logo
These dentist-recommended mouthwashes are the perfect way to round out your oral health routine

These dentist-recommended mouthwashes are the perfect way to round out your oral health routine

CNN5 days ago
Using the best mouthwash can be a great finishing step in your daily oral health routine. Consider it a proverbial cherry on top of the dental sundae. While it's true that you don't need a mouthwash in your lineup to have stellar oral health, it can offer a range of added benefits — from strengthening and whitening teeth to taming bad breath, soothing gums and reducing sensitivity — that can give you a bit of extra support when you need it. To help discern which mouthwash might be most deserving of a spot on your bathroom counter, we consulted four dentists about the best mouthwashes fit to tackle an array of oral health needs.
Listerine Total Care Anticavity Mouthwash
If you're looking for an all-in-one mouthwash packed with whole-mouth benefits, Dr. Michael J. Wei, cosmetic dentist and founder of Manhattan Cosmetic, recommends this Listerine Total Care mouthwash. Made with fluoride for cavity protection, this rinse also fights plaque buildup and comes packed with essential oils to help kill bad breath-causing germs.
Biotène Dry Mouth Oral Rinse
'If you're managing dry mouth — whether due to medication, age or health conditions like Sjögren's [Syndrome] — Biotène Dry Mouth Oral Rinse is a highly recommended solution,' said Dr. Erin Fraundorf, an orthodontist and the founder of Boca Orthodontic and Whitening Studio in Missouri. Formulated with moisturizing agents like glycerin and xylitol to help relieve symptoms of dry mouth for several hours, Fraundorf said you can use this Biotène rinse several times a day to help with saliva replacement. In addition to having a balanced pH that helps support good oral health, Biotène is also alcohol- and sugar-free, so it won't further irritate sensitive gums or contribute to tooth decay.
Crest 3D White Glamorous White Mouthwash
Dr. Kevin B. Sands, a cosmetic dentist based in Beverly Hills, California, said this Crest 3D White rinse is his go-to whitening mouthwash. Formulated with hydrogen peroxide for whitening, this alcohol-free mouthwash promises fresh breath after every use and a brighter smile in just seven days.
Smart Mouth Clinical Prescription-Strength Oral Rinse
Dr. Anjali Rajpal, a cosmetic dentist and the founder of Beverly Hills Dental Arts, said this Smart Mouth rinse uses zinc ion technology to create an odor-blocking barrier in the mouth that targets bad breath at the source. It's also clinically proven to help prevent gingivitis and bleeding gums.
TheraBreath Fresh Breath Oral Rinse
Therabreath's mouthwashes, like this Fresh Breath version, are a dentist favorite for good reason. Made to neutralize odor-causing bacteria and deliver 24-hour fresh breath protection, this mouthwash is also alcohol-free, which, according to Fraundorf, is important for daily use. 'The acid in mouth rinse with alcohol creates an acidic environment and actually promotes demineralization of your enamel,' she said. 'It additionally can lead to bad breath by drying out your mouth, leading to a buildup of bad bacteria that cause bad breath, and killing good bacteria, leading to an imbalance in the microflora that causes bad breath.'
Act Total Care Anticavity Fluoride Mouthwash
Both Sands and Wei like this affordable and effective mouthwash from Act. Made with sodium fluoride to help strengthen enamel, it's a great option for those looking to prevent cavities or who are already cavity-prone, according to Wei. It's also formulated without alcohol, so it won't sting or leave your mouth feeling dry after use either.
GuruNanda Dual-Barrel Breath Harmonizer Mouthwash
The dual-barrel chambers in this GuruNanda mouthwash contain an essential oil blend and sodium chlorite that, when mixed together, activate to create an odor-neutralizing and plaque-fighting rinse. Rajpal likes this fluoride-free rinse for those looking for long-lasting fresh breath and a more holistic approach to oral care.
Colgate Total Alcohol-Free Mouthwash
Wei also likes this alcohol-free Colgate mouthwash, which claims to kill 99% of germs that cause bad breath, gingivitis and plaque on contact.
TheraBreath Healthy Gums Oral Rinse
Another fan of TheraBreath's rinses, Sands recommends this alcohol-free option, which is formulated to promote healthy gums. Sands said this dentist-formulated mouthwash is effective at attacking bacteria linked to gum disease while still being gentle enough to use daily.
Closys Healthy Gums Mouthwash
