Nedosiran Emerging Drug Insight and Market Forecast - 2032

“This “Nedosiran Emerging Drug Insight and Market Forecast - 2032” report provides comprehensive insights about nedosiran for Primary Hyperoxaluria (PH) in the seven major markets. A detailed picture of the nedosiran for primary hyperoxaluria in the 7MM, i.e., United States, EU4 (Germany, France, Italy, Spain), the United Kingdom, and Japan, for the study period 2019 -2032 is provided in this report along with a detailed description of the nedosiran for primary hyperoxaluria. 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 nedosiran market forecast analysis for primary hyperoxaluria in the 7MM, SWOT, analysts' views, comprehensive overview of market competitors, and brief about other emerging therapies in primary hyperoxaluria.

Drug Summary

Dicerna Pharmaceutical's nedosiran (formerly referred to as DCR-PHXC) is an advanced therapy utilizing the company's GalXC RNAi technology to treat patients with PH. It inhibits the lactate dehydrogenase (LDH) enzyme in the final common step of this pathway and thereby attempts to prevent this overproduction of oxalate. This LDH enzyme inhibition occurs specifically in the liver due to the incorporation of GalNAc targeting ligands in nedosiran that bind specifically to the asialoglycoprotein receptors (ASGPR) on hepatic cell surfaces. It is an RNAi therapy in development for the treatment of all three known types of PH. The company is evaluating nedosiran in the PHYOX clinical program.

Dicerna has developed nedosiran as a once-monthly fixed-dose injection for the treatment of PH. This once-monthly formulation of nedosiran is designed to avoid the sudden oxalate spikes that could occur with less frequent administration or missed dosages, which could result in the formation of kidney stones and renal failure. In order to maximize patient convenience, the company is developing prefilled syringes to enable self-administration by most PH patients without the need for the involvement of a health care provider for dosing. The company is studying and evaluating nedosiran in different clinical trials.

Nedosiran demonstrated safety and tolerability results in this trial consistent with previously reported studies in the PHYOX clinical development program. Patients administered nedosiran also showed a trend in urinary oxalate (Uox) reduction; however, these reductions did not meet prespecified secondary efficacy endpoint criteria.

Even though Dicerna is now shifting to focus on PH1, it will further analyze the PH3 data given the significant unmet need in that subtype as they work on out-license for nedosiran. Data from the ongoing study(s) are expected to support the Nedosiran New Drug Application (NDA) submission.

Scope of the Report

The report provides insights into:

• A comprehensive product overview including the nedosiran description, mechanism of action, dosage and administration, research and development activities in primary hyperoxaluria.
• Elaborated details on nedosiran regulatory milestones and other development activities have been provided in this report.
• The report also highlights the nedosiran research and development activities in primary hyperoxaluria across the United States, Europe and Japan.
• The report also covers the patents information with expiry timeline around nedosiran.
• The report contains forecasted sales of for primary hyperoxaluria till 2032.
• Comprehensive coverage of the late-stage emerging therapies for primary hyperoxaluria.
• The report also features the SWOT analysis with analyst views for nedosiran in primary hyperoxaluria.

Methodology

The report is built using data and information sourced primarily from internal databases, primary and secondary research and in-house analysis by the publisher's team of industry experts. Information and data from the secondary sources have been obtained from various printable and nonprintable sources like search engines, news websites, global regulatory authorities websites, trade journals, white papers, magazines, books, trade associations, industry associations, industry portals and access to available databases.

Nedosiran Analytical Perspective

In-depth Nedosiran Market Assessment

This report provides a detailed market assessment of nedosiran for primary hyperoxaluria in the seven major markets, i.e., United States, EU4 (Germany, France, Italy, Spain), the United Kingdom), and Japan. This segment of the report provides forecasted sales data from 2024 to 2032.

Nedosiran Clinical Assessment

The report provides the clinical trials information of nedosiran for primary hyperoxaluria covering trial interventions, trial conditions, trial status, start and completion dates.

Report Highlights

• In the coming years, the market scenario for primary hyperoxaluria 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 nedosiran dominance.
• Other emerging products for primary hyperoxaluria are expected to give tough market competition to nedosiran 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 nedosiran in primary hyperoxaluria.
• The in-depth analysis of the forecasted sales data of nedosiran from 2024 to 2032 will support the clients in the decision-making process regarding their therapeutic portfolio by identifying the overall scenario of the nedosiran in primary hyperoxaluria.

Key Questions Answered

• What is the product type, route of administration and mechanism of action of nedosiran?
• What is the clinical trial status of the study related to nedosiran in primary hyperoxaluria and study completion date?
• What are the key collaborations, mergers and acquisitions, licensing and other activities related to the nedosiran development?
• What are the key designations that have been granted to nedosiran for primary hyperoxaluria?
• What is the forecasted market scenario of nedosiran for primary hyperoxaluria?
• What are the forecasted sales of nedosiran in the seven major countries, including the United States, Europe (Germany, France, Italy, Spain, and the United Kingdom), and Japan?
• What are the other emerging products available and how are these giving competition to nedosiran for primary hyperoxaluria?
• Which are the late-stage emerging therapies under development for the treatment of primary hyperoxaluria?

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