Drugs / Bexsero
Bexsero
Regulatory milestones approvals, filings & regulatory actions · 2 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Filed meningococcal meningitis 1 milestone | |||||
| Filed | EU (EMA) | Bexsero | meningococcal meningitis | 2026-07-20 | “GSK plc (LSE/NYSE: GSK) today announced the European Medicines Agency (EMA) has accepted a submission to update the label for Bexsero” gsk.com ↗ |
| Approved Indication not stated 1 milestone | |||||
| Approved | EU (EMA) | Bexsero | — | 2013-01-13 | europa.eu ↗ |
Trials 21
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 1/23 trials | ||||||
| Phase 1/2 | NCT06128733 | Oct 2023 → Aug 2025 | meningococcal infection | Sanofi Pasteur, a Sanofi Company | Completed | No outcome recorded |
| Phase 1/2 | NCT06033261 | Sep 2023 → Apr 2025 | genital herpes | ModernaTX, Inc. | Completed | No outcome recorded |
| Phase 1/2 | NCT04886154 | Jun 2021 → Feb 2024 | meningococcal infection | GlaxoSmithKline | Completed | Mixed |
| Phase 24 trials | ||||||
| Phase 2 | NCT05294588 | Apr 2022 → Feb 2026 | gonorrhea | University of North Carolina, Chapel Hill | Completed | No outcome recorded |
| Phase 2 | NCT04350138 | Dec 2020 → Feb 2026 overdue | gonorrhea | National Institute of Allergy and Infectious Diseases (NIAID) | Active not recruiting | No outcome recorded |
| Phase 2 | NCT04645966 | Nov 2020 → Sep 2022 | meningococcal infection | Pfizer | Terminated | No outcome recorded |
| Phase 2 | NCT02212457 | Aug 2014 → May 2015 | meningococcal infection | GlaxoSmithKline | Completed | No outcome recorded |
| Phase 38 trials · 1 met primary | ||||||
| Phase 3 | NCT06446752 | Aug 2024 → Oct 2026 expected | gonococcal cervicitis | University of Washington | Active not recruiting | No outcome recorded |
| Phase 3 | NCT04166656 | Sep 2022 → Sep 2028 expected | — | Assistance Publique - Hôpitaux de Paris | Recruiting | No outcome recorded |
| Phase 3 | NCT04597424 | Jan 2021 → Feb 2023 | — | ANRS, Emerging Infectious Diseases | Completed | Mixed |
| Phase 3 | NCT04084769 | Sep 2019 → Sep 2020 | — | Sanofi Pasteur, a Sanofi Company | Completed | No outcome recorded |
| Phase 3 | NCT03621670 | Jul 2018 → Dec 2024 | meningococcal infection | GlaxoSmithKline | Completed | No outcome recorded |
| Phase 3 | NCT02305446 | Dec 2014 → Apr 2015 | meningococcal meningitis | Novartis | Completed | No outcome recorded |
| Phase 3 | NCT02173704 | Sep 2014 → Dec 2015 | meningococcal infection | GlaxoSmithKline | Completed | No outcome recorded |
| Phase 3 | NCT01894919 | Jun 2013 → Sep 2015 | meningococcal meningitis | Novartis Vaccines | Completed | Met primary |
| Phase 44 trials | ||||||
| Phase 4 | NCT07252804 | Feb → Dec 2026 expected | autoimmune disease | University of Sao Paulo General Hospital | Recruiting | No outcome recorded |
| Phase 4 | NCT04875819 | Apr 2021 → Dec 2026 expected | HIV infectious disease, meningococcal infection, pneumococcal infection | Thomas Benfield | Recruiting | No outcome recorded |
| Phase 4 | NCT03682939 | Feb 2019 → Jun 2020 | HIV infectious disease, meningococcal meningitis | St George's, University of London | Unknown | No outcome recorded |
| Phase 4 | NCT02868970 | Feb 2017 → Jul 2021 | — | Canadian Immunization Research Network | Completed | No outcome recorded |
| Phase not applicable2 trials | ||||||
| — | NCT03509051 | Jun 2019 → Mar 2020 | disease related to hematopoietic stem cell transplant, meningococcal infection | Assistance Publique - Hôpitaux de Paris | Completed | No outcome recorded |
| — | NCT04515368 | Jun 2016 → Sep 2020 | — | Imperial College London | Completed | No outcome recorded |
| Comparator or background therapy4 trials | ||||||
| Phase 1 | NCT07395739 Comparator | Mar 2026 → May 2027 expected | meningococcemia | Shanghai Yuguan Biotech Co., Ltd.（Delonix Bioworks) | Recruiting | No outcome recorded |
| Phase 1 | NCT02491463 Comparator | Jul 2015 → Apr 2016 | respiratory syncytial virus infectious disease | GlaxoSmithKline | Completed | No outcome recorded |
| Phase 2 | NCT06025487 Comparator | Mar 2024 → Dec 2025 overdue | splenic disorder | Medical University of Vienna | Recruiting | No outcome recorded |
| Phase 4 | NCT02583412 Comparator | Sep 2015 → Sep 2016 | meningococcal infection | Canadian Immunization Research Network | Completed | No outcome recorded |
News releases announcing trial results or a regulatory action · 7
| Date | Issuer | Release |
|---|---|---|
| 2026-07-20 | GlaxoSmithKline | Regulatory European Medicines Agency accepts submission to update Bexsero label for 1-dose Meningitis B booster in 10+ year olds gsk.com ↗
GSK plc (LSE/NYSE: GSK) today announced the European Medicines Agency (EMA) has accepted a submission to update the label for Bexsero to include a single dose booster for individuals aged 10 years and older who were previously vaccinated with Bexsero. |
