Delving into the Latest Updates on Silibinin with Synapse

Overview

Basic Info

Drug Type

Small molecule drug

Synonyms

Silibinin (INN), Silibinin A, Silybin A

+ [12]

Target

HSP90

Action

inhibitors

Mechanism

HSP90 inhibitors(Heat shock 90kDa proteins inhibitors)

Therapeutic Areas

Digestive System DisordersNeoplasmsCardiovascular Diseases+ [3]

Active Indication

Liver DiseasesNeoplasmsDiabetic Retinopathy+ [1]

Inactive Indication

Beta-ThalassemiaIron Overloadliver function failure+ [1]

Originator Organization-

Active Organization

CU Anschutz Medical CampusMax-Planck Institute of Psychiatry

Augusta University

Inactive Organization

Nhat Nhat Pharmaceutical Co.，LtdMadaus SA

License Organization-

Drug Highest PhaseApproved

First Approval Date-

Regulation-

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Structure/Sequence

Molecular FormulaC25H22O10

InChIKeySEBFKMXJBCUCAI-HKTJVKLFSA-N

CAS Registry22888-70-6

Drug-induced liver injury (DILI) can lead to potentially fatal complications, such as acute liver failure and even death. In clinical practice, glucocorticoids have been considered in some cases of DILI, especially patients with hyperbilirubinemia. However, the available evidence remains controversial and its quality is also very limited. Herein, a multicenter randomized controlled trial (RCT) has been designed to explore the efficacy and safety of glucocorticoids in patients with acute DILI and hyperbilirubinemia.

Start Date01 Jun 2025

Sponsor / Collaborator

The General Hospital of Shenyang Military Region

ChiCTR2500099866

/ SuspendedPhase 4IIT

A multicenter, randomized controlled study of silymarin and chiglitazar sodium in patients with T2DM and MASLD

Start Date01 Apr 2025

Sponsor / Collaborator

Southeast University Affiliated Zhonda Hospital

NCT06213857

/ RecruitingPhase 2IIT

Clinical Study Evaluating the Possible Beneficial Effect of Silymarin in Patients With Ulcerative Colitis

The goal of this clinical trial is to evaluate the possible beneficial effect of silymarin in Ulcerative Colitis adult patients receiving mesalamine. This is trial that will be conducted on 44 adult patients with Ulcerative Colitis. Patients will be enrolled after obtaining an informed consent from them or their guardians.
Patients will be recruited from Rajhy Hospital Outpatient Clinics and Health Insurance Outpatient Clinics at Mabarra Hospital in Assiut, Egypt. The patients will be randomized based on hospital admission days into two groups:
* Group Ⅰ (Control group): 22 patients will receive Mesalamine (2g/day) + Azathioprine (50mg/day) for 3 months.
* Group Ⅱ (Silymarin group): 22 patients will receive Mesalamine (2g/day) + Azathioprine (50mg/day) + Silymarin (140 mg/day) for 3 months.
The primary outcome will be clinical improvement defined as a 2 point or more decrease in the Mayo score from baseline. The secondary outcomes will be the change in the level of fecal calprotectin, superoxide dismutase and TNF-α.

Start Date01 Feb 2025

Sponsor / Collaborator

Tanta University

100 Clinical Results associated with Silibinin

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100 Translational Medicine associated with Silibinin

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100 Patents (Medical) associated with Silibinin

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6,756

Literatures (Medical) associated with Silibinin

01 Dec 2025·Molecular Biology Reports

The synergistic effects of citicoline and silymarin on liver injury and thyroid hormone disturbances in γ-irradiated rats

Article

Author: Abdel-Aziz, Nahed ; Ibrahim, Ehab A ; El-Bahkery, Azza

BACKGROUNDExposure to ionizing radiation is inevitable due to its extensive use in industrial and medical applications. The search for effective and safe natural therapeutic agents as alternatives to chemical drugs is crucial to mitigate their side effects. This study aimed to evaluate the effects of citicoline as a standalone treatment or in combination with the anti-hepatotoxic drug silymarin in protecting against liver injury caused by γ-radiation in rats.METHODS AND RESULTSThe rats were exposed to γ-radiation (7 Gy) and treated with citicoline (300 mg/kg/day) and/or silymarin (50 mg/kg/day). The results showed that citicoline alleviated liver damage in irradiated rats by reducing hepatic malondialdehyde levels, serum aspartate aminotransferase activity, and inflammatory mediators such as tumor necrosis factor-alpha (TNF-α), interleukin-1 beta (IL-1β), and nuclear factor-kappa B (NF-κB). It also increased acetylcholine (ACh) levels and the gene expression of the anti-inflammatory protein α7 nicotinic acetylcholine receptor (α7nAChR). Additionally, citicoline improved serum triiodothyronine (T3) levels, thyroid hormone receptor beta (TRβ) gene expression, and iodothyronine deiodinase type 1 activity in hepatic tissues of irradiated rats. Furthermore, citicoline enhanced the effects of silymarin on thyroxine (T4), TRβ, ACh, and α7nAChR when co-administered in irradiated rats. Histopathological analysis confirmed these findings, demonstrating improved liver tissue structure.CONCLUSIONSCiticoline mitigates γ-radiation-induced liver damage by reducing oxidative stress, activating the cholinergic anti-inflammatory pathway, and modulating thyroid hormone metabolism. These findings support the use of citicoline as a safe standalone treatment or as an adjuvant with silymarin for managing liver damage and thyroid hormone disturbances caused by γ-irradiation.

