Drugs / Arexvy
Arexvy
Regulatory milestones approvals, filings & regulatory actions · 1 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Approved | EU (EMA) | Arexvy | — | 2023-06-06 | europa.eu ↗ |
Trials 7 · a red edge is where a trial was stopped
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 1/21 trial | ||||||
| Phase 1/2 | NCT06686654 | Nov 2024 → Jan 2027 expected | respiratory syncytial virus infectious disease | Sanofi Pasteur, a Sanofi Company | Active not recruiting | No outcome recorded |
| Phase 22 trials | ||||||
| Phase 2 | NCT07050732 | Dec 2025 → Nov 2026 expected | respiratory syncytial virus infectious disease | Johns Hopkins University | Recruiting | No outcome recorded |
| Phase 2 | NCT06597916 | Sep 2024 → Aug 2025 overdue | respiratory syncytial virus infectious disease | Medical University of Vienna | Recruiting | No outcome recorded |
| Phase 31 trial | ||||||
| Phase 3 | NCT07203365 | Aug 2025 → May 2027 expected | respiratory syncytial virus bronchiolitis | Karin Karin Loré | Recruiting | No outcome recorded |
| Phase 42 trials | ||||||
| Phase 4 | NCT06077149 | Nov 2023 → Nov 2024 | respiratory syncytial virus infectious disease | University of Rochester | Completed | No outcome recorded |
| Phase 4 | NCT05170399 | Sep 2022 → Aug 2026 overdue | lymphoma | National Heart, Lung, and Blood Institute (NHLBI) | Recruiting | No outcome recorded |
| Phase not applicable1 trial | ||||||
| — | NCT06259487 | Sep 2023 → Jun 2024 | heart failure, influenza, respiratory syncytial virus infectious disease | Wroclaw Medical University | Unknown | No outcome recorded |
Also used as a comparator or background therapy in 6 trials
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 14 trials | ||||||
| Phase 1 | NCT06843317 Comparator | Mar 2025 → Mar 2026 overdue | respiratory syncytial virus infectious disease | Clover Biopharmaceuticals USA, LLC | Recruiting | No outcome recorded |
| Phase 1 | NCT06556147 Comparator | Aug 2024 → Feb 2025 overdue | — | Sanofi | Active not recruiting | No outcome recorded |
| Phase 1 | NCT06442241 Comparator | Jul 2024 → Dec 2025 overdue | respiratory syncytial virus infectious disease | Guangzhou Patronus Biotech Co., Ltd. | Active not recruiting | No outcome recorded |
| Phase 1 | NCT06194318 Comparator | Dec 2023 → Feb 2025 | respiratory syncytial virus infectious disease | Clover Biopharmaceuticals AUS Pty | Completed | No outcome recorded |
| Phase 21 trial | ||||||
| Phase 2 | NCT06481579 Comparator | Jun → Jul 2024 | — | Icosavax, Inc. | Completed | No outcome recorded |
| Phase 41 trial | ||||||
| Phase 4 | NCT07508644 Comparator | Jul 2027 → Jun 2030 expected | chronic obstructive pulmonary disease, respiratory syncytial virus infectious disease | Chinese University of Hong Kong | Not yet recruiting | No outcome recorded |
Evidence & citations 5 cited values
Every value below carries the sentence it was read from. 13 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | Arexvy | “All participants will get either the Pfizer RSV vaccine (RSVpreF (ABRYSVO)) or the GSK RSV vaccine (RSVpreF (AREXVY)) at 120 ug of the RSV prefusion F antigen intramuscularly...” NCT06077149 ↗10“In an open-label, prospective study, 105 patients received concurrent influenza (Vaxigrip Tetra, season 2023/2024, Sanofi) and RSV (Arexvy, GSK) vaccinations from September...” PMID 38531725 ↗ Mar 2024 “AREXVY. Dosage forms and strengths: Solution for injection.” NCT06442241 ↗ |
| Known as | GSK RSV vaccine | “All participants will get either the Pfizer RSV vaccine (RSVpreF (ABRYSVO)) or the GSK RSV vaccine (RSVpreF (AREXVY)) at 120 ug of the RSV prefusion F antigen intramuscularly...” NCT06077149 ↗ |
| Known as | Licensed RSV Vaccine | ClinicalTrials.gov intervention name — accepted as the source's own label NCT06686654 ↗ |
| Modality | Vaccine | “Respiratory Syncytial Virus Vaccine” NCT05170399 ↗ |
| Route | Intramuscular | “at 120 ug of the RSV prefusion F antigen intramuscularly in the the non-dominant deltoid muscle” NCT06077149 ↗ |