[Translation] A randomized, open-label, two-period, two-sequence, crossover bioequivalence study of a single oral dose of Pemabet tablets in healthy adult study participants in the fasting state and after a high-fat meal

主要研究目的：研究重庆圣华曦药业股份有限公司生产的佩玛贝特片（规格：0.1mg）在中国健康研究参与者中空腹状态及高脂餐后以口服途径单次给药的药代动力学特征，并以興和株式会社持有，興和株式会社生产的佩玛贝特片（商品名：PARMODIA®；规格：.1mg）为参比制剂，进行生物等效性评价。次要研究目的：初步考察佩玛贝特片受试制剂和参比制剂在健康研究参与者中的安全性。

[Translation]

Primary study objective: To study the pharmacokinetic characteristics of a single oral dose of Pemabet tablets (specification: 0.1 mg) produced by Chongqing Shenghuaxi Pharmaceutical Co., Ltd. in Chinese health study participants in the fasting state and after a high-fat meal, and to evaluate the bioequivalence of Pemabet tablets (trade name: PARMODIA®; specification: 0.1 mg) owned by Kowa Co., Ltd. and produced by Kowa Co., Ltd. Secondary study objective: To preliminarily investigate the safety of the test and reference formulations of Pemabet tablets in healthy study participants.

Start Date23 Jul 2025

Sponsor / Collaborator

Chongqing Shenghuaxi Pharmaceutical Co. Ltd.

CTR20251870

/ Active, not recruitingNot Applicable

佩玛贝特片（0.1mg）在中国健康受试者中餐后给药条件下随机、开放、单剂量、两序列、两周期、双交叉生物等效性试验

[Translation] A randomized, open-label, single-dose, two-sequence, two-period, double-crossover bioequivalence study of Pemabet tablets (0.1 mg) in healthy Chinese subjects after meal administration

主要研究目的：按有关生物等效性试验的规定，选择興和株式会社为持证商的佩玛贝特片（商品名：PARMODIA®，规格：0.1mg）为参比制剂，对辰欣药业股份有限公司生产并提供的受试制剂佩玛贝特片（规格：0.1mg）进行餐后给药人体生物等效性试验，比较受试制剂中药物的吸收速度和吸收程度与参比制剂的差异是否在可接受的范围内，评估两种制剂在餐后给药条件下的生物等效性。次要研究目的：观察健康志愿受试者口服受试制剂佩玛贝特片（规格：0.1mg）和参比制剂佩玛贝特片（商品名：PARMODIA®，规格：0.1mg）的安全性。

[Translation]

Main research purpose: According to the relevant provisions of bioequivalence tests, Pemabet Tablets (trade name: PARMODIA®, specification: 0.1 mg) of which Kowa Co., Ltd. is the licensee was selected as the reference preparation, and the test preparation Pemabet Tablets (specification: 0.1 mg) produced and provided by Chenxin Pharmaceutical Co., Ltd. was subjected to a postprandial bioequivalence test in humans. The absorption rate and degree of the drug in the test preparation were compared with those of the reference preparation to see whether they were within an acceptable range, and the bioequivalence of the two preparations under postprandial administration conditions was evaluated. Secondary study objective: To observe the safety of oral administration of the test preparation Pemabet tablets (specification: 0.1 mg) and the reference preparation Pemabet tablets (trade name: PARMODIA®, specification: 0.1 mg) in healthy volunteers.

Start Date20 Jun 2025

Sponsor / Collaborator

Cisen Pharmaceutical Ltd.

CTR20251976

/ CompletedNot Applicable

佩玛贝特片（0.1mg）在中国健康受试者中空腹及餐后给药条件下随机、开放、单剂量、两制剂、交叉生物等效性试验

[Translation] A randomized, open-label, single-dose, two-formulation, crossover bioequivalence study of Pemabet tablets (0.1 mg) in Chinese healthy subjects under fasting and fed conditions

主要目的：以江西泰吉立生物医药科技有限公司的佩玛贝特片为受试制剂；并以興和株式会社的佩玛贝特片为参比制剂，进行人体相对生物利用度和生物等效性评价。

[Translation]

Main purpose: To evaluate the relative bioavailability and bioequivalence in humans using Pemabet tablets produced by Jiangxi Taijili Biopharmaceutical Technology Co., Ltd. as the test preparation and Pemabet tablets produced by Kowa Co., Ltd. as the reference preparation.

Start Date26 May 2025

Sponsor / Collaborator

Jiangxi Taijili Biomedical Technology Co., Ltd.

100 Clinical Results associated with Pemafibrate

100 Translational Medicine associated with Pemafibrate

100 Patents (Medical) associated with Pemafibrate

316

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: Kalaitzidis, Rigas G ; Vlachakis, Panayotis K ; 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 Dec 2025·Current Atherosclerosis Reports

Remnant Cholesterol: Should it be a Target for Prevention of ASCVD?

Review

Author: Nordestgaard, Børge Grønne ; Doi, Takahito ; Langsted, Anne

PURPOSE OF REVIEW:

To summarize studies analyzing whether remnant cholesterol should be a target for prevention of atherosclerotic cardiovascular disease (ASCVD).

RECENT FINDINGS:

There is a growing body of evidence from epidemiologic and Mendelian randomization studies implicating remnant cholesterol as a causal risk factor for ASCVD. However, the results of randomized controlled trials, particularly those conducted in the current high-intensity statin era, have been inconsistent. Most recently, the PROMINENT trial failed to show a beneficial effect of 0.4 mg/day of pemafibrate on the risk of ASCVD. In the Copenhagen General Population Study (CGPS), which mimics PROMINENT, the estimated hazard ratio for ASCVD was 1.05 (0.96-1.14) when absolute changes in remnant cholesterol, LDL cholesterol, and apolipoprotein B were combined, whereas the hazard ratio for ASCVD in PROMINENT was 1.03 (0.91-1.15). Further trials are warranted to ascertain the efficacy of novel remnant cholesterol- and triglyceride-lowering agents in the prevention of ASCVD. To reduce ASCVD, active agents need to reduce total atherogenic cholesterol (LDL and remnant cholesterol) and apolipoprotein B.

