COMPARISON OF THE EFFECT OF INTRAVENOUS DEXMEDETOMIDINE ADMINISTERED AS BOLUS OR BOLUS PLUS INFUSION ON SENSORY AND MOTOR BLOCKADE AFTER SPINAL ANAESTHESIA IN LOWER LIMB SURGERIES- A PROSPECTIVE CONTROL STUDY - Nil

Start Date15 Jan 2025

Sponsor / Collaborator-

NCT05935293 / Not yet recruitingPhase 4IIT

Impact of Continuous Perioperative Dexmedetomidine Infusion on Postoperative Renal Function Among Patients Undergoing Kidney Transplantation: a Randomized Controlled Trial

Dexmedetomidine, an alpha 2 agonist, is being increasingly used in recent years for the maintaining of anesthesia as it allows sedation and analgesia with only a modest respiratory depression effect when compared to opioids and inhaled anesthetic agents and allows maintenance of spontaneous ventilation. Most common side effects are bradycardia and hypotension. Drug's metabolism is exclusively hepatic and therefor do not require dosage adaptation for patient's kidney function.
Post-Operative acute kidney injury (AKI) is a common complication after major surgery and might incur serious adverse outcomes such as longer hospital stay, dialysis, chronic kidney disease and death. The most common theory for the occurrence of post-operative AKI is the ischemic-reperfusion syndrome.
Several in vitro animal studies as well as human studies have suggested the nephroprotective effects of per-operative continuous infusion of dexmedetomidine and its ability to decrease post-operative AKI.
Kidney transplantation (KT) is the treatment of choice for patients with End Stage Renal Disease. It is considered a major surgery and it was shown that optimized perioperative management could improve post-operative outcomes such as early graft function as measured by urine output and serum creatinine trends. However, delayed graft function (DGF), which is defined by the need for dialysis within the first seven days after transplantation remains a significant issue for post-operative KT care with an incidence of up to 30%.
A retrospective study of 780 patients receiving KT, has shown that preoperative dexmedetomidine could significantly decrease occurrence of DGF. Recently, two single-center, randomized controlled trials, with similar sample sizes of 104 and 111 patients, compared peri-operative continuous infusion of dexmedetomidine to placebo. One study failed to show significant impact on DGF incidence while the second showed a significant 50% reduction in DGF in the dexmedetomidine group. Due to increasing evidence concerning the nephroprotective effects and improved post-operative outcomes of perioperative continuous dexmedetomidine infusion, a larger, multi-center randomized-controlled trial to study and potentially confirm the evidence in the settings of KT would be of benefit.
The aim of our study is to assess whether the perioperative continuous infusion of dexmedetomidine during KT could improve peri-operative renal function among KT recipients as compared to placebo.

Start Date01 Dec 2024

Sponsor / Collaborator-

CTRI/2024/04/065972 / Not yet recruitingPhase 2

Comparison of levobupivacaine with dexmedetomidine Vs bupivacaine with dexmedetomidine in ultrasound guided erector spinae block for post operative analgesia in patients undergoing lumbar vertebral laminectomy – A randomized double blinded prospective study. - A randomized prospective study

Start Date10 Oct 2024

Sponsor / Collaborator-

100 Clinical Results associated with Dexmedetomidine Hydrochloride

100 Translational Medicine associated with Dexmedetomidine Hydrochloride

100 Patents (Medical) associated with Dexmedetomidine Hydrochloride

9,952

Literatures (Medical) associated with Dexmedetomidine Hydrochloride

01 May 2024·American journal of otolaryngology

The use of dexmedetomidine for controlled hypotension in middle ear surgery: Trial sequential analysis

Article

Author: Hung, Kuo-Chuan ; Wang, Wei-Ting ; Chen, I-Wen

01 May 2024·Journal of clinical anesthesia

Dexmedetomidine improves pulmonary outcomes in thoracic surgery under one-lung ventilation: A meta-analysis

Article

Author: Law, Martin ; Grant, Michael C ; Pelosi, Paolo ; Varelmann, Dirk ; Zorrilla-Vaca, Andres ; Messinger, Chelsea J

INTRODUCTION:

Dexmedetomidine improves intrapulmonary shunt in thoracic surgery and minimizes inflammatory response during one-lung ventilation (OLV). However, it is unclear whether such benefits translate into less postoperative pulmonary complications (PPCs). Our objective was to determine the impact of dexmedetomidine on the incidence of PPCs after thoracic surgery.

