5 | Homo sapiens (human) | 25516790 | Agonist |
| dt1084 | 44623998 | Etrasimod | 8698 | S1PR4 | Homo sapiens (human) | Agonist |
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 | |
|---|---|---|---|---|---|---|---|
| NCT03996369 | Etrasimod Versus Placebo as Induction Therapy in Moderately to Severely Active Ulcerative Colitis | PHASE3 | COMPLETED | Arena Pharmaceuticals | Ulcerative Colitis | DRUG: Etrasimod|DRUG: Placebo | Details |
| NCT06398626 | An Observational Study of Etrasimod in Adult Patients With Moderate to Severe Ulcerative Colitis | None | RECRUITING | Pfizer | Colitis, Ulcerative | DRUG: Etrasimod | Details |
| NCT03945188 | Etrasimod Versus Placebo for the Treatment of Moderately to Severely Active Ulcerative Colitis | PHASE3 | COMPLETED | Arena Pharmaceuticals | Ulcerative Colitis | DRUG: Etrasimod|DRUG: Placebo | Details |
| NCT02447302 | Safety and Efficacy of Etrasimod (APD334) in Patients With Ulcerative Colitis | PHASE2 | COMPLETED | Arena Pharmaceuticals | Ulcerative Colitis | DRUG: Etrasimod|DRUG: Placebo | Details |
| NCT04706793 | Oral Etrasimod Versus Placebo for the Treatment of Moderately to Severely Active Ulcerative Colitis in Adult Japanese Participants (ELEVATE UC 40 JAPAN) | PHASE3 | COMPLETED | Pfizer | Ulcerative Colitis | DRUG: Etrasimod|DRUG: Placebo | Details |
| NCT03139032 | Efficacy and Safety of Etrasimod (APD334) in Inflammatory Bowel Disease Patients With Active Skin Extra-intestinal Manifestations | PHASE2 | TERMINATED | Arena Pharmaceuticals | Inflammatory Bowel Diseases|Skin Extra-intestinal… | DRUG: APD334 | Details |
| NCT02536404 | Extension Study of APD334-003 in Patients With Moderately to Severely Active Ulcerative Colitis | PHASE2 | COMPLETED | Arena Pharmaceuticals | Ulcerative Colitis | DRUG: Etrasimod|DRUG: Placebo | Details |
| NCT06025227 | Provide Pre-approval Single Patient Expanded Access (Compassionate Use) of Etrasimod for Patients. | None | AVAILABLE | Pfizer | Colitis, Ulcerative | DRUG: Etrasimod | Details |
| NCT04176588 | A Phase 3 Study of Etrasimod in Subjects With Moderately to Severely Active Ulcerative Colitis | PHASE3 | ACTIVE_NOT_RECRUITING | Everstar Therapeutics Limited | Moderately to Severely Active Ulcerative Colitis | DRUG: Etrasimod|DRUG: Placebo | Details |
| EUCTR2016-003797-40-BE | A Phase 2a, Proof of Concept, Open-label Study Evaluating the Efficacy and Safety of Etrasimod (APD334) in Inflammatory Bowel Disease Patients with active Skin Extra-intestinal Manifestations | PHASE2 | Not Recruiting | Arena Pharmaceuticals, Inc. | Active Skin Extra-Intestinal Manifestations in In… | Product Name: APD334 Pharmaceutical Form: Tablet … | Details |
| NCT06294925 | A Study to Learn About the Effectiveness of Etrasimod in People With Ulcerative Colitis | None | RECRUITING | Pfizer | Colitis, Ulcerative | DRUG: Etrasimod | Details |
| NCT03950232 | An Extension Study for Treatment of Moderately to Severely Active Ulcerative Colitis | PHASE3 | ACTIVE_NOT_RECRUITING | Pfizer | Ulcerative Colitis | DRUG: Etrasimod | Details |
| NCT05061446 | Etrasimod Dose-Ranging Versus Placebo as Induction Therapy Study in Adult Japanese Subjects With Moderately to Severely Active Ulcerative Colitis | PHASE2 | COMPLETED | Pfizer | Ulcerative Colitis | DRUG: Etrasimod|DRUG: Etrasimod|DRUG: Placebo | Details |
| NCT04607837 | Etrasimod Versus Placebo for the Treatment of Moderately Active Ulcerative Colitis | PHASE2 | COMPLETED | Pfizer | Ulcerative Colitis | DRUG: Etrasimod|DRUG: Placebo | Details |
| NCT05287126 | A Study to Evaluate Etrasimod Treatment in Adolescents With Ulcerative Colitis | PHASE2 | RECRUITING | Pfizer | Ulcerative Colitis | DRUG: Etrasimod | Details |
| EUCTR2015-002109-12-GB | An Extension Study of APD334-003 in Patients with Moderately to Severely Active Ulcerative Colitis | PHASE2 | Not Recruiting | Arena Pharmaceuticals, Inc. | Ulcerative colitis _ MedDRA versi… | Product Name: APD334 Pharmaceutic… | Details |
| EUCTR2015-002109-12-LV | An Extension Study of APD334-003 in Patients with Moderately to Severely Active Ulcerative Colitis | PHASE2 | Not Recruiting | Arena Pharmaceuticals, Inc. | Ulcerative colitis MedDRA version: 19.0_Level: L… | Product Name: APD334 Pharmaceutical Form: Film-co… | Details |
| EUCTR2015-001942-28-CZ | A Phase 2, Randomized, Double-Blind, Placebo-Controlled, Parallel Group, Multi-Center Study to Investigate the Safety and Efficacy of APD334 in Patients with Moderately to Severely Active Ulcerative Colitis | PHASE2 | Not Recruiting | Arena Pharmaceuticals, Inc. | Ulcerative colitis MedDRA version: 19.0_Level: L… | Product Code: APD334 Pharmaceutical Form: Capsule… | Details |
| Disease ID | Disease Name | Definition | Category | Related Drugs | Mechanism | |
|---|---|---|---|---|---|---|
| No data available | ||||||
| Strategy ID | Therapeutic Strategy | Synonyms | Related Drugs | Mechanism | |
|---|---|---|---|---|---|
| No data available | |||||
Etrasimod as induction and maintenance therapy for ulcerative colitis (ELEVATE)…
PMID: 36871574
Year: 2023
Relationship Type:
Treatment
Score: 6.5
BACKGROUND: Etrasimod, a once-daily, oral, sphingosine 1-phosphate (S1P) receptor modulator that selectively activates S1P receptor subtypes 1, 4, an…
Etrasimod for the treatment of ulcerative colitis
PMID: 36789612
Year: 2023
Relationship Type:
Treatment
Score: 6.5
Sphingosine-1-phosphate (S1P) and its receptor (S1PR) are involved in the pathogenesis of multiple immune-mediated inflammatory disorders, including …
Long-term Safety and Efficacy of Etrasimod for Ulcerative Colitis: Results from…
PMID: 33475734
Year: 2021
Relationship Type:
Treatment
Score: 6.5
BACKGROUND AND AIMS: Etrasimod is an oral, selective, sphingosine 1-phosphate receptor modulator. In a phase 2, randomised, double-blind, placebo-con…