Last reviewed 2026-06-02 · How we verify

GSK3640254 bis-hydrochloride salt capsule

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

GSK3640254 bis-hydrochloride salt capsule is a Small molecule drug developed by ViiV Healthcare. It is currently in Phase 1 development.

GSK3640254 bis-hydrochloride salt capsule is a small molecule intervention used in clinical studies. It has been studied in relation to HIV Infections in a Phase 1 study.

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	GSK3640254 bis-hydrochloride salt capsule
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 Compare the Relative Bioavailability of Two Different Formulations of GSK3640254 (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:

GSK3640254 bis-hydrochloride salt capsule CI brief — competitive landscape report
GSK3640254 bis-hydrochloride salt capsule updates RSS · CI watch RSS
ViiV Healthcare portfolio CI

Frequently asked questions about GSK3640254 bis-hydrochloride salt capsule

What is GSK3640254 bis-hydrochloride salt capsule?

GSK3640254 bis-hydrochloride salt capsule is a Small molecule drug developed by ViiV Healthcare.

Who makes GSK3640254 bis-hydrochloride salt capsule?

GSK3640254 bis-hydrochloride salt capsule is developed by ViiV Healthcare (see full ViiV Healthcare pipeline at /company/viiv-healthcare).

What development phase is GSK3640254 bis-hydrochloride salt capsule in?

GSK3640254 bis-hydrochloride salt capsule is in Phase 1.

Manufacturer: ViiV Healthcare — full pipeline

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