Last reviewed 2026-05-27 · How we verify

VT301

VTBIO Co. LTD · Phase 1 active Biologic ✓ Verified May 2026

VT301 is a Biologic drug developed by VTBIO Co. LTD. It is currently in Phase 1 development.

VT301 is a treatment being studied in a Phase 1 clinical trial for Alzheimer's disease. The trial, NCT05016427, is an open-label dose-escalating study to determine the safety and tolerability of VT301 in subjects with mild-to-moderate Alzheimer's disease.

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	VT301
Sponsor	VTBIO Co. 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 Study of Possibility of Using Regulatory T Cells(VT301) for Treatment of 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:

VT301 CI brief — competitive landscape report
VT301 updates RSS · CI watch RSS
VTBIO Co. LTD portfolio CI

Frequently asked questions about VT301

What is VT301?

VT301 is a Biologic drug developed by VTBIO Co. LTD.

Who makes VT301?

VT301 is developed by VTBIO Co. LTD (see full VTBIO Co. LTD pipeline at /company/vtbio-co-ltd).

What development phase is VT301 in?

VT301 is in Phase 1.

Manufacturer: VTBIO Co. LTD — full pipeline

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