Last reviewed 2026-05-27 · How we verify

Vitaliver

Hospital Authority, Hong Kong · Phase 2 active Small molecule ✓ Verified May 2026

Vitaliver is a Small molecule drug developed by Hospital Authority, Hong Kong. It is currently in Phase 2 development.

Vitaliver is a treatment being studied for Hepatitis B, Hepatitis C, and Liver Cirrhosis in a Phase II clinical trial. The trial is evaluating the efficacy and safety of Vitaliver compared to a placebo in patients with decompensated cirrhosis.

Likelihood of approval

15.3% vs 15.3% industry baseline

If approved by FDA: likely 2031–2034

Steps remaining: Phase 3 → NDA/BLA submission

Confidence: Medium

Why this estimate

Baseline phase 2 → approval rate +15.3pp
Industry-wide phase 2 drugs reach approval ~15.3% 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	2031–2034	—
EMA	EU	2032–2035	+0.7 yr
MHRA	GB	2032–2035	+0.7 yr
Health Canada	CA	2032–2036	+0.9 yr
TGA	AU	2032–2036	+1.2 yr
PMDA	JP	2032–2036	+1.5 yr
NMPA	CN	2033–2037	+2.3 yr
MFDS	KR	2032–2036	+1.4 yr
CDSCO	IN	2032–2037	+1.8 yr
ANVISA	BR	2033–2037	+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	Vitaliver
Sponsor	Hospital Authority, Hong Kong
Modality	Small molecule
Therapeutic area	Gastroenterology
Phase	Phase 2

Approved indications

No approved indications tracked.

Common side effects

No common side effects on file.

Key clinical trials

A Phase II, Double-blinded, Randomized, Controlled Study to Evaluate the Efficacy and Safety of Vitalliver in Patients With Decompensated Cirrhosis (PHASE2)

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:

Vitaliver CI brief — competitive landscape report
Vitaliver updates RSS · CI watch RSS
Hospital Authority, Hong Kong portfolio CI

Frequently asked questions about Vitaliver

What is Vitaliver?

Vitaliver is a Small molecule drug developed by Hospital Authority, Hong Kong.

Who makes Vitaliver?

Vitaliver is developed by Hospital Authority, Hong Kong (see full Hospital Authority, Hong Kong pipeline at /company/hospital-authority-hong-kong).

What development phase is Vitaliver in?

Vitaliver is in Phase 2.

Manufacturer: Hospital Authority, Hong Kong — full pipeline
Therapeutic area: All drugs in Gastroenterology

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