Last reviewed 2026-04-20 · How we verify

LAIV H2N2

PATH · Phase 1 active Biologic Quality 0/100

LAIV H2N2 is a Biologic drug developed by PATH. It is currently in Phase 1 development. Also known as: Monovalent A/17/California/66/395 (LAIV H2N2) vaccine.

Likelihood of approval

9.6% 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).

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 name	LAIV H2N2
Also known as	Monovalent A/17/California/66/395 (LAIV H2N2) vaccine
Sponsor	PATH
Modality	Biologic
Phase	Phase 1

Approved indications

No approved indications tracked.

Common side effects

No common side effects on file.

Key clinical trials

Reactogenicity, Safety and Immunogenicity of a Live Monovalent A/17/CALIFORNIA/66/395 (H2N2) Influenza Vaccine (PHASE1)

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:

LAIV H2N2 CI brief — competitive landscape report
LAIV H2N2 updates RSS · CI watch RSS
PATH portfolio CI

Frequently asked questions about LAIV H2N2

What is LAIV H2N2?

LAIV H2N2 is a Biologic drug developed by PATH.

Who makes LAIV H2N2?

LAIV H2N2 is developed by PATH (see full PATH pipeline at /company/path).

Is LAIV H2N2 also known as anything else?

LAIV H2N2 is also known as Monovalent A/17/California/66/395 (LAIV H2N2) vaccine.

What development phase is LAIV H2N2 in?

LAIV H2N2 is in Phase 1.

Manufacturer: PATH — full pipeline
Also known as: Monovalent A/17/California/66/395 (LAIV H2N2) vaccine

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