Author: Tajiri, Ikuko ; Takeuchi, Jun ; Orita, Sumihisa ; Suzuki‐Narita, Miyako ; Tokeshi, Soichiro ; Terakawa, Hiroakira ; Ohtori, Seiji ; Kawarai, Yuya ; Arai, Takahito ; Inage, Kazuhide

AbstractDiclofenac etalhyaluronate (DF‐HA) sustained diclofenac release with the effects of hyaluronic acid (HA), offering long‐term analgesia in osteoarthritis. In this study, the effects of DF‐HA on pain improvement and osteoarthritis were evaluated in a rat knee monoiodoacetate‐induced osteoarthritis model compared to HA. Eight rats per group had been injected with monoiodoacetate (2.0 mg) or saline in the right knee for 4 weeks and were injected with either DF‐HA (1.25 mg/kg; 0.5 mg), HA (0.5 mg), vehicle which was a substrate without DF‐HA (50 μL), or saline and followed for 4 weeks. Mechanical plantar skin sensitivity was assessed weekly using the von Frey assay. Osteoarthritis changes were monitored with Larsen scores via CT imaging at every 2 weeks. The articular cartilage was analyzed using OARSI scores through H&E, Safranin‐O staining at 8 weeks. The percentage of Iba‐1 positive microglia in the spinal dorsal horn and of FG + CGRP‐labeled cells among FG‐positive cells in the dorsal root ganglion were evaluated by immunohistochemical staining. TNF‐α and IL‐6 mRNA expression levels in the knee synovium were evaluated by PCR. The DF‐HA showed significantly improved pain hypersensitivity compared with the HA at 6–8 weeks. The percentage of Iba‐1‐positive microglia was significantly lower than that in the vehicle and the percentage of FG + CGRP/FG was significantly lower than that in the HA. OARSI scores did not differ among treatment groups, Larsen scores indicated lower in the DF‐HA than in the vehicle. DF‐HA was as effective as HA in joint protection and significantly improved inflammatory pain compared to HA.

16 Jan 2025·Modern Rheumatology Case Reports

Anaphylaxis and prolonged allergic reactions caused by intra-articular injection of diclofenac etalhyaluronate in knee osteoarthritis: A case report

Article

Author: Kohmaru, Makiko ; Watanabe, Junko ; Hotchi, Yuta ; Takahashi, Kazuhisa ; Takeshige, Tomohito ; Kido, Kenji ; Kawai, Kenji ; Koyama, Ryo ; Yae, Toshifumi ; Sugita, Manabu ; Akimoto, Takashi

ABSTRACTOsteoarthritis (OA) is a common condition. The treatment of knee OA aims to improve the quality of life and clinical symptoms, mainly knee pain. To develop a new treatment option, diclofenac etalhyaluronate (ONO-5704/SI-613; trade name: JOYCLU) was developed. Its anti-inflammatory and pain-relieving effects have been demonstrated. Conversely, adverse events have also been reported. Here, we report the case of a 71-year-old female who presented with anaphylaxis and prolonged allergic reactions after an intra-articular injection of JOYCLU. A basophil activation test (BAT) was performed to determine the cause of the anaphylaxis. BAT showed no positive findings. As the incidence of knee OA increases, the number of cases of JOYCLU use is expected to grow; therefore, careful administration is required. In this case, the cause was unknown by BAT. Thus, further development of appropriate testing methods is necessary. Intra-articular allergic reactions in knee OA may be modified and worsened besides normal allergic reactions; therefore, caution is required.

31 Dec 2024·Journal of Immunotoxicology

Consideration of the EXiLE test for predicting anaphylaxis after diclofenac etalhyaluronate administration

Article

Author: Nakamura, Ryosuke ; Takada, Shuhei ; Kurisaka, Chisato ; Muramatsu, Dai ; Akiyama, Haruyo ; Yoshioka, Keiji ; Toyama, Kei

Diclofenac etalhyaluronate, an active pharmaceutical ingredient in JOYCLU^® (JCL), serves as a joint function improvement agent in knee and hip osteoarthritis patients. However, frequent cases of anaphylaxis induced by JCL administration have been reported. Recent clinical research suggests the potential utility of the basophil activation test (BAT) in predicting JCL-induced anaphylaxis. Nonetheless, the BAT is deemed impractical for routine diagnostic testing due to complex procedures involving whole blood stimulation and flow cytometry-based analyses. In the study reported here, an IgE crosslinking-induced luciferase expression (EXiLE) test which uses patient sera without complicated procedures, was performed with patients who had received JCL, with or without subsequent anaphylactic symptoms. The results of this test were then compared with those of the BAT reported in a clinical research study. Of the six BAT-positive JCL-induced anaphylaxis-experienced patients, four were positive in the EXiLE test and all non-experienced patients were negative in both the BAT and EXiLE tests, thus illustrating a high concordance rate of 92.3%. Further validation of testing conditions is expected to improve these rates. Notably, complement inactivation treatment led to a positive EXiLE result in a BAT-negative patient. In conclusion, it appears that the EXiLE test exhibits promise as an alternative to BAT for predicting JCL-induced anaphylaxis, and in so doing offers a simpler diagnostic approach.

