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Anus Neoplasms Drug Pipeline Analysis Report 2025

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    Drug Pipelines

  • 200 Pages
  • June 2025
  • Region: Global
  • Expert Market Research
  • ID: 6102861
Anus neoplasms are anomalies or growths that arise in the anal canal, which is the last segment of the digestive system. Anal squamous cell carcinoma is the most prevalent kind of cancer, but these growths can also be benign (like warts or polyps) or malignant. Chronic HPV infection, anal intercourse, smoking, immunosuppression, and some precancerous diseases such as anal intraepithelial neoplasia are risk factors. Bleeding, pain, itching, or a palpable mass in the anal region are common symptoms. A physical examination, anoscopy, imaging, and biopsy are all used in the diagnosis process. Chemotherapy, radiation, immunotherapy, and surgery are possible forms of treatment. Moreover, the rising prevalence of the disease is anticipated to positively impact the landscape for anus neoplasms emerging drugs.

Report Coverage

The Anus Neoplasms Drug Pipeline Insight Report by the publisher gives comprehensive insights into anus neoplasms therapeutics currently undergoing clinical trials. It covers various aspects related to the details of each of these drugs under development for anus neoplasms. The anus neoplasms report assessment includes the analysis of over 25 pipeline drugs and 10+ companies. The anus neoplasms 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 anus neoplasms 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 anus neoplasms.

Anus Neoplasms Drug Pipeline Outlook

Anus neoplasms are caused by aberrant and unchecked cell proliferation in the anal area, which frequently starts in the squamous epithelium lining the anus. Persistent exposure to high-risk HPV, especially HPV-16 and HPV-18, is often the cause of these alterations. By integrating into the host's DNA, the virus interferes with tumor-suppressor genes including p53 and Rb and causes unregulated cell division and genomic instability. Carcinogenesis in this area is also influenced by immunosuppression, chronic inflammation, and lifestyle choices like smoking.

Due to its capacity to direct the body's immune system against cancer cells, immunotherapies are frequently chosen for the treatment of anus neoplasms. These treatments are especially successful against HPV-related cancers and include immune checkpoint inhibitors and therapeutic vaccinations. Particularly for advanced or recurrent instances, they provide encouraging results, decreased systemic toxicity, and enhanced specificity, improving quality of life and survival rates. Further, the rising focus on the development of anus neoplasms emerging drugs and the advances in the understanding of the molecular pathogenesis of the disease are expected to support the pipeline expansion in the coming years.

Anus Neoplasms Epidemiology

Anal neoplasms, especially squamous cell carcinoma (SCCA), are becoming more common. Their incidence rate is between 1 to 2 per 100,000 people worldwide. According to recent studies, SCCA is on the rise, especially among people 50 and older, with annual rises of roughly 2.7% in the United States. Notably, almost 90% of occurrences of anal cancer are associated with HPV infection, making it a substantial risk factor. About 1 in 500 people will get anal cancer in their lifetime. The risks are higher in women than in males and among certain racial groupings, especially black men and white women born after the 1960s.

Anus Neoplasms - Drug Pipeline Therapeutic Assessment

This section of the report covers the analysis of anus neoplasms 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
  • Biologics
  • Peptides
  • Immunotherapies
  • Others

By Route of Administration

  • Oral
  • Parenteral
  • Others

Anus Neoplasms - 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 clinical trials, with a substantial number of anus neoplasm drugs undergoing clinical development.

Anus Neoplasms - Pipeline Assessment Segmentation, By Drug Classes

The drug molecule categories covered under the anus neoplasms pipeline analysis include small molecules, biologics, peptides, and immunotherapies, among others. The anus neoplasms report provides a comparative analysis of the drug classes for each drug in various phases of clinical trials for anus neoplasms.

Anus Neoplasms Clinical Trials Therapeutic Assessment - Competitive Dynamics

The report for the anus neoplasms drug pipeline covers the profile of key companies involved in clinical trials and their drugs under development. It provides a detailed anus neoplasms therapeutic assessment, analyzing the competitive dynamics of the clinical trial landscape. Below is the list of a few players involved in anus neoplasms clinical trials:
  • Merck Sharp & Dohme LLC
  • Endeavor Biomedicines, Inc.
  • MacroGenics
  • Sumitomo Pharma America, Inc.
  • Beijing Health Guard Biotechnology, Inc
  • Transgene
  • Incyte Corporation
  • Frantz Viral Therapeutics, LLC
  • Shanghai Bovax Biotechnology Co., Ltd.

Anus Neoplasms Emerging Drugs Profile

Major drugs currently in the drug pipeline are as follows:

Drug: V503

Sponsored by Merck Sharp & Dohme LLC, the objective of this multicenter clinical trial is to investigate the efficacy and safety of the anus neoplasms drug candidate V503 in the affected patients. The study is under Phase III clinical development.

Drug: ENV- 101

Endeavor Biomedicines is conducting a study aimed at examining the efficacy of the investigational drug ENV- 101 for the treatment of anus neoplasms. The study is under Phase II clinical development.

Reasons To Buy This Report

The Anus Neoplasms Drug Report provides a strategic overview of the latest and future landscape of treatments for anus neoplasms. 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 market trends, regulatory environments, and potential growth opportunities within anus neoplasms pipeline insights.

Key Questions Answered in the Anus Neoplasms - Pipeline Insight Report

  • What is the current landscape of anus neoplasms disease pipeline drugs?
  • Which companies/institutions are developing anus neoplasms disease emerging drugs?
  • How many phase II drugs are currently present in anus neoplasms disease pipeline drugs?
  • Which company is leading the anus neoplasms disease pipeline development activities?
  • What is the current anus neoplasms disease therapeutic assessment?
  • What are the opportunities and challenges present in the anus neoplasms disease drug pipeline landscape?
  • What is the efficacy and safety profile of anus neoplasms disease pipeline drugs?
  • Which companies/institutions are involved in anus neoplasms disease collaborations aimed at providing enhanced therapeutic alternatives for patients?
  • What are the geographies covered for clinical trials in anus neoplasms disease?

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Table of Contents

1 Preface
1.1 Introduction
1.2 Objectives of the Study
1.3 Research Methodology & Assumptions
2 Executive Summary
3 Overview of Anus Neoplasms
3.1 Signs and Symptoms
3.2 Causes
3.3 Risk Factors
3.4 Types of Anus Neoplasms
3.5 Diagnosis
3.6 Treatment
4 Patient Profile: Anus Neoplasms
4.1 Patient Profile Overview
4.2 Patient Psychology and Emotional Impact Factors
4.3 Risk Assessment and Treatment Success Rate
5 Anus Neoplasms: Epidemiology Snapshot
5.1 Anus Neoplasms Incidence by Key Markets
5.2 Anus Neoplasms - Patients Seeking Treatment in Key Markets
6 Anus Neoplasms: Market Dynamics
6.1 Market Drivers and Constraints
6.2 SWOT Analysis
7 Anus Neoplasms: 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 Anus Neoplasms, Drug Pipeline Assessment
8.1 Assessment by Treatment Type
8.2 Assessment by Route of Administration
8.3 Assessment by Drug Class
9 Drug Pipeline Comparative Analysis
9.1 List of Anus Neoplasms 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 Attribute Scoring Analysis of Pipeline Drugs (Top Drugs)
10 Anus Neoplasms 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: V503
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 Drug: 9-HPV-3004
10.2.3 Other Drugs
11 Anus Neoplasms 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: ENV-101
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: CP-MGC018-03
11.2.3 Other Drugs
12 Anus Neoplasms 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: TP-1454
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 Drugs: INCA 0186
12.2.3 Other Drugs
13 Anus Neoplasms, Key Drug Pipeline Companies
13.1 Merck Sharp & Dohme LLC
13.1.1 Company Snapshot
13.1.2 Pipeline Product Portfolio
13.1.3 Financial Analysis
13.1.4 Recent News and Developments
13.2 Endeavor Biomedicines, Inc.
13.2.1 Company Snapshot
13.2.2 Pipeline Product Portfolio
13.2.3 Financial Analysis
13.2.4 Recent News and Developments
13.3 MacroGenics
13.3.1 Company Snapshot
13.3.2 Pipeline Product Portfolio
13.3.3 Financial Analysis
13.3.4 Recent News and Developments
13.4 Beijing Health Guard Biotechnology, Inc
13.4.1 Company Snapshot
13.4.2 Pipeline Product Portfolio
13.4.3 Financial Analysis
13.4.4 Recent News and Developments
13.5 Transgene
13.5.1 Company Snapshot
13.5.2 Pipeline Product Portfolio
13.5.3 Financial Analysis
13.5.4 Recent News and Developments
13.6 Incyte Corporation
13.6.1 Company Snapshot
13.6.2 Pipeline Product Portfolio
13.6.3 Financial Analysis
13.6.4 Recent News and Developments
13.7 Frantz Viral Therapeutics, LLC
13.7.1 Company Snapshot
13.7.2 Pipeline Product Portfolio
13.7.3 Financial Analysis
13.7.4 Recent News and Developments
13.8 Shanghai Bovax Biotechnology Co., Ltd.
13.8.1 Company Snapshot
13.8.2 Pipeline Product Portfolio
13.8.3 Financial Analysis
13.8.4 Recent News and Developments
14 Regulatory Framework for Drug Approval, By Region15 Terminated or Suspended Pipeline Products