Last reviewed 2026-06-02 · How we verify

Adjuvanted Multimeric-001 250mcg

BiondVax Pharmaceuticals ltd. · Phase 1 active Biologic ✓ Verified Jun 2026 Quality 0/100

Adjuvanted Multimeric-001 250mcg is a Biologic drug developed by BiondVax Pharmaceuticals ltd.. It is currently in Phase 1 development.

Adjuvanted Multimeric-001 250mcg is a small molecule vaccine used to treat Influenza. It is administered as part of a clinical trial to assess its safety and priming potential in elderly volunteers.

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	Adjuvanted Multimeric-001 250mcg
Sponsor	BiondVax Pharmaceuticals ltd.
Modality	Biologic
Phase	Phase 1

Approved indications

No approved indications tracked.

Common side effects

No common side effects on file.

Key clinical trials

A Double-Dose Safety Study of An Influenza Vaccine (Multimeric-001) Injected to Elderly Volunteers (PHASE1, PHASE2)

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:

Adjuvanted Multimeric-001 250mcg CI brief — competitive landscape report
Adjuvanted Multimeric-001 250mcg updates RSS · CI watch RSS
BiondVax Pharmaceuticals ltd. portfolio CI

Frequently asked questions about Adjuvanted Multimeric-001 250mcg

What is Adjuvanted Multimeric-001 250mcg?

Adjuvanted Multimeric-001 250mcg is a Biologic drug developed by BiondVax Pharmaceuticals ltd..

Who makes Adjuvanted Multimeric-001 250mcg?

Adjuvanted Multimeric-001 250mcg is developed by BiondVax Pharmaceuticals ltd. (see full BiondVax Pharmaceuticals ltd. pipeline at /company/biondvax-pharmaceuticals-ltd).

What development phase is Adjuvanted Multimeric-001 250mcg in?

Adjuvanted Multimeric-001 250mcg is in Phase 1.

Manufacturer: BiondVax Pharmaceuticals ltd. — full pipeline

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