This phase III trial compares a smartphone application with or without nicotine replacement therapy in improving smoking cessation among Hispanic adults who would like to quit smoking. The iCanQuit smartphone application focuses on skills for managing urges, motivation, and relapse prevention with personalized quit plans. Nicotine replacement therapy works by giving small, steady doses of nicotine to help stop cravings and relieve symptoms that occur when a person is trying to quit smoking without any of the other harmful chemicals found in tobacco products.

Start Date01 Jun 2025

Sponsor / Collaborator

Fred Hutchinson Cancer Research Center

[+1]

NCT06334016

/ Not yet recruitingEarly Phase 1IIT

Acute Effects of Sequential Nicotine Vaping on the Pharmacokinetic and Pharmacodynamic Properties of Vaped THC: A Double-Blind, Placebo-Controlled, Randomized Within-Subject Crossover Study

This clinical trial assesses differences in the delivery of THC to the bloodstream depending on whether nicotine vapes are used before or after THC. While there has been much recent publicity about vaping products and concern about their safety considering their increasing use for THC administration, the THC delivery profile associated with THC liquid vaping products in human subjects is currently unknown. Importantly, how the delivery to the bloodstream of THC vaping liquids compare to delivery from smoked cannabis, which is the most used method of cannabis delivery, will serve as an important benchmark for evaluating the delivery and effects of THC vaping products, and their relative safety.

Start Date27 May 2025

Sponsor / Collaborator

Roswell Park Comprehensive Cancer Center

[+1]

NCT05999383

/ Not yet recruitingPhase 2IIT

Understanding the Clinical Pharmacology of Marijuana-Tobacco Co-administration

This is a crossover, randomized, double-blinded clinical pharmacology study enrolling dual cannabis-tobacco smokers to better understand the combined effects of co-administering cannabis and tobacco. The project aims to describe the pharmacokinetics and pharmacodynamics of marijuana-tobacco co-administration by delivering THC and nicotine in various combinations. This foundational study will establish a research program focused on elucidating the public health consequences of marijuana-tobacco co-use.

Start Date01 May 2025

Sponsor / Collaborator

The University of California, San Francisco

[+3]

100 Clinical Results associated with Nicotine

100 Translational Medicine associated with Nicotine

100 Patents (Medical) associated with Nicotine

50,639

Literatures (Medical) associated with Nicotine

01 Sep 2025·TALANTA

A diverse paper sensor for the rapid determination of nicotine and cotinine traces in air, vaping liquid, and human saliva

Article

Author: Nihal, Serena ; Sarfo, Daniel ; Nihal, Aneel ; Sonar, Prashant ; Izake, Emad L ; Tesfamichael, Tuquabo ; Ayoko, Godwin

The smoking of nicotine and passive exposure to environmental tobacco smoke can lead to many chronic medical conditions such as respiratory, cardiovascular, and cancer diseases. Nicotine smoking can also cause complications for patients undergoing medical procedures. The prevalence of vaping among young people has added a significant challenge to the health care systems as many commercial vaping oils contain undeclared nicotine content, thus leading to nicotine addiction. Governments around the world criminalised the undeclared presence of nicotine in vaping oils. Therefore, there a is strong demand for new materials and sensors that can rapidly detect nicotine/tobacco smoke in vaping products and the environment. Similarly, there is an ongoing need for rapid methods to determine the concentration of the nicotine metabolite, cotinine, in patients prior to medical procedures. To address these needs, we have synthesised and utilised a cost-effective paper sensor for the rapid screening of nicotine and cotinine in vaping the oil, the gas phase, and the human saliva by surface-enhanced Raman spectroscopy (SERS). The new sensor can detect ultra traces of nicotine and cotinine down to 1 pg/mL and 1 ng/mL respectively, within 20 min. The new sensor can be recycled for repeated screening of nicotine and its metabolite, thus maximizing its economic viability. The was successfully utilised for the detection of nicotine in tobacco smoke and in spiked human saliva by a handheld Raman spectrometer, thus indicating its potential for real-life applications.

01 Aug 2025·ADDICTIVE BEHAVIORS

Switching between vaping devices, nicotine concentration, and flavors among people who use e-cigarettes daily: Results from a 12-Month longitudinal study

Article

Author: Martin, Connor D ; Kaiser, Lisa M ; Block, Ashleigh C ; Miller, Connor R ; Goniewicz, Maciej L

BACKGROUND:

E-cigarettes vary widely in product characteristics (e.g., device type, nicotine concentration, and flavor). Little is known about how people who use e-cigarettes switch between products with different characteristics. We tracked the stability/variability in characteristics of products used by individuals who vaped e-cigarettes daily over one year.

METHODS:

Of 126 enrolled participants who vaped e-cigarettes daily and did not use other nicotine products, 80 completed 12 monthly study visits. Participants reported device type, nicotine concentration, and flavors used in the past 30 days at each visit. Participants were also asked to bring e-cigarette devices and e-liquids to each visit. Study staff took pictures of products carried by participants and categorized product characteristics.

RESULTS:

Over one year, 35.0 % of participants did not change device type, nicotine concentration, or flavor type. However, 35 % of participants changed device type, 31.3 % changed nicotine concentration, and 46.3 % changed flavor at least once. The most common change in device type was switching from open to closed system devices (67.9 %). The rate of switching from low to high nicotine (≤24 vs. > 24 mg/mL) was more common than the reverse (56.6 % vs. 43.4 %). The most common change in flavor was switching between Fruit/Sweet and Hybrid (Fruit/Sweet with a cooling additive, 75.7 % of flavor switching events).

