Last update 30 Jun 2024

Aceclofenac

Last update 30 Jun 2024

Overview

R&D Status

Clinical Result

Translational Medicine

Overview

Basic Info

Drug Type

Small molecule drug

Synonyms

2-[(2',6'-dichlorophenyl)amino]phenylacetoxyacetic acid, 2-[(2,6-dichlorophenyl)amino]benzeneacetic acid carboxymethyl ester, 2-[(2,6-dichlorophenyl)amino]phenylacetoxyacetic acid

+ [27]

Target

COX

Mechanism

COX inhibitors(Cyclooxygenases inhibitors)

Therapeutic Areas

Immune System DiseasesInfectious DiseasesSkin and Musculoskeletal Diseases

Active Indication

Rheumatic DiseasesAnkylosing SpondylitisOsteoarthritis+ [1]

Inactive Indication

Leiomyoma

Originator Organization-

Active Organization

Daewoong Pharmaceutical Co., Ltd.Gedeon Richter Pharma GmbH

UCB SA

+ [2]

Inactive Organization

Chemical Works of Gedeon Richter Plc

Drug Highest PhaseApproved

First Approval Date

(01 Jan 1992),

Ankylosing SpondylitisOsteoarthritisRheumatoid Arthritis

Regulation-

Structure

Molecular FormulaC16H13Cl2NO4

InChIKeyMNIPYSSQXLZQLJ-UHFFFAOYSA-N

CAS Registry89796-99-6

Clinical Trials associated with Aceclofenac

CTR20241757 / Active, not recruitingNot Applicable

随机、开放、单剂量、两制剂、两序列、自身交叉对照设计，评价空腹及餐后状态下单次口服受试制剂醋氯芬酸片与参比制剂醋氯芬酸片（商品名：Airtal®）在中国健康受试者中的生物等效性正式试验

[Translation] A formal trial of randomized, open, single-dose, two-formulation, two-sequence, self-crossover design to evaluate the bioequivalence of a single oral dose of the test formulation, aceclofenac tablets, and the reference formulation, aceclofenac tablets (trade name: Airtal®), in healthy Chinese subjects in the fasting and fed state

以广东迈恒医药研发有限公司提供的醋氯芬酸片为受试制剂；并以Almirall,S.A.生产的醋氯芬酸片为参比制剂，进行人体相对生物利用度和生物等效性评价。

[Translation]

Aceclofenac tablets provided by Guangdong Maiheng Pharmaceutical Research and Development Co., Ltd. were used as the test preparation, and Aceclofenac tablets produced by Almirall, S.A. were used as the reference preparation to evaluate the relative bioavailability and bioequivalence in humans.

Start Date14 Jun 2024

Sponsor / Collaborator

Guangzhou Maiheng Medical Technology Co., Ltd.

CTR20241626 / Active, not recruitingNot Applicable

随机、开放、单剂量、两制剂、两序列、两周期、自身交叉对照设计，评价空腹及餐后状态下单次口服受试制剂醋氯芬酸片与参比制剂醋氯芬酸片（商品名：Airtal®）在中国健康受试者中的生物等效性正式试验

[Translation] A formal trial of randomized, open, single-dose, two-formulation, two-sequence, two-period, self-crossover control design to evaluate the bioequivalence of a single oral dose of the test formulation Aceclofenac Tablets and the reference formulation Aceclofenac Tablets (trade name: Airtal®) in healthy Chinese subjects in the fasting and fed state

主要目的：以广东君康药业有限公司提供的醋氯芬酸片为受试制剂；并以Almirall,S.A.生产的醋氯芬酸片为参比制剂，进行人体相对生物利用度和生物等效性评价。

[Translation]

Main objective: To evaluate the relative bioavailability and bioequivalence of Aceclofenac Tablets provided by Guangdong Junkang Pharmaceutical Co., Ltd. as the test preparation and Aceclofenac Tablets produced by Almirall, S.A. as the reference preparation.

Start Date29 May 2024

Sponsor / Collaborator

GuangDong Junkang Pharmaceutical Co., Ltd.

