A Phase 3, Multicenter, 22-Week, Double-Blind and 30-Week Open-Label Study to Evaluate the Efficacy and Safety of X0002 Spray in Relief of the Signs and Symptoms of Subjects With Osteoarthritis of the Lumbar Spine

This is a Phase 3, Multicenter, Randomized, 22 Week, Double-Blind, Placebo Controlled and 3-Week, Open-Label Study to Evaluate the Efficacy and Safety of X0002 Spray in relief of the signs and symptoms of Subjects with Osteoarthritis of the Lumbar Spine. To evaluate the efficacy of X0002 spray compared to placebo for the relief of low back pain disability in subjects with osteoarthritis (OA) of the low back.

Start Date30 Mar 2023

Sponsor / Collaborator

Suzhou Techfields Pharma Co., Ltd.

CTR20211917 / CompletedPhase 3

评价盐酸布洛胺喷雾剂治疗膝关节骨关节炎患者的疗效和安全性的多中心、随机双盲、安慰剂以及阳性药对照的Ⅲ期临床研究

[Translation] A multicenter, randomized, double-blind, placebo- and active drug-controlled phase III clinical study to evaluate the efficacy and safety of bromocriptine hydrochloride spray in the treatment of patients with knee osteoarthritis

主要研究目的: 与塞来昔布胶囊相比较，在盐酸布洛胺喷雾剂治疗12周时，评价盐酸布洛胺喷雾剂治疗受试者目标膝关节骨关节炎的疗效。次要研究目的: 评估盐酸布洛胺喷雾剂在膝关节骨关节炎受试者中的安全性。

[Translation]

Primary study objective: Compared with celecoxib capsules, to evaluate the efficacy of bromocriptine hydrochloride spray in the treatment of target knee osteoarthritis in subjects treated with bromocriptine hydrochloride spray for 12 weeks. Secondary study objective: To evaluate the safety of bromocriptine hydrochloride spray in subjects with knee osteoarthritis.

Start Date29 Sep 2021

Sponsor / Collaborator

Tianjin Xinchen Taifeier Pharmaceutical Technology Co., Ltd.

NCT05324163 / CompletedPhase 3

A Phase 3, Multicenter, Double-blind and Placebo and Active Control Study to Evaluate the Efficacy and Safety of X0002 Spray in Treatment of Subjects With Osteoarthritis of the Knee

This study is a randomized, double-blind clinical trial in a Chinese population

Start Date29 Sep 2021

Sponsor / Collaborator

Techfields Biochemical Technology Co Ltd

100 Clinical Results associated with Ibuprofenamine Hydrochloride

100 Translational Medicine associated with Ibuprofenamine Hydrochloride

100 Patents (Medical) associated with Ibuprofenamine Hydrochloride

Literatures (Medical) associated with Ibuprofenamine Hydrochloride

01 Apr 2013·Bioorganic & medicinal chemistry lettersQ4 · MEDICINE

Design, synthesis and antithrombotic evaluation of novel dabigatran prodrugs containing methyl ferulate

Q4 · MEDICINE

Article

Author: Wen-Hui Yang ; Feng Li ; Guang-Wei He ; Guo-Qing Gong ; Xiao-Juan Diao ; Yun-Gen Xu ; Xiao-Zhi Yang

A novel series of prodrugs containing dabigatran and methyl (E)-3-(4-hydroxy-2-methoxyphenyl)propenoate (methyl ferulate) were synthesized. All of them reveal the effect of thrombin-induced anti-platelet aggregation in vitro. In addition, in vivo experiment shows that one of the target compounds, X-2 (ED50=3.7 ± 1.0 μmol/kg) possesses a more potent activity for inhibiting venous thrombosis than that of dabigatran etexilate (ED50=7.8 ± 1.5 μmol/kg).

01 Oct 2008·Drug metabolism and disposition: the biological fate of chemicalsQ2 · MEDICINE

Re-engineering of CYP2C9 to Probe Acid-Base Substrate Selectivity

Q2 · MEDICINE

Article

Author: Elizabeth M. J. Gillam ; James J. DeVoss ; Leslie J. Dickmann ; Allan E. Rettie ; Nicholas Matovic ; Guoying Tai

