Last reviewed 2026-05-29 · How we verify

VH4004280 Formulation A

ViiV Healthcare · Phase 1 active Small molecule ✓ Verified May 2026

VH4004280 Formulation A is a Small molecule drug developed by ViiV Healthcare. It is currently in Phase 1 development.

VH4004280 Formulation A is being studied in a clinical trial for its relative bioavailability and food effect in healthy participants. The study is focused on an oral capsid inhibitor tablet formulation for HIV infections.

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	VH4004280 Formulation A
Sponsor	ViiV Healthcare
Modality	Small molecule
Phase	Phase 1

Approved indications

No approved indications tracked.

Common side effects

No common side effects on file.

Key clinical trials

A Study to Investigate the Relative Bioavailability and Food Effect of an Oral Capsid Inhibitor Tablet Formulation Compared With Other Oral Tablet Formulations in Male and Female Healthy Participants (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:

VH4004280 Formulation A CI brief — competitive landscape report
VH4004280 Formulation A updates RSS · CI watch RSS
ViiV Healthcare portfolio CI

Frequently asked questions about VH4004280 Formulation A

What is VH4004280 Formulation A?

VH4004280 Formulation A is a Small molecule drug developed by ViiV Healthcare.

Who makes VH4004280 Formulation A?

VH4004280 Formulation A is developed by ViiV Healthcare (see full ViiV Healthcare pipeline at /company/viiv-healthcare).

What development phase is VH4004280 Formulation A in?

VH4004280 Formulation A is in Phase 1.

Manufacturer: ViiV Healthcare — full pipeline

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