Mouthwashes can help penetrate deeper into gum pockets to reduce inflammation in areas that your toothbrush bristles can't reach. This powerful antibacterial mouthwash by Closys is made with Cloralstan, an antimicrobial agent that eliminates bacteria that can lead to gingivitis and bad breath, making it a good choice for those struggling with sensitive gums.
Essential Oxygen BR Organic Mouthwash and Brushing Rinse
Rajpal also likes this Essential Oxygen rinse, which combines food-grade hydrogen peroxide and a blend of essential oils to help naturally whiten teeth and freshen breath. This rinse can be used before brushing, while brushing or after brushing as a regular mouthwash, plus anytime you just want an extra boost of fresh breath.
Crest Pro-Health Multiprotection Mouthwash
This Crest Pro-Health mouthwash is a favorite of Wei's since it's made to help reduce gum inflammation, prevent plaque buildup and kill bad breath-causing bacteria in the mouth. It's also alcohol-free and perfect for daily use if you want extra prevention against the causes of early gum disease.
Crest 3D White Brilliance Stain Prevention Mouthwash
Though mouthwashes aren't very effective as the main means by which to whiten your teeth, they can boost the load of whitening agents in your overall dental routine. This Crest rinse is safe to use daily, and the hydrogen peroxide-infused formula helps to prevent surface stains from settling into teeth.
Boka Renew Liquid Mouthwash
For those interested in alternatives to traditional fluoride mouthwashes, Fraundorf likes this alcohol-free formula from Boka. Formulated without dyes, harsh chemicals or artificial additives, this Boka Renew mouthwash uses nano-hydroxyapatite to remineralize teeth. Fraundorf said it's also made from 'naturally derived antibacterial agents and botanicals that help reduce plaque and promote fresh breath while maintaining the mouth's natural balance.'
Tom's of Maine Whole Care Mouthwash
A natural mouthwash fortified with fluoride and free from artificial colors or flavors, this Tom's of Maine Whole Care rinse has a thin, water-like feel in the mouth. It also leaves behind a subtle minty aftertaste without any harsh alcohol burn.
SuperMouth Hydroxamin Nonfluoride Mouthwash
If you're sick of mint-flavored mouthwashes — or want something safe for your kiddos to use too — try this SuperMouth wash, which is fluoride-free and available in three ice cream-inspired flavors: vanilla, strawberry and chocolate. While this wash is free from alcohol, essential oils and artificial colors and flavors, it is formulated with nano-hydroxyapatite to help keep teeth strong. There are loads of different mouthwashes out there to choose from, but the one that's best for you will depend on what specific oral concerns you're looking to address. 'Many people choose mouthwash based on flavor or branding without considering whether it meets their specific oral health needs,' Fraundorf said. 'For example, someone dealing with gum inflammation may need an antimicrobial formula, while someone prone to cavities may benefit more from a fluoride-based rinse.'
Fraundorf recommends consulting your dentist to determine your specific oral health needs but offered some common ingredients to be on the lookout for. Mouthwashes formulated with fluoride, calcium phosphate or nano-hydroxyapatite can help to remineralize enamel, which aids in preventing cavities and reducing teeth sensitivity, while ingredients like cetylpyridinium chloride are antimicrobial and can help to reduce plaque and bacteria responsible for gingivitis and bad breath, according to Fraundorf. Rajpal said some natural ingredients such as essential oil blends containing mint, eucalyptus and tea tree oil, or zinc can be helpful for neutralizing odor and freshening breath, adding that some mouthwashes made with synthetic ingredients or artificial dyes might irritate sensitive mouths.
Our dental experts said it's important to remember that mouthwash is not a replacement for regular brushing and flossing. 'While [mouthwash] can be a helpful supplement and add-on to your oral care routine, it doesn't physically remove plaque or food particles the way brushing and flossing do,' Fraundorf said. 'It should always be seen as an add-on, not a substitute.'
Wei said to follow the recommended guidelines for using mouthwash per the instructions on the label, including following the recommended duration of time for rinsing and frequency of use. Both Rajpal and Wei added that you should not rinse your mouth with water immediately after using a mouthwash, since this can wash away active ingredients and reduce the overall effectiveness.
The dental experts we spoke to also cautioned against overusing mouthwash, specifically ones formulated with alcohol. 'Using mouthwash too frequently — especially those with alcohol or strong antibacterial agents — can lead to oral tissue dryness, irritation or disruption of the healthy oral microbiome,' Fraundorf said. 'This is especially important for people with sensitive tissues or dry mouth conditions.'