CTRI/2024/01/062033 / RecruitingPhase 4

Evaluation of Efficacy and safety of aceclofenac plus paracetamol plus serratiopeptidase combination after Impacted lower third molar surgery: A randomized, double blind comparison with aceclofenac plus paracetamol combination

Start Date12 Feb 2024

Sponsor / Collaborator

Ipca Laboratories Ltd.

100 Clinical Results associated with Aceclofenac

100 Translational Medicine associated with Aceclofenac

100 Patents (Medical) associated with Aceclofenac

505

Literatures (Medical) associated with Aceclofenac

19 Dec 2023·ACS omega

Drug Polymeric Carrier of Aceclofenac Based on Amphiphilic Chitosan Micelles

Article

Author: Abourehab, Mohammed A S ; Abukhadra, Mostafa R ; Bokhari, Mohammed G ; Alenazi, Noof A

Amphiphilic micelles based on chitosan (CS) were applied as drug carriers of aceclofenac (ACF) as a potential method to induce its bioavailability and therapeutic efficiency. N-octyl-N,O-succinyl CS (OSCS), an amphiphilic CS derivative, was successfully synthesized and loaded physically by ACF at different pH values and using different dosages of ACF, forming ACF-loaded polymeric micelles (PMs). The obtained PMs and ACF-loaded PMs were characterized by different analytical techniques, including AFM, TEM, DLS, UV-vis spectrophotometry, ¹H NMR spectroscopy, and FT-IR spectroscopy. The pH 5 sample with a 30% ACF/polymer ratio showed the highest ACF loading capacity (LC) and entrapment efficiency (EE). In vitro release behaviors of pure ACF and ACF-loaded PMs at each release point indicated that the release profile of pH-responsive PMs loaded with ACF demonstrated quicker release rates (94% after 480 min) compared to the release behavior noticed for free ACF (59.56% after 480 min). Furthermore, the release rates exhibit a notable rise when the pH is increased from 1.2 to 4.7. In the carrageenan-induced inflammation model of paw edema in rats, it has been demonstrated that the injection of ACF-loaded PMs (at a dose of 10 mg/kg) resulted in a strengthened inflammatory activity compared to the injection of free ACF at equivalent dosages as well as at time intervals. However, the use of ACF-loaded PMs for a duration of 6 h displayed a notable reduction of paw edema, with an inhibition percentage of 85.09%, in contrast to the 74.9% inhibition percentage observed for the free ACF medication.

13 Dec 2023·Journal of chromatographic science

A New Stability-Indicating RP-HPLC Method for Simultaneous Quantification of Diacerein and Aceclofenac in Novel Nanoemulgel Formulation and Commercial Tablet Dosage Form in the Presence of their Major Degradation Products Using DoE Approach

Article

Author: Dandagi, Panchaxari M ; Kazi, Taufik M

Abstract:

The present study aimed to develop a simple, robust, sensitive and effective stability-indicating reversed-phase high-performance liquid chromatography method for simultaneous quantification of diacerein (DCN) and aceclofenac (ACE) in novel nanoemulgel formulation and commercial tablets in the presence of their main degradation product: rhein (RH) and diclofenac sodium (DLS), respectively. A fractional factorial design was used to screen the crucial independent factors, whereas a central composite design was used for the optimization of the chromatographic conditions. The separation was carried out on Phenomenex C18 column (5 μm, 250 × 4.6 mm), using a mobile phase consisting of phosphate buffer pH 3 (0.1% v/v orthophosphoric acid) and acetonitrile (40:60 v/v) at a flow rate of 1 mL/min with detection at 264 nm. The analytes were exposed to a variety of stress conditions, including heat, alkali, acid, oxidation, photochemical, humidity and hydrolysis. DCN, ACE, RH and DLS were found to have retention times of 4.32 ± 0.15, 5.77 ± 0.07, 8.28 ± 0.20 and 9.10 ± 0.18 min, respectively. The percent recovery for all four analytes was found to be between 98 and 102, and the procedure was discovered to be linear in the range of 0.1–64 μg/mL with R2 value > 0.999. The established method was validated as per ICH guidelines and successfully used to assay DCN and ACE in their combined marketed tablet dosage form and developed nanoemulgel formulation.

10 Nov 2023·Cureus

Comparison of Efficacy of Combination of Bromelain, Rutocide, and Trypsin With Serratiopeptidase on Postoperative Sequelae Following Mandibular Third Molar Surgery: A Randomized Clinical Trial

Article

Author: Selvarasu, Kathiravan ; Krishnan, Murugesan ; Bhuvan Chandra, Raparthi

Introduction Pain, swelling, trismus, and dry socket are common postoperative complications of mandibular third molar surgery (MTMS), which is a routine minor oral surgical procedure. The purpose of this study was to compare the efficacy of the combination of bromelain, rutocide, and trypsin versus serratiopeptidase in reducing postoperative sequelae after MTMS. Materials and methods It was a pilot study conducted from October 2022 to May 2023 in the outpatient department of a private dental institution. Patients with horizontal position C mandibular third molar impaction were enrolled, and a surgical procedure was performed. Patients were divided into two groups. Group A received tab Rutocide D (trypsin 48mg, bromelain 90mg, rutoside 100mg, and diclofenac 50mg) twice daily, and Group B received tab Zerodol SP (aceclofenac 100mg, paracetamol 325mg, and serratiopeptidase 15mg) twice daily in the postoperative period of five days. Outcome parameters like pain, using the visual analog scale (VAS), and mouth opening, were measured on postoperative days one and seven. An Excel spreadsheet (Microsoft, Redmond, WA, USA) was used for data entry and statistical analysis was performed using SPSS (version 23.0; IBM Corp., Armonk, NY, USA). The patients included in the study were analyzed postoperatively. The statistical significance was set at p < 0.05. An independent sample t-test was used to assess the variables between groups. Results The data analyzed showed that the pain perception in Group A was less when compared to Group B. On postoperative day one, the mean VAS score in Group A was 4.0 ± 0.3 and in Group B was 5.2 ± 0.4. On postoperative day seven the mean VAS score in Group A was 1.4 ± 0.43 and in Group B was 3.0 ± 0.4. The results were statistically significant with less pain experienced by participants in Group A compared to participants in Group B on both postoperative day one and postoperative day seven. On the first postoperative day, patients in Group A had a mean mouth opening of 33.68 ± 1.42, whereas patients in Group B had a mean mouth opening of 29.41 ± 1.86, which was statistically significant. Similarly, on postoperative day seven, patients in Group B had a mean mouth opening of 31.73 ± 3.27, whereas patients in Group A had a mean mouth opening of 36.32 ± 0.24, which was statistically significant. Conclusion It is concluded that the proteolytic enzyme combination of trypsin, bromelain, and rutocide is more efficacious than serratiopeptidase in reducing postoperative sequelae after MTMS.

News (Medical) associated with Aceclofenac

02 Aug 2023

·www.pharmaceutical-technology.com

Filings signal: Despite Covid losses, pharma earnings are promising

Isaac Hanson As Covid-19 product sales dip, other profits remain healthy. Credit: CROCOTHERY / Shutterstock.com. Each week, Pharmaceutical Technology’s journalists pick out insights from company filings that highlight sentiments in our sector. These filings signals are based on GlobalData’s analysis of earnings statements, call transcripts, investor presentations and sustainability reports. They tell us about key topics on the minds of business leaders and investors, and the themes driving a company’s activities. This new, thematic filings coverage is powered by our underlying Disruptor data which tracks all major deals, patents, company filings, hiring patterns and social media buzz across our sectors. Recommended Reports Reports LOA and PTSR Model - Naltrexone in Low Back Pain GlobalData Reports LOA and PTSR Model - (Aceclofenac + Eperisone Sr) in Low Back Pain GlobalData View all Companies Intelligence AstraZeneca Plc Takeda UK Ltd Roche Group Roche S.A. View all In the last week week, pharmaceutical giants including Takeda, AstraZeneca and Roche released their half-year earnings reports, and the numbers give cause for optimism. Covid-19 profits continue to diminish as demand for vaccines wanes, but sales growth in other product areas remains strong enough to compensate. This refocusing is reflected in the mentions of key industry themes within the filings of the three companies. Continuing a trend from Q1, weakening Covid-19 sales are impacting profits, sometimes to the point of exclusion from growth figures. AstraZeneca notes in its H1 report that total revenue was up 4%, but that figure jumps to 16% excluding Covid-19 medications. Takeda reported a similar situation, with core operating profit up 2.3% in actual foreign exchange, but down 2% at constant exchange rate, which it attributes in part to Covid-19 product sales. In its Q1 earnings call , CFO Costa Saroukos explained: “This decline reflects product mix due to generic entry and lower Covid-19 vaccine revenues and also continued investment in R&D and data”. Roche Group’s core profit was in fact down 6% , driven predominantly by declining Covid-19 product sales, which fell by CHF 5bn ($5.75bn) in Q2. Despite this, base business sales grew by 8%, indicating long-term sustainability, especially as a large portion of this growth was coming from new medication. Declining Covid-19 product sales were inevitable as the global vaccination rate continues to increase and governmental funding for prevention tapers off. The exceptional profits created during the pandemic provided big pharma companies with healthy cash reserves, and the return to normal operation appears to be going smoothly. Another indicator of a healthy market is the mass investment in artificial intelligence (AI) that many of these companies are undertaking. Of particular interest is Roche’s in-house language model that functions similarly to ChatGPT announced in early 2022.

VaccineFinancial Statement

27 Apr 2023

·www.pharmaceutical-technology.com

Amicus’ Opfolda wins positive CHMP opinion in Pompe Disease

Robert Barrie Opfolda is intended to be used as part of a two-part therapy, which includes Pombiliti (cipaglucosidase alfa). Image credit: Shutterstock/Sonia Bonet Amicus Therapeutics announced that the Committee for Medicinal Products for Human Use (CHMP) has adopted a positive opinion for Opfolda (miglustat) intended for treatment of Pompe Disease. The CHMP used evidence from a Phase III trial ( NCT03729362 ) involving 123 patients with late-onset Pompe Disease (LOPD) to adopt a positive opinion for Opfolda. A decision from the European Commission (EC) is expected in Q3 2023. Yesterday, the EC released broad reforms , which included a stipulation that the EC will award approval decisions in 46 days after a CHMP opinion, instead of 67 days. Recommended Reports Reports LOA and PTSR Model - Naltrexone in Low Back Pain GlobalData Reports LOA and PTSR Model - (Aceclofenac + Eperisone Sr) in Low Back Pain GlobalData View all Pompe Disease, also known as glycogen storage type II, is a rare inherited lysosomal disorder caused by a deficiency of enzyme acid alpha-glucosidase (GAA) leading to the accumulation of glycogen in skeletal and cardiac muscles. Opfolda is intended to be used as part of a two-part therapy, which includes Pombiliti (cipaglucosidase alfa), the biologic component, which is an enzyme replacement therapy (ERT) to help break down glycogen. Opfolda is a pharmacokinetic enzyme stabilizer that minimises the loss of cipaglucosidase alfa’s activity. If approved, this will become the first two-component therapy approved in the European Union for late-onset Pompe Disease (LOPD). The recommendation follows Pombilit’s EC approval in March 2023. The treatment will go up against Sanofi’s Nexviazyme (avalglucosidase alfa-ngpt) which received an EC approval in June 2022, following a US Food and Drug Administration ( FDA) approval in August 2021. Sanofi markets avalglucosidase alfa as Lumizyme in the US to treat LOPD since its approval in 2010. Sanofi’s Nexviazyme generated €196m ($215m) in global revenues in 2022, while Lumizyme was associated with €958m ($1.05bn) according to the company’s full-year report . The market for Pompe disease is expected to grow as new therapies get approved. “Based on the strength of the label and our launch readiness, once fully approved we believe there is significant opportunity to bring Pombiliti and Opfolda as the first two-component therapy for adult LOPD patients in Europe, and to establish this novel treatment combination as a potential new standard of care in Pompe disease,” said Bradley Campbell, president and CEO of Amicus Therapeutics.

