Efficacy of external oblique intercostal block (EOIB) with or without dexmedetomidine on postoperative anaglesia in laparoscopic upper abdominal surgeries – a double blinded randomised control trial - Nil

Start Date01 Sep 2027

Sponsor / Collaborator

All India Institute of Medical Sciences

NCT05619627

/ Not yet recruitingPhase 1IIT

Utility of Oral Dexmedetomidine as the Sole Sedative Agent in Pediatric Population Undergoing MRI

The objective of this preliminary study is to assess the utility of oral dexmedetomidine as the sole sedative agent in pediatric population undergoing MRI.

Start Date01 May 2025

Sponsor / Collaborator

The Children's Mercy Hospital

NCT06865469

/ Not yet recruitingPhase 3IIT

Comparing Efficacy of Intravenous Dexmedetomidine and Lidocaine on Postoperative Analgesia in Patients Undergoing Fracture Hip Surgery

Perioperative pain management has been a major challenge for anesthesiologists, and there have been persistent efforts to bring out the best possible analgesic technique with the least side effects.
Hip fractures are devastating injuries, constituting a global public health burden and remain one of the largest healthcare challenges of the 21st century. The incidence increases with advancing age and the number of hip fractures is expected to increase to 6.26 million per year in 2050.
Hip fractures impact on patient's psychological, functional, and social wellbeing, and account for substantial healthcare system costs.
Drugs of potential interest such as intravenous (i.v.) lidocaine and dexmedetomidine have been administered both intra and/or postoperatively to decrease perioperative pain and improve other outcomes. Lidoocaine has analgesic, anti inflammatory, and anti hyperalgesia properties.
Several studies have demonstrated that perioperative lidocaine infusion reduces postoperative pain intensity and opioid consumption .
Ease of availability, cost effectiveness, simplicity of administration, safety, and analgesic action make lignocaine an attractive option.
Dexmedetomidine is a highly selective and specific α2 adrenoceptor agonist with useful analgesic, sedative, anxiolytic, and sympatholytic properties.
I.V. dexmedetomidine has gained immense popularity owing to its efficacy as an analgesic adjuvant, translating into reduced opioid consumption.
Intraoperative dexmedetomidine and lignocaine also confirm the enhanced recovery after surgery protocol advocating the reduction of opioid use.
While numerous studies have analyzed i.v. lidoocaine and dexmedetomidine versus placebo regarding postoperative analgesia and outcomes, researches and evidence in the context of minimally invasive surgeries regarding adverse effect profile, postoperative analgesic requirement, perioperative analgesia, anesthesia recovery, and opioid requirements are always welcome(rephrase). Our study was conducted to analyze the effects of intraoperative i.v. lidocaine and dexmedetomidine on pain relief, intra- and postoperative opioid consumption, and effects of these infusions on intraoperative hemodynamic parameters and to evaluate the side effect profiles the aim of the study to analyze the effects of intraoperative intravenous lignocaine/dexmedetomidine on postoperative pain relief and analgesit consumption

Start Date01 May 2025

Sponsor / Collaborator

Assiut University

100 Clinical Results associated with Dexmedetomidine Hydrochloride

100 Translational Medicine associated with Dexmedetomidine Hydrochloride

100 Patents (Medical) associated with Dexmedetomidine Hydrochloride

16,816

Literatures (Medical) associated with Dexmedetomidine Hydrochloride

31 Dec 2025·ANNALS OF MEDICINE

Optimal doses of intranasal esketamine plus dexmedetomidine for sedating toddlers during transthoracic echocardiography: a prospective, double-blind, randomized trial

Article

Author: Qu, Shuangquan ; Du, Zhen ; Xiao, Ting ; Zeng, Li ; Wei, Siwei ; Wang, Lei ; Pei, Dongjie

INTRODUCTION:

Esketamine has unique advantages in combination with dexmedetomidine for sedation in young children, owing to its sympathetic activity and mild respiratory depression. However, the optimal dose is yet to be determined. In this study, we compared the different doses of intranasal esketamine combined with dexmedetomidine for sedation during transthoracic echocardiography in toddlers.

PATIENTS AND METHODS:

A total of 121 eligible children aged 13 years, who were scheduled for transthoracic echocardiography were randomized into three groups. They were treated with intranasal dexmedetomidine 1 mcg.kg^-1 + esketamine 0.5 mg.kg^-1 (group S1), dexmedetomidine 1 mcg.kg^-1 + esketamine 1 mg.kg^-1 (group S2), or dexmedetomidine 1 mcg.kg^-1 + esketamine 1.5 mg.kg^-1 (group S3). The primary outcome was the success rate of sedation, other outcomes included HR, SpO₂, onset time, wake-up time, and adverse effects.

RESULTS:

The success rate of sedation was significantly higher in groups S2 (85.4%) and S3 (87.5%) than ingroup S1 (60%) (p = 0.004). The baseline HR and SpO₂ did not differ between the groups at the corresponding time points following drug administration. The onset time and duration of sedation in group S1 were significantly longer than those in groups S2 and S3 (p = 0.000). However, there were no differences in the wake-up time or adverse effects among the three groups.

CONCLUSIONS:

Intranasal administration of 1 mg.kg^-1 esketamine combined with 1 mcg.kg^-1 dexmedetomidine provided satisfactory sedation in young children undergoing transthoracic echocardiography. This sedative approach offers a rapid onset of awakening with few side effects.

CLINICAL TRIAL REGISTRATION NUMBER:

ChiCTR2200060976, 2022/06/14 (trail from August 2022 to January 2023).

