Last update 14 Dec 2024

Aceclofenac

Last update 14 Dec 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

Guangzhou Baiyunshan Guang Hua Pharmacy Co., Ltd.

Daewoong Pharmaceutical Co., Ltd.Gedeon Richter Pharma GmbH

+ [3]

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

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

533

Literatures (Medical) associated with Aceclofenac

16 Dec 2024·Journal of biomolecular structure & dynamics

Water dynamics on the structural properties of some NSAID’s with leucine in the picosecond region using time domain spectroscopy

Article

Author: Alwaleedy, Suad ; Karale, Ravikant R. ; Kumbharkhane, Ashok C. ; Kabara, Komal B. ; Sarode, Arvind V. ; Kamble, Savita ; Al-Hamdani, Saeed

Concentration-dependent dielectric response for non-steroidal anti-inflammatory drugs (NSAIDs): Aceclofenac (ACF) and Diclofenac (DCF) in the aqueous leucine solution have been reported at different concentrations and temperatures (298.15 K to 283.15 K). The time domain reflectometry technique in the frequency region of 1 GHz to 30 GHz was used for the present study. Complex permittivity (ε*), static dielectric constant (ε), dielectric relaxation time (τ), dipole moment (μ) and Kirkwood correlation factor (g) have been calculated and discussed in terms of the molecular interaction of water and the used drugs. To give more insights into the structural dynamics of drug-induced amino acids, the study includes molar enthalpy of activation (ΔH), entropy of activation (ΔS), and free energy of activation (ΔF). The overall study concludes that the drug (DCF) having a potent inhibitor of cyclooxygenase found a higher static dielectric constant (ε₀) than that of the drug (ACF) having more carbon (C), hydrogen (H), and oxygen (O) in the chain, which is more efficient in controlling pain.Communicated by Ramaswamy H. Sarma.

01 Dec 2024·INTERNATIONAL JOURNAL OF PHARMACEUTICS

Strategic development of aceclofenac loaded organosomes for topical application: An explorative ex-vivo and in-vivo investigation for arthritis

Article

Author: Katare, O P ; Raza, Kaisar ; Katare, O.P. ; Thakur, Anil ; Thakur, Kanika ; Singh, Vijay ; Nirbhavane, Pradip ; Sharma, Gajanand

Present study intends to develop aceclofenac-encapsulated organosomes (OS), which consist of phospholipids coupled with a combination of organic solvents, for the management of arthritis. The formulation was characterized and tested for efficacy using formalin-induced hyperalgesia, air pouch, and CFA-induced arthritic rat models. OS system exhibited spherical dimension, nanometric size with low PDI (278.3 ± 12.21 nm; 0.145), zeta potential (-24.56 ± 7.53 mV), drug entrapment (85.62 ± 7.2 %) and vesicles count (4.2x104 mm³). The gelled OS formulation demonstrated increased drug permeability and accumulation rate (51.77 ± 7.1 % and 396.19 ± 59.21 µg/cm²) compared to the MKT product (102.93 ± 13.78 µg/cm² and 16.14 ± 4.3 %). Dermatokinetic assessments exhibited significantly higher drug levels in dermal layers compared to MKT product (p < 0.001), and CLSM studies further supported the OS system's deeper penetration. The results of arthritic index significantly better (9 times) in the OS-treated group than the MKT product. OS system treatment significantly reduced biochemicals and cytokines levels, such as CRP, ESR, TLC, lymphocytes, TNF-α, IL-6, and IL-1β to levels of the control group (p < 0.001). Pseudoplastic behaviour of the developed product was indicated by the rheological results, and it also demonstrated biocompatibility through skin compliance studies. Based on the current findings, it appears that OS may be a better choice for managing arthritis and related inflammations.

01 Nov 2024·Drug delivery and translational research

Enhancing collagen based nanoemulgel for effective topical delivery of Aceclofenac and Citronellol oil: Formulation, optimization, in-vitro evaluation, and in-vivo osteoarthritis study with a focus on HMGB-1/RAGE/NF-κB pathway, Klotho, and miR-499a

Article

Author: Ragab, Ghada Mohamed ; Aldeeb, Reem Abd Elhameed ; Gomaa, Asmaa Ahmed ; Taha, Amal Anwar ; Younis, Mona Kamal ; Khalil, Islam Ahmed ; El-Gazar, Amira Ahmed ; Ibrahim, Sherihan Salaheldin Abdelhamid ; Hassan, Doaa Hussien

Abstract:

The majority of conventional osteoarthritis (OA) treatments are based on molecular adjustment of certain signaling pathways associated with osteoarthritis (OA) pathogenesis, however there is a significant need to search for more effective and safe treatments. This study centers around formulating Aceclofenac (ACF) with high bioavailability in combination with Citronellol oil and collagen. The optimal concentrations of Citronellol oil/D-Limonene oil, Tween 80, and Transcutol HP were determined using a pseudoternary phase diagram. The formulated nanoemulsions were studied for thermophysical stability. Thermodynamically stable formula were analyzed for droplet size, zeta potential, and in-vitro permeation. Then, collagen based nanoemulsion were prepared to capitalize on its efficacy in reducing osteoarthritis side effects and characterized for nano size properties. Formulae F10 and F10C were chosen as optimum nanosize formula. Hense, they were prepared and characterized as nanoemulgel dosage form. The nanoemulgel formulae F10NEG1 and F10CNEG1 showed reasonable viscosity and spreadability, with complete drug release after 4 h. These formulae were chosen for further In vivo anti-OA study. Collagen based ACF/citronellol emugel were able to modulate HMGB-1/RAGE/NF-κB pathway, mitigating the production of inflammatory cytokine TNF-α. They were also able to modulate Klotho and miR-499, reducing serum CTXII and COMP, by reducing the cartilage destruction. Histological investigations validated the efficacy, safety, and superiority of Aceclofenac in combination with Citronellol oil and collagen (F10CNEG1) over solo the treated group (F10NEG1 and blank). Hence, the findings of the current work encourage the use of this promising combined formula in treatment of OA patients.Graphical abstract

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


EULAR2015	Not Applicable	Osteoarthritis	-	NSAIDs	cntnchpmmy(dtgzluyxcz) = sxudsrmvkr wbfbktdodt (wtdriijprp, 1.7 - 3.1)	-	10 Jun 2015
NCT00635349 (CTgov)	Phase 4	Osteoarthritis, Knee	143	Tramadol Hydrochloride Plus Acetaminophen+aceclofenac+meloxicam	ledpgpbata(umowyjmdfq) = ijsbxrkpfd zhnjbkworq (yvaifzewgi, iokvnarnkd - wxrqvbtujr) View more	-	24 Jun 2013
EULAR2012	Not Applicable	Osteoarthritis, Knee	200	Aceclofenac 200mg/day	quhwnopwzz(dvplcvcjtz) = Adverse effects were noted in 3% of Aceclofenac treated OA patients and in 12% subjects treated with Diclofenac kemkhowrqb (hjbvzemcdp )	-	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	dczzvyzwwa(oedzexpqqb) = sdnoahnayk yxzyleoqqk (ziooaxhkkz ) View more	Positive	12 Jun 2002

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