01 Sep 2025·Comparative Biochemistry and Physiology Part D: Genomics and Proteomics

Silymarin mediates the gut-liver axis pathway to alleviate Carassius auratus hepatic lipid metabolism disorders caused by carbonate exposure

Article

Author: Li, Yue-Hong ; Wang, Xin ; Lei, Xin-Yu ; Cao, Xue

An 8-week feeding trial was conducted to investigate the mechanism of silymarin alleviating the abnormal lipid metabolism of Hefang Crucian Carp (HCC) (13.43 ± 0.059 g) liver caused by carbonate exposure. The fish were randomly divided into three groups: Control group (group B, 0 g/L carbonate, 0 mg/kg silymarin), carbonate stress group (group CA, 3 g/L carbonate, 0 mg/kg silymarin) and silymarin group (group SI, 3 g/L carbonate, 60 mg/kg silymarin). The results showed that the growth performance of group CA was significantly increased compared with group B. Compared with CA group, brush villi in SI group recovered significantly, and the width of submucosa decreased. Compared with group B, the intestinal barrier was damaged and permeability increased in group CA, while the damage was alleviated in group SI. Intestinal microbiota analysis showed that the bacterial community function genes related to lipopolysaccharide biosynthesis protein and lipopolysaccharide biosynthesis in CA group were higher than those in B and SI groups, and it was found that the change of LPS content in fish was echoed by the results of intestinal microflora. Compared with group B, the liver of group CA was damaged and the lipid metabolism process was abnormal, resulting in lipid metabolism disorder. SI group alleviated the liver damage caused by carbonate exposure, promoted the process of liver lipid synthesis, and balanced the body's lipid metabolism. More than 50 % of the metabolites are closely related to lipids and lipid molecules. The most metabolites in metabolism are oxidative phosphorylation and pyruvate metabolism. In summary, this study demonstrated that silymarin alleviating carbonate exposure altered intestinal microbiota homeostasis in HCC, leading to intestinal inflammation and increased mucosal barrier permeability, inhibiting LPS synthesis and absorption, preventing it from entering the liver through the intestinal liver, and increasing oxidative stress in the liver and abnormal lipid metabolism in the liver, thereby leading to liver injury. To provide theoretical basis for the development and utilization of silymarin functional feed additives and the mitigation strategy of carbonate exposure to liver damage in fish.

01 Jul 2025·Archives of Biochemistry and Biophysics

AMPK-YAP signaling pathway-mediated mitochondrial dynamics and mitophagy participate in the protective effect of silibinin on HaCaT cells under high glucose conditions

Article

Author: Sun, Xueying ; Wang, Lu ; Xia, Junlong ; Zhang, Xiaodi ; Ye, Shasha ; Shen, Naiying ; Wang, Xianshi

UVB irradiation and diabetes lead to skin injury. However, UVB irradiation has rarely been studied in the field of diabetes. Silibinin has a positive therapeutic effect on many diseases. Nevertheless, the inhibitory effects of silibinin on UVB-induced damage to epidermal cells under high glucose (HG) conditions have been infrequently investigated. Consequently, this study examined the protective efficacy and mechanisms of silibinin in mitigating UVB-induced apoptosis in epidermal cells cultured under HG conditions. The effects of combination of HG and UVB on mitochondrial apoptosis and pro-inflammatory factors production in human immortalized keratinocytes (HaCaT) were mitigated by silibinin. Meantime, silibinin reversed the UVB-induced imbalance of fission/fusion in HG-cultured HaCaT cells. Furthermore, UVB exposure increased ROS levels and reduced mitophagy in HaCaT cells under HG conditions; however, these effects were subsequently reversed by silibinin treatment. AMPK preserves energy balance by negatively regulating YAP. Silibinin increased the levels of p-AMPK and cytoplasmic YAP proteins in HaCaT cells subjected to HG and UVB treatment. Moreover, silibinin improved the dysfunction of mitochondrial dynamics, increased mitophagy levels, the viability and the expression of cytoplasmic YAP protein, and these effects were reversed via the application of an AMPK inhibitor (compound C). In summary, silibinin safeguarded epidermal cells from UVB-induced apoptosis under HG conditions by modulating mitochondrial dynamics and mitophagy through the AMPK-YAP signaling pathway.

