I/ONTAK (E7777) Emerging Drug Insight

“I/ONTAK (E7777) Market Size, Forecast, and Emerging Insight – 2032” report provides comprehensive insights about I/ONTAK (E7777) for Cutaneous T-cell lymphoma (CTCL) in the seven major markets. A detailed picture of the I/ONTAK (E7777) for Cutaneous T-cell lymphoma  in the 7MM, i.e., the United States, EU4 (Germany, France, Italy and Spain) and the United Kingdom, and Japan for the study period 2019–2032 is provided in this report along with a detailed description of the I/ONTAK (E7777) for Cutaneous T-cell lymphoma. The report provides insight about mechanism of action, dosage and administration, as well as research and development activity including regulatory milestones, along with other developmental activities. Further, it also consists of future market assessments inclusive of the I/ONTAK (E7777) market forecast, analysis for Cutaneous T-cell lymphoma in the 7MM descriptive analysis such as SWOT, analyst views, comprehensive overview of market competitors, and brief about other emerging therapies in Cutaneous T-cell lymphoma.

Drug Summary

I/ONTAK (E7777), is a purified reformulation of denileukin diftitox (ONTAK), a previously FDA-approved cancer immunotherapy for the treatment of persistent or recurrent CTCL. Improvements to the original formulation resulted in a therapy that maintains the same amino acid sequence but features greater purity and bioactivity. E7777 is a fusion protein that combines the interleukin-2 (IL-2) receptor-binding domain with diphtheria toxin fragments. The agent specifically binds to IL-2 receptors on the cell surface, causing diphtheria toxin fragments that have entered cells to inhibit protein synthesis. Its unique mechanism of action targets both malignant T-cells and immunosuppressive regulatory T-cells (Tregs). In December 2021, the company completed the Phase III pivotal trial.

ONTAK was marketed in the US from 1999 to 2014, when it was voluntarily withdrawn from the market. Manufacturing improvements resulted in a new formulation, which maintains the same amino acid sequence but features improved purity and bioactivity. The new formulation received regulatory approval in Japan for the treatment of CTCL and PTCL in 2021.

In December 2022, Citius Pharmaceuticals announced that the US Food and Drug Administration (FDA) has accepted the company's biologics license application (BLA) for denileukin diftitox (""I/ONTAK"" or ""E7777""), for the treatment of patients with persistent or recurrent cutaneous T-cell lymphoma (CTCL). I/ONTAK (E7777) biologics license application (BLA) under review by the US Food and Drug Administration (FDA) with Prescription Drug User Fee Act (PDUFA) target decision date of July 28, 2023.

Scope of the Report

The report provides insights into:

• A comprehensive product overview including the I/ONTAK (E7777) description, mechanism of action, dosage and administration, research and development activities in Cutaneous T-cell lymphoma.
• Elaborated details on I/ONTAK (E7777) regulatory milestones and other development activities have been provided in this report.
• The report also highlights the I/ONTAK (E7777) research and development activity in Cutaneous T-cell lymphoma in detail across the United States, Europe and Japan.
• The report also covers the patents information with expiry timeline around I/ONTAK (E7777).
• The report contains forecasted sales of I/ONTAK (E7777) for Cutaneous T-cell lymphoma till 2032.
• Comprehensive coverage of the late-stage emerging therapies for Cutaneous T-cell lymphoma.
• The report also features the SWOT analysis with analyst views for I/ONTAK (E7777) in Cutaneous T-cell lymphoma.

Methodology

The report is built using data and information sourced primarily from internal databases, primary and secondary research and in-house analysis by DelveInsight’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.

I/ONTAK (E7777) Analytical Perspective by DelveInsight

• In-depth I/ONTAK (E7777) Market Assessment

This report provides a detailed market assessment of I/ONTAK (E7777) in Cutaneous T-cell lymphoma in the seven major markets, i.e., the United States, EU4 (Germany, France, Italy, and Spain) and the United Kingdom, and Japan. This segment of the report provides forecasted sales data from 2023 to 2032.

• I/ONTAK (E7777) Clinical Assessment

The report provides the clinical trials information of I/ONTAK (E7777) in Cutaneous T-cell lymphoma covering trial interventions, trial conditions, trial status, start and completion dates.

Report Highlights 

• In the coming years, the market scenario for Cutaneous T-cell lymphoma 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 I/ONTAK (E7777) dominance.
• Other emerging products for Cutaneous T-cell lymphoma are expected to give tough market competition to I/ONTAK (E7777) 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 I/ONTAK (E7777) in Cutaneous T-cell lymphoma.
• Our in-depth analysis of the forecasted sales data from 2023 to 2032 will support the clients in the decision-making process regarding their therapeutic portfolio by identifying the overall scenario of the I/ONTAK (E7777) in Cutaneous T-cell lymphoma.

Key Questions

• What is the product type, route of administration and mechanism of action of I/ONTAK (E7777)?
• What is the clinical trial status of the study related to I/ONTAK (E7777) in Cutaneous T-cell lymphoma and study completion date?
• What are the key collaborations, mergers and acquisitions, licensing and other activities related to the I/ONTAK (E7777) development?
• What are the key designations that have been granted to I/ONTAK (E7777) for Cutaneous T-cell lymphoma?
• What is the forecasted market scenario of I/ONTAK (E7777) for Cutaneous T-cell lymphoma?
• What are the forecasted sales of I/ONTAK (E7777) 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 in Cutaneous T-cell lymphoma and how are they giving competition to I/ONTAK (E7777) for Cutaneous T-cell lymphoma?
• Which are the late-stage emerging therapies under development for the treatment of Cutaneous T-cell lymphoma?