METHODS:

Major databases were used to identify randomized trials that compared dexmedetomidine versus placebo during thoracic surgery in terms of PPCs. Our primary outcome was atelectasis within 7 days after surgery. Other specific PPCs included hypoxemia, pneumonia, and acute respiratory distress syndrome (ARDS). Secondary outcome included intraoperative respiratory mechanics (respiratory compliance [Cdyn]) and postoperative lung function (forced expiratory volume [FEV1]). Random effects models were used to estimate odds ratios (OR).

RESULTS:

Twelve randomized trials, including 365 patients in the dexmedetomidine group and 359 in the placebo group, were analyzed in this meta-analysis. Patients in the dexmedetomidine group were less likely to develop postoperative atelectasis (2.3% vs 6.8%, OR 0.42, 95%CI 0.18-0.95, P = 0.04; low certainty) and hypoxemia (3.4% vs 11.7%, OR 0.26, 95%CI 0.10-0.68, P = 0.01; moderate certainty) compared to the placebo group. The incidence of postoperative pneumonia (3.2% vs 5.8%, OR 0.57, 95%CI 0.25-1.26, P = 0.17; moderate certainty) or ARDS (0.9% vs 3.5%, OR 0.39, 95%CI 0.07-2.08, P = 0.27; moderate certainty) was comparable between groups. Both intraoperative Cdyn and postoperative FEV1 were higher among patients that received dexmedetomidine with a mean difference of 4.42 mL/cmH₂O (95%CI 3.13-5.72) and 0.27 L (95%CI 0.12-0.41), respectively.

CONCLUSION:

Dexmedetomidine administration during thoracic surgery may potentially reduce the risk of postoperative atelectasis and hypoxemia. However, current evidence is insufficient to demonstrate an effect on pneumonia or ARDS.

Archives of gynecology and obstetrics

Effect of intraperitoneal infusion of ropivacaine combined with dexmedetomidine in patients undergoing total laparoscopic hysterectomy: a single-center randomized double-blinded controlled trial

Article

Author: Wang, Yuping ; Miao, Liyan ; Wang, Denggui ; Zhou, Min ; Chen, Qiuchun

Abstract:

Purpose:

To investigate the effect of intraperitoneal infusion of ropivacaine combined with dexmedetomidine and ropivacaine alone on the quality of postoperative recovery of patients undergoing total laparoscopic hysterectomy (TLH).

Methods:

Female patients scheduled to undergo a TLH under general anesthesia at Fujian Maternity and Child Health Hospital were included. Before the end of pneumoperitoneum, patients were laparoscopically administered an intraperitoneal infusion of 0.25% ropivacaine 40 ml (R group) or 0.25% ropivacaine combined with 1 µg/kg dexmedetomidine 40 ml (RD group). The primary outcome was QoR-40, which was assessed before surgery and 24 h after surgery. Secondary outcomes included postoperative NRS scores, postoperative anesthetic dosage, the time to ambulation, urinary catheter removal, and anal exhaust. The incidence of dizziness, nausea, and vomiting was also analyzed.

Results:

A total of 109 women were recruited. The RD group had higher QoR scores than the R group at 24 h after surgery (p < 0.05). Compared with the R group, NRS scores in the RD group decreased at 2, 6, 12, and 24 h after surgery (all p < 0.05). In the RD group, the time to the first dosage of postoperative opioid was longer and the cumulative and effective times of PCA compression were less than those in the R group (all p < 0.05). Simultaneously, the time to ambulation (p = 0.033), anal exhaust (p = 0.002), and urethral catheter removal (p = 0.018) was shortened in the RD group. The RD group had a lower incidence of dizziness, nausea, and vomiting (p < 0.05).

