Last reviewed 2026-05-22 · How we verify

Sillymarin

University of Malaya · Phase 2 active Small molecule ✓ Verified May 2026

Sillymarin is a Small molecule drug developed by University of Malaya. It is currently in Phase 2 development. Also known as: Legalon.

Silymarin is being studied as a potential treatment for Non-alcoholic Fatty Liver Disease (NAFLD) in a randomized, double-blind, placebo-controlled clinical trial. The trial is assessing the safety and efficacy of 700 mg Silymarin capsules taken three times a day.

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	Sillymarin
Also known as	Legalon
Sponsor	University of Malaya
Modality	Small molecule
Therapeutic area	Other
Phase	Phase 2

Approved indications

No approved indications tracked.

Common side effects

No common side effects on file.

Key clinical trials

Silymarin for the Treatment of Non-Alcoholic Fatty Liver Disease (NAFLD) (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:

Sillymarin CI brief — competitive landscape report
Sillymarin updates RSS · CI watch RSS
University of Malaya portfolio CI

Frequently asked questions about Sillymarin

What is Sillymarin?

Sillymarin is a Small molecule drug developed by University of Malaya.

Who makes Sillymarin?

Sillymarin is developed by University of Malaya (see full University of Malaya pipeline at /company/university-of-malaya).

Is Sillymarin also known as anything else?

Sillymarin is also known as Legalon.

What development phase is Sillymarin in?

Sillymarin is in Phase 2.

Manufacturer: University of Malaya — full pipeline
Therapeutic area: All drugs in Other
Also known as: Legalon

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