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Last update 17 Apr 2025

Aceclofenac

Last update 17 Apr 2025

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

COXs

Action

inhibitors

Mechanism

COX inhibitors(Cyclooxygenases inhibitors)

Therapeutic Areas

Immune System DiseasesInfectious DiseasesSkin and Musculoskeletal Diseases

Active Indication

Rheumatoid ArthritisAnkylosing SpondylitisOsteoarthritis+ [1]

Inactive Indication

Leiomyoma

Originator Organization-

Active Organization

Gedeon Richter Pharma GmbH

Almirall SAPT Cipta Sintesa Mustika

+ [3]

Inactive Organization

Chemical Works of Gedeon Richter Plc

Drug Highest PhaseApproved

First Approval Date

Spain (19 May 1993),

Rheumatic Diseases

Regulation-

Structure/Sequence

Molecular FormulaC16H13Cl2NO4

InChIKeyMNIPYSSQXLZQLJ-UHFFFAOYSA-N

CAS Registry89796-99-6

Clinical Trials associated with Aceclofenac

CTRI/2024/11/077314

/ Not yet recruitingNot Applicable

A post approval observational study to assess the impaCt Of fixed dose coMbination of Trypsin: Chymotrypsin+ Aceclofenac + Paracetamol In Outpatient SEttings of India (COMPOSE I) - Compose I

Start Date09 Dec 2024

Sponsor / Collaborator

Torrent Pharmaceuticals Ltd.

CTRI/2024/11/077228

/ Not yet recruitingPhase 3IIT

A Comparative Evaluation of The Effect of Low-Level LASER Therapy, LASER-Activated Irrigation and Preoperative Aceclofenac on Post Endodontic Pain After Single Visit Root Canal Treatment - A Randomized Controlled Trial. - NIL

Start Date03 Dec 2024

Sponsor / Collaborator-

CTR20243256

/ CompletedNot Applicable

醋氯芬酸片（100mg）在中国健康受试者中空腹和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 aceclofenac tablets (100 mg) in Chinese healthy subjects under fasting and fed conditions

以合肥英太制药有限公司提供的醋氯芬酸片为受试制剂（规格：100mg）（T），以Almirall,S.A.为持证商的醋氯芬酸片（商品名：Airtal®，规格：100mg）为参比制剂（R），评估健康受试者在空腹及餐后状态下单次口服受试制剂和参比制剂的药代动力学特征，评价两种制剂的人体生物等效性。

[Translation]

Aceclofenac tablets provided by Hefei Yingtai Pharmaceutical Co., Ltd. were used as the test preparation (specification: 100 mg) (T), and Aceclofenac tablets (trade name: Airtal®, specification: 100 mg) licensed by Almirall, S.A. were used as the reference preparation (R). The pharmacokinetic characteristics of the test preparation and the reference preparation after a single oral administration in healthy subjects under fasting and postprandial conditions were evaluated, and the bioequivalence of the two preparations in humans was evaluated.

Start Date26 Sep 2024

Sponsor / Collaborator

Hefei Yingtai Pharmaceutical Co Ltd.

100 Clinical Results associated with Aceclofenac

100 Translational Medicine associated with Aceclofenac

100 Patents (Medical) associated with Aceclofenac

1,972

Literatures (Medical) associated with Aceclofenac

01 Feb 2025·JOURNAL OF MOLECULAR STRUCTURE

Drug-amino acid interaction: Molecular dynamics in aqueous medium using time domain reflectometry

Author: Narwade, Pallavi ; Alwaleedy, Suad ; Kumbharkhane, Ashok C. ; Karale, Ravikant R. ; Al-Hamdani, Saeed Mohammed ; Kamble, Savita ; Sarode, Arvind V.

Present work reports dielec. response of the non-steroidal anti-inflammatory drug (NSAID) aceclofenac in aqueous valine solutions at various concentrations and temperatures (278.15 K-298.15 K) in the frequency range of 0.01 GHz to 30 GHz using Time-domain reflectometry (TDR) technique.The frequency dependent complex dielec. permittivity has been analyzed by Harviliak-Negami equation.Debye model is used for the description of complex dielec. permittivity spectra ε^*(ν).The structural and dynamical properties of water has been investigated at different concentrations of valine and aceclofenac using dielec. as well as thermodn. parameters that includes static dielec. constant (ε₀), relaxation time (τ₀), Kirkwood correlation factor (g), free energy of activation (ΔF), entropy of activation (ΔS), and enthalpy of activation (ΔH).Towards the measured low temperature and high concentrations of Valine and Aceclofenac (ACF), static dielec. constant (ε₀) was found to be increasing.This could be due to increased effective dipole-dipole parallel alignment and can be confirmed by the increasing values of correlation factor (g > 1).The dipole-dipole interaction between Drug-Amino acid resulted in increased dielec. relaxation time (τ₀) of system due to increased steric hindrance for the rotation of dipoles.The free energy of activation was found to be in the range of 2.22 and 2.58 Kcal mol^-1.The entropy is more neg. at high concentration suggesting more ordered structure.The slope of log (Tτ₀) vs. 1000/T gives the value of enthalpy (ΔH).

02 Jan 2025·Expert Opinion On Drug Safety

Risk of drug-induced delirium in older patients- a pharmacovigilance study of FDA adverse event reporting system database

Article

Author: Li, Jiayu ; Zhou, Ying ; Jia, Boying ; Zhou, Shuang ; Wan, Liyan ; Cui, Yimin

BACKGROUND:

Drug-induced delirium is known risk factors associated with increased morbidity and mortality in older patients. The objective was to evaluate the risk of drug-related delirium in older patients based on the FDA Adverse Event Reporting System (FAERS).

