In order to reduce the prevalence of cigarette smoking among Veterans, it is vital that healthcare providers 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 Apr 2026

Sponsor / Collaborator

VA Office of Research and Development

NCT07145866

/ Not yet recruitingPhase 4IIT

Evaluation of Varenicline and Accelerated TMS for Reduction of Nicotine Use

The goal of this clinical trial is to learn if a combination of varenicline and accelerated Transcranial Magnetic Stimulation (aTMS) works to help adults quit using nicotine products. Researchers will compare varenicline + active aTMS to varenicline + sham (inactive) aTMS to see the effect of aTMS on reaching abstinence. The main question it aims to answer is: Does receiving active aTMS + varenicline lead to higher abstinence rates and lower nicotine craving?
Participants will be asked to:
* Complete 2 brain MRI scans
* Take varenicline every day for 12 weeks
* Quit using nicotine products at the end of the second week of varenicline
* Complete 5 consecutive days (Monday-Friday, uninterrupted) of TMS treatments
* Complete 12 brief, weekly follow-up visits
* Complete a brief daily survey each day that they take the study drug

Start Date15 Mar 2026

Sponsor / Collaborator

The Massachusetts General Hospital

[+1]

NCT07099638

/ Not yet recruitingPhase 2IIT

Randomized Factorial Trial of Varenicline With Nicotine Lozenges and a Smartphone Medication Adherence Intervention to Promote Smoking Cessation

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 Date01 Mar 2026

Sponsor / Collaborator

University of Oklahoma

[+4]

100 Clinical Results associated with Varenicline Tartrate

100 Translational Medicine associated with Varenicline Tartrate

100 Patents (Medical) associated with Varenicline Tartrate

2,231

Literatures (Medical) associated with Varenicline Tartrate

01 May 2026·Journal of substance use and addiction treatment

Assessing the impact of nicotinic partial agonists compared to NRT on opioid and cigarette use: A secondary analysis investigating treatment outcomes for co-occurring nicotine and opioid use

Article

Author: Bendiks, Sally ; Forman, Leah ; Patts, Gregory J ; Rich, Zachary C ; Freiberg, Matthew S ; Cheng, Debbie M ; Tindle, Hilary A ; Samet, Jeffrey H ; Gnatienko, Natalia ; Stein, Michael D ; Krupitsky, Evgeny

INTRODUCTION:

Cigarette and opioid use are two leading causes of preventable death and disability in the United States and are often comorbid. Nicotinic partial agonists, such as varenicline and cytisine, are considered highly effective for Nicotine Use Disorder in the general population. However, their efficacy and safety in smokers who use opioids remain unclear, with concerns about reduced efficacy or increased opioid use. We evaluated the impact of nicotinic agonists compared to nicotine replacement therapy (NRT) on opioid and cigarette use.

METHODS:

We conducted a secondary analysis of the St PETER HIV study, a randomized, double-blinded, placebo-controlled trial of 400 HIV-positive individuals recruited from July 2017 to December 2020 at HIV care sites in St. Petersburg, Russia. Participants (daily smokers with risky alcohol use) were randomized to varenicline, cytisine, or NRT. Our analysis focused on the 97 participants who reported opioid use at baseline. Logistic regression assessed the relationship between treatment arms and our primary outcome of self-reported opioid use. Hochberg-adjusted p-values accounted for multiple comparisons.

RESULTS:

The 97 St. PETER HIV participants with baseline opioid use exhibited significant differences from non-opioid users: higher rates of HCV infection; lower CD4 counts; and higher alcohol consumption and smoking rate. Among this opioid use subgroup, there was no significant difference in self-reported opioid use between participants randomized to nicotinic partial agonists and those randomized to NRT at 1, 3, 6 or 12 months.

CONCLUSIONS:

Nicotinic partial agonists do not significantly impact opioid use outcomes compared to NRT in persons who use opioids. Clinicians should consider these options as part of a treatment approach to address nicotine use in this population.

