Last reviewed 2026-06-01 · How we verify

Oltipraz 1 (90mg)

PharmaKing · Phase 3 active Small molecule Under review

Oltipraz 1 (90mg) is a Phase II enzyme inducer Small molecule drug developed by PharmaKing. It is currently in Phase 3 development for Cancer chemoprevention in high-risk populations, Aflatoxin-induced hepatocellular carcinoma prevention.

Oltipraz is an organosulfur compound that induces phase II detoxification enzymes and antioxidant pathways, enhancing cellular defense against oxidative stress and carcinogens.

Oltipraz 1 (90mg) is being studied for its efficacy and safety in reducing liver fat in patients with non-alcoholic fatty liver disease, except for those with liver cirrhosis. This 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 1 (90mg)
Sponsor	PharmaKing
Drug class	Phase II enzyme inducer
Target	NQO1, GST, Nrf2 pathway
Modality	Small molecule
Therapeutic area	Oncology
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 protective pathways, it increases the body's ability to neutralize and eliminate carcinogenic and toxic compounds, thereby reducing cancer risk and oxidative damage.

Approved indications

Cancer chemoprevention in high-risk populations
Aflatoxin-induced hepatocellular carcinoma prevention

Common side effects

Gastrointestinal disturbance
Headache
Dizziness

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 1 (90mg) CI brief — competitive landscape report
Oltipraz 1 (90mg) updates RSS · CI watch RSS
PharmaKing portfolio CI

Frequently asked questions about Oltipraz 1 (90mg)

What is Oltipraz 1 (90mg)?

Oltipraz 1 (90mg) is a Phase II enzyme inducer drug developed by PharmaKing, indicated for Cancer chemoprevention in high-risk populations, Aflatoxin-induced hepatocellular carcinoma prevention.

How does Oltipraz 1 (90mg) work?

Oltipraz is an organosulfur compound that induces phase II detoxification enzymes and antioxidant pathways, enhancing cellular defense against oxidative stress and carcinogens.

What is Oltipraz 1 (90mg) used for?

Oltipraz 1 (90mg) is indicated for Cancer chemoprevention in high-risk populations, Aflatoxin-induced hepatocellular carcinoma prevention.

Who makes Oltipraz 1 (90mg)?

Oltipraz 1 (90mg) is developed by PharmaKing (see full PharmaKing pipeline at /company/pharmaking).

What drug class is Oltipraz 1 (90mg) in?

Oltipraz 1 (90mg) belongs to the Phase II enzyme inducer class. See all Phase II enzyme inducer drugs at /class/phase-ii-enzyme-inducer.

What development phase is Oltipraz 1 (90mg) in?

Oltipraz 1 (90mg) is in Phase 3.

What are the side effects of Oltipraz 1 (90mg)?

Common side effects of Oltipraz 1 (90mg) include Gastrointestinal disturbance, Headache, Dizziness.

What does Oltipraz 1 (90mg) target?

Oltipraz 1 (90mg) targets NQO1, GST, Nrf2 pathway and is a Phase II enzyme inducer.

Drug class: All Phase II enzyme inducer drugs
Target: All drugs targeting NQO1, GST, Nrf2 pathway
Manufacturer: PharmaKing — full pipeline
Therapeutic area: All drugs in Oncology
Indication: Drugs for Cancer chemoprevention in high-risk populations
Indication: Drugs for Aflatoxin-induced hepatocellular carcinoma prevention

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