A Phase 3 Randomized, Active-Controlled, Double-Masked Study to Evaluate the Safety and Efficacy of TRS01 Eye Drops in the Treatment of Subjects With Active Non-infectious Anterior Uveitis Including Subjects With Uveitic Glaucoma

The primary objective of this study is to evaluate the efficacy and safety of TRS01 eye drops compared to active comparator in subjects with active non-infectious anterior uveitis with or without uveitic glaucoma

开始日期2021-09-20

申办/合作机构

Tarsier Pharma Ltd.初创企业

NCT04222712 / Completed临床1/2期

A Randomized, Double-Masked, Dose-Ranging Study to Evaluate the Safety and Tolerability of TRS01 Eye Drops in Participants With Active Non-infectious Anterior Uveitis.

The objective of this study is to evaluate the safety of TRS01 eye drops in participants with active non-infectious anterior uveitis
.

开始日期2020-02-01

申办/合作机构

Tarsier Pharma Ltd.初创企业

NCT04222725 / Completed临床1/2期

A Multicenter, Double-Masked, Randomized, Vehicle-controlled, Dose-ranging Study to Evaluate the Safety of TRS01 Eye Drops in Participants With Post-surgical Inflammation

The objective of this study is to evaluate the safety and preliminary efficacy of TRS01 eye drops as compared to placebo on participants with ocular inflammation after cataract surgery.

开始日期2020-02-01

申办/合作机构

Tarsier Pharma Ltd.初创企业

100 项与 Dazdotuftide 相关的临床结果

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100 项与 Dazdotuftide 相关的转化医学

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100 项与 Dazdotuftide 相关的专利（医药）

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项与 Dazdotuftide 相关的文献（医药）

2024-11-01·JOURNAL OF PEDIATRIC PSYCHOLOGY

Associations between tripartite dimensions of internalizing symptoms and transition readiness in a sample of emerging adults with and without chronic physical health conditions

Article

作者: Macaulay, Taylor ; Buscemi, Joanna ; Tran, Susan ; Miller, Steven A ; Greenley, Rachel Neff

Abstract:

Objective:

Theoretical models note psychosocial functioning as a key influence on transition readiness skills (TRS) among emerging adults (EA), but little is known about the relative importance of unique vs. shared anxiety and depressive dimensions, operationalized according to Clark and Watson’s (1991) tripartite model, in contributing to TRS. Moreover, although development of TRS is important for all EA, few studies have examined whether the strength of relationships between internalizing symptoms and TRS vary between EA with and without chronic physical health conditions (CHC). Given the links between suboptimal TRS and adverse health outcomes, additional research is needed. This study examined individual and additive associations between three internalizing symptom dimensions (anxious arousal, anhedonic depression, and general distress) and TRS, as well as the moderating role of CHC status.

Method:

One hundred twenty-six EA completed an online survey measuring TRS and internalizing symptoms. The sample was 70.6% women, 39.7% of minoritized racial identity, and 21.2% Hispanic ethnicity. The mean participant age was 21.23 years.

Results:

In two of three regression models, anhedonic depression alone was significantly related to TRS. CHC moderated the relationship between internalizing and TRS in only two of nine models. In both cases, internalizing symptoms were negatively associated with TRS for those without CHCs, but not for those with CHCs.

Conclusions:

Assessment of anhedonic depression may be particularly useful in identifying youth at risk for suboptimal TRS regardless of CHC status. Moreover, interventions such as behavioral activation to improve TRS skill attainment warrant additional investigation.

2024-10-01·TALANTA

Surface-enhanced Raman sensor with molecularly imprinted nanoparticles as highly sensitive recognition material for cancer marker amino acids

Article

作者: Quezada, Camila ; Salas, Alexis ; Sánchez-Sanhueza, G ; Samhitha, Shiva ; Meléndrez, M F ; Esquivel, Samir ; Ges, Adrián ; Palacio, Daniel A ; Barraza, Luis F ; Blanco-López, María Carmen

