Although the prevalence of smoking has declined among U.S. adults, smoking remains the leading preventable cause of cancer incidence and mortality. Quitting smoking increases life expectancy, and quitting at an earlier age is associated with more years of life gained. Effective pharmacotherapies to aid cessation are available, and the combination of behavioral support with pharmacotherapy optimizes cessation outcomes. Varenicline is an effective, first-line smoking cessation treatment, and recent research has investigated combination pharmacotherapy to improve the modest quit rates observed with monotherapy. The findings of two meta-analyses have indicated that varenicline combined with the nicotine patch was more effective than varenicline alone for smoking cessation However, no published studies to date have evaluated the combined impact of varenicline and oral nicotine replacement therapy (NRT) on smoking cessation in a randomized trial. Oral NRT, such as nicotine lozenges, can provide acute relief from cravings/withdrawal, and offers individuals the flexibility to deliver nicotine quickly, in contrast with the continuous, passive, and slow-acting delivery of the nicotine patch. Nevertheless, in clinical trials of other combination pharmacotherapies, participants' adherence to of oral NRT has been suboptimal, making it difficult to determine whether there is an added benefit. Given the near-ubiquity of smartphone ownership (85% of U.S. adults), it is plausible that smartphone-based medication adherence interventions could have a positive influence on pharmacotherapy adherence and smoking cessation. This investigative team has demonstrated the feasibility and potential efficacy of using combination varenicline plus oral NRT treatment to promote smoking cessation in a pilot factorial randomized trial. Likewise, pilot findings showed that medication adherence and smoking cessation rates were higher among those who received smartphone-based medication reminders than those who did not. The proposed study will enroll 496 adults who smoke cigarettes daily. The study will employ a 2x2 factorial design in which participants will be randomized to one of four combinations of two treatment factors: 1) pharmacological treatment (varenicline + nicotine lozenges vs. varenicline alone) and 2) smartphone medication adherence intervention (smartphone-based smoking cessation app with vs. without adherence components). The primary study outcomes will be biochemically-confirmed 7-day point prevalence abstinence at 26 weeks after a scheduled quit date, and medication adherence over the 13-week treatment period. Smartphone-based daily diaries will be employed to assess daily smoking and medication adherence. Notably, the proposed study will employ entirely remote assessment and treatment delivery strategies. Exploratory analyses will evaluate the potential interaction between medication type and the smartphone adherence intervention, and compare the influences of pharmacological treatment type and the medication adherence intervention on weekly physical symptoms (e.g., withdrawal, medication side effects). The overarching goal of the proposed research is to improve smoking cessation treatment and decrease cancer risk.

Start Date05 Jan 2026

Sponsor / Collaborator

University of Oklahoma

[+4]

NCT06966362

/ Not yet recruitingPhase 4IIT

Varenicline for Smoking Reduction in Veterans Unwilling to Quit

In order to reduce the prevalence of cigarette smoking among Veterans, it is vital that the investigators offer effective tobacco treatment to all Veterans who smoke, including those not ready to make a quit attempt. Smoking treatments currently available to Veterans who are not ready to quit are only weakly effective. This project will generate new knowledge about the effectiveness of a promising varenicline-based intervention designed to increase quit attempts and long-term abstinence in Veterans who are initially not ready to quit. This project has great potential to engage Veterans not ready to quit smoking in treatment that increases quit attempts and quitting success, thereby reducing morbidity and mortality caused by smoking in Veterans.

Start Date01 Dec 2025

Sponsor / Collaborator

VA Office of Research and Development

NCT07171112

/ RecruitingPhase 2IIT

Smoking Cessation Treatment Escalation Among Patients With Recurrent Acute Pancreatitis and Chronic Pancreatitis

The purpose of this research is to assess the effectiveness of two treatment strategies for smoking cessation in patients with acute recurrent pancreatitis or chronic pancreatitis who smoke cigarettes. All participants will receive varenicline, a commonly used medication that helps people stop smoking, at its standard dose. For those who are unable to stop smoking after 6 weeks of treatment, they will be randomly selected to either 1) increase their dose of varenicline, 2) combine varenicline with bupropion (another medication that helps with smoking cessation) or continue on the standard dose of varenicline. At the end of 12 weeks of treatment, participants will be asked if they have stopped smoking with confirmation done by measuring carbon monoxide levels in their breath.

