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 · 6 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Filed schizophrenia 4 milestones | |||||
| Filed | US (FDA) | — | schizophrenia | 2017-10-26 | “the New Drug Application (NDA) for Aripiprazole Lauroxil NanoCrystal® Dispersion (ALNCD), a novel, investigational product designed for initiation onto ARISTADA® (aripiprazole...” alkermes.com ↗ “A NDA was filed with the FDA for Aripiprazole Lauroxil NanoCrystal® Dispersion (ALNCD), a novel, investigational product designed for initiation onto ARISTADA.” alkermes.com ↗ |
| Filed | US (FDA) | ARISTADA | schizophrenia | 2016-08-08 | “it has submitted a supplemental New Drug Application (sNDA) to the U.S. Food and Drug Administration (FDA) for a two-month dosing interval of ARISTADA®” alkermes.com ↗ |
| Filed | US (FDA) | — | schizophrenia | 2014-10-22 | “the U.S. Food and Drug Administration (FDA) has accepted for filing the New Drug Application (NDA) for aripiprazole lauroxil” alkermes.com ↗ |
| Filed | US (FDA) | — | schizophrenia | 2014-08-25 | “submitted a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for approval of aripiprazole lauroxil” alkermes.com ↗ |
| Approved Indication not stated 2 milestones | |||||
| Label expansion | US (FDA) | ARISTADA | — | 2017-06-05 | fda.gov ↗ |
| Approved | US (FDA) | ARISTADA | — | 2015-10-05 | fda.gov ↗ |
Trials 10
| 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 · 2 met primary | ||||||
| Phase 3 | NCT03345979 | Nov 2017 → Mar 2019 | schizophrenia | Alkermes, Inc. | Completed | Met primary |
| 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 | Met primary |
| Phase 43 trials · 1 missed | ||||||
| Phase 4 | NCT05662306 | Jan 2024 → Mar 2025 | schizophrenia | University of Miami | Terminated | No outcome recorded Stop: Enrollment |
| Phase 4 | NCT04203056 | Dec 2019 → Oct 2022 | schizoaffective depressive disorder, schizophrenia, schizophreniform disorder | University of California, Los Angeles | Terminated | No outcome recorded Stop: Business |
| Phase 4 | NCT02634320 | Dec 2015 → Jul 2017 | schizophrenia | Alkermes, Inc. | Completed | Missed primary |
News releases announcing trial results or a regulatory action · 21
| Date | Issuer | Release |
|---|---|---|
| 2022-04-07 | Alkermes, Inc. | Results Alkermes Presents New Data From Psychiatry Portfolio at 2022 Congress of the Schizophrenia International Research Society alkermes.com ↗ |
| 2021-04-20 | Alkermes, Inc. | Results Alkermes Presents New Data From Psychiatry Portfolio at Virtual 2021 Congress of the Schizophrenia International Research Society alkermes.com ↗
Results suggest that handwriting kinematic measures may serve as a biomarker for anticipating response to antipsychotic treatment. |
| 2020-05-20 | Alkermes, Inc. | Results Journal of Clinical Psychiatry Publishes Data from Alkermes' ALPINE Study in Patients With Schizophrenia alkermes.com ↗
Alkermes plc (Nasdaq: ALKS) today announced that data from its phase 3b ALPINE (Aripiprazole Lauroxil and Paliperidone palmitate: INitiation Effectiveness) study were published in the Journal of Clinical Psychiatry. |
| 2019-04-09 | Alkermes, Inc. | Results Alkermes Announces Positive Topline Results From Innovative Study of ARISTADA® and INVEGA SUSTENNA® for the Treatment of Schizophrenia alkermes.com ↗
The ALPINE study showed that both ARISTADA, given every two months, and INVEGA SUSTENNA, given every month, demonstrated statistically significant improvements from baseline in schizophrenia symptoms, and that the efficacy was similar for both medicines throughout the six-month study. |
| 2018-07-02 | Alkermes, Inc. | Regulatory FDA Approves ARISTADA INITIO™ for the Initiation of ARISTADA® for Schizophrenia alkermes.com ↗
Alkermes plc (Nasdaq: ALKS) today announced that the U.S. Food and Drug Administration (FDA) has approved ARISTADA INITIO™ (aripiprazole lauroxil) for the initiation of ARISTADA® (aripiprazole lauroxil), a long-acting injectable atypical antipsychotic for the treatment of schizophrenia in adults. |
| 2017-11-16 | Alkermes, Inc. | Regulatory Alkermes’ New Drug Application for Investigational Product Designed for Initiation Onto ARISTADA® Accepted for Filing by U.S. FDA alkermes.com ↗ |
| 2017-10-26 | Alkermes, Inc. | Regulatory Alkermes Unveils Investigational Product Designed for Initiation Onto ARISTADA® for Treatment of Schizophrenia alkermes.com ↗
Alkermes has submitted a New Drug Application (NDA) for ALNCD to the U.S. Food and Drug Administration (FDA). |
| 2017-09-18 | Alkermes, Inc. | Results Patients Switched to Alkermes’ ARISTADA® Showed Significant Improvement in Schizophrenia Symptoms After Inadequate Response or Intolerance to INVEGA SUSTENNA® alkermes.com ↗
Alkermes plc (NASDAQ: ALKS) today announced positive topline results from a phase 4 clinical study of ARISTADA® (aripiprazole lauroxil) extended-release injectable suspension for the treatment of schizophrenia. |
| 2017-06-06 | Alkermes, Inc. | Regulatory FDA Approves Two-Month ARISTADA® for Treatment of Schizophrenia alkermes.com ↗
