Drugs / Olanzapine
Olanzapine
DrugOlanzapine is an atypical antipsychotic used primarily for schizophrenia and bipolar disorder, with additional approved combination indications. It is available in oral and intramuscular formulations and is marketed under the trade name Zyprexa among others. It was approved for medical use in the United States in 1996.
- Trials
- 391
- Recruiting
- 22
- Completed
- 275
- With results
- 99
Last revised
Pipeline
Phase by status
| Phase | Recruiting | Not yet | By invitation | Active | Completed | Terminated | Withdrawn | Suspended | Unknown | Available | Total |
|---|---|---|---|---|---|---|---|---|---|---|---|
| Early Phase 1 | — | 1 | — | — | 1 | — | — | — | 1 | — | 3 |
| Phase 1 | — | — | — | 3 | 32 | 1 | — | — | — | — | 36 |
| Phase 1/2 | 1 | — | — | — | 4 | — | — | — | 1 | — | 6 |
| Phase 2 | 3 | 1 | 1 | — | 26 | 4 | 3 | 1 | 9 | — | 48 |
| Phase 2/3 | — | — | — | — | 5 | 1 | 1 | — | — | — | 7 |
| Phase 3 | 12 | 2 | — | 2 | 73 | 8 | 4 | — | 7 | — | 108 |
| Phase 4 | 2 | 1 | — | 1 | 93 | 8 | 4 | — | 6 | — | 115 |
| Not applicable | 3 | 1 | — | — | 31 | 4 | 1 | — | 8 | — | 48 |
| Unknown | 1 | — | — | — | 10 | 2 | 1 | — | 5 | 1 | 20 |
Trials started per year
Conditions studied, by phase
| Condition | Early Phase 1 | Phase 1 | Phase 1/2 | Phase 2 | Phase 2/3 | Phase 3 | Phase 4 | Not applicable | Unknown | Total |
|---|---|---|---|---|---|---|---|---|---|---|
| Schizophrenia | 1 | 13 | 3 | 21 | 1 | 43 | 61 | 20 | 9 | 172 |
| Psychotic Disorders | — | 4 | 1 | 4 | — | 12 | 28 | 10 | 2 | 61 |
| Bipolar Disorder | — | 1 | — | — | — | 11 | 27 | 3 | 5 | 47 |
| Vomiting | — | — | — | 11 | 2 | 14 | 2 | 1 | 2 | 32 |
| Nausea | — | — | — | 9 | 2 | 8 | — | — | 2 | 21 |
| Diabetes Mellitus | — | — | — | — | 1 | — | 6 | 3 | 1 | 11 |
| Insulin Resistance | 1 | — | — | — | — | — | 4 | 5 | 1 | 11 |
| Neoplasms | — | — | — | 3 | 1 | 5 | — | — | — | 9 |
| Psychomotor Agitation | — | 1 | — | — | — | 1 | 2 | 3 | 2 | 9 |
| Anorexia Nervosa | — | — | — | 2 | — | 1 | 2 | 2 | 1 | 8 |
Most active sponsors
| # | Sponsor | Trials | Phase 3 |
|---|---|---|---|
| 1 | Eli Lilly and Company | 38 | 15 |
| 2 | Organon and Co | 15 | 14 |
| 3 | Alkermes, Inc. | 9 | 4 |
| 4 | H. Lundbeck A/S | 6 | 5 |
| 5 | Northwell Health | 6 | 0 |
| 6 | Washington University School of Medicine | 6 | 1 |
| 7 | National Institute of Mental Health (NIMH) | 5 | 0 |
| 8 | New York State Psychiatric Institute | 5 | 0 |
| 9 | Otsuka Pharmaceutical Development & Commercialization, Inc. | 5 | 2 |
| 10 | Augusta University | 4 | 3 |
Most studied interventions
| # | Intervention | Trials |
|---|---|---|
| 1 | Olanzapine | 391 |
| 2 | Risperidone | 96 |
| 3 | Quetiapine Fumarate | 61 |
| 4 | Aripiprazole | 57 |
| 5 | ziprasidone | 39 |
| 6 | Haloperidol | 31 |
| 7 | Paliperidone Palmitate | 24 |
| 8 | asenapine | 21 |
| 9 | Clozapine | 19 |
| 10 | Dexamethasone | 16 |
Evidence
- Results reported
- 36%99 of 275 completed
- Published
- 14.9%41 of 275 completed
- Primary endpoint met
- 46.8%44 of 94 analyses
- Median months to report
- 13
Documents disclosed
Trial profile
- Median enrollment
- 106
- Median duration
- 29months
- Countries
- 61
- Study sites
- 3317
Who is enrolled
Median enrollment by phase
- Early Phase 1
- 31
- Phase 1
- 32
- Phase 1/2
- 132
- Phase 2
- 87
- Phase 2/3
- 32
- Phase 3
- 222
- Phase 4
- 100
- Not applicable
- 90
- Unknown
- 200
Where trials run
Busiest cities
| # | City | Country | Trials |
|---|---|---|---|
| 1 | New York | United States | 39 |
| 2 | San Diego | United States | 38 |
| 3 | Chicago | United States | 35 |
| 4 | Atlanta | United States | 33 |
| 5 | St Louis | United States | 31 |
| 6 | Austin | United States | 25 |
| 7 | Garden Grove | United States | 23 |
| 8 | Philadelphia | United States | 23 |
| 9 | Little Rock | United States | 21 |
| 10 | Houston | United States | 20 |
Terminations
- Terminated
- 28
- Withdrawn
- 14
- Suspended
- 1
- Stopped for recruitment
- 4.1%16 of 391 trials
Stated reasons
Reasons are grouped from the sponsor's own wording with a rule-based classifier; the original text is shown below.
Recently stopped
| Trial | Status | Stated reason | Stopped |
|---|---|---|---|
| NCT05403580 Withdrawn | Withdrawn | Closed due to slow accrual | 2024-12-31 |
| NCT04518319 Suspended | Suspended | The COVID-19 affects the recruitment of patients. | 2024-11-30 |
| NCT02088060 Terminated | Terminated | Following the expiry of the original research grant, no follow-up financing could be provided to complete the study. | 2024-09-16 |
| NCT06133114 Withdrawn | Withdrawn | Enrollment was discontinued after limited accrual prevented feasible completion of the trial. | 2024-03-13 |
| NCT04503668 Terminated | Terminated | Lack of Patient Population | 2024-03-11 |
| NCT05179772 Withdrawn | Withdrawn | NIDA has advised us to terminate this protocol due to the difficulties in finding appropriate subjects. | 2023-01-30 |
| NCT03960151 Withdrawn | Withdrawn | Compound was sold by funder and development ceased. | 2022-03-31 |
| NCT02380118 Terminated | Terminated | Primary endpoint reached based on data projection from interim analysis. | 2019-09-30 |
| NCT01625923 Terminated | Terminated | Inadequate recruitment numbers | 2019-06-30 |
| NCT02893371 Terminated | Terminated | Per PI, this study is not a clinical trial and was inadvertently entered in the system | 2019-06-30 |
Trial records
Individual study records live on ClinicalTrials.gov. A sample of the trials counted above: