Clinical Trials

Numerous clinical trials evaluate the therapeutic profile of etrasimod across autoimmune and inflammatory conditions, including ulcerative colitis, Crohn's disease, primary biliary cholangitis, and atopic dermatitis. Spanning Phase 1 through Phase 4 development, these studies assess efficacy, safety, and pharmacokinetics in pediatric and adult populations, with recruitment statuses ranging from completed and recruiting to active not recruiting and terminated. Sponsored by pharmaceutical companies such as Pfizer and Arena Pharmaceuticals alongside medical institutions like Tang-Du Hospital and Sir Run Run Shaw Hospital, key research centers on Phase 2 and Phase 3 evaluations.

NCT Number Recruitment Conditions Sponsor/Collaborators Start Date Phases
NCT07470879 RECRUITING
Colitis, Ulcerative
Pfizer
 2026-05-28 PHASE2
NCT07486921 RECRUITING
Pouchitis
Maia Kayal
 2026-06-12 PHASE2
NCT03950232 ACTIVE_NOT_RECRUITING
Ulcerative Colitis
Pfizer
 2019-09-05 PHASE3
NCT05287126 RECRUITING
Ulcerative Colitis
Pfizer
 2022-12-16 PHASE2
NCT06521762 WITHDRAWN
Immune Checkpoint Inhibitor-Related Diarrhea and Colitis
Yale University
 2026-01 PHASE2
NCT07768254 NOT_YET_RECRUITING
Colitis, Ulcerative
Helixon Biotechnology (Suzhou) Co., Ltd
 2026-09-09 PHASE1
NCT07243639 RECRUITING
Ulcerative Colitis (Disorder)
Showa Inan General Hospital
 2025-10-01
NCT07782242 NOT_YET_RECRUITING
Etrasimod; Mesalazine; Ulcerative Colitis (UC); Head-to-head
Sir Run Run Shaw Hospital
 2026-07-31 PHASE4
NCT07153159 RECRUITING
Healthy Participant
Pfizer
 2025-08-07 PHASE1
NCT04173273 TERMINATED
Crohn's Disease
Pfizer
 2020-01-06 PHASE2; PHASE3
NCT04176588 UNKNOWN
Moderately to Severely Active Ulcerative Colitis
Everstar Therapeutics Limited
 2019-09-10 PHASE3
NCT04607837 COMPLETED
Ulcerative Colitis
Pfizer
 2021-04-12 PHASE2
NCT05732454 TERMINATED
Atopic Dermatitis; Atopic Dermatitis, Unspecified; Eczema; Eczema, Atopic
Pfizer
 2023-01-18 PHASE2; PHASE3
NCT06140290 COMPLETED
Healthy Participants
Pfizer
 2023-12-20 PHASE1
NCT05956002 COMPLETED
Healthy Participants
Pfizer
 2023-09-04 PHASE1
NCT05061446 COMPLETED
Ulcerative Colitis
Pfizer
 2021-09-10 PHASE2
NCT04556734 COMPLETED
Alopecia Areata
Pfizer
 2020-07-29 PHASE2
NCT05287126 Recruiting
Ulcerative Colitis
Pfizer|Arena is a wholly owned subsidiary of Pfizer
 2022-12-16 Phase 2
NCT04682639 COMPLETED
Eosinophilic Esophagitis
Pfizer
 2020-12-15 PHASE2
NCT04706793 COMPLETED
Ulcerative Colitis
Pfizer
 2020-12-25 PHASE3
NCT03945188 COMPLETED
Ulcerative Colitis
Arena Pharmaceuticals
 2019-06-13 PHASE3
NCT03996369 COMPLETED
Ulcerative Colitis
Arena Pharmaceuticals
 2020-09-15 PHASE3
NCT04706793 Completed
Ulcerative Colitis
Pfizer|Arena is a wholly owned subsidiary of Pfizer
 2020-12-25 Phase 3
NCT04162769 COMPLETED
Atopic Dermatitis
Arena Pharmaceuticals
 2019-10-04 PHASE2
NCT03155932 TERMINATED
Primary Biliary Cholangitis
Arena Pharmaceuticals
 2017-12-29 PHASE2
NCT02536404 COMPLETED
Ulcerative Colitis
Arena Pharmaceuticals
 2016-01-25 PHASE2
NCT03072953 TERMINATED
Pyoderma Gangrenosum
Arena Pharmaceuticals
 2017-06-07 PHASE2
NCT02447302 COMPLETED
Ulcerative Colitis
Arena Pharmaceuticals
 2015-10-15 PHASE2
NCT03139032 TERMINATED
Inflammatory Bowel Diseases; Skin Extra-intestinal Manifestations
Arena Pharmaceuticals
 2017-07-17 PHASE2
NCT03155932 Terminated
Primary Biliary Cholangitis
Arena Pharmaceuticals
 2017-12-29 Phase 2
NCT02536404 Completed
Ulcerative Colitis
Arena Pharmaceuticals
 2016-01-25 Phase 2

(data from https://clinicaltrials.gov, updated on 2026-08-24)

Check the Etrasimod(APD334) product page for in-depth specifications, including solubility, stock solutions, MOA, and working concentrations.

Compliance for Clinical Use

Mechanism and Biochemical Profile

Etrasimod functions as a potent, selective antagonist of the sphingosine-1-phosphate-1 (S1P1) receptor, binding to the receptor with an EC50 of 1.88 nM to inhibit downstream receptor-mediated signaling pathways. This receptor blockade prevents the egress of lymphocytes from secondary lymphoid tissues into the systemic circulation, thereby diminishing pathogenic immune cell infiltration and inflammatory tissue damage in clinical trial conditions such as ulcerative colitis and Crohn's disease.

Appendix RUO and cGMP Quality Standards

Quality Dimension RUO (Research Use Only) cGMP (Current Good Manufacturing Practice)
Clinical Applicability Prohibited in human clinical trials or medical diagnostics. Mandatory for human clinical trials (Phase I–III) and therapies.
Regulatory Status Non-regulated grade; exempt from drug manufacturing laws. Legally enforced by health authorities (e.g., FDA, EMA, NMPA).
Facility Environment Unclassified analytical or research laboratories. Validated Cleanrooms (ISO Class 5–8) with continuous monitoring.
Quality Control Basic purity and activity testing. Rigorous safety release testing (Sterility, Endotoxin, Mycoplasma).
Process Validation Basic equipment calibration; no process validation required. Full qualification (IQ/OQ/PQ) and complete batch records.
Quality Assurance Vendor self-declared without required formal QMS. Mandatory QA/QC unit, Change Control, CAPA, and vendor audits.
Regulatory Impact High risk of IND rejection if used as a critical raw material. Required for IND/NDA filings, supported by Drug Master Files (DMF).

Footnotes

Regulatory Note: Governed by FDA (21 CFR Parts 210/211/312), EMA (EudraLex Vol 4), ICH Guidelines (E6/Q7/Q9/Q10), and compendial standards (USP <71>/<85>/<1043>).

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Note: Technical data last updated: Sep 1, 2026.