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Last update 30 Apr 2025

Olanzapine

Last update 30 Apr 2025

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 HTR3 x D2 receptor

Action

antagonists

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(5-hydroxytryptamine receptors, ionotropic (HTR3) 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

European Union (27 Sep 1996),

Bipolar DisorderManiaSchizophrenia

RegulationPriority Review (China)

Structure/Sequence

Molecular FormulaC17H20N4S

InChIKeyKVWDHTXUZHCGIO-UHFFFAOYSA-N

CAS Registry132539-06-1

541

Clinical Trials associated with Olanzapine

NCT06850454

/ RecruitingPhase 3IIT

A Prospective Randomized, Double-blind Controlled Trial of Olanzapine Versus Placebo in Addition to Ondansetron Plus Dexamethasone As Antiemetic Prophylaxis in Patients Receiving Moderately Emetogenic Chemotherapy

A study comparing efficacy of olanzapine versus placebo to prevent nausea and vomiting from moderate emetic risk chemotherapy

Start Date10 Jan 2025

Sponsor / Collaborator

Mahidol University

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

IRCT20120215009014N541

/ RecruitingPhase 3IIT

Effect of olanzapine plus Rhus coriaria versus olanzapine plus placebo on the lipid profile of patients with bipolar disorder: a double-blind randomized clinical trial

Start Date21 Dec 2024

Sponsor / Collaborator

Hamedan University of Medical Sciences

100 Clinical Results associated with Olanzapine

100 Translational Medicine associated with Olanzapine

100 Patents (Medical) associated with Olanzapine

13,353

Literatures (Medical) associated with Olanzapine

01 Aug 2025·JOURNAL OF AFFECTIVE DISORDERS

A double-blind, placebo-controlled trial of exenatide for the treatment of olanzapine-related weight gain in obese and overweight adults

Article

Author: DelBello, Melissa P ; Welge, Jeffrey A ; Adler, Caleb M ; Patino, Luis R ; Blom, Thomas J ; Strawn, Jeffrey R

OBJECTIVE:

To assess the safety and efficacy of exenatide in overweight or obese patients treated with olanzapine.

METHODS:

Adults with stable major mood or psychotic disorders were randomized to double-blind exenatide or placebo for 16 weeks. Weight and body mass index (BMI) were monitored throughout the study. A secondary objective was to evaluate the tolerability of exenatide and its effects on mood and psychotic symptoms.

RESULTS:

A significant difference in weight change was detected between the treatment groups. Participants in the exenatide group experienced on average a minor weight loss, while participants in the placebo group on average experienced weight gain (-0.5 kg [-0.6 %] vs. +2.6 kg [+2.8 %], both p < .01). The most common side effects in the exenatide group were gastrointestinal symptoms and headaches. There were no clinically meaningful differences between the groups in changes to mood or psychotic symptoms.

CONCLUSIONS:

Exenatide is effective and well-tolerated for attenuating olanzapine-associated weight gain.

CLINICAL TRIAL REGISTRATION INFORMATION:

Exenatide for the Treatment of Weight Gain Associated with Olanzapine in Obese Adults. NCT00845507.

01 Jul 2025·JOURNAL OF AFFECTIVE DISORDERS

Prediction of remission of pharmacologically treated psychotic depression: A machine learning approach

Article

Author: Banerjee, Samprit ; Bingham, Kathleen S ; Marino, Patricia ; Meyers, Barnett S ; Whyte, Ellen M ; Mulsant, Benoit H ; Flint, Alastair J ; Alexopoulos, George S ; Neufeld, Nicholas H ; Rothschild, Anthony J ; Carter, Emily ; Voineskos, Aristotle N

BACKGROUND:

The combination of antidepressant and antipsychotic medication is an effective treatment for major depressive disorder with psychotic features ('psychotic depression'). The present study aims to identify sociodemographic and clinical predictors of remission of psychotic depression treated with combination pharmacotherapy and determine the accuracy of prediction models.