Start Date06 Nov 2025

Sponsor / Collaborator

Mayo Clinic

100 Clinical Results associated with Varenicline Tartrate

100 Translational Medicine associated with Varenicline Tartrate

100 Patents (Medical) associated with Varenicline Tartrate

2,448

Literatures (Medical) associated with Varenicline Tartrate

01 Jan 2026·ANNALS OF VASCULAR SURGERY

Smoking Cessation Adjuncts Are Cost Effective Prior to Elective Revascularization

Article

Author: Tzeng, Edith ; Smith, Kenneth J ; Sridharan, Natalie D ; Nassereldine, Hasan ; Lowenkamp, Mikayla ; Reitz, Katherine M ; Chaer, Rabih ; Madigan, Michael

BACKGROUND:

Preoperative smoking cessation can reduce adverse postoperative outcomes. Investment in smoking cessation therapies has therefore proven cost effective prior to elective interventions across numerous disciplines. Despite high rates of smoking among patients with peripheral artery disease (PAD), the cost effectiveness of smoking cessation before elective revascularization is unclear.

METHODS:

Using a Markov model, we evaluated the cost effectiveness of preoperative smoking cessation therapies (standard care, counseling, nicotine replacement therapy [NRT], varenicline, bupropion) for 65-year-old patients undergoing open or endovascular revascularization for symptomatic PAD. Local data quantified smoking cessation therapy costs. Established literature informed therapy effectiveness, postoperative outcomes (stroke, myocardial infarction, major amputation, patency, death) frequencies, and postoperative costs. Lifetime costs were quantified in US dollars and effectiveness in quality-adjusted life-years (QALYs), with a willingness-to-pay threshold of $100,000/QALY gained. Sensitivity analyses tested model robustness.

RESULTS:

In the base-case scenario, standard care was least expensive ($326,280) and varenicline was costliest ($333,335). However, varenicline was the most effective (7.11 QALYs), while standard care was least effective (6.43 QALYs). NRT and varenicline were the most cost-effective therapies. In the probabilistic simulation (randomly varying model parameters over 1,000 iterations), varenicline was favored in 80.3% at $100,000/QALY gained. Assuming no mortality differences by smoking status, in one-way sensitivity analyses varenicline dominated all other therapies.

CONCLUSION:

Smoking cessation adjuncts are cost effective prior to PAD interventions. Varenicline and NRT were the most cost-effective smoking cessation strategies. Our results highlight the value of supplemented coverage for smoking cessation therapies among patients with PAD undergoing revascularization.

01 Nov 2025·DRUG AND ALCOHOL DEPENDENCE

Efficacy and safety of varenicline for electronic cigarette cessation: A systematic review and meta-analysis

Review

Author: de Melo Neto, Altair Pereira ; Marçal, Jordana Belgamasco Cavalcanti ; Sobral, Milene Vitória Sampaio ; Acuia, Thaísa Aparecida de Souza ; da Cunha Pirolla, Rafaela ; Menechini, Rodrigo Bettanim

BACKGROUND:

The use of electronic cigarettes has increased markedly over the past decade, particularly among young adults, representing a growing public health concern. Pharmacological interventions for the cessation of vaping are thus limited. This meta-analysis assessed the efficacy and safety of varenicline compared with that of placebo in vaping cessation.