Surface-enhanced Raman scattering (SERS) is a powerful technique primarily due to its high sensitivity and signal-enhancing properties, which enable the identification of unique vibrational fingerprints. These fingerprints can be used for the diagnosis and monitoring of diseases such as cancer. It is crucial to selectively identify cancer biomarkers for early diagnosis. A correlation has been established between the reduction in the concentration of specific amino acids and the stage of the disease, particularly tryptophan (TPP) and tyrosine (TRS) in individuals diagnosed with prostate cancer. In this work, we present a strategy to analyze TPP and TRS amino acids using molecularly imprinted polymer nanoparticles (nanoMIPs), which selectively detect target molecules in a SERS sensor. NanoMIPs are synthesized using the solid-phase molecular imprinting method with TPP and TRS as templates. These are then immobilized on a SERS substrate with gold nanoparticles to measure samples prepared from tryptophan and tyrosine in phosphate-buffered saline. The detection and quantification limits of the designed sensor are 7.13 μM and 23.75 μM for TPP, and 22.11 μM and 73.72 μM for TRS, respectively. Our study lays the groundwork for future investigations utilizing nanoMIPs in SERS assessments of TPP and TRS as potential biomarkers for prostate cancer detection.

2024-07-01·INTERNATIONAL IMMUNOPHARMACOLOGY

Colorectal carcinoma cell targeting aromatherapy with Teucrium ramosissimum essential oil to sensitize TRAIL/Apo2L-induced HCT-116 cell death

Article

作者: Barkaoui, Taha ; Giuffrè, Angelo Maria ; Tahri, Wiem ; Guesmi, Fatma ; Prasad, Sahdeo ; Mehrez, Amel ; Landoulsi, Ahmed

This report drives insights for the investigation of the underlying mechanisms of antitumor effects of Teucrium ramosissimum (TrS) essential oil (EO) that elicits colon tumor protection via activation of cell death machinery. A study of the aerial part phytocomplex was performed by FTIR spectra and GC/MS. In vivo colon carcinogenesis induced by LPS was carried out using mouse model. HCT-116 cells were coincubated with TrS EO and TRAIL-resistant cancer cells, and then cell lysates were assessed using Western blotting technique for death and decoy receptor expression. TrS essential oil potentiates TRAIL-mediated apoptosis cell death of HCT-116 as detected by PARP cleavage and caspase activation. Further data suggest that TrS up-regulates DR 5/4 expression, and down-regulates DcRs expression. Additionally, TrS potentiates apoptosis in TRAIL-resistant tumor cells through induction of MAPK signalling components, including ERK, p38 kinase, JNK, and activation of CHOP, and SP1, involved in DR5 expression. Moreover, Teucrium EO phytoconstituents mediate HCT-116 cells apoptosis by evoking cell cycle arrest at the G1 and G2/M phase through diminishing the expression of cyclin D1 acting as a potent multitargeted factors of inhibition of JAK/STAT oncogenic signaling pathway. These results demonstrate that TRAIL-induced apoptosis enhancing effect of TrS mediated through proto-oncogene expression in HCT-116. TrS administered intragastrically is able to prevent tumor of colon by stopping carcinogenesis process and impede tumor cell growth in in vivo analysis promoted by LPS. On the whole, our results revealed that TrS is an effective antitcancer agent through the induction of transcription factor and kinases, either are needed to trigger Apo2L receptors.

项与 Dazdotuftide 相关的新闻（医药）

2024-07-16

·PRNewswire

Uveitis Treatment Market Size is Estimated at $1.4 Billion by 2034, Growing at a 7% CAGR, Says Fact.MR