01 Feb 2026·Contemporary Clinical Trials

The Pharmaceutically Enhanced Reinforcement for Reduced Alcohol and Smoking (PERRAS) Study: Protocol for a randomized clinical trial

Article

Author: Palombo, Paola ; Hovland, Sean ; Rodin, Nicole ; Ryan, Rachel ; Schmidt, Alex ; Akana, Nicole ; Burduli, Ekaterina ; Stark, B Connor ; Smith, Crystal L ; Miguel, André Q ; McDonell, Michael G ; Bowen, Abigail ; Chaytor, Naomi ; Layton, Matthew ; McPherson, Sterling M ; Roll, John M

BACKGROUND:

Alcohol and tobacco are often used together, and their co-use is directly associated with a high incidence of morbidity and mortality. While there are currently no guidelines for treating co-addiction to alcohol and tobacco, studies suggest that integrated approaches may effectively reduce the use of both substances. Grounded in the Addiction Neuroclinical Assessment (ANA) framework, this study aims to evaluate the effectiveness of combining Contingency Management (CM) for Alcohol Use Disorder (AUD) with Varenicline for smoking cessation to significantly reduce alcohol and tobacco use among individuals with an AUD who smoke and are seeking treatment. In addition, the study will evaluate the mediator effect of the ANA domains, systematically measured and evaluated to determine their role in treatment outcomes.

METHODS:

Study will take place in Spokane-WA. After a two-week induction period, a total of 205 eligible participants will be randomized into one of two 12-week treatment conditions in equal proportions: CM + varenicline (experimental condition) and Non-Contingent (NC) + varenicline (control condition). Participants in the CM + varenicline group will receive rewards contingent on the submission of negative alcohol samples, while the NC + varenicline group will receive rewards for submitting urine samples, independent of alcohol positivity. Primary outcomes include objective verification of abstinence during the 12-week intervention phase (measured thrice-weekly). Follow-up evaluations will be conducted during the first, third, and sixth months.

CONCLUSIONS:

If demonstrated to be efficacious, this treatment approach has the potential to produce important health benefits for a highly prevalent population in desperate need for an integrated treatment. It may also assist in identifying how different ANA-based responses impact treatment outcomes.

01 Feb 2026·INJURY-INTERNATIONAL JOURNAL OF THE CARE OF THE INJURED

Effects of varenicline as an adjunct to analgesic and anti-inflammatory therapy in acute nerve injury

Article

Author: Rusen, Yasemen Adali ; Ertener, Ozge ; Ozgenc, Serhat ; Seval-Celik, Yasemin ; Dastan, Ali Engin ; Ozturk, Volga ; Baris, Elif

INTRODUCTION:

Acute nerve injury (ANI) leads to significant neuropathic pain and functional impairment. Current treatments, including nonsteroidal anti-inflammatory drugs (NSAIDs) like meloxicam, provide symptomatic relief but have limited neuroregenerative effects. Varenicline, a nicotinic acetylcholine receptor (nAChR) agonist, has demonstrated neuroprotective and anti-inflammatory properties.

AIM:

This study evaluates the effects of varenicline as an add-on therapy to meloxicam in a rat model of ANI.

METHODS:

Eighteen female Wistar rats were randomized into four groups: Control (CONT), Sham (SHAM), Acute Nerve Injury + Meloxicam (ANI+Melox), and Acute Nerve Injury + Meloxicam + Varenicline (ANI+Melox+VAR). Varenicline (2.5 mg/kg, s.c.) was administered alongside meloxicam (2 mg/kg, s.c.). Functional recovery, histopathological changes, and biochemical markers, including prostaglandins (PGE₂, PGI₂), substance P, IL-6, levels, were assessed after 30 days.

RESULTS:

Varenicline and meloxicam co-treatment significantly reduced inflammatory and pain biomarkers including prostaglandins, interleukin-6 and substance P, compared to meloxicam alone. Histopathological evaluation revealed enhanced Schwann cell proliferation, reduced fibrosis, and increased Bands of Büngner formation, suggesting nerve regeneration.

