Opioid Related Disorder Pipeline Analysis Report 2025

Opioid related disorder (ORD) is a chronic condition characterized by the compulsive use of opioids, leading to significant physical, psychological, and social impairments. According to Alexander M. Dydyk et al., opioid use disorder (OUD) affects over 16 million individuals globally. According to the opioid related disorder pipeline analysis by Expert Market Research, there is a growing focus on advanced therapies, including long-acting formulations, monoclonal antibodies, and biologics, aimed at reducing relapse and overdose risks. Key factors driving growth include increasing opioid misuse, rising overdose fatalities, and supportive government initiatives.

Report Coverage

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

Opioid Related Disorder Pipeline Outlook

Opioid related disorder (ORD) is a chronic condition marked by compulsive opioid use, causing significant physical, psychological, and social impairment. It arises from prolonged exposure to prescription opioids, heroin, or synthetic opioids, leading to dependence, tolerance, and withdrawal symptoms. Genetic, environmental, and behavioral factors further increase susceptibility.

Opioid related disorder treatments involve medication for opioid use disorder (MOUD), such as buprenorphine, methadone, and extended-release naltrexone, alongside counseling and behavioral therapy to reduce relapse and enhance patient outcomes. In the ORD drug pipeline, innovative long-acting formulations of buprenorphine and methadone are being developed to improve adherence, minimize misuse risk, and expand treatment access, reflecting notable progress in the market.

Opioid Related Disorder Epidemiology

According to Alexander M. Dydyk et al., opioid use disorder (OUD) affects approximately 16 million people globally, including 2.1 million in the United States. According to the same source, OUD contributes to over 120,000 deaths worldwide and 47,000 deaths in the United States annually. Men are more prone to opioid dependence and overdoses, while women receive opioids for analgesia more frequently. Opioid-related mortality peaks between ages 40-50, whereas heroin overdoses are most common among individuals aged 20-30 years.

Opioid Related Disorder - Pipeline Therapeutic Assessment

This section of the report covers the analysis of opioid related disorder 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 opioid related disorder pipeline analysis report covers 50+ drug analyses based on drug classes:

• Small Molecules
• Monoclonal Antibodies
• Natural Metabolites

By Route of Administration

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

• Oral
• Parenteral
• Others

Opioid Related Disorder 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, accounting for 40%, covers a major share of the total opioid related disorder clinical trials, reflecting strong clinical activity and potential breakthroughs. Phase I contributes 18%, phase III 16%, and phase IV 16%. This robust distribution across phases indicates a growth outlook, fostering innovation and expanding treatment options in the market.

Opioid Related Disorder Pipeline Assessment Segmentation, By Drug Classes

The drug molecule categories covered under the opioid related disorder pipeline analysis include small. The opioid related disorder report provides a comparative analysis of the drug classes for each drug in various phases of clinical trials for opioid related disorder. Glucagon-like peptide-1 receptor agonists (GLP-1RAs) are emerging as potential treatments for opioid-related disorder. For example, semaglutide and liraglutide are under clinical investigation for their ability to modulate the brain’s reward system and reduce opioid cravings. These drugs act on the mesolimbic pathway, helping prevent relapse without the risk of addiction associated with traditional opioid-based therapies.

Opioid Related Disorder Clinical Trials - Key Players

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

• Filament Health Corp.
• BioXcel Therapeutics Inc.
• Indivior Inc.
• Boehringer Ingelheim
• Jazz Pharmaceuticals
• SafeMedWaste, Inc.
• Friends Research Institute, Inc.
• Go Medical Industries Pty Ltd.
• Clinilabs, Inc.
• Altasciences Company Inc.

Opioid Related Disorder - 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 opioid related disorder. It includes product description, trial ID, study type, drug class, mode of administration, and recruitment status of opioid related disorder drug candidates.

Drug: PEX010-Assisted Therapy

PEX010 is a psychedelic-assisted therapy drug being developed by Filament Health Corp. for treating opioid use disorder (OUD). This Phase 2 study is assessing the feasibility, safety, and participant retention while administering PEX010 in combination with psychotherapy. Standardized to contain 25mg or 35mg psilocybin, the drug is being given in two sessions alongside cognitive behavioral therapy. The study is examining neurocognitive, behavioral, and clinical outcomes to evaluate its potential as a novel OUD treatment.

Drug: BXCL501

Sublingual Dexmedetomidine (BXCL501) is being developed by the New York State Psychiatric Institute to treat opioid withdrawal in individuals with opioid use disorder. This Phase 1B study is examining the safety and efficacy of BXCL501 compared to lofexidine and placebo during a 7-day inpatient methadone taper. BXCL501 is a sublingual, orally dissolving film formulation of dexmedetomidine, a selective alpha-2 adrenergic receptor agonist, designed to reduce withdrawal symptoms such as anxiety, muscle pain, and insomnia, while minimizing cardiovascular side effects. The study is enrolling 160 participants across three sites.

Drug: INDV-2000

INDV-2000, a potent and highly selective oral Orexin-1 Receptor (OX1R) antagonist, is being evaluated by Indivior Inc. in a Phase II proof-of-concept and dose-ranging study for individuals with moderate to severe opioid use disorder (OUD). This study is examining the safety, efficacy, and dose-response relationship of INDV-2000 in participants transitioning from short-term buprenorphine treatment to a non-opioid therapy. The drug is showing promise in reducing opioid intake and craving in preclinical models and is actively contributing to the development of non-opioid treatment options.

Key Questions Answered in the Opioid Related Disorder Pipeline Insight Report

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

Reasons To Buy This Report

The Opioid Related Disorder Pipeline Analysis Report provides a strategic overview of the latest and future landscape of treatments for opioid related disorder. 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 opioid related disorder collaborations, regulatory environments, and potential growth opportunities.

This product will be delivered within 3-5 business days.