CONCLUSIONS:

Most study participants switched one product characteristic at least once during a 12-month study period. Users most frequently switched flavors and least frequently switched nicotine concentrations. Future studies should consider the variability of product use patterns among people who use e-cigarettes.

01 Aug 2025·ADDICTIVE BEHAVIORS

Nicotine and cannabis vaping-related workplace absenteeism among U.S. Adults, 2022

Article

Author: Yang, Kevin H ; Palamar, Joseph J ; Urban, Cooper

INTRODUCTION:

Vaping of nicotine and cannabis has increased substantially among US adults, but its impact on workplace productivity remains poorly understood. This study examines the associations between nicotine and cannabis vaping patterns and workplace absenteeism.

METHODS:

Cross-sectional data from a US nationally representative sample of noninstitutionalized part-time and full-time employed adults aged ≥ 18 from the 2022 National Survey on Drug Use and Health (N = 30,591) were analyzed. The associations between nicotine vaping (recency and frequency), cannabis vaping (recency), and workplace absenteeism (measured by self-reported number of missed days due to illness/injury and skipped work in the past month) were evaluated using negative binomial regression adjusting for sociodemographic characteristics and other past-month drug use.

RESULTS:

An estimated 10.4 % of full-time workers vaped nicotine in the past month and 6.4 % vaped cannabis. Compared to never-vapers of nicotine, those with any history of vaping had higher estimated incidence of absences with past-month vaping associated with increased incidence of missed work due to illness/injury (aIRR = 1.34, 95 % CI: 1.14-1.59) and skipping work (aIRR = 1.65, 95 % CI: 1.24-2.21). Past-month cannabis vaping was associated with increased estimated incidence of missed work due to illness/injury (aIRR = 1.35, 95 % CI: 1.06-1.72) and skipping work (aIRR = 1.70, 95 % CI: 1.32-2.18), although these rates did not differ significantly from those associated with non-vaped cannabis use. Associations were generally stronger among full-time workers compared to part-time workers.

CONCLUSION:

Both nicotine and cannabis vaping are associated with increased workplace absenteeism. Results support the development and implementation of workplace policies to address vaping-related productivity losses.

184

News (Medical) associated with Nicotine

21 Apr 2025

·ir.achievelifesciences.com

Achieve Life Sciences Announces Cytisinicline Phase 3 ORCA-3 Trial Publication on Smoking Cessation in JAMA Internal Medicine