METHODS:

A systematic review and meta-analysis of randomized controlled trials (RCTs) was conducted following the Cochrane Collaboration and PRISMA guidelines. The PubMed, Embase, and Cochrane databases were searched until April 2025. The outcomes included continuous abstinence, seven-day point prevalence abstinence at the end of treatment and follow-up, and adverse events, including nausea and vivid dreams.

RESULTS:

Three RCTs comprising 355 participants were included. Varenicline significantly increased seven-day point-prevalence abstinence at the end of treatment (RR, 2.30; 95 % CI, 1.64-3.24) and at follow-up (RR, 2.14; 95 % CI, 1.47-3.10) and improved continuous abstinence rates (RR, 2.71; 95 % CI, 1.48-4.99). The overall incidence of adverse events did not differ significantly between the groups (RR: 1.49; 95 % CI: 0.68-3.25). However, nausea (RR: 2.35; 95 % CI 1.77-3.13) and vivid dreams (RR: 2.56; 95 % CI 1.59-4.11) were more frequent among patients receiving varenicline treatment CONCLUSION: Varenicline improved vaping cessation rates compared to placebo and was generally well tolerated, despite a higher incidence of nausea and vivid dreams.

01 Nov 2025·EUROPEAN JOURNAL OF PHARMACOLOGY

Varenicline as a cardioprotective agent against doxorubicin-induced toxicity: A study on apoptotic, TLR4/NF-κB, and inflammasome/caspase-1/IL-1β pathway modulation in a rat model

Article

Author: Badr, Naglaa M ; Youssef, Mahmoud E ; Shaaban, Ahmed A ; El-Kashef, Hassan

Doxorubicin-induced cardiotoxicity represents a significant challenge in oncology, impacting treatment efficacy and patient quality of life. The search for cardioprotective agents that preserve anticancer efficacy remains ongoing. Varenicline, a prescription medication commonly used to treat smoking addiction, showed promising outcomes in modulating inflammatory responses, indicating a potential protective role against doxorubicin-induced cardiac injury. This study investigates varenicline's cardioprotective effects on doxorubicin-induced cardiotoxicity, focusing on inflammatory and apoptotic signaling pathways. In this study, rats were divided into five experimental groups: control (Saline), a varenicline-only group (100 μg/kg/day), a doxorubicin-only group (2.5 mg/kg every 48 h for eight doses), and two combination groups receiving doxorubicin with either a high (100 μg/kg/day) or low (50 μg/kg/day) dose of varenicline, over 18 days. ECG analysis indicated that doxorubicin treatment caused significant disruptions, including ST-segment elevation and prolonged QT intervals, along with elevated levels of cTnT and CK-MB, signifying cardiac injury. Doxorubicin treatment also significantly increased pro-inflammatory and apoptotic markers such as TLR4, Bax, TNF-α, NF-κB, TRAF-6, IL-1β, and IL-6, while activating inflammasome components like NLRP3 and elevating the Bax/Bcl-2 ratio and caspase-3 activity along with decreasing the expression of α7-nAchR. In contrast, varenicline co-treatment improved ECG parameters, reduced TLR4 and NF-κB levels, attenuated pro-apoptotic markers, and increased α7-nAchR expression, highlighting its potential as a therapeutic agent for mitigating doxorubicin-induced cardiotoxicity. In conclusion, varenicline demonstrates protective effects by modulating inflammatory and apoptotic pathways, improving cardiac function and electrical stability. Therefore, we suggest that varenicline may be a potential therapeutic agent for mitigating doxorubicin-induced cardiotoxicity.

