“Paltusotine Emerging Drug Insight and Market Forecast - 2032” report provides comprehensive insights about paltusotine for acromegaly in the seven major markets. A detailed picture of the paltusotine for acromegaly in the 7MM, i.e., United States, EU5 (Germany, France, Italy, 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 paltusotine for acromegaly. 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 paltusotine market forecast analysis for acromegaly in the 7MM, SWOT, analyst views, comprehensive overview of market competitors, and brief about other emerging therapies in acromegaly.
The company has completed two global Phase II clinical trials of paltusotine in acromegaly patients, the ACROBAT Evolve, and ACROBAT Edge, trials, and have initiated a Phase III development program for paltusotine in acromegaly, PATHFNDR-1 trial (NCT04837040). Enrollment in Evolve was terminated early, enabling data to be available for regulatory interactions on the same timeline as the Edge study. The reduced sample size did not allow meaningful statistical comparisons between groups in the randomized withdrawal period. Data from these patients on lower doses of paltusotine were included in the post-hoc dose-response analyses in combination with data from patients in the Edge study, most of whom received the higher doses.
Drug Summary
Paltusotine (formerly known as CRN 00808), Crinetics pharmaceuticals lead product candidate, establishes a new class of oral, selective, nonpeptide, somatostatin receptor type 2 (SST2) agonists designed for the treatment of acromegaly. It is designed to reduce excess GH secretion from benign pituitary tumors and normalize IGF-1 levels in patients with acromegaly. Somatostatin is a neuropeptide hormone that broadly inhibits the secretion of other hormones, including growth hormone, or GH, from the pituitary gland. Acromegaly arises from a benign pituitary tumor that secretes excess GH that in turn causes excess secretion of insulin-like growth factor-1, or IGF-1, by the liver. This loss of homeostasis in the GH axis results in excess tissue growth and other adverse effects throughout the body.The company has completed two global Phase II clinical trials of paltusotine in acromegaly patients, the ACROBAT Evolve, and ACROBAT Edge, trials, and have initiated a Phase III development program for paltusotine in acromegaly, PATHFNDR-1 trial (NCT04837040). Enrollment in Evolve was terminated early, enabling data to be available for regulatory interactions on the same timeline as the Edge study. The reduced sample size did not allow meaningful statistical comparisons between groups in the randomized withdrawal period. Data from these patients on lower doses of paltusotine were included in the post-hoc dose-response analyses in combination with data from patients in the Edge study, most of whom received the higher doses.
Scope of the Report
The report provides insights into:- A comprehensive product overview including the paltusotine description, mechanism of action, dosage and administration, research and development activities in acromegaly.
- Elaborated details on paltusotine regulatory milestones and other development activities have been provided in this report.
- The report also highlights the paltusotine research and development activities in acromegaly across the United States, Europe and Japan.
- The report also covers the patents information with expiry timeline around paltusotine.
- The report contains forecasted sales of paltusotine for acromegaly till 2032.
- Comprehensive coverage of the late-stage emerging therapies for acromegaly.
- The report also features the SWOT analysis with analyst views for paltusotine in acromegaly.
Methodology
The report is built using data and information sourced primarily from internal databases, primary and secondary research and in-house analysis by a 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.Paltusotine Analytical Perspective
In-depth Paltusotine Market Assessment
This report provides a detailed market assessment of paltusotine for acromegaly in the seven major markets, i.e., United States, EU5 (Germany, France, Italy, Spain, and the United Kingdom), and Japan. This segment of the report provides forecasted sales data from 2026 to 2032.Paltusotine Clinical Assessment
The report provides the clinical trials information of paltusotine for acromegaly covering trial interventions, trial conditions, trial status, start and completion dates.Report Highlights
- In the coming years, the market scenario for acromegaly 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 paltusotine dominance.
- Other emerging products for acromegaly are expected to give tough market competition to paltusotine 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 paltusotine in acromegaly.
- Our in-depth analysis of the forecasted sales data of paltusotine from 2026 to 2032 will support the clients in the decision-making process regarding their therapeutic portfolio by identifying the overall scenario of the paltusotine in acromegaly.
Key Questions Answered
- What is the product type, route of administration and mechanism of action of paltusotine?
- What is the clinical trial status of the study related to paltusotine in acromegaly and study completion date?
- What are the key collaborations, mergers and acquisitions, licensing and other activities related to the paltusotine development?
- What are the key designations that have been granted to paltusotine for acromegaly?
- What is the forecasted market scenario of paltusotine for acromegaly?
- What are the forecasted sales of paltusotine 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 paltusotine for acromegaly?
- Which are the late-stage emerging therapies under development for the treatment of acromegaly?
Table of Contents
1. Report Introduction3. Competitive Landscape (Marketed Therapies)4. Competitive Landscape (Late-stage Emerging Therapies)6. SWOT Analysis7. Analysts’ Views9. Publisher Capabilities10. Disclaimer11. About the Publisher12. Report Purchase Options
2. Paltusotine Overview in Acromegaly
5. Paltusotine Market Assessment
8. Appendix
List of Tables
List of Figures