[Translation] A single-center, randomized, open-label, single-dose, fasting and postprandial, two-formulation, two-sequence, two-period, double-crossover bioequivalence study of Pemabet tablets in healthy adult Chinese subjects

主要研究目的：考察单次口服（空腹/餐后）受试制剂佩玛贝特片【规格：0.1 mg，海南赛立克药业有限公司生产】与参比制剂【商品名：Parmodia®，规格：0.1 mg，興和株式会社（Kowa Company）持证，海南赛立克药业有限公司提供】在中国健康人体的相对生物利用度，分析两种制剂的药代动力学参数，评价两制剂的生物等效性，为该药的申报及临床用药提供参考依据。次要研究目的：评价单次口服（空腹/餐后）受试制剂和参比制剂在中国成年健康受试者中的安全性。

[Translation]

Main research objectives: The relative bioavailability of a single oral (fasting/postprandial) dose of the test formulation Pemabet tablets [Specification: 0.1 mg, produced by Hainan Sellik Pharmaceutical Co., Ltd.] and the reference formulation [Trade name: Parmodia®, Specification: 0.1 mg, certified by Kowa Company, provided by Hainan Sellik Pharmaceutical Co., Ltd.] in healthy Chinese humans was investigated, the pharmacokinetic parameters of the two formulations were analyzed, and the bioequivalence of the two formulations was evaluated, providing a reference basis for the application and clinical use of the drug. Secondary study objectives: To evaluate the safety of a single oral dose (fasting/fed) of the test and reference formulations in healthy adult Chinese subjects.

Start Date10 Mar 2025

Sponsor / Collaborator

Hainan Selection Pharmaceutical Co. Ltd.

CTR20250021

/ CompletedNot Applicable

佩玛贝特片人体生物等效性研究

[Translation] Study on the bioequivalence of Pemabet tablets in human body

主要目的：比较空腹和餐后给药条件下江苏奥赛康药业有限公司提供的佩玛贝特片（规格：0.1 mg）与興和株式会社持证的参比制剂R佩玛贝特片（规格：0.1 mg；商品名：PARMODIA®）在中国健康人群吸收程度和吸收速度的差异。次要目的：评价空腹及餐后条件下，江苏奥赛康药业有限公司提供的佩玛贝特片（规格：0.1 mg）与興和株式会社持证的参比制剂R佩玛贝特片（规格：0.1 mg；商品名：PARMODIA®）在健康研究参与者体内的安全性。

[Translation]

Main purpose: Compare the Pemafibrate tablets (specification: 0.1 mg) provided by Jiangsu Aosaikang Pharmaceutical Co., Ltd. and the certified reference preparation R Pemafibrate tablets (specification: 0.1) from Xinghe Co., Ltd. under fasting and postprandial administration conditions. mg; Trade name: PARMODIA®) Differences in the degree and rate of absorption among healthy people in China. Secondary purpose: To evaluate under fasting and postprandial conditions, the Pemafibrate tablets (specification: 0.1 mg) provided by Jiangsu Aosaikang Pharmaceutical Co., Ltd. and the certified reference preparation R Pemafibrate tablets (specification: 0.1 mg) from Xinghe Co., Ltd. ; Trade name: PARMODIA®) safety in healthy study participants.

Start Date20 Feb 2025

Sponsor / Collaborator

Jiangsu Aosaikang Pharmaceutical Co. Ltd.

CTR20250071

/ CompletedNot Applicable

安徽美来药业股份有限公司的佩玛贝特片与興和株式会社的佩玛贝特片(商品名: PARMODIA®)在健康受试者中单中心随机、开放、单次给药、两周期、双交叉、空腹及餐后状态下的生物等效性研究。

[Translation] Anhui Meilai Pharmaceutical Co., Ltd.'s Pemafibrate tablets and Xinghe Co., Ltd.'s Pemafibrate tablets (trade name: PARMODIA®) were randomized, open-label, single-dose, and two-dose trials in healthy subjects in a single center. Bioequivalence studies in cyclic, double-crossover, fasting and postprandial states.

以中国健康受试者为试验对象，采用自身交叉对照的试验设计，测定受试制剂佩玛贝特片给药后血浆中的佩玛贝特在健康受试者体内的血药浓度经时过程，估算相应的药代动力学参数，并以興和株式会社持证生产的佩玛贝特片（商品名：PARMODIA®，规格：0.1 mg）为参比，评价制剂间的生物等效性，并观察佩玛贝特片在中国健康受试者中的安全性。

[Translation]

Taking Chinese healthy subjects as the test subjects, a self-cross-control experimental design was adopted to measure the time course of the blood concentration of pemafibrate in the plasma of healthy subjects after administration of the test preparation pemafibrate tablets. , estimate the corresponding pharmacokinetic parameters, and use Pemafibrate tablets (trade name: PARMODIA®, specification: 0.1 mg) produced by Xinghe Co., Ltd. with a license as a reference to evaluate the bioequivalence between preparations. And observe the safety of Pemafibrate tablets in Chinese healthy subjects.

Start Date19 Feb 2025

Sponsor / Collaborator

Anhui Meilai Pharmaceutical Co., Ltd.Startup

100 Clinical Results associated with Pemafibrate

100 Translational Medicine associated with Pemafibrate

100 Patents (Medical) associated with Pemafibrate

302

Literatures (Medical) associated with Pemafibrate

01 Dec 2025·Current Atherosclerosis Reports

Impact of Selective Peroxisome Proliferator-Activated Receptor (PPAR)-α Modulators and Fibrates on Microvascular Disease: Is There Still Room?

Review

Author: Iatan, Iulia ; Maranhão, Raul Cavalcante ; Rached, Fabiana Hanna ; Godoy, Lucas Colombo ; Marinho, Lucas Lage ; Lawler, Patrick R ; Ribeiro, Matheus Laterza

PURPOSE OF REVIEW:

This review examines the role of fibrates and the selective PPAR-alpha modulators (SPPARM-α), pemafibrate, in diabetic microvascular disease. It reviews their potential to mitigate residual risk in retinopathy, nephropathy, neuropathy and peripheral vascular disease.

RECENT FINDINGS:

These pharmacotherapies, beyond their lipid-lowering effects, may exert anti-inflammatory, antioxidant, and endothelial-protective actions. Secondary analyses of large clinical trials supports their efficacy in slowing retinopathy progression, reducing albuminuria, and preventing minor amputations. Recent analyses suggest that pemafibrate offers an enhanced efficacy and safety profile compared to conventional fibrate and may lower the incidence of diabetic foot ulcers and gangrene. Fibrates and SPPARM-α agonists represent promising therapies to prevent diabetic microvascular complications. Their benefits in reducing microvascular damage support their broader adoption in clinical practice. However, additional dedicated randomized trials are essential to validate the efficacy of those agents in contemporary diabetes care era and to address the growing burden of diabetes-related microvascular complications.

01 Dec 2025·Current Atherosclerosis Reports

Managing Dyslipidemia in Chronic Kidney Disease: Implications for Cardiovascular and Renal Risk

Review

Author: Vlachakis, Panayotis K ; Kalaitzidis, Rigas G ; Theofilis, Panagiotis ; Karakasis, Paschalis

PURPOSE OF REVIEW:

The review aims to address the complex relationship between dyslipidemia and chronic kidney disease (CKD), emphasizing its dual role in driving cardiovascular disease (CVD) risk and contributing to CKD progression. It explores pathophysiological mechanisms, highlights recent biomarker discoveries, and evaluates contemporary and emerging lipid-lowering therapies tailored for CKD patients.

RECENT FINDINGS:

Recent studies have highlighted the inadequacy of traditional lipid markers like LDL-C in reflecting cardiovascular risk in CKD. Novel biomarkers, such as remnant cholesterol and lipoprotein(a), demonstrate stronger associations with adverse outcomes. Emerging lipid-lowering agents, including bempedoic acid, pemafibrate, and PCSK9 inhibitors, show promise for risk reduction, especially in non-dialysis-dependent CKD. However, evidence remains limited for advanced stages of CKD and dialysis patients. Furthermore, alterations in lipid metabolism, such as dysfunctional HDL and triglyceride-rich lipoproteins, are now recognized as significant contributors to CVD and renal damage in CKD populations. Dyslipidemia is a pivotal modifiable risk factor in CKD, exacerbating both cardiovascular risk and disease progression. While statins remain the cornerstone of therapy in early-to-moderate CKD, their efficacy diminishes in advanced stages. The advent of novel therapeutic options and a deeper understanding of dyslipidemia's pathophysiology hold potential for improving outcomes. Future research should prioritize personalized approaches, focusing on the unique metabolic derangements of CKD and advancing treatments for high-risk and dialysis-dependent patients.

01 Mar 2025·International journal of cardiology. Cardiovascular risk and prevention

Evaluation of the beneficial effects of pemafibrate in hypertriglyceridemia with or without alcohol drinking (PAR-CHAT: PARmodia-CHikushi Anti-dyslipidemia Trial)

Article

Author: Ike, Amane ; Kawamura, Akira ; Takamiya, Yosuke ; Urata, Hidenori ; Imanaga, Chiyori

Purpose:

To examine the efficacy and safety of pemafibrate in outpatients with hypertriglyceridemia, including alcoholic hypertriglyceridemia.

Method:

This multicenter, open-label, prospective observational study (C20-07-009) included outpatients with hypertriglyceridemia being treated with pemafibrate who were registered at Fukuoka University Chikushi Hospital or associated clinics. Endpoints were changes in serum triglyceride (TG) and high-density lipoprotein cholesterol (HDL-C), hepatic biomarkers, and other blood values from baseline to 24 weeks and safety. Patients were compared according to alcohol drinking.

Result:

From October 2020 to March 2022, 203 patients were registered at 14 facilities. We analyzed 174 patients (mean age, 65.5 years) with baseline fasting TG values who continued pemafibrate for 24 weeks; 55 % drank alcohol, and 35 % were receiving statins. Median fasting TG was 284 mg/dL (IQR, 228-392 mg/dL) at baseline and decreased significantly to 141 mg/dL (IQR, 108-194 mg/dL) at 24 weeks (p < 0.01), independent of alcohol use (non-drinking group, 259 to 134 mg/dL; daily drinking group, 318 to 169 mg/dL; occasional drinking group, 298 to 158 mg/dL; all p < 0.01). Median HDL-C increased significantly from 46 mg/dL (IQR, 39-53 mg/dL) at baseline to 53 mg/dL (IQR, 45-60 mg/dL) at 24 weeks (p < 0.01). Hepatic biomarkers improved significantly at 24 weeks. Low-density lipoprotein cholesterol (LDL-C) increased significantly overall, but not in patients receiving statins. Side effects throughout the study period included dizziness and nausea (1 patient each).

Conclusion:

Pemafibrate improves TG, HDL-C, hepatic biomarkers and hypertriglyceridemia regardless of alcohol consumption and is safe. Increase of LDL-C was suppressed in patients treated with statins.

News (Medical) associated with Pemafibrate

18 Sep 2024

·medcitynews.com

Millions are Taking a Drug that Falls Short of its Promise to Lower Risk of Heart Attack - MedCity News

For the past century, heart disease has remained the leading cause of death in the United States. Fortunately, as our understanding of the disease has evolved over time, we have made advances in treatment options to help people reduce their risk for a devastating cardiovascular event, like a heart attack or stroke. But staying one step ahead of this disease requires both providers and patients to continually follow and implement the latest science and regulatory guidance on what treatment options are safe, effective, and FDA-approved. Sadly, this isn’t happening and misinformation about treatment options poses a significant public health concern, which the FDA has acknowledged and in July issued new guidance on how companies can combat it. This is why HealthyWomen, the nation’s leading independent nonprofit health information source for women, recently filed a citizen petition with the FDA urging regulators to take further action on the labeling of fibrates, a class of medication commonly prescribed to address cardiovascular disease risk factors. presented by Health IT Accelerating Claim Processing: Strategies to Shorten the Life of a Claim These strategies and practices can significantly shorten the life cycle of claims, leading to quicker resolutions and improved financial outcomes. By Greenway Health While fibrates are proven to lower triglyceride levels, which can serve as a biomarker for cardiovascular disease risk, several major clinical studies from the past 20 years have failed to show a benefit of fenofibrates over and above statins in further reducing heart-related events. As a result of these failed outcomes studies, the FDA took significant action. In 2015, the agency removed the statin co-administration indication from the labeling of fenofibrates. When announcing the withdrawal of the indication in 2016, the FDA explained that it had determined that the benefits of fenofibrates with statins no longer outweighed the risks to patients. But despite the significance of the FDA’s withdrawal more than eight years ago, prescribing behavior has lagged, ultimately putting patients at risk. Even with a slight decline in fenofibrate use since 2015, more than 1 million patients are being treated today with the drug off-label to reduce cardiovascular disease risk. In fact, prescription rates are actually increasing year-over-year among some providers like nurse practitioners. Sponsored Post What Healthcare Can Learn from Costco The path forward is clear: employers must evaluate their health plan the same way they do their Saturday shopping excursion. By Jeff Bak, Imagine360 CEO and President Adding more concern, the 2022 Pemafibrate to Reduce Cardiovascular Outcomes by Reducing Triglycerides in Patients with Diabetes (PROMINENT) trial reinforced the FDA’s finding that fibrates did not reduce cardiovascular disease risk over and above statins. This was especially shocking because the trial specifically enrolled a population that was most likely to benefit: those with type 2 diabetes and high triglycerides and low HDL-cholesterol. Even in this high-risk population, the trial had to be stopped early for futility, or lack of benefit. Several other studies have shown how fibrate therapy can potentially cause harm, like adverse kidney events and blood clots, or even liver injury and hospitalization when used concurrently with a statin. And unnecessary use of fibrates with statins exposes people to potentially needless, serious side effects including myopathy, venous thromboembolism (VTE), and rhabdomyolysis, which pose significant risks to patients, particularly those from communities of color who already face barriers to quality care and experience disproportionate rates of cardiovascular disease. Furthermore, these patients should not have to spend their hard-earned dollars at the pharmacy counter for a drug proven ineffective in lowering their risk for having a cardiovascular event while also demonstrating consistent signals of harm across multiple studies. HealthyWomen’s citizen petition to the FDA is putting a spotlight on this problem by asking for two key changes: updating the label for fibrates to reflect the latest data and benefit-risk information and communicating to healthcare providers that fibrates do not lower cardiovascular event risk over and above statins. As a clinician, I applaud this action. The fact is, there are numerous alternative safe and effective FDA-approved therapies available that actually reduce risk for cardiovascular events for patients and not just lower biomarker scores. Increased awareness and following the latest science will help ensure patients have the best chance at achieving their healthiest outcomes.

AHA

24 Apr 2024

·www.globenewswire.com

Amarin Applauds HealthyWomen’s Citizen’s Petition Urging FDA To Take Further Action On Fenofibrate Prescribing in Patients at Risk of Cardiovascular Event

Citizen Petition Spotlights Risks for Patients on Drug Proven to Have No Benefit in Improving Cardiovascular Outcomes and Need for Urgent Regulatory Action to Protect PatientsDUBLIN, Ireland and BRIDGEWATER, N.J., April 24, 2024 (GLOBE NEWSWIRE) -- Amarin Corporation plc (NASDAQ:AMRN) today announced its support for a petition filed with the U.S. Food and Drug Administration (FDA) requesting that the Commissioner focus on and take further action to address significant off-label prescribing of fenofibrates, due to the fact that multiple clinical trials have proven fenofibrates have no clinical benefit when used in combination with statins to reduce cardiovascular disease (CVD) risk. The filing comes as heart disease continues to be the leading cause of death in the United States, accounting for one in five deaths in 2021.1,2 Approximately 805,000 people in the United States have a heart attack each year, which amounts to one person every 40 seconds.1 The annual treatment cost for CVD is $555 billion, which is expected to double within 20 years.3 Despite the FDA mandating label changes in 2015 for fenofibrates,4 more than 11 million prescriptions were written and more than one million patients were treated with a fenofibrate in combination with a statin in 2023.5,6 Those patients are also being unnecessarily exposed to the serious side effects of fenofibrates and payors are subjected to unnecessary spending from off-label fenofibrate prescriptions. “Despite the many safe, effective, and FDA-approved treatments available on the market with clinically proven reductions of CVD risk, patients are still being treated with fenofibrates off-label. This results in patients taking a drug proven to have no clinical benefit to reduce CVD risk,” said Nabil Abadir, M.D., Chief Medical Officer at Amarin. “This is a significant issue that is risking patient health and should be addressed quickly by the FDA. We applaud HealthyWomen for taking action to help ensure patients get the best care possible for their CV health.” The petition, filed by HealthyWomen, the nation’s leading nonprofit dedicated to educating and empowering women to make informed decisions about their health, requests that the FDA require revised labelling for fenofibrate drugs to incorporate important results from recent clinical studies showing their ineffectiveness and to communicate this information with healthcare professionals and patients. The petition also urges the FDA Commissioner to further clarify the position the agency previously took by removing the statin co-administration from fenofibrate labeling. To view the petition, click here. The petition is supported by the recent 2023 American Heart Association/American College of Cardiology Joint Guidelines for the Management of Patients with Chronic Coronary Disease7 and CV outcomes trials such as the 2005 FIELD8 and 2010 ACCORD9 Lipid studies with fenofibrates that resulted in previous FDA action. More recently, the 2022 PROMINENT10 clinical trial yet again confirmed the lack of benefit of adding a fibrate to statin-treated patients in reducing CVD risk. “As heart disease is the leading cause of death in the United States, we cannot minimize the importance of taking effective and approved therapies to treat overall cardiovascular outcomes and not just lowering biomarker scores,” said Dr. Payal Kohli, Founder and Medical Director of Cherry Creek Health and Associate Professor of Medicine at the University of Colorado Anschutz Medical Campus. “Achieving better outcomes for people with a prior history or high-risk for cardiovascular disease starts with ensuring prescribers and patients know and implement the latest science in prescribing practices. By taking an unproven and ineffective treatment, patients are being put at unnecessary risk for a devastating cardiovascular event, like a heart attack or stroke, which also strains the healthcare system in the U.S.” This petition was received and processed under 21 CFR 10.30 by the FDA Office of Operations Dockets Management Staff on April 23, 2024 and it was assigned docket number FDA-2024-P-1988. About AmarinAmarin is an innovative pharmaceutical company leading a new paradigm in cardiovascular disease management. We are committed to increasing the scientific understanding of the cardiovascular risk that persists beyond traditional therapies and advancing the treatment of that risk for patients worldwide. Amarin has offices in Bridgewater, New Jersey in the United States, Dublin in Ireland, Zug in Switzerland, and other countries in Europe as well as commercial partners and suppliers around the world. Availability of Other Information About AmarinInvestors and others should note that Amarin communicates with its investors and the public using the company website (www.amarincorp.com), the investor relations website (investor.amarincorp.com), including but not limited to investor presentations and investor FAQs, U.S. Securities and Exchange Commission filings, press releases, public conference calls and webcasts. The information that Amarin posts on these channels and websites could be deemed to be material information. As a result, Amarin encourages investors, the media, and others interested in Amarin to review the information that is posted on these channels, including the investor relations website, on a regular basis. This list of channels may be updated from time to time on Amarin’s investor relations website and may include social media channels. The contents of Amarin’s website or these channels, or any other website that may be accessed from its website or these channels, shall not be deemed incorporated by reference in any filing under the Securities Act of 1933. Amarin Contact Information Investor & Media Inquiries: Mark Marmur Amarin Corporation plc PR@amarincorp.com 1 Tsao CW, Aday AW, Almarzooq ZI, Beaton AZ, Bittencourt MS, Boehme AK, et al. Heart Disease and Stroke Statistics—2023 Update: A Report From the American Heart Association. Circulation. 2023;147:e93–e621.2National Center for Health Statistics. Multiple Cause of Death 2018–2021 on CDC WONDER Database. Accessed February 2, 2023.3American Heart Association, Cardiovascular Disease: A Costly Burden For America Projections Through 2035 (2017).4 FDA, NDA 22224/S-011, Trilipix (fenofibric acid) Approval Letter (Apr. 27, 2015) (removing the indication and related labeling statements).5 [Database footnote.] This estimate is calculated using product wholesale acquisition cost (WAC) and does not account for any manufacturer discounts and rebates related to such products.6 IQVIA data.7 2023 AHA/ACC/ACCP/ASPC/NLA/PCNA Guideline for the Management of Patients With Chronic Coronary Disease: A Report of the American Heart Association/American College of Cardiology Joint Committee on Clinical Practice Guidelines, Circulation. 2023;148:e00–e00 (July 2023), DOI: 10.1161/CIR.0000000000001168, at e29.8 The FIELD Study Investigators, Effects of long-term fenofibrate therapy on cardiovascular events in 9795 people with type 2 diabetes mellitus (“FIELD Study”): randomised controlled trial, The Lancet 366 (Nov. 26, 2005).9 The ACCORD Study Group, Effects of Combination Lipid Therapy in Type 2 Diabetes Mellitus, NEJM 362:1563-1574 (Apr. 29, 2010) (“ACCORD Lipid Study”)10 A.D. Pradhan et al., Triglyceride Lowering with Pemafibrate to Reduce Cardiovascular Risk, NEJM 387:1923 (2022) (“PROMINENT Study”).