117

News (Medical) associated with Varenicline Tartrate

15 Oct 2025

·www.prnewswire.com

Viatris Completes Acquisition of Aculys Pharma Including Exclusive Rights to Pitolisant in Japan and to Spydia® in Japan and Certain Other Markets in the Asia-Pacific Region

Strengthens Viatris' Presence in Japan With the Addition of Two Innovative Assets Targeting Areas of Significant Unmet Medical Need Leverages Existing Infrastructure and Expertise in Central Nervous System Therapy Area Aligned with Strategy to Target Accretive Regional Business Development Opportunities PITTSBURGH, Oct. 15, 2025 /PRNewswire/ -- Viatris Inc. (Nasdaq: VTRS), a global healthcare company, today announced it has acquired Aculys Pharma, Inc., a clinical stage biopharmaceutical company focused on commercializing innovative treatments for neurological conditions. Viatris received rights to develop and commercialize pitolisant and Spydia®, two assets in the Central Nervous System (CNS) therapy area, further expanding Viatris' portfolio of innovative products in Japan. As part of the transaction, Viatris has acquired exclusive development and commercialization rights in Japan for pitolisant, a selective/inverse agonist of the histamine H3 receptor. Based on the strength of recent Phase 3 clinical trial results in Japanese patients and the positive benefit-risk profile established globally, Viatris is on track to file for marketing approval from the Ministry of Health, Labour and Welfare (MHLW) of Japan for the treatment of excessive daytime sleepiness (EDS) or cataplexy in adult patients with narcolepsy and for the treatment of excessive daytime sleepiness associated with obstructive sleep apnea syndrome (OSAS) by the end of 2025. The transaction also includes exclusive rights in Japan and certain other markets in the Asia-Pacific region for Spydia Nasal Spray, which was approved in Japan in June 2025 for the treatment of status epilepticus. "The acquisition of Aculys Pharma leverages our deep commercial infrastructure in Japan and longstanding expertise in CNS, positioning us to bring these innovative treatments to more patients in need," said Corinne Le Goff, Chief Commercial Officer, Viatris. "The addition of pitolisant and Spydia to our portfolio of innovative products is strategically aligned with our commitment to grow in areas where we can make the greatest impact and is a great example of our business development strategy designed to complement our core strengths in markets across the world." This acquisition further expands Viatris' portfolio of innovative products in Japan which includes Effexor for the treatment of generalized anxiety disorder (GAD) which is under regulatory review, selatogrel in Acute MI, Nefecon in IgA nephropathy, and cenerimod in systemic lupus erythematosus (SLE), all of which have pivotal Phase 3 trials currently on going and Tyrvaya in dry eye disease for which a Phase 3 trial is anticipated to start in 2026. Terms of the Transaction Under the terms of the acquisition agreement, Viatris has made an upfront payment to Aculys Pharma shareholders as consideration for the acquisition, with additional consideration contingent upon the achievement of specified regulatory and commercial milestones, and royalties on net sales. About Pitolisant Pitolisant is an antagonist/inverse agonist that selectively binds to the histamine H3 receptor, an autoreceptor located in the presynaptic region of the histamine-containing neurons in the human brain that plays a critical role in regulating sleep and wake rhythm. The drug was approved by the European Medicines Agency (EMA) for the treatment of narcolepsy with or without cataplexy in 2016 and for the treatment of excessive daytime sleepiness associated with OSAS in 2021. In 2019, the U.S. Food and Drug Administration (FDA) approved pitolisant under the brand name Wakix® for the treatment of excessive daytime sleepiness associated with narcolepsy and cataplexy associated with narcolepsy in 2020. As of the end of 2023, pitolisant had obtained regulatory approval in 38 countries including the U.S. and the EU for the treatment of narcolepsy, and in 29 countries in the EU for the treatment of OSAS. Positive Pivotal study results in Japanese patients were recently achieved in both narcolepsy and OSAS. In the narcolepsy Phase 3 trial, the primary endpoint of improvement in excessive daytime sleepiness (EDS) compared to a placebo group using the Epworth Sleepiness Scale (ESS) was met. Statistically significant difference in ESS was observed between the two groups. Furthermore, the key secondary endpoint of the frequency of cataplexy attacks showed a suppression effect comparable to that observed in prior global Phase 3 trials. No serious adverse events were noted, and the safety and tolerability results were consistent with global clinical trials. The OSAS Phase 3 trial evaluated the effect of pitolisant in Japanese patients with OSAS who were experiencing residual