Drugs / Arexvy
Regulatory milestones approvals, filings & regulatory actions · 4 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Filed respiratory syncytial virus bronchiolitis 2 milestones | |||||
| Filed | China (NMPA) | Arexvy | respiratory syncytial virus bronchiolitis | 2026-02-10 | “its regulatory application for Arexvy (Respiratory Syncytial Virus vaccine, [recombinant, adjuvanted]), has been accepted for review by China’s Center for Drug Evaluation (CDE)” gsk.com ↗ |
| Filed | US (FDA) | Arexvy | respiratory syncytial virus bronchiolitis | 2025-07-14 | “FDA has accepted for review an application to extend the indication of Arexvy” gsk.com ↗ |
| Approved Indication not stated 2 milestones | |||||
| Filed | Japan (PMDA) | Arexvy | RSV disease | 2025-06-20 | “MHLW has accepted the company’s regulatory application to expand the use of its adjuvanted recombinant respiratory syncytial virus (RSV) vaccine” gsk.com ↗ |
| Approved | EU (EMA) | Arexvy | — | 2023-06-06 | europa.eu ↗ |
Trials 6
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| 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 | Active not 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 |
| Comparator or background therapy5 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 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 |
News releases announcing trial results or a regulatory action · 28
| Date | Issuer | Release |
|---|---|---|
| 2026-05-18 | GlaxoSmithKline | Regulatory GSK’s RSV vaccine, Arexvy, receives expanded approval in Japan for adults aged 18–59 at increased risk gsk.com ↗
GSK plc (LSE/NYSE: GSK) today announced that Japan’s Ministry of Health, Labour and Welfare (MHLW) has expanded the eligible population for Arexvy (Respiratory Syncytial Virus vaccine, [adjuvanted, recombinant]), to include adults aged 18 to 49 years at increased risk (AIR) for RSV disease. |
| 2026-03-13 | GlaxoSmithKline | Regulatory GSK’s RSV vaccine, Arexvy, approved in US for expanded age indication in adults aged 18–49 years at increased risk gsk.com ↗
GSK plc (LSE/NYSE: GSK) today announced that the US Food and Drug Administration (FDA) has expanded the approved age indication of Arexvy (Respiratory Syncytial Virus vaccine, [adjuvanted]) to adults aged 18 to 49 years at increased risk for lower respiratory tract disease (LRTD) caused by RSV. |
| 2026-02-17 | GlaxoSmithKline | Results GSK’s Arexvy associated with reductions in certain RSV-related risks including heart attack, stroke and severe flare-ups of COPD and asthma, real world study shows gsk.com ↗
GSK plc (LSE/NYSE: GSK) today announced new effectiveness data for its adjuvanted recombinant respiratory syncytial virus (RSV) vaccine at RSVVW’26, the 9th Conference of the Respiratory Syncytial Virus Foundation (ReSViNET) in Rome, Italy. |
| 2026-02-10 | GlaxoSmithKline | Regulatory GSK’s RSV vaccine, Arexvy, accepted for regulatory review in China for adults aged 60 years and older gsk.com ↗ |
| 2026-01-26 | GlaxoSmithKline | Regulatory GSK’s RSV vaccine, Arexvy, receives European approval for expanded use in all adults 18 years and older gsk.com ↗
GSK plc (LSE/NYSE: GSK) today announced that its adjuvanted recombinant respiratory syncytial virus (RSV) vaccine, Arexvy, has been approved by the European Commission* (EC) for use in adults aged 18 years and older. |
| 2025-12-12 | GlaxoSmithKline | Regulatory GSK’s RSV vaccine, Arexvy, receives positive CHMP opinion for all adults 18 years and older gsk.com ↗
GSK plc (LSE/NYSE: GSK) today announced that the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) has recommended expanding the indication of its adjuvanted recombinant respiratory syncytial virus (RSV) vaccine to all adults aged 18 years and older. |
| 2025-07-14 | GlaxoSmithKline | Regulatory US FDA accepts application to review expanded use of GSK’s RSV vaccine, Arexvy, for adults 18-49 at increased risk gsk.com ↗
