Last reviewed 2026-05-28 · How we verify

VAL-339851

ModernaTX, Inc. · Phase 1 active Biologic ✓ Verified May 2026

VAL-339851 is a Biologic drug developed by ModernaTX, Inc.. It is currently in Phase 1 development.

VAL-339851 is a protein-based intervention being studied in a Phase 1 clinical trial for the treatment of influenza. The trial is evaluating the safety, tolerability, and immunogenicity of VAL-339851 in healthy adult subjects.

Likelihood of approval

12.6% 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).
Big-pharma sponsor +3.0pp
ModernaTX, Inc. is a top-20 pharma sponsor — historical approval rates run ~3pp above average due to scale, regulatory experience, and trial-design quality.

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	VAL-339851
Sponsor	ModernaTX, Inc.
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 VAL-339851 in Healthy Adult Subjects (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:

VAL-339851 CI brief — competitive landscape report
VAL-339851 updates RSS · CI watch RSS
ModernaTX, Inc. portfolio CI

Frequently asked questions about VAL-339851

What is VAL-339851?

VAL-339851 is a Biologic drug developed by ModernaTX, Inc..

Who makes VAL-339851?

VAL-339851 is developed by ModernaTX, Inc. (see full ModernaTX, Inc. pipeline at /company/modernatx-inc).

What development phase is VAL-339851 in?

VAL-339851 is in Phase 1.

Manufacturer: ModernaTX, Inc. — full pipeline

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