The following FAQs have been answered by dental experts Dr. Erin Fraundorf, Dr. Anjali Rajpal, Dr. Kevin B. Sands and Dr. Michael J. Wei.
What is the best way to incorporate mouthwash into your existing dental routine?
What is the best way to incorporate mouthwash into your existing dental routine?
The dental experts we spoke to all recommended using mouthwash after brushing and flossing. Rajpal said that brushing and flossing help remove debris and plaque from the tooth surface, while mouthwash can rinse away remaining particles and deliver additional benefits, like bacteria reduction or enamel strengthening.
You can use mouthwash both in the morning and at night, but Fraundorf said you want to be careful not to overuse mouthwash. 'Once or twice a day is usually sufficient, but overuse — particularly with alcohol-based formulas — can lead to excessive dryness, irritation and an imbalanced oral microbiome,' she said. In order for the active ingredients in mouthwash — like fluoride, nano-hydroxyapatite or antibacterial agents — to have the greatest benefit, Fraundorf recommends avoiding eating, drinking or rinsing for at least 30 minutes after using a mouthwash, especially if you're using a therapeutic oral rinse.
What happens if you accidentally swallow mouthwash?
What happens if you accidentally swallow mouthwash?
Though most mouthwashes, like toothpastes, are not meant to be swallowed, Fraundorf said accidentally ingesting a small amount is generally not dangerous. 'However, ingredients like fluoride and alcohol can cause stomach upset or toxicity in large amounts, especially in children,' she added. 'This is why mouthwash use should be supervised for kids under six, and only alcohol-free, fluoride-free options should be considered for young children who might swallow.'
Does mouthwash go bad?
Does mouthwash go bad?
According to Fraundorf, if you're using mouthwash daily, you'll likely finish the bottle well before expiration becomes an issue. 'The expiration date printed on the bottle is your best reference, as it reflects when active ingredients like fluoride or antimicrobials may begin to lose effectiveness and will vary based on the manufacturer and the specific type of mouthwash,' Fraundorf said. If there is no expiration date listed, Wei recommends replacing your mouthwash around three to four months after you open it.
To best preserve the ingredients, Fraundorf said to keep mouthwash stored in a cool, dry place with the cap tightly sealed. If you're buying mouthwashes for your household in bulk, Sands said unopened mouthwashes can last anywhere from two to three years if stored in this same manner.
While using expired mouthwash isn't usually harmful, Fraundorf said the ingredients can degrade over time, so a mouthwash may not provide the intended benefits if it's been open for a long period. Both Fraundorf and Rajpal added that if you notice any changes in the color, smell or taste of the mouthwash or see sediment forming and liquids separating, you should discard it.
Do I need to use a mouthwash?
Do I need to use a mouthwash?
Mouthwash is not a necessity for everyone to have in their routine. 'Individuals who brush twice daily with fluoride or nano-hydroxyapatite toothpaste and floss effectively may not need to include mouthwash,' Fraundorf said. 'Particularly if they are not dealing with dry mouth, gum disease or an elevated risk of cavities.'
However, for those trying to manage chronic bad breath, gum disease, enamel demineralization, orthodontic appliances or who are in post-surgical recovery, Fraundorf said adding a mouthwash into their daily routine might prove helpful.
For this article, we consulted the following dental experts to gain their professional insights.
Dr. Erin Fraundorf, orthodontist and founder of Boca Orthodontic and Whitening Studio in St. Louis, Missouri
Dr. Anjali Rajpal, cosmetic dentist and founder of Beverly Hills Dental Arts
Dr. Kevin B. Sands, cosmetic dentist based in Beverly Hills, California
Dr. Michael J. Wei, cosmetic dentist and founder of Manhattan Cosmetic in New York City
CNN Underscored has a team of writers and editors who have many years of experience testing, researching and recommending products, and they ensure each article is carefully edited and products are properly vetted. We talk to top experts when relevant to make certain we are testing each product accurately, recommending only the best products and considering the pros and cons of each item. For this story, associate editor Jillian Tracy consulted four dentists on the best mouthwashes to add to your oral health routine.
Orange background

