Last reviewed 2026-05-31 · How we verify

Oltipraz 2 (120mg)

PharmaKing · Phase 3 active Small molecule Under review

Oltipraz 2 (120mg) is a Phase II enzyme inducer / chemopreventive agent Small molecule drug developed by PharmaKing. It is currently in Phase 3 development for Hepatocellular carcinoma chemoprevention in patients with chronic hepatitis B, Aflatoxin-related cancer prevention.

Oltipraz is an organosulfur compound that induces phase II detoxification enzymes and antioxidant pathways to protect cells from oxidative stress and carcinogenic damage.

Oltipraz 2 (120mg) is being studied in a clinical trial for its efficacy and safety in reducing liver fat in patients with non-alcoholic fatty liver disease. The study is a multicenter, randomized, double-blind, placebo-controlled, parallel phase 3 clinical trial.

Likelihood of approval

61.3% vs 58.3% industry baseline

If approved by FDA: likely 2028–2030

Steps remaining: NDA/BLA submission

Confidence: High

Why this estimate

Baseline phase 3 → approval rate +58.3pp
Industry-wide phase 3 drugs reach approval ~58.3% of the time (BIO/Informa 2023 industry benchmark across all therapeutic areas).
Oncology Phase 3 boost +3.0pp
Oncology Phase 3 trials have higher approval rates (~61%) than the cross-industry average due to clearer endpoints and FDA oncology pathway.

Predicted approval windows by jurisdiction (conditional on FDA approval)

Regulator	Country	Likely year	Lag vs FDA
FDA	US	2028–2030	—
EMA	EU	2029–2031	+0.7 yr
MHRA	GB	2029–2031	+0.7 yr
Health Canada	CA	2029–2032	+0.9 yr
TGA	AU	2029–2032	+1.2 yr
PMDA	JP	2029–2032	+1.5 yr
NMPA	CN	2030–2033	+2.3 yr
MFDS	KR	2029–2032	+1.4 yr
CDSCO	IN	2029–2033	+1.8 yr
ANVISA	BR	2030–2033	+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	Oltipraz 2 (120mg)
Sponsor	PharmaKing
Drug class	Phase II enzyme inducer / chemopreventive agent
Target	NAD(P)H quinone oxidoreductase (NQO1), glutathione S-transferases (GSTs)
Modality	Small molecule
Therapeutic area	Oncology / Chemoprevention
Phase	Phase 3

Mechanism of action

Oltipraz acts as a potent inducer of NAD(P)H quinone oxidoreductase (NQO1) and glutathione S-transferases (GSTs), which are phase II detoxification enzymes. By upregulating these cytoprotective pathways, it enhances cellular defense against oxidative stress, electrophilic compounds, and carcinogenic agents. This mechanism has been explored primarily for chemoprevention in high-risk populations.

Approved indications

Hepatocellular carcinoma chemoprevention in patients with chronic hepatitis B
Aflatoxin-related cancer prevention

Common side effects

Gastrointestinal disturbance
Elevated liver enzymes
Rash

Key clinical trials

Efficacy and Safety of Oltipraz for Liver Fat Reduction in Patients With Non-Alcoholic Fatty Liver Disease Except for Liver Cirrhosis (PHASE3)

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:

Oltipraz 2 (120mg) CI brief — competitive landscape report
Oltipraz 2 (120mg) updates RSS · CI watch RSS
PharmaKing portfolio CI

Frequently asked questions about Oltipraz 2 (120mg)

What is Oltipraz 2 (120mg)?

Oltipraz 2 (120mg) is a Phase II enzyme inducer / chemopreventive agent drug developed by PharmaKing, indicated for Hepatocellular carcinoma chemoprevention in patients with chronic hepatitis B, Aflatoxin-related cancer prevention.

How does Oltipraz 2 (120mg) work?

Oltipraz is an organosulfur compound that induces phase II detoxification enzymes and antioxidant pathways to protect cells from oxidative stress and carcinogenic damage.

What is Oltipraz 2 (120mg) used for?

Oltipraz 2 (120mg) is indicated for Hepatocellular carcinoma chemoprevention in patients with chronic hepatitis B, Aflatoxin-related cancer prevention.

Who makes Oltipraz 2 (120mg)?

Oltipraz 2 (120mg) is developed by PharmaKing (see full PharmaKing pipeline at /company/pharmaking).

What drug class is Oltipraz 2 (120mg) in?

Oltipraz 2 (120mg) belongs to the Phase II enzyme inducer / chemopreventive agent class. See all Phase II enzyme inducer / chemopreventive agent drugs at /class/phase-ii-enzyme-inducer-chemopreventive-agent.

What development phase is Oltipraz 2 (120mg) in?

Oltipraz 2 (120mg) is in Phase 3.

What are the side effects of Oltipraz 2 (120mg)?

Common side effects of Oltipraz 2 (120mg) include Gastrointestinal disturbance, Elevated liver enzymes, Rash.

What does Oltipraz 2 (120mg) target?

Oltipraz 2 (120mg) targets NAD(P)H quinone oxidoreductase (NQO1), glutathione S-transferases (GSTs) and is a Phase II enzyme inducer / chemopreventive agent.

Drug class: All Phase II enzyme inducer / chemopreventive agent drugs
Target: All drugs targeting NAD(P)H quinone oxidoreductase (NQO1), glutathione S-transferases (GSTs)
Manufacturer: PharmaKing — full pipeline
Therapeutic area: All drugs in Oncology / Chemoprevention
Indication: Drugs for Hepatocellular carcinoma chemoprevention in patients with chronic hepatitis B
Indication: Drugs for Aflatoxin-related cancer prevention

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