Olanzapine
- Generic Name
- Olanzapine
- Brand Names
- Lybalvi, Olazax, Symbyax, Zalasta, Zypadhera, Zyprexa, Olanzapine Glenmark Europe, Olanzapine Apotex, Olanzapine Teva, Olazax Disperzi, Olanzapine Mylan, Zyprexa Velotab, Olanzapine Glenmark
- Drug Type
- Small Molecule
- Chemical Formula
- C17H20N4S
- CAS Number
- 132539-06-1
- Unique Ingredient Identifier
- N7U69T4SZR
- Background
Olanzapine is a thienobenzodiazepine classified as an atypical or second-generation antipsychotic agent. The second-generation antipsychotics were introduced in the 90s and quickly gained traction due to their impressive efficacy, reduced risk for extrapyramidal side effects and reduced susceptibility to drug-drug interactions. Olanzapine very closely resembles clozapine and only differs by two additional methyl groups and the absence of a chloride moiety. It was discovered by scientists at Eli Lilly and approved to be marketed in the US in 1996.
- Indication
Olanzapine was initially used orally and intramuscularly for the chronic treatment of schizophrenia in patients over 13 years old and other psychiatric disorders such as bipolar I disorder including mixed or manic episodes.
Olanzapine is also indicated, in combination with lithium or valproate for the short-term treatment of acute manic or mixed episodes associated with bipolar I disorder in adults.
As well, olanzapine is indicated, in combination with fluoxetine for the treatment of episodes of depression associated with bipolar disorder type 1 and treatment-resistant depression in patients over 10 years old.
Olanzapine is also approved for the management of psychomotor agitation associated with schizophrenia and bipolar I mania.
Schizophrenia is a complex biochemical brain disorder that affects the person's ability to differentiate reality. It is usually observed as the presence of delusions, hallucinations, social withdrawal and disturbed thinking.
Bipolar disorder is a mental health condition defined by periods of extreme mood disturbances. It is categorized in different types from which type 1 is known to involve episodes of severe mania and often depression while type 2 presents less severe forms of mania.
Olanzapine is also indicated in combination with samidorphan for the treatment of bipolar I disorder, either as an adjunct to lithium or valproate or as monotherapy for the acute treatment of manic or mixed episodes or as maintenance therapy, and for the treatment of schizophrenia in adults.
- Associated Conditions
- Acute Agitation, Bipolar 1 Disorder, Bipolar Disorder With Manic or Mixed Episodes, Delirium, Delusional Parasitosis, Depressive Episodes, Gilles de la Tourette's Syndrome, Major depressive disorder, recurrent episode, Mixed manic depressive episode, Post Traumatic Stress Disorder (PTSD), Psychosis, Schizophrenia, Acute Manic episode
Bristol Myers Squibb's Cobenfy Fails to Meet Primary Endpoint as Adjunctive Schizophrenia Treatment in Phase 3 ARISE Trial
• Bristol Myers Squibb's Cobenfy (xanomeline and trospium chloride) did not achieve statistical significance as an adjunctive therapy for schizophrenia in the Phase 3 ARISE trial, showing only a 2.0-point reduction in PANSS scores compared to placebo.
• Post-hoc analysis revealed that patients on non-risperidone antipsychotics showed significant improvement with Cobenfy (-3.4 points, p=0.03), while those on risperidone did not benefit from the adjunctive treatment.
• Despite the primary endpoint miss, researchers noted "noteworthy improvement" in most patients and a tolerable safety profile, with Bristol Myers Squibb planning to discuss potential next steps with regulators.
Transneural Therapeutics Unveils Novel Non-Hallucinogenic Neuroplastogens for Neuropsychiatric Disorders
• Transneural Therapeutics has emerged from stealth mode with a preclinical pipeline of non-hallucinogenic neuroplastogens designed to treat neuropsychiatric and neurodegenerative diseases.
• The company's lead candidate, TN-001, is a dual 5-HT2A partial agonist/5-HT2B antagonist engineered to deliver rapid antidepressant effects without hallucinations, targeting major depressive disorder and PTSD.
• Industry veteran Charmaine Lykins, with 30 years of CNS drug development experience, will lead Transneural as CEO following its spin-out from CaaMTech.
Optimizing Treatment Strategies for Relapsed Multiple Myeloma: From CAR T-Cell Therapy to Novel Combinations
• CAR T-cell therapy has emerged as a valuable option for multiple myeloma patients after first relapse when they are lenalidomide-refractory, with careful consideration needed for pre-treatment strategies to optimize outcomes.
• Experts recommend avoiding BCMA-targeted therapies before BCMA-directed CAR T-cell therapy, as this can lead to lower response rates and progression-free survival, while non-BCMA bispecifics like talquetamab may be effective bridging options.
• Selinexor-based combinations, including selinexor/pomalidomide/dexamethasone and selinexor/carfilzomib/dexamethasone, show promising efficacy in heavily pretreated patients with response rates of 50-65% and progression-free survival ranging from 6-15 months.
MedinCell's Olanzapine LAI Phase 3 Trial Completes, Triggering $5M Milestone Payment from Teva
• MedinCell has successfully completed the SOLARIS Phase 3 trial for their long-acting injectable olanzapine formulation in schizophrenia treatment, reaching a significant development milestone.
• The completion of the pivotal study has triggered a $5 million milestone payment from development partner Teva Pharmaceuticals, demonstrating continued progress in the program.
• The companies are advancing towards U.S. regulatory submission, aiming to address an important unmet need in schizophrenia treatment through this novel long-acting formulation.
Major Pipeline Expansion in Schizophrenia Treatment: 55+ Companies Developing 60+ Novel Therapies
• DelveInsight's latest pipeline report reveals over 55 pharmaceutical companies actively developing 60+ innovative drug candidates for schizophrenia treatment, indicating significant industry investment in addressing this serious mental illness.
• Several promising candidates are advancing in clinical trials, including Lyndra's weekly oral risperidone (LYN-005), AbbVie's selective M4 receptor PAM emraclidine, and Kynexis's cognitive function-targeting KYN-5356.
• Multiple clinical trials are scheduled for early 2025, including LB-102 for acute schizophrenia, Click Therapeutics' digital therapeutics, and Cerevel's emraclidine safety study, demonstrating diverse therapeutic approaches.
UZEDY® Exceeds Sales Expectations with $117M Revenue in First Full Year
Teva Pharmaceuticals reports UZEDY® achieved $117 million in sales for 2024, surpassing their updated outlook of $100 million. The company projects 2025 sales to reach $160 million, while MedinCell stands to receive mid- to high-single digit royalties and potential commercial milestones.
Schizophrenia Market Set for Strong Growth, Driven by Novel Therapies
• The schizophrenia market is expected to grow significantly, driven by the launch of novel therapies and increased diagnosis rates.
• Long-acting injectables (LAIs) are gaining traction despite higher costs, offering an alternative to oral antipsychotics.
• The US dominates the schizophrenia market due to a large patient population and high drug costs.
• Emerging treatments like Cobenfy, evenamide, Ingrezza, and iclepertin aim to address unmet needs in managing both positive and negative symptoms.
Imfinzi Approved for Limited-Stage Small Cell Lung Cancer, Redefining Treatment
• The FDA has approved AstraZeneca's Imfinzi (durvalumab) for treating adults with limited-stage small cell lung cancer (LS-SCLC) after platinum-based chemotherapy and radiation therapy.
• The approval was based on the ADRIATIC Phase III trial, which showed a 27% reduction in the risk of death compared to placebo, marking a significant breakthrough.
• Median overall survival improved to 55.9 months with Imfinzi versus 33.4 months with placebo, establishing a new benchmark for LS-SCLC treatment.
• Imfinzi is now the only immunotherapy approved for both limited and extensive-stage small cell lung cancer, underscoring its potential to improve survival rates.
Fremanezumab Shows Positive Phase 3 Results for Episodic Migraine Prevention in Children and Adolescents
• Teva's fremanezumab demonstrated statistically significant efficacy compared to placebo in preventing episodic migraine in children and adolescents aged 6-17 years.
• The Phase 3 SPACE trial showed a significant reduction in monthly migraine days (MMD) and monthly headache days (MHD) with fremanezumab versus placebo.
• A significantly higher percentage of children achieved a 50% response rate with fremanezumab compared to placebo (47.2% vs 27.0%).
• Fremanezumab was well-tolerated, with a safety profile consistent with that observed in adults, offering a potential new treatment option for young migraine sufferers.
DATROWAY® (Datopotamab Deruxtecan) Receives EU Approval for Previously Treated Metastatic HR+/HER2- Breast Cancer
• DATROWAY, a TROP2-directed antibody drug conjugate (ADC), has been approved in the European Union for treating adult patients with unresectable or metastatic HR+/HER2- breast cancer who have received endocrine therapy and at least one line of chemotherapy.
• The approval is based on the TROPION-Breast01 phase 3 trial, which showed DATROWAY reduced the risk of disease progression or death by 37% compared to chemotherapy, with a median PFS of 6.9 months versus 4.9 months.
• This marks the second ADC approved for breast cancer based on Daiichi Sankyo's DXd technology and the third medicine from their oncology pipeline to receive EU approval, highlighting their commitment to developing innovative cancer treatments.
