己曲安奈德/透明质酸钠(Triamcinolone hexacetonide/Sodium Hyaluronate) - 药物靶点：GR_在研适应症：骨关节炎_专利_临床

概要

基本信息

药物类型

小分子化药

别名

Cingal、Hyaluronic acid/triamcinolone、Sodium hyaluronate/triamcinolone hexacetonide

+ [2]

靶点

GR

作用机制

GR激动剂(糖皮质激素受体激动剂)

治疗领域

免疫系统疾病皮肤和肌肉骨骼疾病

在研适应症

骨关节炎

非在研适应症

膝关节炎

原研机构

Anika International Ltd.

在研机构

Anika Therapeutics, Inc.

非在研机构-

最高研发阶段批准上市

首次获批日期

加拿大 (2015-11-03),

骨关节炎

最高研发阶段(中国)-

特殊审评-

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结构/序列

分子式C30H41FO7

InChIKeyTZIZWYVVGLXXFV-FLRHRWPCSA-N

CAS号5611-51-8

关联

4

项与己曲安奈德/透明质酸钠相关的临床试验

NCT04231318

/ Completed临床3期

A Randomized, Double-Blind, Placebo Controlled, Multi-Center Study of a Single Injection Cross-Linked Sodium Hyaluronate Combined With Triamcinolone Hexacetonide (Cingal®) to Provide Symptomatic Relief of Osteoarthritis of the Knee

This is a multi-center, randomized, double-blind, parallel group, placebo controlled trial to compare the safety and effectiveness of a single injection of Cingal® to a single injection of Triamcinolone Hexacetonide (TH) to achieve pain relief and other symptoms of osteoarthritis of the knee.

开始日期2020-09-11

申办/合作机构

Anika Therapeutics, Inc.

NCT03390036

/ Completed临床3期

Trial Extension Protocol to Add a 39 Week Follow Up to Cingal 16-02, a Randomized, Double-Blind, Active Comparator Controlled, Multi-Center Study of a Single Injection of Cingal to Provide Symptomatic Relief of Knee Osteoarthritis

Extension study to Cingal 16-02 to obtain 39-week safety and efficacy follow-up data

开始日期2017-12-07

申办/合作机构

Anika Therapeutics, Inc.

NCT03191903

/ Completed临床3期

Randomized, Double-Blind, Active Comparator Controlled, Multi-Center Study of a Single Injection Cross-Linked Sodium Hyaluronate Combined With Triamcinolone Hexacetonide (Cingal™) to Provide Symptomatic Relief of Osteoarthritis of the Knee

This is a multi-center, randomized, double-blind, parallel group, active comparator controlled trial to evaluate the efficacy and safety of a single injection of Cingal for the relief of joint pain in subjects with OA of the knee.

开始日期2017-05-25

申办/合作机构

Anika Therapeutics, Inc.

100 项与己曲安奈德/透明质酸钠相关的临床结果

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100 项与己曲安奈德/透明质酸钠相关的转化医学

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100 项与己曲安奈德/透明质酸钠相关的专利（医药）

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3

项与己曲安奈德/透明质酸钠相关的文献（医药）

2025-02-01·Journal of ISAKOS Joint Disorders & Orthopaedic Sports Medicine

Intra-articular injection of a cross-linked hyaluronic acid combined with triamcinolone hexacetonide improves pain at six months in patients with mild to moderate hip osteoarthritis: A prospective observational study

Article

作者: Dessouki, Shariff ; Williams, Ryan ; Lautenbach, Justin ; Rabinovich, Alexander ; Duong, Andrew ; Dalziel, Katie ; Hitchon, Maggie ; Maida, Eugene ; Kapuvari, Stephen ; de SA, Darren ; Bourgeault-Gagnon, Yoan ; Ayeni, Olufemi R. ; Heels-Ansdell, Diane ; Simunovic, Nicole ; Sim, Yan

OBJECTIVES:

Joint-preserving interventions, such as intra-articular viscosupplementation injections, are evolving and requiring efficacy and safety evaluations through an evidence-based approach. The objective of this study was to assess the use of a hyaluronic acid and corticosteroid-based injection (Cingal™; Anika Therapeutics, Bedford, MA, USA) in improving pain and functional outcomes for patients aged between 40 and 65 with mild to moderate hip osteoarthritis (OA) six months post-injection.