Conclusion:

Intraperitoneal infusion of ropivacaine combined with dexmedetomidine improved the quality of recovery in patients undergoing TLH.

Trial registration:

ChiCTR2000033209, Registration Date: May 24, 2020.

125

News (Medical) associated with Dexmedetomidine Hydrochloride

25 Jun 2024

·www.biospace.com

BioXcel Therapeutics Announces Positive Topline Results from Post-Marketing Requirement Study Evaluating PRN Treatment of IGALMI™ (dexmedetomidine) Sublingual Film for Agitation Associated with Bipolar Disorders or Schizophrenia

Study achieved its objective and demonstrated no evidence of tachyphylaxis, tolerance, or withdrawal with 180 mcg dose (highest approved dose) For each episode occurring over seven days, a reduction in agitation was observed and no serious adverse events were reported following treatment Results supportive of Phase 3 SERENITY and TRANQUILITY programs NEW HAVEN, Conn., June 25, 2024 (GLOBE NEWSWIRE) -- BioXcel Therapeutics, Inc. (Nasdaq: BTAI), a biopharmaceutical company utilizing artificial intelligence to develop transformative medicines in neuroscience and immuno-oncology, today announced positive topline results from a post-marketing requirement (PMR) study of IGALMI™ (dexmedetomidine) sublingual film that demonstrated no evidence of tachyphylaxis, tolerance, or withdrawal with the 180 mcg dose after seven days of PRN (as-needed) treatment. “We are encouraged by these study results showing a lack of tachyphylaxis, tolerance, and withdrawal at the highest approved dose of IGALMI for patients experiencing frequent episodes of agitation,” said Vincent O’Neill, M.D., Chief of Product Development and Medical Officer of BioXcel Therapeutics. “This new dataset may help address potential changes to the language in the current label. This dataset also adds to our body of evidence for our lead neuroscience asset as we prepare to advance our Phase 3 SERENITY and TRANQUILITY trials.” PMR Study Methods and Topline Results In the single-arm, open-label study, 28 inpatient adults with frequent episodes of agitation associated with bipolar disorders or schizophrenia self-administered 180 mcg dose of IGALMI™ as needed over seven days. A total of 83 episodes were treated. Efficacy Measurements: although this PMR study was not statistically powered to evaluate repeat-dose efficacy, changes in agitation were assessed through the Positive and Negative Syndrome Scale-Excitatory Component (PEC or PANSS-EC) Score and the Clinical Global Impressions – Improvement (CGI-I) Scale, the same measures as used in previous Phase 3 studies. Mean PEC score reduction was observed following all doses of IGALMI administered as needed over the treatment period (see graph below). All patients showed improvement in agitation symptoms as assessed by the CGI-I Scale for all doses administered as needed over the treatment period. Prior to treatment with IGALMI, most patients exhibited mild to moderate agitation as assessed by the Agitation Calmness Evaluation Scale (ACES). ACES scores post-dose revealed a marked calming effect with no patient experiencing unarousable somnolence (ACES score 9). In addition, no withdrawal or rebound phenomena were observed. Mean PEC Score Changes During Study Period Safety and Tolerability Results: The 180 mcg dose of IGALMI was generally well tolerated and showed favorable safety results in treating patients with frequent episodes of agitation. There were no discontinuations due to adverse events. No serious adverse events were reported. “We are pleased these study findings showed consistent responses to PRN treatment for episodes of agitation over the study duration with no evidence of worsening or withdrawal,” said Rob Risinger, M.D., Chief Medical Officer of Neuroscience. “We look forward to sharing these IGALMI PMR data with FDA.” AboutIGALMI™(dexmedetomidine)sublingualfilm 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. IMPORTANTSAFETYINFORMATION IGALMIcancauseserioussideeffects,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,andolderpatients. 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. Withdrawalreactions,tolerance,anddecreasedresponse/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. Themostcommonsideeffects 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 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 the Positive and Negative Syndrome Scale-Excitatory Component Score (PEC or PANSS-EC) The PEC total score is a validated endpoint for use in clinical research to quantify the severity of a patient’s acute agitation. The PEC rating evaluates 5 elements associated with agitation: poor impulse control, tension, hostility, uncooperativeness, and excitement; each scored 1 (minimum) to 7 (maximum). The PEC total score is the sum of these 5 elements and thus ranges from 5 to 35. About the Clinical Global Impressions – Improvement Scale (CGI-I) The CGI-I scale is a widely used rating scale to assess overall improvement or change in a patient's condition. It provides a subjective evaluation of the patient's global improvement relative to their baseline or previous state. The scale consists of categories ranging from "Very much improved" to "Very much worse," allowing healthcare professionals or researchers to rate the patient's progress based on their clinical judgment. 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-LookingStatements 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 potential efficacy, safety and tolerability of IGALMI™ (dexmedetomidine) for PRN treatment of agitation associated with bipolar disorders or schizophrenia; the Company’s expectations regarding the warnings and precautions language in the current IGALMITM label; and the potential for the results from the Company’s completed, ongoing and proposed clinical trials to support regulatory approvals for its product candidates; . 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 program; its dependence on the success and commercialization of IGALMI™, BXCL501, BXCL502, BXCL701 and BXCL702 and other product candidates; 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 March 31, 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 and the Investors section of the Company’s website at 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. ContactInformation Corporate BioXcel Therapeutics Erik Kopp 1.203.494.7062 ekopp@bioxceltherapeutics.com Media Russo Partners David Schull 1.858.717.2310 David.schull@russopartnersllc.com Scott Stachowiak 1.646.942.5630 Scott.stachowiak@russopartnersllc.com Source: BioXcel Therapeutics, Inc. IGALMI™ is a trademark of BioXcel Therapeutics, Inc. BT BIOXCEL THERAPEUTICS is a registered trademark of BioXcel Therapeutics, Inc.  All other trademarks are the properties of their respective owners. Copyright © 2024, BioXcel Therapeutics, Inc. All rights reserved. A photo accompanying this announcement is available at Mean PEC Score Changes During Study Period (caption is Included in image)

