Last reviewed 2026-05-23 · How we verify

VGX-6150

GeneOne Life Science, Inc. · Phase 1 active Biologic ✓ Verified May 2026

VGX-6150 is a Biologic drug developed by GeneOne Life Science, Inc.. It is currently in Phase 1 development.

VGX-6150 is a small molecule being studied in a Phase I trial for the treatment of chronic hepatitis C infection. The exact mechanism of action of VGX-6150 is currently unknown.

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	VGX-6150
Sponsor	GeneOne Life Science, Inc.
Modality	Biologic
Phase	Phase 1

Approved indications

No approved indications tracked.

Common side effects

No common side effects on file.

Key clinical trials

Phase I Trial to Evaluate the Safety, Tolerability and Immunogenicity of VGX-6150 for Second-line Therapy of Chronic Hepatitis C Infection (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:

VGX-6150 CI brief — competitive landscape report
VGX-6150 updates RSS · CI watch RSS
GeneOne Life Science, Inc. portfolio CI

Frequently asked questions about VGX-6150

What is VGX-6150?

VGX-6150 is a Biologic drug developed by GeneOne Life Science, Inc..

Who makes VGX-6150?

VGX-6150 is developed by GeneOne Life Science, Inc. (see full GeneOne Life Science, Inc. pipeline at /company/geneone-life-science-inc).

What development phase is VGX-6150 in?

VGX-6150 is in Phase 1.

Manufacturer: GeneOne Life Science, Inc. — full pipeline

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