METHODS:

This prospective observational study included 100 patients receiving a single ultrasound-guided intra-articular injection of Cingal™. Eligible patients seen in participating orthopaedic, physiatry and sports medicine clinics were evaluated at baseline, one-month, and six-month follow-up. The primary outcome was patient-reported hip pain (Visual Analogue Scale, VAS) at six months post-injection. Secondary outcomes included hip function (Hip Disability and Osteoarthritis Outcome Score, HOOS), quality of life (Short-Form 12, SF-12), pain medication use, range of motion (ROM), physical activity (activity tracker), and adverse events.

RESULTS:

Ninety-six patients received the injection; 91 had complete data for primary outcome analysis. Statistically significant improvements were observed in VAS (p < 0.001), HOOS (p < 0.001), and SF-12 scores (Physical Component Summary, p = 0.005; Mental Component Summary, p = 0.022) from baseline to six months post-injection. Pain medication use decreased from 50.0% to 34.0% (p = 0.035). No statistically significant change was observed in ROM or activity level. Adverse events were reported in 9.5% of patients: five (5.3%) experienced hip pain for less than seven days, one for more than seven days but less than one month, and three (3.2%) underwent hip arthroplasty.

CONCLUSION:

Patients receiving an ultrasound-guided Cingal™ injection for hip OA reported statistically significantly reduced hip pain, improved function and quality of life, and reduced pain medication use at six months. The most common adverse event was transient hip pain.

LEVEL OF EVIDENCE:

Prospective observational study, Level III.

2018-07-01·Cartilage3区 · 医学

Intraarticular Injection of a Cross-Linked Sodium Hyaluronate Combined with Triamcinolone Hexacetonide (Cingal) to Provide Symptomatic Relief of Osteoarthritis of the Knee: A Randomized, Double-Blind, Placebo-Controlled Multicenter Clinical Trial

3区 · 医学

Article

作者: Vasarhelyi, Gabor ; Stevens, Gary ; Zgadzaj, Wojciech ; Hangody, György ; Dokoupilova, Eva ; Lukasik, Piotr ; Szody, Robert ; Lénárt, Endre ; Ficzere, Andrea ; Bichovsk, Daniela ; Szendroi, Miklos ; Hangody, Laszlo ; Berta, Agnes

Objective::

To evaluate the efficacy and safety of an intraarticular injection of Cingal (Anika Therapeutics, Inc., Bedford, MA) compared with Monovisc (Anika Therapeutics, Inc., Bedford, MA) or saline for the treatment of knee osteoarthritis.

Design::

This multicenter, double-blind, saline-controlled clinical trial randomized subjects with knee osteoarthritis (Kellgren-Lawrence grades I-III) to a single injection of Cingal (4 mL, 88 mg hyaluronic acid [HA] plus 18 mg triamcinolone hexacetonide [TH]), Monovisc (4 mL, 88 mg HA), or saline (4 mL, 0.9%). The primary efficacy outcome was change in WOMAC (Western Ontario and McMaster Universities Arthritis Index) Pain Score through 12 weeks with Cingal versus saline. Secondary outcomes included Patient and Evaluator Global Assessments, OMERACT-OARSI Responder index, and WOMAC Total, Stiffness, and Physical Function scores through 26 weeks.

Results::

A total of 368 patients were treated (Cingal, n = 149; Monovisc, n = 150; saline, n = 69). Cingal improvement from baseline was significantly greater than saline through 12 weeks ( P = 0.0099) and 26 weeks ( P = 0.0072). WOMAC Pain was reduced by 70% at 12 weeks and by 72% at 26 weeks with Cingal. Significant improvements were found in most secondary endpoints for pain and function at most time points through 26 weeks. At 1 and 3 weeks, Cingal was significantly better than Monovisc for most endpoints; Cingal and Monovisc were similar from 6 weeks through 26 weeks. A low incidence of related adverse events was reported.

Conclusions::

Cingal provides immediate and long-term relief of osteoarthritis-related pain, stiffness, and function, significant through 26 weeks compared to saline. Cingal had similar immediate advantages compared with HA alone, while showing benefit comparable to HA at 6 weeks and beyond.

2008-01-01·AJNR. American journal of neuroradiology2区 · 医学

Evaluation of a Neck-Bridge Device to Assist Endovascular Treatment of Wide-Neck Aneurysms of the Anterior Circulation

2区 · 医学

Article

作者: De Keukeleire, K ; Defreyne, L ; Vanlangenhove, P

BACKGROUND AND PURPOSE:

Intracranial aneurysms with a wide-neck or an unfavorable dome-to-neck ratio may be difficult to treat properly and safely. Our aim was to evaluate the TriSpan neck-bridge device to assist coiling of wide-neck bifurcation aneurysms in the anterior circulation.

MATERIALS AND METHODS:

In 14 patients, we performed 16 TriSpan-assisted coil embolizations with wide-neck bifurcation aneurysms of the anterior circulation. Eleven procedures were indicated for acutely ruptured aneurysms. Five were performed electively for the following: recurrent aneurysm after coil only (n = 1) or after TriSpan-assisted embolization (n = 2), aneurysm remnant after clipping (n = 1), and aneurysm incidentally found (n = 1). Procedural and clinical complications were recorded. Follow-up angiography was performed, and clinical outcomes were assessed by using the modified Rankin Scale score.

RESULTS:

TriSpan-assisted embolization was successful in 15/16 (93.8%) procedures, with complete occlusion in 2/16 (12.5%), near-complete occlusion in 10/16 (62.5%), and incomplete occlusion in 3/16 (18.75%). There were 6 (37.5%) intraprocedural complications: thrombus formation (n = 3), protrusion of a TriSpan loop in the parent artery (n = 1), TriSpan displacement in the aneurysm (n = 1), and tangling of a coil loop in the device (n = 1). Three patients died in the hospital (21.4%). Follow-up angiography or MR angiography was available in 8 (57.1%) patients and showed complete (n = 2), near-complete (n = 2), and incomplete occlusion (n = 4). Long-term clinical outcome was no (n = 4) or minor symptoms (n = 1) and moderate (n = 2), moderately severe (n = 2), or severe handicap (n = 2).

CONCLUSION:

The use of the TriSpan device is feasible in the anterior circulation and can assist treatment of difficult wide-neck bifurcation aneurysms.

1

项与己曲安奈德/透明质酸钠相关的新闻（医药）

2019-01-16

·BioSpace

Anika Announces Plans to Showcase HYALOFAST at the International Cartilage Regeneration and Joint Preservation Society (ICRS) Summit in San Diego

