Familial Adenomatous Polyposis Pipeline Analysis Report 2025

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 the publisher 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 the publisher 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 ß-catenin antagonist, for the treatment of familial adenomatous polyposis (FAP). ST316 targets the Wnt/ß-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

By Drug Class

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

By Route of Administration

The familial adenomatous polyposis therapeutic assessment covers 50+ drug analyses based on the 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 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 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.

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.

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?

Reasons To Buy This 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.

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