ORCA-3 Demonstrated a Significant Increase in Quitting and Reduction in Nicotine Cravings for Cytisinicline-Treated Participants Compared to Placebo Cytisinicline New Drug Application (NDA) Submission to FDA Planned for June 2025 SEATTLE and VANCOUVER, British Columbia, April 21, 2025 (GLOBE NEWSWIRE) -- Achieve Life Sciences, Inc. (Nasdaq: ACHV), a late-stage specialty pharmaceutical company focused on the global development and commercialization of cytisinicline as a treatment of nicotine dependence for smoking cessation, today announced that complete trial results from its ORCA-3 were published in the Journal of the American Medical Association (JAMA) Internal Medicine. ORCA-3 was the second randomized, placebo-controlled Phase 3 clinical trial evaluating cytisinicline for smoking cessation in 792 U.S. adults. The authors concluded that ORCA-3 reaffirms cytisinicline’s efficacy and tolerability for smoking cessation in adult smokers at both 6- and 12-week treatment durations, including reduction in nicotine cravings and extended cessation benefits through 24 weeks. In addition to previously reported topline results announced in May 2023, the published completed trial results provided further evidence of cytisinicline’s highly targeted effect on treating nicotine dependence by binding to specific nicotine receptors. These consistent results, now published from two large, randomized Phase 3 trials, demonstrated that cytisinicline significantly reduced nicotine cravings and increased the likelihood of quitting smoking. In clinical trials, cytisinicline was well tolerated, which is thought to be due to limited other off-target binding effects that can result in side effects known to be associated with currently available treatments. Similar to the first Phase 3 trial, ORCA-3 participants had an average age of 53 years, smoked a median of 20 cigarettes per day at baseline, and had a median smoking history of 36 years with four prior quit attempts. “Most people who smoke want to quit and it often takes multiple attempts to do so successfully. Our trial participants were no exception and had multiple previous quit attempts, although less than half had previously tried varenicline, possibly due to its well-known adverse event profile,” said Cindy Jacobs, MD, PhD, President and Chief Medical Officer of Achieve Life Sciences. “Cytisinicline is very selective in targeting only nicotine receptors and has shown limited binding to other off-target receptors that can cause side effects, like nausea and gastrointestinal disturbances. We believe this leads to a highly tolerable treatment with cytisinicline, as demonstrated in our clinical trial program.” Results from the ORCA-3 study show that cytisinicline significantly increased the odds of smoking cessation compared to placebo. Cytisinicline also reduced nicotine craving which led to decreased nicotine intake, even among those who continued smoking, as evidenced by both lower craving scores and reduced cotinine levels, a well-known metabolite of nicotine. “More deaths each year in the U.S. are attributed to cigarette smoking than to any other preventable cause, and our current smoking cessation treatment options are limited,” said Nancy Rigotti, MD, Professor of Medicine at Harvard Medical School, Director of Tobacco Research and Treatment Center, Massachusetts General Hospital, and ORCA Program Investigator. “The study findings published today suggest that cytisinicline, if approved by the FDA, could help many smokers to quit and reduce the smoking-related risks to their health.” Achieve plans to submit the cytisinicline New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) in June 2025. About ORCA-3 The Phase 3 ORCA-3 trial evaluated 792 adults who smoked cigarettes daily and was conducted at 20 clinical trial locations in the U.S. The trial was initiated in January 2022 and completed enrollment in September 2022, with topline results reported in May 2023. ORCA-3 participants received 3mg cytisinicline dosed 3 times daily for either 6 or 12 weeks and were monitored through 24 weeks post randomization. The trial was blinded, placebo-controlled, and all subjects received behavioral support for the duration of the trial. The primary endpoint was biochemically verified continuous abstinence during the last four weeks of treatment. Secondary outcome measures assessed continued abstinence rates through 6 months from the start of study treatment. The full manuscript is published in Journal of the American Medical Association (JAMA) Internal Medicine. About Achieve Life Sciences, Inc. Achieve Life Sciences is a late-stage specialty pharmaceutical company committed to addressing the global smoking health and nicotine dependence epidemic through the development and commercialization of cytisinicline. The company has successfully completed two Phase 3 studies with cytisinicline for smoking cessation and one Phase 2 study with cytisinicline in vaping cessation. The company has fully enrolled its ongoing open-label safety study with cytisinicline and plans to submit its new drug application for smoking cessation in June 2025. Achieve has also conducted a successful end-of-Phase 2 meeting with the FDA for a future vaping indication. About Cytisinicline There are approximately 29 million adults who smoke combustible cigarettes.1 Tobacco use is currently the leading cause of preventable death that is responsible for more than eight million deaths worldwide and nearly half a million deaths in the United States annually.2,3 More than 87% of lung cancer deaths, 61% of all pulmonary disease deaths, and 32% of all deaths from coronary heart disease are attributable to smoking and exposure to secondhand smoke.3 In addition, there are over 11 million adults in the United States who use e-cigarettes, also known as vaping.4 In 2024, approximately 1.6 million middle and high school students in the United States reported using e-cigarettes.5 There are no FDA-approved treatments indicated specifically as an aid to nicotine e-cigarette cessation. Cytisinicline has been granted Breakthrough Therapy designation by the FDA to address this critical need. Cytisinicline is a plant-based alkaloid with a high binding affinity to the nicotinic acetylcholine receptor. It is believed to aid in treating nicotine addiction for smoking and e-cigarette cessation by interacting with nicotine receptors in the brain, reducing the severity of nicotine craving symptoms, and reducing the reward and satisfaction associated with nicotine products. Cytisinicline is an investigational product candidate being developed for the treatment of nicotine addiction and has not been approved by the Food and Drug Administration for any indication in the United States. Forward Looking Statements This press release contains forward-looking statements within the meaning of the “safe harbor” provisions of the Private Securities Litigation Reform Act of 1995, including, but not limited to, statements regarding the timing and nature of cytisinicline clinical development and regulatory review and approval, data results and commercialization activities, the potential market size for cytisinicline, the potential benefits, efficacy, safety and tolerability of cytisinicline, the development and effectiveness of new treatments, and the successful commercialization of cytisinicline. All statements other than statements of historical fact are statements that could be deemed forward-looking statements. Achieve may not actually achieve its plans or product development goals in a timely manner, if at all, or otherwise carry out its intentions or meet its expectations or projections disclosed in these forward-looking statements. These statements are based on management’s current expectations and beliefs and are subject to a number of risks, uncertainties and assumptions that could cause actual results to differ materially from those described in the forward-looking statements, including, among others, the risk that cytisinicline may not demonstrate the hypothesized or expected benefits; the risk that Achieve may not be able to obtain additional financing to fund the development and commercialization of cytisinicline; the risk that cytisinicline will not receive regulatory approval in a timely manner or at all, or be successfully commercialized; the risk that new developments in the smoking and vaping cessation landscapes require changes in business strategy or clinical development plans; the risk that Achieve’s intellectual property may not be adequately protected; general business and economic conditions; risks related to the impact on our business of macroeconomic and geopolitical conditions, including fluctuating inflation, interest and tariff rates, volatility in the debt and equity markets, actual or perceived instability in the global banking system, global health crises and pandemics and geopolitical conflict and the other factors described in the risk factors set forth in Achieve’s filings with the Securities and Exchange Commission from time to time, including Achieve’s Annual Reports on Form 10-K and Quarterly Reports on Form 10-Q. Achieve undertakes no obligation to update the forward-looking statements contained herein or to reflect events or circumstances occurring after the date hereof, other than as may be required by applicable. Achieve Contact Nicole Jones ir@achievelifesciences.com 425-686-1510 References 1VanFrank B, Malarcher A, Cornelius ME, Schecter A, Jamal A, Tynan M. Adult Smoking Cessation — United States, 2022. MMWR Morb Mortal Wkly Rep 2024;73:633–641. 2World Health Organization. WHO Report on the Global Tobacco Epidemic, 2019. Geneva: World Health Organization, 2017. 3U.S. Department of Health and Human Services. The Health Consequences of Smoking – 50 Years of Progress. A Report of the Surgeon General, 2014. 4Cornelius ME, Loretan CG, Jamal A, et al. Tobacco Product Use Among Adults – United States, 2021. MMWR Morb Mortal Wkly Rep 2023;72:475–483. 5Jamal A, Park-Lee E, Birdsey J, et al. Tobacco Product Use Among Middle and High School Students — National Youth Tobacco Survey, United States, 2024. MMWR Morb Mortal Wkly Rep 2024;73:917–924. Released April 21, 2025