Investments from Pharmaceutical Entities in R&D Endeavors Increasing to Enhance Uveitis Treatment Efficacy and Patient Outcomes ROCKVILLE, Md., July 16, 2024 /PRNewswire/ -- According to a recently released industry report by Fact.MR, the global Uveitis Treatment Market is poised to be valued at US$ 791 million in 2024 and further expand at 5.8% CAGR from 2024 to 2034. Technological advancements in therapy approaches, particularly in the creation of sustained-release drug delivery devices, are key factors driving uveitis treatment market growth. Advanced treatment methods, which include biodegradable microspheres and intravitreal implants, provide significant advantages since they directly administer prolonged pharmaceutical exposure to the affected eye tissues. Reducing the need for repeated injections or systemic medications lowers the risk of undesirable systemic effects while increasing patient compliance and convenience. The rising incidence of uveitis in some countries due to the increasing aging population, a rise in the prevalence of autoimmune disorders, and a focus on improving diagnostic capabilities are major aspects driving the growth of the market for uveitis treatment. Increased funding from pharmaceutical companies and organizations for research and development initiatives aimed at uveitis treatment is driving the exploration of new medicinal agents and treatment strategies. For More Insights into the Market, Request a Sample of this Report: Key Takeaways from the Market Study The global market for uveitis treatment is projected to reach US$ 1.4 billion by 2034-end. North America is estimated to hold 36.8% of the global market share in 2024. Demand for uveitis treatment in East Asia is estimated at a market value of US$ 117 million in 2024. The Canada market is evaluated to generate revenue of US$ 90 million by 2034-end. The market in South Korea is forecasted to expand at a CAGR of 9.4% from 2024 to 2034. Based on disease, the anterior uveitis segment is forecasted to hold 59.5% of the global market share by 2034. In the North American region, the United States is expected to lead the market with a 73.4% revenue share in 2024. "Revenue from uveitis treatment is growing at a steady pace as a result of ongoing advancements such as sustained-release medication delivery techniques that improve patient convenience and therapeutic efficacy," says a Fact.MR analyst. Leading Players Driving Innovation in the Uveitis Treatment Market Key players in the uveitis treatment industry are Sun Pharmaceutical Industries Ltd., EyePoint Pharmaceuticals, Inc., Ophthotech Corporation, Regeneron Pharmaceuticals, Inc., Takeda Pharmaceutical Company Limited, Inflammasome Therapeutics Inc., Graybug Vision, Inc., TopiVert Pharma Ltd., Pfizer Inc., Bausch Health Companies Inc. Hospital Pharmacies Account for Substantial Market Share Hospital pharmacies are generating substantial revenue compared to other distribution channels such as retail pharmacies, online pharmacies, and drug stores. Hospital pharmacies face a constant need for uveitis medications since uveitis is a fairly common condition that requires ongoing care and because hospitals often have a big patient base. Hospitals benefit financially from treating an increasing number of uveitis patients who require continuous access to the prescribed medications. Hospital pharmacies benefit from discounted rates on these medications due to contracts with specific suppliers of uveitis medications. Uveitis Treatment Industry News: Targeting non-infectious uveitis, including uveitic glaucoma, Tarsier Pharma received FDA permission in January 2024 for the Tarsier-04 Phase 3 trial of the TRS01 ocular solution under the Special Protocol Assessment (SPA). The FDA approved triamcinolone acetonide injectable suspension, or XIPER, in October 2021 for use as a suprachoroidal medication to treat retinal edema associated with uveitis. Targeting non-infectious posterior segment uveitis (NIPU) and diabetic macular edema (DME), Alimera Sciences Europe Ltd. launched ILUVIEN in the Netherlands in December 2020 to expand geographically to reach more doctors and patients. Get Customization on this Report for Specific Research Solutions: Global Market Analysis 2019 to 2023 and Forecast 2024 to 2034, by Treatment: Corticosteroids Immunosuppressants Monoclonal Antibodies Cycloplegic Agents Antibiotics Antivirals Antifungals Analgesics Global Market Analysis 2019 to 2023 and Forecast 2024 to 2034, by Disease: Anterior Uveitis Posterior Uveitis Intermediate Uveitis Panuveitis Global Market Analysis 2019 to 2023 and Forecast 2024 to 2034, by Cause: Infectious Uveitis Non-infectious Uveitis Global Market Analysis 2019 to 2023 and Forecast 2024 to 2034, by Distribution Channel: Hospital Pharmacies Retail Pharmacies Online Pharmacies Drug Stores More Valuable Insights: Fact.MR, in its new offering, presents an unbiased analysis of the uveitis treatment market, presenting historical demand data (2019 to 2023) and forecast statistics for 2024 to 2034. The study divulges essential insights into the market based on treatment (corticosteroids, immunosuppressants, monoclonal antibodies, cycloplegic agents, antibiotics, antivirals, antifungals, analgesics), disease (anterior uveitis, posterior uveitis, intermediate uveitis, panuveitis), cause (infectious uveitis, non-infectious uveitis), and distribution channel (hospital pharmacies, retail pharmacies, online pharmacies, drug stores), across seven major regions of the world (North America, Western Europe, Eastern Europe, East Asia, Latin America, South Asia & Pacific, and MEA). Check out More Related Studies Published by Fact.MR: Eye Health Supplements Market stands at US$ 1.9 billion in 2023 and is forecasted to reach US$ 3.5 billion by the end of 2033, increasing at a CAGR of 6.2%. Dry Eye Syndrome Treatment Market is anticipated to be worth US$ 4,027.2 million in 2024 and is expected to expand to an astounding size of US$ 10,961.2 million by 2034. Rare Neurological Disease Treatment Market is projected to expand at a stellar CAGR of over 8.5% and is anticipated to grow 2.3x between 2018 and 2028. Ophthalmic Drugs Market is valued at US$ 38 billion in 2023 and is thus anticipated to reach US$ 72 billion by 2033. Ocular Drug Delivery Technology Market is poised to flourish at a CAGR of 8.2% to reach a value of US$ 39 Billion by 2032. Refsum Disease Treatment Market is predicted to accelerate at a CAGR of 5.6% and reach a market valuation of US$ 2.56 billion by the end of 2033. About Us: Fact.MR is a distinguished market research company renowned for its comprehensive market reports and invaluable business insights. As a prominent player in business intelligence, we deliver deep analysis, uncovering market trends, growth paths, and competitive landscapes. Renowned for its commitment to accuracy and reliability, we empower businesses with crucial data and strategic recommendations, facilitating informed decision-making and enhancing market positioning. With its unwavering dedication to providing reliable market intelligence, FACT.MR continues to assist companies in navigating dynamic market challenges with confidence and achieving long-term success. With a global presence and a team of experienced analysts, FACT.MR ensures its clients receive actionable insights to capitalize on emerging opportunities and stay competitive. Contact: 11140 Rockville Pike Suite 400 Rockville, MD 20852 United States Tel: +1 (628) 251-1583 Sales Team: [email protected] Follow Us: LinkedIn | Twitter | Blog SOURCE Fact.MR

