Last update 24 Dec 2024

Olanzapine

Last update 24 Dec 2024

Overview

R&D Status

Clinical Result

Translational Medicine

Overview

Basic Info

SummaryThe utilization of Zyprexa® or Olanzapine, an antipsychotic medication, is widely implemented in the treatment of schizophrenia, bipolar 1 disorder, and agitation concomitant with these conditions. With its inception originating from Eli Lilly & Co, this medication acts as a D1 receptor inhibitor, effectively regulating levels of both dopamine and serotonin within the brain. Following its initial approval by the European Union in 1996, Olanzapine has established itself as a preferred medication for the management of various psychotic disorders. Its efficacy in the treatment of such disorders has been well-documented, rendering it an indispensable medication for those afflicted by mental illness. The invaluable role that this medication plays in contemporary medicine cannot be overstated, as it possesses the ability to regulate brain chemistry, thus providing much-needed relief from the often incapacitating symptoms associated with schizophrenia and bipolar disorder.

Drug Type

Small molecule drug

Synonyms

2-methyl-4-(4-methyl-1-piperazinyl)-10H-thieno[2,3-b][1,5]benzodiazepine, Olanzapin, olanzapine LAI

+ [35]

Target

5-HT2A receptor x 5-HT2C receptor x 5-HT3 receptor x D2 receptor

Mechanism

5-HT2A receptor antagonists(Serotonin 2a (5-HT2a) receptor antagonists), 5-HT2C receptor antagonists(Serotonin 2c (5-HT2c) receptor antagonists), 5-HT3 receptor antagonists(Serotonin 3 (5-HT3) receptor antagonists)

Therapeutic Areas

Nervous System DiseasesOther Diseases

Active Indication

Chemotherapy-induced nausea and vomitingAgitationDepressive Disorder+ [7]

Inactive Indication

Anorexia NervosaBorderline Personality DisorderDepressive Disorder, Major+ [4]

Originator Organization

Eli Lilly & Co.

Active Organization

Qilu Pharmaceutical Co., Ltd.

CHEPLAPHARM Arzneimittel GmbHApotex Europe BV

+ [12]

Inactive Organization

Cipla (EU) Ltd.

Jiangsu Hengrui Pharmaceuticals Co., Ltd.Teva Medical Information Consulting (Shanghai) Co., Ltd.

+ [3]

Drug Highest PhaseApproved

First Approval Date

EU (27 Sep 1996),

Bipolar DisorderManiaSchizophrenia

RegulationPriority Review (CN)

Structure

Molecular FormulaC17H20N4S

InChIKeyKVWDHTXUZHCGIO-UHFFFAOYSA-N

CAS Registry132539-06-1

537

Clinical Trials associated with Olanzapine

CTRI/2024/11/076214 / Not yet recruitingPhase 3IIT

Low-dose Olanzapine vs. Placebo in Preventing Weight Lossduring Radiation for Patients with Locally Advanced HNSCC:A Double Blinded RCT - Nil

Start Date01 Jan 2025

Sponsor / Collaborator

Jawaharlal Institute of Post Graduate Medical Education & Re

CTRI/2024/12/077603 / Not yet recruitingNot Applicable

Role of olanzapine in improving appetite and health related quality of life in patients with intermediate or locally advanced hepatocellular carcinoma: An open-label randomized controlled trial - Nil

Start Date16 Dec 2024

Sponsor / Collaborator

All India Institute of Medical Sciences

NCT06554613 / Not yet recruitingPhase 2IIT

An Open-label, Two-arm, Multicenter, Phase II Randomized Controlled Trial Assessing the Impact of Olanzapine on the Efficacy of First-line Immunotherapy in Patients With Advanced EGFR Mutation-negative Non-small Cell Lung Cancer (NSCLC).

Clinical Trial
The objective of this clinical trial is to determine whether antidepressant medications, such as olanzapine, in combination with immune checkpoint inhibitors are more effective than the use of immune checkpoint inhibitors alone. The main questions it aims to answer are:
Is the combination therapy of antidepressant medication with immune checkpoint inhibitors more efficacious than the therapy with immune checkpoint inhibitors alone? What medical issues might participants encounter when treated with the combination of antidepressant medication and immune checkpoint inhibitors?
Participants will:
Take olanzapine in combination with immune checkpoint inhibitors or immune checkpoint inhibitors alone for 2 months.
Visit the clinic for check-ups and tests every two weeks, and have follow-up visits every six weeks after the treatment ends.
Keep a record of their symptoms and disease progression.

Start Date01 Dec 2024

Sponsor / Collaborator

The Second Affiliated Hospital of Nanchang University

100 Clinical Results associated with Olanzapine

100 Translational Medicine associated with Olanzapine

100 Patents (Medical) associated with Olanzapine

9,692

Literatures (Medical) associated with Olanzapine

01 Mar 2025·Neuropsychopharmacology reports

Current status and features of antipsychotic prescriptions in Japanese forensic psychiatric wards based on a forensic inpatient database

Article

Author: Kubota, Ryotaro ; Kashiwagi, Hiroko ; Yamada, Yuji ; Kono, Toshiaki ; Kako, Yuki ; Takeda, Koji ; Hirabayasi, Naotsugu ; Koike, Junko ; Naoe, Ryo ; Takanobu, Keisuke

Abstract:

Aim:

Psychopharmacotherapy plays an important role in the treatment of mentally disordered offenders (MDOs) with schizophrenia spectrum disorders. However, there have been few large‐scale reports from multiple forensic psychiatric wards. This study aimed to clarify the current state of antipsychotic medications for MDOs with schizophrenia spectrum disorders in Japanese forensic psychiatric wards.

Methods:

Medical information, including age, sex, psychiatric diagnosis, index offense, seclusion or restraint experience during hospitalization, and medication for patients discharged from 32 forensic wards nationwide between September 1, 2019 and December 31, 2021 was provided by the Database Scientific Utilization Project of Japanese forensic psychiatric wards. We analyzed the data of MDOs with schizophrenia spectrum disorders who were prescribed psychotropic medications at the time of discharge, especially focusing on comparing differences between the three groups (clozapine, long‐acting injection (LAI), and other medications).