News (Medical) associated with Diclofenac etalhyaluronate

30 Mar 2022

·www.pharmaceutical-technology.com

Pipeline therapies promising better disease management for osteoarthritis

Osteoarthritis (OA) is a degenerative joint disease that affects millions of people worldwide and is the most common form of arthritis. It is caused by deterioration of the protective cartilage layer that connects the ends of the bones, and most commonly impacts the hands, hips and knees. OA is more frequently seen in people older than 50 years of age, but younger people can also develop it due to injuries, abnormal joint structure or genetic background. Despite Zilretta’s (triamcinolone acetonide extended-release) and Joycle’s (diclofenac etalhyaluronate) launches in 2017 and last year, respectively, their addition has not provided a novel approach to the management of OA. GlobalData has identified candidates in the late-stage pipeline that have the potential to shift the competitive landscape and treatment paradigm by addressing important unmet needs over the following decade. There are currently 120 pipeline products within the seven major markets (7MM: the US, France, Germany, Italy, Spain, UK and Japan). Of these, eight are expected to launch over the next decade (Phases IIb–III). Therapies targeting OA treatment are distinguished into two categories: pain management medications and disease-modifying osteoarthritis drugs (DMOADs). To date, treatments approved or recommended for OA treatment only include pain management regimens that aim to relieve symptoms without stopping disease progression. Drugs currently in the pipeline, however, are targeting both strategies, with a quarter of the late-stage products being DMOADs. Even though OA is among the most prevalent diseases worldwide, basic unmet needs such as lack of early diagnosis and inability to halt disease progression have yet to be addressed. According to key opinion leaders (KOLs), a significant number of OA patients seek treatment after experiencing pain for months or even years. Lack of knowledge prevents patients from recognising OA-specific symptoms early, which eventually leads to chronic pain and compromises quality of life. In addition, as current OA treatments only target pain and do not prevent disease progression, DMOADs are medications highly anticipated both by physicians and patients. Related Two DMOADs currently in the third phase of clinical studies, namely Kolon TissueGene’s Invossa (NCT03203330, NCT03291470) and Biosplice Therapeutics’ lorecivivint (NCT03928184, NCT04385303), are being studied in moderate-to-severe patients and are competing for first-to-market advantage. KOLs interviewed by GlobalData expect that should they make it to market, physicians will swiftly adopt DMOADs in their treatment paradigm and patients will more actively seek treatment for OA, being hopeful that these treatments will effectively prevent disease progression. OA impacts a large percentage of the population, meaning there is ample opportunity for developers to enter the OA space to address the lack of DMOADs in the market. Developers are striving to be first to market to treat this debilitating joint disease, which has a significant impact on patient quality of life. The first DMOAD to market is likely to grasp a significant market share from current pain management treatments. GlobalData expects the launch of these therapies to shape the OA market and mark a new chapter in the management of OA.