上市批准临床3期

2024-05-28

·PRNewswire

Tarsier Pharma Announces the Appointment of Emilee Fulcher as Vice President of Clinical Affairs

TEL-AVIV, Israel, May 28, 2024 /PRNewswire/ -- Tarsier Pharma, Ltd, a late-stage ophthalmic biopharmaceutical company focused on developing and commercializing first-in-class new therapies for the treatment of blinding ocular diseases proudly announces the appointment of Emilee Fulcher as Vice President of Clinical Affairs. Continue Reading Emilee Fulcher, VP Clinical Affairs, Tarsier Pharma Ltd. In her new role, Emilee Fulcher will spearhead the execution of the TRS01 and TRS02 clinical programs towards the advancement of Tarsier Pharma's pipeline for Dazdotuftide (TRS). Dazdotuftide is a novel, multi-target drug with a unique mechanism of action in development for the treatment of ocular blinding diseases as an eye drop formulation (TRS01) and slow-release biodegradable intravitreal injection (TRS02). "We are thrilled to welcome Emilee to the Tarsier team as our Vice President of Clinical Affairs," said Daphne Haim-Langford CEO of Tarsier. "Emilee's exceptional leadership, proven track record, and deep understanding of ophthalmic research make her the ideal candidate to lead our clinical development efforts. She is knowledgeable, professional, deeply compassionate, and fully aligned with the company's vision to save sight, which makes her an invaluable asset to the team". Emilee has 20 years of experience in the pharmaceutical industry with a specialized background in executing ophthalmology clinical trials. Prior to joining Tarsier, Emilee was one of the first employees of Lexitas, an ophthalmic-focused CRO. During her 11-year tenure at Lexitas she successfully led trials spanning across multiple ophthalmic indications and phases, including all three trials in the TRS01 clinical program completed to-date. Prior to that, she held positions in preclinical drug development and in clinical operations at UCB Biosciences and Inspire Pharmaceuticals. Emilee stated "I am deeply honored to officially join the talented team at Tarsier and am excited to leverage my expertise as we strive to bring our innovative treatment to patients. I am passionate about our mission at Tarsier and eager to progress our clinical programs that have the potential to revolutionize the treatment paradigm for patients with debilitating and blinding conditions including uveitis and specifically uveitic glaucoma. As we embark on initiating the Tarsier-04 Phase 3 trial, we are poised to build on the momentum of our recently completed TRS4Vision Phase 3 trial that demonstrated the potential of TRS01 to serve as an effective and safe treatment in uveitis that meets the urgent need for a drug that resolves inflammation and with a superior IOP safety profile." Tarsier Pharma congratulates Emilee Fulcher on her appointment and looks forward to her leadership in driving the company's clinical development efforts forward. Photo: Contact: Investor Relations Tarsier Pharma [email protected] SOURCE Tarsier Pharma

