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Report Overview

Nicotine addiction remains a significant global public health concern, reporting that around 1 in 5 adults globally (nearly 20%) remains addicted to tobacco and nicotine products; while the global number of tobacco users has declined from 2000 levels, overall nicotine dependence continues due to the growing use of e-cigarettes and other non-combustible nicotine products, maintaining a large patient pool. This persistent burden sustained research and drug development efforts, as reflected in the nicotine addiction pipeline analysis by Expert Market Research. The report captures the increasing focus on innovative pharmacological therapies aimed at improving smoking cessation outcomes and reducing long-term relapse rates.

  • Major companies involved in the nicotine addiction pipeline include Pfizer, Nabi Biopharmaceuticals, and others.

  • Leading drugs currently in the pipeline include Varenicline, Bupropion, and others.

  • The nicotine addiction pipeline is driven by rising global smoking prevalence, unmet need for effective relapse-prevention therapies, and increasing regulatory and public health focus on smoking cessation innovation.

Report Coverage

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

Nicotine Addiction Pipeline Analysis by Drug Class

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Nicotine Addiction Pipeline Outlook

The nicotine addiction pipeline is expanding significantly as public health demand and market incentives drive research into more effective pharmacotherapies and combination strategies. With traditional cessation aids like varenicline and bupropion already established, novel candidates, including immunotherapies, receptor modulators, and metabolic agents, are progressing through Phase II and III trials, often targeting withdrawal symptoms, cravings, and dual dependencies such as vaping and diabetes-associated nicotine use.

Nicotine addiction treatment innovation is expected to increase as understanding of the neurobiology of addiction deepens and as regulatory agencies encourage therapies that improve long-term abstinence rates, reduce relapse, and address emerging nicotine products like e-cigarettes, creating a broader and more diversified therapeutic landscape.

Nicotine Addiction Epidemiology

Nicotine addiction remains highly prevalent across major regions, driven by continued tobacco use and the growing uptake of alternative nicotine products. For instance, in the United Kingdom, adult smoking prevalence has declined to around 9–10%, yet nicotine dependence persists due to widespread e-cigarette use among nearly 10% of adults, particularly in younger populations. Meanwhile, in India, nicotine addiction remains substantially higher, with approximately 29% of adults using tobacco in smoked or smokeless forms, reflecting one of the largest nicotine-dependent populations globally. At a global level, the World Health Organization reports that around 1 in 5 adults worldwide (nearly 20%) remain addicted to tobacco and nicotine products, highlighting the sustained public health burden and the continued need for effective nicotine addiction treatments.

Nicotine Addiction – Pipeline Therapeutic Assessment

This section of the report covers the analysis of nicotine addiction 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 nicotine addiction pipeline analysis report covers 50+ drug analyses based on drug classes:

  • Small Molecules
  • Peptides

By Route of Administration

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

  • Oral
  • Parenteral
  • Others

Nicotine Addiction 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 IV, with 33%, covers a major share of the total nicotine addiction clinical trials. It is followed by phase I at 26% and other phases. This phase-wise distribution highlights a strong focus on late-stage validation alongside a steady inflow of early- and mid-stage innovations, reflecting a balanced and evolving nicotine addiction pipeline.

Nicotine Addiction Pipeline Assessment Segmentation, By Drug Classes

The drug molecule categories covered under the nicotine addiction pipeline analysis include small molecules and peptides. The nicotine addiction report provides a comparative analysis of the drug classes for each drug in various phases of clinical trials for Nicotine Addiction. For example, varenicline, a key drug in the nicotine addiction pipeline, is classified as a small-molecule partial agonist of the α4β2 nicotinic acetylcholine receptor and has been extensively evaluated across advanced clinical stages for smoking cessation, highlighting the dominance of small-molecule therapies in this therapeutic area.

Nicotine Addiction Clinical Trials – Key Players

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

  • Antidote Therapeutics, Inc.
  • Achieve Life Sciences
  • NFL Biosciences SAS
  • Axsome Therapeutics
  • Embera NeuroTherapeutics, Inc.
  • Currax Pharmaceuticals LLC
  • Omeros Corporation
  • Otsuka Pharmaceutical
  • Pfizer
  • Nabi Biopharmaceuticals
  • Chrono Therapeutics, Inc.
  • Evotec Neurosciences GmbH

Nicotine Addiction – 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 nicotine addiction. It includes product description, trial ID, study type, drug class, mode of administration, and recruitment status of nicotine addiction drug candidates.

Drug: Bupropion

Bupropion is being evaluated in the Phase IV interventional clinical trial. The study targets tobacco smoking, tobacco withdrawal, nicotine addiction, and nicotine withdrawal, and is currently recruiting participants. Bupropion acts as a dopamine and norepinephrine reuptake inhibitor, reducing nicotine cravings and withdrawal symptoms by modulating brain reward pathways linked to addiction, while nicotine patches provide a controlled transdermal dose of nicotine to ease withdrawal without exposure to harmful tobacco smoke components. Sponsored by the National Institute of Respiratory Diseases, Mexico, the trial runs from 15 January 2025 to 15 June 2026.

Drug: Varenicline

Varenicline 1 mg BID, sponsored by Yale University with support from the National Cancer Institute (NCI), is being evaluated in the Phase II interventional clinical trial. The study focuses on individuals with e-cigarette use, vaping behavior, and nicotine dependence and compares varenicline administered twice daily with a placebo. Varenicline is a selective partial agonist of the α4β2 nicotinic acetylcholine receptors, working by reducing nicotine cravings and withdrawal symptoms while simultaneously blocking nicotine’s rewarding effects from e-cigarette use. This dual mechanism supports cessation by lowering relapse risk. The trial is currently recruiting and is scheduled to run from 30 July 2030 to 30 October 2030.

Drug: Semaglutide

Semaglutide, sponsored by the Ottawa Heart Institute Research Corporation, is being evaluated in the Phase III interventional clinical trial. The study targets individuals with type 2 diabetes mellitus who also experience nicotine addiction and tobacco dependence and investigates semaglutide in combination with nicotine replacement therapy. Semaglutide is a glucagon-like peptide-1 (GLP-1) receptor agonist that may support smoking cessation by modulating brain reward pathways, reducing cravings, and improving impulse control, while nicotine replacement therapy helps alleviate withdrawal symptoms. The trial is currently not yet recruiting and is scheduled to run from July 2026 to July 2027.

*Please note that this is only a partial list; the complete list of drugs will be available in the full report.*

Key Questions Answered in the Nicotine Addiction Pipeline Insight Report

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

Reasons To Buy This Report

The Nicotine Addiction Pipeline Analysis Report provides a strategic overview of the latest and future landscape of treatments for Nicotine Addiction. 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 nicotine addiction collaborations, regulatory environments, and potential growth opportunities.

Related Reports

Global Clinical Trials Market

Nicotine Addiction Epidemiology Forecast

*While we strive to always give you current and accurate information, the numbers depicted on the website are indicative and may differ from the actual numbers in the main report. At Expert Market Research, we aim to bring you the latest insights and trends in the market. Using our analyses and forecasts, stakeholders can understand the market dynamics, navigate challenges, and capitalize on opportunities to make data-driven strategic decisions.*

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Report Summary

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Key Highlights of the Report

Please note that the figures mentioned in the description serve as estimates and may vary from the actual figures presented in the final report.

Scope of the Report

Details

Drug Pipeline by Clinical Trial Phase

  • Late-Stage Products (Phase III and Phase IV)
  • Mid-Stage Products (Phase II)
  • Early-Stage Products (Phase I)
  • Preclinical and Discovery Stage Products

Route of Administration

  • Oral
  • Parenteral
  • Others

Drug Classes

  • Small Molecules
  • Peptides

Leading Sponsors Covered

  • Antidote Therapeutics, Inc.
  • Achieve Life Sciences
  • NFL Biosciences SAS
  • Axsome Therapeutics
  • Embera NeuroTherapeutics, Inc.
  • Currax Pharmaceuticals LLC
  • Omeros Corporation
  • Otsuka Pharmaceutical
  • Pfizer
  • Nabi Biopharmaceuticals
  • Chrono Therapeutics, Inc.
  • Evotec Neurosciences GmbH

Geographies Covered

  • North America
  • Europe
  • Asia Pacific
  • Others

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