A common feature of many CYP2C9 ligands is their weak acidity. As revealed by crystallography, the structural basis for this behavior involves a charge-pairing interaction between an anionic moiety on the substrate and an active site R108 residue. In the present study we attempted to re-engineer CYP2C9 to better accept basic ligands by charge reversal at this key residue. We expressed and purified the R108E and R108E/D293N mutants and compared their ability with that of native CYP2C9 to interact with (S)-warfarin, diclofenac, pyrene, propranolol, and ibuprofen amine. As expected, the R108E mutant maintained all the native enzyme's pyrene 1-hydroxylation activity, but catalytic activity toward diclofenac and (S)-warfarin was abrogated. In contrast, the double mutant displayed much less selectivity in its behavior toward these control ligands. Neither of the mutants displayed significant enhancement of propranolol metabolism, and all three preparations exhibited a type II (inhibitor) rather than type I (substrate) spectrum with ibuprofen amine, although binding became progressively weaker with the single and double mutants. Collectively, these data underscore the importance of the amino acid at position 108 in the acid substrate selectivity of CYP2C9, highlight the accommodating nature of the CYP2C9 active site, and provide a cautionary note regarding facile re-engineering of these complex cytochrome P450 active sites.

01 Jun 2000·European journal of pharmaceutical sciences : official journal of the European Federation for Pharmaceutical SciencesQ2 · MEDICINE

Binding of [3H]MSX-2 (3-(3-hydroxypropyl)-7-methyl-8-(m-methoxystyryl)-1-propargylxanthine) to rat striatal membranes — a new, selective antagonist radioligand for A2A adenosine receptors

Q2 · MEDICINE

Article

Author: Muller, C. E. ; Maurinsh, J. ; Sauer, R.

The present study describes the preparation and binding properties of a new, potent, and selective A(2A) adenosine receptor (AR) antagonist radioligand, [3H]3-(3-hydroxypropyl)-7-methyl-8-(m-methoxystyryl)-1-propargy lxanth ine ([3H]MSX-2). [3H]MSX-2 binding to rat striatal membranes was saturable and reversible. Saturation experiments showed that [3H]MSX-2 labeled a single class of binding sites with high affinity (K(d)=8.0 nM) and limited capacity (B(max)=1.16 fmol.mg(-1) of protein). The presence of 100 microM GTP, or 10 mM magnesium chloride, respectively, had no effect on [3H]MSX-2 binding. AR agonists competed with the binding of 1 nM [3H]MSX-2 with the following order of potency: 5'-N-ethylcarboxamidoadenosine (NECA)>2-[4-(carboxyethyl)phenylethylamino]-5'-N-ethylcarboxami doaden osine (CGS-21680)>2-chloroadenosine (2-CADO)>N(6)-cyclopentyladenosine (CPA). AR antagonists showed the following order of potency: 8-(m-bromostyryl)-3, 7-dimethyl-1-propargylxanthine (BS-DMPX)>1, 3-dipropyl-8-cyclopentylxanthine (DPCPX)>(R)-5, 6-dimethyl-7-(1-phenylethyl)-2-(4-pyridyl)-7H-pyrrolo[2, 3-d]pyrimidine-4-amine (SH-128)>3,7-dimethyl-1-propargylxanthine (DMPX)>caffeine. The K(i) values for antagonists were in accordance with data from binding studies with the agonist radioligand [3H]CGS21680, while agonist affinities were 3-7-fold lower. [3H]MSX-2 is a highly selective A(2A) AR antagonist radioligand exhibiting a selectivity of at least two orders of magnitude versus all other AR subtypes. The new radioligand shows high specific radioactivity (85 Ci/mmol, 3150 GBq/mmol) and acceptable nonspecific binding at rat striatal membranes of 20-30%, at 1 nM.

News (Medical) associated with Ibuprofenamine Hydrochloride

14 Dec 2023

·www.prnewswire.com

X0002: An Ibuprofenamine Hydrochloride Spray - Emerging Drug Insights and Market Forecasts to 2032

DUBLIN, Dec. 13, 2023 /PRNewswire/ -- The "X0002 Emerging Drug Insight and Market Forecast - 2032" report has been added to ResearchAndMarkets.com's offering. This report provides comprehensive insights about X0002 for osteoarthritis in the six major markets. A detailed picture of the X0002 for osteoarthritis in the 6MM, i.e., the United States, EU4 (Germany, France, Italy, and Spain) and the United Kingdom, along with Canada, and Korea for the study period 2019 -2032 is provided in this report along with a detailed description of the X0002 for osteoarthritis. The report provides insights about mechanism of action, dosage and administration, as well as research and development including regulatory milestones, along with other developmental activities. Further, it also consists of future market assessments inclusive of the X0002 market forecast analysis for osteoarthritis in the 6MM, along with Canada and Korea, SWOT, analysts' views, comprehensive overview of market competitors, and brief about other emerging therapies in osteoarthritis. Drug Summary X0002 (ibuprofenamine hydrochloride spray) is a novel transdermal NSAID under clinical development to treat rheumatoid arthritis and OA as a novel transdermal drug. Techfields has initiated a Phase III clinical trial of a novel drug-X0002, TF-X0002-31 (Freedom-1), in 56 sites in the US for the treatment of knee OA. They have completed the second human factors study for X0002 spray devices, and two Phase II trials in patients with knee OA, one of which was conducted in China. Preclinical studies showed the potential for a greater than 98.5% reduction in the required dose for a disease like OA, which is currently being examined in Phase III clinical trials. X0002 Analytical Perspective In-depth X0002 Market Assessment This report provides a detailed market assessment of X0002 for osteoarthritis in the six major markets, i.e., the United States, EU4 (Germany, France, Italy, and Spain) and the United Kingdom, along with Canada and Korea. This segment of the report provides forecasted sales data from 2024 to 2032. X0002 Clinical Assessment The report provides the clinical trials information of X0002 for osteoarthritis covering trial interventions, trial conditions, trial status, start and completion dates. Report Highlights In the coming years, the market scenario for osteoarthritis is set to change due to the extensive research and incremental healthcare spending across the world; which would expand the size of the market to enable the drug manufacturers to penetrate more into the market. The companies are developing therapies that focus on novel approaches to treat/improve the disease condition, assess challenges, and seek opportunities that could influence X0002 dominance. Other emerging products for osteoarthritis are expected to give tough market competition to X0002 and launch of late-stage emerging therapies in the near future will significantly impact the market. A detailed description of regulatory milestones, and developmental activities, provide the current development scenario of X0002 in osteoarthritis. This in-depth analysis of the forecasted sales data of X0002 from 2024 to 2032 will support the clients in the decision-making process regarding their therapeutic portfolio by identifying the overall scenario of the X0002 in osteoarthritis. Key Topics Covered: 1. Report Introduction 2. X0002 Overview in Osteoarthritis 2.1. Product Detail 2.2. Clinical Development 2.2.1. Clinical studies 2.2.2. Clinical trials information 2.2.3. Safety and efficacy 2.3. Other Developmental Activities 2.4. Product Profile 3. Competitive Landscape (Marketed Therapies) 4. Competitive Landscape (Late-stage Emerging Therapies) 5. X0002 Market Assessment 5.1. Market Outlook of X0002 in Osteoarthritis 5.2. 6MM, Canada and Korea Analysis 5.2.1. Market Size of X0002 in the 6MM, Canada and Korea for Osteoarthritis 5.3. Country-wise Market Analysis 5.3.1. Market Size of X0002 in the United States for Osteoarthritis 5.3.2. Market Size of X0002 in Germany for Osteoarthritis 5.3.3. Market Size of X0002 in France for Osteoarthritis 5.3.4. Market Size of X0002 in Italy for Osteoarthritis 5.3.5. Market Size of X0002 in Spain for Osteoarthritis 5.3.6. Market Size of X0002 in the United Kingdom for Osteoarthritis 5.3.7. Market Size of X0002 in Canada for Osteoarthritis 5.3.8. Market Size of X0002 in Korea for Osteoarthritis 6. SWOT Analysis 7. Analysts' Views For more information about this report visit About ResearchAndMarkets.com ResearchAndMarkets.com is the world's leading source for international market research reports and market data. We provide you with the latest data on international and regional markets, key industries, the top companies, new products and the latest trends. Media Contact: Research and Markets Laura Wood, Senior Manager [email protected] For E.S.T Office Hours Call +1-917-300-0470 For U.S./CAN Toll Free Call +1-800-526-8630 For GMT Office Hours Call +353-1-416-8900 U.S. Fax: 646-607-1907 Fax (outside U.S.): +353-1-481-1716 Logo - SOURCE Research and Markets

Phase 3Phase 2

26 May 2021

·www.globenewswire.com

New Osteoarthritis Drugs Coming Down the Pipeline: A Clinical Trial Review by DelveInsight