01 Jun 2025·NEUROPHARMACOLOGY

Modulation of spinal morphine pharmacokinetics and antinociception by α2-adrenergic agonists in the male rat

Article

Author: Kurkela, Mika ; Rosenholm, Marko ; Niemi, Mikko ; Farzaneh Kari, Melina ; Lohela, Terhi J ; Copie, Radu G ; Lilius, Tuomas O ; Rauhala, Pekka V ; Blomqvist, Kim

The synergistic antinociceptive effects of α₂-adrenergic agonists and intrathecal (i.t.) opioids were initially linked to pharmacodynamics. However, the α₂-agonist dexmedetomidine also enhances brain delivery of CSF-administered drugs by increasing glymphatic influx. Here, fadolmidine, a hydrophilic α₂-agonist designed for spinal analgesia, was studied for its sedative, antinociceptive, and pharmacokinetic effects with co-administered lumbar intrathecal morphine. Subcutaneous and i.t. dexmedetomidine served as comparators. Forty-eight male Sprague-Dawley rats received i.t. lumbar catheters. Sedative effects of i.t. fadolmidine (1-10 μg) and i.t. dexmedetomidine (1-10 μg) were assessed by open field and rotarod tests. The antinociceptive effects of morphine alone (1.5 μg i.t.) and co-administered with i.t. fadolmidine (3 and 10 μg) were evaluated using the tail-flick test. Effects of i.t. fadolmidine and subcutaneous dexmedetomidine (0.2 mg/kg) on morphine concentration within CNS were assessed by liquid chromatography-tandem mass spectrometry at 60 min. While i.t. dexmedetomidine was sedating, i.t fadolmidine was not. The antinociceptive effects of other treatment regimens weaned at latest after 90 min, whereas the combination of fadolmidine 10 μg i.t. and morphine 1.5 μg i.t. provided antinociception until the end of the measurement period (%maximum possible effect of 77.5 ± 11.5 vs saline 10.6 ± 11.1, p = 0.0002 at 120 min). Subcutaneous dexmedetomidine effectively targeted lumbar morphine towards the injection site resulting in a 3335-fold (95% CI: 929-11978) lower brain-to-injection site ratio, versus a 355-fold (95% CI: 196-641) difference with saline. By improving spinal opioid targeting, α₂-adrenergic agonists dexmedetomidine and fadolmidine may reduce supraspinal side effects, enabling safe and efficacious intrathecal analgesia.

01 Feb 2025·Current Neuropharmacology

Disease-Modifying Symptomatic Treatment (DMST) Potential of Cannabinoids in Patients with Multiple Sclerosis

Article

Author: Bruno, Antonio ; Annovazzi, Pietro ; Totaro, Rocco ; Clerici, Valentina Torri ; Centonze, Diego ; Marfia, Girolama Alessandra ; Conte, Antonella ; Clerico, Marinella ; Cocco, Eleonora ; Dolcetti, Ettore ; Tomassini, Valentina ; Salvetti, Marco

With the recent introduction of a number of highly effective disease-modifying treatments (DMTs) and the resulting almost complete prevention of acute relapses in many patients with multiple sclerosis (MS), the interest of MS clinicians has gradually shifted from relapse prevention to counteraction of disease progression and the treatment of residual symptoms. Targeting the cannabinoid system with nabiximols is an approved and effective strategy for the treatment of spasticity secondary to MS. Recently, the concept of spasticity plus syndrome (SPS) was introduced to account for the evidence that spasticity often appears in MS patients in clusters with other symptoms (such as pain, bladder dysfunction, sleep, and mood disorders), where cannabinoids can also be effective due to their broader action on many immune and neuronal functions. Interestingly, outside these symptomatic benefits, extensive pre-clinical and clinical research indicated how the modulation of the cannabinoid system results in significant anti-inflammatory and neuroprotective effects, all potentially relevant for MS disease control. This evidence makes nabiximols a potential disease modifying symptomatic treatment (DMST), a concept introduced in an attempt to overcome the often artificial distinction between DMTs and symptomatic therapies (STs).

159

News (Medical) associated with Dexmedetomidine Hydrochloride

11 Mar 2025

·www.globenewswire.com

BioXcel Therapeutics Strengthens Cash Position to Advance SERENITY At-Home Pivotal Phase 3 Safety Trial for Acute Treatment of Agitation Associated with Bipolar Disorders or Schizophrenia

Topline data expected in second half of 2025 to support potential sNDA submission for label expansion of IGALMI® in the home setting Company has $35M of cash following closing of recent equity financing NEW HAVEN, Conn., March 11, 2025 (GLOBE NEWSWIRE) -- BioXcel Therapeutics, Inc. (Nasdaq: BTAI), a biopharmaceutical company utilizing artificial intelligence to develop transformative medicines in neuroscience, today announced that, following the successful raise of $14 million gross proceeds in an equity financing that closed on March 4, 2025, it has approximately $35 million in cash. The strengthened cash position will support continued advancement of the Company’s pivotal Phase 3 SERENITY At-Home trial. The trial is designed to evaluate the safety of BXCL501, BioXcel Therapeutics’ investigational, proprietary, orally dissolving film formulation of dexmedetomidine, in the at-home setting for the acute treatment of agitation associated with bipolar disorders or schizophrenia. “We are pleased the recent financing enables us to progress our SERENITY At-Home trial,” said Vimal Mehta, Ph.D., CEO of BioXcel Therapeutics. “Patient enrollment is continuing and topline data results expected in the second half of 2025 are intended to support a potential sNDA submission to expand the label for IGALMI® in the at-home setting. We are highly motivated by the prospect of bringing — for the first time — an acute treatment option for agitation to millions of additional patients in this setting.” About the SERENITY At-Home Phase 3 Trial The SERENITY At-Home Phase 3 trial is a double-blind, placebo-controlled study designed to evaluate the safety of a 120 mcg dose of BXCL501 for the acute treatment of agitation associated with bipolar disorders or schizophrenia in the home setting. The trial is enrolling 200 patients with a history of agitation episodes residing at home either alone or with caregivers/informants. Patients will self-administer 120 mcg of BXCL501 or placebo when agitation episodes occur over the 12-week trial period, with safety data (adverse events) collected during the trial. Patients or caregivers/informants will complete a modified global impression of severity (mCGI-S) and a clinical global impression of change (mCGI-C) two hours after dosing as an exploratory endpoint to evaluate use in the outpatient setting. About IGALMI® (dexmedetomidine) sublingual film INDICATION IGALMI® (dexmedetomidine) sublingual film is a prescription medicine, administered under the supervision of a health care provider, that is placed under the tongue or behind the lower lip and is used for the acute treatment of agitation associated with schizophrenia and bipolar disorder I or II in adults. The safety and effectiveness of IGALMI has not been studied beyond 24 hours from the first dose. It is not known if IGALMI is safe and effective in children. IMPORTANT SAFETY INFORMATION IGALMI can cause serious side effects, including: Decreased blood pressure, low blood pressure upon standing, and slower than normal heart rate, which may be more likely in patients with low blood volume, diabetes, chronic high blood pressure, and older patients. IGALMI is taken under the supervision of a healthcare provider who will monitor vital signs (like blood pressure and heart rate) and alertness after IGALMI is administered to help prevent falling or fainting. Patients should be adequately hydrated and sit or lie down after taking IGALMI and instructed to tell their healthcare provider if they feel dizzy, lightheaded, or faint. Heart rhythm changes (QT interval prolongation). IGALMI should not be given to patients with an abnormal heart rhythm, a history of an irregular heartbeat, slow heart rate, low potassium, low magnesium, or taking other drugs that could affect heart rhythm. Taking IGALMI with a history of abnormal heart rhythm can increase the risk of torsades de pointes and sudden death. Patients should be instructed to tell their healthcare provider immediately if they feel faint or have heart palpitations. Sleepiness/drowsiness. Patients should not perform activities requiring mental alertness, such as driving or operating hazardous machinery, for at least 8 hours after taking IGALMI. Withdrawal reactions, tolerance, and decreased response/efficacy. IGALMI was not studied for longer than 24 hours after the first dose. Physical dependence, withdrawal symptoms (e.g., nausea, vomiting, agitation), and decreased response to IGALMI may occur if IGALMI is used longer than 24 hours. The most common side effects of IGALMI in clinical studies were sleepiness or drowsiness, a prickling or tingling sensation or numbness of the mouth, dizziness, dry mouth, low blood pressure, and low blood pressure upon standing. These are not all the possible side effects of IGALMI. Patients should speak with their healthcare provider for medical advice about side effects. Patients should tell their healthcare provider about their medical history, including if they suffer from any known heart problems, low potassium, low magnesium, low blood pressure, low heart rate, diabetes, high blood pressure, history of fainting, or liver impairment. They should also tell their healthcare provider if they are pregnant or breastfeeding or take any medicines, including prescription and over-the-counter medicines, vitamins, and herbal supplements. Patients should especially tell their healthcare provider if they take any drugs that lower blood pressure, change heart rate, or take anesthetics, sedatives, hypnotics, and opioids. Everyone is encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch or call 1-800-FDA-1088. You can also contact BioXcel Therapeutics, Inc. at 1-833-201- 1088 or medinfo@bioxceltherapeutics.com. Please see full Prescribing Information. About BXCL501Outside of its approved indication by the U.S. Food and Drug Administration as IGALMI® (dexmedetomidine) sublingual film, BXCL501 is an investigational proprietary, orally dissolving film formulation of dexmedetomidine, a selective alpha-2 adrenergic receptor agonist. BXCL501 is under investigation by BioXcel Therapeutics for the acute treatment of agitation associated with Alzheimer’s dementia and for the acute treatment of agitation associated with bipolar I or II disorder or schizophrenia in the at-home setting. The safety and efficacy of BXCL501 for these investigational uses have not been established. BXCL501 has