Opioid Dependence- Pipeline Insight, 2025

DelveInsight's, "Opioid Dependence- Pipeline Insight, 2025" report provides comprehensive insights about 20+ companies and 25+ pipeline drugs in Opioid Dependence pipeline landscape. It covers the pipeline drug profiles, including clinical and nonclinical stage products. It also covers the therapeutics assessment by product type, stage, route of administration, and molecule type. It further highlights the inactive pipeline products in this space.

Geography Covered:

• Global coverage

Opioid Dependence: Understanding

Opioid Dependence: Overview

Opioid dependence is a chronic, relapsing disorder characterized by the compulsive use of opioid drugs despite negative consequences. This condition can result from the prolonged use of prescription opioids (such as morphine, oxycodone, or hydrocodone) or illicit drugs like heroin. Opioids interact with the brain's reward system, leading to an intense craving for the substance and, over time, physical and psychological dependence. Opioid dependence is a significant public health crisis, often contributing to the spread of infectious diseases (such as HIV and hepatitis C) and increasing the risk of overdose deaths.

The symptoms of opioid dependence often include both physical and psychological manifestations. Common physical signs include increased tolerance (requiring higher doses for the same effect), withdrawal symptoms when the drug is not used, and disrupted daily functioning. Psychological symptoms may include cravings, anxiety, depression, and a persistent desire to quit or cut down on drug use without success. Behavioral signs, such as neglecting responsibilities, social withdrawal, and continuing use despite knowing the harm, are also indicative of dependence.

Diagnosis of opioid dependence involves a comprehensive assessment, including a detailed history of drug use, physical examinations, and screening for other substance use or mental health conditions. The Diagnostic and Statistical Manual of Mental Disorders (DSM-5) sets criteria for diagnosing opioid use disorder, focusing on the inability to control use, impaired functioning, withdrawal, and tolerance. Doctors may also use urine drug testing to detect opioid use, confirm adherence to prescribed treatments, or identify illicit drug use.

Treatment for opioid dependence involves a comprehensive approach, combining medication, behavioral therapies, and long-term support to help individuals manage their condition. Medications like methadone, buprenorphine, and naltrexone are commonly prescribed to reduce cravings and withdrawal symptoms, stabilizing patients and allowing them to focus on recovery. These medications are often part of Medication-Assisted Treatment (MAT), which, when combined with behavioral therapies such as Cognitive Behavioral Therapy (CBT) and counseling, has proven to be highly effective. Behavioral therapies help patients address the psychological aspects of addiction, teaching them how to cope with triggers, stress, and avoid relapse. In some cases, residential or inpatient rehabilitation programs are recommended, providing a structured environment for recovery. Continued support, including outpatient programs, peer support groups, and aftercare, is crucial to maintaining long-term recovery and preventing relapse.

Endoscopic ultrasonography is the most sensitive test for the diagnosis of pancreatic NETs (sensitivity 82%-93%). Endoscopic ultrasonography is particularly useful for identifying tumours less than 2 cm in size and for the localization of insulinoma, and often is employed intraoperatively for this purpose.

"Opioid Dependence- Pipeline Insight, 2025" report by DelveInsight outlays comprehensive insights of present scenario and growth prospects across the indication. A detailed picture of the Opioid Dependence pipeline landscape is provided which includes the disease overview and Opioid Dependence treatment guidelines. The assessment part of the report embraces, in depth Opioid Dependence commercial assessment and clinical assessment of the pipeline products under development. In the report, detailed description of the drug is given which includes mechanism of action of the drug, clinical studies, NDA approvals (if any), and product development activities comprising the technology, Opioid Dependence collaborations, licensing, mergers and acquisition, funding, designations and other product related details.

Report Highlights:

• The companies and academics are working to assess challenges and seek opportunities that could influence Opioid Dependence R&D. The therapies under development are focused on novel approaches to treat/improve Opioid Dependence.

Opioid Dependence Emerging Drugs Chapters

This segment of the Opioid Dependence report encloses its detailed analysis of various drugs in different stages of clinical development, including phase III, II, II/III I, preclinical and Discovery. It also helps to understand clinical trial details, expressive pharmacological action, agreements and collaborations, and the latest news and press releases.

Opioid Dependence Emerging Drugs

• OX 124: Orexo

OX124 is a late-stage, high-dose nasal powder to be used in life-threatening situations where the overdose on any opioid is suspected, indicated by e.g., unconsciousness or opioid-induced respiratory depression (OIRD). OX124 is a powerful naloxone rescue medication, designed to reverse opioid overdoses, including those from highly potent synthetic opioids, such as fentanyl. Naloxone (OX-124) is under development for the treatment of drug overdose such as opioid overdose. In addition, the AmorphOX technology, which is the backbone in OX124, contributes to improved stability of the active substance and reduces its sensitivity related to temperature changes. OX124 is protected by patents until 2039.

In July 2024, Orexo AB announced that the company had received a complete response letter (CRL) from the US Food and Drug Administration (FDA) regarding the New Drug Application (NDA) for OX124, a high-dose naloxone rescue medication in development for opioid overdose. The NDA was submitted to the FDA on September 18, 2023. The CRL indicates the need for an additional Human Factors (HF) study, which is in line with previous communication. Furthermore, additional technical data on the final commercial product has been requested. The CRL does not indicate a need for additional clinical or non-clinical studies.

• BXCL501: BioXcel Therapeutics

BXCL501 is BioXcel Therapeutics' investigational, sublingual film formulation of dexmedetomidine, a selective alpha-2a adrenergic receptor agonist. Initially developed for acute agitation in neuropsychiatric disorders, it is now being explored as a non-opioid treatment for opioid withdrawal symptoms. In the Phase Ib/II RELEASE trial, BXCL501 was generally well tolerated across various doses, with the 240 mcg BID dose showing significant reductions in withdrawal symptoms, including anxiety and insomnia, even among patients exposed to fentanyl. Supported by a multi-year NIH NIDA grant, a 160-patient Phase IIb study is underway to further evaluate its efficacy compared to placebo and standard treatments like lofexidine. The drug is currently in Phase II stage of its development for the treatment of opioid dependence.

• ALA-1000: Alar Pharmaceuticals Inc

ALA-1000 is an investigational long-acting injectable (LAI) formulation of buprenorphine developed by Alar Pharmaceuticals for the treatment of opioid use disorder (OUD). Designed for subcutaneous administration once every three months, it aims to reduce the burden of daily dosing and improve patient adherence. In a Phase 1b/2 single-ascending-dose study, ALA-1000 demonstrated a sustained release profile with consistent therapeutic plasma levels over 12 weeks, showing good safety and tolerability without significant injection site reactions. The study also reported that patients experienced mild withdrawal symptoms and cravings, with over 80% of urine tests negative for opioids during the outpatient phase. Alar has completed a successful end-of-phase 2 meeting with the U.S. FDA and plans to initiate a Phase 3 pivotal trial to support a New Drug Application (NDA) submission.

• SBS 226: Sparian Biosciences

SBS-226 is a first-in-class MOR partial agonist / DOR antagonist being developed for OUD and OWS. Structurally, it is a derivative of mitragynine pseudoindoxyl - one of the primary alkaloids in Kratom. SBS-226 is a new chemical entity (NCE) synthesized and developed in the Majumdar Lab. Preclinically, SBS-226 can ameliorate opioid withdrawal but does not demonstrate abuse potential, respiratory depression, or physical dependence. The drug is currently in Preclinical stage of its development for the treatment of opioid dependence.

Opioid Dependence: Therapeutic Assessment

This segment of the report provides insights about the different Opioid Dependence drugs segregated based on following parameters that define the scope of the report, such as:

• Major Players in Opioid Dependence

There are approx. 20+ key companies which are developing the therapies for Opioid Dependence. The companies which have their Opioid Dependence drug candidates in the most advanced stage, i.e. Preregistration include, Orexo.

• Phases

DelveInsight's report covers around 25+ products under different phases of clinical development like

• Late stage products (Phase III)
• Mid-stage products (Phase II)
• Early-stage product (Phase I) along with the details of
• Pre-clinical and Discovery stage candidates
• Discontinued & Inactive candidates
• Route of Administration

Opioid Dependence pipeline report provides the therapeutic assessment of the pipeline drugs by the Route of Administration. Products have been categorized under various ROAs such as

• Intravenous
• Subcutaneous
• Oral
• Intramuscular
• Molecule Type

Products have been categorized under various Molecule types such as

• Monoclonal antibody
• Small molecule
• Peptide
• Product Type

Drugs have been categorized under various product types like Mono, Combination and Mono/Combination.

Opioid Dependence: Pipeline Development Activities

The report provides insights into different therapeutic candidates in phase II, I, preclinical and discovery stage. It also analyses Opioid Dependence therapeutic drugs key players involved in developing key drugs.

Pipeline Development Activities

The report covers the detailed information of collaborations, acquisition and merger, licensing along with a thorough therapeutic assessment of emerging Opioid Dependence drugs.

Opioid Dependence Report Insights

• Opioid Dependence Pipeline Analysis
• Therapeutic Assessment
• Unmet Needs
• Impact of Drugs

Opioid Dependence Report Assessment

• Pipeline Product Profiles
• Therapeutic Assessment
• Pipeline Assessment
• Inactive drugs assessment
• Unmet Needs

Key Questions:

Current Treatment Scenario and Emerging Therapies:

• How many companies are developing Opioid Dependence drugs?
• How many Opioid Dependence drugs are developed by each company?
• How many emerging drugs are in mid-stage, and late-stage of development for the treatment of Opioid Dependence?
• What are the key collaborations (Industry-Industry, Industry-Academia), Mergers and acquisitions, licensing activities related to the Opioid Dependence therapeutics?
• What are the recent trends, drug types and novel technologies developed to overcome the limitation of existing therapies?
• What are the clinical studies going on for Opioid Dependence and their status?
• What are the key designations that have been granted to the emerging drugs?

Key Players

• Orexo
• Aphios
• BioXcel Therapeutics
• Omeros Corporation
• Alar Pharmaceuticals Inc
• DemeRx IB, Inc
• Inventage Lab., Inc.
• Bridge Therapeutics, Inc.
• Sparian Biosciences

Key Products

• OX 124
• APH-1501
• BXCL501
• OMS405
• ALA-1000
• DMX-1002
• IVL3004
• BT-219
• SBS 226