GSK plc (LSE/NYSE: GSK) today announced that the US Food and Drug Administration (FDA) has accepted for review an application to extend the indication of Arexvy (respiratory syncytial virus (RSV) vaccine, adjuvanted) to adults aged 18-49 who are at increased risk. |
| 2025-06-20 | GlaxoSmithKline | Regulatory Japan’s Ministry of Health, Labour and Welfare accepts regulatory application to expand use of GSK’s RSV vaccine, Arexvy, in adults aged 18-49 at increased risk of severe RSV disease gsk.com ↗ |
| 2025-06-13 | GlaxoSmithKline | Regulatory GSK’s RSV vaccine, Arexvy, accepted for regulatory review by the European Medicines Agency to expand use in adults 18 years and older gsk.com ↗
GSK plc (LSE/NYSE: GSK) today announced that the European Medicines Agency (EMA) has accepted the company’s regulatory application to expand the use of its adjuvanted recombinant respiratory syncytial virus (RSV) vaccine to include adults from 18 years of age. |
| 2025-04-16 | GlaxoSmithKline | Regulatory Arexvy recommended for adults aged 50-59 at increased risk for severe respiratory syncytial virus (RSV) disease by US Advisory Committee on Immunization Practices gsk.com ↗
We are pleased with ACIP's recommendation to expand the benefits of RSV immunisation to more than 13 million adults aged 50-59 who are at increased risk for the severe consequences of this virus. |
| 2024-11-22 | GlaxoSmithKline | Regulatory Arexvy approval expanded to adults aged 50-59 at increased risk of severe RSV disease in Japan gsk.com ↗
GSK plc (LSE/NYSE: GSK) today announced that Japan’s Ministry of Health, Labour and Welfare (MHLW) has approved a regulatory application to extend the indication of Arexvy (respiratory syncytial virus vaccine, recombinant adjuvanted) for the prevention of RSV disease to include adults aged 50-59 at increased risk. |
| 2024-10-24 | GlaxoSmithKline | Results New data for Arexvy, GSK’s respiratory syncytial virus vaccine, show potential to help protect a broader group of adults at increased risk for RSV disease gsk.com ↗
GSK plc (LSE/NYSE: GSK) today announced new preliminary data for Arexvy (respiratory syncytial virus vaccine, recombinant adjuvanted) in adults aged 18-49 at increased risk for RSV-LRTD due to certain underlying medical conditions and in adults who are immunocompromised. |
| 2024-10-10 | GlaxoSmithKline | Results GSK and ViiV Healthcare to showcase advances across industry-leading infectious disease portfolio at IDWeek 2024 gsk.com ↗
Robust and Consistent Immune Response of the Adjuvanted Respiratory Syncytial Virus (RSV) Prefusion F Protein Vaccine (RSVPreF3 OA) Across Different Age Ranges and Frailty Status in Older Adults |
| 2024-10-08 | GlaxoSmithKline | Results GSK presents positive data for Arexvy, its respiratory syncytial virus (RSV) vaccine, indicating protection over three RSV seasons gsk.com ↗
Today's results indicate that after a single dose of GSK’s RSV vaccine, cumulative efficacy over three full RSV seasons was clinically meaningful at 62.9% against RSV-LRTD (97.5% CI, 46.7-74.8, 48 of 12,468 vs 215 of 12,498) and 67.4% against severe RSV-LRTD (95% CI, 42.4-82.7, 15 of 12,468 vs 75 of 12,498) compared to placebo. |
| 2024-08-29 | GlaxoSmithKline | Regulatory European Commission approves expanded age indication for GSK’s Arexvy, the first respiratory syncytial virus (RSV) vaccine for adults aged 50-59 at increased risk gsk.com ↗ |
| 2024-07-29 | GlaxoSmithKline | Regulatory Arexvy, GSK’s Respiratory Syncytial Virus (RSV) vaccine, receives positive European Medicines Agency CHMP opinion for adults aged 50-59 at increased risk for RSV disease gsk.com ↗
Today’s positive opinion is the first time that an indication for adults aged 50-59 has been recommended by CHMP for a RSV vaccine, one of the final steps prior to the extension of the marketing authorisation by the European Commission. |
| 2024-06-26 | GlaxoSmithKline | Regulatory Statement: US Centers for Disease Control and Prevention’s Advisory Committee on Immunisation Practices updates recommendations on adult RSV vaccines ahead of the next season gsk.com ↗