Olanzapine LAI Shows Promise in Schizophrenia Treatment with Improved Safety Profile
• Phase III data for TEV-'749, an olanzapine long-acting injectable (LAI), demonstrates significant improvement in social functioning and quality of life for schizophrenia patients.
• TEV-'749 shows no incidents of post-injection delirium/sedation syndrome (PDSS), a major barrier for existing olanzapine LAIs due to FDA black box warning.
• Real-world data indicates high use and adherence rates for subcutaneous UZEDY® (risperidone) LAI in adults with schizophrenia facing treatment barriers.
• UZEDY was employed as a first-line treatment option in 12% of cases, suggesting its potential as an early intervention for schizophrenia.
Teva's TEV-749 Shows Promise in Phase III Trial for Schizophrenia
• Teva's TEV-749 (olanzapine) demonstrated statistically significant improvements in schizophrenia symptoms in the Phase III SOLARIS trial over eight weeks.
• The trial assessed three doses of TEV-749, showing improvements in social functioning and quality of life compared to placebo.
• TEV-749, administered via subcutaneous injection, aims to improve patient adherence and reduce the risk of post-injection delirium/sedation syndrome (PDSS).
• If approved, TEV-749 is projected to reach annual sales of $315 million by 2030 in the US, offering a new long-acting treatment option.
Teva's Olanzapine LAI Shows Positive Phase 3 Results for Schizophrenia
• Teva presented Phase 3 SOLARIS trial data showing Olanzapine LAI significantly improved social functioning and quality of life in schizophrenia patients.
• The study reported no cases of Post-Injection Delirium/Sedation Syndrome (PDSS) with Medincell's subcutaneous delivery technology.
• Real-world data on UZEDY demonstrated high adherence rates among schizophrenia patients with social vulnerabilities.
• UZEDY's usage data highlights the need for innovative treatments to address the challenges faced by individuals with schizophrenia.
Teva's TEV-‘749 Shows Positive Phase 3 Results for Schizophrenia Treatment
• Teva's TEV-‘749 demonstrated significant improvement in social functioning and quality of life in schizophrenia patients during the Phase 3 SOLARIS trial.
• The systemic safety profile of TEV-‘749 was consistent with approved oral olanzapine formulations, with no new safety signals identified.
• In vitro data and Phase 1 results suggest TEV-‘749's delivery method may mitigate the risk of Post-Injection Delirium/Sedation Syndrome (PDSS).
• The data, focusing on patient outcomes, were presented at Psych Congress 2024, highlighting the potential of TEV-‘749 as a schizophrenia treatment.
Schizophrenia Clinical Trial Pipeline Boasts 60+ Drugs Under Development
• The schizophrenia treatment landscape is expanding with over 60 drugs in active development, driven by increased R&D and innovative therapies.
• Key players like Sumitomo Pharma, Boehringer Ingelheim, and Reviva Pharmaceuticals are advancing novel antipsychotics and personalized medicine approaches.
• Recent progress includes positive Phase III trial results for brilaroxazine and LY03020's IND approval in China, signaling potential new treatment options.
• COBENFY, a first-in-class muscarinic agonist, received FDA approval, marking a significant advancement in schizophrenia treatment after 35 years.
Teva's TEV-749 Shows Promise in Schizophrenia Treatment with No PDSS Incidence
• Teva's TEV-749, a once-monthly subcutaneous olanzapine injection, significantly improved schizophrenia symptoms in a Phase 3 trial, meeting its primary endpoint.
• The SOLARIS trial demonstrated statistically significant improvements in PANSS, CGI-S, and PSP scores compared to placebo at week 8 across three dosing groups.
• Notably, no cases of post-injection delirium/sedation syndrome (PDSS) were observed, a significant advantage over existing long-acting olanzapine treatments.
• The safety profile of TEV-749 was consistent with oral olanzapine, with long-term safety data expected in the first half of 2025.
FDA Approves Cobenfy, a Novel Schizophrenia Treatment Targeting Cholinergic Receptors
• The FDA has approved Cobenfy (xanomeline and trospium chloride) as the first new class of drug for schizophrenia in over 30 years, offering a novel approach to treatment.
• Cobenfy targets muscarinic receptors, unlike traditional antipsychotics that focus on dopamine, potentially reducing side effects like weight gain and movement disorders.
• Clinical trials demonstrated Cobenfy significantly reduced schizophrenia symptoms compared to placebo, marking a transformative moment in managing this challenging condition.
• Expected to launch in late October, Cobenfy offers a new option for adults with schizophrenia, with ongoing studies exploring its potential in Alzheimer's psychosis and other conditions.
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