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Olanzapine | CAS No: 132539-06-1 | GMP-certified suppliers
A medication that supports the management of schizophrenia and bipolar I disorder, including manic, mixed, and depressive episodes, helping stabilize mood and reduce key psychiatric symptoms for diverse treatment settings.
Therapeutic categories
Primary indications
- 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
- [FDA label]
Product Snapshot
- Oral and intramuscular small‑molecule antipsychotic available in multiple tablet, ODT, and injectable powder presentations
- Used for schizophrenia, bipolar I disorder (manic, mixed, and depressive episodes), treatment‑resistant depression in combination with fluoxetine, and management of psychomotor agitation
- Approved in the US, EU, and Canada, with some investigational uses noted
Clinical Overview
Olanzapine exerts therapeutic effects through antagonism of multiple central receptors. Its clinical efficacy in reducing hallucinations, delusions, disorganized thought, and other positive symptoms of schizophrenia is primarily linked to dopamine D2 receptor blockade in mesolimbic pathways. Antagonism at serotonin 5HT2A receptors contributes to mitigation of negative symptoms and may limit the risk of extrapyramidal effects. Additional activity occurs at D1, D3, D4, 5HT2C, 5HT3, 5HT6, alpha-1 adrenergic, H1 histamine, and several muscarinic receptors. Dissociable binding at D2 receptors allows partial preservation of dopamine signaling, consistent with the tolerability profile typical of second-generation antipsychotics.
Olanzapine has been investigated for chemotherapy-induced nausea and vomiting, where antagonism of dopamine and serotonin receptor pathways involved in emesis has demonstrated benefit in clinical studies.
Absorption, distribution, metabolism, and elimination parameters vary with formulation and patient-specific factors. Olanzapine is a substrate of CYP1A2 and UGT1A4 and can inhibit CYP2C19, CYP2C9, CYP2D6, and CYP3A isoforms to varying degrees. It is also a P-glycoprotein substrate.
Safety considerations include risks of metabolic effects such as weight gain and hyperglycemia, orthostatic hypotension related to alpha-1 blockade, sedation linked to H1 antagonism, anticholinergic effects, and potential QTc prolongation. Use with other serotonergic drugs requires caution due to serotonin syndrome risk.
For API procurement, ensure compliance with pharmacopoeial specifications, robust impurity control for thienobenzodiazepine derivatives, validated potency assays, and secure supply chain documentation suitable for regulatory submissions.
Identification & chemistry
| Generic name | Olanzapine |
|---|---|
| Molecule type | Small molecule |
| CAS | 132539-06-1 |
| UNII | N7U69T4SZR |
| DrugBank ID | DB00334 |
Pharmacology
| Summary | Olanzapine is an atypical antipsychotic that exerts therapeutic effects mainly through antagonism of dopamine D2 and serotonin 5HT2A receptors, with additional activity at multiple serotonergic, dopaminergic, adrenergic, histaminergic, and muscarinic targets. Its broad receptor profile modulates key neurotransmitter pathways involved in psychosis, mood regulation, and nausea. The drug’s relatively rapid dissociation from D2 receptors supports antipsychotic activity while permitting partial dopamine signaling. |
|---|---|
| Mechanism of action | The activity of olanzapine is achieved by the antagonism of multiple neuronal receptors including the dopamine receptor D1, D2, D3 and D4 in the brain, the serotonin receptors 5HT2A, 5HT2C, 5HT3 and 5HT6, the alpha-1 adrenergic receptor, the histamine receptor H1 and multiple muscarinic receptors. As abovementioned, olanzapine presents a wide profile of targets, however, its antagonistic effect towards the dopamine D2 receptor in the mesolimbic pathway is key as it blocks dopamine from having a potential action at the post-synaptic receptor. The binding of olanzapine to the dopamine D2 receptors is easily dissociable and hence, it allows for a certain degree of dopamine neurotransmission. On the other hand, olanzapine acts in the serotonin 5HT2A receptors in the frontal cortex in a similar manner than the reported on dopamine D2 receptors. This determined effect allows for a decrease in adverse effects. |