Los Angeles, USA, May 25, 2021 (GLOBE NEWSWIRE) -- New Osteoarthritis Drugs Coming Down the Pipeline: A Clinical Trial Review by DelveInsight Approximately 80+ key companies are developing Osteoarthritis Drugs. The companies with the Osteoarthritis drug candidates in the most advanced stage include Ampio Pharmaceuticals, Techfields Pharma, Biosplice Therapeutics, Taiwan Liposome Company and Bone Therapeutics. DelveInsight’s “Osteoarthritis Pipeline Insight” report provides comprehensive insights about 80+ companies and 80+ pipeline drugs in the Osteoarthritis pipeline landscapes. It comprises Osteoarthritis pipeline drug profiles, including clinical and non-clinical stage products. It also includes the Osteoarthritis therapeutics assessment by product type, stage, route of administration, and molecule type and further highlights the inactive Osteoarthritis pipeline products. Some of the key takeaways of the Osteoarthritis Pipeline Report Get an overview of pipeline landscape @ Osteoarthritis Clinical Trials Analysis Osteoarthritis is a type of arthritis caused by inflammation, breakdown, and eventual loss of cartilage in the joints. Osteoarthritis treatment can be broadly classified into reducing modifiable risk factors, intraarticular therapy, physical modalities, alternative therapies, and surgical treatments. Osteoarthritis Emerging Drugs Research and Development Phase III NCT03081806: Techfields Pharma, in April 2021, initiated “A Phase 3, Multicenter, 22-Week, Double-Blind and 30-Week Open Label Study to Evaluate the Efficacy and Safety of X0002 Spray in Relief of the Signs and Symptoms of Subjects With Osteoarthritis of the Knee”. This is a Phase 3, Multicenter, 22-Week, double-blind, and 30-Week open-label Study to Evaluate the Efficacy and Safety of X0002 Spray in relief of the signs and symptoms of subjects with Osteoarthritis of the Knee. Results Techfields announced excellent results from the Phase II trial of X0002 in China. X0002 is a new anti-inflammatory drug that demonstrated an excellent safety profile and efficacy. Research and Development Phase III NCT03988023: Ampio Pharmaceuticals, in June 2019, initiated “ A Randomized, Controlled, Double-Blind Study to Evaluate the Efficacy and Safety of an Intra-Articular Injection of Ampion in Adults With Pain Due to Severe Osteoarthritis of the Knee”. The purpose of this study is to confirm the safety and efficacy of Ampion for the treatment of pain and function in patients with severe osteoarthritis of the knee. This study is a randomized, double-blind, single-dose design. This study is conducted on male and female patients between ≥40 and 85 years of age with severe osteoarthritis of the knee. Approximately 1034 patients with severe osteoarthritis of the knee randomized 1 to 1 treatment group (1:1) will receive a single intra- injection of 4 millilitre (mL) of Ampion or saline. Results Ampio Pharmaceuticals has reported that the Phase 3 clinical trial of Ampion met its primary endpoint with 71% of Ampion treated patients meeting the OMERACT-OARSI responder criteria, which exceeds the physician reported threshold of 30% for a meaningful treatment in severe osteoarthritis of the knee (p < 0.001). For further information, refer to the detailed report @ Osteoarthritis Pipeline Therapeutics Scope of Osteoarthritis Pipeline Drug Insight Key Questions regarding Current Osteoarthritis Treatment Landscape and Emerging Therapies Answered in the Pipeline Report Table of Contents

100 Deals associated with Ibuprofenamine Hydrochloride

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Indication	Highest Phase	Country/Location	Organization	Date
Back Pain	Phase 3	-	Suzhou Techfields Pharma Co., Ltd.	30 Mar 2023
Osteoarthritis, Spine	Phase 3	-	Suzhou Techfields Pharma Co., Ltd.	30 Mar 2023
Osteoarthritis	Phase 3	US	Techfields, Inc.	30 Jan 2022
Primary osteoarthritis of knee NOS	Phase 3	CN	Tianjin Xinchen Taifeier Pharmaceutical Technology Co., Ltd.	29 Sep 2021
Osteoarthritis, Knee	Phase 3	US	Suzhou Techfields Pharma Co., Ltd.	24 Sep 2021
Pain	Phase 3	US	Suzhou Techfields Pharma Co., Ltd.	24 Sep 2021
Inflammation	Phase 1	CN	Tianjin Xinchen Taifeier Pharmaceutical Technology Co., Ltd.	03 Jun 2016
Soft tissue pain	Phase 1	CN	Tianjin Xinchen Taifeier Pharmaceutical Technology Co., Ltd.	03 Jun 2016

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