Try Our AI Features

Explore what Daily8 AI can do for you:

Comments

No comments yet...

Related Articles

Sleep Doctors Have Surprisingly Good News If You Like To Fall Asleep Watching TV
Sleep Doctors Have Surprisingly Good News If You Like To Fall Asleep Watching TV

Yahoo

time15 minutes ago

  • Yahoo

Sleep Doctors Have Surprisingly Good News If You Like To Fall Asleep Watching TV

Let's just say that many sleep hygiene tips are far from tempting. For example, there's waking up at the same time every day (no thanks, I like to sleep in on the weekends!). There's also avoiding caffeine close to bedtime (what about my emotional-support Diet Coke?). The good news is, another key example has recently been debunked (to a certain extent). It's watching — or even more so, listening — to a TV show before bed. 'Many people ask me if falling asleep while watching TV is alright,' said Dr. Emma Lin, a board-certified pulmonologist, sleep medicine specialist and co-founder of 'The reality is, it is just right for some individuals.' Typically, we hear it's important to avoid screens before bed because they emit blue light, which can suppress the production of melatonin and disrupt our circadian rhythms (or our bodies' 'internal clocks'). This can make our bodies think it's time to be awake. But according to sleep doctors, it's not that simple. Ahead, they explain how watching TV before bed can actually be beneficial, and how to do it right. Watching TV Can Become Part Of Your Bedtime Routine One more piece of sleep advice you've probably heard, for context: to have a bedtime routine. That might look like showering, taking your medication, brushing your teeth and hopping under the sheets. A routine helps with sleep because, over time, your brain associates the two. For some people, TV is a part of that process. 'Their brain learns to associate it with falling asleep, so trying to sleep without it brings on anxiety,' said Dr. Chester Wu, the medical advisor at Rise Science who's double board-certified in psychiatry and sleep medicine. 'It's not that TV is helping them sleep — it's that it's become a part of their wind-down habit.' Having TV as a part of your routine is even more 'OK' if it's paired with other healthy sleep practices. 'I've often recommended that watching TV before bed (when paired with other tailored and effective sleep strategies) can be a helpful part of a nightly routine,' said Dr. Michael Gradisar, the head of sleep science at Sleep Cycle. TV Screens May Not Be The Problem We Thought Blue light, blue light, blue light … as much as we hear about it, it's not necessarily the thing that keeps you awake. 'While blue light from phones or screens is often blamed for poor sleep, my research has shown that the biggest disrupter is actually delaying bedtime,' Gradisar said. With that said, watching TV may be a better option compared to scrolling on your phone. 'Of the screen-based activities people engage in before bed, watching TV is the least disruptive,' Gradisar said. 'TV is a passive device compared to phones.' Additionally, the light may not be as bright, and therefore as problematic, as we thought. Lin said if the screen isn't super bright, and the content isn't disturbing, 'there's a negligible effect.' Gradisar agreed. He pointed to a 2024 study in Sleep Medicine Reviews that found light emitted from screens is not intense enough to disrupt sleep. TV Time Can Reduce Nighttime Anxiety Feel more anxious at night? Perhaps you can't stop thinking about all you have to get done tomorrow, or you keep having 'cringe attacks'? If so, you're not alone: According to survey findings published by the American Psychological Association, 43% of people have lain awake at night due to stress. Watching TV can get your mind off your worries, allowing your brain to slow down and drift off. But again, it just comes down to timing. 'Watching TV or listening to a podcast as a wind-down routine can be perfectly fine, especially if it helps reduce nighttime overthinking, as long as it doesn't cut into the number of hours of rest you get,' Gradisar said. Lin agreed, with an additional point. 'If what you watch is calm, something you've watched before, it can wind down your brain,' she said. 'That gets you asleep sooner.' TV Isn't Necessarily The No. 1 Answer To Your Sleep Woes, Though However, it's essential to note that other studies have found blue light (or just bright light) from screens to be harmful. Wu said that a TV screen in a darkened room — the latter of which is ideal for sleep — creates more circadian disruption than the same screen in a bright environment. There's also the psychological or sociological piece to consider: We stay up watching TV because, well, we want to stay up watching TV. 'This includes staying up later than planned or engaging in revenge bedtime procrastination, which is when you try to reclaim personal time late at night,' Wu said. And that's a good example of another one of his points: Your sleep may be disrupted more than you realize. 'Even if you don't feel wired after watching TV, it may still impact your sleep quality in subtle ways,' Wu said. (Hello, 'junk sleep.') Follow These Best Practices From Doctors If you're going to fall asleep to a TV show, Lin and Wu suggested following this advice: Set a sleep timer so the TV turns off after 30 to 60 minutes Angle the screen away so it's not directly shining on you Stick to familiar, low-drama, soothing shows Turn down the volume Use night mode or dim your screen Don't wear headphones — sound coming directly into your ears keeps your brain more awake Try blue light-blocking glasses Practice other healthy sleep habits (such as sleeping in a cool, dark room; exercising; avoiding caffeine; and keeping naps to around 20 minutes) Set boundaries around screen time and bedtime Go to bed at the same time every night The bottom line: Listen to your body and watch its patterns. 'If you sleep with [the] TV on, track whether you feel more or less rested on certain nights, or notice differences in how easily you wake up,' Wu said. From there, stick with what works. If you're used to sleeping without a TV or a screen, that may be your best bet. If TV is a part of your nighttime routine, consider following those earlier best practices to ensure it's as least harmful as possible. Related... Hot Sleeper? These 14 Genius Products Can Help You Get Better Rest If You Struggle To Fall Asleep, You Might Have This Specific Type Of Insomnia 'Orthosomnia' Might Be Ruining Your Sleep. Here's What You Should Know.

Boehringer Ingelheim and Re-Vana Therapeutics Announce Strategic Collaboration to Develop Long-Acting Ophthalmic Therapies
Boehringer Ingelheim and Re-Vana Therapeutics Announce Strategic Collaboration to Develop Long-Acting Ophthalmic Therapies

Yahoo

time15 minutes ago

  • Yahoo

Boehringer Ingelheim and Re-Vana Therapeutics Announce Strategic Collaboration to Develop Long-Acting Ophthalmic Therapies