been granted Breakthrough Therapy designation by the FDA for the acute treatment of agitation associated with dementia and Fast Track designation for the acute treatment of agitation associated with schizophrenia, bipolar disorders, and dementia. About BioXcel Therapeutics, Inc.BioXcel Therapeutics, Inc. (Nasdaq: BTAI) is a biopharmaceutical company utilizing artificial intelligence to develop transformative medicines in neuroscience. Its wholly owned subsidiary, OnkosXcel Therapeutics, is focused on the development of medicines in immuno-oncology. The Company’s drug re-innovation approach leverages existing approved drugs and/or clinically validated product candidates together with big data and proprietary machine learning algorithms to identify new therapeutic indications. For more information, please visit bioxceltherapeutics.com. Forward-Looking Statements This press release includes “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995. We intend such forward-looking statements to be covered by the safe harbor provisions for forward-looking statements contained in Section 27A of the Securities Act of 1933, as amended and Section 21E of the Securities Exchange Act of 1934, as amended. All statements contained in this press release other than statements of historical fact should be considered forward-looking statements, including, without limitation, statements related to: the Company’s planned advancement of its SERENITY program; the expected submission of an sNDA to expand the label for IGALMI® in the home setting; the expansion of IGALMI® market potential; bringing IGALMI® as a treatment option to additional patients in the home setting; ; the potential to bring new treatment options to patients, and statements regarding the Company’s operational progress. When used herein, words including “anticipate,” “believe,” “can,” “continue,” “could,” “designed,” “estimate,” “expect,” “forecast,” “goal,” “intend,” “may,” “might,” “plan,” “possible,” “potential,” “predict,” “project,” “should,” “target,” “will,” “would” and similar expressions are intended to identify forward-looking statements, though not all forward-looking statements use these words or expressions. In addition, any statements or information that refer to expectations, beliefs, plans, projections, objectives, performance or other characterizations of future events or circumstances, including any underlying assumptions, are forward-looking. All forward-looking statements are based upon the Company’s current expectations and various assumptions. The Company believes there is a reasonable basis for its expectations and beliefs, but they are inherently uncertain. The Company may not realize its expectations, and its beliefs may not prove correct. Actual results could differ materially from those described or implied by such forward-looking statements as a result of various important factors, including, without limitation: its limited operating history; its incurrence of significant losses; its need for substantial additional funding and ability to raise capital when needed; the impact of the reprioritization; its significant indebtedness, ability to comply with covenant obligations and potential payment obligations related to such indebtedness and other contractual obligations; the Company has identified conditions and events that raise substantial doubt about its ability to continue as a going concern; its limited experience in drug discovery and drug development; risks related to the TRANQUILITY and SERENITY programs; its dependence on the success and commercialization of IGALMI®, BXCL501, BXCL502, BXCL701 and BXCL702 and other product candidates; the number of episodes of agitation and the size of the Company’s total addressable market may be overestimated, and approval that the Company may obtain may be based on a narrower definition of the patient population; its lack of experience in marketing and selling drug products; the risk that IGALMI or the Company’s product candidates may not be accepted by physicians or the medical community in general; the Company still faces extensive and ongoing regulatory requirements and obligations for IGALMI; the failure of preliminary data from its clinical studies to predict final study results; failure of its early clinical studies or preclinical studies to predict future clinical studies; its ability to receive regulatory approval for its product candidates; its ability to enroll patients in its clinical trials; undesirable side effects caused by the Company’s product candidates; its novel approach to the discovery and development of product candidates based on EvolverAI; the significant influence of and dependence on BioXcel LLC; its exposure to patent infringement lawsuits; its reliance on third parties; its ability to comply with the extensive regulations applicable to it; impacts from data breaches or cyber-attacks, if any; risks associated with the increased scrutiny relating to environmental, social and governance (ESG) matters; risks associated with federal, state or foreign health care “fraud and abuse” laws; and its ability to commercialize its product candidates, as well as the important factors discussed under the caption “Risk Factors” in its Quarterly Report on Form 10-Q for the quarterly period ended September 30, 2024, as such factors may be updated from time to time in its other filings with the SEC, which are accessible on the SEC’s website at www.sec.gov and the Investors section of the Company’s website at www.bioxceltherapeutics.com. These and other important factors could cause actual results to differ materially from those indicated by the forward-looking statements made in this press release. Any such forward-looking statements represent management’s estimates as of the date of this press release. While the Company may elect to update such forward-looking statements at some point in the future, except as required by law, it disclaims any obligation to do so, even if subsequent events cause our views to change. These forward-looking statements should not be relied upon as representing the Company’s views as of any date subsequent to the date of this press release. Contact Information Corporate/InvestorsBioXcel TherapeuticsErik Kopp1.203.494.7062 MediaRusso PartnersDavid Schull 1.858.717.2310 Source: BioXcel Therapeutics, Inc. IGALMI® is a registered trademark of BioXcel Therapeutics, Inc.