EDS despite treatment with CPAP therapy. At the end of the 12-week treatment period, patients receiving pitolisant scored lower on the ESS used to measure EDS compared to those in the placebo group and this difference was statistically significant (p=0.007). Additionally, safety and tolerability were consistent with results from global clinical studies. About Spydia (diazepam) In Japan, Aculys Pharma received marketing approval for Spydia Nasal Spray 5 mg, 7.5 mg, and 10 mg for the treatment of status epilepticus in patients 2 years or older in June 2025. This is the first intranasal anti-seizure medication approved in Japan for the treatment of status epilepticus or seizures with potential progression to status epilepticus. It is also the first rescue medication approved for adults for out-of-hospital use. This drug was developed by Neurelis, Inc. in the US and Aculys Pharma obtained exclusive development and commercialization rights in Japan and certain markets in the Asia-Pacific region, including Australia, Brunei, Cambodia, Indonesia, Laos, Malaysia, Myanmar, New Zealand, Philippines, South Korea, Thailand and Vietnam. In 2020, the FDA approved diazepam nasal spray under the brand name Valtoco® for the acute treatment of intermittent, stereotypic episodes of frequent seizure activity that are distinct from a usual seizure pattern in patients with epilepsy aged 6 years and older. In April 2025, the FDA extended the indication to include patients aged 2 years and older. Diazepam has been used for approximately 60 years in Japan, primarily in injectable form as a treatment for epileptic seizures. About Viatris Viatris Inc. (Nasdaq: VTRS) is a global healthcare company uniquely positioned to bridge the traditional divide between generics and brands, combining the best of both to more holistically address healthcare needs globally. With a mission to empower people worldwide to live healthier at every stage of life, we provide access at scale, currently supplying high-quality medicines to approximately 1 billion patients around the world annually and touching all of life's moments, from birth to the end of life, acute conditions to chronic diseases. With our exceptionally extensive and diverse portfolio of medicines, a one-of-a-kind global supply chain designed to reach more people when and where they need them, and the scientific expertise to address some of the world's most enduring health challenges, access takes on deep meaning at Viatris. We are headquartered in the U.S., with global centers in Pittsburgh, Shanghai and Hyderabad, India. Learn more at viatris.com and investor.viatris.com, and connect with us on LinkedIn, Instagram, YouTube and X. About Aculys Pharma, Inc. Aculys Pharma is a clinical stage biopharmaceutical company that is pioneering ways to eliminate drug lag/drug loss in Japan and is working to resolve social issues related to neurological and psychiatry diseases. Its corporate name was created from the philosophy of serving as a "Catalyst to Access". Aiming to act as a bridge for innovative medical care in the field of neuropsychiatry, Aculys Pharma develops and commercializes novel pharmaceuticals introduced from the US and European countries and provides innovations for better medical care to patients, their families, healthcare professionals, and society. Forward-Looking Statements This press release includes statements that constitute "forward-looking statements." These statements are made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. Such forward-looking statements may include statements regarding Viatris completes acquisition of Aculys Pharma including exclusive rights to pitolisant in Japan and to Spydia® in Japan and certain other markets in the Asia-Pacific region; strengthens Viatris' presence in Japan with the addition of two innovative assets targeting areas of significant unmet medical need; leverages existing infrastructure and expertise in Central Nervous System therapy area; aligned with strategy to target accretive regional business development opportunities; based on the strength of recent Phase 3 clinical trial results in Japanese patients and the positive benefit-risk profile established globally, Viatris is on track to file for marketing approval from the Ministry of Health, Labour and Welfare (MHLW) of Japan for the treatment of excessive daytime sleepiness (EDS) or cataplexy in adult patients with narcolepsy and for the treatment of excessive daytime sleepiness associated with obstructive sleep apnea syndrome (OSAS) by the end of 2025; the acquisition of Aculys Pharma leverages our deep commercial infrastructure in Japan and longstanding expertise in CNS, positioning us to bring these innovative treatments to more patients in need; the addition of pitolisant and Spydia to our portfolio of innovative products is strategically aligned with our commitment to grow in areas where we can make the greatest impact and is a great example of our