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Ad26.Filo

Janssen Vaccines & Prevention B.V. · Phase 1 active Biologic

Ad26.Filo is a Viral vector vaccine Biologic drug developed by Janssen Vaccines & Prevention B.V.. It is currently in Phase 1 development for Ebola.

Ad26.Filo is a viral vector vaccine that targets filoviruses.

Ad26.Filo is a viral vector vaccine that targets filoviruses. Used for Ebola.

Likelihood of approval
14.6% vs 9.6% industry baseline
If approved by FDA: likely 2033–2036
Steps remaining: Phase 2 → Phase 3 → NDA/BLA submission
Confidence: Medium
Why this estimate
  • Baseline phase 1 → approval rate +9.6pp
    Industry-wide phase 1 drugs reach approval ~9.6% 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
    Janssen Vaccines & Prevention B.V. 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 2033–2036
EMA EU 2034–2037 +0.7 yr
MHRA GB 2034–2037 +0.7 yr
Health Canada CA 2034–2038 +0.9 yr
TGA AU 2034–2038 +1.2 yr
PMDA JP 2034–2038 +1.5 yr
NMPA CN 2035–2039 +2.3 yr
MFDS KR 2034–2038 +1.4 yr
CDSCO IN 2034–2039 +1.8 yr
ANVISA BR 2035–2039 +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 nameAd26.Filo
SponsorJanssen Vaccines & Prevention B.V.
Drug classViral vector vaccine
TargetFilovirus glycoprotein
ModalityBiologic
Therapeutic areaInfectious Disease
PhasePhase 1

Mechanism of action

It uses a replication-deficient adenovirus type 26 as a vector to express the filovirus glycoprotein, eliciting an immune response against filoviruses.

Approved indications

Common side effects

Key clinical trials

Primary sources

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

SourceUsed for
ClinicalTrials.govTrial 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:

Frequently asked questions about Ad26.Filo

What is Ad26.Filo?

Ad26.Filo is a Viral vector vaccine drug developed by Janssen Vaccines & Prevention B.V., indicated for Ebola.

How does Ad26.Filo work?

Ad26.Filo is a viral vector vaccine that targets filoviruses.

What is Ad26.Filo used for?

Ad26.Filo is indicated for Ebola.

Who makes Ad26.Filo?

Ad26.Filo is developed by Janssen Vaccines & Prevention B.V. (see full Janssen Vaccines & Prevention B.V. pipeline at /company/janssen-vaccines-prevention-b-v).

What drug class is Ad26.Filo in?

Ad26.Filo belongs to the Viral vector vaccine class. See all Viral vector vaccine drugs at /class/viral-vector-vaccine.

What development phase is Ad26.Filo in?

Ad26.Filo is in Phase 1.

What are the side effects of Ad26.Filo?

Common side effects of Ad26.Filo include Pain at injection site, Fatigue, Headache.

What does Ad26.Filo target?

Ad26.Filo targets Filovirus glycoprotein and is a Viral vector vaccine.

Related

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