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Adenoid Cystic Carcinoma Pipeline Analysis Report 2025

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    Report

  • 200 Pages
  • March 2026
  • Region: Global
  • Expert Market Research
  • ID: 6228206
Adenoid cystic carcinoma (ACC) is a rare, slow-growing malignant tumour arising from salivary glands and other secretory tissues. According to Yu-Ting Yin et al., 2025, ACC represents approximately 1.5-2% of all head and neck cancers. Current therapies include surgery, radiotherapy, and systemic treatments, but the growing focus is on targeted agents (such as those acting on the MYB/NFIB fusion or Notch pathway) and immunotherapy driven by biomarker-led strategies. According to the adenoid cystic carcinoma pipeline analysis by Expert Market Research, the pipeline is expanding significantly, and this is expected to drive substantial growth in treatment options over the coming years.

Report Coverage

The Adenoid Cystic Carcinoma Pipeline Analysis Report by Expert Market Research gives comprehensive insights into adenoid cystic carcinoma therapeutics currently undergoing clinical trials. It covers various aspects related to the details of each of these drugs under development for adenoid cystic carcinoma. The adenoid cystic carcinoma report assessment includes the analysis of over 100 pipeline drugs and 50+ companies. The adenoid cystic carcinoma 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 adenoid cystic carcinoma 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 adenoid cystic carcinoma.

Adenoid Cystic Carcinoma Pipeline Outlook

Adenoid cystic carcinoma (ACC) is a rare, slow-growing cancer that typically develops in the salivary glands but can also occur in other glandular tissues. It arises due to genetic mutations that lead to the overexpression of the MYB oncogene, causing uncontrolled cell proliferation and tumor formation. ACC often spreads along nerves and can metastasize to distant organs.

Adenoid cystic carcinoma treatment involves surgical removal of the tumor followed by radiation therapy to prevent recurrence. Chemotherapy or targeted therapies may be used for advanced or metastatic cases. In September 2025, Rgenta Therapeutics received Orphan Drug Designation from the U.S. Food and Drug Administration for RGT-61159, an oral small molecule inhibitor targeting the MYB oncogene. The drug is being evaluated in a Phase 1a/b clinical trial for patients with advanced, relapsed, or refractory ACC, aiming to offer a novel therapeutic option for this rare malignancy.

Adenoid Cystic Carcinoma Epidemiology

According to Yu-Ting Yin et al. (2025), adenoid cystic carcinoma (ACC) represents approximately 1.5-2% of all head and neck cancers. It is known for its aggressive nature, frequent recurrence, and distant metastases occurring in 35-50% of cases, leading to a poor long-term survival rate. As per the Cleveland Clinic, around 1,200 individuals in the United States are diagnosed with ACC annually, with the majority aged between 40 and 60 years. Ongoing epidemiological studies continue to refine incidence patterns and disease outcomes.

Adenoid Cystic Carcinoma - Pipeline Therapeutic Assessment

This section of the report covers the analysis of adenoid cystic carcinoma 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 adenoid cystic carcinoma pipeline analysis report covers 50+ drug analyses based on drug classes:

  • Small Molecules
  • Oligonucleotides
  • Peptides

By Route of Administration

The pipeline assessment report covers 50+ drug analyses based on the route of administration.

  • Oral
  • Parenteral
  • Others

Adenoid Cystic Carcinoma 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 adenoid cystic carcinoma clinical trials, at 50%. It is followed by Phase I with 50%. The active developments in Phase I and Phase II indicate promising advancements in the pipeline, potentially accelerating future treatment innovations and market growth.

Adenoid Cystic Carcinoma Pipeline Assessment Segmentation, By Drug Classes

The drug molecule categories covered under the adenoid cystic carcinoma pipeline analysis include small molecules, oligonucleotides, and peptides. The adenoid cystic carcinoma report provides a comparative analysis of the drug classes for each drug in various phases of clinical trials for adenoid cystic carcinoma. Immune checkpoint inhibitors targeting B7-H4 are emerging as a novel drug class in the adenoid cystic carcinoma (ACC) treatment pipeline. For instance, AZD8205, an investigational therapy, specifically blocks B7-H4 to restore immune activity against tumor cells. Preclinical studies have shown promising tumor regression in B7-H4-expressing ACC, highlighting its potential as a targeted and personalized treatment approach.

Adenoid Cystic Carcinoma Clinical Trials - Key Players

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

  • Rgenta Therapeutics Inc.
  • Cellestia Biotech AG
  • AstraZeneca
  • Novelty Nobility, Inc.
  • Bristol-Myers Squibb
  • Ayala Pharmaceuticals, Inc.
  • Novartis Pharmaceuticals
  • GlaxoSmithKline

Adenoid Cystic Carcinoma - 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 adenoid cystic carcinoma. It includes product description, trial ID, study type, drug class, mode of administration, and recruitment status of adenoid cystic carcinoma drug candidates.

Drug: CB-103

CB-103 is an oral pan-NOTCH pathway inhibitor being evaluated in combination with either Lenvatinib or Abemaciclib for patients with NOTCH-activated adenoid cystic carcinoma (ACC). Sponsored and supported by Cellestia Biotech AG, this Phase 1/2 study is examining the drug’s ability to slow tumor progression and enhance survival outcomes. CB-103 targets the NOTCH intracellular domain, aiming to inhibit tumor growth in advanced, metastatic, or recurrent ACC cases.

Drug: RGT-61159

RGT-61159, developed by Rgenta Therapeutics Inc., is an oral small-molecule MYB inhibitor currently being evaluated in a Phase 1 clinical study for adults with relapsed or refractory adenoid cystic carcinoma (ACC) or colorectal carcinoma (CRC). The study is assessing the drug’s safety, tolerability, and anti-tumor activity. RGT-61159 functions as an mRNA degrader that reduces MYB mRNA and protein levels, potentially slowing or halting cancer cell growth and progression.

Key Questions Answered in the Adenoid Cystic Carcinoma Pipeline Insight Report

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

Reasons To Buy This Report

The Adenoid Cystic Carcinoma Pipeline Analysis Report provides a strategic overview of the latest and future landscape of treatments for adenoid cystic carcinoma. 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 adenoid cystic carcinoma collaborations, regulatory environments, and potential growth opportunities.

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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 Adenoid Cystic Carcinoma
3.1 Signs and Symptoms
3.2 Causes
3.3 Risk Factors
3.4 Diagnosis
3.5 Treatment
4 Patient Profile: Adenoid Cystic Carcinoma
4.1 Patient Profile Overview
4.2 Patient Psychology and Emotional Impact Factors
4.3 Risk Assessment and Treatment Success Rate
5 Adenoid Cystic Carcinoma: Epidemiology Snapshot
5.1 Adenoid Cystic Carcinoma Incidence by Key Markets
5.2 Adenoid Cystic Carcinoma - Patients Seeking Treatment in Key Markets
6 Adenoid Cystic Carcinoma: Market Dynamics
6.1 Market Drivers and Constraints
6.2 SWOT Analysis
7 Adenoid Cystic Carcinoma: 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 Adenoid Cystic Carcinoma, 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 Adenoid Cystic Carcinoma 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 Adenoid Cystic Carcinoma 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 1
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 Adenoid Cystic Carcinoma 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: CB-103
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: P-Sam
11.2.3 Other Drugs
12 Adenoid Cystic Carcinoma 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: AL101
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 Drug: RGT-61159
12.2.3 Drug: NN3201
12.2.4 Other Drugs
13 Adenoid Cystic Carcinoma 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 Adenoid Cystic Carcinoma, Key Drug Pipeline Companies
14.1 Rgenta Therapeutics 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 Cellestia Biotech AG
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 AstraZeneca
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 Novelty Nobility, Inc.
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 Bristol-Myers Squibb
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 Ayala Pharmaceuticals, Inc.
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 Novartis Pharmaceuticals
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 GlaxoSmithKline
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 Region16 Terminated or Suspended Pipeline Products