Legalon

(silymarin)

ApprovedSmall molecule

Silymarin is used to support liver health and help protect the liver from damage, often taken as a supplement to aid recovery from liver disease or toxic exposure.[2] Legalon is currently approved and in use across 23 indications[4].[1]

Legalon is one of 620 small molecule programs targeting Rheumatic Disease. It is currently in Approved.

Indications

Total Trials

Active Trials

619

Competitors

Pipeline

Status by Indication[4][1]

Indication

Rheumatic DiseaseActive, not recruiting

HepatitisActive, not recruiting

AdenocarcinomaActive, not recruiting

HyperbilirubinemiaActive, not recruiting

Chronic HepatitisActive, not recruiting

Beta-Thalassemia MajorActive, not recruiting

FibrosisActive, not recruiting

PneumoniaActive, not recruiting

HepatotoxicityActive, not recruiting

Metastatic Colorectal CancerActive, not recruiting

Rheumatic DiseasePreclinical

Active, not recruiting

HepatitisApproved

Active, not recruiting

AdenocarcinomaPhase 2/Phase 3

Active, not recruiting

HyperbilirubinemiaPreclinical

Active, not recruiting

Chronic HepatitisPhase 2

Active, not recruiting

Beta-Thalassemia MajorPhase 1

Active, not recruiting

FibrosisPreclinical

Active, not recruiting

PneumoniaPhase 3

Active, not recruiting

HepatotoxicityPreclinical

Active, not recruiting

Metastatic Colorectal CancerPhase 3

Active, not recruiting

Showing 10 of 23 indications

Competition

Competitive Landscape

2828 competitors in Breast Cancer

#DrugCompanyPhaseTrials

Legalon

BBukwang Pharmaceutical

Approved

1 2

Trodelvy

Gilead

Preclinical

37 3

Tykerb

GSK

Preclinical

80 4

Nolvadex

SSan Diego Pacific Oncology & Hematology Associates

Preclinical

78 5

Lexiscan

Astellas

Preclinical

1 6

Lupron

EEastern Cooperative Oncology Group

Preclinical

5 7

Effexor

WWyeth-Lederle Vaccines

Preclinical

2 8

Cortef

PPfizer's Upjohn has merged with Mylan to form Viatris Inc.

Preclinical

1 9

Systemic Therapy

Bristol-Myers Squibb

Preclinical

1 10

Apatinib Mesylate

BBukwang Pharmaceutical

Preclinical

Ranked by pipeline maturity and clinical activity. Current drug highlighted in teal.

Timeline

Expected Milestones

Q4 2026

N/ARecruiting

Fibromyalgia

NCT07293767

Q3 2027

N/ARecruiting

Hyperbilirubinemia

NCT06922669

Clinical

Trials by Indication[1]

Chronic Hepatitis5 trials

Clinical Study With Silymarin in the Patients With Chronic Hepatitis C Infection Who Failed Conventional Antiviral Therapy

Completed·BBukwang Pharmaceutical·Phase 3·NCT01258686·53 enrolled

Safety, Metabolism, and Antioxidant Activity of Silymarin and Green Tea Extract in Patients With Chronic Hepatitis C

Completed·UUniversity of North Carolina, Chapel Hill·Phase 1·NCT01018615·28 enrolled

Phase II Trial of Silymarin for Patients With Chronic Hepatitis C Who Have Failed Conventional Antiviral Treatment

Completed·NNational Center for Complementary and Integrative Health (NCCIH)·Phase 2·NCT00680342·154 enrolled

Show 2 more trials

Evaluating Silymarin for Chronic Hepatitis C

Completed·NNational Center for Complementary and Integrative Health (NCCIH)·Phase 2·NCT00030030

Effects of Silybum Marianum on Treatment of Patients With Chronic Hepatitis C

Completed·IIsfahan University of Medical Sciences·Phase 2·NCT01292161·55 enrolled

Hepatotoxicity2 trials

The Efficacy of Silymarin on the Prevention of Hepatotoxicity From Antituberculosis Drugs

Completed·RRamathibodi Hospital·N/A·NCT01800487·80 enrolled

Effect of Prophylactic Use of Silymarin on Hepatotoxicity Induced by Anti-tuberculosis Drugs

Unknown status·SSeoul National University Hospital·N/A·NCT01436929·600 enrolled

Completed·TTehran University of Medical Sciences·Phase 2/3·NCT01829178·30 enrolled

23 more indications

Pneumonia1 trial

Silymarin in COVID-19 Pneumonia

Unknown status·—·Phase 3·NCT04394208·50 enrolled

Metastatic Colorectal Cancer1 trial

Effect of Silymarin in Metastatic Colorectal Cancer Patients

Unknown status·TTanta University·Phase 3·NCT05631041·64 enrolled

NAFLD1 trial

Silymarin in NAFLD

Withdrawn·UUniversity Hospital Rijeka·Phase 4·NCT02973295

Proteinuria1 trial

Impact of Silymarin Adjunct Therapy on Proteinuria in Type 2 Diabetic Patients on RAS Inhibitors

Completed·LLahore General Hospital·Phase 2·NCT06425705·70 enrolled

Chronic Kidney Disease1 trial

Dextromethorphan and Silymarin in Chronic Kidney Disease (CKD) Patients

Unknown status·NNational Cheng-Kung University Hospital·Phase 3·NCT01091324·45 enrolled

Atrial Fibrillation1 trial

Silymarin for the Prevention of Atrial Fibrillation After Cardiac Surgery

Completed·UUniversity of Novi Sad·Phase 3·NCT06114719·160 enrolled

Liver Disease1 trial

Phase I Trial of Silymarin for Chronic Liver Diseases

Completed·NNational Center for Complementary and Integrative Health (NCCIH)·Phase 1·NCT00389376·56 enrolled

