Drugs / Etrasimod
Regulatory milestones approvals, filings & regulatory actions · 3 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Filed ulcerative colitis 2 milestones | |||||
| Filed | EU (EMA) | — | ulcerative colitis | 2022-12-21 | “The European Medicines Agency (EMA) has also accepted the Marketing Authorization Application (MAA) for etrasimod in the same patient population” pfizer.com ↗ |
| Filed | US (FDA) | — | ulcerative colitis | 2022-12-21 | “FDA) has accepted for review a New Drug Application (NDA) for etrasimod for individuals living with moderately-to-severely active ulcerative colitis” pfizer.com ↗ |
| Approved Indication not stated 1 milestone | |||||
| Approved | EU (EMA) | Velsipity | — | 2024-02-16 | europa.eu ↗ |
Trials 24
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 13 trials | ||||||
| Phase 1 | NCT07153159 | Aug 2025 → Sep 2026 overdue | — | Pfizer | Recruiting | No outcome recorded |
| Phase 1 | NCT06140290 | Dec 2023 → Mar 2024 | — | Pfizer | Completed | No outcome recorded |
| Phase 1 | NCT05956002 | Sep 2023 → Jan 2024 | — | Pfizer | Completed | No outcome recorded |
| Phase 212 trials · 2 met primary · 3 missed | ||||||
| Phase 2 | NCT07470879 | May 2026 → Sep 2030 expected | ulcerative colitis | Pfizer | Recruiting | No outcome recorded |
| Phase 2 | NCT06521762 | Jan 2026 → Jan 2029 | — | Yale University | Withdrawn | No outcome recorded Stop: Enrollment |
| Phase 2 | NCT05287126 | Dec 2022 → Jun 2029 expected | ulcerative colitis | Pfizer | Recruiting | No outcome recorded |
| Phase 2 | NCT05061446 | Sep 2021 → Oct 2023 | ulcerative colitis | Pfizer | Completed | Met primary |
| Phase 2 | NCT04607837 | Apr 2021 → Jun 2024 | ulcerative colitis | Pfizer | Completed | Missed primary |
| Phase 2 | NCT04556734 | Jul 2020 → Jun 2023 | alopecia areata | Pfizer | Completed | Missed primary |
| Phase 2 | NCT04162769 | Oct 2019 → Sep 2020 | atopic eczema | Arena Pharmaceuticals | Completed | Missed primary |
| Phase 2 | NCT03155932 | Dec 2017 → Jan 2019 | primary biliary cholangitis | Arena Pharmaceuticals | Terminated | No outcome recorded Stop: Business |
| Phase 2 | NCT03139032 | Jul → Dec 2017 | inflammatory bowel disease | Arena Pharmaceuticals | Terminated | No outcome recorded Stop: Business |
| Phase 2 | NCT03072953 | Jun 2017 → May 2018 | pyoderma gangrenosum | Arena Pharmaceuticals | Terminated | No outcome recorded Stop: Business |
| Phase 2 | NCT02536404 | Jan 2016 → Nov 2018 | ulcerative colitis | Arena Pharmaceuticals | Completed | No outcome recorded |
| Phase 2 | NCT02447302 | Oct 2015 → Feb 2018 | ulcerative colitis | Arena Pharmaceuticals | Completed | Met primary |
| Phase 2/32 trials · 2 missed | ||||||
| Phase 2/3 | NCT05732454 | Jan 2023 → Apr 2024 | atopic eczema | Pfizer | Terminated | Missed primary |
| Phase 2/3 | NCT04173273 | Jan 2020 → Apr 2025 | Crohn disease | Pfizer | Terminated | Missed primary |
| Phase 35 trials · 3 met primary | ||||||
| Phase 3 | NCT04706793 | Dec 2020 → Aug 2022 | ulcerative colitis | Pfizer | Completed | No outcome recorded |
| Phase 3 | NCT03996369 | Sep 2020 → Dec 2021 | ulcerative colitis | Arena Pharmaceuticals | Completed | Met primary |
| Phase 3 | NCT04176588 | Sep 2019 → Jul 2024 | ulcerative colitis | Everstar Therapeutics Limited | Unknown | Met primary |
| Phase 3 | NCT03950232 | Sep 2019 → Jun 2029 expected | ulcerative colitis | Pfizer | Active not recruiting | No outcome recorded |
| Phase 3 | NCT03945188 | Jun 2019 → Feb 2022 | ulcerative colitis | Arena Pharmaceuticals | Completed | Met primary |
| Phase not applicable1 trial | ||||||
| — | NCT07243639 | Oct 2025 → Sep 2026 overdue | ulcerative colitis | Showa Inan General Hospital | Recruiting | No outcome recorded |
| Phase not stated1 trial | ||||||
| — | NCT06025227 | — | ulcerative colitis | Pfizer | Available | No outcome recorded |
| Comparator or background therapy2 trials | ||||||