Results:

A total of 362 MDOs with schizophrenia spectrum disorders were prescribed psychotropic medications at discharge. The prescription rates of clozapine and LAI were 23.2% and 24.9%, respectively. Additionally, the rate of antipsychotic polypharmacy was 37.8%. Among the three groups, the clozapine group had the highest rate of seclusion experience (46.4%), a long mean length of hospitalization (1758 days), and the lowest rate of antipsychotic polypharmacy (4.8%). Olanzapine was the most commonly prescribed antipsychotic medication.

Conclusion:

This study revealed the current state of antipsychotic medications for MDOs admitted to forensic psychiatric wards in Japan. Future studies are needed to clarify the relevance of antipsychotic medications in the prognosis of MDOs.

01 Jan 2025·ACTA PSYCHIATRICA SCANDINAVICA

Dosing levels of antipsychotics and mood stabilizers in bipolar disorder: A Nationwide cohort study on relapse risk and treatment safety

Article

Author: Lähteenvuo, Markku ; Tanskanen, Antti ; Hamina, Aleksi ; Taipale, Heidi ; Lintunen, Jonne ; Paljärvi, Tapio ; Tiihonen, Jari

Abstract:

Background:

Finding effective treatment regimens for bipolar disorder is challenging, as many patients suffer from significant symptoms despite treatment. This study investigated the risk of relapse (psychiatric hospitalization) and treatment safety (non‐psychiatric hospitalization) associated with different doses of antipsychotics and mood stabilizers in persons with bipolar disorder.

Methods:

Individuals aged 15–65 with bipolar disorder were identified from Finnish national health registers in 1996–2018. Studied antipsychotics included olanzapine, risperidone, quetiapine, aripiprazole; mood stabilizers lithium, valproic acid, lamotrigine, and carbamazepine. Medication use was divided into three time‐varying dose categories: low, standard, and high. The studied outcomes were risk of psychiatric hospitalization (relapse) and the risk of non‐psychiatric hospitalization (treatment safety). Stratified Cox regression in within‐individual design was used.

Results:

The cohort included 60,045 individuals (mean age 41.7 years, SD 15.8; 56.4% female). Mean follow‐up was 8.3 years (SD 5.8). Of antipsychotics, olanzapine and aripiprazole were associated with a decreased risk of relapse in low and standard doses, and risperidone in low dose. The lowest adjusted hazard ratio (aHR) was observed for standard dose aripiprazole (aHR 0.68, 95% CI 0.57–0.82). Quetiapine was not associated with a decreased risk of relapse at any dose. Mood stabilizers were associated with a decreased risk of relapse in low and standard doses; lowest aHR was observed for standard dose lithium (aHR 0.61, 95% CI 0.56–0.65). Apart from lithium, high doses of antipsychotics and mood stabilizers were associated with an increased risk of non‐psychiatric hospitalization. Lithium was associated with a decreased risk of non‐psychiatric hospitalization in low (aHR 0.88, 95% CI 0.84–0.93) and standard doses (aHR 0.81, 95% CI 0.74–0.88).

Conclusions:

Standard doses of lithium and aripiprazole were associated with the lowest risk of relapse, and standard dose of lithium with the lowest risk of non‐psychiatric hospitalization. Quetiapine was not associated with decreased risk of relapse at any dose.

01 Jan 2025·EUROPEAN NEUROPSYCHOPHARMACOLOGY

The microRNA profile of brain-derived extracellular vesicles: A promising step forward in developing pharmacodynamic biomarkers for psychiatric disorders

Review

Author: Schulze, Thomas G. ; Rossner, Moritz ; Mueller, Thorsten ; Oraki Kohshour, Mojtaba ; Schulze, Thomas G ; Heilbronner, Urs ; Papiol, Sergi

MicroRNAs (miRNAs) have the potential to affect drug metabolism, and some drugs affect cellular miRNA expression. miRNAs are found inside extracellular vesicles (EVs), and the profile of these EV-miRNAs can change across different diseases and disease states. Consequently, in recent years EV-miRNAs have attracted increasing attention as possible non-invasive biomarkers. For example, analyzing the miRNA expression profile of brain-derived EVs in blood may allow us to non-invasively assess miRNA dysregulation and thus to gain knowledge about the pathophysiology of psychiatric disorders and identify potential new predictive targets. We searched PubMed for all studies related to the effects of psychiatric medications on EV-miRNAs and identified 14 relevant articles. Taken together, findings indicate that certain EV-miRNAs may be targets for psychiatric medications and that antipsychotics such as olanzapine and antidepressants such as fluoxetine may alter the expression levels of particular EV-miRNAs. If confirmed and replicated, these findings may lead to the suggested miRNA profiles being used as pharmacodynamic biomarkers. However, heterogeneities and uncertainties remain regarding the role of EV-miRNAs in psychiatric disorders and their interaction with neuronal gene expression and drugs. This minireview summarizes some of the findings on the effects of psychiatric medications on EV-miRNAs and describes the potential role of EV-miRNAs as pharmacodynamic biomarkers for psychiatric disorders.

117

News (Medical) associated with Olanzapine

06 Dec 2024

·www.prnewswire.com

NEURELIS PRESENTS STUDIES ON SEIZURE CLUSTERS AT THE AMERICAN EPILEPSY SOCIETY ANNUAL MEETING

Ten poster presentations highlight analyses of immediate-use seizure medication and treatment for seizure clusters SAN DIEGO, Dec. 6, 2024 /PRNewswire/ -- Neurelis, Inc., today announced details of its presentations at the American Epilepsy Society (AES) Annual Meeting to be held December 6-10 in Los Angeles. The collection of ten posters highlights analyses of immediate-use seizure medication for treatment of seizure clusters. A wide variety of presentations include pharmacokinetics (PK) and safety analyses from the study of VALTOCO® (diazepam nasal spray) for the treatment of seizure clusters in patients with epilepsy aged 2-5 years, time to treatment and seizure cluster termination, treatment of prolonged seizures within a cluster, as well as potential drug effects beyond the immediate treated seizure cluster, implications of seizure clusters in the epilepsy monitoring unit, and development of evidence-based self-management criteria encompassing the use of immediate-use seizure medication. "The AES Annual Meeting is an important opportunity for the epilepsy community to engage with each other on critical research and the latest advancements in the field," said Adrian L. Rabinowicz, MD, Neurelis Chief Medical Officer. "We are proud to have such a strong set of pre-clinical and clinical presentations to share at this year's meeting and look forward to connecting with healthcare practitioners, researchers, people with epilepsy, and care partners as we share a common mission to improve quality of life for people with epilepsy." Neurelis' presentations at the Annual Meeting include the following. Poster Session 1, December 7th 12:00 PM to 2:00 PM PT: Exploring Proposed Recommendations for Acute Cluster Treatment and Rapid and Early Seizure Termination Using Data from a Long-Term Safety Study of Diazepam Nasal Spray Presentation of data from the long-term safety study of diazepam nasal spray explores clinical evidence supporting recent expert consensus recommendations for medications appropriate for acute cluster treatment and for rapid and early seizure termination. The study objective was to examine a single immediate-use seizure medication for both acute cluster treatment and rapid and early seizure termination, with the potential to simplify patient care. Findings in the study demonstrate the benefit of diazepam nasal spray use for both termination of acute seizure clusters and prolonged seizures within clusters. Effect of Diazepam Intervention on Seizure-Cluster Expression in a Rat Model of Epilepsy This poster shares data from a preclinical study investigating the possible impact of diazepam on seizure cluster expression in a post-kainic acid status epilepticus (KASE) rat model of chronic epilepsy. Results demonstrated that in this rat model, expression was consistent with potential disease-modifying effects on seizure clusters, including reduced seizure severity, interseizure interval, and stability within clusters, supporting further exploration of the potential disease-modifying effect of diazepam. Is Disease Modification in Seizure Clusters Possible? Results From the Long-Term Safety Study of Diazepam Nasal Spray A subgroup analysis of patients treated with diazepam nasal spray in a long-term open label safety study was evaluated to assess the intervals of treated seizure clusters (SEIVAL) over time as a potential indicator of disease modification. Results were consistent across subgroups based on age, sex, with and without change in concomitant medications, pediatric developmental/epileptic encephalopathies, with prolonged seizures, and with self-administration of diazepam nasal spray. Poster Session 2, December 8th 12:00 PM to 2:00 PM PT: Treatment of Prolonged Seizure with Diazepam Nasal Spray: A Post Hoc Cohort Analysis Prolonged seizures within a seizure cluster, treated with diazepam nasal spray within 5-15 minutes of seizure onset, were investigated in a post hoc subgroup analysis of a Phase 3 long-term safety study. Across age, seizure type, and high treatment usage subgroups, similar times to seizure termination were observed. Results also show low use of second doses demonstrating preserved effectiveness in seizures that have become prolonged within a cluster. Pharmacokinetic Characteristics of Diazepam Nasal Spray in Children with Epilepsy 2 to 5 Years of Age The PK of diazepam nasal spray for treatment of seizure clusters in patients 2-5 years of age was evaluated. Results demonstrated that diazepam nasal spray was readily absorbed with similar exposure for patients aged 2-3 years and 4-5 years and also showed a consistent PK profile in 2-5 year olds with that of older children and adults aged 6-59 years. Safety Profile of Diazepam Nasal Spray in Patients Aged 2-5 Years from an Ongoing, Open-Label 180-Day Safety Period Following Pharmacokinetic Sampling in a Phase 1/2a Study Safety of diazepam nasal spray in patients aged 2-5 years was assessed through the 180-day open-label safety period. Overall, the safety profile of diazepam nasal spray was similar to that established for older children and adults. Second Dose Use as a Proxy for Effectiveness of Diazepam Nasal Spray in Patients with Epilepsy Aged 2-5 Years: Interim Results from a Phase 1/2a Study The effectiveness of diazepam nasal spray in the 2-5 years age group was evaluated using the proportion of second doses (doses given within 24 hours of initial doses) used to treat seizure clusters as a proxy for effectiveness. Results showed comparable rates of seizure clusters treated with second doses among pediatric patients aged 6-17 years in the long-term safety study of diazepam nasal spray, supporting the effectiveness of the age-based dosing regimen in patients aged 2-5. Potential Adverse Events of Clinical Interest with Use of Diazepam Nasal Spray in Children: Interim Results from an Ongoing Open-Label, Pharmacokinetic and Safety Study Treatment-emergent adverse events (TEAEs) of clinical interest associated with the use of benzodiazepines were assessed in patients aged 2-5 who received at least one dose of diazepam nasal spray through the 180-day open-label safety period of a Phase 1/2a pharmacokinetic and safety study. Treatment-related TEAEs of clinical interest were uncommon and primarily nasal, with none reported in more than one patient. There were no clinically significant changes in vital signs or laboratory values and no new safety signals of clinical interest in children aged 2-5 years. Immediate-Use Seizure Medication for Acute Repetitive Seizures in the Epilepsy Monitoring Unit: Experiences from an Expert Panel A pilot survey of a group of expert epileptologists discussed practice experience with immediate-use seizure medications (ISM, rescue) before, during, and after long-term video-electroencephalogram monitoring (LTVEM) in the epilepsy monitoring unit (EMU). Results highlighted the importance of expanding this research and the potential value of expert guidelines. Development of Self-Management Tool for Individuals with Seizure Clusters The study presents an ongoing study focused on self-management for people with epilepsy and a history of negative health events (SMART), an evidence-based program investigating integration of immediate-use seizure medications (rescue medication) into the self-management program. The American Epilepsy Society is dedicated to advancing knowledge and supporting evidence-based clinical practice to improve outcomes for persons with epilepsy and their families. About Neurelis Neurelis, Inc., is a neuroscience company focused on the development and commercialization of therapeutics for the treatment of epilepsy and neurologic disorders characterized by high unmet medical need. The FDA has approved Neurelis' VALTOCO® (diazepam nasal spray) as an acute treatment of intermittent, stereotypic episodes of frequent seizure activity (i.e., seizure clusters, acute repetitive seizures) that are distinct from an individual's usual seizure pattern in adult and pediatric patients 6 years of age and older. VALTOCO is a proprietary formulation of diazepam incorporating the science of INTRAVAIL®, a transmucosal absorption enhancement technology that enables the noninvasive delivery of a broad range of protein, peptide and small-molecule drugs. For more information on VALTOCO, please visit . For the latest scientific information on VALTOCO, please visit . Neurelis is also developing NRL-1004, an investigational, Phase 1 stage intranasal olanzapine for treatment of acute agitation episodes associated with schizophrenia and bipolar disorder. In addition, Neurelis is also developing NRL-1049 (previously known as BA-1049), an investigational, Phase 1 new chemical entity Rho kinase (ROCK) inhibitor, for the treatment of cerebral cavernous malformations (CCMS), a rare disorder of the central nervous system (CNS). For more information on Neurelis, please visit . Important Safety Information about VALTOCO: Indication VALTOCO® (diazepam nasal spray) is indicated for the acute treatment of intermittent, stereotypic episodes of frequent seizure activity (i.e., seizure clusters, acute repetitive seizures) that are distinct from a patient's usual seizure pattern in patients with epilepsy 6 years of age and older. WARNING: RISKS FROM CONCOMITANT USE WITH OPIOIDS; ABUSE, MISUSE, AND ADDICTION; and DEPENDENCE AND WITHDRAWAL REACTIONS Concomitant use of benzodiazepines and opioids may result in profound sedation, respiratory depression, coma, and death. Reserve concomitant prescribing of these drugs for patients for whom alternative treatment options are inadequate. Limit dosages and durations to the minimum required. Follow patients for signs and symptoms of respiratory depression and sedation. The use of benzodiazepines, including VALTOCO, exposes users to risks of abuse, misuse, and addiction, which can lead to overdose or death. Abuse and misuse of benzodiazepines commonly involve concomitant use of other medications, alcohol, and/or illicit substances, which is associated with an increased frequency of serious adverse outcomes. Before prescribing VALTOCO and throughout treatment, assess each patient's risk for abuse, misuse, and addiction. The continued use of benzodiazepines may lead to clinically significant physical dependence. The risks of dependence and withdrawal increase with longer treatment duration and higher daily dose. Although VALTOCO is indicated only for intermittent use, if used more frequently than recommended, abrupt discontinuation or rapid dosage reduction of VALTOCO may precipitate acute withdrawal reactions, which can be life-threatening. For patients using VALTOCO more frequently than recommended, to reduce the risk of withdrawal reactions, use a gradual taper to discontinue VALTOCO. Contraindications: VALTOCO is contraindicated in patients with: Hypersensitivity to diazepam Acute narrow-angle glaucoma Central Nervous System (CNS) Depression Benzodiazepines, including VALTOCO, may produce CNS depression. Caution patients against engaging in hazardous activities requiring mental alertness, such as operating machinery, driving a motor vehicle, or riding a bicycle, until the effects of the drug, such as drowsiness, have subsided, and as their medical condition permits. The potential for a synergistic CNS-depressant effect when VALTOCO is used with alcohol or other CNS depressants must be considered, and appropriate recommendations made to the patient and/or care partner. Suicidal Behavior and Ideation Antiepileptic drugs (AEDs), including VALTOCO, increase the risk of suicidal ideation and behavior. Patients treated with any AED for any indication should be monitored for the emergence or worsening of depression, suicidal thoughts or behavior, and/or unusual changes in mood or behavior. Glaucoma Benzodiazepines, including VALTOCO, can increase intraocular pressure in patients with glaucoma. VALTOCO may only be used in patients with open-angle glaucoma only if they are receiving appropriate therapy. VALTOCO is contraindicated in patients with narrow-angle glaucoma. Neonatal Sedation and Withdrawal Syndrome Use of VALTOCO late in pregnancy can result in sedation (respiratory depression, lethargy, hypotonia) and/or withdrawal symptoms (hyperreflexia, irritability, restlessness, tremors, inconsolable crying, and feeding difficulties) in the neonate. Monitor neonates exposed to VALTOCO during pregnancy or labor for signs of sedation and monitor neonates exposed to VALTOCO during pregnancy for signs of withdrawal; manage these neonates accordingly. Risk of Serious Adverse Reactions in Infants due to Benzyl Alcohol Preservative VALTOCO is not approved for use in neonates or infants. Serious and fatal adverse reactions, including "gasping syndrome," can occur in neonates and low-birth-weight infants treated with benzyl alcohol–preserved drugs, including VALTOCO. The "gasping syndrome" is characterized by central nervous system depression, metabolic acidosis, and gasping respirations. The minimum amount of benzyl alcohol at which serious adverse reactions may occur is not known. Adverse Reactions The most common adverse reactions (at least 4%) were somnolence, headache, and nasal discomfort. Diazepam, the active ingredient in VALTOCO, is a Schedule IV controlled substance. To report SUSPECTED ADVERSE REACTIONS, contact Neurelis, Inc. at 1-866-696-3873 or FDA at 1-800-FDA-1088 (). Please read full Prescribing Information , including Boxed Warning. Contacts: Brittany Bradrick, Chief Operating Officer and Chief Financial Officer, +1 858 251 2100 SOURCE Neurelis, Inc. WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

Clinical ResultDrug ApprovalPhase 1Phase 3

18 Nov 2024

·www.prnewswire.com

NEURELIS TO JOIN EPILEPSY COMMUNITY AT 12TH ANNUAL SOFIE'S JOURNEY EPILEPSY AWARENESS DAY AND EDUCATION EXPO AT DISNEYLAND® RESORT

One of the largest gatherings of people with epilepsy, care partners, and healthcare practitioners to address unmet needs for increased education SAN DIEGO, Nov. 18, 2024 /PRNewswire/ -- Neurelis, Inc., today announced it will participate in the 12th Annual Sofie's Journey Epilepsy Awareness Day & Education Expo at Disneyland (EADDL), one of the largest gatherings of people with epilepsy, care partners, and healthcare practitioners. The event was established to help address the unmet need for increased education for people with epilepsy and their families. Neurelis will participate in the free education expo November 18th and 19th, 9:00 AM to 5:00 PM at the Disneyland Hotel Convention Center. Epilepsy Awareness Day will take place on Nov. 20th at Disneyland Resort, where families will spend the day in the park together. "Participating in the Epilepsy Awareness Day event is such a valuable opportunity for me and people in the epilepsy community to learn about progress in the field and exchange information with other families and medical professionals," commented Colleen, care partner and Neurelis Ambassador. "It is an honor to represent Neurelis at the Expo and share my experience with VALTOCO® (diazepam nasal spray), an immediate-use seizure medication which has been key to having my son, Paul, and I feel prepared to address his seizure clusters." "Since I found VALTOCO, I feel I have more freedom to go out and do things and want to help others with seizure clusters realize there may be treatment options to help them experience that too. It means a lot to be able to share my story with kids and young adults with epilepsy, so they understand that they have support from a community of their peers," added Paul, person with epilepsy and Neurelis Ambassador. Neurelis will sponsor a presentation on its FDA-approved product, VALTOCO, a treatment for episodes of frequent seizures in patients six years of age or older, on Monday Nov. 18th from 11:00 AM to 11:30 AM in the Expo Center, Room D. The presentation will feature Paul with his care partner and mother Colleen, who will speak about their journey with epilepsy and answer questions during a live Q&A. Paul was diagnosed with epilepsy when he was 12 years old. Navigating his diagnosis and effectively managing his seizures and seizure clusters, as well as advocating for proper care of students with epilepsy have been a key focus for both Paul and Colleen following his diagnosis. Together they helped create legislation for seizure safe schools in the state of New Jersey, Paul's Law. Paul is now successfully attending college and enjoys golf. Colleen continues her advocacy efforts and is currently working on advancing the Seizure Awareness and Preparedness Act. Joining Neurelis and the epilepsy community at the Expo will also be Neurelis Ambassador Danielle. Danielle was diagnosed with epilepsy almost 25 years ago, after she was unable to wake up for school one day. Epilepsy significantly impacted her life during her adolescence and college years. Now with proper management, a detailed seizure action plan, and a strong support system, Danielle has been able to increase her independence. She served as president of a regional epilepsy nonprofit focused on helping people with epilepsy to manage the logistics of accessing appropriate healthcare. She continues to be dedicated to increasing advocacy and awareness for people with epilepsy. Danielle spoke about her experiences living with and managing seizure clusters on Sunday Nov. 17 at a dinner co-sponsored by Epilepsy Alliance of America for families attending the meeting. "VALTOCO has enabled me to have more freedom to travel and give back to the epilepsy community through my advocacy work," said Danielle. "It is exciting to participate in the Epilepsy Awareness Day Expo which is such a powerful event for learning and creating a community. Having the opportunity to engage with doctors, caregivers, and others who live daily with the challenges of epilepsy gives a sense of empowerment and support." "Our focus at Neurelis has been on improving overall care and increasing awareness of the unmet needs of people with epilepsy," said Neurelis Founder and CEO Craig Chambliss. "We are proud to join the epilepsy community at this important event to promote education and to help advance the discussion on how to empower people with epilepsy and improve the quality of their lives." Additionally, Neurelis has committed to sponsoring two new seizure detection and response puppies through Little Angels Service Dogs, an Assistance Dog International accredited organization that specializes in training service dogs for seizure alert and several other types of assistance. The puppies will be featured at the VALTOCO exhibit booth. EADDL is part of November's National Epilepsy Awareness Month, which promotes the importance of epilepsy education and awareness, and improving the lives of those impacted by the condition. For more information about EADDL, visit and to register for the Expo, click here. About EADDL and Sofie's Journey EADDL is the combined effort of one family's thankfulness for their own daughter's recovery (10+ years seizure free) and a united community with a passion for winning the fight against epilepsy. It is operated by the Irvine, Calif.-based, non-profit foundation, Sofie's Journey, to drive epilepsy awareness by bringing together patients, families/caregivers, physicians, advocates, non-profits, services, and the biopharmaceutical industry. EADDL and Sofie's Journey were launched by Candy and Brad Levy, whose daughter Sofie, now 19 years old, underwent surgery in 2013 to remove a part of her brain that caused her seizures. Their mission is to drive epilepsy awareness, the key to overcoming challenges created by epilepsy. About Neurelis Neurelis, Inc., is a neuroscience company focused on the development and commercialization of therapeutics for the treatment of epilepsy and neurologic disorders characterized by high unmet medical need. The FDA has approved Neurelis' VALTOCO® (diazepam nasal spray) as an acute treatment of intermittent, stereotypic episodes of frequent seizure activity (i.e., seizure clusters, acute repetitive seizures) that are distinct from an individual's usual seizure pattern in adult and pediatric patients 6 years of age and older. VALTOCO is a proprietary formulation of diazepam incorporating the science of INTRAVAIL®, a transmucosal absorption enhancement technology that enables the noninvasive delivery of a broad range of protein, peptide, and small-molecule drugs. For more information on VALTOCO, please visit . For the latest scientific information on VALTOCO, please visit . Neurelis is also developing NRL-1004, an investigational, Phase 1 stage intranasal olanzapine for treatment of acute agitation episodes associated with schizophrenia and bipolar disorder. In addition, Neurelis is also developing NRL-1049 (previously known as BA-1049), an investigational, Phase 1 new chemical entity Rho kinase (ROCK) inhibitor, for the treatment of cerebral cavernous malformations (CCMS), a rare disorder of the central nervous system (CNS). For more information on Neurelis, please visit . Important Safety Information about VALTOCO: Indication VALTOCO® (diazepam nasal spray) is indicated for the acute treatment of intermittent, stereotypic episodes of frequent seizure activity (i.e., seizure clusters, acute repetitive seizures) that are distinct from a patient's usual seizure pattern in patients with epilepsy 6 years of age and older. WARNING: RISKS FROM CONCOMITANT USE WITH OPIOIDS; ABUSE, MISUSE, AND ADDICTION; and DEPENDENCE AND WITHDRAWAL REACTIONS Concomitant use of benzodiazepines and opioids may result in profound sedation, respiratory depression, coma, and death. Reserve concomitant prescribing of these drugs for patients for whom alternative treatment options are inadequate. Limit dosages and durations to the minimum required. Follow patients for signs and symptoms of respiratory depression and sedation. The use of benzodiazepines, including VALTOCO, exposes users to risks of abuse, misuse, and addiction, which can lead to overdose or death. Abuse and misuse of benzodiazepines commonly involve concomitant use of other medications, alcohol, and/or illicit substances, which is associated with an increased frequency of serious adverse outcomes. Before prescribing VALTOCO and throughout treatment, assess each patient's risk for abuse, misuse, and addiction. The continued use of benzodiazepines may lead to clinically significant physical dependence. The risks of dependence and withdrawal increase with longer treatment duration and higher daily dose. Although VALTOCO is indicated only for intermittent use, if used more frequently than recommended, abrupt discontinuation or rapid dosage reduction of VALTOCO may precipitate acute withdrawal reactions, which can be life-threatening. For patients using VALTOCO more frequently than recommended, to reduce the risk of withdrawal reactions, use a gradual taper to discontinue VALTOCO. Contraindications: VALTOCO is contraindicated in patients with: Hypersensitivity to diazepam Acute narrow-angle glaucoma Central Nervous System (CNS) Depression Benzodiazepines, including VALTOCO, may produce CNS depression. Caution patients against engaging in hazardous activities requiring mental alertness, such as operating machinery, driving a motor vehicle, or riding a bicycle, until the effects of the drug, such as drowsiness, have subsided, and as their medical condition permits. The potential for a synergistic CNS-depressant effect when VALTOCO is used with alcohol or other CNS depressants must be considered, and appropriate recommendations made to the patient and/or care partner. Suicidal Behavior and Ideation Antiepileptic drugs (AEDs), including VALTOCO, increase the risk of suicidal ideation and behavior. Patients treated with any AED for any indication should be monitored for the emergence or worsening of depression, suicidal thoughts or behavior, and/or unusual changes in mood or behavior. Glaucoma Benzodiazepines, including VALTOCO, can increase intraocular pressure in patients with glaucoma. VALTOCO may only be used in patients with open-angle glaucoma only if they are receiving appropriate therapy. VALTOCO is contraindicated in patients with narrow-angle glaucoma. Neonatal Sedation and Withdrawal Syndrome Use of VALTOCO late in pregnancy can result in sedation (respiratory depression, lethargy, hypotonia) and/or withdrawal symptoms (hyperreflexia, irritability, restlessness, tremors, inconsolable crying, and feeding difficulties) in the neonate. Monitor neonates exposed to VALTOCO during pregnancy or labor for signs of sedation and monitor neonates exposed to VALTOCO during pregnancy for signs of withdrawal; manage these neonates accordingly. Risk of Serious Adverse Reactions in Infants due to Benzyl Alcohol Preservative VALTOCO is not approved for use in neonates or infants. Serious and fatal adverse reactions, including "gasping syndrome," can occur in neonates and low-birth-weight infants treated with benzyl alcohol–preserved drugs, including VALTOCO. The "gasping syndrome" is characterized by central nervous system depression, metabolic acidosis, and gasping respirations. The minimum amount of benzyl alcohol at which serious adverse reactions may occur is not known. Adverse Reactions The most common adverse reactions (at least 4%) were somnolence, headache, and nasal discomfort. Diazepam, the active ingredient in VALTOCO, is a Schedule IV controlled substance. To report SUSPECTED ADVERSE REACTIONS, contact Neurelis, Inc. at 1-866-696-3873 or FDA at 1-800-FDA-1088 (). Please read full Prescribing Information , including Boxed Warning. Contacts: Brittany Bradrick, Chief Operating Officer and Chief Financial Officer, +1 858 251 2100 SOURCE Neurelis, Inc. WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

Drug ApprovalPhase 1

11 Nov 2024

·www.prnewswire.com

NEURELIS TO SHARE CLINICAL STUDY DESIGN INSIGHTS FOR INVESTIGATION OF VALTOCO® (DIAZEPAM NASAL SPRAY) IN AGES 2 TO 5 AT CHILD NEUROLOGY SOCIETY ANNUAL MEETING

Presentation highlights study-enrollment challenges and strategies to overcome potential barriers SAN DIEGO, Nov. 11, 2024 /PRNewswire/ -- Neurelis, Inc., today announced a presentation on insights into study design from the enrollment process for the new Stellina study investigating VALTOCO® (diazepam nasal spray) for the treatment of seizure clusters in patients with epilepsy aged 2 to 5 years. This age group is not included in the current indication of treatment of seizure clusters in patients with epilepsy aged ≥6 years. The poster presentation will be given at the 53rd Child Neurology Society Annual Meeting in San Diego, November 11-14th. "Data from clinical studies of repetitive seizures in early childhood are critical to help advance new treatments for a young population with currently limited alternatives," said Adrian L. Rabinowicz, MD, Neurelis Chief Medical Officer. "We are pleased to join the child neurology community and exchange learnings at this year's annual meeting as we focus on improving health outcomes for people with epilepsy." Highlights of the presentation include the identification of study-enrollment challenges and strategies to overcome potential barriers in young patients with treatment-resistant epilepsy. Identified findings may be helpful in designing future protocols. The poster titled "Challenges Associated with Enrolling Pediatric Patients with Treatment-Resistant Epilepsy Aged 2–5 Years in a Clinical Trial and Lessons Learned for Future Trials" will be presented on Tuesday November 12th from 12:30 PM-1:45 PM and 5:30 PM-7:00 PM PT. The mission of the Child Neurology Society is to raise awareness about the importance of child neurologists and the health needs of children with chronic neurological conditions. About Neurelis Neurelis, Inc., is a neuroscience company focused on the development and commercialization of therapeutics for the treatment of epilepsy and neurologic disorders characterized by high unmet medical need. The FDA has approved Neurelis' VALTOCO® (diazepam nasal spray) as an acute treatment of intermittent, stereotypic episodes of frequent seizure activity (i.e., seizure clusters, acute repetitive seizures) that are distinct from an individual's usual seizure pattern in adult and pediatric patients 6 years of age and older. VALTOCO is a proprietary formulation of diazepam incorporating the science of INTRAVAIL®, a transmucosal absorption enhancement technology that enables the noninvasive delivery of a broad range of protein, peptide and small-molecule drugs. For more information on VALTOCO, please visit . For the latest scientific information on VALTOCO, please visit . Neurelis is also developing NRL-1004, an investigational, Phase 1 stage intranasal olanzapine for treatment of acute agitation episodes associated with schizophrenia and bipolar disorder. In addition, Neurelis is also developing NRL-1049 (previously known as BA-1049), an investigational, Phase 1 new chemical entity Rho kinase (ROCK) inhibitor, for the treatment of cerebral cavernous malformations (CCMS), a rare disorder of the central nervous system (CNS). For more information on Neurelis, please visit . Important Safety Information about VALTOCO: Indication VALTOCO® (diazepam nasal spray) is indicated for the acute treatment of intermittent, stereotypic episodes of frequent seizure activity (i.e., seizure clusters, acute repetitive seizures) that are distinct from a patient's usual seizure pattern in patients with epilepsy 6 years of age and older. Contraindications: VALTOCO is contraindicated in patients with: Hypersensitivity to diazepam Acute narrow-angle glaucoma Central Nervous System (CNS) Depression Benzodiazepines, including VALTOCO, may produce CNS depression. Caution patients against engaging in hazardous activities requiring mental alertness, such as operating machinery, driving a motor vehicle, or riding a bicycle, until the effects of the drug, such as drowsiness, have subsided, and as their medical condition permits. The potential for a synergistic CNS-depressant effect when VALTOCO is used with alcohol or other CNS depressants must be considered, and appropriate recommendations made to the patient and/or care partner. Suicidal Behavior and Ideation Antiepileptic drugs (AEDs), including VALTOCO, increase the risk of suicidal ideation and behavior. Patients treated with any AED for any indication should be monitored for the emergence or worsening of depression, suicidal thoughts or behavior, and/or unusual changes in mood or behavior. Glaucoma Benzodiazepines, including VALTOCO, can increase intraocular pressure in patients with glaucoma. VALTOCO may only be used in patients with open-angle glaucoma only if they are receiving appropriate therapy. VALTOCO is contraindicated in patients with narrow-angle glaucoma. Neonatal Sedation and Withdrawal Syndrome Use of VALTOCO late in pregnancy can result in sedation (respiratory depression, lethargy, hypotonia) and/or withdrawal symptoms (hyperreflexia, irritability, restlessness, tremors, inconsolable crying, and feeding difficulties) in the neonate. Monitor neonates exposed to VALTOCO during pregnancy or labor for signs of sedation and monitor neonates exposed to VALTOCO during pregnancy for signs of withdrawal; manage these neonates accordingly. Risk of Serious Adverse Reactions in Infants due to Benzyl Alcohol Preservative VALTOCO is not approved for use in neonates or infants. Serious and fatal adverse reactions, including "gasping syndrome," can occur in neonates and low-birth-weight infants treated with benzyl alcohol–preserved drugs, including VALTOCO. The "gasping syndrome" is characterized by central nervous system depression, metabolic acidosis, and gasping respirations. The minimum amount of benzyl alcohol at which serious adverse reactions may occur is not known. Adverse Reactions The most common adverse reactions (at least 4%) were somnolence, headache, and nasal discomfort. Diazepam, the active ingredient in VALTOCO, is a Schedule IV controlled substance. To report SUSPECTED ADVERSE REACTIONS, contact Neurelis, Inc. at 1-866-696-3873 or FDA at 1-800-FDA-1088 (). Please read full Prescribing Information , including Boxed Warning. Contacts: Brittany Bradrick, Chief Operating Officer and Chief Financial Officer, +1 858 251 2100 SOURCE Neurelis, Inc. WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

Drug ApprovalPhase 1

100 Deals associated with Olanzapine

External Link

KEGG	Wiki	ATC	Drug Bank
D00454	Olanzapine	N05AH03	DB00334

R&D Status

Approved

10 top approved records.

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Indication	Country/Location	Organization	Date
Chemotherapy-induced nausea and vomiting	JP	CHEPLAPHARM Arzneimittel GmbH	25 Dec 2017
Chemotherapy-induced nausea and vomiting	JP	Eli Lilly & Co.	25 Dec 2017
Agitation	US	CHEPLAPHARM Arzneimittel GmbH	19 Mar 2009
Depressive Disorder	US	CHEPLAPHARM Arzneimittel GmbH	19 Mar 2009
Depressive Disorder, Treatment-Resistant	US	CHEPLAPHARM Arzneimittel GmbH	19 Mar 2009
Bipolar and Related Disorders	CN	Eli Lilly & Co.	01 Jan 2006
Bipolar I disorder	US	CHEPLAPHARM Arzneimittel GmbH	30 Sep 1996
Bipolar Disorder	EU	CHEPLAPHARM Arzneimittel GmbH	27 Sep 1996
Bipolar Disorder	IS	CHEPLAPHARM Arzneimittel GmbH	27 Sep 1996
Bipolar Disorder	LI	CHEPLAPHARM Arzneimittel GmbH	27 Sep 1996
Bipolar Disorder	NO	CHEPLAPHARM Arzneimittel GmbH	27 Sep 1996
Mania	EU	CHEPLAPHARM Arzneimittel GmbH	27 Sep 1996
Mania	IS	CHEPLAPHARM Arzneimittel GmbH	27 Sep 1996
Mania	LI	CHEPLAPHARM Arzneimittel GmbH	27 Sep 1996
Mania	NO	CHEPLAPHARM Arzneimittel GmbH	27 Sep 1996
Schizophrenia	EU	CHEPLAPHARM Arzneimittel GmbH	27 Sep 1996
Schizophrenia	IS	CHEPLAPHARM Arzneimittel GmbH	27 Sep 1996
Schizophrenia	LI	CHEPLAPHARM Arzneimittel GmbH	27 Sep 1996
Schizophrenia	NO	CHEPLAPHARM Arzneimittel GmbH	27 Sep 1996