Phase 3Clinical ResultPhase 2NDABreakthrough Therapy

17 Apr 2025

·www.prnewswire.com

Prominent Psychiatrist Introduces Breakthrough Treatment for Addiction

NEW YORK, April 17, 2025 /PRNewswire/ -- Dr. DiFrancesco () is deeply enthusiastic about new developments in the treatment of addiction and has launched a new website for individuals who would like to learn more and are seeking treatment. Experience the full interactive Multichannel News Release here: Continue Reading Dr. Eileen DiFrancesco Introduces Breakthrough Treatment For Addiction Dr. Eileen DiFrancesco Introduces Breakthrough Treatment For Addiction Dr. Eileen DiFrancesco a physician in New York City has specialized in Psychiatry and Psychopharmacology for over two decades treating a wide variety of neuropsychiatric disorders, focusing on addiction. She has had the opportunity to train in Ivy League schools and work in the ivory towers of Medicine, but unfortunately, she says there has never been an effective medication for the treatment of addiction - until now. Patients who are taking the popular drug Ozempic, also known as semaglutide which was developed for the treatment of diabetes and weight loss are experiencing remarkable results. Surprisingly, they are not only reporting a decrease in the over consumption of food, but also little or no interest in alcohol. DiFrancesco says this is not a coincidence or a side effect. As published in JAMA, Nature and Science Direct -these medications target neural circuits involved in reward and satiety and therefore greatly curb craving for addictive substances. Semaglutide and a similar medication tirzepatidetide are medication's that mimic a natural hormone called glucagon -like peptide – 1 or GLP -1. These hormones are activated when the GLP one receptor agonist attached to their receptors. What is truly exciting is that GLP one receptors are all over the brain reward pathway. This pathway exists to provide a sense of pleasure or reward when we do something that is essential for our survival or survival of the species such as eating healthy foods having sex and nurturing relationship relationships. The reward or sense of pleasure is intended to make us repeat these behaviors so that our species will survive because we eat well, procreate and take care of others. However, substances and things that are highly pleasurable can take over these reward circuits. This causes the natural rewards to become less pleasurable and even ignored. This is what addictive substances do, they hijack the reward pathway in such a way that they become the focus of an individual's life. According to JAMA, a nationwide register based study with GLP one receptor agonist Semaglutide were associated with a markedly, reduced risk of alcohol use disorders and substance use disorder related hospitalizations. In the journal nature, the administration of GLP one has convincingly shown to reduce alcohol intake and pre-clinical models. Observational studies clearly show that GLP one receptor Agnes are associated with non-volitional reduction and the use of alcohol, nicotine, cocaine and opioids. When GLP one receptor agonist activate the GLP one receptors in the reward pathway, the sense of reward from the addictive substances, including alcohol, nicotine cocaine, and even opioid becomes less rewarding. This serendipitous finding is truly amazing and wonderful. When combined with already existing treatment for addiction, DiFrancesco Psychiatry feels there is finally help and hope for treating this destructive and debilitating disease. If you or someone you love is suffering and would like to learn more, please contact us at: [email protected]. About Dr. Eileen DiFrancesco Dr. Eileen DiFrancesco graduated with honors from the University of Pennsylvania where she received her Bachelor's Degree. After earning a medical degree from Temple University School of Medicine, she received additional training in both Psychiatry and Neurology. Upon completing residency training at Mount Sinai Medical Center in New York City she was appointed Medical Director of the Learning Laboratory, a private facility in Connecticut. There she specialized in diagnosing and treating Attention Deficit Disorder, Addiction, Depression and Bipolar Disorder, using Quantitative EEG also known as Brain Mapping. Her diagnostic skills were also utilized at the Mount Sinai School of Medicine where she assessed psychotic adolescents for Schizophrenia treatment and eligibility for research protocols. SOURCE xsrxdoctor WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

27 Feb 2025

·investors.viridiantherapeutics.com

Viridian Therapeutics Highlights Recent Progress and Reports Fourth Quarter and Full Year 2024 Financial Results

