Aripiprazole Lauroxil

Summary

Aripiprazole Lauroxil (CHEMBL2219425) is an approved small-molecule H1-receptor antagonist; indicated across 2 conditions including schizoaffective disorder.

At a glance

• Status: Approved (max clinical phase 4)
• Modality: Small molecule
• Indications: 2 conditions
• Clinical trials: 10
• Chemistry: 660.7 Da · C36H51Cl2N3O4

Identifiers

Drug identity and classification

Field	Value
ChEMBL ID	CHEMBL2219425
Name	Aripiprazole Lauroxil
Type	Small molecule
Max phase	4
FDA approved	yes
PubChem CID	49831411
ChEBI	CHEBI:90930
Molecular formula	C36H51Cl2N3O4
Molecular weight	660.7
InChIKey	DDINXHAORAAYAD-UHFFFAOYSA-N

SMILES: CCCCCCCCCCCC(=O)OCN1C(=O)CCC2=C1C=C(C=C2)OCCCCN3CCN(CC3)C4=C(C(=CC=C4)Cl)Cl

IUPAC name: [7-[4-[4-(2,3-dichlorophenyl)piperazin-1-yl]butoxy]-2-oxo-3,4-dihydroquinolin-1-yl]methyl dodecanoate

ChEBI definition: A dodecanoate ester obtained by formal condensation of the carboxy group of dodecanoic acid with the hydroxy group of 7-{4-[4-(2,3-dichlorophenyl)piperazin-1-yl]butoxy}-2-oxo-3,4-dihydroquinolin-1(2H)-yl]methanol. A prodrug for aripiprazole, it is used for treatment of schizophrenia.

Pharmacological roles (ChEBI): H1-receptor antagonist, second generation antipsychotic, serotonergic agonist, prodrug.

Also known as: ALKS 9072, ALKS-9070, ALKS-9072, Aripiprazole lauroxil, Aristada, Aristada initio, Aristada initio kit, RDC-3317, RDC3317, ARIPIPRAZOLE LAUROXIL

Patent coverage: 154 distinct patent families (462 SureChEMBL compound mentions), from 6 matched compound structure(s). One matched structure accounts for 298 (65%) of the total. Mentions count patents naming the compound (not distinct inventions), so promiscuous / reference molecules inflate the mention figure — families are the dedup metric.

Targets

Targets

No target linkage available.

Bioactivity

No ChEMBL bioactivity rows at pChembl ≥ 5 (expected for biologics / antibodies).

Target pathways

No target-pathway data for this drug (no mapped target genes).

Indications & clinical

Indications

2 indications (1 at ChEMBL trial phase 4). Phase below is the highest clinical-trial phase recorded for this drug against each disease — not the molecule’s overall approval status (that is in the Summary).

Indication	Trial phase	MONDO	EFO
schizoaffective disorder	1	MONDO:0005487	EFO:0005411

1 further indication record had no mapped disease name (EFO/MeSH-only) or were duplicates, and are omitted.

Clinical trials

Total trials: 10.

Phase distribution

Phase	Trials
PHASE3	4
PHASE4	3
PHASE1	3

Top trials by phase / activity

NCT	Phase	Status	Title
NCT02634320	PHASE4	COMPLETED	A Study of Aripiprazole Lauroxil (Also Known as ARISTADA TM) in Subjects With Schizophrenia
NCT04203056	PHASE4	TERMINATED	Aripiprazole Lauroxil for Preventing Psychotic Relapse After an Initial Schizophrenia Episode
NCT05662306	PHASE4	TERMINATED	C-Cog in Early Course Schizophrenia Study
NCT01469039	PHASE3	COMPLETED	A Study to Evaluate the Efficacy and Safety of ALKS 9072 (Also Known as Aripiprazole Lauroxil, ALKS 9070, or ARISTADA) in Subjects With Schizophrenia
NCT01626456	PHASE3	COMPLETED	A Long-term Safety Study of ALKS 9072 (Also Known as ALKS 9070)
NCT01895452	PHASE3	COMPLETED	An Extension of a Long-term Safety Study of ALKS 9072 (Also Known as ALKS 9070)
NCT03345979	PHASE3	COMPLETED	A Study of Aripiprazole Lauroxil or Paliperidone Palmitate for the Treatment of Schizophrenia
NCT01493726	PHASE1	COMPLETED	A Study of ALKS 9072 in Subjects With Chronic Stable Schizophrenia
NCT02320032	PHASE1	COMPLETED	An Open-Label Study of Aripiprazole Lauroxil in Subjects With Stable Schizophrenia
NCT02636842	PHASE1	COMPLETED	A Study of Aripiprazole Lauroxil in Subjects With Schizophrenia or Schizoaffective Disorder

Clinical evidence (CIViC)

No CIViC predictive evidence (expected for non-precision-medicine drugs).

Pharmacology

Pharmacogenomics

No CPIC/DPWG dosing guideline or drug-level clinical/variant annotations in PharmGKB for this molecule.

Related molecules

Related molecules

No competitor molecules sharing a primary target (ChEMBL phase ≥2 or PubChem drug-class).