Drug ApprovalPhase 3Clinical Result

27 Mar 2023

·www.drugs.com

Comparative Effectiveness of Meds for Acute Low Back Pain Unclear

MONDAY, March 27, 2023 -- For patients with acute low back pain , the comparative effectiveness and safety of analgesic medications is unclear, according to a systematic review and meta-analysis published online March 22 in The BMJ . Michael A. Wewege, from the University of New South Wales in Sydney, and colleagues conducted a systematic review and network meta-analysis to assess the comparative effectiveness and safety of analgesic medicines for acute nonspecific low back pain. Data were reviewed from 98 randomized controlled trials (15,134 participants), which included 69 medicines and combinations. The researchers observed low or very low confidence in evidence for reduced pain intensity after treatment with tolperisone, aceclofenac plus tizanidine, pregabalin (mean differences, −26.1, −26.1, and −24.7, respectively), and 14 other medicines versus placebo. There was low or very low confidence seen for no difference between the effects of several of these medications. There was moderate to very low confidence noted for increased adverse events with tramadol, acetaminophen plus sustained-release tramadol, baclofen, and acetaminophen plus tramadol compared with placebo (risk ratio, 2.6, 2.4, 2.3, and 2.1, respectively). There was moderate-to-low confidence for these medicines increasing the risk for adverse events compared with other medicines. For secondary outcomes and a secondary analysis of medicine classes, moderate-to-low confidence was also noted. "Despite nearly 60 years of research involving more than 15,000 patients, high quality evidence to guide clinical decisions on analgesic medicines for acute nonspecific low back pain remains limited," the authors write. The Sydney Pharmacy School receives funding from GlaxoSmithKline for a postgraduate scholarship supporting a research student supervised by one of the authors. Abstract/Full Text Posted March 2023

Clinical Result

100 Deals associated with Aceclofenac

External Link

KEGG	Wiki	ATC	Drug Bank
D01545	Aceclofenac	M01AB16 M02AA25	DB06736

R&D Status

10 top approved records.

to view more data

Indication	Country/Location	Organization	Date
Leiomyoma	EU	Chemical Works of Gedeon Richter Plc	27 Aug 2018
Leiomyoma	IS	Chemical Works of Gedeon Richter Plc	27 Aug 2018
Leiomyoma	LI	Chemical Works of Gedeon Richter Plc	27 Aug 2018
Leiomyoma	NO	Chemical Works of Gedeon Richter Plc	27 Aug 2018
Rheumatic Diseases	ES	-	19 May 1993
Ankylosing Spondylitis	-	-	01 Jan 1992
Osteoarthritis	-	-	01 Jan 1992
Rheumatoid Arthritis	-	-	01 Jan 1992

Clinical Result

Indication

Phase

Evaluation

View All Results

Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT00635349 (CTgov)	Phase 4	Osteoarthritis, Knee	143	Tramadol Hydrochloride Plus Acetaminophen+aceclofenac+meloxicam	akwgywdyer(moargqacas) = paehidlyet kkqpeqwtre (szbmpxhuot, gqhuahtpbs - nioqiwiuph) View more	-	24 Jun 2013
EULAR2012	Not Applicable	Osteoarthritis, Knee	200	Aceclofenac 200mg/day	cgxkeqejxk(wzrxklimzc) = Adverse effects were noted in 3% of Aceclofenac treated OA patients and in 12% subjects treated with Diclofenac ixovhlvyll (dopsgqshyo )	-	06 Jun 2012
EULAR2012	Not Applicable	Osteoarthritis, Knee	200	Diclofenac 100mg/day		-	06 Jun 2012
EUROPEAN OBSERVATIONAL COHORT STUDY (EULAR2002)	Not Applicable	Inflammatory pain	-	Aceclofenac	pqgqgbbshq(avvnrmwhxk) = edzpyosjkg lroolkflre (amfghovagw ) View more	Positive	12 Jun 2002

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