- Reported positive topline phase 3 data for veligrotug from both THRIVE and THRIVE-2 in patients with active and chronic thyroid eye disease (TED); veligrotug has the potential to transform the standard of care in TED with a differentiated clinical profile achieved with fewer infusions; Biologics License Application (BLA) submission on track for second half of 2025 - - REVEAL-1 and REVEAL-2, phase 3 clinical trials assessing Q4W or Q8W subcutaneous (SC) VRDN-003 in active and chronic TED, progressing as planned and on track for topline data for both trials in the first half of 2026 - - Proof-of-concept IgG reduction clinical data in healthy volunteers anticipated in the third quarter of 2025 for VRDN-006, an Fc fragment inhibitor of the neonatal Fc receptor (FcRn) - - VRDN-008, a bispecific FcRn inhibitor with an extended half-life, expected to have additional preclinical data in 2025 with an Investigational New Drug (IND) submission planned for year-end 2025 - - Viridian appoints Radhika Tripuraneni, M.D., to the role of Chief Medical Officer - - Strong cash position of $717.6 million as of December 31, 2024; provides cash runway into the second half of 2027 - WALTHAM, Mass.--(BUSINESS WIRE)-- Viridian Therapeutics, Inc. (NASDAQ: VRDN), a biotechnology company focused on discovering, developing and commercializing potential best-in-class medicines for serious and rare diseases, today reported recent business highlights and financial results for the fourth quarter and full year ended December 31, 2024. “We made tremendous progress in 2024 which was capped off by the positive and better-than-expected pivotal data for our lead TED program veligrotug in active and chronic TED, and advancing towards the clinic with an IND submission for our lead FcRn inhibitor program VRDN-006,” said Steve Mahoney, Viridian’s President and CEO. “The veligrotug BLA submission is on track for 2H 2025 and our early commercial preparations are underway. In the new start TED market, we are excited about the potential for veligrotug to become the treatment-of-choice for patients. Our team executed throughout 2024, enrolling over 400 TED patients in veligrotug clinical trials, and we are carrying that momentum into our REVEAL studies, the phase 3 clinical trials for our potential best-in-class subcutaneous VRDN-003. Both REVEAL studies are on track to report topline data in the first half of 2026, which would enable a BLA submission by the end of 2026.” “Turning to our FcRn inhibitor portfolio, we anticipate proof-of-concept data in healthy volunteers, including IgG reduction, in Q3 2025. We also continue to advance our bispecific, half-life extended, potential best-in-class VRDN-008 program and anticipate sharing additional data from the ongoing VRDN-008 preclinical studies later this year. Building on the execution success of 2024, we are excited to continue delivering important catalysts across both our TED and FcRn portfolios.” TED Portfolio Progress Veligrotug is an intravenously (IV) delivered anti-insulin-like growth factor-1 receptor (IGF-1R) antibody in phase 3 development for thyroid eye disease, with the potential to be the IV treatment-of-choice for active and chronic TED. Positive Topline Data in THRIVE and THRIVE-2:Veligrotug achieved all primary and secondary endpoints in THRIVE and THRIVE-2, pivotal phase 3 clinical trials for patients with active and chronic TED, respectively. Pivotal Data Show a Differentiated Clinical Profile:Veligrotug showed a differentiated clinical profile in THRIVE and THRIVE-2, with a rapid onset of treatment effect and statistically significant and meaningful reduction and resolution of diplopia, including the first demonstration of diplopia response and resolution in a global chronic TED phase 3 study. Veligrotug was also generally well tolerated and had a low rate of hearing impairment, a key AE of interest, in both clinical trials. BLA On Track for 2H 2025, Marketing Authorization Application (MAA) Submission Expected 1H 2026:BLA submission is on track for the second half of 2025, with an MAA submission to the European Medicines Agency expected in the first half of 2026. VRDN-003 is a potential best-in-class, subcutaneous, half-life extended anti-IGF-1R antibody with the same binding domain as veligrotug. Viridian designed VRDN-003 to be an infrequent, at-home, and self-administered subcutaneous injection using a low-volume autoinjector. REVEAL-1 and REVEAL-2 Progressing as Planned:Patient enrollment and dosing continues in both phase 3 clinical trials. Topline Data On Track for 1H 2026: Viridian anticipates topline data from both REVEAL-1 and REVEAL-2 in the first half of 2026, with a BLA submission planned by year-end 2026. Viridian plans to launch VRDN-003 with a commercially available low-volume autoinjector for at-home administration. FcRn Inhibitor Portfolio Progress FcRn inhibitors have the potential to treat a broad array of autoimmune diseases, representing significant potential commercial market opportunities. The two marketed indications of myasthenia gravis (MG) and chronic inflammatory demyelinating polyneuropathy (CIDP) alone are projected to have a market size close to $10 billion by 2030. An additional 17 indications are currently in clinical development with an FcRn inhibitor, with dozens more autoimmune diseases thought to be addressable by FcRn inhibitors. VRDN-006 is a highly selective Fc fragment which inhibits FcRn and is designed to be a convenient subcutaneous and self-administered option for patients. Proof-of-Concept Phase 1 Clinical Data On Track for Q3 2025:Viridian expects data from the phase 1 clinical trial in Q3 