| Phase 2 | NCT07486921 Comparator | Jun 2026 → Feb 2030 expected | pouchitis | Maia Kayal | Recruiting | No outcome recorded |
| Phase 2 | NCT04682639 Comparator | Dec 2020 → Sep 2022 | eosinophilic esophagitis | Pfizer | Completed | No outcome recorded |
News releases announcing trial results or a regulatory action · 6
| Date | Issuer | Release |
|---|---|---|
| 2024-02-19 | Pfizer | Regulatory European Commission Approves Pfizer’s VELSIPITY® for Patients with Moderately to Severely Active Ulcerative Colitis pfizer.com ↗
Pfizer Inc. (NYSE: PFE) announced today that the European Commission (EC) has granted marketing authorization for VELSIPITY ® (etrasimod) in the European Union to treat patients 16 years of age and older with moderately to severely active ulcerative colitis (UC) |
| 2023-10-13 | Pfizer | Regulatory U.S. FDA Approves Pfizer’s VELSIPITY™ for Adults with Moderately to Severely Active Ulcerative Colitis (UC) pfizer.com ↗
Pfizer Inc. (NYSE: PFE) announced today that the U.S. Food and Drug Administration (FDA) has approved VELSIPITY™ (etrasimod), an oral, once-daily, selective sphingosine-1-phosphate (S1P) receptor modulator for adults with moderately to severely active ulcerative colitis (UC). |
| 2022-12-21 | Pfizer | Regulatory Pfizer Announces FDA and EMA Acceptance of Etrasimod Regulatory Submissions for Ulcerative Colitis pfizer.com ↗ |
| 2022-05-24 | Pfizer | Results Pfizer Presents ELEVATE Pivotal Findings Demonstrating Etrasimod’s Potentially Best-in-Class Profile in Ulcerative Colitis pfizer.com ↗
Pfizer Inc. (NYSE: PFE) today announced detailed results from two pivotal studies that make up the ELEVATE UC Phase 3 registrational program evaluating etrasimod, a once-daily, oral, selective sphingosine 1-phosphate (S1P) receptor modulator for the treatment of moderately-to-severely active ulcerative colitis (UC). |
| 2022-03-29 | Pfizer | Results Pfizer Announces Positive Top-line Results from Yearlong Phase 3 Trial of Etrasimod in Ulcerative Colitis, Underscoring Best-in-Class Potential pfizer.com ↗
In this 52-week study, also known as ELEVATE UC 52, etrasimod patients achieved statistically significant improvements in the co-primary endpoints of clinical remission at weeks 12 and 52 when compared to placebo. |
| 2022-03-23 | Pfizer | Results Pfizer Announces Positive Top-Line Results for Phase 3 Trial of Etrasimod in Ulcerative Colitis Patients pfizer.com ↗
In the study, etrasimod patients achieved statistically significant improvements in the primary endpoint of clinical remission at week 12 as compared with placebo. |
All press releases naming this drug 6 releases
Evidence & citations 10 cited values
Every value below carries the sentence it was read from. 28 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | Etrasimod | “A Study to Evaluate the Study Medication (Etrasimod) When Mixed With Food in Healthy Participants” NCT05956002 ↗ |
| Known as | APD-334(FREE ACID) | ChEMBL registry synonym — accepted as the source's own label CHEMBL3358920 ↗ |
| Known as | APD334 | ClinicalTrials.gov intervention name — accepted as the source's own label NCT03139032 ↗ |
| Known as | PF-07915503 | “A PHASE 1, OPEN-LABEL, RANDOMIZED, SINGLE DOSE, CROSSOVER STUDY TO ESTIMATE THE RELATIVE BIOAVAILABILITY OF ETRASIMOD (PF-07915503) MINI TABLETS IN WATER AND 3 FOOD VEHICLES...” NCT05956002 ↗ |
| Action | Activate | “Etrasimod, a once-daily, oral, sphingosine 1-phosphate (S1P) receptor modulator that selectively activates S1P receptor subtypes 1, 4, and 5, with no detectable activity on...” PMID 36871574 ↗ Mar 20231“Sphingosine 1-phosphate receptor Edg-1 agonist” CHEMBL3358920 ↗ |
| Modality | Small molecule | — CHEMBL3358920 ↗ |
| Route | Oral | “Oral, low dose, daily for 12 Weeks” NCT02447302 ↗ |
| Target | S1PR1 | “Sphingosine 1-phosphate receptor Edg-1 agonist” CHEMBL3358920 ↗ |
| Target | S1PR4 | “Sphingosine 1-phosphate receptor Edg-6 modulator” CHEMBL3358920 ↗ |
| Target | S1PR5 | “Sphingosine 1-phosphate receptor Edg-8 modulator” CHEMBL3358920 ↗ |