A Multicenter, Open-Label, Extension Clinical Trial to Evaluate Safety and Efficacy of Saroglitazar Magnesium in Participants with Primary Biliary Cholangitis (PBC)

Open-Label Extension Study of Saroglitazar Magnesium in Participants With Primary Biliary Cholangitis

Start Date16 Jul 2024

Sponsor / Collaborator

Zydus Wellness Ltd.

CTRI/2024/03/063735 / Not yet recruitingPhase 3IIT

Effect of Saroglitazar on hepatic steatosis in non-alcoholic fatty liver disease patients: a randomised double blind placebo controlled trial - NAFLD

Start Date31 Mar 2024

Sponsor / Collaborator-

CTRI/2023/11/059677 / Not yet recruitingPhase 4IIT

Randomised Open Label Comparative Study Of Saroglitazar In Patients Of Non Alcoholic Fatty Liver Disease With Type 2 Diabetes Mellitus And Non Diabetic Population - NIL

Start Date15 Nov 2023

Sponsor / Collaborator-

100 Clinical Results associated with Saroglitazar

100 Translational Medicine associated with Saroglitazar

100 Patents (Medical) associated with Saroglitazar

123

Literatures (Medical) associated with Saroglitazar

01 Dec 2024·Molecular Biology Reports

The effect of saraglitazar on TGF-β-induced smad3 phosphorylation and expression of genes related to liver fibrosis in LX2 cell line

Article

Author: Dinarvand, Negar ; Shakerian, Elham ; Bavarsad, Samaneh Salehipour ; Afarin, Reza ; Mohammadtaghvaei, Narges

BACKGROUND AND PURPOSELiver fibrosis is a reversible liver injury that occurs as a result of many chronic inflammatory diseases and can lead to cirrhosis, which is irreversible and fatal. So, we studied the anti-fibrotic effects of saroglitazar on LX-2 cell lines, as a dual PPARα/γ agonist.METHODSCells, after 80% confluence, were treated with TGF-β (2 ng/mL) for 24 h. Then cells were treated with saroglitazar at different doses (2.5, 5, 10 µM) for 24 h. After same incubation, the cells of control group, TGF-β group, and TGF-β + saroglitazar group were harvested for RNA and protein extraction to determine the effects of saroglitazar. RT-PCR and western blot methods were used to express genes related to fibrosis.RESULTSOur results show that the relative expression of α-SMA, collagen1α, N-cadherin, NOX (1, 2, and 4), and phosphorylated Smad3 protein was significantly higher in TGF-β-treated cells compared with the normal group, and E-cadherin expression was decreased in TGF-β-treated cells. After TGF-β-treated cells were exposed to saroglitazar, the expression of these genes was significantly reversed (P < 0.05).CONCLUSIONSOur results clearly show the short-term inhibitory role of saroglitazar in the expression of fibrotic factors using the TGF-β/Smad signaling pathway. These results suggest that saroglitazar can be considered as a suitable therapeutic strategy for fibrotic patients. Although more studies are needed.

01 Dec 2024·Molecular Biology Reports

Lomitapide: navigating cardiovascular challenges with innovative therapies

Review

Author: Sahyoun, Amal M ; Apu, Ehsanul Hoque ; Kassan, Modar ; Kassan, Adam ; Abidi, Ammaar H ; Ait-Aissa, Karima ; Munkhsaikhan, Undral