Clinical ResultPhase 3

11 Jun 2024

·www.sciencedaily.com

Preparing for a world where Alzheimer's disease is treatable

Drugs with the potential to change the course of Alzheimer's disease are expected to be approved by mid-year in the UK. Healthcare services may need to change to ensure that all patients have equitable access to these new modifying anti-amyloid therapies, according to new research. Drugs with the potential to change the course of Alzheimer's disease are expected to be approved by mid-year in the UK. Healthcare services may need to change to ensure that all patients have equitable access to these new modifying anti-amyloid therapies, according to research led by Queen Mary University of London and University College London (UCL). Alzheimer's disease is the most common cause of dementia. Of the 944,000 people living with dementia in the UK, 60-80% have Alzheimer's. Currently, the only available drugs for Alzheimer's treat symptoms. However, recent clinical trials show that new therapies -- which use monoclonal antibodies to remove amyloid plaques that form on the brain -- may slow down disease progression. Two of these 'disease-modifying therapies' (DMTs) have been granted 'breakthrough therapy' designation in the UK and are likely to become available to patients by mid-2024 (pending regulatory approval). In the UK, dementia care is mostly centred around psychiatry-led memory clinics in the community. In their current state, it is extremely unlikely that DMTs will be administered in these settings. Delivery of these new treatments will require a major restructure to existing dementia services -- from determining eligibility to delivery of the treatment itself, including follow-up. It will require additional staff and training across imaging, diagnostics and pathology, and other clinical services. It will also require access to laboratories that can carry out biomarker testing to confirm whether a patient is eligible for the treatment. The potential roll-out of DMTs presents major challenges for services and has real potential to amplify existing inequities in service access. To anticipate and mitigate these challenges, researchers from Queen Mary's Centre for Preventive Neurology, UCL's Dementia Research Centre, and UCL Partners carried out essential research to estimate how many patients are likely to be eligible for DMTs. The researchers compared clinical case notes from over 1,000 people attending either community memory clinics or specialist cognitive services in England. They found that 32% of those attending memory services and 14% of people attending specialist cognitive services would likely be referred for consideration for the new DMTs. Researchers found that amyloid biomarker tests were available for people attending specialist cognitive services in the form of specialist scans called PET scans and spinal fluid tests. However, fewer than 1% of people attending community memory clinics had undergone biomarker tests. While a sizeable proportion of patients attending memory clinics may be referred for therapy for Alzheimer's disease, only a minority are likely to be suitable, once they have undergone biomarker testing. The researchers highlight an immediate need for biomarker testing to ensure that the right patients can be identified for these treatments. First author, Professor Ruth Dobson, Professor of Neurology at Queen Mary University of London, Consultant Neurologist and Dementia Theme Co-Lead for UCL Partners, said: "The development of disease modifying therapies for dementia has the potential to drive significant service changes. We have seen the impact of this in MS and stroke. It is crucial to understand and plan such changes proactively in order to ensure best care for all people living with dementia, regardless of initial treatment availability and eligibility." Study lead, Professor Rimona Weil, Consultant Neurologist at UCL and the National Hospital for Neurology and Neurosurgery, and Dementia Theme Co-Lead