business development strategy designed to complement our core strengths in markets across the world; this acquisition further expands Viatris' portfolio of innovative products in Japan which includes Effexor for the treatment of generalized anxiety disorder (GAD) which is under regulatory review, selatogrel in Acute MI, Nefecon in IgA nephropathy, and cenerimod in systemic lupus erythematosus (SLE), all of which have pivotal Phase 3 trials currently on going and Tyrvaya in dry eye disease for which a Phase 3 trial is anticipated to start in 2026; under the terms of the acquisition agreement, Viatris has made an upfront payment to Aculys Pharma shareholders as consideration for the acquisition, with additional consideration contingent upon the achievement of specified regulatory and commercial milestones, and royalties on net sales; positive Pivotal study results in Japanese patients were recently achieved in both narcolepsy and OSAS; in the narcolepsy Phase 3 trial, the primary endpoint of improvement in excessive daytime sleepiness (EDS) compared to a placebo group using the Epworth Sleepiness Scale (ESS) was met; statistically significant difference in ESS was observed between the two groups; furthermore, the key secondary endpoint of the frequency of cataplexy attacks showed a suppression effect comparable to that observed in prior global Phase 3 trials; no serious adverse events were noted, and the safety and tolerability results were consistent with global clinical trials; the OSAS Phase 3 trial evaluated the effect of pitolisant in Japanese patients with OSAS who were experiencing residual EDS despite treatment with CPAP therapy; at the end of the 12-week treatment period, patients receiving pitolisant scored lower on the ESS used to measure EDS compared to those in the placebo group and this difference was statistically significant (p=0.007); additionally, safety and tolerability were consistent with results from global clinical studies. Because forward-looking statements inherently involve risks and uncertainties, actual future results may differ materially from those expressed or implied by such forward-looking statements. Factors that could cause or contribute to such differences include, but are not limited to: Viatris not realizing the anticipated benefits of the acquisition; the uncertainties inherent in research and development, including the outcomes of clinical trials; the ability to meet anticipated clinical endpoints; the possibility of unfavorable new clinical data and further analyses of existing clinical data; the risk that clinical trial data are subject to differing interpretations and assessments by regulatory authorities; whether regulatory authorities will be satisfied with the design of and results from clinical studies; actions and decisions of healthcare and pharmaceutical regulators; our ability to comply with applicable laws and regulations; changes in healthcare and pharmaceutical laws and regulations in the U.S. and abroad; any regulatory, legal or other impediments to Viatris' ability to bring new products to market; products in development and/or that receive regulatory approval may not achieve expected levels of market acceptance, efficacy or safety; longer review, response and approval times as a result of evolving regulatory priorities and reductions in personnel at health agencies; Viatris' or its partners' ability to develop, manufacture, and commercialize products; the scope, timing and outcome of any ongoing legal proceedings, and the impact of any such proceedings on Viatris; Viatris' failure to achieve expected or targeted future financial and operating performance and results; goodwill or impairment charges or other losses; any changes in or difficulties with Viatris' manufacturing facilities; risks associated with international operations; changes in third-party relationships; the effect of any changes in Viatris' or its partners' customer and supplier relationships and customer purchasing patterns; the impacts of competition; changes in the economic and financial conditions of Viatris or its partners; uncertainties regarding future demand, pricing and reimbursement for Viatris' products; uncertainties and matters beyond the control of management, including but not limited to general political and economic conditions, potential adverse impacts from future tariffs and trade restrictions, inflation rates and global exchange rates; and the other risks described in Viatris' filings with the Securities and Exchange Commission ("SEC"). Viatris routinely uses its website as a means of disclosing material information to the public in a broad, non-exclusionary manner for purposes of the SEC's Regulation Fair Disclosure (Reg FD). Viatris undertakes no obligation to update these statements for revisions or changes after the date of this press release other than as required by law. SOURCE Viatris Inc. WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

