Last reviewed 2026-05-31 · How we verify

V160 Low Dose IM

Merck Sharp & Dohme LLC · Phase 1 active Biologic ✓ Verified May 2026

V160 Low Dose IM is a Biologic drug developed by Merck Sharp & Dohme LLC. It is currently in Phase 1 development.

V160 Low Dose IM is a vaccine being studied for safety, tolerability, and immunogenicity in healthy adults with cytomegalovirus infections. The mechanism of V160 is currently unknown.

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
Merck Sharp & Dohme LLC 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	V160 Low Dose IM
Sponsor	Merck Sharp & Dohme LLC
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 the Human Cytomegalovirus Vaccine (V160) in Healthy Adults (V160-001) (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:

V160 Low Dose IM CI brief — competitive landscape report
V160 Low Dose IM updates RSS · CI watch RSS
Merck Sharp & Dohme LLC portfolio CI

Frequently asked questions about V160 Low Dose IM

What is V160 Low Dose IM?

V160 Low Dose IM is a Biologic drug developed by Merck Sharp & Dohme LLC.

Who makes V160 Low Dose IM?

V160 Low Dose IM is developed by Merck Sharp & Dohme LLC (see full Merck Sharp & Dohme LLC pipeline at /company/merck).

What development phase is V160 Low Dose IM in?

V160 Low Dose IM is in Phase 1.

Manufacturer: Merck Sharp & Dohme LLC — full pipeline

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