1

News (Medical) associated with Silibinin

16 Feb 2024

·www.prnewswire.com

Capsulyte Unveils PREGAME: The Ultimate Solution for Party Recovery, Marking Its Debut at DC Fashion Week

Capsulyte PREGAME, a doctor formulated supplement to aid alcohol recovery, launches at DC Fashion Week as the hangover recovery market is set to grow over the next decade. CRANBURY, N.J., Feb. 16, 2024 /PRNewswire/ -- Capitalizing on cutting-edge ingredients, Capsulyte's PREGAME has emerged as the most advanced product to aid in party recovery and address symptoms often associated with hangovers. As a significant milestone for the brand, Capsulyte has been invited to participate in the prestigious DC Fashion Week, a testament to the company's alignment with premium lifestyles and the fashion industry's elite. This invitation further underscores Capsulyte's commitment to excellence and positions PREGAME as the preferred choice for discerning individuals seeking to enjoy social occasions to the fullest, without the next-day regrets. Many individuals face the unpleasant reality of hangover symptoms such as headaches, fatigue, and nausea, resulting from alcohol consumption. These effects can be primarily attributed to acetaldehyde, a toxic compound that is created when the liver metabolizes alcohol. According to Persistence Market Research, the global hangover recovery market is estimated to reach $4.2 billion by the year 2030. PREGAME is uniquely situated to help solve the issue of acetaldehyde accumulation among individuals who want to live healthy, balanced lives while also maintaining their productivity. PREGAME addresses the challenge of party recovery head-on with a formulation enriched with the scientifically backed ingredients Siliphos® and Clovinol® to support liver detoxification, overall liver health, and acetaldehyde metabolism. Siliphos®, a patented botanical derivative from milk thistle, has been clinically shown to improve liver function, inhibit fibrotic cells, and shield against oxidative stress. Its unique Phytosome technology enhances the bioavailability of silybin, a key component for liver health that is otherwise poorly absorbed by the body. This innovative approach ensures marked improvement over standard milk thistle extracts, offering comprehensive liver protection and recovery. Clovinol®, sourced from the potent spice clove, is distinguished by its capacity to increase the potent antioxidant, glutathione. It's also a robust liver protector that accelerates the elimination of acetaldehyde from the body up to 2.5 times faster than usual, thereby reducing alcohol's negative effects and the severity of symptoms associated with hangovers. With the synergy of Siliphos® and Clovinol®, combined with Dihydromyricetin (DHM) and N-Acetyl Cysteine (NAC), PREGAME represents the pinnacle of a doctor-formulated, research-backed solution for those seeking to mitigate the aftereffects of alcohol consumption. As the brand marks its presence at DC Fashion Week, Capsulyte is set to redefine the standards of social indulgence and wellness. Its participation not only highlights the efficacy and luxury associated with PREGAME but also solidifies Capsulyte's stance as a trailblazer in the dietary supplement industry. Unlock the ability to embrace a healthier, more vibrant lifestyle with Capsulyte's PREGAME, where premium care meets unparalleled social experiences. Capsulyte's PREGAME and HYDRATION are available on the store site and Amazon. FDA Disclaimer: The statements made regarding this product have not been evaluated by the Food and Drug Administration. These products are not intended to diagnose, treat, cure or prevent any disease. All information presented here is not meant as a substitute for or alternative to information from healthcare practitioners. Please consult your doctor. The news site hosting this press release is not associated with Capsulyte. It is merely publishing a press release announcement submitted by a company, without any stated or implied endorsement of the product or service. About Capsulyte Capsulyte is a doctor-founded dietary supplement company dedicated to enhancing the health and wellbeing of individuals through scientifically backed, innovative products. Specializing in alcohol and party recovery solutions, Capsulyte is committed to delivering superior quality, efficacy, and safety in every product, supporting people in living their best lives. For more information, visit Press Contact Dan Nguyen 908-292-3110 SOURCE Capsulyte

100 Deals associated with Silibinin

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External Link

KEGG	Wiki	ATC	Drug Bank
D08515	Silibinin	A05BA03	DB09298

R&D Status

Approved

10 top approved records.