Phase 3Clinical ResultDrug ApprovalAcquisition

08 Aug 2025

·pharma.economictimes.indiatimes.com

Zydus’ anti-smoking drug secures approval in Canada

Ahmedabad: Zydus Lifesciences announced that its anti-smoking generic drug ‘ ZDS-Varenicline ’ has secured regulatory approval in Canada. marketing has received marketing approval The company has received Notice of Compliance (NOC) the country’s nodal drug regulator Health Canada and Varenicline is a popular partial nicotinic acetylcholine receptor agonist, used as an aid in smoking cessation . The drug is designed to partially activate the nicotinic acetylcholine receptor (nAChR, while displacing nicotine at its sites of action in the brain. Unlike nicotine replacement therapies, such as patches, gums etc., these drugs do not contain nicotine, but targets the nicotinic acetylcholine receptors which helps to reduce nicotine cravings and withdrawal symptoms. According to IQVIA, in 2024 the drug reported total sales of ‘15 million Canadian dollar’ (around ₹94 crore). As per the company release, this is the group’s first NOC approval in Canada and the drug will be manufactured at its Ahmedabad plant in India. By Online Bureau ,

Drug Approval

08 Aug 2025

·pharma.economictimes.indiatimes.com

Zydus’ anti-smoking drug secures approval in Canada

Drug Approval

100 Deals associated with Varenicline Tartrate

External Link

KEGG	Wiki	ATC	Drug Bank
D06282	Varenicline Tartrate	N07BA03	DB01273

R&D Status

Approved

10 top approved records.

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Indication	Country/Location	Organization	Date
Xerophthalmia	Macao	Corxel Pharmaceuticals (Shanghai) Co., Ltd	01 Feb 2023
Dry Eye Syndromes	United States	Oyster Point Pharma, Inc.	15 Oct 2021
Tobacco Use Disorder	Japan	Pfizer Japan, Inc.	25 Jan 2008
Smoking Cessation	United States	PF Prism CV	10 May 2006

Developing

10 top R&D records.

to view more data

Indication	Highest Phase	Country/Location	Organization	Date
Harm Reduction	Phase 3	United States	Rose Research Center LLC	19 Nov 2019
Lung Cancer	Phase 3	United States	Pfizer Inc.	29 Sep 2017
Nicotine Dependence	Phase 3	United States	Pfizer Inc.	01 May 2010
HIV Infections	Phase 3	France	Pfizer Inc.	01 Oct 2009
Acral Lentiginous Malignant Melanoma	Phase 3	Denmark	Pfizer Inc.	01 Sep 2009
Friedreich Ataxia	Phase 3	United States	Pfizer Inc.	01 May 2009
Schizoaffective disorder	Phase 3	United States	Pfizer Inc.	01 May 2008
Schizoaffective disorder	Phase 3	Canada	Pfizer Inc.	01 May 2008
Schizophrenia	Phase 3	United States	Pfizer Inc.	01 May 2008
Schizophrenia	Phase 3	Canada	Pfizer Inc.	01 May 2008