Phase 3Breakthrough TherapyFast Track

18 Feb 2025

·www.prnewswire.com

Global Transmucosal Drugs Market to Reach ~USD 28 Billion by 2032 | DelveInsight

The increasing prevalence of chronic conditions like cardiovascular disease is driving the demand for transmucosal drugs. Key factors contributing to the transmucosal drugs market's growth from 2025 to 2032 include the rising adoption of these drugs, along with growing research and development efforts and collaborations among major industry players. LAS VEGAS, Feb. 18, 2025 /PRNewswire/ -- DelveInsight's Transmucosal Drugs Market Insights report provides the current and forecast market analysis, individual leading transmucosal drugs companies' market shares, challenges, transmucosal drugs market drivers, barriers, trends, and key market transmucosal drugs companies in the market. Key Takeaways from the Transmucosal Drugs Market Report As per DelveInsight estimates, North America is anticipated to dominate the global transmucosal drugs market during the forecast period. In the product segment of the transmucosal drugs market, the tablet category had a significant revenue share in the transmucosal drugs market in 2024. Notable transmucosal drugs companies such as Teva Pharmaceutical Industries Ltd, Indivior PLC, GSK plc, Emergent BioSolutions Inc., Bayer AG, AbbVie Inc., Organon group of companies, Pfizer Inc., Prestige Consumer Healthcare, Inc., Merck & Co., Inc., Aquestive Therapeutics, Inc., Ferring, Novartis AG, Adalvo Limited, Sumitomo Pharma Co., Ltd., ZIM LABORATORIES LIMITED, BioXcel Therapeutics, Inc., BIAL, Almac Group, Boehringer Ingelheim International GmbH, and several others, are currently operating in the transmucosal drugs market. In March 2024, BIAL launched KYNMOBI (apomorphine hydrochloride) in Germany. KYNMOBI is the sublingual film for the intermittent treatment of OFF episodes in adult patients with Parkinson's disease. In March 2024, Tonix Pharmaceuticals announced its collaboration with Almac Pharma Services for the launch and commercialization of TonmyaTM (cyclobenzaprine HCl sublingual tablets) in the U.S. Tonmya is a centrally acting opioid analgesic for the treatment of fibromyalgia. To read more about the latest highlights related to the transmucosal drugs market, get a snapshot of the key highlights entailed in the Global Transmucosal Drugs Market Report Transmucosal Drugs Overview Transmucosal drugs are a category of medications designed to be absorbed through mucous membranes, such as those found in the mouth, nasal passages, or gastrointestinal tract. These drugs are typically formulated as lozenges, films, sprays, or tablets that dissolve upon contact with mucosal surfaces. The primary advantage of transmucosal drug delivery is its ability to bypass the digestive system, leading to faster absorption and onset of action compared to oral administration. This can be particularly beneficial for drugs that are poorly absorbed through the gastrointestinal tract or those that need to act quickly, such as pain relief medications or treatments for acute conditions. The transmucosal route can offer increased bioavailability, as the drug is absorbed directly into the bloodstream through the mucosal membranes, often avoiding first-pass metabolism in the liver. This can reduce the required dosage and minimize side effects. Additionally, transmucosal drug delivery systems are typically non-invasive and convenient for patients, making them an attractive option for chronic treatments or for populations that may struggle with traditional oral medications, such as pediatric or geriatric patients. However, this form of drug delivery requires careful formulation to ensure proper drug release, stability, and patient adherence. Transmucosal Drugs Market Insights North America is projected to hold the largest share of the transmucosal drugs market in the coming years compared to other regions. This growth is primarily driven by the increasing prevalence of chronic conditions such as hypertension and neurological diseases, alongside the growing research and development efforts by major industry players. Notable market players are focusing on creating innovative treatments for neurological disorders. For example, in April 2022, BioXcel Therapeutics, Inc. received approval from the U.S. Food and Drug Administration (FDA) for IGALMITM (dexmedetomidine) sublingual film to treat acute agitation linked to schizophrenia or bipolar I or II disorder in adults. These advancements in drug development are expected to further boost market expansion in North America. Thus, the rising incidence of chronic diseases and the introduction of new products by key players are key drivers of the transmucosal drugs market growth in the region. To know more about why North America is leading the market growth in the transmucosal drugs market, get a snapshot of the Transmucosal Drugs Market Outlook Transmucosal Drugs Market Dynamics The transmucosal drugs market has been witnessing significant growth, driven by its ability to offer an effective and less invasive alternative to conventional drug administration methods. Transmucosal delivery involves the absorption of therapeutic agents through mucous membranes, such as the nasal, buccal, or sublingual areas. This method bypasses the digestive system, allowing for faster onset of action and enhanced bioavailability, particularly for drugs that are poorly absorbed through the gastrointestinal tract. The demand for this delivery method is particularly prominent in the management of conditions that require rapid symptom relief, such as acute pain, migraine, and anxiety disorders. Technological advancements play a key role in the dynamics of the transmucosal drugs market. Innovations such as nanoparticles, liposomes, and microneedles are improving the efficiency and accuracy of drug delivery systems. For example, the development of nasal sprays and sublingual tablets has revolutionized the administration of both peptide and non-peptide drugs. These technologies not only enhance drug absorption but also help in reducing side effects by targeting specific areas in the body. Moreover, the ease of administration and the patient-friendly