Jan. 16, 2019 21:05 UTC BEDFORD, Mass.--(BUSINESS WIRE)-- Anika Therapeutics, Inc. (NASDAQ: ANIK), a global, integrated orthopedic and regenerative medicines company specializing in therapeutics based on its proprietary hyaluronic acid ("HA") technology, today announced plans to showcase HYALOFAST, a biodegradable, HA-based cartilage repair scaffold, at the 2019 International Cartilage Repair Society (ICRS) Summit. The 2019 ICRS Summit, which will be focused on Bio-Orthopaedics in Sports Medicine, will be held in San Diego, CA at the Hyatt Regency Mission Bay on January 17-18, 2019. At the 2019 ICRS Summit, Dr. Alberto Gobbi, world-renowned specialist in arthroscopic surgery, cartilage repair and regenerative medicine, will present findings from a 10-year follow-up study of patients treated with HYALOFAST HA scaffold with Bone Marrow Aspirate Concentrate (BMAC) in a one-step surgery. The session will also provide a comparative review of HYALOFAST in comparison to ACI (Autologous Chondrocyte Implantation) and MACI (Matrix Autologous Chondrocyte Implantation), two-step surgeries requiring cell cultivation. “The ICRS Summit in San Diego is a great opportunity to showcase the significant advantages of HYALOFAST before an assembly of world-renowned specialists in the field of cartilage repair and regeneration,” said Joseph Darling, President and CEO, Anika Therapeutics. “We believe that HYALOFAST is a truly remarkable advancement in the treatment of cartilage injuries and defects due to its flexible, minimally-invasive means of application and adaptive fit to individual patient needs.” HYALOFAST is a non-woven, single-step, off-the-shelf, biodegradable HA-based scaffold for hyaline-like cartilage regeneration to treat cartilage injuries and defects. HYALOFAST is commercially available in approximately 15 countries and has been used to successfully treat more than 15,000 patients internationally, with strong ten-year patient follow-up data. HYALOFAST is pending regulatory submission in the United States following its FastTRACK Phase III trial which is currently enrolling patients across the U.S. and Europe. Technical Session 3: Cartilage Title: “One or Two Steps: Long Term Results” Presenter: Dr. Alberto Gobbi, OASI Bioresearch Foundation, Milano – Italy Date/Time: January 17, 2019 at 10:45 – 11:40am Company-Sponsored Booth Anika will be a Gold Sponsor and will host a booth (#6), where it will showcase HYALOFAST. About ICRS The ICRS (International Cartilage Regeneration and Joint Preservation Society) is the main forum for international collaboration in cartilaginous tissue research that brings together basic scientists, clinical researchers, physicians and members of industry, engaged or interested in the field of articular biology, its genetic basis and regenerative medicine. It provides continuing education and training to physicians and scientists with an active interest in the prevention and treatment of joint disease to improve patient care through regenerative medicine approaches. 2018 HYALOFAST Publications Gobbi A., et al. Use of bone marrow aspirate concentrate combined with hyaluronan-based scaffold for early osteoarthritis in athletes. Football Medicine Outcomes Abstract book XXVII Isokinetic Medical Group International Conference – Camp Nou, Barcelona 2-4 June 2018. Ed Calzetti & Mariucci. Page 442. Sofu H. et al. Clinical and radiographic outcomes of chitosan-glycerol phosphate/blood implant are similar with hyaluronic acid-based cell-free scaffold in the treatment of focal osteochondral lesions of the knee joint. Knee Surg Sports Traumatol Arthrosc. 2018 Aug 1. (Epub ahead of print). Gollwitzer H. Operative Therapie - Knorpelschäden der Hϋfte Einzeitiges arthroskopisches Verfahren zur Regeneration. Sportärztezeitung 03/2018 (Cartilage Damage to the Hip. One-Stage Arthroscopic Method of Regeneration). About Anika Therapeutics, Inc. Anika Therapeutics, Inc. (NASDAQ: ANIK) is a global, integrated orthopedic and regenerative medicines company based in Bedford, Massachusetts. Anika is committed to improving the lives of patients with degenerative orthopedic diseases and traumatic conditions with clinically meaningful therapies along the continuum of care, from palliative pain management to regenerative tissue repair. The Company has over two decades of global expertise developing, manufacturing, and commercializing more than 20 products based on its proprietary hyaluronic acid (HA) technology. Anika's orthopedic medicine portfolio includes ORTHOVISC®, MONOVISC®, and CINGAL®, which alleviate pain and restore joint function by replenishing depleted HA, and HYALOFAST, a solid HA-based scaffold to aid cartilage repair and regeneration. For more information about Anika, please visit .

100 项与己曲安奈德/透明质酸钠相关的药物交易

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外链

KEGG	Wiki	ATC	Drug Bank
-	-	H02AB08	-

研发状态

批准上市

10 条最早获批的记录,

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适应症	国家/地区	公司	日期
骨关节炎	加拿大	Anika Therapeutics, Inc.	2015-11-03

未上市

10 条进展最快的记录,

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适应症	最高研发状态	国家/地区	公司	日期
膝关节炎	临床3期	捷克	Anika Therapeutics, Inc.	2015-02-01
膝关节炎	临床3期	匈牙利	Anika Therapeutics, Inc.	2015-02-01
膝关节炎	临床3期	波兰	Anika Therapeutics, Inc.	2015-02-01