Clinical Result

Indication

Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT06218823 (CTgov)	Phase 4	Smoking Cessation \| Neoplasms	52	Standard Telephone Counseling+Transdermal Nicotine Patch (Low-Intensity Standard Smoking Cessation Treatment)	ufbeuryuue = glxexbqfrh kkixegruuv (urscxmpiqv, nsuvjbihgc - obxydutbvn) View more	-	27 Oct 2025
				Cancer-Targeted Telephone Counseling+Varenicline (High-Intensity, Cancer-Targeted Smoking Cessation Treatment)	ufbeuryuue = drggzmayff kkixegruuv (urscxmpiqv, mumskeatgn - uyuoxwpmui) View more
NCT04445662 (CTgov)	Not Applicable	-	184	Varenicline (Control (n=68))	pzmgvaeaba = ipksiawkoe aggubxyfvy (fuemdbwdqc, qseeprmgks - awjsnhkebi) View more	-	21 Oct 2025
				Varenicline (Financial incentives (n=69))	pzmgvaeaba = huhefsfgcn aggubxyfvy (fuemdbwdqc, fhkemjmiff - burmcocryq) View more
NCT04228965 (CTgov)	Phase 4	Tobacco Use Disorder	181	Contingency Management+Varenicline (Co-Use Group)	ihrukynpbm = vtxfbefask wiobwfliyi (qrhkicaqej, nqowvmyymf - gbiglfuwst) View more	-	15 Jun 2025
				Contingency Management+Varenicline (Tobacco Only Group)	ihrukynpbm = mwfboprlcp wiobwfliyi (qrhkicaqej, jskzconqej - nwtgslcuua) View more
NCT04590404 (CTgov)	Phase 3	Smoking	606	Metabolism Informed Smoking Treatment (Nicotine metabolite ratio (NMR)-based selection of pharmacotherapy)+Nicotine Replacement Therapy+Varenicline	ajkebsabmq = pxfdnexxga jyprkphttv (czbvxuiurf, dpviyhzjry - spulwguffa) View more	-	05 Jun 2025
NCT05918406 (CTgov)	Phase 4	Kerato conjunctivitis sicca	30	Tyrvaya (Tyrvaya Nasal Spray Administered With the Nasal Guide)	gwittoodir = trpelussbs iktnkiiymv (vpncnwcgfy, adxickoqsm - qblnbprhep)	-	06 May 2025
				Varenicline (Tyrvaya (Varenicline Solution 0.3mg) Nasal Spray Administered With the Nasal Guide)	chxulubpol(jugmzcvuon) = hapesgislo grdeqznzez (dtykialwhd, oqibaqqibl - qskjcuhgoe) View more
NCT01314001 (Pubmed \| Nicotine Tob Res)	Phase 3	Smoking Cessation \| Smoking	828	Varenicline	bxpqnyxarw(wfserjolet) = hctypaeqbf ryouspsgav (lzlbsbshbx ) View more	-	04 May 2025
NCT06329687 (CTgov)	Phase 4	Kerato conjunctivitis sicca	5	Tyrvaya Nasal Pump	axmvlibydl = qfkvaybska kswzicoumh (jcklncftoy, jlmpzniwxu - yixkdlogli) View more	-	02 May 2025
NCT05367492 (ViVA, CTgov)	Phase 4	Nicotine Dependence	261	This Is Quitting	uisorcgwso = sxyxbpgsfb bckuqjgqny (hprzfgufjx, sfbbmxbrxk - tfsqjyhfsm) View more	-	27 Apr 2025
NCT05367492 (Pubmed \| JAMA)	Phase 4	Smoking Cessation	261	Varenicline	gqvjnpblna(sjjgjetoii) = dnlcfwpjhk uxtwzwresz (xihuwwhcze ) View more	Positive	23 Apr 2025
				Placebo	gqvjnpblna(sjjgjetoii) = zrllhoqacz uxtwzwresz (xihuwwhcze ) View more
NCT05541497 (CTgov)	Phase 2	Smoking Cessation	40	Varenicline Tartrate (Varenicline + Self-Change Pamphlet)	vefojuihjy = yjvzgtacxr uqllhqnsvb (ltjoentzul, qeywxcksbn - qbokvwmukj) View more	-	02 Dec 2024
				Placebo (Placebo + Self-Change Pamphlet)	vefojuihjy = ulmetbudrs uqllhqnsvb (ltjoentzul, tsooxbwuqo - kecqayehot) View more

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