nature of these systems have made them a preferred choice, particularly in the pediatric and geriatric populations. Additionally, market growth is supported by an increasing demand for personalized medicine. As treatments become more tailored to individual patient needs, transmucosal delivery systems provide an effective way to fine-tune drug doses and achieve optimal therapeutic outcomes. For instance, the ability to deliver drugs directly into the bloodstream through the mucosal membranes allows for better control over drug release rates, which is particularly important for chronic conditions requiring long-term management. This shift towards more personalized treatments has been further augmented by the rise of digital health technologies, such as remote monitoring tools that ensure patients adhere to their prescribed treatments. Despite the many advantages, the transmucosal drugs market also faces challenges. The high cost of research and development, coupled with regulatory hurdles for new drug delivery systems, can impede market expansion. Furthermore, the potential for irritation or infection at the site of drug administration, particularly for chronic use, remains a concern. As a result, manufacturers must invest in developing more user-friendly, efficient, and safer products to maintain consumer trust. Overall, while the transmucosal drugs market shows great promise, the need for continuous innovation and rigorous safety standards will be critical for its sustained growth. Get a sneak peek at the transmucosal drugs market dynamics @ Transmucosal Drugs Market Dynamics Analysis Transmucosal Drugs Market Assessment Transmucosal Drugs Market Segmentation Transmucosal Drugs Market Segmentation By Product: Nasal Spray, Tablet, Film, and Others Transmucosal Drugs Market Segmentation By Route of Administration: Oral, Nasal, Sublingual, Buccal, and Others Transmucosal Drugs Market Segmentation By Distribution Channel: Hospital Pharmacy, Retail Pharmacy, and Online Pharmacy Transmucosal Drugs Market Segmentation By Geography: North America, Europe, Asia-Pacific, and Rest of World Porter's Five Forces Analysis, Product Profiles, Case Studies, KOL's Views, Analyst's View Which MedTech key players in the transmucosal drugs market are set to emerge as the trendsetter explore @ Transmucosal Drugs Companies Table of Contents Interested in knowing the transmucosal drugs market by 2032? Click to get a snapshot of the Transmucosal Drugs Market Trends Related Reports Transmucosal Drug Delivery Devices Market Transmucosal Drug Delivery Devices Market Insight, Competitive Landscape, and Market Forecast – 2032 report delivers an in-depth understanding of market trends, market drivers, market barriers, and key transmucosal drug delivery devices companies, including 3M, Cephalon Inc., Biopharmaceutical, Antares Pharma, Teva Pharmaceutical Industries Ltd., Slan Medicinal Holdings Ltd, MMB Healthcare, LLC, BioDelivery Sciences International Inc., Mylan N.V., among others. Hypertension Market Hypertension Market Insights, Epidemiology, and Market Forecast – 2034 report delivers an in-depth understanding of the disease, historical and forecasted epidemiology, as well as the market trends, market drivers, market barriers, and key hypertension companies, including JeniVision, Inc., AI Therapeutics, Inc., Apnimed, AstraZeneca, Aerovate Therapeutics, Merck Sharp & Dohme LLC, AbbVie, Alnylam Pharmaceuticals, Gossamer Bio Inc., Insmed Incorporated, Actelion, Boehringer Ingelheim, Acceleron Pharma, Bayer, Perfuse Therapeutics, Inc., KBP Biosciences, Novartis, Gmax Biopharm LLC, United Therapeutics, Tarsier Pharma, among others. Hypertension Pipeline Hypertension Pipeline Insight – 2025 report provides comprehensive insights about the pipeline landscape, pipeline drug profiles, including clinical and non-clinical stage products, and the key hypertension companies, including Quantum Genomics, CinCor Pharma, Mineralys Therapeutics, Alnylam Therapeutics, Ionis Pharmaceuticals, Future Medicine, Pharmosa BioPharm, Aerovate Therapeutics, Novartis, Cereno Scientific AB, Torrent Pharmaceuticals Limited, JeniVision, Inc., Merck Sharp & Dohme LLC, AbbVie, Acceleron Pharma Inc., Hanmi Pharmaceutical Company Limited, Gossamer Bio Inc., Shanghai Pharmaceuticals Holding Co., Ltd, Insmed Incorporated, Gmax Biopharm LLC., Altavant Sciences GmbH, Bayer, Respira Therapeutics, Inc., Aadi Bioscience, Inc., Boehringer Ingelheim, JW Pharmaceutical, PRM Pharma, LLC, PolyActiva Pty Ltd, pH Pharma, Nicox Ophthalmics, Inc., Ocular Therapeutix, Inc., Santen SAS, Whitecap Biosciences, LLC, Chong Kun Dang Pharmaceutical, AJU Pharm Co., Ltd., Laboratoires Thea, Aerami Therapeutics, KBP Biosciences, Cumberland Pharmaceuticals, Vigonvita Life Sciences, IlDong Pharmaceutical Co Ltd, Qlaris Bio, Inc., Santen Pharmaceutical, VivaVision Biotech, Mitsubishi Chemical Group Corporation., Idorsia Pharmaceuticals, United Therapeutics Corporation, VIVUS LLC., PhaseBio Pharmaceuticals, Vascular Biosciences, CAR peptide, Liquidia Corporation, Centessa Pharmaceuticals, Claritas Pharmaceuticals, Halo Biosciences, PulmoSIM Therapeutics, Keros Therapeutics, among others. Pulmonary Arterial Hypertension Market Pulmonary Arterial Hypertension Market Insights, Epidemiology, and Market Forecast – 2034 report deliver an in-depth understanding of the disease, historical and forecasted epidemiology, as well as the market trends, market drivers, market barriers, and key pulmonary arterial hypertension companies including Merck, United Therapeutics, Liquida Technologies, Tenax Therapeutics, Respira Therapeutics, Gossamer Bio, Pharmosa Biopharma, Aerovate Therapeutics, Insmed, Novartis, Cumberland Pharmaceuticals, Enzyvant Therapeutics, AstraZeneca, Cereno Scientific, PhaseBio Pharmaceutical, among others. About DelveInsight DelveInsight is a leading Business Consultant, and Market Research firm focused exclusively on life sciences. It supports pharma companies by providing comprehensive end-to-end solutions to improve their performance. Contact Us Shruti Thakur [email protected] +14699457679 Logo: SOURCE DelveInsight Business Research, LLP WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

