Last reviewed 2026-05-19 · How we verify

AFFITOPE AD01 adjuvanted

Affiris AG · Phase 1 active Biologic ✓ Verified May 2026 Quality 0/100

AFFITOPE AD01 adjuvanted is a Biologic drug developed by Affiris AG. It is currently in Phase 1 development.

AFFITOPE AD01 is an adjuvanted treatment being studied for Alzheimer's Disease. The exact mechanism of AFFITOPE AD01 is unknown, but it is being tested in combination with an adjuvant known as MATRIX-M or MATRIX-M1 ADJUVANT.

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	AFFITOPE AD01 adjuvanted
Sponsor	Affiris AG
Modality	Biologic
Phase	Phase 1

Approved indications

No approved indications tracked.

Common side effects

No common side effects on file.

Key clinical trials

Tolerability and Safety of Subcutaneous Administration of Affitope AD01 in Mild to Moderate Alzheimer's Disease (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:

AFFITOPE AD01 adjuvanted CI brief — competitive landscape report
AFFITOPE AD01 adjuvanted updates RSS · CI watch RSS
Affiris AG portfolio CI

Frequently asked questions about AFFITOPE AD01 adjuvanted

What is AFFITOPE AD01 adjuvanted?

AFFITOPE AD01 adjuvanted is a Biologic drug developed by Affiris AG.

Who makes AFFITOPE AD01 adjuvanted?

AFFITOPE AD01 adjuvanted is developed by Affiris AG (see full Affiris AG pipeline at /company/affiris-ag).

What development phase is AFFITOPE AD01 adjuvanted in?

AFFITOPE AD01 adjuvanted is in Phase 1.

Manufacturer: Affiris AG — full pipeline

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