Last reviewed 2026-05-18 · How we verify

AADvac1 40 µg

Axon Neuroscience SE · Phase 1 active Small molecule Quality 40/100

AADvac1 40 µg is a Tau-targeted immunotherapy Small molecule drug developed by Axon Neuroscience SE. It is currently in Phase 1 development.

Active immunotherapy that stimulates the immune system to produce antibodies against pathological tau protein aggregates in the brain.

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	AADvac1 40 µg
Sponsor	Axon Neuroscience SE
Drug class	Tau-targeted immunotherapy
Modality	Small molecule
Phase	Phase 1

Mechanism of action

AADvac1 is a synthetic peptide vaccine that targets misfolded tau protein. By inducing an active immune response, it aims to generate antibodies that can recognize and clear pathological tau aggregates, potentially slowing neurodegeneration in Alzheimer's disease and related tauopathies.

Approved indications

Common side effects

No common side effects on file.

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.

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:

AADvac1 40 µg CI brief — competitive landscape report
AADvac1 40 µg updates RSS · CI watch RSS
Axon Neuroscience SE portfolio CI

Frequently asked questions about AADvac1 40 µg

What is AADvac1 40 µg?

AADvac1 40 µg is a Tau-targeted immunotherapy drug developed by Axon Neuroscience SE.

How does AADvac1 40 µg work?

Active immunotherapy that stimulates the immune system to produce antibodies against pathological tau protein aggregates in the brain.

Who makes AADvac1 40 µg?

AADvac1 40 µg is developed by Axon Neuroscience SE (see full Axon Neuroscience SE pipeline at /company/axon-neuroscience-se).

What drug class is AADvac1 40 µg in?

AADvac1 40 µg belongs to the Tau-targeted immunotherapy class. See all Tau-targeted immunotherapy drugs at /class/tau-targeted-immunotherapy.

What development phase is AADvac1 40 µg in?

AADvac1 40 µg is in Phase 1.

Drug class: All Tau-targeted immunotherapy drugs
Manufacturer: Axon Neuroscience SE — full pipeline

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