METHODS:

Two hundred and sixty-nine participants aged 18 to 85 years with psychotic depression were acutely treated with protocolized sertraline plus olanzapine for up to 12 weeks. Three cross-validated machine learning models were implemented to predict remission based on 74 sociodemographic and clinical variables measured at acute baseline. The optimal model for each method was selected by the average fold C-index. Based on the performance of each method, grouped elastic net (cox) regression was chosen to examine the association of each predictor with remission of psychotic depression.

RESULTS:

Of the 269 participants, 145 (53.9 %) experienced full remission of the depressive episode and psychotic features. Multivariable models had 65.1 % to 67.4 % accuracy in predicting remission. In the grouped elastic net (cox) regression model, longer duration of index episode, somatic or tactile hallucinations, higher burden of comorbid physical problems, and single or divorced marital status were independent predictors of longer time to remission. A higher number of lifetime depressive episodes and peripheral vascular or cardiovascular disease were predictors of shorter time to remission.

CONCLUSIONS:

Future research needs to determine whether the addition of biomarkers to clinical and sociodemographic variables can improve model accuracy in predicting remission of pharmacologically-treated psychotic depression.

01 Jun 2025·JOURNAL OF PSYCHIATRIC RESEARCH

Antipsychotic-like pharmacological profile of the low impact ampakine CX691 (farampator): Implications for the use of low impact ampakines in the treatment of schizophrenia

Article

Author: Witkin, Jeffrey M ; Smith, Jodi L ; Lippa, Arnold ; Cerne, Rok ; Radin, Daniel P

Ampakines, positive allosteric modulators of AMPA-glutamate receptors (AMPAR), have therapeutic implications in neuropsychiatric and neurological disorders in which AMPAR signaling is compromised such as Alzheimer's, ADHD, and schizophrenia. Low impact ampakines are a distinct subset of ampakines that only partially offset receptor desensitization and do not meaningfully alter binding affinity of AMPAR agonists, which may explain their lack of seizurogenic effects seen with other AMPAR positive modulators. Herein, we describe the preclinical pharmacology and antipsychotic activity of the low impact ampakine 1-(benzofurazan-5-ylcarbonyl)piperidine (CX691). CX691 moderately offsets desensitization in hippocampal patches, supporting its designation as a low impact ampakine and penetrates the blood-brain barrier. CX691 is more potent than well characterized high impact ampakines CX614 and CX546 and low impact ampakine CX516 in abrogating amphetamine-stimulated locomotor activity in Sprague Dawley rats. Low-dose CX691 synergistically reduces methamphetamine-induced locomotor activity when paired with approved antipsychotics clozapine and olanzapine. In rats treated chronically with amphetamine, CX691 retains antipsychotic activity whereas high doses of CX516 lack therapeutic effects. In contrast to haloperidol, CX691 is devoid of cataleptic activity at supratherapeutic doses in rats. CX691 enhances performance in the eight-arm radial maze, a spatial task that assesses hippocampal function, an activity of potential value for ameliorating cognitive deficits in schizophrenia. Taken together, these findings illustrate that low impact ampakines with improved potency might be useful therapeutic interventions in schizophrenic patients when given alone or as adjuncts to ongoing traditional antipsychotic drug therapies.

158

News (Medical) associated with Olanzapine

23 Apr 2025

·www.prnewswire.com

J&J and Eli Lilly Concealed Breast Cancer Risks in Blockbuster Antipsychotics for Decades, Wisner Baum Lawsuit Alleges

