Last reviewed 2026-06-01 · How we verify

GX-051

Genexine, Inc. · Phase 1 active Biologic ✓ Verified Jun 2026

GX-051 is a Biologic drug developed by Genexine, Inc.. It is currently in Phase 1 development.

GX-051 is a genetically modified mesenchymal stem cell therapeutic being studied in a clinical trial for the treatment of head and neck cancer. The trial, NCT02079324, is a single-center, open-label, dose-escalating study to evaluate the safety and tolerability of GX-051 in patients with head and neck 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	GX-051
Sponsor	Genexine, Inc.
Modality	Biologic
Phase	Phase 1

Approved indications

No approved indications tracked.

Common side effects

No common side effects on file.

Key clinical trials

Genetically Modified Mesenchymal Stem Cell Theraopeutic Against Head and Neck Cancer (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:

GX-051 CI brief — competitive landscape report
GX-051 updates RSS · CI watch RSS
Genexine, Inc. portfolio CI

Frequently asked questions about GX-051

What is GX-051?

GX-051 is a Biologic drug developed by Genexine, Inc..

Who makes GX-051?

GX-051 is developed by Genexine, Inc. (see full Genexine, Inc. pipeline at /company/genexine-inc).

What development phase is GX-051 in?

GX-051 is in Phase 1.

Manufacturer: Genexine, Inc. — full pipeline

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