{"id":"penbraya","rwe":[],"tags":[],"phase":"preclinical","safety":{"boxedWarnings":[],"safetySignals":[],"drugInteractions":[],"commonSideEffects":[],"contraindications":[],"specialPopulations":{},"discontinuationRates":[],"seriousAdverseEvents":[]},"status":"active","trials":["NCT07197762"],"aliases":[],"patents":[],"pricing":[],"offLabel":[],"timeline":[{"date":"2026","type":"neutral","milestone":"Phase 4 Initiated","description":"Phase 4 trial (MenB-FHbp or MenACWY-TT/MenB-FHbp Vaccine in MenB-4C Primed Young Adults) — Neisseria Meningitidis"}],"aiSummary":"Penbraya is a pentavalent conjugate vaccine developed by Pfizer for the prevention of invasive meningococcal disease in people 10 through 25 years of age. It targets Neisseria meningitidis groups A, C, W, Y, and B, and is approved for use by the US Food and Drug Administration (FDA).","brandName":"PENBRAYA","companyId":"pfizer","ecosystem":[],"mechanism":{"target":"","novelty":"","modality":"Vaccine","drugClass":"PENBRAYA is a combination vaccine that protects against meningococcal serogroups A, B, C, W, and Y. ","explanation":"PENBRAYA works by targeting a fundamental mechanism in heart cells that controls how ions move in and out. Normally, heart cells use a pump called the sodium-potassium ATPase to maintain a balance of charged particles. When PENBRAYA blocks this pump, it causes calcium to accumulate inside the heart muscle cells, which is the trigger that makes these cells contract more forcefully.\n\nThis increased contractility means the heart pumps blood more efficiently with each beat, which is particularly valuable for patients whose hearts have weakened and struggle to circulate blood effectively. Additionally, PENBRAYA slows the heart rate, which gives the heart more time to fill with blood between beats and reduces the overall workload on the organ.\n\nThe clinical advantage of PENBRAYA is that it improves heart function through a direct cellular mechanism rather than through stimulating nerve pathways like other cardiac drugs do. This approach can produce more stable benefits with fewer side effects related to excessive nervous system stimulation, making it useful for patients who need sustained improvement in heart contractility.","oneSentence":"PENBRAYA is a combination vaccine that protects against meningococcal serogroups A, B, C, W, and Y. ","technicalDetail":""},"commercial":null,"references":[],"biosimilars":[],"companyName":"Pfizer Inc.","competitors":[],"genericName":"penbraya","indications":{"approved":[],"offLabel":[],"pipeline":[{"name":"Neisseria Meningitidis","phase":"preclinical","trialId":"","patients":null,"diseaseId":"vaccines","trialName":"","primaryEndpoint":"","expectedCompletion":""}]},"labelChanges":[],"relatedDrugs":[],"trialDetails":[{"nctId":"NCT07197762","phase":"Phase 4","title":"MenB-FHbp or MenACWY-TT/MenB-FHbp Vaccine in MenB-4C Primed Young Adults","status":"Recruiting","sponsor":"Emory University","isPivotal":false,"enrollment":125,"indication":"Neisseria Meningitidis","completionDate":"2026-12","primaryEndpoint":"The goal of this clinical trial is to determine the immunogenicity of certain vaccines in protecting against meningitis B (MenB) in young adults who have previously received a different MenB vaccine."}],"genericFilers":[],"latestUpdates":[],"manufacturing":[],"administration":{"icon":"","route":"","frequency":"","formulation":""},"crossReferences":{"rxcui":"2670561","chemblId":"CHEMBL6068498"},"formularyStatus":[],"developmentCodes":[],"ownershipHistory":[],"therapeuticAreas":["Infectious Disease"],"biosimilarFilings":[],"firstApprovalDate":"","companionDiagnostics":[],"firstApprovalCountry":null,"genericManufacturerList":[],"modality":"Vaccine","enrichmentLevel":3,"visitCount":4,"regulatoryByCountry":[{"country_code":"EU","regulator":"EMA","status":"withdrawn","approval_date":"2024-11-14T00:00:00.000Z","mah":"Pfizer Europe MA EEIG","brand_name_local":"Penbraya","application_number":"EMEA/H/C/006165"}],"regulatorySummaries":{"EU_EMA_approval_188997":{"country_code":"EU","agency":"EMA","entity_type":"approval","entity_id":"188997","summary_short":"PENBRAYA, a vaccine, has been approved by the EMA for individuals 10 years and older to prevent invasive disease caused by Neisseria meningitidis groups A, B, C, W, and Y.","summary_long":"The European Medicines Agency (EMA) has granted marketing authorisation for PENBRAYA, a vaccine, on 14 November 2024. PENBRAYA is indicated for active immunisation of individuals 10 years of age and older to prevent invasive disease caused by Neisseria meningitidis groups A, B, C, W, and Y. The use of this vaccine should be in accordance with official recommendations.","key_points":["PENBRAYA is a vaccine for individuals 10 years and older to prevent invasive disease caused by Neisseria meningitidis groups A, B, C, W, and Y.","The EMA granted marketing authorisation for PENBRAYA on 14 November 2024."],"citations":[{"source":"https://www.ema.europa.eu/en/medicines/human/EPAR/penbraya"}],"generated_at":"2026-05-18T08:45:50.069Z"}},"trialStats":{"total":0,"withResults":0},"verificationStatus":"partial","dataCompleteness":{"mechanism":true,"indications":false,"safety":false,"trials":true,"score":2}}