Dyslipidemia is the most significant risk factor for cardiovascular diseases (CVDs) Secondary dyslipidemia: its treatments and association with atherosclerosis. Glob Health Med, Efficacy and safety of saroglitazar for the management of dyslipidemia: A systematic review and meta-analysis of interventional studies. The current treatment strategies for managing dyslipidemia focus on reducing low-density lipoprotein cholesterol (LDL-C) to minimize the risks of atherosclerosis and myocardial infarction (MI). Homozygous Familial Hypercholesterolemia (HoFH) is an inherited autosomal dominant disease caused by a mutation in the LDL receptor (LDLr), which can lead to extremely high levels of LDL-C The Beneficial Effect of Lomitapide on the Cardiovascular System in LDLr(-/-) Mice with Obesity, The microsomal triglyceride transfer protein inhibitor lomitapide improves vascular function in mice with obesity. Although statin therapy has been the primary treatment for dyslipidemia, HoFH patients do not respond well to statins, requiring alternative therapies. Microsomal triglyceride transfer protein (MTP) inhibition has emerged as a potential therapeutic target for treating HoFH. MTP is primarily responsible for transferring triglyceride and other lipids into apolipoprotein B (ApoB) during the assembly of very low-density lipoprotein (VLDL) particles in the liver. Lomitapide, an inhibitor of MTP, has been approved for treatingof HoFH adults. Unlike statins, lomitapide does not act on the LDLr to reduce cholesterol. Instead, lomitapide lowers the levels of ApoB-containing proteins, primarily VLDL, eventually decreasing LDL-C levels. Studies have shown that lomitapide can reduce LDL-C levels by more than 50% in patients with HoFH who have failed to respond adequately to other treatments. Lowering LDL-C levels is important for preventing atherosclerosis, reducing cardiovascular risk, improving endothelial function, and promoting overall cardiovascular health, especially for patients with HoFH Efficacy and safety of a microsomal triglyceride transfer protein inhibitor in patients with homozygous familial hypercholesterolaemia: a single-arm, open-label, phase 3 study. This review paper focuses on research findings regarding the therapeutic benefits of lomitapide, highlighting its effectiveness in lowering cholesterol levels and reducing the risk of CVDs The microsomal triglyceride transfer protein inhibitor lomitapide improves vascular function in mice with obesity.

01 Dec 2024·NeuroToxicology

Saroglitazar, a PPAR α/γ agonist alleviates 3-Nitropropionic acid induced neurotoxicity in rats: Unveiling the underlying mechanisms

Article

Author: Kolusu, Aravinda Sai ; Arakareddy, Bhanu Prakash ; Samudrala, Pavan Kumar ; Nori, Lakshmi Prashanthi ; Rongala, Suma ; Jakkamsetti, Madhuri Suma

Saroglitazar (SGZ), a peroxisomal proliferated activated receptor α/γ agonist showed neuroprotective effects in various neurodegenerative disorders like Alzheimer's and Parkinson's. However, no studies were performed on Huntington's, so the goal of the current study is to examine the effect of SGZ on Huntington's disease like symptoms induced by 3-Nitropropionic acid. In this protocol, twenty-four rats were divided into four groups, each group consisting of 6 animals. Group 1: The control group received 1 % CMC 10 mg/kg, p.o. for 14 days. Groups 2, 3, and 4 received 3-NP 15 mg/kg, i.p. from Day 1 to Day 7. Groups 3 and 4 received SGZ 5 mg/kg, p.o. and 10 mg/kg, p.o. respectively once daily from day 1 to day 14. Various behavioral tests like OFT, rotarod, hanging wire, narrow beam walk, MWM, and Y-maze were performed. On day-15, the animals were euthanised by cervical dislocation and brain sample were isolated for biochemical and histopathological analysis. Administration of 3-NP showed a significant decrease in motor coordination and cognitive function. Furthermore, 3-NP altered the activity of acetylcholinesterase, anti-oxidant enzymes, Nrf-2, NF-κB, BDNF, CREB levels, and histological features. However, treatment with SGZ showed ameliorative effects in the 3-NP induced neurotoxicity via PPAR α/γ pathway by reducing motor dysfunction, memory impairment, cholinesterase levels, oxidative stress, neuroinflammation. It also enhanced the levels of Nrf-2, BDNF, and CREB expression and improved histological features. In conclusion, treatment with Saroglitazar attenuated Huntington's disease-like symptoms in rats which are induced by 3-NP via activation of PPAR α/γ pathway.

News (Medical) associated with Saroglitazar

02 Oct 2024

·www.prnewswire.com

Ipsen's IQIRVO Approval Has Intensified the Primary Biliary Cholangitis Market Space | DelveInsight

