Delving into the Latest Updates on Fenofibric acid with Synapse

Overview

Basic Info

Drug Type

Small molecule drug

Synonyms

非诺贝酸, 悦思立普

+ [1]

Target

PPARα

Action

agonists

Mechanism

PPARα agonists(Peroxisome proliferator-activated receptor α agonists)

Therapeutic Areas

Endocrinology and Metabolic Disease

Active Indication

DyslipidemiasHyperlipidemias

Inactive Indication

Hypertriglyceridemia

Originator Organization

Hanmi Pharmaceutical Co., Ltd.

Active Organization

Hanmi Pharmaceutical Co., Ltd.

Changchun Haiyue Pharmaceutical Co., Ltd

Inactive Organization

Athena Bioscience Llc

Drug Highest PhaseApproved

First Approval Date

United States (14 Aug 2009),

DyslipidemiasHyperlipidemiasHypertriglyceridemia

Regulation-

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Structure/Sequence

Molecular FormulaC17H15ClO4

InChIKeyMQOBSOSZFYZQOK-UHFFFAOYSA-N

CAS Registry42017-89-0

Primary objective: To conduct human bioavailability and bioequivalence studies of fenofibric acid tablets (test preparation) produced by Changchun Haiyue Pharmaceutical Co., Ltd. and the drug of the original research company in the United States (reference preparation). Secondary objective: To observe the safety of the test preparation and the reference preparation in healthy subjects.

Start Date14 Oct 2019

Sponsor / Collaborator

Changchun Haiyue Pharmaceutical Co., Ltd

CTR20191478

/ CompletedNot Applicable

非诺贝酸片随机、开放、两周期、两交叉单次空腹状态下健康人体生物等效性试验

[Translation] A randomized, open-label, two-period, two-crossover single-dose bioequivalence study of fenofibric acid tablets in healthy volunteers under fasting conditions

主要目的：长春海悦药业股份有限公司生产的非诺贝酸片（受试制剂）与美国原研公司药品（参比制剂）进行人体生物利用度与生物等效性试验。次要目的：观察受试制剂与参比制剂在健康受试者中的安全性。

[Translation]

Primary objective: To conduct human bioavailability and bioequivalence studies of fenofibric acid tablets (test preparation) produced by Changchun Haiyue Pharmaceutical Co., Ltd. and the drug of the original research company in the United States (reference preparation). Secondary objective: To observe the safety of the test preparation and the reference preparation in healthy subjects.

Start Date18 Jul 2019

Sponsor / Collaborator

Changchun Haiyue Pharmaceutical Co., Ltd

CTR20190653

/ CompletedPhase 1

一项开放、随机、在中国健康男性和女性受试者中进行的单次和多次服用ABT-335后非诺贝特酸的药代动力学研究

[Translation] An open-label, randomized, pharmacokinetic study of fenofibric acid after single and multiple doses of ABT-335 in healthy Chinese male and female subjects

主要目的：确定健康中国男性和女性受试者单次和多次服用ABT-335后非诺贝特酸的药代动力学特征。安全性目的：评价健康中国男性和女性受试者单次和多次服用ABT-335 45 mg和135 mg胶囊制剂后的安全性和耐受性。

[Translation]

Primary objective: To determine the pharmacokinetic profile of fenofibric acid after single and multiple doses of ABT-335 in healthy Chinese male and female subjects. Safety objective: To evaluate the safety and tolerability of ABT-335 45 mg and 135 mg capsule formulations after single and multiple doses in healthy Chinese male and female subjects.

Start Date08 May 2019

Sponsor / Collaborator

Fournier Laboratories Ireland Ltd.

[+2]

100 Clinical Results associated with Fenofibric acid

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100 Translational Medicine associated with Fenofibric acid

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100 Patents (Medical) associated with Fenofibric acid

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885

Literatures (Medical) associated with Fenofibric acid

14 Feb 2025·Organic Letters

Nickel/Photo-Cocatalyzed Cross-Coupling of Enol Silyl Ethers with α-Trifluoromethyl Bromides to Access β-CF₃-Substituted Ketones

Author: Jiang, Yan ; Pan, Fei ; Liao, Youzhi ; Zhao, Yi

Herein, we introduce a nickel-photocatalyzed cross-coupling reaction between enol silyl ethers and CF3-substituted alkyl bromides.This method provides a streamlined approach for synthesizing a wide array of structurally diverse β-CF3-substituted ketones, achieving favorable yields under mild conditions.The practicality of this methodol. is further underscored by its successful application in the late-stage functionalization of various pharmaceuticals and natural products.

05 Feb 2025·Crystal Growth & Design

Solid-State Diversity of Fenofibric Acid: Synthon Polymorphs and Salts with Altered Solubility and Dissolution

Author: Chernyshev, Vladimir V. ; Prajapati, Aditya Kumar ; Sanphui, Palash ; Varsa S, Richu Bagya ; Ramanujan, Ganesh Munuswamy

Fenofibric acid (hereafter FFA) is a lipid-lowering agent used to treat dyslipidemia, hyperlipidemia, and cardiovascular diseases.The drug belongs to the biopharmaceutical classification system (BCS) Class II category with poor aqueous solubility and high permeability, resulting in improved bioavailability (81%) compared to its prodrug fenofibrate (69%).FFA is marketed in its active form as well as prodrug formulations (fenofibrate and choline fenofibrate) as a sustained-release formulation, because of poor absorption.In order to expand the structural landscape of FFA, solid-form screening resulted in a novel polymorph (FFA-2) along with a reported com. form (FFA-1).While the crystal structure of FFA-1 maintains an unusual acid···carbonyl heterosynthon-mediated dimer, FFA-2 offers a more robust carboxylic acid dimer, and thus they are designated as synthon polymorphs.Moreover, the novel polymorph (FFA-2) improved its dissolution profile (4-fold) compared to FFA-1 in a neutral pH medium.In order to enhance the aqueous solubility of FFA, further salt screening was carried out that resulted in two ionized forms with heterocyclic amines, specifically piperidine (PPD) and piperazine (PPZ).The crystal structure of the PPZ salt was confirmed by single-crystal XRD, while that of PPD salts was obtained from PXRD data.The FFA-PPZ (1:0.5) salt maintains zigzag packing similar to that of FFA-1, while FFA-PPD (1:1) salt sustains layered packing similar to that of FFA-2.The PPZ salt facilitated much-controlled release, while the PPD salt exceptionally enhanced the solubility and dissolution rate of the drug.Both salts demonstrated exceptional stability in moist environments.Similar to FFA-1, both salts maintained identical cell viability in the human monocyte THP-1 cell line.To summarize, a novel polymorph (FFA-2) and PPD salt can be formulated to improve bioavailability and potentially decrease the required dosage.

01 Feb 2025·International Journal of Biological Macromolecules

Administration time modify the anxiolytic and antidepressant effects of inulin via gut-brain axis

Article

Author: Li, Kaikai ; Li, Chunmei ; Chen, Fanyang ; Hu, Xueqin ; Hou, Tao ; Xia, Chenxing ; Zhang, Jiaming ; Shen, Shanshan ; Chen, Ping

An imbalance in the microbiota-gut-brain axis exerts an essential effect on the pathophysiology of depressive and anxiety disorders. Our previous research revealed that the timing of inulin administration altered its effects on chronic unpredictable mild stress (CUMS)-induced anxiety and depression. However, it is still unclear if the gut-brain axis is primarily responsible for these effects. In this study, fecal microbiota transplantation (FMT) confirmed that inulin administration at different times alleviated CUMS-induced anxiety- and depression-like behaviors via the gut-brain axis. The time of administration seemed to modify the anxiolytic and antidepressant effects of inulin, and inulin intervention in the evening was more pronounced in inhibiting the inflammatory responses than that of morning inulin intervention. Serum metabolomics analysis showed that the main differential metabolites, including fenofibric acid, 4'-Hydroxyfenoprofen glucuronide and 5-(4-Hydroxybenzyl)thiazolidine-2,4-dione may be vital for the anxiolytic and antidepressant effects of different inulin treatment times. Our results suggested that inulin administration in the evening was more effective in alleviating the inflammatory responses and improving amino acids metabolism. This study provides a new potential link between the microbiota-gut-brain axis and chrono-nutrition, demonstrating that a more appropriate administration time results in a better intervention effect.

100 Deals associated with Fenofibric acid

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External Link

KEGG	Wiki	ATC	Drug Bank
-	Fenofibric acid	-	DB13873

R&D Status

10 top approved records.

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Indication	Country/Location	Organization	Date
Dyslipidemias	China	Changchun Haiyue Pharmaceutical Co., Ltd	10 May 2022

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Clinical Result

Indication

Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT01472380 (CTgov)	Phase 1	-	30	Efavirenz (Efavirenz Alone)	riezhowqxt(aszkqhkeao) = wunqnqnkwk zrzowgezha (dpmdgqxxlp, dphkuiavla - ngdqpppybd) View more	-	23 Jul 2012
				Fenofibric Acid+Efavirenz (Efavirenz With Fenofibric Acid)	riezhowqxt(aszkqhkeao) = aptggpbyez zrzowgezha (dpmdgqxxlp, jiwexsrvxh - kkcqpoefeh) View more
NCT00960570 (CTgov)	Phase 1	-	30	Efavirenz 600 mg	ykxnxkuxys(hakzjllgpb) = etvlzldkyx hquoxhapfk (jlwacsgrmv, cjnjhmjvqy - znomfqvvfp) View more	-	14 Oct 2009
NCT00960687 (CTgov)	Phase 1	-	54	Fenofibric Acid (Fenofibric Acid 105 mg Tablets)	(logdfutzhg) = flxmjrsbvj rfmoseeiev (bnjhtcusgy, hgelzdqgji - guthgjfoue) View more	-	14 Oct 2009
				Fenofibrate (Fenofibrate 145 mg Tablets)	(logdfutzhg) = sorixvlhqk rfmoseeiev (bnjhtcusgy, uhgyujxbva - lvfwucspsj) View more
NCT00961116 (CTgov)	Phase 1	-	54	Fenofibric Acid (Fenofibric Acid 105 mg Tablets)	(eyvzwszjmq) = vqlpewaciw furxcqpxpe (viqsraqxjh, wnntttpiqo - zqitydfdsw) View more	-	01 Oct 2009
				Fenofibrate (Fenofibrate 145 mg Tablets)	(eyvzwszjmq) = ccrcfoomou furxcqpxpe (viqsraqxjh, junlvodikd - zrctdadfxo) View more