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ademetionine butanedisulfonate (Samyr / Transmetil / Donamet)

✓ Approved

AbbVie, Inc. · 小分子 · 小分子

什么是 ademetionine butanedisulfonate？

ademetionine butanedisulfonate 是一种小分子，由AbbVie, Inc.研发。该药已获批，用于治疗相关适应症，给药途径：Oral (PO)。

药物档案

商品名Samyr, Transmetil, Donamet
公司AbbVie, Inc.
药物类别小分子
给药途径Oral (PO)
状态Approved
来源： ClinicalTrials.gov, AbbVie, Inc.

治疗适应症

ademetionine butanedisulfonate 针对 2 个适应症，涉及 1 个治疗领域。

治疗领域疾病/病症分期
Hepatobiliary disordersHepatic function abnormal✓ Approved
Hepatobiliary disordersMetabolic dysfunction-associated steatohepatitisPhase III

相关研究文献

PubMedAmerican journal of translational research2026-10-25

Ademetionine 1,4-butanedisulfonate plus dexamethasone for cholestatic hepatitis: therapeutic efficacy and risk factors.

Mo Qiong Q, Kong Dena D, Song Le L, He Lijun L et al.

This retrospective study analyzes how patients with cholestatic hepatitis (CH) have responded to the dual-drug therapy consisting of Ademetionine 1,4-Butanedisulfonate (SAMe-BD) and Dexamethasone (DEX) and discusses the associated risk factors. First, we enrolled 128 CH patients admitted to our hospital (July 2022-July 2025), with 60 patients in the control group receiving SAMe-BD, and the remaining 68 cases in the research group receiving SAMe-BD+DEX. We then conducted comparative assessments of the following outcome measures: therapeutic efficacy, safety (nausea, diarrhea, insomnia, myalgia), symptom relief (fatigue, itching), liver function (total bilirubin [TBIL], alanine transaminase [ALT], alkaline phosphatase [ALP], γ-glutamyltransferase [GGT]), inflammation (interleukin [IL]-6, tumor necrosis factor [TNF-α]), fibrosis markers (type III procollagen peptide [PCIII], hyaluronic acid [HA], laminin [LN]), and serum lipid profiles (total cholesterol [TC], triglyceride [TG], low-density lipoprotein cholesterol [LDL-C]). Significant clinical correlates of therapeutic efficacy were analyzed using univariate and multivariate approaches. In the research group, markedly greater overall efficacy was observed compared to controls, alongside an equivalent incidence of total adverse reactions, significantly better symptom relief, and notably lower post-treatment levels of indices associated with liver function, inflammation, fibrosis, and blood lipids. Through further analysis, diabetes comorbidity, ALP, and therapeutic method were identified as independent determinants of therapeutic efficacy in CH patients. These findings support the role of SAMe-BD+DEX in significantly enhancing therapeutic effectiveness in CH patients. Also, the risk of treatment ineffectiveness is heightened in patients presenting with diabetes or high pre-treatment ALP, as well as in those using SAMe-BD alone.

PMID 42923650
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PubMedFrontiers in pharmacology2026-09-06

Temporal association between adjunctive bicyclol initiation and discordant biochemical trends in severe early-onset pregnancy-associated cholestasis: a Case Report.