高管变更临床3期

2024-03-06

·Business Wire

Global Anterior Uveitis (Iritis) Drug Pipeline Research Report 2024 - ResearchAndMarkets.com

DUBLIN--( BUSINESS WIRE )--The "Anterior Uveitis - Pipeline Insight, 2024" clinical trials has been added to ResearchAndMarkets.com's offering. This report provides comprehensive insights about 3+ companies and 3+ pipeline drugs in Anterior Uveitis pipeline landscape. It covers the pipeline drug profiles, including clinical and nonclinical stage products. It also covers the therapeutics assessment by product type, stage, route of administration, and molecule type. It further highlights the inactive pipeline products in this space. The report outlays comprehensive insights of present scenario and growth prospects across the indication. A detailed picture of the Anterior Uveitis pipeline landscape is provided which includes the disease overview and Anterior Uveitis treatment guidelines. The assessment part of the report embraces, in depth Anterior Uveitis commercial assessment and clinical assessment of the pipeline products under development. In the report, detailed description of the drug is given which includes mechanism of action of the drug, clinical studies, NDA approvals (if any), and product development activities comprising the technology, Anterior Uveitis collaborations, licensing, mergers and acquisition, funding, designations and other product related details. Report Highlights The companies and academics are working to assess challenges and seek opportunities that could influence Anterior Uveitis R&D. The therapies under development are focused on novel approaches to treat/improve Anterior Uveitis Anterior Uveitis Emerging Drugs Chapters This segment of the Anterior Uveitis report encloses its detailed analysis of various drugs in different stages of clinical development, including phase II, I, preclinical and Discovery. It also helps to understand clinical trial details, expressive pharmacological action, agreements and collaborations, and the latest news and press releases. Anterior Uveitis Emerging Drugs TRS01: Tarsier Pharma Dazdotuftide (formerly known as TRS01) is a first-in-class drug with a new and unique mechanism of action, for the treatment of ocular blinding diseases of back- and front- of the eye. Dazdotuftide is a bio-inspired novel proprietary technology platform, based on a New Chemical Entity (NCE) with a disruptive mechanism of action. Dazdotuftide was found to modulate macrophages from inflammatory macrophages (M1) to IL-10 secreting ant-inflammatory macrophages (M2). Due to dazdotuftide's unique mechanism of action of immunomodulation, it has the potential to treat these debilitating diseases with a sustained effect and minimal risk of IOP elevation. Currently, the drug is Phase III stage of its clinical trial for the treatment of anterior uveitis. Anterior Uveitis Pipeline Development Activities The report provides insights into different therapeutic candidates in phase II, I, preclinical and discovery stage. It also analyses Anterior Uveitis therapeutic drugs key players involved in developing key drugs. Pipeline Development Activities The report covers the detailed information of collaborations, acquisition and merger, licensing along with a thorough therapeutic assessment of emerging Anterior Uveitis drugs. Anterior Uveitis Therapeutic Assessment Major Players in Anterior Uveitis There are approx. 3+ key companies which are developing the therapies for Anterior Uveitis. The companies which have their Anterior Uveitis drug candidates in the most advanced stage, i.e. Phase III include, Tarsier Pharma. Phases: The report covers around 3+ products under different phases of clinical development like Late stage products (Phase III) Mid-stage products (Phase II) Early-stage product (Phase I) along with the details of Pre-clinical and Discovery stage candidates Discontinued & Inactive candidates Route of Administration Anterior Uveitis pipeline report provides the therapeutic assessment of the pipeline drugs by the Route of Administration. Products have been categorized under various ROAs such as Oral Intravenous Subcutaneous Parenteral Topical Molecule Type Products have been categorized under various Molecule types such as Recombinant fusion proteins Small molecule Monoclonal antibody Peptide Polymer Gene therapy Product Type Anterior Uveitis Report Insights Anterior Uveitis Pipeline Analysis Therapeutic Assessment Unmet Needs Impact of Drugs Anterior Uveitis Report Assessment Pipeline Product Profiles Therapeutic Assessment Pipeline Assessment Inactive drugs assessment Unmet Needs Key Players Tarsier Pharma Oculis Pharma Novaliq Key Products TRS01 OCS 2 Tacrolimus For more information about this clinical trials report visit https://www.researchandmarkets.com/r/tkzvsx 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.

