Last reviewed 2026-05-27 · How we verify

ACI-24 high dose

AC Immune SA · Phase 1 active Biologic ✓ Verified May 2026 Quality 0/100

ACI-24 high dose is a Biologic drug developed by AC Immune SA. It is currently in Phase 1 development.

ACI-24 is a vaccine being studied in a Phase Ib clinical trial for safety, tolerability, and immunogenicity in adults with Down Syndrome. The trial is comparing the effects of ACI-24 high dose, ACI-24 low dose, and a placebo in this population.

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	ACI-24 high dose
Sponsor	AC Immune SA
Modality	Biologic
Phase	Phase 1

Approved indications

No approved indications tracked.

Common side effects

No common side effects on file.

Key clinical trials

Safety, Tolerability and Immunogenicity of ACI-24 Vaccine in Adults With Down Syndrome (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:

ACI-24 high dose CI brief — competitive landscape report
ACI-24 high dose updates RSS · CI watch RSS
AC Immune SA portfolio CI

Frequently asked questions about ACI-24 high dose

What is ACI-24 high dose?

ACI-24 high dose is a Biologic drug developed by AC Immune SA.

Who makes ACI-24 high dose?

ACI-24 high dose is developed by AC Immune SA (see full AC Immune SA pipeline at /company/ac-immune-sa).

What development phase is ACI-24 high dose in?

ACI-24 high dose is in Phase 1.

Manufacturer: AC Immune SA — full pipeline

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