The European Commission has granted conditional approval for Ipsen's IQIRVO (elafibranor) for the treatment of primary biliary cholangitis in adults, marking the first new therapy for this condition to be approved in the EU in almost ten years. With this approval, other companies such as CymaBay Therapeutics, Zydus Therapeutics, GlaxoSmithKline, and others also geared up to bring their candidates into the primary biliary cholangitis market. LAS VEGAS, Oct. 2, 2024 /PRNewswire/ -- Primary biliary cholangitis (PBC), previously referred to as primary biliary cirrhosis, is a long-term liver condition characterized by the gradual destruction of the small bile ducts within the liver, known as intrahepatic bile ducts. Over time, prolonged bile flow obstruction can result in cirrhosis and the development of portal hypertension. As per DelveInsight analysis, in 2023, the total diagnosed prevalent cases of primary biliary cholangitis in the 7MM were approximately 298K. These cases are projected to increase further during the forecast period (2024–2034). In 2023, the United States had the highest proportion of diagnosed prevalent cases of primary biliary cholangitis among the 7MM, comprising approximately 48% of the total cases. DelveInsight's epidemiology model for primary biliary cholangitis estimates a higher prevalence among females across the 7MM. Specifically, in the US in 2023, it suggests approximately 25K cases among males and 117K cases among females, indicating a female predominance. The primary treatment objectives are to reduce the progression rate of the disease and manage symptoms such as itching, osteoporosis, and dry eye/mouth (sicca syndrome). Liver transplantation remains the only life-saving option. Ursodeoxycholic acid (UDCA) is the main medication used to slow disease progression. Patients in the early stages often experience clinical, biochemical, and histological improvements. Studies suggest UDCA postpones the need for liver transplantation and extends survival, though its effectiveness in advanced stages like cirrhosis is uncertain. While initially approved by the US FDA for treating primary biliary cholangitis, UDCA now has generic versions available. The use of corticosteroids in patients without signs of autoimmune hepatitis remains a subject of ongoing research. Studies have shown that combining UDCA with dexamethasone can enhance the activity of the anion exchanger from two alternate promoters in liver cells in vitro. Budesonide is being considered due to its extensive first-pass hepatic metabolism, which may help minimize side effects. Corticosteroids may help relieve symptoms and improve biochemical and histological outcomes, though corticosteroid-induced osteoporosis is a major concern. The criteria for liver transplantation in patients with primary biliary cholangitis are generally the same as those for other chronic liver diseases. However, severe and unmanageable itching is a unique reason for considering a transplant. Fatigue, which may continue after transplantation, is not regarded as an indication for the procedure. Liver transplantation for PBC patients typically offers a better prognosis than for most other chronic liver diseases, with a 5-year survival rate of 84–87% and a 10-year survival rate of 79–84%. In May 2016, the US FDA granted accelerated approval for OCALIVA (obeticholic acid) as a treatment for primary biliary cholangitis. It is approved for use alongside UDCA in adults who do not respond adequately to UDCA, or as a standalone treatment for those who cannot tolerate UDCA. OCALIVA is a semi-synthetic bile acid analog with the chemical structure 6α-ethyl-chenodeoxycholic acid. OCALIVA remains the only approved second-line therapy for this condition. Later, in December 2016, the European Commission gave conditional approval for OCALIVA for the same uses—either in combination with UDCA or as monotherapy for adults unable to tolerate UDCA. Learn more about the FDA-approved primary biliary cholangitis drugs @ Drugs for Primary Biliary Cholangitis Treatment Recently, the European Commission has granted conditional approval for IQIRVO (elafibranor) 80mg tablets for treating primary biliary cholangitis. It can be used alongside ursodeoxycholic acid in adults who have an inadequate response to UDCA or as a standalone therapy for those who cannot tolerate UDCA. This decision follows a positive recommendation from the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) on