CONCLUSION:

Varenicline, as an adjunct to meloxicam, enhances neuroprotection, reduces inflammation, and promotes histological and biochemical indicators of regeneration in rats with acute sciatic nerve injury. Future studies should explore its long-term effects and potential as a monotherapy for peripheral nerve injuries.

118

News (Medical) associated with Varenicline Tartrate

16 Jan 2026

·www.drugs.com

Varenicline Can Cut Cannabis Use Among Men With Cannabis Use Disorder

FRIDAY, Jan. 16, 2026 -- Among men, but not women, with cannabis use disorder (CUD) seeking treatment, varenicline with medical management results in decreased cannabis use, according to a study published online Jan. 15 in Addiction . Aimee L. McRae-Clark, Pharm.D., from the Medical University of South Carolina in Charleston, and colleagues conducted a phase 2, randomized, placebo-controlled trial in two outpatient research clinics to examine the efficacy of varenicline with medical management for reducing cannabis use in treatment-seeking individuals with CUD. A total of 174 participants were randomly assigned to either varenicline (titrated to goal dose of 1 mg twice daily) or placebo for 12 weeks (90 and 84 individuals, respectively) stratified by smoking status and sex. The researchers found that during weeks 6 to 12, there was no main effect of treatment on reduction of total number of cannabis use sessions. However, there was a significant treatment-by-sex interaction, with a significant effect of varenicline on reduction of cannabis use sessions per week among men, but not women (between-group differences, 4.2 and −1.4, respectively). "Our study found that varenicline, a drug that helps people to reduce or stop smoking, may be effective at reducing cannabis use as well, but only for men," McRae-Clark said in a statement. "Our next step is to further explore varenicline for cannabis use disorder, using a larger sample size of women, to better understand this sex difference in the treatment outcome." Two authors disclosed ties to the pharmaceutical industry. Abstract/Full Text

Phase 2Clinical Result

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

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.

to view more data

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
Ophthalmologic surgical procedures	NDA/BLA	Canada	BGP Pharma ULC	01 Dec 2025
Harm Reduction	Phase 3	United States	Rose Research Center LLC	19 Nov 2019
Lung Cancer	Phase 3	United States	Pfizer Inc.	29 Sep 2017
Parkinson Disease	Phase 3	Netherlands	Pfizer BV	09 Aug 2012
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