· Up to three development programs per year leading to a potential total deal value exceeding $1 billion contingent on milestone achievements. Ingelheim, Germany, Tampa, Florida, USA, and Belfast, Northern Ireland, UK [28 July 2025] – Boehringer Ingelheim and Re-Vana Therapeutics, a US and UK based developer of ocular therapeutics and ocular drug delivery technologies, today announced a strategic collaboration and license agreement that aims to develop first-in-class extended-release therapies for eye diseases. Globally, millions of people living with eye health conditions face a progressive decline in their independence and connection to the world due to vision loss. With its diverse pipeline in eye health, which includes four assets in Phase II, Boehringer Ingelheim is committed to preserving the retina, protecting people's way of life and preventing vision loss. Treating ophthalmic diseases often requires frequent injections directly into the eye, which can be very burdensome for patients. Re-Vana's drug delivery technology is designed to release treatments slowly over six to 12 months, aiming to drastically reduce how often patients need injections. Lowering the treatment burden could lead to higher treatment compliance, and potentially result in better therapeutic outcomes. Boehringer Ingelheim will explore combining this technology with its unique pipeline in eye health. 'We're looking forward to team up with Re-Vana to push the boundaries of what's possible in eye health,' said Nedim Pipic, Global Head of Mental Health, Eye Health and Emerging Areas at Boehringer Ingelheim. 'Together, we want to tackle the limits of today's treatments – aiming to help people keep their sight, with fewer injections. This partnership is a bold step forward in our mission to protect vision and ease the burden on patients.' 'The strategic collaboration with Boehringer Ingelheim marks a transformational moment for Re-Vana,' said Michael O'Rourke, Re-Vana Chief Executive Officer. 'By combining our extended-release platform with Boehringer Ingelheim's world-class research and development capabilities and eye health pipeline, we strive to bring forward a new generation of long-acting treatments for eye diseases that offer clinical and quality-of-life benefits for patients.' Under the collaboration, Boehringer Ingelheim aims to add up to three projects per year across therapeutic modalities. The companies will jointly oversee Re-Vana's feasibility and development activities for the extended-release programs, with Boehringer Ingelheim assuming sole responsibility for clinical development, regulatory approval, and global commercialization of the products. The terms of the agreement grant Boehringer Ingelheim target exclusivity, and provide for upfront, development, regulatory and commercial milestone payments to Re-Vana, with total potential deal value exceeding $1 billion for the initial three targets, in addition to royalty payments on net sales. Boehringer Ingelheim Boehringer Ingelheim is a biopharmaceutical company active in both human and animal health. As one of the industry's top investors in research and development, the company focuses on developing innovative therapies that can improve and extend lives in areas of high unmet medical need. Independent since its foundation in 1885, Boehringer takes a long-term perspective, embedding sustainability along the entire value chain. Our approximately 54,500 employees serve over 130 markets to build a healthier and more sustainable tomorrow. Learn more at (Global) or (UK). About Re-Vana Therapeutics Re-Vana Therapeutics Ltd, founded in 2016 as a spin-out from Queen's University Belfast, is an ocular therapeutics and innovative ocular drug delivery company based in Belfast, Northern Ireland, and a wholly owned subsidiary of Re-Vana Holding, Inc., Tampa, Florida. Re-Vana is venture backed with leading US Ophthalmic investors including Visionary Ventures, ExSight Ventures, InFocus Capital Partners and UK investors including QUBIS, TechStart Ventures, Invest Northern Ireland and Clarendon Fund Managers. Re-Vana is currently raising a Series B round for their sustained release anti-VEGF asset. Learn more at Intended Audiences Notice This press release is issued from our Corporate Headquarters in Ingelheim, Germany and is intended to provide information about our global business. Please be aware that information relating to the approval status and labels of approved products may vary from country to country, and a country-specific press release on this topic may have been issued in the countries where we do business. Media Contacts Boehringer Ingelheim: Dr. Reinhard MalinBoehringer Ingelheim Corporate Center GmbH Innovation Unit/Bio Comms, Corp. Affairs Media + PR press@ Linda RuckelBoehringer IngelheimInnovation Unit Re-Vana: Michele Gray Gray Communications, LLCMichele@ 917 449 9250Sign in to access your portfolio

Celcuity Announces Clinically Meaningful Improvement in Both Progression-Free Survival ('PFS') Primary Endpoints from PIK3CA Wild-Type Cohort of Phase 3 VIKTORIA-1 Trial
Celcuity Announces Clinically Meaningful Improvement in Both Progression-Free Survival ('PFS') Primary Endpoints from PIK3CA Wild-Type Cohort of Phase 3 VIKTORIA-1 Trial

Yahoo

time15 minutes ago

  • Yahoo

Celcuity Announces Clinically Meaningful Improvement in Both Progression-Free Survival ('PFS') Primary Endpoints from PIK3CA Wild-Type Cohort of Phase 3 VIKTORIA-1 Trial