Drug Approval

11 Feb 2025

·www.globenewswire.com

BioXcel Therapeutics Provides Clinical and Business Update

Patient enrollment advancing in SERENITY At-Home Phase 3 trial of BXCL501 for acute treatment of agitation associated with bipolar disorders or schizophrenia Developed plans for TRANQUILITY In-Care Phase 3 trial of BXCL501 for agitation associated with Alzheimer’s dementia Enhanced operational and financial flexibility through existing credit amendment Strengthened strategic leadership with recent Board appointments Feb. 05, 2025 -- BioXcel Therapeutics, Inc. (Nasdaq: BTAI), a biopharmaceutical company utilizing artificial intelligence to develop transformative medicines in neuroscience, today provided an update on the progress of its late-stage clinical programs for lead neuroscience asset BXCL501, as well as its recent steps to enhance operational and financial flexibility and strengthen its Board leadership. “We continue to focus on advancing our SERENITY and TRANQUILITY programs to bring a much-needed new treatment option to address the estimated 140 million annual acute agitation episodes associated with bipolar disorders, schizophrenia, and Alzheimer’s dementia1-3,” said Vimal Mehta, Ph.D., CEO of BioXcel Therapeutics. “In addition, we have strengthened the business by amending our existing credit agreement, raising capital, and appointing additional leaders with considerable operational and clinical expertise to our Board of Directors. In parallel, we are continuing to manage costs and more closely align management and shareholder interests. Collectively, we believe these actions will help create value for all stakeholders.” The majority of trial sites have been opened and patient enrollment is progressing with the SERENITY At-Home trial of BXCL501 for acute treatment of agitation associated with bipolar disorders or schizophrenia. Developed plans for the TRANQUILITY In-Care trial of BXCL501 for agitation associated with Alzheimer’s dementia (AAD). The Company plans to continue to supply IGALMI® to current and future customers through existing distribution channels, without commercial support. Continue to generate deeper mechanistic insights for BXCL502 in support of its potential to be developed for the treatment of chronic AAD. A poster was presented at the annual meeting of the American College of Neuropsychopharmacology in Phoenix in December 2024. Enhanced operational and financial flexibility through existing credit agreement amendment announced on Nov. 25, 2024. Successfully raised $7 million gross proceeds in equity funding, which closed on Nov. 25, 2024. The company has strengthened its Board of Directors with clinical, financial, and legal expertise. Dr. Rajiv Patni has broad global product-development expertise in diverse therapeutic areas. He is currently CEO of Judo Bio, having previously served as Chief R&D Officer at Reata Pharmaceuticals, a commercial-stage company acquired by Biogen. Earlier, Dr. Patni was Chief Medical Officer at Global Blood Therapeutics, Portola Pharmaceuticals, and Adamas Pharmaceuticals, until their acquisitions by larger companies. He also held roles of increasing responsibility at Pfizer, Roche, and Actelion. David Mack has a distinguished record of providing financial and legal leadership to a diverse range of domestic and international companies that has enabled them to effectively navigate through periods of transition. He has more than 25 years of experience as an attorney, director, and investor. He has extensive experience in leading transactions as well as deep knowledge of complex business matters. Outside of its approved indication by the U.S. Food and Drug Administration as IGALMI® (dexmedetomidine) sublingual film, BXCL501 is an investigational proprietary, orally dissolving film formulation of dexmedetomidine, a selective alpha-2 adrenergic receptor agonist. BXCL501 is under investigation by BioXcel Therapeutics for the acute treatment of agitation associated with Alzheimer’s dementia and for the acute treatment of agitation associated with bipolar I or II disorder or schizophrenia in the at-home setting. The safety and efficacy of BXCL501 for these investigational uses have not been established. BXCL501 has been granted Breakthrough Therapy designation by the FDA for the acute treatment of agitation associated with dementia and Fast Track designation for the acute treatment of agitation associated with schizophrenia, bipolar disorders, and dementia. BioXcel Therapeutics, Inc. (Nasdaq: BTAI) is a biopharmaceutical company utilizing artificial intelligence to develop transformative medicines in neuroscience. Its wholly owned subsidiary, OnkosXcel Therapeutics, is focused on the development of medicines in immuno-oncology. The Company’s drug re-innovation approach leverages existing approved drugs and/or clinically validated product candidates together with big data and proprietary machine learning algorithms to identify new therapeutic indications. For more information, please visit bioxceltherapeutics.com. References 1. Data on file relating to agitation episodes associated with schizophrenia or bipolar I or II disorder. BioXcel Therapeutics, Inc. New Haven, CT December 2020. Episode estimations may not reflect potential treatable episodes, and actual addressable market may be smaller. 2. Data from Wu EQ, Shi L, Birnbaum H, et al. Annual prevalence of diagnosed schizophrenia in the USA: a claims data analysis approach. Psychol Med. 2006;36(11):1535-1540. Estimates based on whether indications are approved for at-home use for the intended patient population and such patients are treatable. Episode estimations may not reflect potential treatable episodes, and actual addressable market may be smaller. 3. National Institute of Mental Health. Prevalence of bipolar disorder in adults. November 2017. Accessed December 16, 2022. https://www-nimh-nih-gov.libproxy1.nus.edu.sg/health/statistics/bipolar-disorder. Episode estimations may not reflect potential treatable episodes, and actual addressable market may be smaller. The content above comes from the network. if any infringement, please contact us to modify.