July 26, 2024, and the US FDA's Accelerated Approval granted on June 10, 2024. Elafibranor, a pioneering molecule, has been marketed and commercialized in the US by Ipsen under the brand name IQIRVO since June 2024. It was originally developed by GENFIT, from its discovery through the completion of a 52-week Phase III clinical trial. In 2021, Ipsen obtained exclusive global rights to elafibranor, except for China, Hong Kong, Taiwan, and Macau, through a licensing agreement with GENFIT. The EU approval was based on favorable outcomes from the Phase III ELATIVE trial, which demonstrated a 47% clinical benefit of IQIRVO combined with UDCA compared to placebo plus UDCA on the composite primary endpoint. The main objective for cholestasis response was defined as alkaline phosphatase (ALP) being less than 1.67 times the upper limit of normal (ULN), with a ≥15% reduction in ALP and total bilirubin levels within the normal range after one year. Additionally, the treatment showed a reduction in pruritus when compared to placebo. Additionally, in August 2024, Gilead Sciences, Inc. announced that the FDA has granted accelerated approval for LIVDELZI (seladelpar) to treat primary biliary cholangitis. This treatment can be used alongside ursodeoxycholic acid in adults who have not responded adequately to UDCA or as a standalone therapy for those unable to tolerate UDCA. Livdelzi is not advised for patients with or who develop decompensated cirrhosis. Seladelpar (MBX-8025) is a potent and selective PPARδ agonist, administered orally, and is currently being developed for patients with PBC who either do not respond to or cannot tolerate UDCA. In March 2024, Gilead Sciences completed its acquisition of CymaBay and announced the validation of a Marketing Authorization Application (MAA) for Seladelpar by the European Medicines Agency (EMA). Seladelpar has been granted Breakthrough Therapy Designation (BTD) by the US FDA, PRIME status by the EMA, and Orphan Drug Designation (ODD) from both agencies, which may accelerate the approval process. To know more about primary biliary cholangitis treatment options, visit @ New Treatment for Primary Biliary Cholangitis With this approval, several companies have also geared up to bring their lead assets into the market. The expected launch of emerging therapies, such as Saroglitazar Magnesium (Zydus Therapeutics), Linerixibat (GlaxoSmithKline), Setanaxib (Calliditas Therapeutics AB), Bezafibrate + obeticholic acid (Intercept Pharmaceuticals/Alfasigma), Volixibat (Mirum Pharmaceuticals), EP547 (Escient Pharmaceuticals), and others are expected to create a positive impact on the market. Other therapies in the early stages of the trial are also being developed. Discover which therapies are expected to grab major primary biliary cholangitis market share @ Primary Biliary Cholangitis Market Report Saroglitazar (LIPAGLYN) comprises two primary types of PPAR agonists: PPARα (alpha) and PPARγ (gamma). This medication simultaneously reduces lipid and glucose levels, effectively decreasing elevated triglycerides and blood sugar while enhancing insulin sensitivity. The US FDA has awarded Saroglitazar orphan drug designation (ODD) and fast track designation (FTD) for primary biliary cholangitis (PBC). It is presently undergoing Phase II/III trials for this condition. Linerixibat (GSK2330672) is a medication under development for patients with primary biliary cholangitis who suffer from itching. It is a small molecule inhibitor of the ileal bile acid transporter (IBAT) that is minimally absorbed and taken as an oral tablet. By preventing the reabsorption of bile acids in the small intestine, linerixibat lowers the levels of pruritic bile acids in the bloodstream. In 2019, the FDA designated it as an orphan drug (ODD). It is currently being evaluated in a Phase III trial for treating cholestatic pruritus in individuals with PBC. Discover more about drugs for primary biliary cholangitis in development @ Primary Biliary Cholangitis Clinical Trials The anticipated launch of these emerging therapies for primary biliary cholangitis are poised to transform the market landscape in the coming years. As these cutting-edge therapies continue to mature and gain regulatory approval, they are expected to reshape the primary biliary cholangitis market landscape, offering new standards of care and unlocking opportunities for medical innovation and economic growth. DelveInsight estimates that