Olanzapine: clinical trials recruiting now
FDA drug label
- FDA-approved
- Yes. Olanzapine appears in the FDA drug-label database. Marketed as Olanzapine.
- Drug class
- Atypical Antipsychotic (FDA established pharmacologic class)
- Boxed warning
- The FDA label for Olanzapine carries a boxed warning (the FDA's most serious warning). See the full label for details.
FDA-approved use
Olanzapine is an atypical antipsychotic indicated: As oral formulation for the: Treatment of schizophrenia. ( 1.1 ) Adults: Efficacy was established in three clinical trials in patients with schizophrenia: two 6-week trials and one maintenance trial. ( 14.1 ) Adolescents (ages 13-17): Efficacy was established in one 6-week trial in patients with schizophrenia ( 14.1 ). The increased potential (in adolescents compared with adults) for weight gain and dyslipidemia may lead clinicians to consider prescribing other drugs first in adolescents. ( 1.1 ) Acute treatment of manic or mixed episodes associated with bipolar I disorder and maintenance treatment of bipolar I disorder. ( 1.2 ) Adults: Efficacy was established in three clinical trials in patients with manic or mixed episodes of bipolar I disorder: two 3- to 4-week trials and one maintenance trial. ( 14.2 ) Adolescents (ages 13-17): Efficacy was established in one 3-week trial in patients with manic or mixed episodes associated with bipolar I disorder ( 14.2 ). The increased potential (in adolescents compared with adults) for weight gain and dyslipidemia may lead clinicians to consider prescribing other drugs first in adolescents.…
FDA recalls / enforcement
| Reason (FDA) | Classification | Status | Initiated |
|---|---|---|---|
| cGmp Deviations — Macleods Pharma Usa Inc | Class II (FDA: may cause temporary or reversible harm) | Terminated | 2022-02-16 |
| Failed impurities/degradation specifications: due to out-of-specification result for the Related Substance Compound C (Impurity 6 - N-Oxide at the 18 month stability station. — Dr. Reddy's Laboratories, Inc. | Class III (FDA: unlikely to cause harm) | Terminated | 2016-10-13 |
| Failed Impurities/Degradation Specifications — Macleods Pharmaceuticals Ltd | Class II (FDA: may cause temporary or reversible harm) | Ongoing | 2024-11-25 |
Phase breakdown
Conditions being studied
Recruiting trials involving Olanzapine
- "Extended" (Alternate Day) Antipsychotic Dosing
- A Study of Olanzapine in Participants With Bipolar Disorder.
- Empagliflozin Addition in Modulating Metabolic Disturbances Associated With Olanzapine in Schizophrenia Patients
- Olanzapine Based Dexamethasone-sparing Regimen for Breast Cancer Patients With Metabolic-risk Factors
- Olanzapine Impact on First-line Immunotherapy for Advanced EGFR-negative NSCLC
- Olanzapine for the Management of Cancer Associated Appetite Loss in Patients With Advanced Esophagogastric, Hepatopancreaticobiliary, Colorectal or Lung Cancer
- Sequenced Treatment Alternatives to Relieve Adolescent Depression (STAR-AD)
- Study to Evaluate Efficacy and Safety of Roluperidone in Adult Subjects With Negative Symptoms and Stable Positive Symptoms of Schizophrenia and to Evaluate the Relapse Rate of Roluperidone and Antipsychotic Medications
- Study to Evaluate Weight Gain as Assessed by Change in BMI Z-score in Pediatric Subjects With Schizophrenia or Bipolar I Disorder
Common questions
Is Olanzapine FDA-approved?
Yes, marketed as Olanzapine. Its FDA label carries a boxed warning.
How many recruiting trials involve Olanzapine?
9 recruiting trials across 15 conditions.
Is this list of trials complete?
No. For the full record, search ClinicalTrials.gov.