Executive ChangeFast TrackBreakthrough Therapy

100 Deals associated with Dexmedetomidine Hydrochloride

External Link

KEGG	Wiki	ATC	Drug Bank
D01205	Dexmedetomidine Hydrochloride	N05CM18	DB00633

R&D Status

Approved

10 top approved records.

to view more data

Indication	Country/Location	Organization	Date
Bipolar I disorder	United States	BioXcel Therapeutics, Inc.	05 Apr 2022
Bipolar II disorder	United States	BioXcel Therapeutics, Inc.	05 Apr 2022
Schizophrenia	United States	BioXcel Therapeutics, Inc.	05 Apr 2022
Sedation	United States	Hospira, Inc.	17 Dec 1999

Developing

10 top R&D records.

to view more data

Indication	Highest Phase	Country/Location	Organization	Date
Dementia	Phase 3	United States	BioXcel Therapeutics, Inc.	27 Apr 2022
Stress Disorders, Post-Traumatic	Phase 3	United States	Pfizer Inc.	10 May 2021
Bipolar Disorder	Phase 3	United States	BioXcel Therapeutics, Inc.	24 Feb 2020
Psychomotor Agitation	Phase 3	United States	BioXcel Therapeutics, Inc.	24 Feb 2020
Schizoaffective disorder	Phase 3	United States	BioXcel Therapeutics, Inc.	24 Jan 2020
Agitation	Phase 3	Australia	Hospira, Inc.	01 Feb 2011
Delirium	Phase 3	Australia	Hospira, Inc.	01 Feb 2011
Intracranial Hypertension	Phase 3	United States	Hospira, Inc.	01 Oct 2009
Emergence Delirium	Phase 3	United States	Hospira, Inc.	01 Apr 2007
Hip Fractures	Phase 3	United States	Hospira, Inc.	01 Apr 2007

Clinical Result

Indication

Phase

Evaluation

View All Results

Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT05626998 (Pubmed \| BMC Anesthesiol)	Phase 4	Emergence Delirium	-	Intramuscular Dexmedetomidine	kidfshvwno(anxioqmmjo) = fmjudbcfci btfhabdnwf (gkayanjfki )	Positive	31 Jan 2025
				Oral Gabapentin	kidfshvwno(anxioqmmjo) = wkwvtlbavi btfhabdnwf (gkayanjfki )
NCT04528173 (CTgov)	Phase 4	Dyssomnias \| Anesthesia \| Tonsillitis	35	Fentanyl+Morphine (Traditional Care Group (TCG))	pchnyoljuj(iyyybtjxcq) = mmgtbrmxwl rtypvvyqya (fstkyvvslf, 3.45) View more	-	20 Dec 2024
				Dexmedetomidine+ketorolac (Opioid-Free Group (OFG))	pchnyoljuj(iyyybtjxcq) = jtijrhkyza rtypvvyqya (fstkyvvslf, 3.04) View more
NCT05283083 (DecatSepsis, Pubmed \| Chest)	Phase 3	Shock, Septic	90	Dexmedetomidine infusion	mjeacbdwyx(xepzkwzxbv) = zqzvxdzhzz cqiumafqly (psttsxuhyp, -78 to -3.4)	Negative	01 Dec 2024
Pubmed \| BMJ Open	Not Applicable	Labor Pain	-	Dexmedetomidine-ropivacaine combination	qinwqobfgz(cszcbhjaco) = vvhrxgknoj ayzfsqkbnz (uyyejvcbjx ) View more	-	01 Dec 2024
				Sufentanil-ropivacaine combination	qinwqobfgz(cszcbhjaco) = maekrmiigb ayzfsqkbnz (uyyejvcbjx ) View more
NCT04734418 (Pubmed \| J Intensive Care) Manual	Not Applicable	-	179	Remifentanil	wmmozendni(bfbkmnjqxx) = llklmvknmp ekyjelflla (dgxensuaaz ) View more	Negative	18 Sep 2024
				Dexmedetomidine	wmmozendni(bfbkmnjqxx) = jghspeejwt ekyjelflla (dgxensuaaz ) View more
NCT03770130 (Pubmed \| Int J Surg) Manual	Early Phase 1	Disorder related to transplantation	330	Dexmedetomidine	iwwppfxuzl(drtaqyqiqh) = wopvfafpxr elyltwhuev (mwmzcrbxxw )	Negative	01 Sep 2024
				Normal Saline	iwwppfxuzl(drtaqyqiqh) = qndnwmqyle elyltwhuev (mwmzcrbxxw )
Pubmed \| Drug Des Devel Ther	Not Applicable	Cognitive Dysfunction	80	Dexmedetomidine	mgopuklnmh(vqafpqzqis) = cyflqthysf wyugetdbat (vtnbjudeax ) View more	Positive	01 Aug 2024
				Placebo	mgopuklnmh(vqafpqzqis) = ylhbtvquiw wyugetdbat (vtnbjudeax ) View more
NCT03844841 (Pubmed)	Phase 4	-	-	Dexmedetomidine	ojszvmjcwh(jlhcirpwws) = bwodjefcaz npzjnfvexg (rtdccbsbwn ) View more	Positive	31 Jul 2024
				Propofol	ojszvmjcwh(jlhcirpwws) = kefpigrrot npzjnfvexg (rtdccbsbwn ) View more
NCT02053766 (CTgov)	Not Applicable	Mitochondrial Diseases	19	Dexmedetomidine (Dexmedetomidine (Precedex®))	arkxnkvfvv = cpjpdtohib ncejirhjkp (jbkfwlvlay, adtqovlxli - nllbqzdfji) View more	-	17 Jul 2024
				Propofol (Propofol)	arkxnkvfvv = aroivauedn ncejirhjkp (jbkfwlvlay, dlbtouwyel - vlvvsenrjr) View more
NCT01887184 (CTgov)	Phase 3	Gastrointestinal Diseases	50	Placebo (Normal Saline)	nstyemugav(hgthrrfpfo) = enwjeaqhcu wgubxjrseo (xtlorinmky, 23.5) View more	-	11 Jul 2024
				Dexmedetomidine (Dexmedetomidine)	nstyemugav(hgthrrfpfo) = nirefmrxgz wgubxjrseo (xtlorinmky, 23.9) 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