Developing

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Solid tumor	Phase 3	CN	Jiangsu Hansoh Pharmaceutical Co., Ltd.	01 Oct 2020
Vomiting	Phase 3	CN	Jiangsu Hansoh Pharmaceutical Co., Ltd.	01 Oct 2020
Gambling	Phase 3	US	Eli Lilly & Co.	01 Feb 2007
Weight Gain	Phase 3	US	Eli Lilly & Co.	01 Nov 2006
Weight Gain	Phase 3	BR	Eli Lilly & Co.	01 Nov 2006
Weight Gain	Phase 3	IL	Eli Lilly & Co.	01 Nov 2006
Weight Gain	Phase 3	MX	Eli Lilly & Co.	01 Nov 2006
Weight Gain	Phase 3	PR	Eli Lilly & Co.	01 Nov 2006
Weight Gain	Phase 3	RU	Eli Lilly & Co.	01 Nov 2006
Weight Gain	Phase 3	KR	Eli Lilly & Co.	01 Nov 2006

Clinical Result

Indication

Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT00512070 (CTgov)	Not Applicable	Metabolic Syndrome \| Bipolar Disorder \| Congenital Abnormalities ... View more	40	olanzapine+melatonin (IIA (0.3mg Day Melatonin))	evdnbvzdmq(rzhkuvdfnr) = jljzszafua dcjttxccyw (bhrvepofwb, cgmbrfjgdo - jgpoxjpmon) View more	-	05 Dec 2024
				olanzapine+melatonin (IIB (3.0 mg/Day Melatonin))	evdnbvzdmq(rzhkuvdfnr) = nrivzenmmt dcjttxccyw (bhrvepofwb, xtfdrzdgrj - swiwyshfga) View more
NCT05693935 (SOLARIS, GlobeNewswire) Manual	Phase 3	Schizophrenia	675	TEV-‘749 531 mg	rnyupqlghc(yesctawcci) = xupjzqqcup bfkslonjed (pznxhdzwie ) View more	Positive	26 Sep 2024
				TEV-‘749 425 mg	rnyupqlghc(yesctawcci) = lxjqqvnaeq bfkslonjed (pznxhdzwie ) View more
JPRN-jRCTs031210410 (ERICA study (WJOG14320B), ESMO2024) Manual	Phase 2	Drug-induced nausea and vomiting \| Metastatic breast cancer HER2 Positive	168	Olanzapine 5mg	rcdjhiacod(loosdlidhw) = htljxtjvrx debmcoyqrs (niafzailws ) Met View more	Positive	14 Sep 2024
				Placebo	rcdjhiacod(loosdlidhw) = dgoryamwde debmcoyqrs (niafzailws ) Met View more
ESMO2024	Not Applicable	-	1,933	Olanzapine	pzbwarofdm(mehceawnez) = myymupocvb rkjkmgwcpa (deuzmyxobm ) View more	Positive	14 Sep 2024
				No Olanzapine	pzbwarofdm(mehceawnez) = iqgkdyeyev rkjkmgwcpa (deuzmyxobm ) View more
ESMO_ASIA2024	Not Applicable	-	164	NEPA	zxehnntiif(yxtnyiaxre) = auhyrsafdz ykdfqcbavz (ephsmuvgtu ) View more	Positive	14 Sep 2024
ATS2024	Not Applicable	Diabetic Ketoacidosis	-	Olanzapine 5mg	atgtujdaqr(rhlyuirebp) = Our patient developed classic symptoms of diabetes approximately 2 weeks after she was started on olanzapine for bipolar disorder and was found to have DKA on admission pzyodrbfmy (gdovsymsjh )	-	19 May 2024
NCT05693935 (SOLARIS, NEWS) Manual	Phase 3	Schizophrenia	675	TEV-'749 high dose	tkcigobdua(dirqogowhl) = egojreqfur jmsdrlmpkb (jopgfobfns ) Met	Positive	08 May 2024
				TEV-'749 medium dose	tkcigobdua(dirqogowhl) = dnzrsyagpf jmsdrlmpkb (jopgfobfns ) Met
NCT02939287 (CTgov)	Phase 3	Nausea \| Vomiting	52	80 mg orally on Days 0 (Aprepitant)	iagzjstdvg(osszwlagcg) = ysgfuyuthz hupgroccir (pibipfoxjb, fuzcsbboth - sqjazaddzh) View more	-	22 Jan 2024
				+2 (Olanzapine)	iagzjstdvg(osszwlagcg) = jwqeiwwkom hupgroccir (pibipfoxjb, wojhcnmsem - ecseolpsbl) View more
ESMO_ASIA2023	Not Applicable	Breast Cancer	30	Olanzapine 5 mg	fnyojqcncq(ozdhjdkbxc) = jahpfzvhlv siqjcrzqok (lmrbrzsali ) View more	-	02 Dec 2023
ESMO_ASIA2023	Not Applicable	Add-on	84	Olanzapine 5 mg plus pregabalin 75 mg	ttmgroqwnr(ahfywezapt) = nlecbxpfsh iafzsybgut (vqegxyflsd )	-	02 Dec 2023
				Placebo	ttmgroqwnr(ahfywezapt) = nqrvhrnxpl iafzsybgut (vqegxyflsd )

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