Hazard Ratios and Improvements in Median PFS areUnprecedented in HR+/HER2- Advanced Breast Cancer ('ABC') Gedatolisib + palbociclib + fulvestrant ('gedatolisib triplet') reduced the risk of disease progression or death by 76% vs. fulvestrant (HR=0.24; 95% CI: 0.17–0.35; p<0.0001). Median PFS was 9.3 months with the gedatolisib triplet versus 2.0 months with fulvestrant Gedatolisib + fulvestrant ('gedatolisib doublet') reduced the risk of progression or death by 67% vs. fulvestrant (HR=0.33; 95% CI: 0.24–0.48; p<0.0001). Median PFS was 7.4 months with the gedatolisib doublet versus 2.0 months with fulvestrant The efficacy results establish several new milestones in the history of drug development for HR+/HER2- advanced breast cancer Treatment discontinuation due to a treatment-related adverse event for the gedatolisib triplet and gedatolisib doublet was lower than was observed in Arm D of Celcuity's Phase 1b trial in ABC patients and lower than observed in any Phase 3 trials for currently approved drug combinations in HR+/HER2- ABC The favorable safety profile with the gedatolisib triplet and gedatolisib doublet was better than observed in the Phase 1b trial in ABC, including lower rates of hyperglycemia and stomatitis Full data from the PIK3CA wild-type cohort of the VIKTORIA-1 clinical trial will be presented at an upcoming medical conference later this year. Celcuity expects to submit a New Drug Application for gedatolisib to the U.S. Food and Drug Administration in the fourth quarter of 2025. Topline data for the VIKTORIA-1 PIK3CA mutation cohort is expected by the end of 2025. Management to host webcast and conference call today, July 28, 2025, at 8:00 a.m. ET MINNEAPOLIS, July 28, 2025 (GLOBE NEWSWIRE) -- Celcuity Inc. (Nasdaq: CELC), a clinical-stage biotechnology company pursuing development of targeted therapies for oncology, today announced positive topline results from the PIK3CA wild-type cohort of the Phase 3 VIKTORIA-1 clinical trial evaluating gedatolisib plus fulvestrant with and without palbociclib versus fulvestrant in adults with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative, PIK3CA wild-type, locally advanced or metastatic breast cancer, following progression on, or after, treatment with a CDK4/6 inhibitor and an aromatase inhibitor. In the trial, the gedatolisib triplet demonstrated a statistically significant and clinically meaningful improvement in PFS among patients, reducing the risk of disease progression or death by 76% compared to fulvestrant (based on a hazard ratio [HR] of 0.24, 95% confidence interval [CI] 0.17-0.35; p<0.0001). The mPFS, as assessed by blinded independent central review ('BICR'), was 9.3 months with the gedatolisib triplet versus 2.0 months with fulvestrant, an incremental improvement of 7.3 months. The gedatolisib doublet also demonstrated a statistically significant and clinically meaningful improvement in PFS among patients, reducing the risk of disease progression or death by 67% compared to fulvestrant (HR of 0.33, 95% CI 0.24-0.48; p<0.0001). The mPFS, as assessed by BICR, was 7.4 months with the gedatolisib doublet versus 2.0 months with fulvestrant, an incremental improvement of 5.4 months. The topline efficacy data from the VIKTORIA-1 PIK3CA wild-type cohort established several new milestones in the history of drug development for HR+/HER2- advanced breast cancer: The hazard ratios for the gedatolisib triplet and doublet are more favorable than have ever been reported by any Phase 3 trial for patients with HR+/HER2- ABC. The 7.3- and 5.4-months incremental improvements in median PFS for the gedatolisib triplet and gedatolisib doublet over fulvestrant, respectively, are higher than have ever been reported by any Phase 3 trial for patients with HR+/HER2- ABC receiving at least their second line of therapy. Gedatolisib is the first inhibitor targeting the PI3K/AKT/mTOR pathway to demonstrate positive Phase 3 results in patients with HR+/HER2-/PIK3CA wild-type ABC whose disease progressed on or after treatment with a CDK4/6 inhibitor. Sara Hurvitz, MD, Senior Vice President, Clinical Research Division, Fred Hutchinson Cancer Center, Professor and Head, Division of Hematology and Oncology, University of Washington, Department of Medicine and co-principal investigator for the trial said: 'Patients with HR-positive, HER2-negative, PIK3CA wild-type advanced breast cancer whose disease has progressed while on, or after, treatment with a CDK4/6 inhibitor typically derive limited benefit from subsequent endocrine-based therapy. The topline data for both gedatolisib regimens from VIKTORIA-1 are potentially practice-changing. To my knowledge, we have not seen Phase 3 results in patients with HR-positive, HER2-negative advanced breast cancer before where there was a quadrupling of the likelihood of survival without disease progression relative to the study control.' Treatment discontinuation due to a treatment-related adverse event for the gedatolisib triplet and gedatolisib doublet was lower than was observed in Arm D of the Phase 1b trial in patients with ABC, and lower than observed in any Phase 3 trials for currently approved drug combinations in HR+/HER2- ABC. Additionally, the gedatolisib triplet and gedatolisib doublet were better tolerated than was observed in the Phase 1b trial in patients