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.

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

Developing

10 top R&D records.

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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, Type 2	Phase 3	United States	Kowa Research Institute, Inc.	23 Mar 2017
Diabetes Mellitus, Type 2	Phase 3	Japan	Kowa Research Institute, Inc.	23 Mar 2017
Diabetes Mellitus, Type 2	Phase 3	Argentina	Kowa Research Institute, Inc.	23 Mar 2017
Diabetes Mellitus, Type 2	Phase 3	Brazil	Kowa Research Institute, Inc.	23 Mar 2017
Diabetes Mellitus, Type 2	Phase 3	Bulgaria	Kowa Research Institute, Inc.	23 Mar 2017
Diabetes Mellitus, Type 2	Phase 3	Canada	Kowa Research Institute, Inc.	23 Mar 2017
Diabetes Mellitus, Type 2	Phase 3	Colombia	Kowa Research Institute, Inc.	23 Mar 2017

Clinical Result

Indication

Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT04447820 (CTgov)	Phase 2	Dyslipidemias	96	K-877-IR (K-877-IR)	ebguipwcen(gtohumynkj) = ulxzvbjoct taztwgqfsp (pefteefphb, 3.295) View more	-	22 Dec 2023
				K-877-ER (Dose A) (K-877-ER Dose A)	ebguipwcen(gtohumynkj) = rolwwqdedu taztwgqfsp (pefteefphb, 3.319) View more
ESC2023	Phase 2	-	63	Immediate-Release Pemafibrate 0.2 mg/day	begksazvwe(ddrhaiiyar) = zbbcyamxiq mejxicqkum (jatpitvpje ) View more	-	27 Aug 2023
				Extended-Release Pemafibrate 0.4 mg/day	begksazvwe(ddrhaiiyar) = rvtymgeylg mejxicqkum (jatpitvpje ) View more
NCT03001817 (CTgov)	Phase 3	Hypertriglyceridemia	551	K-877 (K-877)	zxdvlhxejs(jguxyirqoy) = uifzxvurig lfeoplsbqj (wrhmwarsqn, tdeagrrvaz - lqmgqqjnak) View more	-	30 Nov 2022
				Placebo+K-877 (Placebo)	zxdvlhxejs(jguxyirqoy) = ywmpdcuciw lfeoplsbqj (wrhmwarsqn, mexuyhwxpz - bzwytznbaz) View more
NCT03071692 (PROMINENT, Pubmed \| N Engl J Med)	Phase 3	Hypertriglyceridemia \| Diabetes Mellitus, Type 2 \| Hypercholesterolemia	10,544	Pemafibrate	arxelhpuyt(wmcgnmbnjn) = vzndsqjwpm bfnadzfwci (hrhszldynp )	-	05 Nov 2022
NCT03011450 (CTgov)	Phase 3	Hypertriglyceridemia	471	K-877 (K-877)	npedpbcigf(titlvuesen) = tabxbrjlem dkgcnxdiym (mshpozrkky, xhtfwluaff - wqdgashest) View more	-	28 Oct 2022
				Placebo+K-877 (Placebo)	npedpbcigf(titlvuesen) = wpliefzmfb dkgcnxdiym (mshpozrkky, phoyzjpdea - txvtezpjev) View more
NCT03350165 (Pubmed \| Aliment Pharmacol Ther) Manual	Phase 2	Metabolic dysfunction-associated steatotic liver disease	118	Pemafibrate	pgkcoimfsb(fvqwmlpgwv) = etxwwahjvc xevszuewid (dlpsrdoicl )	Negative	01 Nov 2021
				Placebo	pgkcoimfsb(fvqwmlpgwv) = wiwdgxuddi xevszuewid (dlpsrdoicl )
NCT03011450 (Pubmed \| Int J Mol Sci) Manual	Phase 3	Hypertriglyceridemia \| Renal Insufficiency	189	Pemafibrate	pnvazezrdf(yjbateymfc) = jshkinvmyx xsbjnwswhp (cdqlcxdjjl ) View more	Positive	06 Feb 2019
JPRN-JapicCTI-121837 \| JPRN-JapicCTI-121764 (EASD2014)	Phase 2/3	Dyslipidemias Add-on HOMA-IR	676	K-877 0.05 mg/day	lspxzbjwqg(nqmvvxppcn) = incidence of all adverse drug reactions in K-877 groups were similar to placebo (placebo; 8.0%, 0.05mg/day; 5.4%, 0.1mg/day; 4.7%, 0.2mg/day; 7.9%, 0.4mg/day; 8.1%) vswrzvpqza (unddecabcc ) View more	Positive	17 Sep 2014
				K-877 0.1 mg/day

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Core Patent

Boost your research with our Core Patent data.

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Clinical Trial

Identify the latest clinical trials across global registries.

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Approval

Accelerate your research with the latest regulatory approval information.

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Regulation

Understand key drug designations in just a few clicks with Synapse.

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Accelerate Strategic R&D decision making with Synapse, PatSnap’s AI-powered Connected Innovation Intelligence Platform Built for Life Sciences Professionals.

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Synapse data is also accessible to external entities via APIs or data packages. Empower better decisions with the latest in pharmaceutical intelligence.

Bio

Bio Sequences Search & Analysis

Chemical

Chemical Structures Search & Analysis