Substance Use Disorder (SUD) Pipeline Analysis Report 2026

Substance use disorder remains a critical global health concern characterized by dependence on alcohol and other addictive substances that significantly affect physical, mental, and social well-being. According to World Health Organization, nearly 400 million people worldwide live with alcohol use disorders, representing the largest share of substance-related conditions. Rising prevalence among younger populations and changing substance consumption patterns continue to shape the global burden. The substance use disorder pipeline analysis highlights growing research efforts focused on developing targeted pharmacotherapies and innovative treatment strategies.

Report Coverage

The Substance Use Disorder (SUD) Pipeline Analysis Report gives comprehensive insights into substance use disorder (SUD) therapeutics currently undergoing clinical trials. It covers various aspects related to the details of each of these drugs under development for substance use disorder (SUD). The substance use disorder (SUD) report assessment includes the analysis of over 100 pipeline drugs and 50+ companies. The substance use disorder (SUD) 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 substance use disorder (SUD) 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 substance use disorder (SUD).

Substance Use Disorder (SUD) Pipeline Outlook

Substance use disorder (SUD) is a chronic brain condition where a person compulsively uses substances, such as alcohol, drugs, or medications, despite harmful consequences. It occurs when repeated substance exposure alters brain chemistry, particularly the dopamine reward system, creating intense cravings, tolerance, and dependence, making voluntary control increasingly difficult over time.

Substance use disorder treatment strategies typically involve medication-assisted therapies, behavioral interventions, and long-acting pharmacotherapies such as Buprenorphine and Naltrexone to reduce cravings and withdrawal symptoms. For instance, in February 2025, the UnitedStates Food and Drug Administration approved updated labeling for Sublocade (extended-release buprenorphine injection) for moderate to severe opioid use disorder. The update introduced a rapid-initiation protocol and additional injection-site options, enabling treatment after a single buprenorphine dose and improving clinical flexibility for healthcare providers managing opioid addiction.

Substance Use Disorder (SUD) Epidemiology

Substance use disorders represent a major global public health burden, driven largely by alcohol and drug dependence. According to the World Health Organization, approximately 400 million people worldwide live with alcohol use disorders, including nearly 209 million individuals with alcohol dependence, representing severe SUD cases. Drug use disorders affecting substances such as cannabis and opioids impact tens of millions globally. Epidemiological trends show the highest incidence among young adults aged 20-39 years, while men consistently demonstrate higher prevalence and mortality rates, although the prevalence among women has been gradually increasing across several substance categories.

Substance Use Disorder (SUD) - Pipeline Therapeutic Assessment

This section of the report covers the analysis of substance use disorder (SUD) 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 substance use disorder (SUD) pipeline analysis report covers 50+ drug analyses based on drug classes:

• Small Molecules
• Monoclonal Antibodies
• Peptides

By Route of Administration

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

• Oral
• Parenteral
• Others

Substance Use Disorder (SUD) 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, covers a major share of the total substance use disorder (SUD) clinical trials. Early phase I accounts for 8%, phase I 20%, phase II 49%, phase III 14%, and phase IV 9% of trials. According to EMR analysis, phase II dominates the clinical pipeline.

Substance Use Disorder (SUD) Pipeline Assessment Segmentation, By Drug Classes

The drug molecule categories covered under the substance use disorder (SUD) pipeline analysis include small molecules, monoclonal antibodies, and peptides. The substance use disorder (SUD) report provides a comparative analysis of the drug classes for each drug in various phases of clinical trials for substance use disorder (SUD). For instance, in May 2023, the United States Food and Drug Administration approved Brixadi (buprenorphine extended-release injection) for the treatment of moderate to severe opioid use disorder. The therapy provides weekly or monthly subcutaneous dosing to reduce opioid cravings and withdrawal symptoms. The long-acting formulation is designed to improve treatment adherence and expand medication-assisted treatment options for patients with opioid dependence.

Substance Use Disorder (SUD) Clinical Trials - Key Players

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

• Afasci Inc.
• Friends Research Institute, Inc.
• Pop Test Oncology LLC
• Eli Lilly and Company
• Boehringer Ingelheim
• Imbrium Therapeutics
• Altimmune, Inc.
• Antidote Therapeutics, Inc.
• Revive Therapeutics, Ltd.
• Alkermes, Inc.
• ViiV Healthcare

Substance Use Disorder (SUD) - 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 substance use disorder (SUD). It includes product description, trial ID, study type, drug class, mode of administration, and recruitment status of substance use disorder (SUD) drug candidates.

Drug: XR-B|Drug: XR-NTX

XR-B and XR-NTX, sponsored by the Friends Research Institute, Inc., are extended-release formulations of buprenorphine and naltrexone being investigated for the treatment of substance use disorder, specifically opioid use disorder (OUD). These therapies belong to the opioid agonist and opioid antagonist drug classes, respectively. XR-B works by partially activating opioid receptors to reduce cravings and withdrawal symptoms, while XR-NTX blocks opioid receptors to prevent euphoric effects and relapse. The institute conducts clinical studies and collaborative research programs focused on improving evidence-based treatments for addiction and behavioral health disorders.

Drug: AFA-281

AFA-281, a small-molecule, orally administered dual inhibitor sponsored by Afasci Inc., is currently advancing through a Phase I clinical trial targeting Alcohol Use Disorder. The drug works by simultaneously inhibiting overactivated ion channels, normalizing neuronal excitability, and restoring nervous system function, while suppressing a pro-inflammatory enzyme to enhance the body's natural anti-inflammatory response. This randomized, double-blind, placebo-controlled crossover study is evaluating pharmacokinetic and pharmacodynamic interactions between AFA-281 and alcohol in healthy adult volunteers. The study is estimated to be completed by September 2029.

Key Questions Answered in the Substance Use Disorder (SUD) Pipeline Insight Report

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

Reasons To Buy This Report

The Substance Use Disorder (SUD) Pipeline Analysis Report provides a strategic overview of the latest and future landscape of treatments for substance use disorder (SUD). 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 substance use disorder (SUD) collaborations, regulatory environments, and potential growth opportunities.