Familial Adenomatous Polyposis Pipeline Analysis Report 2025
Description
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. The familial adenomatous polyposis pipeline analysis by Expert Market Research provides an insight into the increasing research on novel therapeutics, including chemo-preventive agents and gene therapies, is driving pipeline growth in the coming years.
Report Coverage
The Familial Adenomatous Polyposis 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 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. In December 2024, Sapience Therapeutics, Inc. received U.S. FDA Orphan Drug Designation for ST316, a first-in-class β-catenin antagonist, for the treatment of familial adenomatous polyposis (FAP). ST316 targets the Wnt/β-catenin pathway, a key driver of FAP and colorectal cancer. Currently in a Phase 2 study, ST316 aims to provide a non-surgical therapeutic option for FAP patients.
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 Pipeline Therapeutic Assessment
This section of the report covers the analysis of familial adenomatous polyposis drug candidates based on several segmentations, including:
By Phase
The pipeline assessment report covers 50+ drug analyses based on phase:
The familial adenomatous polyposis drug pipeline assessment report covers 50+ drug analyses based on drug classes:
The familial adenomatous polyposis therapeutic assessment covers 50+ drug analyses based on the route of administration.
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. Phase II holds the largest share at 7%, reflecting promising advancements in mid-stage clinical trials for familial adenomatous polyposis treatments. Phase I follows with 3%, highlighting early-stage research progress. Phase III accounts for 2%, showcasing therapies nearing regulatory approval.
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. The familial adenomatous polyposis pipeline includes mTOR inhibitors as a promising therapeutic approach. For instance, eRapa, a proprietary oral formulation of rapamycin, demonstrated a 75% non-progression rate and a median 17% reduction in polyp burden at 12 months in a Phase 2 trial. These results support its advancement to a Phase 3 registrational study.
Key Players in the Familial Adenomatous Polyposis Pipeline
The EMR report for the familial adenomatous polyposis 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:
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.
Key Questions Answered in the Familial Adenomatous Polyposis Pipeline Analysis Report
The Familial Adenomatous Polyposis Pipeline Analysis 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.
Related Reports
Colorectal Cancer Market
Global Colorectal Cancer Therapeutics Market
Colorectal Cancer Drug Pipeline
Global Clinical Trials Market
Report Coverage
The Familial Adenomatous Polyposis 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 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. In December 2024, Sapience Therapeutics, Inc. received U.S. FDA Orphan Drug Designation for ST316, a first-in-class β-catenin antagonist, for the treatment of familial adenomatous polyposis (FAP). ST316 targets the Wnt/β-catenin pathway, a key driver of FAP and colorectal cancer. Currently in a Phase 2 study, ST316 aims to provide a non-surgical therapeutic option for FAP patients.
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 Pipeline Therapeutic Assessment
This section of the report covers the analysis of familial adenomatous polyposis drug candidates based on several segmentations, including:
By Phase
The pipeline assessment report covers 50+ drug analyses based on phase:
- Late-Stage Products (Phase 3 and Phase 4)
- Mid-Stage Products (Phase 2)
- Early-Stage Products (Phase I)
- Preclinical and Discovery Stage Products
The familial adenomatous polyposis drug pipeline assessment report covers 50+ drug analyses based on drug classes:
- Small Molecules
- Monoclonal Antibodies
- Gene Therapies
- RNA-Based Therapies
- Immunotherapies
- Others
The familial adenomatous polyposis therapeutic assessment covers 50+ drug analyses based on the route of administration.
- Oral
- Parenteral
- Others
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. Phase II holds the largest share at 7%, reflecting promising advancements in mid-stage clinical trials for familial adenomatous polyposis treatments. Phase I follows with 3%, highlighting early-stage research progress. Phase III accounts for 2%, showcasing therapies nearing regulatory approval.
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. The familial adenomatous polyposis pipeline includes mTOR inhibitors as a promising therapeutic approach. For instance, eRapa, a proprietary oral formulation of rapamycin, demonstrated a 75% non-progression rate and a median 17% reduction in polyp burden at 12 months in a Phase 2 trial. These results support its advancement to a Phase 3 registrational study.
Key Players in the Familial Adenomatous Polyposis Pipeline
The EMR report for the familial adenomatous polyposis 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.
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.
Key Questions Answered in the Familial Adenomatous Polyposis Pipeline Analysis 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?
The Familial Adenomatous Polyposis Pipeline Analysis 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.
Related Reports
Colorectal Cancer Market
Global Colorectal Cancer Therapeutics Market
Colorectal Cancer Drug Pipeline
Global Clinical Trials Market
Table of Contents
200 Pages
- 1 Preface
- 1.1 Introduction
- 1.2 Objectives of the Study
- 1.3 Research Methodology & Assumptions
- 2 Executive Summary
- 3 Overview of Familial Adenomatous Polyposis
- 3.1 Signs and Symptoms
- 3.2 Causes
- 3.3 Risk Factors
- 3.4 Diagnosis
- 3.5 Treatment
- 4 Patient Profile: Familial Adenomatous Polyposis
- 4.1 Patient Profile Overview
- 4.2 Patient Psychology and Emotional Impact Factors
- 4.3 Risk Assessment and Treatment Success Rate
- 5 Familial Adenomatous Polyposis: Epidemiology Snapshot
- 5.1 Familial Adenomatous Polyposis Incidence by Key Markets
- 5.2 Familial Adenomatous Polyposis – Patients Seeking Treatment in Key Markets
- 6 Familial Adenomatous Polyposis: Market Dynamics
- 6.1 Market Drivers and Constraints
- 6.2 SWOT Analysis
- 7 Familial Adenomatous Polyposis: Key Facts Covered
- 7.1 Top Countries Contributing to Clinical Trials in Asia-Pacific
- 7.2 Top Countries Contributing to Clinical Trials in Europe
- 7.3 Top Countries Contributing to Clinical Trials in North America
- 7.4 Top Countries Contributing to Clinical Trials in Other Regions
- 8 Familial Adenomatous Polyposis, Drug Pipeline Assessment
- 8.1 Assessment by Treatment Type
- 8.2 Assessment by Route of Administration
- 8.3 Assessment by Drug Class
- 9 EMR Drug Pipeline Comparative Analysis
- 9.1 List of Familial Adenomatous Polyposis Pipeline Drugs
- 9.1.1 By Company
- 9.1.2 By Phase
- 9.1.3 By Indication
- 9.1.4 By Trial Status
- 9.1.5 By Funder Type
- 9.2 EMR Attribute Scoring Analysis of Pipeline Drugs (Top Drugs)
- 10 Familial Adenomatous Polyposis Drug Pipeline - Late-Stage Products (Phase III and IV) (Top Drugs)
- 10.1 Comparative Analysis for Late-Stage Drugs
- 10.1.1 Study Type
- 10.1.2 Recruitment Status
- 10.1.3 Company
- 10.1.4 Funder Type
- 10.2 Product Level Analysis*
- 10.2.1 Drug: Celecoxib and Metformin
- 10.2.1.1 Product Description
- 10.2.1.2 Trial ID
- 10.2.1.3 Sponsor Name
- 10.2.1.4 Study Type
- 10.2.1.5 Drug Class
- 10.2.1.6 Eligibility Criteria
- 10.2.1.7 Study Record Dates
- 10.2.1.7.1 First Submitted
- 10.2.1.7.2 First Posted
- 10.2.1.7.3 Last Update Posted
- 10.2.1.7.4 Last Verified
- 10.2.1.8 Indication
- 10.2.1.9 Study Design
- 10.2.1.10 Recruitment Status
- 10.2.1.11 Enrollment (Estimated)
- 10.2.1.12 Location Countries
- 10.2.1.13 Recent Results
- 10.2.2 Other Drugs
- 11 Familial Adenomatous Polyposis Drug Pipeline - Mid-Stage Products (Phase II) (Top Drugs)
- 11.1 Comparative Analysis for Mid-Stage Drugs
- 11.1.1 Study Type
- 11.1.2 Recruitment Status
- 11.1.3 Company
- 11.1.4 Funder Type
- 11.2 Product Level Analysis*
- 11.2.1 Drug: Encapsulated Rapamycin
- 11.2.1.1 Product Description
- 11.2.1.2 Trial ID
- 11.2.1.3 Sponsor Name
- 11.2.1.4 Study Type
- 11.2.1.5 Drug Class
- 11.2.1.6 Eligibility Criteria
- 11.2.1.7 Study Record Dates
- 11.2.1.7.1 First Submitted
- 11.2.1.7.2 First Posted
- 11.2.1.7.3 Last Update Posted
- 11.2.1.7.4 Last Verified
- 11.2.1.8 Indication
- 11.2.1.9 Study Design
- 11.2.1.10 Recruitment Status
- 11.2.1.11 Enrollment (Estimated)
- 11.2.1.12 Location Countries
- 11.2.1.13 Recent Results
- 11.2.2 Drug: REC-4881
- 11.2.3 Drug: Rapamycin
- 11.2.4 Other Drugs
- 12 Familial Adenomatous Polyposis Drug Pipeline - Early-Stage Products (Phase I) (Top Drugs)
- 12.1 Comparative Analysis for Early-Stage Drugs
- 12.1.1 Study Type
- 12.1.2 Recruitment Status
- 12.1.3 Company
- 12.1.4 Funder Type
- 12.2 Product Level Analysis*
- 12.2.1 Drug 1
- 12.2.1.1 Product Description
- 12.2.1.2 Trial ID
- 12.2.1.3 Sponsor Name
- 12.2.1.4 Study Type
- 12.2.1.5 Drug Class
- 12.2.1.6 Eligibility Criteria
- 12.2.1.7 Study Record Dates
- 12.2.1.7.1 First Submitted
- 12.2.1.7.2 First Posted
- 12.2.1.7.3 Last Update Posted
- 12.2.1.7.4 Last Verified
- 12.2.1.8 Indication
- 12.2.1.9 Study Design
- 12.2.1.10 Recruitment Status
- 12.2.1.11 Enrollment (Estimated)
- 12.2.1.12 Location Countries
- 12.2.2 Other Drugs
- 13 Familial Adenomatous Polyposis Drug Pipeline - Preclinical and Discovery Stage Products (Top Drugs)
- 13.1 Comparative Analysis for Preclinical and Discovery Stage Drugs
- 13.1.1 Study Type
- 13.1.2 Recruitment Status
- 13.1.3 Company
- 13.1.4 Funder Type
- 13.2 Product Level Analysis*
- 13.2.1 Drug 1
- 13.2.1.1 Product Description
- 13.2.1.2 Trial ID
- 13.2.1.3 Sponsor Name
- 13.2.1.4 Study Type
- 13.2.1.5 Drug Class
- 13.2.1.6 Eligibility Criteria
- 13.2.1.7 Study Record Dates
- 13.2.1.7.1 First Submitted
- 13.2.1.7.2 First Posted
- 13.2.1.7.3 Last Update Posted
- 13.2.1.7.4 Last Verified
- 13.2.1.8 Indication
- 13.2.1.9 Study Design
- 13.2.1.10 Recruitment Status
- 13.2.1.11 Enrollment (Estimated)
- 13.2.1.12 Location Countries
- 13.2.2 Other Drugs
- 14 Familial Adenomatous Polyposis, Key Drug Pipeline Companies
- 14.1 Rapamycin Holdings Inc.
- 14.1.1 Company Snapshot
- 14.1.2 Pipeline Product Portfolio
- 14.1.3 Financial Analysis
- 14.1.4 Recent News and Developments
- 14.2 Recursion Pharmaceuticals Inc.
- 14.2.1 Company Snapshot
- 14.2.2 Pipeline Product Portfolio
- 14.2.3 Financial Analysis
- 14.2.4 Recent News and Developments
- 14.3 Biodexa Pharmaceuticals
- 14.3.1 Company Snapshot
- 14.3.2 Pipeline Product Portfolio
- 14.3.3 Financial Analysis
- 14.3.4 Recent News and Developments
- 14.4 S.L.A. Pharma AG
- 14.4.1 Company Snapshot
- 14.4.2 Pipeline Product Portfolio
- 14.4.3 Financial Analysis
- 14.4.4 Recent News and Developments
- 14.5 Janssen Research & Development, LLC
- 14.5.1 Company Snapshot
- 14.5.2 Pipeline Product Portfolio
- 14.5.3 Financial Analysis
- 14.5.4 Recent News and Developments
- 14.6 Takeda Pharmaceutical
- 14.6.1 Company Snapshot
- 14.6.2 Pipeline Product Portfolio
- 14.6.3 Financial Analysis
- 14.6.4 Recent News and Developments
- 14.7 TherapyX
- 14.7.1 Company Snapshot
- 14.7.2 Pipeline Product Portfolio
- 14.7.3 Financial Analysis
- 14.7.4 Recent News and Developments
- 14.8 Marina Biotech Inc.
- 14.8.1 Company Snapshot
- 14.8.2 Pipeline Product Portfolio
- 14.8.3 Financial Analysis
- 14.8.4 Recent News and Developments
- 15 Regulatory Framework for Drug Approval, By Region
- 16 Terminated or Suspended Pipeline Products
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