Last reviewed 2026-06-01 · How we verify

PENBRAYA (penbraya)

Pfizer Inc. · preclinical active Vaccine Under review Quality 0/100

PENBRAYA (generic name: penbraya) is a PENBRAYA is a combination vaccine that protects against meningococcal serogroups A, B, C, W, and Y. Vaccine drug developed by Pfizer Inc.. It is currently in preclinical development.

PENBRAYA is a combination vaccine that protects against meningococcal serogroups A, B, C, W, and Y.

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).

Likelihood of approval

10% vs 5% industry baseline

If approved by FDA: likely 2036–2040

Steps remaining: Phase 1 → Phase 2 → Phase 3 → NDA/BLA submission

Confidence: Low

Why this estimate

Baseline preclinical → approval rate +5.0pp
Industry-wide preclinical drugs reach approval ~5% of the time (BIO/Informa 2023 industry benchmark across all therapeutic areas).
Anti-infectives pathway favourability +2.0pp
Microbiological endpoints + non-inferiority designs raise approval rates above baseline.
Big-pharma sponsor +3.0pp
Pfizer Inc. is a top-20 pharma sponsor — historical approval rates run ~3pp above average due to scale, regulatory experience, and trial-design quality.

Predicted approval windows by jurisdiction (conditional on FDA approval)

Regulator	Country	Likely year	Lag vs FDA
FDA	US	2036–2040	—
EMA	EU	2037–2041	+0.7 yr
MHRA	GB	2037–2041	+0.7 yr
Health Canada	CA	2037–2042	+0.9 yr
TGA	AU	2037–2042	+1.2 yr
PMDA	JP	2037–2042	+1.5 yr
NMPA	CN	2038–2043	+2.3 yr
MFDS	KR	2037–2042	+1.4 yr
CDSCO	IN	2037–2043	+1.8 yr
ANVISA	BR	2038–2043	+2.3 yr

Hover any row for the lag rationale. Lag estimates are reduced when the drug has FDA Breakthrough or EMA PRIME designation (sponsors file globally in parallel).

Estimate based on the BIO/Informa industry phase transition rates plus per-drug modifiers for therapeutic area, sponsor type, FDA designations, mechanism, and trial design. Per-jurisdiction lags from Tufts CSDD international approval studies. Not investment, clinical or regulatory advice. Methodology: /methodology#likelihood.

At a glance

Generic name	penbraya
Sponsor	Pfizer Inc.
Drug class	PENBRAYA is a combination vaccine that protects against meningococcal serogroups A, B, C, W, and Y.
Modality	Vaccine
Therapeutic area	Infectious Disease
Phase	preclinical

Mechanism of action

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. This 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. The 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.

Approved indications

No approved indications tracked.

Pipeline indications

Neisseria Meningitidis — preclinical

Common side effects

No common side effects on file.

Key clinical trials

MenB-FHbp or MenACWY-TT/MenB-FHbp Vaccine in MenB-4C Primed Young Adults (Phase 4)

Primary sources

Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.

Source	Used for
ClinicalTrials.gov	Trial enrolment, design, endpoints, results

Competitive intelligence

For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:

PENBRAYA CI brief — competitive landscape report
PENBRAYA updates RSS · CI watch RSS
Pfizer Inc. portfolio CI

Frequently asked questions about PENBRAYA

What is PENBRAYA?

PENBRAYA (penbraya) is a PENBRAYA is a combination vaccine that protects against meningococcal serogroups A, B, C, W, and Y. drug developed by Pfizer Inc..

How does PENBRAYA work?

PENBRAYA is a combination vaccine that protects against meningococcal serogroups A, B, C, W, and Y.

Who makes PENBRAYA?

PENBRAYA is developed by Pfizer Inc. (see full Pfizer Inc. pipeline at /company/pfizer).

What is the generic name of PENBRAYA?

penbraya is the generic (nonproprietary) name of PENBRAYA.

What drug class is PENBRAYA in?

PENBRAYA belongs to the PENBRAYA is a combination vaccine that protects against meningococcal serogroups A, B, C, W, and Y. class. See all PENBRAYA is a combination vaccine that protects against meningococcal serogroups A, B, C, W, and Y. drugs at /class/penbraya-is-a-combination-vaccine-that-protects-against-meningococcal-serogroups-a-b-c-w-and-y.

What development phase is PENBRAYA in?

PENBRAYA is in preclinical.

Drug class: All PENBRAYA is a combination vaccine that protects against meningococcal serogroups A, B, C, W, and Y. drugs
Manufacturer: Pfizer Inc. — full pipeline
Therapeutic area: All drugs in Infectious Disease

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing