Smoking cessation refers to the process of quitting tobacco use to improve health and prevent disease. Tobacco kills up to half of its users who do not stop, accounting for over 8 million deaths annually, including 1.3 million non-smokers exposed to secondhand smoke. There is a high unmet clinical need for better therapies as current treatment options, such as nicotine replacement therapies and prescription drugs, often yield limited success. The growing focus on innovative pharmacological approaches and personalized therapies is expected to drive advancements in the smoking cessation drug pipeline, addressing existing gaps and providing improved options for long-term cessation.
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 smoking cessation.
Treatments for smoking cessation include nicotine replacement therapies, which deliver controlled doses of nicotine to ease cravings. Prescription medications like varenicline (Chantix) and bupropion (Zyban) help reduce withdrawal symptoms and control urges. These treatments, along with counseling, improve the chances of quitting and maintaining long-term cessation. In December 2024, Qnovia, Inc., a pharmaceutical company focused on inhalation device technologies announced that it had raised USD 16 million in a Series B funding, intended for the development of smoking cessation therapeutics. The company also received the FDA clearance for its RespiRx™ Nicotine Inhaler (QN-01), a prescription inhaled smoking cessation medicine.
A report by the U.S. Department of Health and Human Services revealed that around 80 to 90% of individuals engaged in smoking are nicotine addicts. Approximately 8.5% of Americans aged 12 or above are dependent on nicotine. Moreover, the United States witnesses 480,000 annual deaths due to cigarette smoking, with 41000 deaths caused by secondhand smoke exposure.
In the smoking cessation drug pipeline, most drugs are currently in the middle to later stages of clinical testing. About 32% of the drugs are in Phase 2. This reflects that a large portion is being evaluated for effectiveness and safety in a larger group of people. Phase 4 accounts for 25% of the drugs while Phase 3 includes 23% of the pipeline, indicating many drugs are in the final stage before potential approval. Phase 1 holds 17%, showing early testing for safety and dosage. Lastly, Early Phase 1 makes up 3%, representing the initial testing stages. This distribution highlights strong ongoing efforts in advancing treatments to help people quit smoking.
Immune-based drug therapies for smoking cessation are also emerging to provide effective solutions to the patients. For instance, NFL-101, a denicotinized aqueous extract of tobacco leaves is under investigation. Moreover, a plant-based alkaloid compound Cytisinicline is also under evaluation as a new treatment option. It works by selectively binding to the nicotine receptors in the brain and reducing the dependence on smoking, thereby, improving the severity of nicotine withdrawal symptoms as well.
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Report Coverage
The Smoking Cessation Drug Pipeline Insight Report by the publisher gives comprehensive insights into smoking cessation therapeutics currently undergoing clinical trials. It covers various aspects related to the details of each of these drugs under development for smoking cessation. The smoking cessation report assessment includes the analysis of over 100 pipeline drugs and 50+ companies. The smoking cessation 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 smoking cessation 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 smoking cessation.
Smoking Cessation Drug Pipeline Outlook
Smoking cessation is the process of quitting tobacco smoking, driven by the need to overcome nicotine addiction. It involves addressing physical and psychological dependence, to reduce the risk of life-threatening diseases such as lung cancer, heart disease, and stroke. Successful cessation generally combines behavioral therapy, pharmacological treatments, and strong support systems.Treatments for smoking cessation include nicotine replacement therapies, which deliver controlled doses of nicotine to ease cravings. Prescription medications like varenicline (Chantix) and bupropion (Zyban) help reduce withdrawal symptoms and control urges. These treatments, along with counseling, improve the chances of quitting and maintaining long-term cessation. In December 2024, Qnovia, Inc., a pharmaceutical company focused on inhalation device technologies announced that it had raised USD 16 million in a Series B funding, intended for the development of smoking cessation therapeutics. The company also received the FDA clearance for its RespiRx™ Nicotine Inhaler (QN-01), a prescription inhaled smoking cessation medicine.
Smoking Cessation Epidemiology
The smoking cessation drug pipeline is vital in addressing the global tobacco use epidemic, responsible for 33% of cancer-related deaths. In India, tobacco-related cancers contribute to 27% of the cancer burden. Southeast Asia exhibits the highest prevalence, with 27.9% tobacco use. By 2030, over 8 million deaths are expected globally. Innovative treatments are crucial to reduce nicotine dependence, especially in high-prevalence regions like Southeast Asia and India.A report by the U.S. Department of Health and Human Services revealed that around 80 to 90% of individuals engaged in smoking are nicotine addicts. Approximately 8.5% of Americans aged 12 or above are dependent on nicotine. Moreover, the United States witnesses 480,000 annual deaths due to cigarette smoking, with 41000 deaths caused by secondhand smoke exposure.