AHA

30 Sep 2023

·synapse.patsnap.com

Advances in Clinical Research on PPAR Agonists

PPAR, or peroxisome proliferator-activated receptor, is a group of nuclear receptor proteins found in the human body. These receptors play a crucial role in regulating various physiological processes, including metabolism, inflammation, and cell differentiation. PPARs, as a nuclear hormone receptor family, are ligand-activated intranuclear transcription factors, composed of three homologous members: PPARα, PPARβ/δ, and PPARγ. Among them, PPARα primarily regulates the transport, esterification, and oxidation of fatty acids. PPARβ/δ is majorly associated with the oxidation of fatty acids and glucose uptake. PPARγ primarily controls the differentiation of adipocytes, lipid storage, and insulin sensitivity. PPARs act as transcription factors, meaning they can influence gene expression by binding to specific DNA sequences. They are involved in lipid and glucose metabolism, making them important targets for pharmaceutical interventions in conditions like diabetes, obesity, and cardiovascular diseases. PPARs also have anti-inflammatory properties and are implicated in regulating immune responses. Understanding the role of PPARs is essential for developing drugs that can modulate these receptors and potentially treat various diseases. PPAR Competitive LandscapeAccording to the data provided by Patsnap Synapse-Global Drug Intelligence Database: the following figure shows that as of 22 Sep 2023, there are a total of 277 PPAR drugs worldwide, from 281 organizations, covering 180 indications, and conducting 1926 clinical trials. 👇Please click on the picture link below for free registration or login directly if you have freemium accounts, you can browse the latest research progress on drugs , indications, organizations, clinical trials, clinical results, and drug patents related to this target. The analysis of the target PPAR reveals a competitive landscape with multiple companies actively involved in research and development. Takeda Pharmaceutical Co., Ltd., Viatris Inc., and GSK Plc are among the companies with the highest number of approved drugs, indicating their strong R&D progress. The indications with the highest number of approved drugs are hyperlipidemias and diabetes mellitus type 2, suggesting a focus on these areas. Small molecule drugs are the most rapidly progressing drug type, indicating their significance in PPAR-targeted drug development. China, the European Union, Japan, and the United States are the countries/locations with the highest number of approved drugs, with China showing significant progress. Overall, the target PPAR presents a competitive landscape with a focus on specific indications and drug types, and China emerges as a key player in the development of PPAR-targeted drugs. The World's First PPAR Agonist:Chiglitazar SodiumChiglitazar Sodium is a small molecule drug that falls under the category of biomedicine. It primarily targets PPAR. The drug is designed to address various therapeutic areas, including digestive system disorders and endocrinology and metabolic diseases. Chiglitazar Sodium has shown potential in treating specific indications, such as Diabetes Mellitus, Type 2, and Nonalcoholic Steatohepatitis. These conditions are prevalent worldwide and pose significant health challenges. By targeting PPAR, Chiglitazar Sodium aims to regulate glucose and lipid metabolism, potentially improving the management of these diseases. 👇Please click on the image below to directly access the latest data (R&D Status | Core Patent | Clinical Trial | Approval status in Global countries) of this drug. The drug was developed by Shenzhen Chipscreen Biosciences Co., Ltd., an originator organization in the pharmaceutical industry. It has undergone rigorous clinical trials and has achieved the highest phase of approval in China. This indicates that the drug has successfully met the necessary regulatory requirements and demonstrated its safety and efficacy in treating the targeted indications. Chiglitazar Sodium received its first approval in China in October 2021. This signifies a significant milestone for the drug and its potential impact on patients in the country. However, it is important to note that the drug's approval is currently limited to China, and its availability in other countries may vary. The approval of Chiglitazar Sodium highlights the continuous efforts in the field of biomedicine to develop innovative treatments for complex diseases. The drug's focus on PPAR as a therapeutic target reflects the growing understanding of the molecular mechanisms underlying various disorders. In conclusion, Chiglitazar Sodium is a small molecule drug developed by Shenzhen Chipscreen Biosciences Co., Ltd. It targets PPAR and aims to address digestive system disorders and endocrinology and metabolic diseases. With its approval in China, the drug holds promise in treating Diabetes Mellitus, Type 2, and Nonalcoholic Steatohepatitis. Its successful development and approval underscore the ongoing advancements in the pharmaceutical industry to improve patient outcomes in the field of biomedicine. PemafibratePemafibrate is a small molecule drug that targets PPARα, a receptor involved in regulating lipid metabolism. It is primarily used in the treatment of various disorders related to the digestive system, endocrinology, and metabolic diseases. The drug has been approved for use in several indications, including hyperlipidemias, hypercholesterolemia, dyslipidemias, hypertriglyceridemia, nonalcoholic steatohepatitis, liver cirrhosis, biliary, and primary biliary cholangitis. 👇Please click on the image below to directly access the latest data (R&D Status | Core Patent | Clinical Trial | Approval status in Global countries) of this drug. Pemafibrate was developed by Kowa Co., Ltd., a pharmaceutical company based in Japan. It received its first approval in July 2017 in Japan, making it available for use in the country. The drug has also undergone clinical trials in China, reaching phase 3, which indicates that it is in an advanced stage of development in the Chinese market. One notable aspect of Pemafibrate is its regulatory status as an orphan drug. Orphan drugs are medications developed to treat rare diseases or conditions that affect a small number of patients. This designation provides certain incentives and benefits to the drug's manufacturer, such as extended market exclusivity and financial support for research and development. Overall, Pemafibrate represents a significant advancement in the field of biomedicine, particularly in the treatment of lipid-related disorders. Its approval in Japan and ongoing clinical trials in China suggest that it has shown promising results in terms of safety and efficacy. As a small molecule drug targeting PPARα, it offers a potential therapeutic option for patients suffering from various digestive system disorders, endocrinology, and metabolic diseases.