RESEARCH DESIGN AND METHODS:

Delirium reports in older patients (age ≥65) extracted from the FAERS database using Open Vigil 2.1. The reported odds ratio and the proportional reported ratio were calculated to detect the adverse reaction signal of delirium. Combined with published evidence, suspected drugs were categorized as known, possible, or new potential delirium-risk-increasing drugs.

RESULTS:

Of the 130,885 reports (including 28,850 delirium events and 1,857 drugs) analyzed for this study, 314 positive signal drugs were detected. Positive signal drugs are mainly concentrated on the drug of nervous system, cardiovascular system , alimentary tract and metabolism and anti-infectives for systemic use. Of the positive signal drugs, 26.11% (82/314) were known delirium-risk increasing drugs, 44.90% (141/314) were possible and 28.98% (91/314) were new potential.

CONCLUSION:

Drug-induced delirium risk is prevalent in older patients, according to the FAERS. The risk level of drug-induced delirium should be taken into account to optimize drug therapy in clinical practice.

01 Jan 2025·Recent Advances in Inflammation & Allergy Drug Discovery

Formulation and Evaluation of Microsponges-loaded Transdermal Gel for the Management of Osteoarthritis

Article

Author: Mittal, Vishnu ; Kriplani, Priyanka ; Sharma, Anjali ; Sen, Shiwani ; Malhotra, Hitesh

Background::

Osteoarthritis (OA) stands as the most widespread form of arthritis, representing a primary source of pain and functional impairment among the elderly. It is often referred to as a degenerative joint disease. OA is more than just wear and tear; it is an aberrant remodelling of joint tissues prompted by a deluge of inflammatory mediators released within the compromised joint. This disease affects 15 million people in India annually.

Objective::

Aceclofenac is a COX-2 inhibitor that has anti-inflammatory activity. However, aceclofenac has a short mean plasma elimination half-life and poor water solubility. It requires frequent dosing, which has been linked to a number of negative side effects, including bleeding and gastrointestinal irritation. A potential solution to this problem is the transdermal administration of aceclofenac using microsponges. In order to have a synergistic effect along with the bioenhancer effects, piperine was incorporated into the formulation.

Methods::

Microsponges were created using the quasi-emulsion solvent diffusion method. After characterization, the prepared microsponges were incorporated into the Carbopol gel. The in vivo study focused on evaluating the optimized formulation, F1.

Results::

All the prepared microsponge formulations underwent assessment based on parameters including yield of production, entrapment efficiency, and in vitro drug release. The outcomes indicated that batches ranging from F1 to F9 showed positive entrapment efficiency and in vitro drug release. From 50.37% to 80.76 % and 71.18% to 91.8% and in vivo studies the results reveal that the inflammatory cells in the best formulation Ace(B)group were reduced hence the formulation's anti-inflammatory impact was achieved.

Conclusion::

The findings indicate that Formulation F1 exhibits superior entrapment and enhanced drug release. The kinetics study suggests that the optimized formulation aligns well with the Higuchi model and adheres to the Fickian transport drug release mechanism. Animal study findings suggest that optimized formulation Ace(B)may possess ideal -anti-osteoarthritic activity for osteoarthritic disease. Further clinical trials on humans may be conducted in order to make the research fruitful for society.

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	European Union	Chemical Works of Gedeon Richter Plc	27 Aug 2018
Leiomyoma	Iceland	Chemical Works of Gedeon Richter Plc	27 Aug 2018
Leiomyoma	Liechtenstein	Chemical Works of Gedeon Richter Plc	27 Aug 2018
Leiomyoma	Norway	Chemical Works of Gedeon Richter Plc	27 Aug 2018
Rheumatoid Arthritis	United Kingdom	UCB SA	08 Apr 1996
Ankylosing Spondylitis	United Kingdom	UCB SA	24 Mar 1996
Osteoarthritis	United Kingdom	UCB SA	24 Mar 1996
Rheumatic Diseases	Spain	-	19 May 1993

Clinical Result

Indication

Phase

Evaluation

View All Results

Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


WCO_IOF_ESCEO2020	Not Applicable	Arthritis \| Rheumatoid Arthritis	120	Aceclofenac 100 mg twice a day	yycvudrxus(qgxghigqbw) = Adverse events of therapy were mild and not require discontinuation of therapy koocrgmxxx (zjkwdmrtop )	Positive	20 Aug 2020
EULAR2015	Not Applicable	Osteoarthritis	-	NSAIDs	ccneajsoot(dbdqjgfmuj) = kxmtmretmp mbrnmcequk (xombyqutyu, 1.7 - 3.1)	-	10 Jun 2015
NCT00635349 (CTgov)	Phase 4	Osteoarthritis, Knee	143	Tramadol Hydrochloride Plus Acetaminophen+aceclofenac+meloxicam	zffwloyhpa(enpzmlhbkq) = leuwaqkpch lxsxnlzzhm (iwlmpqnqod, 14.17) View more	-	24 Jun 2013
EULAR2012	Not Applicable	Osteoarthritis, Knee	200	Aceclofenac 200mg/day	nmmbdpucal(zdmyyirglm) = Adverse effects were noted in 3% of Aceclofenac treated OA patients and in 12% subjects treated with Diclofenac rohqgwgvro (yppubuqddz )	-	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	qimpfuguqs(sapmxinixl) = twnwxquclt pvpbccihyw (wcvjbnrzjk ) View more	Positive	12 Jun 2002

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Aceclofenac

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