the primary biliary cholangitis market saw a significant emergence of a dominant treatment modality, valued at USD 1.1 billion in the 7MM. This modality likely reflects advancements in therapeutic approaches such as first-line agents like UDCA, second-line treatments like obeticholic acid, and potentially emerging biologics or combination therapies aiming to address the complex pathophysiology of PBC, thus enhancing patient outcomes and market share. DelveInsight's latest published market report titled as Primary Biliary Cholangitis Market Insight, Epidemiology, and Market Forecast – 2034 will help you to discover which market leader is going to capture the largest market share. The report provides comprehensive insights into the primary biliary cholangitis country-specific treatment guidelines, patient pool analysis, and epidemiology forecast to help understand the key opportunities and assess the market's underlying potential. The primary biliary cholangitis market report proffers epidemiological analysis for the study period 2020–2034 in the 7MM segmented into: Total Diagnosed Prevalent cases of Primary Biliary Cholangitis Gender-specific Diagnosed Prevalent cases of Primary Biliary Cholangitis Age-specific Diagnosed Prevalent cases of Primary Biliary Cholangitis The report provides an edge while developing business strategies by understanding trends shaping and driving the 7MM primary biliary cholangitis market. Highlights include: 11-year Forecast 7MM Analysis Epidemiology-based Market Forecasting Historical and Forecasted Market Analysis up to 2034 Emerging Drug Market Uptake Peak Sales Analysis Key Cross Competition Analysis Industry Expert's Opinion Access and Reimbursement Download this primary biliary cholangitis market report to assess the epidemiology forecasts, understand the patient journeys, know KOLs' opinions about the upcoming treatment paradigms, and determine the factors contributing to the shift in the primary biliary cholangitis market. Also, stay abreast of the mitigating factors to improve your market position in the primary biliary cholangitis therapeutic space. Related Reports Primary Biliary Cholangitis Pipeline Primary Biliary Cholangitis Pipeline Insight – 2024 report provides comprehensive insights about the pipeline landscape, pipeline drug profiles, including clinical and non-clinical stage products, and the key PBC companies, including Genfit, Zydus Discovery, Ohara Pharmaceutical, Chia Tai Tianqing Pharmaceutical Group Co., Ltd., Novartis, CymaBay Therapeutics, among others. Primary Biliary Cholangitis Epidemiology Forecast Primary Biliary Cholangitis Epidemiology Forecast – 2032 report delivers an in-depth understanding of the disease, historical and forecasted epidemiology, and PBC epidemiology trends. Liver Cirrhosis Market Liver Cirrhosis Market Insights, Epidemiology, and Market Forecast – 2032 report delivers an in-depth understanding of the disease, historical and forecasted epidemiology, as well as the market trends, market drivers, market barriers, and key liver cirrhosis companies, including Madrigal Pharmaceuticals, Inc., Galectin Therapeutics Inc., Grifols Therapeutics LLC, CymaBay Therapeutics, Akero Therapeutics, Inc., NGM Biopharmaceuticals, Inc., Gilead Sciences, Novo Nordisk A/S, Cellaion, Promethera Therapeutics, Lipocine Inc., Bristol Myers Squibb, Prism Pharma, Ohara Pharmaceutical, Shionogi, among others. Liver Cirrhosis Pipeline Liver Cirrhosis Pipeline Insight – 2024 report provides comprehensive insights about the pipeline landscape, pipeline drug profiles, including clinical and non-clinical stage products, and the key liver cirrhosis companies, including Versantis AG, Mirum Pharmaceuticals, Sagimet Biosciences, TenNor Therapeutics, Prism Pharma, Vedanta Biosciences, Intercept Pharmaceuticals, Boehringer Ingelheim, Ohara Pharmaceutical, Ocelot Bio, Calliditas Therapeutics, Galecto Biotech, Pharmicell, among others. About DelveInsight DelveInsight is a leading Business Consultant and Market Research firm focused exclusively on life sciences. It supports pharma companies by providing comprehensive end-to-end solutions to improve their performance. Get hassle-free access to all the healthcare and pharma market research reports through our subscription-based platform PharmDelve . Contact Us Shruti Thakur [email protected] +14699457679 Logo: SOURCE DelveInsight Business Research, LLP WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

Phase 3Drug ApprovalOrphan DrugClinical ResultBreakthrough Therapy

13 Jun 2024

·www.globenewswire.com

From Awareness to Action on Global Fatty Liver Day

Global Liver Institute Unites the Field in Times of Name Changes and New Treatments WASHINGTON, June 13, 2024 (GLOBE NEWSWIRE) -- Today marks the seventh annual Global Fatty Liver Day (formerly International NASH Day), led by Global Liver Institute (GLI) with the theme “Act Now, Screen Today.” This campaign underscores the crucial need for early identification and treatment of fatty liver disease to prevent its progression to chronic liver disease, cirrhosis, or cancer. Fatty liver disease is now estimated to affect 1 in 3 adults worldwide, and its prevalence is increasing. Fatty liver disease during childhood, once unheard of, is also on the rise. Early detection and timely intervention, whether through lifestyle changes or medical treatments, are essential in stopping and even reversing the progression of the disease. “Act Now, Screen Today'' emphasizes that liver health is achievable, but action must begin immediately. Across the globe, partners are driving awareness and educational efforts and ensuring broader access to essential screenings and care. Global Fatty Liver Day, observed annually on the second Thursday of June, is a rallying cry for collective action to address the growing prevalence of fatty liver disease, the most common liver disease worldwide. “Act Now, Screen Today” reminds everyone that liver health is within reach. Here are specific actions you can take today: Take advantage of liver health screening events happening globally to get assessed for fatty liver disease or schedule a check-up with your doctor, especially if you are managing closely associated metabolic conditions like obesity or diabetesIncrease physical activity, as maintaining an active lifestyle can improve liver healthLearn about fatty liver disease and its risk factors to take proactive steps towards prevention and management yourself or learn more about the latest research and guidelines for your patients. With a robust pipeline of pharmaceutical treatments that address diverse mechanisms of action in progress, it is important to identify individuals’ position within the progression of fatty liver disease so that they are poised to receive the most appropriate care possible. Notably, pharmaceutical treatments are available (for certain groups with advanced disease) in two countries, the United States (resmetirom) and India (saroglitazar). “As a community, we stand at a critical time for the broader global health system to act now to support patients,” shares Donna R. Cryer, JD, Founder and CEO of GLI. “As pharmaceutical treatment options gain approval in different geographies, health payers and systems must listen to the call from global advocates and not place undue obstacles to care – whether that be required biopsy, ambiguous lifestyle requirements, or other hurdles – so that patients are able to access the care they require, no matter who or where they are.” Recognizing the importance of early detection, a diverse range of partners, including healthcare providers, patient advocacy groups, and community organizations, have joined forces to “Act Now, Screen Today” and launch screening events around the world. From Chile to Nigeria to the Netherlands, the Philippines, and beyond, these events aim to raise awareness, provide education, and offer screening services to individuals at risk of fatty liver disease or the providers who care for them. Global Fatty Liver Day activities are driving positive change at the grassroots level. “Global Fatty Liver Day is an urgent call-to-action to unite our global efforts to confront the scourge of fatty liver disease,” shares Cat Evans, Director of Program Operations at GLI. “We must act now. By working together, we have the power to create significant change in preventing and managing this pressing health issue through our collaborative efforts.” Although the challenge of fatty liver disease to the well-being of communities around the globe is great, the power of locally-rooted, collective efforts can turn the tide towards positive change by heightening awareness, equipping people and their healthcare providers with prevention and management tools, expanding understanding of the disease through research, and protecting future liver health through effective policies. About Global Liver Institute Global Liver Institute (GLI) is a 501(c)3 nonprofit organization founded in the belief that liver health must take its place on the global public health agenda commensurate with the prevalence and impact of liver illness. GLI promotes innovation, encourages collaboration, and supports the scaling of optimal approaches to help eradicate liver diseases. Operating globally, GLI is committed to solving the problems that matter to liver patients and equipping advocates to improve the lives of individuals and families impacted by liver disease. Follow GLI on Facebook, Instagram, LinkedIn, and YouTube, or visit www.globalliver.org. GLI is the host of Global Fatty Liver Day. Christine Maalouf Global Liver Institutecmaalouf@globalliver.org

100 Deals associated with Saroglitazar

External Link

KEGG	Wiki	ATC	Drug Bank
-	Saroglitazar	C10A	DB13115

R&D Status

Approved

10 top approved records.

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Indication	Country/Location	Organization	Date
Nonalcoholic Steatohepatitis	IN	Zydus Cadila Healthcare Ltd.	30 Dec 2020
Diabetes Mellitus, Type 2	IN	Zydus Lifesciences Ltd.	16 Jan 2020
Hypertriglyceridemia	IN	Zydus Cadila Healthcare Ltd.	05 Jun 2013

Developing

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Primary Biliary Cholangitis	Phase 3	US	Zydus Wellness Ltd.	16 Jul 2024
Primary Biliary Cholangitis	Phase 3	AR	Zydus Wellness Ltd.	16 Jul 2024
Primary Biliary Cholangitis	Phase 3	TR	Zydus Wellness Ltd.	16 Jul 2024
Nonalcoholic Steatohepatitis	Phase 2	MX	Zydus Lifesciences Ltd.	09 Jul 2019
Metabolic dysfunction-associated steatotic liver disease	Phase 2	MX	Zydus Wellness Ltd.	04 Dec 2018
Polycystic Ovary Syndrome	Phase 2	MX	Zydus Wellness Ltd.	04 Dec 2018
Polycystic Ovary Syndrome	Phase 2	US	Zydus Wellness Ltd.	04 Dec 2018
Lipodystrophy	Phase 2	IN	Zydus Lifesciences Ltd.	29 May 2014
Dyslipidemias	Phase 1	US	Zydus Wellness Ltd.	06 Apr 2017
Hypertriglyceridemia	Phase 1	US	Zydus Discovery DMCC Dubai	16 Mar 2017

