| 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 | |||||
Efficacy and Safety of Etrasimod in a Phase 2 Randomized Trial of Patients With…
PMID: 31711921
Year: 2020
Relationship Type:
Adverse Effect
Score: 7.5
BACKGROUND & AIMS: Etrasimod (APD334) is an oral, selective sphingosine 1-phosphate receptor modulator in development for immune-mediated inflammator…
Efficacy of etrasimod in ulcerative colitis: analysis of ELEVATE UC 52 and ELEV…
PMID: 40618942
Year: 2025
Relationship Type:
Treatment
Score: 6.5
BACKGROUND AND AIMS: Etrasimod is an oral, once-daily, selective sphingosine 1-phosphate (S1P)(1,4,5) receptor modulator for the treatment of moderat…
Safety, tolerability, pharmacokinetics, and pharmacodynamics of etrasimod in he…
PMID: 40529495
Year: 2025
Relationship Type:
Treatment
Score: 6.5
OBJECTIVES: Etrasimod is an investigational, oral, once-daily, selective S1P(1,4,5) receptor modulator in development for the treatment of immune-med…
Etrasimod: Modulating Sphingosine-1-Phosphate Receptors to Treat Ulcerative Col…
PMID: 40507651
Year: 2025
Relationship Type:
Treatment
Score: 6.5
This review aimed to provide a comprehensive overview of the current landscape of etrasimod. Etrasimod is an oral, once-daily selective modulator of …
Etrasimod in Treatment of Ulcerative Colitis: A Comprehensive Review
PMID: 40501185
Year: 2025
Relationship Type:
Treatment
Score: 6.5
Ulcerative colitis (UC) is a chronic, inflammatory disease of the colon. The unpredictable, systemic, and debilitating nature of UC puts disease mana…
S1PR4-dependent effects of Etrasimod on primary human myeloid immune cell activ…
PMID: 40342995
Year: 2025
Relationship Type:
Treatment
Score: 6.5
BACKGROUND: Sphingosine-1-phosphate (S1P) and its five receptors S1PR1-5 play an essential role in the migration, differentiation and activation of v…
Efficacy and safety of etrasimod in Japanese patients with ulcerative colitis: …
PMID: 40275818
Year: 2025
Relationship Type:
Treatment
Score: 6.5
BACKGROUND/AIMS: Etrasimod is an oral, once-daily, selective sphingosine 1-phosphate1,4,5 receptor modulator for the treatment of moderately to sever…
Assessment and Impact of Age on the Safety and Efficacy of Etrasimod in Patient…
PMID: 40184206
Year: 2025
Relationship Type:
Treatment
Score: 6.5
BACKGROUND: Patient age can impact the safety and efficacy of ulcerative colitis (UC) treatments. Etrasimod is an oral, once daily (QD), selective sp…
Efficacy and Safety of Etrasimod in Patients With Moderately to Severely Active…
PMID: 40036804
Year: 2025
Relationship Type:
Treatment
Score: 6.5
BACKGROUND: Etrasimod is an oral, once daily, selective sphingosine 1-phosphate (S1P)1,4,5 receptor modulator for the treatment of moderately to seve…
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,…
Concomitant Use of Etrasimod With Opioids or Antidepressants in Patients With U…
PMID: 39891572
Year: 2025
Relationship Type:
Treatment
Score: 6.5
BACKGROUND: Etrasimod is an oral, once-daily (q.d.), selective sphingosine 1-phosphate (S1P)(1,4,5) receptor modulator for the treatment of moderatel…
Body Mass Index Did Not Affect Efficacy and Safety of Etrasimod: A Post Hoc Ana…
PMID: 39878434
Year: 2025
Relationship Type:
Treatment
Score: 6.5
INTRODUCTION: High body mass index (BMI) may reduce ulcerative colitis (UC) treatment efficacy. Etrasimod is an oral, once-daily (QD), selective sphi…
Etrasimod: Review of the efficacy and therapeutic prospects of a new oral thera…
PMID: 39855296
Year: 2025
Relationship Type:
Treatment
Score: 6.5
Etrasimod is a synthetic, non-biological, orally administered small molecule sphingosine-1-phosphate receptor (S1PR) modulator. Etrasimod was approve…
Cardiovascular events observed among patients in the etrasimod clinical program…
PMID: 39778975
Year: 2025
Relationship Type:
Treatment
Score: 6.5
OBJECTIVE: Etrasimod is an oral, once-daily, selective sphingosine 1-phosphate (S1P)(1,4,5) receptor modulator for the treatment of moderately to sev…
Low Incidence of Macular Edema and Other Ocular Events in the Etrasimod Develop…
PMID: 39575597
Year: 2025
Relationship Type:
Treatment
Score: 6.5
BACKGROUND AND AIMS: Sphingosine 1-phosphate receptor modulators have been associated with an increased risk of macular edema. Etrasimod is an oral, …
Health-Related Quality of Life Outcomes With Etrasimod Treatment in Patients Wi…
PMID: 39326009
Year: 2025
Relationship Type:
Treatment
Score: 6.5
BACKGROUND: Etrasimod is an oral, once-daily (QD), selective sphingosine 1-phosphate1,4,5 receptor modulator for the treatment of moderately to sever…
Etrasimod Corticosteroid-Free Efficacy, Impact of Concomitant Corticosteroids o…
PMID: 39306680
Year: 2025
Relationship Type:
Treatment
Score: 6.5
BACKGROUND: Etrasimod is an oral, once-daily, selective sphingosine 1-phosphate (S1P)1,4,5 receptor modulator for the treatment of moderately to seve…
The Effect of Etrasimod on Fecal Calprotectin and High-sensitivity C-reactive P…
PMID: 38899786
Year: 2025
Relationship Type:
Treatment
Score: 6.5
BACKGROUND: Biomarkers offer potential alternatives to endoscopies in monitoring ulcerative colitis (UC) progression and therapeutic response. This p…
Etrasimod (Velsipity) for ulcerative colitis
PMID: 37983118
Year: 2023
Relationship Type:
Association
Score: 6.5
In moderately to severely active UC, etrasimod increased remission at 12 and 52…
PMID: 37399559
Year: 2023
Relationship Type:
Treatment
Score: 6.5
Sandborn WJ, Vermeire S, Peyrin-Biroulet L, et al. Etrasimod as induction and maintenance therapy for ulcerative colitis (ELEVATE): two randomised, d…