for UCL Partners said: "Working with clinicians running memory clinics was crucial to this work, meaning that we could get real-world estimates for how many people are likely to be referred for these new drugs for the first time." Study co-lead, Professor Catherine Mummery, Consultant Neurologist at UCL and the National Hospital for Neurology and Neurosurgery, said: "We demonstrate that diagnostic resources affect the accuracy of diagnosis and referral habits, and that a collaborative networked approach is critical to developing a functioning treatment service in preparation for these new therapies." David Thomas, Head of Policy and Public Affairs at Alzheimer's Research UK, said: "New Alzheimer's drugs are finally on the horizon, but for their full potential to be realised, health systems need to be able to offer people with symptoms of dementia an accurate and early diagnosis to find out whether these treatments could benefit them. "As this research demonstrates, the NHS is a long way from being able to do this testing routinely. Whoever forms the next government must invest in the NHS urgently, to ensure we have the right diagnostics and workforce in place to help identify people who could benefit from new treatments should they be deemed safe and effective by the regulators. A key part of the solution is cheaper, more scalable diagnostics, such as blood tests, for use in clinical care." This study was produced by researchers from a network of universities who form the Academic Health Science Centre for UCLPartners and in collaboration with a network of clinicians in memory clinics in London and the South East.

Breakthrough Therapy

28 May 2024

·www.globenewswire.com

BioXcel Therapeutics to Present at Jefferies Global Healthcare Conference

NEW HAVEN, Conn., May 28, 2024 (GLOBE NEWSWIRE) -- BioXcel Therapeutics, Inc. (Nasdaq: BTAI), a biopharmaceutical company utilizing artificial intelligence to develop transformative medicines in neuroscience and immuno-oncology, today announced that CEO Vimal Mehta, Ph.D., will present at the Jefferies Global Healthcare Conference in New York City. The presentation is set for Wednesday, June 5 at 3 p.m. ET, and will highlight BioXcel Therapeutics’ late-stage clinical programs with BXCL501 for the acute treatment of agitation associated with Alzheimer’s dementia, bipolar disorders, and schizophrenia. Dr. Mehta will be joined by Vincent J. O’Neill, M.D., Executive Vice President, Chief of Product Development and Medical Officer. To access a live webcast of the presentation and accompanying presentation materials, please visit the Events & Presentations page under the “News/Events” tab in the Investors & Media section of the company’s website at bioxceltherapeutics.com. The webcast replay will be available for 90 days. 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 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 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 participation in and content of the Company’s presentation at the Jefferies Global Healthcare Conference. 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 program; its dependence on the success and commercialization of IGALMI™, BXCL501, BXCL502, BXCL701 and BXCL702 and other product candidates; 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 March 31, 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 CorporateBioXcel Therapeutics Erik Kopp1.203.494.7062ekopp@bioxceltherapeutics.com Investor Relations BioXcel Therapeutics Brennan Doyle 1.475.355.8462bdoyle@bioxceltherapeutics.com MediaRusso PartnersDavid Schull1.858.717.2310David.schull@russopartnersllc.comScott Stachowiak1.646.942.5630Scott.stachowiak@russopartnersllc.comSource: BioXcel Therapeutics, Inc. IGALMI™ is a trademark of BioXcel Therapeutics, Inc.BT BIOXCEL THERAPEUTICS is a registered trademark of BioXcel Therapeutics, Inc. All other trademarks are the properties of their respective owners.Copyright © 2024, BioXcel Therapeutics, Inc. All rights reserved.

Fast TrackBreakthrough Therapy

100 Deals associated with Dexmedetomidine Hydrochloride

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KEGG	Wiki	ATC	Drug Bank
D01205	Dexmedetomidine Hydrochloride	N05CM18	DB00633

R&D Status

Approved

10 top approved records.

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

Developing

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Dyssomnias	Phase 3	-	The First Affiliated Hospital of Xiamen University	01 May 2024
Breast Cancer	Phase 3	EG	The National Cancer Institute (Egypt)	01 Jan 2023
Pain, Postoperative	Phase 3	EG	The National Cancer Institute (Egypt)	01 Jan 2023
Dementia	Phase 3	US	BioXcel Therapeutics, Inc.	27 Apr 2022
Acute Lymphoblastic Leukemia	Phase 3	BR	University of Sao Paulo General Hospital	01 Jun 2021
Analgesia	Phase 3	BR	University of Sao Paulo General Hospital	01 Jun 2021
Pain, Procedural	Phase 3	BR	University of Sao Paulo General Hospital	01 Jun 2021
Bipolar Disorder	Phase 3	US	BioXcel Therapeutics, Inc.	24 Feb 2020
Psychomotor Agitation	Phase 3	US	BioXcel Therapeutics, Inc.	24 Feb 2020
Schizoaffective disorder	Phase 3	US	BioXcel Therapeutics, Inc.	24 Jan 2020