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临床结果

适应症

分期

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研究	分期	人群特征	评价人数	分组	结果	评价	发布日期


NCT04231318 (CTgov)	临床3期	膝关节炎	231	Cingal (Cingal)	觸願製鏇糧窪壓網憲繭(築醖衊淵觸簾醖糧鹽襯) = 鹹淵繭鹽遞鏇願膚網選鏇鹽膚糧夢製齋膚繭廠 (選憲築選願鹹醖襯醖觸, 獵範鏇衊淵積製鹽獵淵 ~ 衊衊觸願網顧蓋鹹膚襯) 更多	-	2023-08-09
				Triamcinolone Hexacetonide (TH) (Triamcinolone Hexacetonide (TH))	觸願製鏇糧窪壓網憲繭(築醖衊淵觸簾醖糧鹽襯) = 鏇蓋餘觸淵範構繭膚齋鏇鹽膚糧夢製齋膚繭廠 (選憲築選願鹹醖襯醖觸, 廠憲選遞鏇築選襯獵積 ~ 醖築積糧願範觸膚艱鹽) 更多
NCT03390036 (Cingal17-02, CTgov)	临床3期	膝关节炎	526	Cingal (Cingal)	糧壓醖繭選顧壓積衊鑰(鹹淵襯範顧餘廠餘鑰壓) = 齋壓衊鬱蓋範衊築餘鹽遞選鹹衊製製鹹鏇鹹鬱 (醖醖範襯選憲廠壓鹽積, 醖糧鹽餘製夢襯齋構製 ~ 顧襯廠鹹範願顧齋構夢) 更多	-	2023-05-31
				Monovisc (Monovisc)	糧壓醖繭選顧壓積衊鑰(鹹淵襯範顧餘廠餘鑰壓) = 醖齋遞淵窪衊壓憲簾網遞選鹹衊製製鹹鏇鹹鬱 (醖醖範襯選憲廠壓鹽積, 夢繭衊鏇糧積網製膚壓 ~ 艱簾網網選獵製窪齋鹽) 更多
NCT03191903 (CTgov)	临床3期	膝关节炎	576	Cingal (Cingal)	醖廠獵觸顧觸襯鑰艱鏇(齋淵構顧壓夢範鹽顧廠) = 構膚鏇齋蓋鏇獵獵獵獵廠選觸顧鏇壓淵顧襯顧 (淵鑰顧簾壓觸鑰製膚鏇, 製製鑰蓋鬱醖範範構簾 ~ 積築窪鑰窪糧構鑰糧鑰) 更多	-	2022-02-24
				Monovisc (Monovisc)	醖廠獵觸顧觸襯鑰艱鏇(齋淵構顧壓夢範鹽顧廠) = 繭廠範糧繭構襯壓觸繭廠選觸顧鏇壓淵顧襯顧 (淵鑰顧簾壓觸鑰製膚鏇, 膚築衊膚壓積簾網簾憲 ~ 艱鹹鑰夢蓋壓網襯襯壓) 更多
NCT02381652 (CTgov)	临床3期	膝关节炎	242	Cingal (Cingal/Cingal)	鬱衊膚蓋選獵憲衊獵願(遞築鑰選蓋簾膚構齋齋) = 衊鬱鑰衊選遞襯壓淵鏇構襯鹹積築觸窪廠獵齋 (夢觸廠範繭窪窪餘製齋, 衊顧餘膚鏇構齋壓膚顧 ~ 壓製夢窪鹽築網淵鏇齋) 更多	-	2020-09-03
				Cingal (Cingal/Monovisc)	鬱衊膚蓋選獵憲衊獵願(遞築鑰選蓋簾膚構齋齋) = 餘夢襯鹹齋餘壓衊廠願構襯鹹積築觸窪廠獵齋 (夢觸廠範繭窪窪餘製齋, 鹹網憲艱觸鹹顧願積蓋 ~ 鹹夢夢齋觸網積網夢獵) 更多