临床2期临床3期基因疗法

100 项与 Dazdotuftide 相关的药物交易

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研发状态

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适应症	最高研发状态	国家/地区	公司	日期
前葡萄膜炎	临床3期	以色列	Tarsier Pharma Ltd.初创企业	2022-01-30
非感染性前葡萄膜炎	临床3期	美国	Tarsier Pharma Ltd.初创企业	2021-09-20
非感染性前葡萄膜炎	临床3期	法国	Tarsier Pharma Ltd.初创企业	2021-09-20
非感染性前葡萄膜炎	临床3期	德国	Tarsier Pharma Ltd.初创企业	2021-09-20
葡萄膜炎继发性青光眼	临床3期	美国	Tarsier Pharma Ltd.初创企业	2021-09-20
葡萄膜炎继发性青光眼	临床3期	法国	Tarsier Pharma Ltd.初创企业	2021-09-20
葡萄膜炎继发性青光眼	临床3期	德国	Tarsier Pharma Ltd.初创企业	2021-09-20
眼部炎症	临床2期	美国	Tarsier Pharma Ltd.初创企业	2020-02-01
糖尿病性黄斑水肿	临床前	以色列	Tarsier Pharma Ltd.初创企业	2022-01-30
干性年龄相关性黄斑病变	临床前	以色列	Tarsier Pharma Ltd.初创企业	2022-01-30

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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


NCT04222712 (CTgov)	临床1/2期	非感染性前葡萄膜炎	16	TRS01 eye drops (TRS01 Low Dose)	顧齋壓憲簾遞繭獵襯夢(鬱觸齋鏇鑰願襯構衊齋) = 遞構餘築鑰壓鬱廠鹽顧鑰觸夢餘觸衊衊製餘齋 (夢範衊淵顧襯鑰壓鬱齋, 網鹽夢淵觸製網獵壓衊 ~ 憲鏇鬱鏇艱艱夢廠鹹築) 更多	-	2023-10-05
				TRS01 eye drops (TRS01 High Dose)	顧齋壓憲簾遞繭獵襯夢(鬱觸齋鏇鑰願襯構衊齋) = 淵繭蓋襯糧醖鏇獵鑰繭鑰觸夢餘觸衊衊製餘齋 (夢範衊淵顧襯鑰壓鬱齋, 廠網顧獵範構廠鏇齋淵 ~ 衊憲壓願壓窪蓋壓艱憲) 更多
NCT04222725 (CTgov)	临床1/2期	眼部炎症	37	TRS01 eye drops (TRS01 Low Dose)	醖淵築鑰窪鬱築蓋憲憲(積餘範餘襯蓋壓鹽簾蓋) = 窪鹽蓋顧淵顧築膚窪齋齋簾憲鹹顧製鑰觸鏇築 (窪鏇獵夢膚願齋觸遞艱, 膚顧獵鬱範觸願範膚衊 ~ 積憲蓋蓋選膚觸網廠廠) 更多	-	2021-10-14
				TRS01 eye drops (TRS01 Medium Dose)	醖淵築鑰窪鬱築蓋憲憲(積餘範餘襯蓋壓鹽簾蓋) = 齋壓夢鏇簾壓夢壓鬱蓋齋簾憲鹹顧製鑰觸鏇築 (窪鏇獵夢膚願齋觸遞艱, 餘構獵構憲蓋簾淵衊積 ~ 觸窪餘網繭鹹顧襯艱願) 更多