Drugs / Aripiprazole Lauroxil
Aripiprazole Lauroxil
also known as
ALKS 9070 · ALKS 9072 · AL-LAI · ARISTADA · Aristada initio · Aristada initio kit · RDC-3317
Small molecule targets DRD2, HTR1A, HTR2A via activation / inhibition
Regulatory milestones approvals, filings & regulatory actions · 2 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Label expansion | US (FDA) | ARISTADA | — | 2017-06-05 | fda.gov ↗ |
| Approved | US (FDA) | ARISTADA | — | 2015-10-05 | fda.gov ↗ |
Trials 10 · a red edge is where a trial was stopped
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 13 trials | ||||||
| Phase 1 | NCT02636842 | Dec 2015 → Jun 2016 | schizoaffective disorder, schizophrenia | Alkermes, Inc. | Completed | No outcome recorded |
| Phase 1 | NCT02320032 | Dec 2014 → Apr 2016 | schizophrenia | Alkermes, Inc. | Completed | No outcome recorded |
| Phase 1 | NCT01493726 | Dec 2011 → Jun 2013 | schizophrenia | Alkermes, Inc. | Completed | No outcome recorded |
| Phase 34 trials | ||||||
| Phase 3 | NCT03345979 | Nov 2017 → Mar 2019 | schizophrenia | Alkermes, Inc. | Completed | No outcome recorded |
| Phase 3 | NCT01895452 | Jul 2013 → Jun 2016 | schizophrenia | Alkermes, Inc. | Completed | No outcome recorded |
| Phase 3 | NCT01626456 | Jun 2012 → Apr 2015 | schizophrenia | Alkermes, Inc. | Completed | No outcome recorded |
| Phase 3 | NCT01469039 | Dec 2011 → Jan 2014 | schizophrenia | Alkermes, Inc. | Completed | No outcome recorded |
| Phase 43 trials | ||||||
| Phase 4 | NCT05662306 | Jan 2024 → Mar 2025 | schizophrenia | University of Miami | Terminated | No outcome recorded |
| Phase 4 | NCT04203056 | Dec 2019 → Oct 2022 | schizoaffective depressive disorder, schizophrenia, schizophreniform disorder | University of California, Los Angeles | Terminated | No outcome recorded |
| Phase 4 | NCT02634320 | Dec 2015 → Jul 2017 | schizophrenia | Alkermes, Inc. | Completed | No outcome recorded |
Evidence & citations 15 cited values
Every value below carries the sentence it was read from. 13 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | aripiprazole lauroxil | “aripiprazole lauroxil (AL), an atypical long-acting injectable (LAI) antipsychotic approved for the treatment of schizophrenia in adults.” PMID 33761928 ↗ Mar 20218“Long-term safety and tolerability of aripiprazole lauroxil in patients with schizophrenia.” PMID 30109845 ↗ Aug 2018 “Aripiprazole lauroxil (AL), a long-acting injectable antipsychotic” PMID 39145678 ↗ Aug 2024 |
| Known as | AL-LAI | “AL-LAI (aripiprazole lauroxil- long-acting injections)” NCT04203056 ↗ |
| Known as | ALKS 9070 | “This study will determine the pharmacokinetics (PK), safety, and tolerability of ALKS 9072 (also known as ALKS 9070) after 4 monthly doses in adults with chronic stable schizophrenia.” NCT01493726 ↗2“An Extension of a Long-term Safety Study of ALKS 9072 (Also Known as ALKS 9070)” NCT01895452 ↗ “ALKS 9072 (Also Known as Aripiprazole Lauroxil, ALKS 9070, or ARISTADA)” NCT01469039 ↗ |
| Known as | ALKS 9072 | “ALKS 9072 (Also Known as Aripiprazole Lauroxil, ALKS 9070, or ARISTADA)” NCT01469039 ↗ |
| Known as | ARISTADA | “ALKS 9072 (Also Known as Aripiprazole Lauroxil, ALKS 9070, or ARISTADA)” NCT01469039 ↗ |
| Known as | Aristada initio | ChEMBL registry synonym — accepted as the source's own label CHEMBL2219425 ↗ |
| Known as | Aristada initio kit | ChEMBL registry synonym — accepted as the source's own label CHEMBL2219425 ↗ |
| Known as | RDC-3317 | ChEMBL registry synonym — accepted as the source's own label CHEMBL2219425 ↗ |
| Action | Activate | “Serotonin 1a (5-HT1a) receptor partial agonist” CHEMBL2219425 ↗1“Dopamine D2 receptor partial agonist” CHEMBL2219425 ↗ |
| Action | Inhibit | “Serotonin 2a (5-HT2a) receptor antagonist” CHEMBL2219425 ↗ |
| Modality | Small molecule | — CHEMBL2219425 ↗ |
| Route | Intramuscular | “IM injection, given monthly” NCT01493726 ↗ |
| Target | DRD2 | “Dopamine D2 receptor partial agonist” CHEMBL2219425 ↗ |
| Target | HTR1A | “Serotonin 1a (5-HT1a) receptor partial agonist” CHEMBL2219425 ↗ |
| Target | HTR2A | “Serotonin 2a (5-HT2a) receptor antagonist” CHEMBL2219425 ↗ |