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Indication	Country/Location	Organization	Date
Liver Diseases	-	-	-

Developing

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
liver function failure	Phase 2	Vietnam	Nhat Nhat Pharmaceutical Co.，Ltd	15 Jun 2017
Beta-Thalassemia	Phase 2	Iran	Madaus SA	01 Mar 2009
Iron Overload	Phase 2	Iran	Madaus SA	01 Mar 2009
Nonalcoholic Steatohepatitis	Phase 2	United States	Madaus SA	01 Apr 2008
Neoplasms	Preclinical	United States	CU Anschutz Medical Campus	29 Apr 2025
Diabetic Retinopathy	Preclinical	United States	Augusta University	01 May 2022
Cushing Syndrome	Preclinical	Germany	Max-Planck Institute of Psychiatry	09 Feb 2015

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Clinical Result

Indication

Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


AACR2025	Not Applicable	Hepatocellular Carcinoma cortisol- \| leptin-	-	Silymarin	roopgaureb(cdoqnvoeoh) = aolpvuwsgj xoldfjywae (bgppvfujpt )	-	29 Apr 2025
SUSTAIN (ASCO2023) Manual	Phase 2	Brain metastases	30	silibinin	(mcvklyyhja) = Two pts discontinued silibinin-based nutraceutical assumption due to G1 nausea. No other adverse events were reported. ljhyxbxedu (srlyjawkev )	Positive	31 May 2023
NCT00915681 (CTgov)	Phase 2	liver function failure \| Mushroom Poisoning	148	Silibinin	yodackqvai(vdfolwhclz) = lvcwceomzy hkqdseqfle (acxzogpaln, zizrhhenqq - csixzymwei) View more	-	07 Apr 2022
UEGW2019	Not Applicable	Metabolic dysfunction-associated steatotic liver disease	80	Vitamin E 400 IU	rkfvbvsivh(fhlgdktmzm) = ncnqsduxik uuyztbjhuw (nevlcbkecw ) View more	Positive	01 Oct 2019
				Silymarin 280mg	rkfvbvsivh(fhlgdktmzm) = pknftxmzex uuyztbjhuw (nevlcbkecw ) View more
NCT00680407 (Pubmed)	Phase 2	Nonalcoholic Steatohepatitis	78	Legalon® 420 mg	fwklirmsrz(iyuacupyey) = mpzmvvbenc warhftbxgk (qkcwugvwof )	-	01 Jan 2019
				Legalon® 700 mg	fwklirmsrz(iyuacupyey) = txonxzxswo warhftbxgk (qkcwugvwof )
NCT02006498 (Pubmed \| Clin Gastroenterol Hepatol) Manual	Phase 2	Nonalcoholic Steatohepatitis	99	Silymarin	(seiveocmrj) = uwupvmvvwz tegarlfall (ayhorvtatc ) View more	Positive	01 Dec 2017
				Placebo	(seiveocmrj) = zhduhwfuje tegarlfall (ayhorvtatc ) View more
NCT00680407 (SyNCH, CTgov)	Phase 2	Nonalcoholic Steatohepatitis	78	Silymarin 420 mg (Silymarin 420 mg)	(mwjevzhwax) = sovhfglupt daxjnaodqd (eeonawlmdt, oarkajtjgs - feltlirnue) View more	-	29 Jan 2016
				Silymarin 700 mg (Silymarin 700 mg)	(mwjevzhwax) = tvjndeubry daxjnaodqd (eeonawlmdt, mvrhyprjyh - jxcltipkzn) View more
Pubmed \| Chin J Integr Med	Not Applicable	Colitis, Ulcerative	80	Silymarin	(jzrjenxvrm) = nsfnmfptzp cfflnzxqmv (jahluxiiyd ) View more	Positive	01 Dec 2015
				Placebo	(jzrjenxvrm) = mppbfurred cfflnzxqmv (jahluxiiyd ) View more
Pubmed	Not Applicable	Metabolic dysfunction-associated steatotic liver disease	36	Silymarin plus vitamin E	dnmpvnibif(shagnibboy) = cyunfakqxm ppwjkuslbh (cxxgnvjvup )	Positive	01 Aug 2015
				silymarin (Hypocaloric diet)	dnmpvnibif(shagnibboy) = rpqkdismgb ppwjkuslbh (cxxgnvjvup )
NCT00487721 (CTgov)	Phase 2	Localized Prostate Carcinoma	12	Silibin-Phytosome (Silibin-Phytosome)	gwuatyuzct(tfpfmsxjpi) = rbwlkylqih irvkekxeaa (grpelbolxi, bstgdhdyyc - npdpppnxho) View more	-	28 Feb 2014
				placebo (Control)	ymhuqcmaek(pnyonniqrl) = vflukdgymi ojndawrowd (srfppswggi, ygejtlovbf - admmliyoue) View more