Clinical Result

Indication

Phase

Evaluation

View All Results

Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT04525755 (CTgov)	Phase 1/2	Smoking Cessation \| Smoking	652	Varenicline 0.5 MG (Varenicline (.5mg BID))	ecjnonjtsj = palnkcihck uoacpzeddq (ghypfvxqqr, nynppvfnly - mtboqwzpmt) View more	-	17 Feb 2026
				Nicotine Replacement Therapy (NRT) (Nicotine Replacement Therapy (NRT))	ecjnonjtsj = uruopblzey uoacpzeddq (ghypfvxqqr, xdgsdidgud - rhykuhwqva) View more
NCT06218823 (CTgov)	Phase 4	Smoking Cessation \| Neoplasms	52	Standard Telephone Counseling+Transdermal Nicotine Patch (Low-Intensity Standard Smoking Cessation Treatment)	blmdkilbnf = lijpaokgwr wyoyvihcrj (axsmlycnws, yzmmyrodui - ahptqcbfft) View more	-	27 Oct 2025
				Cancer-Targeted Telephone Counseling+Varenicline (High-Intensity, Cancer-Targeted Smoking Cessation Treatment)	blmdkilbnf = sbjzojtkqe wyoyvihcrj (axsmlycnws, hxwzhhjyql - skumrzbygg) View more
NCT04445662 (CTgov)	Not Applicable	-	184	Varenicline (Control (n=68))	utycmymbfl = smyaulbwoc oqtvoszlgo (lnwcpuakpd, bogmikxybs - envribjhlt) View more	-	21 Oct 2025
				Varenicline (Financial incentives (n=69))	utycmymbfl = uytzjhrepe oqtvoszlgo (lnwcpuakpd, pnywdiovfq - suvubkiicf) View more
NCT04228965 (CTgov)	Phase 4	Tobacco Use Disorder	181	Contingency Management+Varenicline (Co-Use Group)	xyvzfteedf = gtztcrnace xvcprsnadp (hsysekxxgq, kdvudggoxs - vvbchrwbfi) View more	-	15 Jun 2025
				Contingency Management+Varenicline (Tobacco Only Group)	xyvzfteedf = buffdrujii xvcprsnadp (hsysekxxgq, botjzoqpqa - rkdjbcnwrf) View more
NCT04590404 (CTgov)	Phase 3	Smoking	606	Metabolism Informed Smoking Treatment (Nicotine metabolite ratio (NMR)-based selection of pharmacotherapy)+Nicotine Replacement Therapy+Varenicline	fprfsdkeot = ceagxwtxlj duibogvmte (nwhgtqpkkq, ezewferpsc - bpxosehjxb) View more	-	05 Jun 2025
NCT05918406 (CTgov)	Phase 4	Kerato conjunctivitis sicca	30	Tyrvaya (Tyrvaya Nasal Spray Administered With the Nasal Guide)	edfoqkyzlf = jixtqgtonb xrkkpxuwku (pzdxbhkwkn, hjnqnazvvh - njgxpdfxxh)	-	06 May 2025
				Varenicline (Tyrvaya (Varenicline Solution 0.3mg) Nasal Spray Administered With the Nasal Guide)	ttypiiqqsp(dfewhrzvvb) = xziwdbaljx brtbhbhpmy (dlasyytswc, eipamaancd - ptkjfdyyjx) View more
NCT01314001 (Pubmed \| Nicotine Tob Res)	Phase 3	Smoking Cessation \| Smoking	828	Varenicline	tiemmskcrs(wokjinqwxe) = ypxhnorjmm cfnwzupied (mnianftzmx ) View more	-	04 May 2025
NCT06329687 (CTgov)	Phase 4	Kerato conjunctivitis sicca	5	Tyrvaya Nasal Pump	ffjyqpnidr = xuzzsihrwc nbjspyoono (yvpbzoxtnk, lsythwivvx - kjxdbbrsca) View more	-	02 May 2025
NCT05367492 (ViVA, CTgov)	Phase 4	Nicotine Dependence	261	This Is Quitting	slwaahmcfw = dvsoaujafc jpkzhpbkoj (lbywdykldw, wgvtfgjtsn - mhejazetra) View more	-	27 Apr 2025
NCT05367492 (Pubmed \| JAMA)	Phase 4	Smoking Cessation	261	Varenicline	ymqjwifhbd(tencyfnwjk) = gzttuefnkz pivbobnwjv (tvuscbsiaj ) View more	Positive	23 Apr 2025
				Placebo	ymqjwifhbd(tencyfnwjk) = cmngjedfhg pivbobnwjv (tvuscbsiaj ) View more

Translational Medicine

Boost your research with our translational medicine data.

view full example data

Deal

Boost your decision using our deal data.

view full example data

Core Patent

Boost your research with our Core Patent data.

view full example data

Clinical Trial

Identify the latest clinical trials across global registries.

view full example data

Approval

Accelerate your research with the latest regulatory approval information.

view full example data

Regulation

Understand key drug designations in just a few clicks with Synapse.

view full example data

AI Agents Built for Biopharma Breakthroughs

Accelerate discovery. Empower decisions. Transform outcomes.

Get started for free today!

Accelerate Strategic R&D decision making with Synapse, PatSnap’s AI-powered Connected Innovation Intelligence Platform Built for Life Sciences Professionals.

Start your data trial now!

Synapse data is also accessible to external entities via APIs or data packages. Empower better decisions with the latest in pharmaceutical intelligence.

Bio

Bio Sequences Search & Analysis

Chemical

Chemical Structures Search & Analysis