22 Jun 2021

·www.globenewswire.com

New Therapeutic Drugs for Tendinitis Treatment Coming Down

Los Angeles, USA, June 21, 2021 (GLOBE NEWSWIRE) -- New Therapeutic Drugs for Tendinitis Treatment Coming Down the Pipeline There are around 4+ key companies that are developing therapies for Tendinitis. MiMedx has its drug candidate in the most advanced stage. However, the Tendinitis pipeline consists of fewer drugs, so there is an opportunity for different companies to work in this arena and dominate the market. DelveInsight’s “Tendinitis Pipeline Insight” report provides comprehensive insights about 4+ companies and 4+ pipeline drugs in the Tendinitis pipeline landscapes. It comprises Tendinitis pipeline drug profiles, including clinical and non-clinical stage products. It also includes the Tendinitis therapeutics assessment by product type, stage, route of administration, and molecule type and further highlights the inactive Tendinitis pipeline products. Some of the key takeaways from the Tendinitis Pipeline Report Get an overview of pipeline landscape @ Tendinitis Clinical Trials Analysis Tendinitis (also called tendonitis) is an inflammation or irritation of a tendon, a thick cord, which attaches bone to muscle. Tendinitis can occur in almost any area of the body. The most common places are the base of the thumb, elbow, shoulder, hip, knee, Achilles tendon. Tendinitis Emerging Drugs SI-613 is a formulation in which hyaluronic acid and a non-steroidal anti-inflammatory drug (NSAID) are chemically bound utilizing Seikagaku’s proprietary technology. SI-613 was developed to offer pain relief and anti-inflammatory effect by sustained release of NSAID, and the joint function was enhanced by the effect of hyaluronic acid. It is anticipated to offer prompt and sustained relief from severe pain and inflammation associated with osteoarthritis and enthesopathy. The drug is currently in phase II of clinical trials for Tendinitis treatment. MP1032’s mode of action is to accelerate the healing process that allows for MP1032 as a therapeutic for tendinitis before tendinosis develops. In addition, MP1032 could speed up the repair of already damaged tendons and hence also decrease the duration of tendinosis treatments. The drug is currently in phase I of clinical trials for the treatment of tendinitis. dHACM is a micronized dehydrated Human Amnion Chorion Membrane developed by MiMedx for Tendinitis and is currently in the phase III stage of development. AmnioFix is processed using Purion, a unique patented method for placental-based allografts according to the American Association of Tissue Banks (AATB) standards. The product is derived from donated C-sections of live births in the US. The product faces active preservation of the extracellular matrix (ECM), regulatory proteins, and elimination of blood contaminants through a proprietary cleansing process. For an additional level of safety, the product is terminally sterilized. For further information, refer to the detailed report @ Tendinitis Pipeline Therapeutics Scope of Tendinitis Pipeline Drug Insight · Tendinitis Therapies Late-stage (Phase III) · Tendinitis Therapies Mid-stage (Phase II)· Tendinitis Therapies Early-stage (Phase I) · Tendinitis Pre-clinical stage and Discovery candidates · Discontinued and Inactive candidates · Cyclooxygenase inhibitors· Cell replacements, Tissue replacements· Collagen modulators; MicroRNA modulators · Peptides· Monoclonal Antibody· Polymer· Small molecule· Gene therapy · Oral· Parenteral· Intravitreal· Subretinal· Topical · Monotherapy· Combination· Mono/Combination Key Questions regarding Current Tendinitis Treatment Landscape and Emerging Therapies Answered in the Pipeline Report Table of Contents Get a customized pipeline report @ Tendinitis Drugs Pipeline Report Related Reports DelveInsight’s Krabbe Disease Market Insights, Epidemiology and Market Forecast - 2030 report provides a detailed overview of the disease and a depth understanding of historical and forecasted epidemiology. DelveInsight’s Laryngeal Cancer Market Insights, Epidemiology and Market Forecast - 2030 report provides a detailed overview of the disease and a depth understanding of historical and forecasted epidemiology. DelveInsight’s Nosocomial Pneumonia Market Insights, Epidemiology and Market Forecast - 2030 report provides a detailed overview of the disease and a depth understanding of historical and forecasted epidemiology. DelveInsight’s Ornithine Transcarbamylase Deficiency (OTC Deficiency) Market Insights, Epidemiology and Market Forecast - 2030 report provides a detailed overview of the disease. About DelveInsightDelveInsight is a leading Business Consultant, and Market Research firm focused exclusively on life sciences. It supports Pharma companies by providing comprehensive end-to-end solutions to improve their performance. It also provides Healthcare Consulting services comprising credible market analysis that will help accelerate the business growth and overcome challenges with a practical approach.

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100 Deals associated with Diclofenac etalhyaluronate

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D11266	-	M	-

R&D Status

Approved

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Indication	Country/Location	Organization	Date
Osteoarthritis	Japan	Seikagaku Corp.	23 Mar 2021

Developing

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Indication	Highest Phase	Country/Location	Organization	Date
Osteoarthritis, Knee	Preclinical	United States	Seikagaku Corp.	19 Oct 2017
Tendinopathy	Preclinical	Japan	-	27 Sep 2017
Enthesopathy	Preclinical	Japan	Seikagaku Corp.	-

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT03209362 (CTgov)	Phase 2	Osteoarthritis, Knee	80	SI-613 (SI-613)	rmqjcwcboo(xnmmrxqnib) = zjwsfbntqm ifmekwxlwz (pxkxkxhgyj, ekuauyyfsl - rkbcqezmob) View more	-	16 Sep 2021
				Placebo (Placebo)	rmqjcwcboo(xnmmrxqnib) = msnfjuyapa ifmekwxlwz (pxkxkxhgyj, sonxilywwv - mqlcmikceo) View more

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