| Pharmacodynamics | The effect of olanzapine in the D2 receptor is reported to produce the positive effects of this drug such as a decrease in hallucinations, delusions, disorganized speech, disorganized thought, and disorganized behavior. On the other hand, its effect on the serotonin 5HT2A receptor prevents the onset of anhedonia, flat affect, alogia, avolition and poor attention.Based on the specific mechanism of action, olanzapine presents a higher affinity for the dopamine D2 receptor when compared to the rest of the dopamine receptor isotypes. This characteristic significantly reduces the presence of side effects. Clinical trials for the original use of olanzapine demonstrated significant effectiveness in the treatment of schizophrenia and bipolar disorder in adults and acute manic or mixed episodes associated with bipolar disorder in adolescents. The effect of olanzapine on dopamine and serotonin receptors has been suggested to reduce chemotherapy-induced nausea and vomiting as those receptors are suggested to be involved in this process. For this effect, several clinical trials have been conducted and it has been shown that olanzapine can produce a significant increase in total control of nausea and vomiting.In a high-level study of the effect of olanzapine for this condition, a complete response on the delay phase was observed in 84% of the individual and control of emesis of over 80% despite the phase. |
Targets
| Target | Organism | Actions |
|---|---|---|
| 5-hydroxytryptamine receptor 2A | Humans | antagonist |
| Dopamine D2 receptor | Humans | antagonist |
| Dopamine D1 receptor | Humans | antagonist |
ADME / PK
| Absorption | Olanzapine presents a linear pharmacokinetic profile and, after daily administration, it reaches steady-state in about a week.Under the administration of a normal dosage of olanzapine, the steady-state plasma concentration does not seem to exceed 150 ng/ml with an AUC of 333 ng/h/ml. The absorption of olanzapine is not affected by the concomitant administration of food. The pharmacokinetic profile of olanzapine is characterized by reaching peak plasma concentration of 156.9 ng/ml approximately 6 hours after oral administration. |
|---|---|
| Half-life | Olanzapine presents a half-life ranging between 21 to 54 hours with an average half-life of 30 hours. |
| Protein binding | Olanzapine is largely bound to plasma proteins and hence, about 93% of the administered dose is bound. The main proteins for binding are albumin and alpha-1 acid glycoprotein. |
| Metabolism | Olanzapine is greatly metabolized in the liver, which represents around 40% of the administered dose, mainly by the activity of glucuronide enzymes and by the cytochrome P450 system. From the CYP system, the main metabolic enzymes are CYP1A2 and CYP2D6.As part of the phase I metabolism, the major circulating metabolites of olanzapine, accounting for approximate 50-60% of this phase, are the 10-N-glucuronide and the 4'-N-desmethyl olanzapine which are clinically inactive and formed by the activity of CYP1A2.On the other hand, CYP2D6 catalyzes the formation of 2-OH olanzapine and the flavin-containing monooxygenase (FMO3) is responsible for N-oxide olanzapine. On the phase II metabolism of olanzapine, UGT1A4 is the key player by generating direct conjugation forms of olanzapine. |
| Route of elimination | Olanzapine is mainly eliminated through metabolism and hence, only 7% of the eliminated drug can be found as the unchanged form. It is mainly excreted in the urine which represents around 53% of the excreted dose followed by the feces that represent about 30%. |
| Volume of distribution | The volume of distribution of olanzapine is reported to be of 1000 liters which indicate a large distribution throughout the body. |
| Clearance | The mean clearance rate of olanzapine is of 29.4 L/hour however, some studies have reported an apparent clearance of 25 L/h. |
Formulation & handling
- Oral formulations rely on a lipophilic small molecule with low aqueous solubility, so solid‑dose designs typically use solubility‑enhancing excipients but are not constrained by food effects.
- Intramuscular products use lyophilized powder or extended‑release suspensions, requiring controlled reconstitution or suspension preparation and protection from moisture.
- The solid, moderately lipophilic API should be handled with attention to particle-size control and uniformity to ensure consistent content in tablets and ODT forms.