Wang Chun-Fei CF, Wei Qiang Q, Yao Kui K

Severe early-onset pregnancy-associated cholestasis with atypical features may reflect an intrahepatic cholestasis of pregnancy (ICP) component superimposed on underlying hepatobiliary disease. Evidence for bicyclol use during pregnancy is very limited. A 34-year-old pregnant woman, developed palmoplantar pruritus and severe cholestasis at 15 weeks of gestation. She had previously undergone cholecystectomy and common bile duct exploration. The working diagnosis was pregnancy-associated cholestasis with a possible ICP component superimposed on suspected chronic hepatobiliary dysfunction. Biochemical abnormalities persisted despite treatment with ursodeoxycholic acid, ademetionine, glutathione, and polyene phosphatidylcholine. Off-label bicyclol at 50 mg three times daily was added at 29 weeks and continued for approximately 5 weeks. Before bicyclol was added, alanine aminotransferase (ALT) level ranged from 724 to 1,492 U/L, and total bile acids (TBA) level ranged from 111.2 to 224.6 μmol/L. Following bicyclol initiation, ALT ranged from 137 to 464 U/L. TBA remained markedly elevated, ranging from 96.7 to 146.6 μmol/L. Total bilirubin ranged from 42.8 to 46.5 μmol/L. Overall, aminotransferase levels were lower than the pretreatment range, whereas TBA and total bilirubin remained markedly elevated. Cesarean delivery was performed at 34+1 weeks of gestation because of worsening maternal symptoms and persistent hyperbilirubinemia. Grade III meconium-stained amniotic fluid was noted during surgery. A liveborn female infant was delivered with Apgar scores of 10, 10, and 10 at 1, 5, and 10 min, respectively. No early neonatal complications were observed. At 42 days postpartum, liver tests remained mildly abnormal, which suggested persistent hepatobiliary dysfunction rather than cholestasis limited to pregnancy. A temporal association was observed between bicyclol initiation and lower aminotransferase levels. However, this temporal association should not be interpreted as evidence of causality because multiple factors, including substantial pretreatment biochemical variability, concomitant multidrug therapy, advancing gestation, and possible underlying hepatobiliary disease, may have contributed to the observed changes. This case does not establish efficacy, pregnancy prolongation, or maternal and fetal safety. Instead, it provides a hypothesis-generating observation and highlights the need for further structural and genetic evaluation and systematic studies with long-term infant follow-up.

PMID 42698751
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PubMedInternational journal of surgery case reports2026-08-11

Eosinophilic cholecystitis associated with vanishing bile duct syndrome: a rare case report of drug-induced hepatobiliary injury.

Garg Gaurav G, Sain Soumyadip S, Das Subhashish S, Rao Seema S et al.

Eosinophilic cholecystitis (EC) is a rare histopathological variant, defined by dense transmural eosinophilic infiltration (>90% of inflammatory cells). It is typically an incidental postoperative diagnosis, as its clinical and radiological features mimic those of conventional acute cholecystitis. A 38-year-old female with recurrent pregnancy loss presented with acute cholecystitis and markedly deranged liver function tests in a cholestatic pattern. Magnetic resonance cholangiopancreatography revealed cholelithiasis with an impacted neck calculus without biliary obstruction. She underwent laparoscopic cholecystectomy, and histopathology confirmed EC. The postoperative course was complicated by persistent and worsening cholestasis. Extensive evaluation, including autoimmune, parasitic, and eosinophilic workup, was negative. Endoscopic ultrasound-guided liver biopsy demonstrated vanishing bile duct syndrome (VBDS) with ductopenia, attributed to drug-induced liver injury from complementary and alternative medications. Following withdrawal of the offending agents and initiation of ursodeoxycholic acid and ademetionine, liver function tests progressively improved. This case documents a previously unreported coexistence of EC and VBDS, identified through a systematic literature review. RUCAM-based causality assessment yielded a score of 4 (Possible), supporting drug-induced liver injury from complementary and alternative medications as the probable cause of VBDS. Persistent postoperative cholestasis in EC should prompt evaluation for secondary causes, particularly drug-induced hepatobiliary injury. Multidisciplinary management is essential for optimal outcomes.

PMID 42578076
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PubMedMedicine2026-01-10

Acute hepatitis of unknown origin in 38-year-old man: A case report.

Trifonov Petar P, Todovichin Donika D, Marinova Cvetelina C, Zasheva Anelia A et al.

