Aripiprazole lauroxil

Generic Name
Aripiprazole lauroxil
Brand Names
Aristada
Drug Type
Small Molecule
Chemical Formula
C36H51Cl2N3O4
CAS Number
1259305-29-7
Unique Ingredient Identifier
B786J7A343
Background

Aripiprazole lauroxil is a long-acting injectable atypical antipsychotic drug used in the treatment of schizophrenia in adult patients. It is a prodrug of aripiprazole, which acts as a partial agonist at the D2 and 5-HT1A receptors, and as an antagonist at the 5-HT2A receptors .

Affecting about 1% of the adult population in the United States and approximately 26 million people worldwide, schizophrenia is a chronic neurological disorder that may result in impairments in cognition and executive functions . The quality of life in patients is greatly reduced due to negative health outcomes, and oftentimes the patients are faced with social stigma and discriminations. Schizophrenia is characterized by positive symptoms such as delusions, hallucinations, thought disorders, and catanoia, and negative symptoms that include social withdrawal, anhedonia, and flattening of emotional responses . D2 receptors have been the most common target for antipsychotic agents used in the treatment of schizophrenia: the positive symptoms are thought to arise from overactivity in the mesolimbic dopaminergic pathway activating D2 receptors, whereas negative symptoms may result from a decreased activity in the mesocortical dopaminergic pathway with D1 receptors predominating . In a randomized, double-blind clinical trial, treatment of aripiprazole lauroxil in adult patients with schizophrenia resulted in improvement of positive and negative symptoms scores at day 85 of treatment .

Aripiprazole lauroxil was initially approved by the FDA in October 2015 under the market name Aristada for the treatment of schizophrenia. It is administered via intramuscular injection, and requires the establishment of tolerability prior to dosing in treatment-naïve patients . On July 2nd, a different formulation of aripiprazole lauroxil marketed as Aristada Initio was FDA-approved for immediate initiation of Aristada at any dose. The patients may receive Aristada Initio in combination with a single 30 mg oral dose of aripiprazole to achieve appropriate levels of aripiprazole more rapidly. Long-acting injectable aripiprazole lauroxil displayed comparable efficacy and safety to aripiprazole , and reduced dosing frequency improves patient adherence.

Indication

Aripiprazole lauroxil is indicated for the treatment of schizophrenia and related psychotic disorders.

Associated Conditions
Schizophrenia
Associated Therapies
-

C-Cog in Early Course Schizophrenia Study

First Posted Date
2022-12-22
Last Posted Date
2024-03-12
Lead Sponsor
University of Miami
Target Recruit Count
60
Registration Number
NCT05662306
Locations
🇺🇸

Jackson Memorial Hospital, Miami, Florida, United States

Aripiprazole Lauroxil for Preventing Psychotic Relapse After an Initial Schizophrenia Episode

First Posted Date
2019-12-18
Last Posted Date
2023-11-28
Lead Sponsor
University of California, Los Angeles
Target Recruit Count
15
Registration Number
NCT04203056
Locations
🇺🇸

University of California, Los Angeles, Los Angeles, California, United States

A Study of Aripiprazole Lauroxil in Subjects With Schizophrenia or Schizoaffective Disorder

First Posted Date
2015-12-22
Last Posted Date
2016-07-14
Lead Sponsor
Alkermes, Inc.
Target Recruit Count
47
Registration Number
NCT02636842
Locations
🇺🇸

Alkermes Investigative Site, Dallas, Texas, United States

🇺🇸

Alkermes Investigational Site, Marlton, New Jersey, United States

A Study of Aripiprazole Lauroxil (Also Known as ARISTADA TM) in Subjects With Schizophrenia

Phase 4
Completed
Conditions
Interventions
First Posted Date
2015-12-18
Last Posted Date
2018-12-04
Lead Sponsor
Alkermes, Inc.
Target Recruit Count
51
Registration Number
NCT02634320
Locations
🇺🇸

Alkermes Investigational Site, DeSoto, Texas, United States

An Open-Label Study of Aripiprazole Lauroxil in Subjects With Stable Schizophrenia

Phase 1
Completed
Conditions
Interventions
First Posted Date
2014-12-19
Last Posted Date
2018-08-29
Lead Sponsor
Alkermes, Inc.
Target Recruit Count
140
Registration Number
NCT02320032
Locations
🇺🇸

Alkermes Investigational Site, Dallas, Texas, United States

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