2025, including proof-of-concept IgG reduction data in healthy volunteers. VRDN-008 is a half-life extended bispecific FcRn inhibitor comprising an Fc fragment and an albumin-binding domain designed to prolong IgG suppression and provide a potentially best-in-class subcutaneous option for patients. Additional Preclinical Data Expected in 2025:Non-human primate (NHP) studies are ongoing to generate additional data for VRDN-008. Once complete, Viridian plans to use the totality of VRDN-008’s NHP data to build a robust pharmacokinetic and pharmacodynamic model to enable the prediction of potential human dosing regimens for VRDN-008. Corporate Updates Today, Viridian announced the appointment of Radhika Tripuraneni, M.D., to the role of Chief Medical Officer, succeeding Thomas Ciulla, M.D. Dr. Tripuraneni joined Viridian in early 2024 as a consultant and brings a strong track record of leading clinical and medical teams at late-stage and commercial organizations with experience in multiple therapeutic areas, including rare disease, hematology/oncology, and neurology. Her prior roles include serving as Prothena’s Chief Development Officer and in senior clinical and medical roles at MyoKardia Inc., Synageva BioPharma Corp., and Alexion Pharmaceuticals Inc. Viridian thanks Dr. Ciulla for his contributions to Viridian’s progress and looks forward to his support as he transitions into a consulting role with the company. Upcoming Investor Conferences Viridian will participate in the following upcoming investor conferences in March 2025. A live webcast of each presentation can be accessed under “Events and Presentations” on the Investors section of the Viridian website at viridiantherapeutics.com. A replay of each webcast will be available following the completion of the event. TD Cowen Health Care Conference: Presentation on Monday, March 3, 2025, at 9:10 a.m. ET in Boston, Massachusetts. Leerink Global Healthcare Conference: Presentation on Wednesday, March 12, 2025, at 10:00 a.m. ET in Miami, Florida. Financial Results Cash Position:Cash, cash equivalents, and short-term investments were $717.6 million as of December 31, 2024, compared with $477.4 million as of December 31, 2023. The company believes that its current cash, cash equivalents, and short-term investments will be sufficient to fund its currently planned operations into the second half of 2027. R&D Expenses:Research and development expenses were $238.3 million during the year ended December 31, 2024, compared to $159.8 million during the year ended December 31, 2023. The increase in research and development expenses was driven by increased costs associated with our ongoing clinical trials for our TED portfolio, additional investment in advancing our FcRn inhibitor portfolio, as well as increased personnel-related costs as a result of increased headcount. G&A Expenses:General and administrative expenses were $61.1 million during the year ended December 31, 2024, compared to $95.0 million during the year ended December 31, 2023. The decrease in general and administrative expenses was driven by $31.0 million in nonrecurring severance costs in 2023. Net Loss:The company’s net loss was $269.9 million for the year ended December 31, 2024, compared with $237.7 million for the same period last year. Shares Outstanding:As of December 31, 2024, Viridian had 99,663,246 shares of common stock outstanding on an as-converted basis, which included 80,994,046 shares of common stock and an aggregate 18,669,200 shares of common stock issuable upon the conversion of 134,864 and 145,160 shares of Series A and Series B preferred stock, respectively. About Viridian Therapeutics Viridian is a biopharmaceutical company focused on discovering, developing and commercializing potential best-in-class medicines for patients with serious and rare diseases. Viridian’s expertise in antibody discovery and protein engineering enables the development of differentiated therapeutic candidates for previously validated drug targets in commercially established disease areas. Viridian is advancing multiple candidates in the clinic for the treatment of patients with thyroid eye disease (TED). The company is conducting a pivotal program for veligrotug (VRDN-001), including two global phase 3 clinical trials (THRIVE and THRIVE-2), to evaluate its efficacy and safety in patients with active and chronic TED. Both THRIVE and THRIVE-2 reported positive topline data, meeting all the primary and secondary endpoints of each study. Viridian is also advancing VRDN-003 as a potential best-in-class subcutaneous therapy for the treatment of TED, including two ongoing global phase 3 pivotal clinical trials, REVEAL-1 and REVEAL-2, to evaluate the efficacy and safety of VRDN-003 in patients with active and chronic TED. In addition to its TED portfolio, Viridian is advancing a novel portfolio of neonatal Fc receptor (FcRn) inhibitors, including VRDN-006 and VRDN-008, which has the potential to be developed in multiple autoimmune diseases. Viridian is based in Waltham, Massachusetts. For more information, please visit www.viridiantherapeutics.com. Follow Viridian on LinkedIn and X. Forward Looking Statements This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. These statements may be identified by the use of words such as, but not limited to, “anticipate,” “believe,” “become,” “continue,” “could,” “estimate,” “expect,” “intend,” “may,” “might,” “on track,” “plan,” “potential,” “predict,” “project,” “design,” “should,” “target,” “will,” or “would” or other similar terms or expressions that concern our expectations, plans and intentions. Forward-looking statements are neither