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Report Overview

Familial adenomatous polyposis (FAP) is a rare inherited disorder characterized by the growth of numerous polyps in the colon and rectum, which can lead to colorectal cancer if untreated. It accounts for approximately 1% of colorectal cancer cases, with an estimated incidence of 1 in 5,000 to 1 in 18,000, affecting men and women equally. There is a high unmet clinical need for better therapies, as current treatment options, such as surgery and NSAIDs, have limitations. Increasing research on novel familial adenomatous polyposis therapeutics, including chemo-preventive agents and gene therapies, is driving pipeline growth in the coming years.

  • Major companies involved in the familial adenomatous polyposis pipeline drugs market include Rapamycin Holdings Inc., Recursion Pharmaceuticals Inc., and others.

  • Leading drugs currently in the pipeline include Encapsulated Rapamycin, REC-4881, and others.

  • Increasing research on novel therapeutics, advancements in gene therapies, and efforts to address high unmet clinical needs are driving the familial adenomatous polyposis pipeline growth.

Report Coverage

The Familial Adenomatous Polyposis Drug Pipeline Insight Report by Expert Market Research gives comprehensive insights into familial adenomatous polyposis therapeutics currently undergoing clinical trials. It covers various aspects related to the details of each of these drugs under development for Familial Adenomatous Polyposis. The familial adenomatous polyposis report assessment includes the analysis of over 100 pipeline drugs and 50+ companies. The familial adenomatous polyposis pipeline landscape will include an analysis based on efficacy and safety measure outcomes published for the trials, including their adverse effects on patients suffering from the condition, and alignment with familial adenomatous polyposis treatment guidelines to ensure optimal care practices.

The assessment part will include a detailed analysis of each drug, drug class, clinical studies, phase type, drug type, route of administration, and ongoing product development activities related to familial adenomatous polyposis.

Familial Adenomatous Polyposis Drug Pipeline Outlook

Familial adenomatous polyposis (FAP) is a rare, inherited disorder causing numerous polyps in the colon and rectum, which can develop into colorectal cancer if untreated. It results from mutations in the adenomatous polyposis coli (APC) gene, affecting cell growth regulation and leading to uncontrolled polyp formation. It typically emerges in adolescence, with cancer risks increasing by adulthood without intervention.

Familial adenomatous polyposis treatment aims to prevent cancer progression. Prophylactic colectomy, removing the colon, is a primary intervention. Regular endoscopic surveillance helps to monitor polyp growth. The use of nonsteroidal anti-inflammatory drugs (NSAIDs), such as celecoxib, reduces polyp numbers. Genetic counseling is beneficial for affected families, while emerging therapies, such as targeted molecular treatments, provide better outcomes.

Familial Adenomatous Polyposis Epidemiology

Familial Adenomatous Polyposis (FAP) is the second most common inherited polyposis syndrome, with an estimated incidence ranging from 1 in 5,000 to 1 in 18,000, affecting both men and women equally. It occurs in 1 in 10,000 to 1 in 30,000 live births and accounts for less than 1% of colorectal cancer cases in the United States. Epidemiological studies indicate a prevalence of 1 in 8,300 in the United Kingdom and 1 in 17,400 in Japan.

Familial Adenomatous Polyposis – Drug Pipeline Therapeutic Assessment

This section of the report covers the analysis of familial adenomatous polyposis drug candidates based on several segmentations, including:

By Phase

  • Late-Stage Products (Phase 3 and Phase 4)
  • Mid-Stage Products (Phase 2)
  • Early-Stage Products (Phase I)
  • Preclinical and Discovery Stage Products

By Drug Class

  • Small Molecules
  • Monoclonal Antibodies
  • Gene Therapies
  • RNA-Based Therapies
  • Immunotherapies
  • Others

By Route of Administration

  • Oral
  • Parenteral
  • Others

Familial Adenomatous Polyposis – Pipeline Assessment Segmentation, By Phases

The report covers phase I, phase II, phase III, phase IV, and early-phase drugs. The coverage includes an in-depth analysis of each drug across these phases. According to EMR analysis, phase II covers a major share of the total familial adenomatous polyposis clinical trials.

Familial Adenomatous Polyposis – Pipeline Assessment Segmentation, By Drug Classes

The drug molecule categories covered under the familial adenomatous polyposis pipeline analysis include small molecules, monoclonal antibodies, gene therapies, RNA-based therapies, immunotherapies, and others. The familial adenomatous polyposis report provides a comparative analysis of the drug classes for each drug in various phases of clinical trials for familial adenomatous polyposis.

Familial Adenomatous Polyposis Clinical Trials Therapeutic Assessment – Competitive Dynamics

The EMR report for the familial adenomatous polyposis drug pipeline covers the profile of key companies involved in clinical trials and their drugs under development. It provides a detailed familial adenomatous polyposis therapeutic assessment, analyzing the competitive dynamics of the clinical trial landscape. Below is the list of a few players involved in familial adenomatous polyposis clinical trials:

  • Rapamycin Holdings Inc.
  • Recursion Pharmaceuticals Inc.
  • Biodexa Pharmaceuticals
  • S.L.A. Pharma AG
  • Janssen Research & Development, LLC
  • Takeda Pharmaceutical
  • TherapyX
  • Marina Biotech Inc.

Familial Adenomatous Polyposis Emerging Drugs Profile

This section covers the detailed analysis of each drug under multiple phases, including phase I, phase II, phase III, phase IV, and emerging drugs for Familial Adenomatous Polyposis. It includes product description, trial ID, study type, drug class, mode of administration, and recruitment status of familial adenomatous polyposis drug candidates.

Drug: Celecoxib and Metformin

Celecoxib, a COX-2 inhibitor, reduces polyp growth, while metformin, an anti-diabetic drug, suppresses tumorigenesis via the mTOR pathway. Yonsei University is sponsoring a Phase III clinical trial to assess the chemopreventive effect of celecoxib and metformin in patients with familial adenomatous polyposis. The study, involving approximately 100 participants, is expected to conclude by December 2025.

Drug: Encapsulated Rapamycin

Encapsulated Rapamycin (eRapa), developed by Rapamycin Holdings Inc., is under Phase IIa evaluation for reducing polyp burden in familial adenomatous polyposis (FAP) patients. eRapa is an oral mTOR inhibitor and uses nanotechnology for enhanced bioavailability. The 24-month trial will enroll around 30 participants and will examine dose efficacy and food effect, with completion expected in 2025.

Drug: REC-4881

REC-4881 is an orally bioavailable, non-ATP-competitive MEK1/2 inhibitor designed to reduce polyp burden and prevent adenocarcinoma progression in FAP patients. Developed by Recursion Pharmaceuticals Inc., it is currently being assessed in a Phase I/II clinical trial, focusing on its efficacy, safety, pharmacokinetics, and pharmacodynamics. With FDA orphan drug designation, REC-4881 demonstrates a favorable gut-localized PK profile. The study is estimated to enroll approximately seven participants and is expected to conclude in 2025.

*Please note that this is only a partial list; the complete list of drugs will be available in the full report.*

Reasons To Buy This Report

The Familial Adenomatous Polyposis Drug Pipeline Insight Report provides a strategic overview of the latest and future landscape of treatments for familial adenomatous polyposis. It provides necessary information for making informed investment decisions along with research, development, and strategic planning efforts. The stakeholders will benefit from the essential insights into familial adenomatous polyposis collaborations, regulatory environments, and potential growth opportunities.

Key Questions Answered in the Familial Adenomatous Polyposis – Pipeline Insight Report

  • Which companies/institutions are leading the familial adenomatous polyposis drug development?
  • What is the efficacy and safety profile of familial adenomatous polyposis pipeline drugs?
  • Which company is leading the familial adenomatous polyposis pipeline development activities?
  • What is the current familial adenomatous polyposis commercial assessment?
  • What are the opportunities and challenges present in the familial adenomatous polyposis drug pipeline landscape?
  • What is the efficacy and safety profile of familial adenomatous polyposis pipeline drugs?
  • Which company is conducting major trials for familial adenomatous polyposis drugs?
  • Which companies/institutions are involved in familial adenomatous polyposis collaborations aimed at providing enhanced therapeutic alternatives for patients?
  • What are the geographies covered for clinical trials in familial adenomatous polyposis?

Related Reports

Colorectal Cancer Market

Global Colorectal Cancer Therapeutics Market

Colorectal Cancer Drug Pipeline

Global Clinical Trials Market

*While we strive to always give you current and accurate information, the numbers depicted on the website are indicative and may differ from the actual numbers in the main report. At Expert Market Research, we aim to bring you the latest insights and trends in the market. Using our analyses and forecasts, stakeholders can understand the market dynamics, navigate challenges, and capitalize on opportunities to make data-driven strategic decisions.*

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Report Summary

Explore our key highlights of the report and gain a concise overview of key findings, trends, and actionable insights that will empower your strategic decisions.

Key Highlights of the Report

Please note that the figures mentioned in the description serve as estimates and may vary from the actual figures presented in the final report.

Scope of the Report

Details

Drug Pipeline by Clinical Trial Phase

  • Late-Stage Products (Phase III and Phase IV)
  • Mid-Stage Products (Phase II)
  • Early-Stage Products (Phase I)
  • Preclinical and Discovery Stage Products

Route of Administration

  • Oral
  • Parenteral
  • Others

Drug Classes

  • Small Molecules
  • Monoclonal Antibodies
  • Gene Therapies
  • RNA-Based Therapies
  • Immunotherapies
  • Others

Leading Sponsors Covered

  • Rapamycin Holdings Inc.
  • Recursion Pharmaceuticals Inc.
  • Biodexa Pharmaceuticals
  • S.L.A. Pharma AG
  • Janssen Research & Development, LLC
  • Takeda Pharmaceutical
  • TherapyX
  • Marina Biotech Inc.

Geographies Covered

  • North America
  • Europe
  • Asia Pacific
  • Others

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