with ABC, including lower rates of hyperglycemia and stomatitis. Igor Gorbatchevsky, MD, Chief Medical Officer of Celcuity said: 'The topline data from VIKTORIA-1 demonstrate the potential for gedatolisib to become a transformative new medicine for the treatment of patients with HR-positive, HER2-negative, PIK3CA wild-type advanced breast cancer whose disease progressed on or after treatment with CDK4/6 inhibitors. The 7.3 and 5.4-months incremental improvement in median PFS relative to fulvestrant for the gedatolisib regimens are potentially paradigm shifting results. We are also very excited that treatment with gedatolisib combined with fulvestrant with or without palbociclib was well-tolerated by the VIKTORIA-1 patients and that only a few patients discontinued treatment due to an adverse event.' Brian Sullivan, Chairman, Chief Executive Officer and co-founder of Celcuity said, 'The efficacy improvement relative to the control that each of the gedatolisib regimens demonstrated was historic for this patient population. We are excited about the potential opportunity to provide a breakthrough therapeutic option for patients with HR-positive, HER2-negative, PIK3CA wild-type advanced breast cancer.' Full data from the PIK3CA wild-type cohort of the VIKTORIA-1 clinical trial will be presented at an upcoming medical conference later this year. Celcuity expects to submit a New Drug Application for gedatolisib to the U.S. Food and Drug Administration in the fourth quarter of 2025. Topline data for the VIKTORIA-1 PIK3CA mutation cohort is expected by the end of 2025. Webcast and Conference Call InformationThe Celcuity management team will host a webcast/conference call on Monday, July 28, 2025, at 8:00 a.m. ET to discuss the topline results from the Phase 3 VIKTORIA-1 trial. Those who would like to participate may access the live webcast here, or register in advance for the teleconference here. A replay of the webcast will be available on the Celcuity website following the live event. Notes HR+/HER2- Breast cancer Breast cancer is the second most common cancer and one of the leading causes of cancer-related deaths worldwide.1 More than two million breast cancer cases were diagnosed globally in 2022.1 While survival rates are high for those diagnosed with early breast cancer, only approximately 30% of patients who are diagnosed with or who progress to metastatic disease are expected to live five years after their diagnosis.2 HR+/HER2- breast cancer is the most common subtype of breast cancer, accounting for approximately 70% of all breast cancers.2 Three interconnected signaling pathways, estrogen, cyclin D1-CDK4/6, and PI3K/AKT/mTOR (PAM), are primary oncogenic drivers of HR+, HER2- breast cancer.3 Therapies inhibiting these pathways are approved and used in various combinations for advanced breast cancer. Currently approved inhibitors of the PAM pathway for breast cancer target a single PAM pathway component, such as PI3Kα, AKT, or mTORC1.4,5,6,7 However, resistance to CDK4/6 inhibitors and current endocrine therapies develops in many patients with advanced disease.8 Survival rates are low with 30% of patients anticipated to live beyond five years after diagnosis.2 Optimizing the inhibition of the PAM pathway is an active area of focus for breast cancer research. VIKTORIA-1VIKTORIA-1 is a Phase 3 open-label, randomized clinical trial to evaluate the efficacy and safety of gedatolisib in combination with fulvestrant with or without palbociclib in adults with HR+/HER2- ABC whose disease progressed on or after prior CDK4/6 therapy in combination with an aromatase inhibitor. The clinical trial is enrolling subjects regardless of PIK3CA status while enabling separate evaluation of subjects according to their PIK3CA status. Subjects who meet eligibility criteria and do not have confirmed PI3KCA mutations (WT) were randomly assigned (1:1:1) to receive a regimen of either gedatolisib, palbociclib, and fulvestrant, gedatolisib and fulvestrant, or fulvestrant. Subjects who meet eligibility criteria and have confirmed PI3KCA mutations (MT) are randomly assigned (3:3:1) to receive a regimen of either the gedatolisib triplet, alpelisib and fulvestrant, or the gedatolisib doublet. GedatolisibGedatolisib is an investigational, multi-target PAM inhibitor that potently targets all four class I PI3K isoforms, mTORC1, and mTORC2 to induce comprehensive blockade of the PAM pathway.9,10,11 As a multi-target PAM inhibitor, gedatolisib's mechanism of action is highly differentiated from currently approved single-target inhibitors of the PAM pathway.11 Inhibition of only a single PAM component gives tumors an escape mechanism through cross-activation of the uninhibited targets. Gedatolisib's comprehensive PAM pathway inhibition ensures full suppression of PAM activity by eliminating adaptive resistance cross-activation that occurs with single-target inhibitors. Unlike single-target inhibitors of the PAM pathway, gedatolisib has demonstrated equal potency and comparable cytotoxicity in PIK3CA-mutant and -wild-type breast tumor cells in nonclinical studies and early clinical data.11,12 About CelcuityCelcuity is a clinical-stage biotechnology company pursuing development of targeted therapies for treatment of multiple solid tumor indications. The company's lead therapeutic candidate is