Last reviewed 2026-05-22 · How we verify

VH4524184 Formulation B IM

ViiV Healthcare · Phase 1 active Small molecule ✓ Verified May 2026 Quality 0/100

VH4524184 Formulation B IM is a Small molecule drug developed by ViiV Healthcare. It is currently in Phase 1 development.

VH4524184 Formulation B is an oral formulation of VH4524184 being studied for the treatment of HIV Infections in a Phase 1 clinical trial (NCT06310551). The study is investigating the safety and tolerability of VH4524184 Formulation B, as well as its comparison to a placebo formulation.

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	VH4524184 Formulation B IM
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

First Time in Human Study of Long Acting VH4524184 Formulations (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:

VH4524184 Formulation B IM CI brief — competitive landscape report
VH4524184 Formulation B IM updates RSS · CI watch RSS
ViiV Healthcare portfolio CI

Frequently asked questions about VH4524184 Formulation B IM

What is VH4524184 Formulation B IM?

VH4524184 Formulation B IM is a Small molecule drug developed by ViiV Healthcare.

Who makes VH4524184 Formulation B IM?

VH4524184 Formulation B IM is developed by ViiV Healthcare (see full ViiV Healthcare pipeline at /company/viiv-healthcare).

What development phase is VH4524184 Formulation B IM in?

VH4524184 Formulation B IM is in Phase 1.

Manufacturer: ViiV Healthcare — full pipeline

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