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Loxapine

Phase 1

Undisclosed | Small molecule | Other |Viatris Inc.|Trials Updated: Apr 24, 2024

Loxapine development status

Highest phase Phase 1
Registered trials 1 across 1 sponsor since Nov 2015

Loxapine target and mechanism

Molecular targetDRD2, DRD3, DRD4, HTR2A, HTR2C
Target classAntagonist
ModalitySmall molecule
ChEMBLCHEMBL831

Success Probability

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Market & Valuation

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Trial Design

RandomizedACTIVE_CONTROLLED
Total Trials1
Total Enrollment53

FDA Designations

No designations recorded

Loxapine clinical trials

Loxapine · 1 trial · 1 indication

Phase 1 1
NCT00648778Fasting Study of Loxapine Succinate Capsules 25 mg and Loxitane® Capsules 25 mgHealthy
COMPLETED53 Analytics
PHASE1COMPLETED
Fasting Study of Loxapine Succinate Capsules 25 mg and Loxitane® Capsules 25 mg
HealthyUnlock trial analytics

Study Endpoints

Primary Endpoints

Bioequivalence
within 30 days
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Study Design & Arms

AllocationRANDOMIZED
MaskingNONE
ModelCROSSOVER
PurposeOTHER

Treatment Arms

ArmTypeDescription
1EXPERIMENTALLoxapine Succinate Capsules 25 mg
2ACTIVE_COMPARATORLoxitane® Capsules 25 mg

Interventions

NameTypeDescription
Loxapine Succinate Capsules 25 mgDRUG25mg, single dose fasting
Loxitane® Capsules 25 mgDRUG25mg, single dose fasting
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Eligibility Criteria

Age Range18 Years to N/A
SexALL
Healthy VolunteersYes
Study Sites1

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...

Countries:United States
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Frequently asked questions about Loxapine

What is Loxapine?

Loxapine is a small molecule drug developed by Viatris Inc. (ticker: VTRS). It is also known as Loxapine Succinate Capsules 25 mg. The drug is currently in Phase 1 clinical development, and its specific indications are undisclosed.

What does Loxapine target?

Loxapine targets dopamine receptors DRD2, DRD3, and DRD4, as well as serotonin receptors HTR2A and HTR2C. It acts as an antagonist at these targets, meaning it blocks their activity. This receptor binding profile is characteristic of its small molecule modality.

Who makes Loxapine?

Loxapine is developed by Viatris Inc., which trades under the ticker symbol VTRS. The company is responsible for the clinical development of Loxapine Succinate Capsules 25 mg.

What phase is Loxapine in?

Loxapine is in Phase 1 clinical development. It is an investigational drug and has not been approved by the FDA. The development program includes one completed Phase 1 trial, and there are currently no active trials.

What clinical trials is Loxapine in?

Loxapine has been studied in one completed Phase 1 trial, NCT00648778, titled "Fasting Study of Loxapine Succinate Capsules 25 mg and Loxitane® Capsules 25 mg." The trial enrolled 53 healthy volunteers in the United States and was active-controlled and randomized.