| 2020-01-23 | GlaxoSmithKline | Results World’s first meningitis B national infant vaccination programme shows 75% drop in cases over three years gsk.com ↗
According to Public Health England, over a three-year period the total number of meningitis B cases dropped 75 percent. |
| 2018-06-27 | GlaxoSmithKline | Regulatory Infants may now be protected against Meningitis B with fewer doses, adding flexibility to vaccination schedules gsk.com ↗
Healthcare professionals now have more options to help protect infants from invasive meningococcal disease (IMD) caused by serogroup B, after European Commission approval of an alternative Bexsero (rDNA, component, adsorbed)1 immunisation schedule requiring one less injection. |
| 2018-02-07 | GlaxoSmithKline | Regulatory GSK’s meningitis B vaccine Bexsero receives Breakthrough Therapy Designation from US FDA for prevention of Invasive Meningococcal Disease in children 2-10 years of age gsk.com ↗
Bexsero is the first vaccine in the world to receive the Breakthrough Therapy Designation (BTD) twice. |
| 2016-09-05 | GlaxoSmithKline | Results ‘Real world’ data shows 83 percent effectiveness for Bexsero® in infants in first year of UK national meningitis B immunisation programme gsk.com ↗
Reported cases of the disease have dropped 50 percent in the vaccine-eligible population in the first ten months of the programme, compared to the average number of cases over the last four years. |
| 2016-05-13 | GlaxoSmithKline | Results GSK’s Bexsero®▼achieves primary and secondary endpoints with reduced 3-dose schedule (2+1) in safety and immunogenicity study in infants and children gsk.com ↗
Across the different groups, the majority of infants and children had a high immune response irrespective of the dosing schedule, with similar safety profiles seen across the groups. |
| 2015-01-23 | Novartis Pharmaceuticals | Regulatory Novartis Bexsero® vaccine approved by FDA for the prevention of meningitis B, a leading cause of bacterial meningitis in the US novartis.com ↗ |
All press releases naming this drug 14 releases
Evidence & citations 8 cited values
Every value below carries the sentence it was read from. 25 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | Bexsero | “One dose (0.5 ml) of conjugate vaccine against meningococcal serogroups ACWY (Menveo®) and one dose of a recombinant protein-based vaccine against meningococcal serogroup B...” NCT04875819 ↗24“The study intervention is vaccination with two doses of BEXSERO™ and two commercially available FDA-approved vaccines that do not have relevance to Neisseria gonorrhoeae:...” NCT05294588 ↗ “A Phase II Randomized, Observer-Blind, Placebo-Controlled Study, to Assess the Efficacy of Meningococcal Group B Vaccine rMenB+OMV NZ (Bexsero) in Preventing Gonococcal Infection” NCT04350138 ↗ “Bexsero is indicated for active immunisation of individuals from 2 months of age and older against invasive meningococcal disease caused by Neisseria meningitidis group B.” NCT02868970 ↗ “Neisserial heparin-binding antigen (NHBA) is a surface-exposed lipoprotein from Neisseria meningitidis and is a component of the meningococcus B vaccine Bexsero.” PMID 28580917 ↗ May 2017 “Bexsero (Meningococcal group B subunit / Outer Membrane Vesicles, GlaxoSmithKline); 0.5 mL. intramuscular. stat.” NCT04515368 ↗ “One intramuscular injection of Bexsero (multicomponent B vaccine) from 6 months after transplant.” NCT03509051 ↗ “GSK's meningococcal group B vaccine, Bexsero” NCT04886154 ↗ “Bexsero®” NCT06128733 ↗ |
| Known as | 4CMenB | “The meningococcal 4CMenB (Bexsero) vaccine (rMenB+OMV NZ), that targets serogroup B N. meningitidis” NCT06446752 ↗ |
| Known as | GSK's meningococcal group B vaccine, Bexsero | “GSK's meningococcal group B vaccine, Bexsero” NCT04886154 ↗ |
| Known as | Meningococcal B | “Meningococcal B (Bexsero)” NCT07252804 ↗ |
| Known as | Meningococcal Group B Vaccine | “A Phase II Randomized, Observer-Blind, Placebo-Controlled Study, to Assess the Efficacy of Meningococcal Group B Vaccine rMenB+OMV NZ (Bexsero) in Preventing Gonococcal Infection” NCT04350138 ↗ |
| Known as | rMenB+OMV NZ | “A Phase II Randomized, Observer-Blind, Placebo-Controlled Study, to Assess the Efficacy of Meningococcal Group B Vaccine rMenB+OMV NZ (Bexsero) in Preventing Gonococcal Infection” NCT04350138 ↗2“The meningococcal 4CMenB (Bexsero) vaccine (rMenB+OMV NZ), that targets serogroup B N. meningitidis” NCT06446752 ↗ “Bexsero (GSK Biologicals' Meningococcal group-B vaccine/ rMenB+OMV NZ)” NCT03621670 ↗ |
| Modality | Vaccine | “licensed rMenB+OMV vaccine (Bexsero™)” NCT02212457 ↗ |
| Route | Intramuscular | “Two doses administered intramuscularly into the deltoid area” NCT02212457 ↗ |