ALAMEDA, Calif., April 23, 2025 /PRNewswire/ -- A lawsuit filed in Alameda County Superior Court alleges pharmaceutical giants Johnson & Johnson and Eli Lilly knowingly concealed evidence that their blockbuster antipsychotic medications Risperdal (risperidone) and Zyprexa (olanzapine) cause breast cancer. Attorneys from Wisner Baum filed the complaint on behalf of plaintiff Bridgett Brown, who was prescribed both brand-name and generic versions of Risperdal and Zyprexa. She was diagnosed with breast cancer in approximately 2024. This is the first lawsuit to allege that these antipsychotic drugs cause breast cancer. The complaint centers on the drugs' capacity to cause hyperprolactinemia—a hormonal imbalance directly tied to breast cancer development. Recent studies cited in the lawsuit show significant increased breast cancer risks: 62% increased breast cancer risk for high-prolactin drugs like Risperdal and 54% increased risk for medium-prolactin drugs like Zyprexa – A study of 540,737 women (Rahman, 2023) 59% increased breast cancer risk for Risperdal – A review of 15 studies conducted on over 1 million individuals (Bird, 2025) 47% increased breast cancer risk after 5+ years of exposure to prolactin-increasing antipsychotics like Risperdal and Zyprexa – A Swedish registry study of 132,061 women (Solmi, 2024) Atypical antipsychotic drugs were initially approved for treating severe schizophrenia. However, the lawsuit alleges the drug manufacturers broadened their customer bases by gaining approval for milder indications and promoting off-label use, including ADD in children and dementia in the elderly, generating billions in profits. "These companies transformed narrow-use schizophrenia drugs into multi-billion-dollar per year blockbusters by targeting extremely vulnerable segments of our population, all while hiding a cancer risk they've known about for decades," said Pedram Esfandiary, attorney for Ms. Brown. The lawsuit alleges that despite knowledge dating back to the 1990s connecting these drugs to hyperprolactinemia, drug labels denied any cancer risk, stating until 2025, "neither clinical trials nor epidemiological studies conducted to date have shown an association between chronic administration of this class of drugs and tumorigenesis in humans." "The science has been clear on prolactin-elevating antipsychotics for decades," said Monique Alarcon, attorney for Ms. Brown. "These companies had a duty to inform; they failed, and now individuals nationwide are suffering the consequences. We intend to hold them accountable." The lawsuit seeks compensatory and punitive damages, alleging strict liability for failure to warn, negligence, and fraud. The case is Brown v. Johnson & Johnson et al (Case No. 25CV119808). Read the complaint here. The award-winning law firm of Wisner Baum has successfully litigated cases against many of the largest pharmaceutical companies in the world. Since 1985, the firm has earned a reputation for breaking new legal ground, holding corporations accountable, influencing public policy, and raising public awareness on important safety issues. Using its longstanding tradition of success in the courtroom, the firm always strives to expose unsafe products or harmful practices to protect consumers from dangerous products. The firm has won over $4 billion in settlements and verdicts across all practice areas. MEDIA CONTACT Steve Crighton, [email protected] SOURCE Wisner Baum WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

Patent Infringement

16 Apr 2025

·www.prnewswire.com

NEURELIS ANNOUNCES FDA APPROVAL FOR IMMEDIATE USE SEIZURE MEDICATION VALTOCO® (DIAZEPAM NASAL SPRAY) IN AGES 2 TO 5

VALTOCO maintains orphan drug exclusivity for VALTOCO to treat episodes of frequent seizures SAN DIEGO, April 16, 2025 /PRNewswire/ -- Neurelis, Inc., today announced that the U.S. Food and Drug Administration (FDA) has approved VALTOCO® (diazepam nasal spray) for short-term treatment of seizure clusters (also known as "acute repetitive seizures") that are different from a person's normal seizure pattern in people 2 years of age and older. VALTOCO is a proprietary formulation which utilizes an absorption enhancement technology, INTRAVAIL®, to enable the noninvasive, enhanced intranasal delivery of diazepam. The intranasal formulation of Neurelis' VALTOCO was previously recognized by the FDA as clinically superior to the rectal gel formulation of diazepam resulting in its orphan drug exclusivity designation. "We are so grateful for all those who participated in the clinical study to enable VALTOCO to reach this milestone, especially the patients and families whose participation in the trial helped expand access to a unique immediate-use medication to help stop an episode of frequent seizures," said Craig Chambliss, Neurelis Founder and CEO. "The FDA's decision to approve VALTOCO for use in early childhood highlights the established balanced safety and efficacy profile," commented Eric Segal, MD, Director of Pediatric Epilepsy at Northeast Regional Epilepsy Group and Hackensack University Medical Center. "VALTOCO fills a large unmet need for children with seizures and their families. I am hopeful that this product will improve quality of life for this specific population." Approximately 3.4 million people in the U.S. have epilepsy, including 400,000 children. While chronic epilepsy can be controlled by medications, some patients are at risk of episodes of frequent seizures, or acute repetitive seizures. "For children who have episodes of frequent seizures, the current standard of care requiring rectal administration of medication to stop a seizure can be a significant challenge for caregivers and children alike," added Jurriaan M Peters, MD, PhD, Director, Localization Laboratory, Division of Epilepsy and Clinical Neurophysiology, Boston Children's Hospital, and Associate Professor in Neurology at Harvard Medical School. "Approval of an immediate-use intranasal diazepam treatment that can be given at any time, even while a child is actively seizing, in this young age group is an important advance for the epilepsy community." Data from the phase 1/2a clinical study evaluating safety and pharmacokinetics demonstrated that VALTOCO is safe and effective with easy nasal administration for patients aged 2 years and older who have episodes of frequent seizures. The company presented data on the study at the 53rd Annual Child Neurology Society Meeting in November 2024 in San Diego and Annual American Epilepsy Society Meeting in December 2024 in Los Angeles. 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 2 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 2 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 1Orphan DrugClinical Result

07 Apr 2025

·www.prnewswire.com

NEURELIS WILL HIGHLIGHT ANALYSES OF SEIZURE TREATMENT WITH DIAZEPAM NASAL SPRAY AT THE AMERICAN ACADEMY OF NEUROLOGY ANNUAL MEETING

Presentations include post hoc analyses assessing at home treatment of status epilepticus, acute seizure termination and rapid and early seizure termination, and treatment of prolonged seizures SAN DIEGO, April 7, 2025 /PRNewswire/ -- Neurelis, Inc., today announced details of three poster presentations at the American Academy of Neurology (AAN) Annual Meeting to be held April 5-9 in person in San Diego and online. The presentations include post hoc analyses of clinical data prospectively collected from studies of diazepam nasal spray as an immediate-use seizure medication for treatment of episodes of frequent seizures. Presentation topics include evaluation of early at home treatment for status epilepticus (SE), acute seizure termination and rapid and early seizure termination, and treatment of prolonged seizures. "We are pleased to join the neurology community at this year's AAN Annual Meeting to discuss the latest learnings on treatments for people with epilepsy and other neurological disorders," said Adrian L. Rabinowicz, MD, Neurelis Chief Medical Officer. "We look forward to sharing our additional analyses of data from studies of immediate-use seizure medication and joining the dialogue on clinical research that has the potential to meaningfully impact those living with the challenges of epilepsy." Neurelis' Annual Meeting presentations include the following. Poster Session 8 – April 8, 8:00 AM-9:00 AM PT: Treatment of Status Epilepticus At and After T1 With Diazepam Nasal Spray: A Combined Cohort Analysis A post hoc analysis of pooled data from two long-term, open-label safety studies was conducted to investigate treatment of early SE episodes in patients with epilepsy aged 2-65 years. Early SE episodes were defined as seizures continuing after Time Point 1 (t1) (5 minutes for generalized seizures; 10 minutes for focal and unclassified seizures). For patients with seizure episodes reaching t1 (671 events of t1 SE in 97 patients), diazepam nasal spray provided timely control of SE episodes. Overall, safety was generally consistent with the established profile of diazepam nasal spray, and most episodes did not result in hospitalization due to serious treatment emergent adverse events (TEAEs) for SE. Additionally, in a responder analysis, the majority of early SE seizures terminated prior to Time Point 2 (when neuronal injury may occur: 30 and 60 minutes for generalized and focal seizures, respectively). Poster Session 12 – April 9, 11:45 AM-12:45 PM PT: Treatment of Prolonged Seizure with Diazepam Nasal Spray: A Post Hoc Cohort Analysis To assess effectiveness of diazepam nasal spray in treating prolonged seizures (5-15 minutes post onset) within seizure clusters (727 events), a post hoc subgroup analysis of data from the long-term safety study of diazepam nasal spray in patients aged 6-65 years was conducted. Across age, seizure type, and high treatment usage subgroups, generally similar times to seizure termination were observed. Use of second doses within 24 hours for prolonged seizures was low (9.3%) and generally consistent across subgroups, demonstrating preserved first-dose effectiveness in seizures that have become prolonged. 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 Clinical data from the long-term safety study of diazepam nasal spray in patients aged 6-65 years was analyzed to determine whether it could support the recent expert consensus recommendations to terminate acute clusters and ongoing seizures that are expected to be prolonged. The effectiveness of diazepam nasal spray to prevent further seizures in a cluster was demonstrated by the low use of second doses across 24 hours. Rapid and early seizure termination was demonstrated in a dataset of 3225 administrations. Notably, for treatment within 5 minutes of seizure onset, rapid time to seizure termination reinforced the importance of early treatment. The American Academy of Neurology and its members are focused on promoting brain health by advancing what is possible in brain disease treatment, cures, and prevention. Neurelis' work supports this mission with a dedication to improving quality of life for people with epilepsy and other neurologic disorders. 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.

to view more data

Indication	Country/Location	Organization	Date
Chemotherapy-induced nausea and vomiting	Japan	CHEPLAPHARM Arzneimittel GmbH	25 Dec 2017
Chemotherapy-induced nausea and vomiting	Japan	Eli Lilly & Co.	25 Dec 2017
Agitation	United States	CHEPLAPHARM Arzneimittel GmbH	19 Mar 2009
Depressive Disorder	United States	CHEPLAPHARM Arzneimittel GmbH	19 Mar 2009
Depressive Disorder, Treatment-Resistant	United States	CHEPLAPHARM Arzneimittel GmbH	19 Mar 2009
Bipolar and Related Disorders	China	Eli Lilly & Co.	01 Jan 2006
Bipolar I disorder	United States	CHEPLAPHARM Arzneimittel GmbH	30 Sep 1996
Bipolar Disorder	European Union	CHEPLAPHARM Arzneimittel GmbH	27 Sep 1996
Bipolar Disorder	Iceland	CHEPLAPHARM Arzneimittel GmbH	27 Sep 1996
Bipolar Disorder	Liechtenstein	CHEPLAPHARM Arzneimittel GmbH	27 Sep 1996
Bipolar Disorder	Norway	CHEPLAPHARM Arzneimittel GmbH	27 Sep 1996
Mania	European Union	CHEPLAPHARM Arzneimittel GmbH	27 Sep 1996
Mania	Iceland	CHEPLAPHARM Arzneimittel GmbH	27 Sep 1996
Mania	Liechtenstein	CHEPLAPHARM Arzneimittel GmbH	27 Sep 1996
Mania	Norway	CHEPLAPHARM Arzneimittel GmbH	27 Sep 1996
Schizophrenia	European Union	CHEPLAPHARM Arzneimittel GmbH	27 Sep 1996
Schizophrenia	Iceland	CHEPLAPHARM Arzneimittel GmbH	27 Sep 1996
Schizophrenia	Liechtenstein	CHEPLAPHARM Arzneimittel GmbH	27 Sep 1996
Schizophrenia	Norway	CHEPLAPHARM Arzneimittel GmbH	27 Sep 1996

Developing

10 top R&D records.

to view more data

Indication	Highest Phase	Country/Location	Organization	Date
Solid tumor	Phase 3	China	Jiangsu Hansoh Pharmaceutical Co., Ltd.	01 Oct 2020
Vomiting	Phase 3	China	Jiangsu Hansoh Pharmaceutical Co., Ltd.	01 Oct 2020
Gambling	Phase 3	United States	Eli Lilly & Co.	01 Feb 2007
Weight Gain	Phase 3	United States	Eli Lilly & Co.	01 Nov 2006
Weight Gain	Phase 3	Brazil	Eli Lilly & Co.	01 Nov 2006
Weight Gain	Phase 3	Israel	Eli Lilly & Co.	01 Nov 2006
Weight Gain	Phase 3	Mexico	Eli Lilly & Co.	01 Nov 2006
Weight Gain	Phase 3	Puerto Rico	Eli Lilly & Co.	01 Nov 2006
Weight Gain	Phase 3	Russia	Eli Lilly & Co.	01 Nov 2006
Weight Gain	Phase 3	South Korea	Eli Lilly & Co.	01 Nov 2006

Clinical Result

Indication

Phase

Evaluation

View All Results

Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


P7-12.004 (AAN2025)	Not Applicable	Migraine Disorders	59	Olanzapine 2.5 mg	vjranovvky(zrsprkydbo) = rebxzvnaer ecbbaufivl (hdlqxurqbg )	Positive	07 Apr 2025
				Olanzapine 5 mg	vjranovvky(zrsprkydbo) = tjnfzacpjo ecbbaufivl (hdlqxurqbg )
ASCO_GU2025	Not Applicable	Drug-Related Side Effects and Adverse Reactions	60	Olanzapine	yliwdpkhto(ugfuirxjxf) = wnxxitimzg jqbxewcbhq (osyukjhvfz, 2.0 - 10.7)	Positive	13 Feb 2025
ESMO_ASIA2024	Not Applicable	Neoplasms	164	NEPA	ugvnvavlxz(rophckfyds) = utvpveixys hvnfzohogr (wqjnjdgvbr ) View more	Positive	07 Dec 2024
NCT00512070 (CTgov)	Not Applicable	Bipolar Disorder \| Schizoaffective disorder \| Schizophrenia	40	olanzapine+melatonin (IIA (0.3mg Day Melatonin))	itupwqcjxs(sgdohyqvfv) = oottrgrhqc omrwdbvnhh (irmyfphdjx, 9.69) View more	-	05 Dec 2024
				olanzapine+melatonin (IIB (3.0 mg/Day Melatonin))	itupwqcjxs(sgdohyqvfv) = gosccdmybi omrwdbvnhh (irmyfphdjx, 10.12) View more
NCT05693935 (SOLARIS, GlobeNewswire) Manual	Phase 3	Schizophrenia	675	TEV-‘749 531 mg	vxdiywdbxg(vuouysnndq) = vevkuxafpd xfzlltkprm (ryprfzlbuf ) View more	Positive	26 Sep 2024
				TEV-‘749 425 mg	vxdiywdbxg(vuouysnndq) = gwceewzhlf xfzlltkprm (ryprfzlbuf ) View more
JPRN-jRCTs031210410 (ERICA study (WJOG14320B), ESMO2024) Manual	Phase 2	Drug-induced nausea and vomiting \| Metastatic breast cancer HER2 Positive	168	Olanzapine 5mg	dvlkmozybo(vgcpvepftd) = qzjkoiftel klmuxncaag (cqewcdozam ) Met View more	Positive	14 Sep 2024
				Placebo	dvlkmozybo(vgcpvepftd) = enntacryvg klmuxncaag (cqewcdozam ) Met View more
ESMO2024	Not Applicable	-	1,933	Olanzapine	eruhtanicl(cizlseedzr) = qfvrtmlxdz ocdjwdvnae (bnavhbzmtl ) View more	Positive	14 Sep 2024
				No Olanzapine	eruhtanicl(cizlseedzr) = rvqfizgvvh ocdjwdvnae (bnavhbzmtl ) View more
ATS2024	Not Applicable	Diabetic Ketoacidosis	-	Olanzapine 5mg	usbbefhiyt(gcdqpybguy) = 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 tzmxsdkbah (upqhemegas )	-	19 May 2024
NCT05693935 (SOLARIS, NEWS) Manual	Phase 3	Schizophrenia	675	TEV-'749 high dose	xrgobkqhjs(rosufhfzqq) = avgttwjnms qcmgbiqmnk (xnzfmrbzts ) Met	Positive	08 May 2024
				TEV-'749 medium dose	xrgobkqhjs(rosufhfzqq) = qjodgkxmxt qcmgbiqmnk (xnzfmrbzts ) Met
NCT02939287 (CTgov)	Phase 3	Nausea \| Vomiting	52	80 mg orally on Days 0 (Aprepitant)	vlioqxgpjy = anzajqsasi hgbvmawhlf (pgtyomevol, ghfsswxlcg - gefupykskm) View more	-	22 Jan 2024
				+2 (Olanzapine)	vlioqxgpjy = nxjsvthimm hgbvmawhlf (pgtyomevol, jxwrptyefn - wkrkgflwvv) View more

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