historical facts nor assurances of future performance. Instead, they are based on our current beliefs, expectations, and assumptions. Forward-looking statements include, without limitation, statements regarding: preclinical development, clinical development, and anticipated commercialization of Viridian’s product candidates veligrotug (formerly VRDN-001), VRDN-003, VRDN-006 and VRDN-008, including Viridian's view that the THRIVE and THRIVE-2 data provides strong support for VRDN-003's clinical profile; anticipated start dates of studies; anticipated data results and timing of their disclosure, including VRDN-003 topline data from the REVEAL-1 and REVEAL-2 trials in the first half of 2026, anticipated VRDN-006 proof-of-concept clinical data, including IgG reduction data, in the third quarter of 2025, and anticipated VRDN-008 preclinical data in 2025; regulatory interactions and anticipated timing of regulatory submissions, including the anticipated BLA submissions for veligrotug in the second half of 2025 and VRDN-003 by year-end 2026, MAA submission for veligrotug in the first half of 2026, and IND submission for VRDN-008 by year-end 2025, pending data; the potential utility, efficacy, potency, safety, clinical benefits, clinical response, convenience and number of indications of veligrotug, VRDN-003, VRDN-006, and VRDN-008; veligrotug’s potential to transform the standard of care and the potential for veligrotug to be the IV treatment-of-choice for active and chronic TED; Viridian’s product candidates potentially being best-in-class; whether veligrotug will serve an unmet need; Viridian’s expectations regarding the potential commercialization of veligrotug and VRDN-003, if approved, including plans to launch VRDN-003 with a low-volume autoinjector; and that Viridian’s cash, cash equivalents and short-term investments will be sufficient to fund its operations into the second half of 2027. New risks and uncertainties may emerge from time to time, and it is not possible to predict all risks and uncertainties. No representations or warranties (expressed or implied) are made about the accuracy of any such forward-looking statements. Such forward-looking statements are subject to a number of material risks and uncertainties including but not limited to: potential utility, efficacy, potency, safety, clinical benefits, clinical response and convenience of Viridian’s product candidates; that results or data from completed or ongoing clinical trials may not be representative of the results of ongoing or future clinical trials; that preliminary data may not be representative of final data; the timing, progress and plans for our ongoing or future research, preclinical and clinical development programs; changes to trial protocols for ongoing or new clinical trials; expectations and changes regarding the timing for regulatory filings; regulatory interactions expectations and changes regarding the timing for enrollment and data; uncertainty and potential delays related to clinical drug development; the duration and impact of regulatory delays in our clinical programs; the timing of and our ability to obtain and maintain regulatory approvals for our therapeutic candidates; manufacturing risks; competition from other therapies or products; estimates of market size; other matters that could affect the sufficiency of existing cash, cash equivalents and short-term investments to fund operations; our financial position and projected cash runway; our future operating results and financial performance; Viridian’s intellectual property position; the timing of preclinical and clinical trial activities and reporting results from same; that our product candidates may not be commercially successful, if approved; and other risks described from time to time in the “Risk Factors” section of our filings with the Securities and Exchange Commission (SEC), including those described in our most recent Annual Report on Form 10-K or Quarterly Report on Form 10-Q, as applicable, and supplemented from time to time by our Current Reports on Form 8-K. Any forward-looking statement speaks only as of the date on which it was made. Neither the company, nor its affiliates, advisors, or representatives, undertake any obligation to publicly update or revise any forward-looking statement, whether as a result of new information, future events or otherwise, except as required by law. These forward-looking statements should not be relied upon as representing the company’s views as of any date subsequent to the date hereof. Three Months Ended December 31, Twelve Months Ended December 31, 2024 2023 2024 2023 $ 72 $ 72 $ 302 $ 314 72 72 302 314 71,959 38,558 238,254 159,765 15,585 32,993 61,083 94,999 87,544 71,551 299,337 254,764 (87,472 ) (71,479 ) (299,035 ) (254,450 ) 8,605 5,535 32,132 18,563 (858 ) (916 ) (3,046 ) (1,847 ) (79,725 ) (66,860 ) (269,949 ) (237,734 ) (942 ) 403 (348 ) 728 $ (80,667 ) $ (66,457 ) $ (270,297 ) $ (237,006 ) $ (64,648 ) $ (48,418 ) $ (208,560 ) $ (175,007 ) $ (0.81 ) $ (0.97 ) $ (3.07 ) $ (3.91 ) 80,052,123 49,681,803 67,885,831 44,755,475 $ (7,261 ) $ (11,204 ) $ (31,718 ) $ (45,421 ) $ (53.84 ) $ (64.98 ) $ (204.82 ) $ (260.70 ) 134,864 172,435 154,856 174,226 $ (7,816 ) $ (7,238 ) $ (29,671 ) $ (17,306 ) $ (53.84 ) $ (64.97 ) $ (204.82 ) $ (260.69 ) 145,160 111,413 144,862 66,385 $ 717,584 $ 477,370 24,819 13,054 $ 742,403 $ 490,424 70,764 48,402 671,639 442,022 $ 742,403 $ 490,424 Anabel Chan, 617-458-8725 Vice President, Investor Relations & Communications IR@viridiantherapeutics.com Louisa Stone, 617-272-4604 Senior Manager, Investor Relations & Communications IR@viridiantherapeutics.com