Acute hepatitis of unknown origin represents a diagnostic and therapeutic challenge, particularly when common viral, autoimmune, and toxic causes of acute liver injury are excluded. We report a case of an adult male. He presents with general fatigue, jaundice, fever, abdominal discomfort. Laboratory findings of severe acute hepatitis and extremely elevated transaminases. Full laboratory, serological, and toxicological tests ruled out viral, autoimmune, and drug-induced hepatitis. Metabolic disorders such as Wilson disease and hemochromatosis were also excluded. Supportive therapy consisting of intravenous glucose solutions, silymarin, vitamin C, and ademetionine was initiated. The patient had rapid clinical improvement, with normalization of liver enzymes at 1-month follow-up. This case shows the importance of a systematic diagnostic approach in acute hepatitis of unknown origin. It suggests that, in adult patients, conservative management with supportive therapy may lead to full recovery despite severe biochemical abnormalities.

PMID 41517723
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PubMedGeorgian medical news2025-11-29

COMPARATIVE ASSESSMENT OF THE EFFECT OF SILYMARIN, FENOFIBRATE, BETAINE AND ADEMETIONINE ON THE DEVELOPMENT OF STEATOHEPATITIS IN WISTAR RATS.

Zozulya A A, Teslevich V V, Abkhazava P P, Ramazanov I I et al.

Metabolic dysfunction-associated steatotic liver disease (MASLD), previously termed NAFLD/MAFLD, can be reproduced in rats by a high-fructose diet and leads to hepatic steatosis and liver injury. To evaluate and compare the effects of silymarin, fenofibrate, betaine and ademetionine on biochemical and morphological manifestations of high-fructose-induced MASLD in rats. Male Wistar rats (n=20 per group) were fed a high-fructose diet for 5 weeks and treated with one of the four agents. Serum ALT and AST activities and hepatic triglyceride (TG) content were measured. Statistical analysis was performed using one-way ANOVA with Tukey HSD post hoc test; results are presented as mean±SD. In the fructose control group ALT and AST were 95.2±2.8 and 88.0±2.1 U/L, respectively; hepatic TG concentration was 12.50±0.38 mg/g. Fenofibrate produced the most pronounced effect, lowering hepatic TG by about 60 % (5.02±0.22 mg/g, p<0.001) and reducing ALT and AST by about 40 % (56.8±2.9 U/L and 55.0±2.4 U/L, p<0.001). Silymarin and betaine induced intermediate reductions (all p<0.001), whereas ademetionine markedly lowered transaminases (p<0.001) with only modest effects on hepatic TG (11.94±0.28 mg/g, p<0.001). Fenofibrate was the most effective agent in preventing fructose-induced hepatic steatosis and transaminase elevation, in line with activation of PPAR-α-dependent β-oxidation and inhibition of lipogenesis.

PMID 41314208
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PubMedFrontiers in physiology2025-04-11

Management of drug-induced liver injury associated with anti-cancer therapy.

Vincenzi Bruno B, Yimin Mao M, Andrade Raúl J RJ, Morales Castillo Mauricio M et al.

Drug-induced liver injury (DILI) is a leading cause of drug withdrawal, a particular cause for concern among patients receiving anti-cancer treatment. This review summarizes the available evidence on the efficacy of hepatoprotective drugs in normalizing liver enzyme abnormalities among patients with DILI due to treatment with anti-cancer therapies. Across relevant publications, the effects of several compounds on anti-cancer therapy-induced DILI were assessed. Treatment with hepatoprotective agents which is usually initiated after DILI has been detected and involves cessation of causative anti-cancer therapy, has demonstrated improvements in liver enzyme elevation. However, prophylactic treatment with two agents in particular, ademetionine and bicyclol have shown hepatoprotective effects that enabled patients to continue with their anti-cancer therapy with a reduced subsequently reduced risk of hepatotoxicity. While these publications show some evidence for the benefits of hepatoprotective agents among patients with DILI due to anti-cancer therapy, more research is needed to fully determine the effects of hepatoprotective drugs in resolving DILI signs and symptoms among patients receiving treatment for cancer.

PMID 40213152
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