100 Deals associated with Pemafibrate

External Link

KEGG	Wiki	ATC	Drug Bank
D10711	Pemafibrate	C10AB	DB15212

R&D Status

Approved

10 top approved records.

to view more data

Indication	Country/Location	Organization	Date
Hyperlipidemias	Japan	Kowa Co., Ltd.	03 Jul 2017

Developing

10 top R&D records.

to view more data

Indication	Highest Phase	Country/Location	Organization	Date
Hypercholesterolemia	Phase 3	Japan	Kowa Co., Ltd.	01 May 2023
Diabetic macular oedema	Phase 3	United States	Kowa Co., Ltd.	15 Jan 2018
Diabetic macular oedema	Phase 3	Canada	Kowa Co., Ltd.	15 Jan 2018
Diabetes Mellitus	Phase 3	United States	Kowa Research Institute, Inc.	23 Mar 2017
Diabetes Mellitus	Phase 3	Japan	Kowa Research Institute, Inc.	23 Mar 2017
Diabetes Mellitus	Phase 3	Argentina	Kowa Research Institute, Inc.	23 Mar 2017
Diabetes Mellitus	Phase 3	Brazil	Kowa Research Institute, Inc.	23 Mar 2017
Diabetes Mellitus	Phase 3	Bulgaria	Kowa Research Institute, Inc.	23 Mar 2017
Diabetes Mellitus	Phase 3	Canada	Kowa Research Institute, Inc.	23 Mar 2017
Diabetes Mellitus	Phase 3	Colombia	Kowa Research Institute, Inc.	23 Mar 2017