Hepatitis C1 trial

A Clinical Research Study Designed To Determine If Treatment of Hepatitis C With Milk Thistle is More Effective Than No Treatment In Patients Infected With Both HIV And Hepatitis C

Completed·HHenry Sacks·Phase 1/2·NCT00246363·40 enrolled

Hyperbilirubinemia1 trial

Glucocorticoids for Acute Drug Induced Liver Injury With Hyperbilirubinemia

Recruiting·GGeneral Hospital of Shenyang Military Region·N/A·NCT06922669·232 enrolled

COVID-191 trial

Silymarin in COVID-19 Patients Admitted to Hospital With Elevated Liver Enzymes

Completed·—·Phase 4·NCT04816682·30 enrolled

Fibrosis1 trial

Impact of Ursodeoxycholic Acid, Silymarin, Antioxidants and Colchicine on Fibrosis Regression in HCV After SVR

Completed·ZZagazig University·N/A·NCT03659058·400 enrolled

Tics1 trial

The Effect of Milk Thistle on the Pharmacokinetics of Indinavir

Completed·NNational Institutes of Health Clinical Center (CC)·Phase 1·NCT00011635·20 enrolled

Efficacy and Safety1 trial

The Efficacy and Safety of Ornithine Aspartic Acid Granules in NAFLD Against Silymarin Capsules

Completed·XXinhua Hospital, Shanghai Jiao Tong University School of Medicine·Phase 4·NCT05042245·237 enrolled

Asthma1 trial

Randomized Controlled Trial of Silymarin in Asthma

Withdrawn·VVanderbilt University·Phase 2/3·NCT01049178

Tuberculosis1 trial

Comparison of the Outcome of Treatment With Silymarin or N-Aceylcysteine in Patients Taking Anti-Tuberculous Drugs for Tuberculosis at a Tertiary Care Hospital , Karachi

Not yet recruiting·LLiaquat National Hospital & Medical College·Phase 1·NCT07058090·410 enrolled

Thalassemia1 trial

Therapeutic Effects of Silymarin in Patients With B-thalassemia Major

Unknown status·IIsfahan University of Medical Sciences·Phase 2/3·NCT00999349·140 enrolled

Beta-Thalassemia Major1 trial

Immunomodulatory Effects of Silymarin in Patients With Beta-Thalassemia Major

Completed·SShiraz University of Medical Sciences·Phase 1·NCT01752153·25 enrolled

Non-Alcoholic Steatohepatitis1 trial

Phase II Trial of Silymarin for Non-Cirrhotic Patients With Non-Alcoholic Steatohepatitis

Completed·MMadaus Inc·Phase 2·NCT00680407·78 enrolled

Hepatitis1 trial

Efficacy of Silymarin for Acute Hepatitis

Completed·UUniversity of Maryland, Baltimore·Phase 4·NCT00412763·200 enrolled

Fibromyalgia1 trial

Silymarin vs Hesperidin/Diosmin in Fibromyalgia

Recruiting·—·N/A·NCT07293767·90 enrolled

Parkinson's Disease1 trial

Role of Silymarin in Neuroprotection and Symptom Management in Parkinson's Disease

Recruiting·TTanta University·Phase 2·NCT07001150·50 enrolled

Colorectal Cancer1 trial

The Efficacy of Silymarin as Adjuvant Therapy on Colorectal Cancer Patients Undergoing FOLFIRI Treatment

Completed·KKaohsiung Medical University Chung-Ho Memorial Hospital·Phase 4·NCT03130634·70 enrolled

Breast Cancer1 trial

Role of Silymarin in Chemotherapy Toxicity and Cognition Improvement in Breast Cancer Patients

Unknown status·TTanta University·Phase 2/3·NCT05595109·56 enrolled

Sources

References

[1]
ClinicalTrials.gov — 33 trial records for silymarin. U.S. National Library of Medicine, National Institutes of Health.
[2]
MedlinePlus Drug Information — Legalon drug information. U.S. National Library of Medicine, National Institutes of Health.
[3]
ChEMBL — silymarin compound record. European Bioinformatics Institute (EMBL-EBI).
[4]
Open Targets Platform — Drug–disease associations for silymarin. EMBL-EBI & Wellcome Sanger Institute.
[5]
SEC EDGAR — Bukwang Pharmaceutical company filings. U.S. Securities and Exchange Commission.

Details

Drug Info

Quick Facts

Modality: Small molecule[3]
Highest Phase: Approved[1]
Company: BBukwang Pharmaceutical

Legalon

Status by Indication[4][1]

Competitive Landscape

Expected Milestones

Q4 2026

Q3 2027

Trials by Indication[1]

Chronic Hepatitis5 trials

Hepatotoxicity2 trials

Drug Interactions1 trial

Rheumatic Disease1 trial

Adenocarcinoma1 trial

Pneumonia1 trial

Metastatic Colorectal Cancer1 trial

NAFLD1 trial

Proteinuria1 trial

Chronic Kidney Disease1 trial

Atrial Fibrillation1 trial

Liver Disease1 trial

Hepatitis C1 trial

Hyperbilirubinemia1 trial

COVID-191 trial

Fibrosis1 trial

Tics1 trial

Efficacy and Safety1 trial

Asthma1 trial

Tuberculosis1 trial

Thalassemia1 trial

Beta-Thalassemia Major1 trial

Non-Alcoholic Steatohepatitis1 trial

Hepatitis1 trial

Fibromyalgia1 trial

Parkinson's Disease1 trial

Colorectal Cancer1 trial

Breast Cancer1 trial

References

Drug Info

Quick Facts

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