Last reviewed 2026-04-23 · How we verify

ADXS31-164

Advaxis, Inc. · Phase 1 active Small molecule

ADXS31-164 is a Cancer vaccine Small molecule drug developed by Advaxis, Inc.. It is currently in Phase 1 development for Non-small cell lung cancer, Ovarian cancer.

Listeria monocytogenes-based immunotherapy targeting MUC1

Listeria monocytogenes-based immunotherapy targeting MUC1 Used for Non-small cell lung cancer, Ovarian cancer.

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	ADXS31-164
Sponsor	Advaxis, Inc.
Drug class	Cancer vaccine
Target	MUC1
Modality	Small molecule
Therapeutic area	Oncology
Phase	Phase 1

Mechanism of action

ADXS31-164 is a live, attenuated Listeria monocytogenes-based immunotherapy that targets the MUC1 antigen, which is overexpressed in various cancers.

Approved indications

Non-small cell lung cancer
Ovarian cancer

Common side effects

Fatigue
Nausea
Diarrhea

Key clinical trials

Dose Escalation Study of ADXS31-164 in Subjects With HER2 Expressing Solid Tumors (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:

ADXS31-164 CI brief — competitive landscape report
ADXS31-164 updates RSS · CI watch RSS
Advaxis, Inc. portfolio CI

Frequently asked questions about ADXS31-164

What is ADXS31-164?

ADXS31-164 is a Cancer vaccine drug developed by Advaxis, Inc., indicated for Non-small cell lung cancer, Ovarian cancer.

How does ADXS31-164 work?

Listeria monocytogenes-based immunotherapy targeting MUC1

What is ADXS31-164 used for?

ADXS31-164 is indicated for Non-small cell lung cancer, Ovarian cancer.

Who makes ADXS31-164?

ADXS31-164 is developed by Advaxis, Inc. (see full Advaxis, Inc. pipeline at /company/advaxis-inc).

What drug class is ADXS31-164 in?

ADXS31-164 belongs to the Cancer vaccine class. See all Cancer vaccine drugs at /class/cancer-vaccine.

What development phase is ADXS31-164 in?

ADXS31-164 is in Phase 1.

What are the side effects of ADXS31-164?

Common side effects of ADXS31-164 include Fatigue, Nausea, Diarrhea.

What does ADXS31-164 target?

ADXS31-164 targets MUC1 and is a Cancer vaccine.

Drug class: All Cancer vaccine drugs
Target: All drugs targeting MUC1
Manufacturer: Advaxis, Inc. — full pipeline
Therapeutic area: All drugs in Oncology
Indication: Drugs for Non-small cell lung cancer
Indication: Drugs for Ovarian cancer

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