Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Loxapine · 1 trial · 1 indication
| Arm | Type | Description |
|---|---|---|
| 1 | EXPERIMENTAL | Loxapine Succinate Capsules 25 mg |
| 2 | ACTIVE_COMPARATOR | Loxitane® Capsules 25 mg |
| Name | Type | Description |
|---|---|---|
| Loxapine Succinate Capsules 25 mg | DRUG | 25mg, single dose fasting |
| Loxitane® Capsules 25 mg | DRUG | 25mg, single dose fasting |
Inclusion Criteria: 1. Age: 18 years and older. 2. Sex: Male and non-pregnant, non-lactating female a. Women of childbearing potential must have negative serum (Beta HCG) pregnancy tests performed within 14 days prior to the start of the study and on the evening prior to each dose administration. A...
Loxapine is an investigational small molecule being studied in healthy volunteers. It is currently in Phase 1 clinical development, with one completed trial evaluating its pharmacokinetics. The drug is being developed by Viatris Inc. and is not yet approved for any indication.
Loxapine is being developed by Viatris Inc., a pharmaceutical company traded on the NASDAQ under the ticker VTRS. The company is conducting clinical research on this small molecule drug candidate, which is currently in Phase 1 development.
Loxapine is in Phase 1 clinical development. One Phase 1 study has been completed, involving 53 healthy volunteers. The drug is investigational and has not been approved by regulatory authorities. It remains in early-stage clinical testing.
Loxapine has one completed clinical trial registered as NCT00648778, titled "Fasting Study of Loxapine Succinate Capsules 25 mg and Loxitane® Capsules 25 mg." This Phase 1 study enrolled 53 healthy volunteers in the United States and was an active-controlled, randomized trial.
Loxapine is being studied as loxapine succinate capsules, which were compared against Loxitane® capsules in a clinical trial. The study evaluated the bioequivalence of the two formulations, suggesting they contain the same active ingredient, loxapine, in different branded presentations.