Smoking Cessation Drug Pipeline Therapeutic Assessment
This section of the report covers the analysis of smoking cessation drug candidates based on several segmentations, including:By 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
- Small Molecules
- Monoclonal Antibodies
- Gene Therapies
By Route of Administration
- Oral
- Parenteral
- Others
Smoking Cessation 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 analysis, phase II covers a major share of the total smoking cessation clinical trials.In the smoking cessation drug pipeline, most drugs are currently in the middle to later stages of clinical testing. About 32% of the drugs are in Phase 2. This reflects that a large portion is being evaluated for effectiveness and safety in a larger group of people. Phase 4 accounts for 25% of the drugs while Phase 3 includes 23% of the pipeline, indicating many drugs are in the final stage before potential approval. Phase 1 holds 17%, showing early testing for safety and dosage. Lastly, Early Phase 1 makes up 3%, representing the initial testing stages. This distribution highlights strong ongoing efforts in advancing treatments to help people quit smoking.
Smoking Cessation - Pipeline Assessment Segmentation, By Drug Classes
The drug molecule categories covered under the smoking cessation pipeline analysis include small molecules, monoclonal antibodies, and gene therapies. The report provides a comparative analysis of the drug classes for each drug in various phases of clinical trials for smoking cessation.Immune-based drug therapies for smoking cessation are also emerging to provide effective solutions to the patients. For instance, NFL-101, a denicotinized aqueous extract of tobacco leaves is under investigation. Moreover, a plant-based alkaloid compound Cytisinicline is also under evaluation as a new treatment option. It works by selectively binding to the nicotine receptors in the brain and reducing the dependence on smoking, thereby, improving the severity of nicotine withdrawal symptoms as well.
Smoking Cessation Clinical Trials Therapeutic Assessment - Competitive Dynamics
The smoking cessation pipeline drug report include the profiles of key companies involved in clinical trials and their drugs under development. Below is the list of a few players involved in smoking cessation clinical trials:- Achieve Life Sciences, Inc.
- NFL Biosciences SAS
- Pfizer
- Nabi Biopharmaceuticals
- Chrono Therapeutics, Inc.
- Evotec Neurosciences GmbH
Smoking Cessation 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 smoking cessation. It includes product description, trial ID, study type, drug class, mode of administration, and recruitment status of smoking cessation drug candidates.Drug: Varenicline, Nicotine Patch
The Phase 4 clinical study is sponsored by M.D. Anderson Cancer Center. It aims to evaluate the effectiveness of varenicline and nicotine patches in aiding smoking cessation across individuals with varying levels of reward sensitivity. The study is expected to be completed by June 30, 2025, with approximately 204 participants involved.Drug: Exenatide 2 milligrams (mg) Injection
The University of Texas Health Science Center, Houston, is sponsoring a Phase 2 study examining exenatide for smoking cessation and weight gain prevention. The study aims to determine whether exenatide improves smoking abstinence rates and mitigates post-cessation weight gain. It is expected to be completed by May 2026, with around 216 participants. The study includes exenatide injections, nicotine patches, and behavioral counseling.Reasons To Buy This Report
The Smoking Cessation Drug Pipeline Insight Report provides a strategic overview of the latest and future landscape of treatments for smoking cessation. 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 market trends, regulatory environments, and potential growth opportunities within the smoking cessation pipeline insights.Key Questions Answered in the Smoking Cessation - Pipeline Insight Report
- Which companies/institutions are leading the smoking cessation drug development?
- What is the efficacy and safety profile of smoking cessation pipeline drugs?
- Which company is leading the smoking cessation pipeline development activities?
- What is the current smoking cessation commercial assessment?
- What are the opportunities and challenges present in the smoking cessation drug pipeline landscape?
- What is the efficacy and safety profile of smoking cessation pipeline drugs?
- Which company is conducting major trials for smoking cessation drugs?
- Which companies/institutions are involved in smoking cessation collaborations aimed at providing enhanced therapeutic alternatives for patients?
- What are the geographies covered for clinical trials in smoking cessation?
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Table of Contents
1 Preface
3 Overview of Smoking Cessation
4 Patient Profile: Smoking Cessation
5 Smoking Cessation: Epidemiology Snapshot
6 Smoking Cessation: Market Dynamics
7 Smoking Cessation: Key Facts Covered
8 Smoking Cessation, Drug Pipeline Assessment
9 Drug Pipeline Comparative Analysis
10 Smoking Cessation Drug Pipeline - Late-Stage Products (Phase III and IV) (Top Drugs)
11 Smoking Cessation Drug Pipeline - Mid-Stage Products (Phase II) (Top Drugs)
12 Smoking Cessation Drug Pipeline - Early-Stage Products (Phase I) (Top Drugs)
13 Smoking Cessation Drug Pipeline - Preclinical and Discovery Stage Products (Top Drugs)
14 Smoking Cessation, Key Drug Pipeline Companies