Regulatory status
| Lifecycle | Most core patent protections for this API lapsed between 2011 and 2018 across the US and Canada, indicating that exclusivity has ended. With products marketed in Canada, the US, and the EU, the API is in a mature, post‑patent phase characterized by established multi‑market availability. |
|---|
| Markets | Canada, US, EU |
|---|
Supply Chain
| Supply chain summary | Olanzapine is originally developed by a single originator company, with a large number of repackagers and distributors indicating a mature and widely dispersed supply chain. The product is marketed across major regions including the United States, Canada, and the European Union. Key patents expired between 2011 and 2018, aligning with the extensive availability of generic versions in these markets. |
|---|
Safety
| Toxicity | The toxicity symptoms of olanzapine are known to include somnolence, mydriasis, blurred vision, respiratory depression, hypotension, extrapyramidal symptoms and anticholinergic effects. The overdosage effects in children are generally associated with more significant side effects. The maximum registered dosage of olanzapine in clinical trials was of 300 mg and it was reported to present drowsiness and slurred speech. However, on post-marketing surveillance, a wide range of symptoms have been presented including agitation, dysarthria, tachycardia, extrapyramidal symptoms, and reduced consciousness. One case of overdosage-driven death was reported after ingestion of 450 mg of olanzapine. In the cases of acute overdosage, the establishment of adequate oxygenation and ventilation, gastric lavage and administration of activated charcoal with a laxative is recommended.[FDA label] In carcinogenesis studies, olanzapine was showed to present an increase in the incidence of liver hemangiomas and hemangiosarcomas as well as mammary gland adenomas, and adenocarcinomas. On fertility studies, there was solely found impairment in male mating performance and delays in ovulation. There is no evidence of mutagenic, genotoxic potential not adverse events on fertility.[FDA label] |
|---|
- Overexposure is associated with CNS depression, anticholinergic effects, hypotension, tachycardia, and extrapyramidal symptoms
- Severe cases have included reduced consciousness and fatal outcomes at very high doses
- Animal carcinogenicity studies reported increased incidences of liver hemangiomas/hemangiosarcomas and mammary gland tumors, indicating potential long‑term hazard classifications for bulk‑handling assessments
Olanzapine is a type of Atypical antipsychotics
Atypical antipsychotics belong to the subcategory of pharmaceutical active pharmaceutical ingredients (APIs) used in the treatment of various mental disorders, particularly schizophrenia and bipolar disorder. These medications are designed to alleviate the symptoms of psychosis by targeting specific neuroreceptors in the brain.
Unlike traditional antipsychotics, atypical antipsychotics exhibit a different pharmacological profile, providing a more favorable side effect profile and improved efficacy. These medications primarily act on dopamine and serotonin receptors, regulating the neurotransmitter levels in the brain to restore the chemical balance.
The mechanism of action of atypical antipsychotics involves blocking dopamine receptors, particularly D2 receptors, as well as modulating serotonin receptors, notably 5-HT2A receptors. By inhibiting excessive dopamine transmission and enhancing serotonin activity, atypical antipsychotics help reduce hallucinations, delusions, and other psychotic symptoms.
Some commonly used atypical antipsychotics include risperidone, olanzapine, quetiapine, and aripiprazole. These APIs are typically formulated into oral tablets or capsules for convenient administration.
Despite their effectiveness, atypical antipsychotics may have potential side effects such as weight gain, metabolic abnormalities, sedation, and extrapyramidal symptoms. Therefore, close monitoring and individualized treatment plans are essential to ensure optimal therapeutic outcomes.
In conclusion, atypical antipsychotics are a crucial subcategory of APIs used in the treatment of mental disorders. Their distinct pharmacological profile and mechanism of action make them valuable in managing psychosis while minimizing adverse effects.
Olanzapine (Atypical antipsychotics), classified under Antipsychotics
Antipsychotics belong to the pharmaceutical API (Active Pharmaceutical Ingredient) category used to treat psychiatric disorders such as schizophrenia, bipolar disorder, and other related conditions. These medications play a crucial role in managing symptoms associated with psychosis, including hallucinations, delusions, and disorganized thinking.
Antipsychotics work by modulating the levels of neurotransmitters in the brain, particularly dopamine and serotonin. They can be categorized into two classes: first-generation (typical) antipsychotics and second-generation (atypical) antipsychotics. Typical antipsychotics primarily target dopamine receptors, while atypical antipsychotics also affect serotonin receptors.
The pharmaceutical API category of antipsychotics includes various well-known drugs, such as haloperidol, chlorpromazine, risperidone, quetiapine, and olanzapine. These APIs are often formulated into different dosage forms, including tablets, capsules, injections, and oral suspensions, to provide flexibility in administration and patient-specific needs.
Antipsychotics offer relief from psychotic symptoms by stabilizing the imbalanced neurotransmitter activity in the brain. However, they may also have certain side effects, such as sedation, weight gain, extrapyramidal symptoms, and metabolic disturbances. It is essential for healthcare professionals to carefully monitor patients receiving antipsychotic treatment to optimize therapeutic benefits while minimizing adverse effects.
In summary, antipsychotics are a vital category of pharmaceutical APIs used to manage psychiatric disorders by modulating neurotransmitter activity in the brain. Their effectiveness in treating psychosis has made them a cornerstone of mental health treatment, providing much-needed relief to individuals suffering from these conditions.
Olanzapine API manufacturers & distributors
Compare qualified Olanzapine API suppliers worldwide. We currently have 27 companies offering Olanzapine API, with manufacturing taking place in 10 different countries. Use the table below to review supplier type, countries of origin, certifications, product portfolio and GMP audit availability.
| Supplier | Type | Country | Product origin | Certifications | Portfolio |
|---|---|---|---|---|---|
| Cipla | Producer | India | India | CEP, CoA, USDMF, WC | 164 products |
| DNP Fine Chemical Utsunom... | Producer | Japan | Japan | CoA, JDMF | 5 products |
| Dr. Reddy's | Producer | India | India | BSE/TSE, CEP, CoA, EDMF/ASMF, FDA, GMP, MSDS, USDMF, WC | 170 products |
| Eli Lilly And Company | Producer | United States | Ireland | CoA, GMP, JDMF | 5 products |
| Hari Ganesh Pharma Privat... | Distributor | India | India | CoA, FDA, GMP, USDMF | 35 products |
| HEC Pharm | Producer | Germany | Germany | CEP, CoA, FDA, GMP, USDMF | 31 products |
| Hetero Drugs | Producer | India | Unknown | CEP, CoA, FDA, GMP, JDMF, USDMF, WC | 98 products |
| Jiangsu Hansoh Pharma | Producer | China | China | CoA, USDMF | 10 products |
| Jubilant Pharmova | Producer | India | India | BSE/TSE, CEP, CoA, GMP, ISO9001, MSDS, USDMF | 52 products |
| JW Pharmaceutical | Producer | South Korea | South Korea | CoA, JDMF | 7 products |
| KRKA | Producer | Slovenia | Slovenia | CoA, GMP | 81 products |
| Lee Pharma | Producer | India | India | CoA, FDA, GMP, ISO9001, USDMF, WC, WHO-GMP | 21 products |
| Moehs | Producer | Spain | Spain | CoA, EDMF/ASMF, GMP, USDMF | 50 products |
| Mylan | Producer | India | India | CoA, GMP, USDMF, WC | 201 products |
| Rampex Labs | Producer | India | India | CEP, CoA | 1 products |
| SETV Global | Producer | India | India | CoA, FDA, GMP | 515 products |
| Shiratori Pharmaceutical | Producer | Japan | Japan | CoA, JDMF | 9 products |
| Sinoway industrial Co.,Lt... | Distributor | China | China | CEP, CoA, ISO9001, MSDS, USDMF, WC | 757 products |
| Strides Pharma Science | Producer | India | Unknown | CEP, CoA, GMP | 14 products |
| Sun Pharma | Producer | India | India | CEP, CoA, USDMF, WC | 219 products |
| Torrent Pharma | Producer | India | India | CEP, CoA, FDA, GMP, USDMF | 34 products |
| Unnati Pharmaceuticals Pv... | Distributor | India | India | CoA | 70 products |
| Veeprho Group | Producer | Czech Republic | Czech Republic | CoA | 134 products |
| Yangtze River Pharmaceuti... | Producer | China | China | CoA, GMP, ISO14001 | 34 products |
| ZCL Chemicals | Producer | India | India | CoA, Other, FDA, ISO9001 | 30 products |
| Zhejiang Hisun Pharma | Producer | China | China | CoA, USDMF | 69 products |
| Zhejiang Supor | Producer | China | China | CoA, USDMF | 13 products |
When sending a request, specify which Olanzapine API quality you need: for example EP (Ph. Eur.), USP, JP, BP, or another pharmacopoeial standard, as well as the required grade (base, salt, micronised, specific purity, etc.).
Use the list above to find high-quality Olanzapine API suppliers. For example, you can select GMP, FDA or ISO certified suppliers. Visit our help page to learn more about sourcing APIs via Pharmaoffer.
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