GSK plc (LSE/NYSE: GSK) today announced that the US Centers for Disease Control and Prevention’s (CDC) Advisory Committee on Immunization Practices (ACIP) voted in favour of recommending the routine use of RSV vaccines in all adults aged 75 and above. |
| 2024-06-07 | GlaxoSmithKline | Regulatory US FDA approves expanded age indication for GSK’s Arexvy, the first respiratory syncytial virus (RSV) vaccine for adults aged 50-59 at increased risk gsk.com ↗
GSK plc (LSE/NYSE: GSK) today announced that the US Food and Drug Administration (FDA) has approved Arexvy (Respiratory Syncytial Virus (RSV) Vaccine, Adjuvanted) for the prevention of RSV lower respiratory tract disease (LRTD) in adults 50 through 59 years of age who are at increased risk. |
| 2024-02-06 | GlaxoSmithKline | Regulatory GSK’s RSV vaccine, Arexvy, accepted under Priority Review in US for the prevention of RSV disease in adults aged 50-59 at increased risk gsk.com ↗ |
| 2024-01-29 | GlaxoSmithKline | Regulatory GSK’s RSV vaccine, Arexvy, accepted for regulatory review by the European Medicines Agency for the prevention of RSV disease in adults aged 50-59 at increased risk gsk.com ↗ |
| 2023-12-12 | GlaxoSmithKline | Regulatory Japan’s Ministry of Health, Labour and Welfare accepts Arexvy (RSV vaccine) regulatory application to prevent RSV disease in adults aged 50-59 at increased risk gsk.com ↗ |
| 2023-10-25 | GlaxoSmithKline | Results New data for Arexvy, GSK’s RSV vaccine, show potential to help protect adults aged 50 to 59 at increased risk for RSV disease gsk.com ↗
Preliminary results from phase III trial show primary endpoints met, with non-inferior immune responses observed in adults aged 50-59 compared to adults aged 60 and older |
| 2023-09-25 | GlaxoSmithKline | Regulatory Japan’s Ministry of Health, Labour and Welfare approves GSK’s Arexvy, the country’s first respiratory syncytial virus (RSV) vaccine for older adults gsk.com ↗
GSK plc (LSE/NYSE: GSK) today announced that Japan’s Ministry of Health, Labour and Welfare (MHLW) has approved Arexvy (respiratory syncytial virus vaccine, recombinant adjuvanted) for the prevention of RSV (respiratory syncytial virus) disease for adults 60 years of age and above. |
| 2023-07-10 | GlaxoSmithKline | Regulatory Medicines and Healthcare products Regulatory Agency authorises GSK’s Arexvy, the first respiratory syncytial virus (RSV) vaccine for older adults gsk.com ↗
This is the first time an RSV vaccine for older adults has been authorised for use in Great Britain by the MHRA. |
| 2023-06-22 | GlaxoSmithKline | Regulatory US Centers for Disease Control and Prevention’s Advisory Committee on Immunization Practices votes to recommend Arexvy for the prevention of RSV disease in adults aged 60 and older with shared clinical decision making gsk.com ↗ |
| 2023-06-21 | GlaxoSmithKline | Results GSK shares positive data for Arexvy, its respiratory syncytial virus (RSV) older adult vaccine, indicating protection over two RSV seasons gsk.com ↗
The results show that one dose of the vaccine is efficacious against RSV-LRTD and severe LRTD over two full RSV seasons. |
| 2023-06-07 | GlaxoSmithKline | Regulatory European Commission authorises GSK’s Arexvy, the first respiratory syncytial virus (RSV) vaccine for older adults gsk.com ↗
GSK plc (LSE/NYSE: GSK) today announced that the European Commission has authorised Arexvy (respiratory syncytial virus vaccine, adjuvanted) for active immunisation for the prevention of lower respiratory tract disease (LRTD) caused by respiratory syncytial virus (RSV) in adults 60 years of age and older. |
| 2023-05-03 | GlaxoSmithKline | Regulatory US FDA approves GSK’s Arexvy, the world’s first respiratory syncytial virus (RSV) vaccine for older adults gsk.com ↗ |
All press releases naming this drug 28 releases
Evidence & citations 4 cited values
Every value below carries the sentence it was read from. 11 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 ↗ |
| 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 ↗ |