gedatolisib, a potent, pan-PI3K and mTORC1/2 inhibitor that comprehensively blockades the PAM pathway. Its mechanism of action and pharmacokinetic properties are differentiated from other currently approved and investigational therapies that target PI3Kα, AKT, or mTORC1 alone or together. A Phase 3 clinical trial, VIKTORIA-1, evaluating gedatolisib in combination with fulvestrant with or without palbociclib in patients with HR+/HER2- advanced breast cancer is currently enrolling patients. A Phase 1/2 clinical trial, CELC-G-201, evaluating gedatolisib in combination with darolutamide in patients with metastatic castration resistant prostate cancer, is ongoing. A Phase 3 clinical trial, VIKTORIA-2, evaluating gedatolisib plus a CDK4/6 inhibitor and fulvestrant as first-line treatment for patients with HR+/HER2- advanced breast cancer is currently enrolling patients. More detailed information about Celcuity's active clinical trials can be found at Celcuity is headquartered in Minneapolis. Further information about Celcuity can be found at Follow us on LinkedIn and X. Forward-Looking StatementsThis press release contains statements that constitute "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995 including statements relating to the potential therapeutic benefits of gedatolisib; the size, design and timing of our clinical trials; our interpretation of topline clinical trial data; the ability of our data to support the filing of an NDA with the FDA; our expectations regarding the timing of and our ability to obtain FDA approval to commercialize gedatolisib; and other expectations with respect to gedatolisib. Words such as, but not limited to, 'look forward to,' 'believe,' 'expect,' 'anticipate,' 'estimate,' 'intend,' "confidence," "encouraged," 'potential,' 'plan,' 'targets,' 'likely,' 'may,' 'will,' 'would,' 'should' and 'could,' and similar expressions or words identify forward-looking statements. The forward-looking statements included in this press release are based on management's current expectations and beliefs which are subject to a number of risks, uncertainties and factors, including that our topline results are based on a preliminary analysis of key efficacy and safety data, and such data may change following a more comprehensive review of the data related to the clinical trial; unforeseen delays in our planned NDA for gedatolisib; and our ability to obtain and maintain regulatory approvals to commercialize gedatolisib. In addition, all forward-looking statements are subject to other risks detailed in our Annual Report on Form 10-K for the year ended December 31, 2024, and our Quarterly Report on Form 10-Q for the quarter ended March 31, 2025, as such risks may be updated in our subsequent filings with the Securities and Exchange Commission. You are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date hereof. All forward-looking statements are qualified in their entirety by these cautionary statements, and we undertake no obligation to revise or update this press release to reflect events or circumstances after the date hereof. References: Sung H, et al. Global Cancer Statistics 2020: GLOBOCAN Estimates of Incidence and Mortality Worldwide for 36 Cancers in 185 Countries. CA Cancer J Clin. 2021;10.3322/caac.21660. National Cancer Institute. Surveillance, Epidemiology and End Results Program (Accessed July 2025). Alves, C. L., & Ditzel, H. J. Drugging the PI3K/AKT/mTOR Pathway in ER+ Breast Cancer. Int J Mol Sci, 2023;24(5),4522. United States Package Insert, US FDA, ITOVEBI United States Package Insert, US FDA, PIQRAY United States Package Insert, US FDA, TRUCAP United States Package Insert, US FDA, AFINITOR Lloyd M R, et al. Mechanisms of Resistance to CDK4/6 Blockade in Advanced Hormone Receptor-positive, HER2-negative Breast Cancer and Emerging Therapeutic Opportunities. Clin Cancer Res. 2022;28(5):821-30 Venkatesan, A. M., et al. Bis(morpholino-1,3,5-triazine) derivatives: potent adenosine 5'-triphosphate competitive phosphatidylinositol-3-kinase/mammalian target of rapamycin inhibitors: discovery of compound 26 (PKI-587), a highly efficacious dual inhibitor. J Med Chem, 2010;53(6), 2636-2645. Mallon, R., et al. Antitumor efficacy of PKI-587, a highly potent dual PI3K/mTOR kinase inhibitor. Clin Cancer Res, 2011;17(10), 3193-3203. Rossetti, S., et al. Gedatolisib shows superior potency and efficacy versus single-node PI3K/AKT/mTOR inhibitors in breast cancer models. NPJ Breast Cancer, 2024;10(1), 40. Layman, R., et al. Gedatolisib in combination with palbociclib and endocrine therapy in women with hormone receptor-positive, HER2-negative advanced breast cancer: results from the dose expansion groups of an open-label, phase 1b study. Lancet Oncol, 2024;25(4), 474-487. View source version of release on Contacts: Celcuity Inc. Brian Sullivan, bsullivan@ Vicky Hahne, vhahne@ (763) 392-0123 ICR HealthcarePatti Bank, (415) 513-1284Fehler beim Abrufen der Daten Melden Sie sich an, um Ihr Portfolio aufzurufen. Fehler beim Abrufen der Daten Fehler beim Abrufen der Daten Fehler beim Abrufen der Daten Fehler beim Abrufen der Daten

DOWNLOAD THE APP

Get Started Now: Download the App

Ready to dive into a world of global content with local flavor? Download Daily8 app today from your preferred app store and start exploring.
app-storeplay-store