Clinical Result

Indication

Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT03639623 (CTgov)	Phase 2	Liver transplant rejection \| Metabolic dysfunction-associated steatotic liver disease	20	Saroglitazar	ourmcnmgjr(dggcjjxjsp) = jlzhfmtlpa iabblmoxct (wtyjmafxyn, wzfflexbca - qlzereckzk) View more	-	24 Oct 2024
NCT03061721 (EVIDENCES IV, CTgov)	Phase 2	Nonalcoholic Steatohepatitis	106	Saroglitazar magnesium 1 mg (Saroglitazar Magnesium 1 mg)	ddyernkzfs(yzhksbnghn) = zfzlcefbrc fdvqoprueu (ajlidcfnit, ebcfeaffhf - fqknzwfnpr) View more	-	24 Oct 2024
				Saroglitazar magnesium 2 mg (Saroglitazar Magnesium 2 mg)	ddyernkzfs(yzhksbnghn) = ynchevpzwv fdvqoprueu (ajlidcfnit, lzvkxmhucy - dcqygqskot) View more
NCT03863574 (EVIDENCES VI, CTgov)	Phase 2	Nonalcoholic Steatohepatitis	16	Saroglitazar Magnesium 2mg (Saroglitazar Magnesium 2 mg)	wcgtrvdqdk(ushgdjmipo) = vpyykzbgop lfjqpulmfd (fajlichwgp, unszrrwrvt - rpckumzqbn) View more	-	15 Oct 2024
				Saroglitazar Magnesium 4mg (Saroglitazar Magnesium 4 mg)	wcgtrvdqdk(ushgdjmipo) = obuqwxvqxe lfjqpulmfd (fajlichwgp, jdqgyzeocz - uveaoavyzb) View more
NCT03112681 (EPICS, CTgov)	Phase 2	Primary Biliary Cholangitis	37	Saroglitazar magnesium 2 mg (Saroglitazar Magnesium 2 mg)	cqfhqekuvb(juxsrmfiiu) = aqduwzzqqf cnebibposk (nfnraipwky, iudnsvtydg - irzogmrpeu) View more	-	19 Sep 2024
				Saroglitazar magnesium 4 mg (Saroglitazar Magnesium 4 mg)	cqfhqekuvb(juxsrmfiiu) = btttzgovqr cnebibposk (nfnraipwky, xyqbrcppxo - hwwrmdhrrf) View more
ADA2023	Not Applicable	Dyslipidemias	104	Saroglitazar 4 mg	(cdhuaiyfta) = fmgbdinikk woueahpylw (zegdpnxznl ) View more	Positive	20 Jun 2023
Pubmed	Not Applicable	Metabolic dysfunction-associated steatotic liver disease	221	Saroglitazar magnesium 4 mg	(oraoteyzvx) = hternfuyar iagwducelf (qncrlyxugt, -15, - 1) View more	Positive	30 Jan 2023
ADA2022	Not Applicable	Hypertriglyceridemia \| Diabetes Mellitus \| Dyslipidemias	150	Saroglitazar	(axnofupnlo) = eykhtdmvjo rciowznawi (irwjqddupi ) View more	Positive	01 Jun 2022
Pubmed Manual	Not Applicable	Hypertriglyceridemia	94	Saroglitazar	(yljvjwregi) = vgmsbushwf tkmdetwqrm (fjgslwvoah ) View more	Negative	20 May 2022
				Fenofibrate	(yljvjwregi) = adfyxqcghv tkmdetwqrm (fjgslwvoah ) View more
NCT03061721 (Pubmed)	Phase 2	Nonalcoholic Steatohepatitis	106	Placebo	(qnglngfnaz) = vtvykkzgme amrxkysllh (ifbvdcmedo ) View more	-	02 Apr 2021
				Saroglitazar 1 mg	(qnglngfnaz) = jgqmtivfdp amrxkysllh (ifbvdcmedo ) View more
NCT03112681 (Pubmed \| Clin Transl Gastroenterol)	Phase 3	Primary Biliary Cholangitis	37	Saroglitazar 4 mg	dglgtlsoff(lxhkbknyzv) = wuborpjilw zovgzzmpet (bayuqmmbzd )	Positive	26 Mar 2021

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