Clinical Result

Indication

Phase

Evaluation

View All Results

Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


UEGW2024	Not Applicable	Dyslipidemias \| Metabolic dysfunction-associated steatotic liver disease	-	Pemafibrate plus SGLT2i	fymjehopde(yqtpnobrdx) = dfshmgpxrs kmoudxkcnw (artrjkuxqv ) View more	-	13 Oct 2024
DDW2024	Not Applicable	Hypertriglyceridemia \| Fatty Liver	-	Pemafibrate 0.2 mg	zeorcalfnh(fkfghvkirt) = veadtdawla xeeqcqtgft (qjisfdyzzx ) View more	-	19 May 2024
NCT04447820 (CTgov)	Phase 2	Dyslipidemias	96	K-877-IR (K-877-IR)	aoqngczzme(blkuybejmx) = bxucbirbtd xrzdyjeure (humzaruoml, 3.295) View more	-	22 Dec 2023
				K-877-ER (Dose A) (K-877-ER Dose A)	aoqngczzme(blkuybejmx) = ilcphqkckq xrzdyjeure (humzaruoml, 3.319) View more
ESC2023	Phase 2	-	63	Immediate-Release Pemafibrate 0.2 mg/day	iuewasuswr(gqrcsrviww) = werqkpnaqo nporagjdto (mwqbyrwhdq ) View more	-	27 Aug 2023
				Extended-Release Pemafibrate 0.4 mg/day	iuewasuswr(gqrcsrviww) = oxejklfpai nporagjdto (mwqbyrwhdq ) View more
PEBE study (ESC2023)	Not Applicable	Metabolic Syndrome \| Coronary Artery Disease	60	Pemafibrate 0.2 mg/day	rqirhkvoei(yjdvlapavn) = ldinaypoow hujrztsvob (xwnqxqslkt ) View more	-	27 Aug 2023
				Bezafibrate 400 mg/day	usvlkatsti(jlpauqcujx) = hifamhztma ahsmmlxhza (ccbchhektw )
NCT03001817 (CTgov)	Phase 3	Hypertriglyceridemia	551	K-877 (K-877)	qssaduyrck(rquagemmaf) = dvpludlfoj cpekrvgooo (oisjfkvnuu, jwdqpcmemc - ytkfzwzxip) View more	-	30 Nov 2022
				Placebo+K-877 (Placebo)	qssaduyrck(rquagemmaf) = tmldikmhff cpekrvgooo (oisjfkvnuu, yjxfgdyzln - nacxodcein) View more
NCT03071692 (PROMINENT, Pubmed \| N Engl J Med)	Phase 3	-	10,544	Pemafibrate	dxcswadwxh(figifkopmy) = erutiwpxhl hwdurkjhxc (sqnbbenozq )	-	05 Nov 2022
NCT03011450 (CTgov)	Phase 3	Hypertriglyceridemia	471	K-877 (K-877)	hfwgayiksq(jacjjxefqs) = qqiqwhoroq amjtxwscsc (jhohgjgzfe, plaxhpriah - hlmkkepvpp) View more	-	28 Oct 2022
				Placebo+K-877 (Placebo)	hfwgayiksq(jacjjxefqs) = wpdjzogmbw amjtxwscsc (jhohgjgzfe, pzpjwysowo - cintayxsch) View more
ESC2022	Not Applicable	Coronary Artery Disease	60	Pemafibrate 0.2 mg/day	wpotdyhyfa(edaqmzecer) = ewvpndldvz bjmvmjvcus (okffkcvmnw ) View more	-	27 Aug 2022
				Bezafibrate 400 mg/day	wpotdyhyfa(edaqmzecer) = dgkhgpsots bjmvmjvcus (okffkcvmnw ) View more
NCT03350165 (Pubmed \| Aliment Pharmacol Ther) Manual	Phase 2	Metabolic dysfunction-associated steatotic liver disease	118	Pemafibrate	yxinrszssx(eqgqkupwmm) = qdqebtldfh osbbzimhhp (nvjsaekygw )	Negative	01 Nov 2021
				Placebo	yxinrszssx(eqgqkupwmm) = eboenqrvmf osbbzimhhp (nvjsaekygw )

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