Phase 3Executive ChangeFinancial StatementPhase 1Clinical Result

100 Deals associated with Nicotine

External Link

KEGG	Wiki	ATC	Drug Bank
D03365	Nicotine	N07BA01	DB00184

R&D Status

Approved

10 top approved records.

to view more data

Indication	Country/Location	Organization	Date
Tobacco Use Disorder	Australia	Johnson & Johnson Pacific Pty Ltd.	27 Nov 2001
Nicotine Dependence	United States	Haleon US Capital LLC	13 Jan 1984

Developing

10 top R&D records.

to view more data

Indication	Highest Phase	Country/Location	Organization	Date
Acral Lentiginous Malignant Melanoma	Phase 3	United States	McNeil AB	01 Mar 2011
Dyskinesia, Drug-Induced	Phase 2	United States	Neuraltus Pharmaceuticals, Inc.	01 Oct 2009
Parkinson Disease	Phase 2	United States	Neuraltus Pharmaceuticals, Inc.	01 Oct 2009
Smoking Cessation	Phase 2	United Kingdom	McNeil AB	01 Oct 2008
Lung Cancer	Phase 1	United States	Pfizer Inc.	16 Jun 2017

Clinical Result

Indication

Phase

Evaluation

View All Results

Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT02265874 (CTgov)	Phase 1/2	Sarcoidosis, Pulmonary	50	Habitrol (Treatment)	ivvphmgojn(orsfflzlth) = wsurbzlrnk eypvviwsve (ylulmgadja, 0.22) View more	-	24 Apr 2025
				Placebo to Habitrol (Control)	ivvphmgojn(orsfflzlth) = sgsnzaytwa eypvviwsve (ylulmgadja, 0.04) View more
NCT04994444 (CTgov)	Phase 2/3	Smoking Cessation	49	Nicoderm CQ (Preloading)	vcamzakktl(qyhtaazmpd) = szcayyfasj qlsfqjhaku (hrlbbpodcp, 13.2) View more	-	06 Apr 2025
				Nicoderm CQ (Standard Treatment)	vcamzakktl(qyhtaazmpd) = uuhcxjiwuv qlsfqjhaku (hrlbbpodcp, 21.8) View more
ISC2025	Not Applicable	Cerebral Hemorrhage nicotine exposure	-	Nicotine-exposed group	jvzkwivpyp(qnceqkotor) = zsexktfqtg zwkklcdogy (qtroezygxe )	Positive	30 Jan 2025
				Nicotine (Saline (control) group)	jvzkwivpyp(qnceqkotor) = nqngcbohwz zwkklcdogy (qtroezygxe )
NCT04433767 (Pubmed)	Phase 2	Depressive Disorder nicotine metabolite concentrations	29	Transdermal nicotine patches	qxvnlsdqjh(kojgqwegrj) = improvement in self-reported affective symptoms (apathy, insomnia, rumination, and generalized anxiety symptoms), negativity bias, and disability ynnqvokieu (kjfffxohyx ) View more	Positive	01 Oct 2024
NCT05253573 (SurvLaos, CTgov)	Phase 2	Smoking Cessation \| Neoplasms	80	Self-help materials (to support smoking cessation)+Nicotine patch (Automated Treatment)	gwsgksdzif = bajgkloqhb taxufcqvrf (tlsrifnjnk, nnedcdunzx - wftdjademt) View more	-	28 Aug 2024
				Self-help materials (to support smoking cessation)+Nicotine patch (Standard Care)	gwsgksdzif = kblkiyulcy taxufcqvrf (tlsrifnjnk, uevtbiyhgz - rwaqqqxroq) View more
NCT03612960 (CTgov)	Not Applicable	Acral Lentiginous Malignant Melanoma	34	Very low nicotine content cigarettes (Very Low Nicotine Content Cigarettes)	rywvgbmycj(wbwjvfbmbl) = lxqohitjpy yfqyaqblok (wfsrpsxznn, 0.18) View more	-	20 Aug 2024
				Normal nicotine content cigarettes (Normal Nicotine Content Cigarettes)	rywvgbmycj(wbwjvfbmbl) = edcnlfszen yfqyaqblok (wfsrpsxznn, 0.18) View more
NCT03272685 (CTgov)	Phase 3	Nicotine Dependence	799	Very Low Nicotine Content Cigarettes (Very Low Nicotine Content Cigarettes)	rgmsacjhhc(nxacjgsxck) = ifbzblrgkv mqgujcaste (njvxzlspzn, 7.88) View more	-	20 Aug 2024
				Normal Nicotine Content Cigarettes (Normal Nicotine Content Cigarettes)	rgmsacjhhc(nxacjgsxck) = ykhzgclgal mqgujcaste (njvxzlspzn, 9.07) View more
NCT03634839 (CTgov)	Phase 1	Tobacco Use Disorder	42	Flavoring Agents+Nicotine (Sweet Non-menthol, Nicotine 36mg/ml)	lyzduewgjp(zrbjwwvfiq) = bvstrcwdiz ocytfcmvuc (bvtmxalasc, 3.158) View more	-	09 Aug 2024
				Flavoring Agents+Nicotine (Sweet Menthol, Nicotine 36mg/ml)	lyzduewgjp(zrbjwwvfiq) = xydvhwdoaq ocytfcmvuc (bvtmxalasc, 3.158) View more
NCT04974580 ((RISE), CTgov)	Phase 4	Nicotine Dependence	508	Phone Counseling (CoachingOnlyArm)	hwmleqvgwg = qdpycdochz lldvwvxtcj (aawknczypp, qvblpzdvtl - zigcgqhqmo) View more	-	29 Jul 2024
				Phone Counseling (DigitalArm)	hwmleqvgwg = vytfzhvflu lldvwvxtcj (aawknczypp, mlevreyufq - jvvphzvoop) View more
NCT03611881 (ScreenASSIST, CTgov)	Phase 4	Lung Cancer \| Smoking	642	Nicotine Patch+Community Resource (Short, Short, Present)	vkthdakbet = gqldbxsadw bkvfqogdvm (knpzzeinbr, onltwxfqkq - dycnmgqlib) View more	-	23 Jul 2024
				Nicotine Patch+Community Resource (Short, Long, Present)	vkthdakbet = hkdcwsqevy bkvfqogdvm (knpzzeinbr, woxwbsqukf - ymmoabsfhs) 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

Chat with Hiro

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