Clinical Result

Indication

Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT04042727 (CTgov)	Phase 2/3	Atrial Fibrillation	13	dexmedetomidine Hydrochloride (Dexmedetomidine Plus Standard of Care)	pbugywhxod(viydjaymmc) = tsmyqmmgrn sbnnwgdobr (thpxniglgu, zlacmwncpd - tlcsxshlaz) View more	-	04 Jun 2024
				Normal saline (Placebo Plus Standard of Care)	pbugywhxod(viydjaymmc) = rvogmevtsq sbnnwgdobr (thpxniglgu, tvabgbpmyf - olbgpgsrjr) View more
NCT02631135 (CTgov)	Phase 4	-	40	Propofol+Rocuronium+Remifentanil (Group 1 (TIVA))	fyznoeklit(glrbhsbqkm) = cfemdldfce bylbtavlgq (tbwqxmtbeg, qcpbyevupe - wamjvkgilf) View more	-	17 May 2024
				Dexmedetomidine+Propofol+Rocuronium+Remifentanil (Group 2 (TIVA+D))	fyznoeklit(glrbhsbqkm) = hdskdcqudo bylbtavlgq (tbwqxmtbeg, vjqklpmtir - mvmjujibcp) View more
NCT02952222 (CTgov)	Phase 4	Anesthesia	39	Propofol (Group P) (Propofol (Group P))	yvdpazkwuv(sqlyelvosg) = ysjuztwavl djnqgyuabr (obnhbnddyc, mbjimeuxvy - pfeixalvsp) View more	-	10 May 2024
				Dexmedetomidine+Propofol (Group DP) (Propofol With Dexmedetomidine (Group DP))	yvdpazkwuv(sqlyelvosg) = xbnqdxcmnq djnqgyuabr (obnhbnddyc, jpzrgjmevp - ukokbomjkz) View more
NCT04798482 (CTgov)	Phase 4	Anesthesia	22	dexmedetomidine	saazazjwme(tomjpplomn) = wxakbjtzcy ylkgmnqlai (rsnathhzna, cirvboqyxt - kxycjhwsqv) View more	-	26 Apr 2024
NCT03417999 (CTgov)	Phase 1	Heart Defects, Congenital	28	Dexmedetomidine (2 μg/kg; Subjects Age >2 yo and ≤ 6 yo)	eprrxunitc(kigxvtqtfr) = rizwgwjgvm haqzchxkte (ozjsmpesdq, jpauguuslb - nefxsvhnhw) View more	-	22 Mar 2024
				Dexmedetomidine (2 ug/kg; Subjects Age ≥1 mo and ≤2 yo)	eprrxunitc(kigxvtqtfr) = mkwuizzhks haqzchxkte (ozjsmpesdq, xrqtcfowza - etixcdofad) View more
NCT01973452 (CTgov)	Phase 3	Pain	333	dexmedetomidine (Dexmedetomidine)	fvusoeduag(ueeyoavcsf) = ghwhgiqwjo lztwzrsxan (kppwuvrhqe, bzuuylnoki - cxmmbqfnmp) View more	-	20 Feb 2024
				Placebo (Placebo)	fvusoeduag(ueeyoavcsf) = rzdxchtcob lztwzrsxan (kppwuvrhqe, xvxwckctkg - bmqofweadw) View more
NCT03435003 (CTgov)	Phase 4	Postoperative Nausea and Vomiting \| Vomiting	83	dexmedetomidine+Compazine+Total intravenous anesthesia+scopolamine transdermal+sugammadex+Reglan+Propofol+Fentanyl+Ondansetron+Aprepitant 80 mg Oral Capsule+Dexamethasone (Intervention Arm)	wrgnooweaw(jyojmpulci) = nlwqhykbyz tigjnsxuef (gtepxbohhb, hskjgaujnp - efqfwyvhid) View more	-	14 Feb 2024
				Compazine+sugammadex+Reglan+Sevoflurane+Desflurane+Ondansetron+Dexamethasone (Control Arm)	wrgnooweaw(jyojmpulci) = tezvxylfyo tigjnsxuef (gtepxbohhb, oeyquvbnnd - xqwghucjiw) View more
NCT02604940 (CTgov)	Phase 4	Pain	46	Dexmedetomidine (Dexmedetomidine)	rauotwziyo(scefojbmkf) = pjccmqatvy ukyyjcpgsj (ubvvmqwusb, hxwafdixps - pzotdomivb) View more	-	17 Jan 2024
				Normal saline (Normal Saline)	rauotwziyo(scefojbmkf) = tegkczqyzg ukyyjcpgsj (ubvvmqwusb, gypciqocyy - qpxdhwhgas) View more
NCT04987372 (CTgov)	Phase 4	Emergence Delirium \| Pain, Postoperative	100	Oxynorm (Oxycodon)+Tramadol+Paracetamol+Fentanyl+Remifentanyl (Classical Protocol)	archocygva(vmbplaiqoj) = oueyhabmdm nrbhfkdyay (fswveheqth, yurnpuevko - cdqdfseyau) View more	-	08 Nov 2023
				Dexmedetomidine (Multimodal Protocol)	archocygva(vmbplaiqoj) = lccadjctlz nrbhfkdyay (fswveheqth, vfiennykxm - icixakvwss) View more
German MS Registry (ECTRIMS2023)	Not Applicable	Multiple Sclerosis	1,159	dimethyl fumarate [DMF]	ppcfxakwem(bnlmefpulb) = bqyogrceiq ceyncqxzlj (zohxwunjfl ) View more	Positive	30 Sep 2023
				diroximel fumarate [DRF]	ppcfxakwem(bnlmefpulb) = vunammupep ceyncqxzlj (zohxwunjfl ) View more

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