Alkermes plc (NASDAQ: ALKS) today announced that the U.S. Food and Drug Administration (FDA) has approved two-month ARISTADA® (aripiprazole lauroxil) extended-release injectable suspension for the treatment of schizophrenia. |
| 2016-08-08 | Alkermes, Inc. | Regulatory Alkermes Submits Supplemental New Drug Application to FDA for Two-Month Dosing Option of ARISTADA® for Treatment of Schizophrenia alkermes.com ↗
Alkermes plc (NASDAQ: ALKS) today announced that it has submitted a supplemental New Drug Application (sNDA) to the U.S. Food and Drug Administration (FDA) for a two-month dosing interval of ARISTADA® (aripiprazole lauroxil) extended-release injectable suspension for the treatment of schizophrenia. |
| 2016-02-25 | Alkermes, Inc. | Results Alkermes Announces Positive Topline Results From Clinical Study of Two-Month Dosing Option of ARISTADA® for Treatment of Schizophrenia alkermes.com ↗
Alkermes plc (NASDAQ: ALKS) today announced positive topline data from a randomized, open-label, pharmacokinetic (PK) study evaluating a two-month dosing interval of ARISTADA® (aripiprazole lauroxil) extended-release injectable suspension for the treatment of schizophrenia. |
| 2015-10-05 | Alkermes, Inc. | Regulatory FDA Approves ARISTADA™ for Treatment of Schizophrenia alkermes.com ↗
Alkermes plc (NASDAQ: ALKS) today announced that the U.S. Food and Drug Administration (FDA) has approved ARISTADA™ (aripiprazole lauroxil) extended-release injectable suspension for the treatment of schizophrenia. |
| 2015-10-05 | Alkermes, Inc. | Regulatory ADDING MULTIMEDIA FDA Approves ARISTADA™ for Treatment of Schizophrenia alkermes.com ↗
Alkermes plc (NASDAQ: ALKS) today announced that the U.S. Food and Drug Administration (FDA) has approved ARISTADA™ (aripiprazole lauroxil) extended-release injectable suspension for the treatment of schizophrenia. |
| 2015-08-21 | Alkermes, Inc. | Regulatory Alkermes Provides Update on FDA Review of ARISTADA™ for the Treatment of Schizophrenia alkermes.com ↗
The FDA indicated that this delay was expected to be brief, measured in terms of weeks, but could not confirm specific timing. |
| 2015-06-09 | Alkermes, Inc. | Results Aripiprazole Lauroxil Phase 3 Schizophrenia Study Results Published in Journal of Clinical Psychiatry alkermes.com ↗
Data from the trial showed that multiple dose strengths of aripiprazole lauroxil administered once monthly demonstrated statistically significant reductions in schizophrenia symptoms, compared to placebo. |
| 2014-10-22 | Alkermes, Inc. | Regulatory Alkermes’ New Drug Application for Aripiprazole Lauroxil for Treatment of Schizophrenia Accepted for Filing by U.S. FDA alkermes.com ↗
Alkermes plc (NASDAQ: ALKS) today announced that the U.S. Food and Drug Administration (FDA) has accepted for filing the New Drug Application (NDA) for aripiprazole lauroxil, the company’s investigational, novel, once-monthly injectable atypical antipsychotic for the treatment of schizophrenia. |
| 2014-08-25 | Alkermes, Inc. | Regulatory Alkermes Submits New Drug Application to FDA for Aripiprazole Lauroxil for Treatment of Schizophrenia alkermes.com ↗
Alkermes plc (NASDAQ: ALKS) today announced that it has submitted a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for approval of aripiprazole lauroxil, the company’s investigational, novel, once-monthly, long-acting injectable atypical antipsychotic for the treatment of schizophrenia. |
| 2014-06-18 | Alkermes, Inc. | Results Alkermes Presents Phase 3 Data From Successful Pivotal Study of Aripiprazole Lauroxil for Treatment of Schizophrenia at ASCP Annual Meeting alkermes.com ↗
In the pivotal study, both doses of aripiprazole lauroxil tested, 441 mg and 882 mg administered once-monthly, met the primary endpoint with statistically and clinically significant reductions in Positive and Negative Syndrome Scale (PANSS) scores, met all secondary endpoints and demonstrated significant improvements in schizophrenia symptoms versus placebo. |
| 2014-04-08 | Alkermes, Inc. | Results Alkermes Announces Positive Topline Results From Pivotal Phase 3 Study of Aripiprazole Lauroxil for Treatment of Schizophrenia alkermes.com ↗
Alkermes plc (NASDAQ: ALKS) today announced positive topline results from a randomized, double-blind, placebo-controlled phase 3 clinical trial of aripiprazole lauroxil in patients with schizophrenia. |
| 2013-12-09 | Alkermes, Inc. | Results Alkermes Presents Data on Two Late-Stage Clinical Candidates, Aripiprazole Lauroxil and ALKS 5461, at 52nd Annual ACNP Meeting alkermes.com ↗
Pharmacokinetic Data Support Aripiprazole Lauroxil’s Competitive Features as Once-Monthly, Long-Acting Injectable Antipsychotic With Both Deltoid and Gluteal Administration |
| 2011-06-30 | Alkermes, Inc. | Results Alkermes Announces Positive Results from Clinical Study of ALKS 9070 For Treatment of Schizophrenia alkermes.com ↗
today announced positive topline results from a phase 1b, double-blind, randomized, placebo-controlled study of ALKS 9070 in patients with schizophrenia. |
All press releases naming this drug 29 releases
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 ↗ |