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ALKS 9072, Low dose

Phase 3

Schizophrenia | Small molecule | Psychiatry |Alkermes plc|Last Updated: Jan 30, 2019

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindPLACEBO_CONTROLLEDDMC
Total Trials4
Total Enrollment1,480

FDA Designations

No designations recorded

Clinical trial landscape

ALKS 9072, Low dose · 4 trials · 1 indication

Phase 3 3Phase 1 1
NCT01895452An Extension of a Long-term Safety Study of ALKS 9072 (Also Known as ALKS 9070)Schizophrenia
COMPLETED291 Analytics
NCT01626456A Long-term Safety Study of ALKS 9072 (Also Known as ALKS 9070)Schizophrenia
COMPLETED478 Analytics
NCT01469039A Study to Evaluate the Efficacy and Safety of ALKS 9072 (Also Known as Aripiprazole Lauroxil, ALKS 9070, or ARISTADA) in Subjects With SchizophreniaSchizophrenia
COMPLETED623 Analytics
PHASE3COMPLETED
An Extension of a Long-term Safety Study of ALKS 9072 (Also Known as ALKS 9070)
SchizophreniaUnlock trial analytics
PHASE3COMPLETED
A Long-term Safety Study of ALKS 9072 (Also Known as ALKS 9070)
SchizophreniaUnlock trial analytics
PHASE3COMPLETED
A Study to Evaluate the Efficacy and Safety of ALKS 9072 (Also Known as Aripiprazole Lauroxil, ALKS 9070, or ARISTADA) in Subjects With Schizophrenia
SchizophreniaUnlock trial analytics

Study Endpoints

Primary Endpoints

Number and Percentage of Subjects With Treatment-emergent Adverse Events (TEAEs)
Up to 12 months

This measure includes all incidences, including those that occurred \>5%.

Number of Subjects With Treatment-emergent Adverse Events (TEAEs)
52 weeks

This measure includes incidences \>5%.

The Change From Baseline at Day 85 in Positive and Negative Syndrome Scale (PANSS) Total Score
Data collected from baseline to day 85

The PANSS scale contains 30 questions, each containing an answer range of 1-7. A total PANSS score can range from between 30 to 210; a higher score indicates a worse disease condition.

Maximum concentration in plasma following last dose
4 months
Time to maximum concentration in plasma following last dose
4 months
Area under the plasma concentration time curve over the last dosing interval
4 months

Secondary Endpoints

Change in Baseline of Positive and Negative Syndrome Scale (PANSS) Total Score Over Time
Up to 12 months
Mean Change From Baseline to Endpoint in Clinical Global Impression - Severity (CGI-S) Over Time
Up to 12 months
Mean Change From Baseline to Endpoint in Clinical Global Impression Scale for Severity (CGI-S)
52 weeks
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Study Design & Arms

AllocationRANDOMIZED
MaskingQUADRUPLE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
ALKS 9072, Low DoseEXPERIMENTAL -
ALKS 9072, High DoseEXPERIMENTAL -
ALKS 9072, LowEXPERIMENTAL -
ALKS 9072, HighEXPERIMENTAL -
ALKS 9072EXPERIMENTAL -
PlaceboPLACEBO_COMPARATOR -
ALKS 9072, Med doseEXPERIMENTAL -

Interventions

NameTypeDescription
ALKS 9072, Low DoseDRUGIntramuscular injection, given monthly
ALKS 9072, High DoseDRUGIntramuscular injection, given monthly
ALKS 9072, LowDRUGIM injection, given monthly
ALKS 9072, HighDRUGIM injection, given monthly
ALKS 9072DRUGIntramuscular (IM) injection, 441 mg or 882 mg given monthly
PlaceboDRUGPlacebo for IM injection, given monthly
ALKS 9072, Med doseDRUGIM injection, given monthly
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Eligibility Criteria

Age Range18 Years to 70 Years
SexALL
Healthy VolunteersNo
Study Sites57

Inclusion Criteria: * Completed the treatment period of Study ALK9072-003EXT * Continues to require chronic treatment with an antipsychotic medication * Continues to reside in a stable living situation * Continues to have an identified reliable informant Exclusion Criteria: * Abnormal clinical la...

Countries:United StatesBulgariaMalaysiaPhilippinesRomaniaRussiaSouth KoreaUkraine
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Frequently asked questions about ALKS 9072, Low dose

What is ALKS 9072 used for?

ALKS 9072 is an investigational small molecule being developed for the treatment of schizophrenia. It is a low-dose formulation studied in patients with this psychiatric condition. The drug has completed clinical trials, including Phase 3 studies, but it is not yet approved and remains in clinical development.

What does ALKS 9072 target?

ALKS 9072 is a small molecule, but its specific molecular target has not been disclosed in the available information. The drug is being studied for its efficacy and safety in treating schizophrenia, a psychiatric disorder. Without a stated target, the mechanism of action is not described here.

Who makes ALKS 9072?

ALKS 9072 is developed by Alkermes plc, a biopharmaceutical company traded on the NASDAQ under the ticker ALKS. The company has conducted clinical trials of this drug for schizophrenia, including Phase 3 studies, and is the sponsor of the research.

What phase is ALKS 9072 in?

ALKS 9072 is in Phase 3 clinical development for schizophrenia. It has completed Phase 3 trials, including a study with 623 participants, but it is not FDA approved. The drug is still investigational and has not yet received regulatory approval for marketing.

What clinical trials is ALKS 9072 in?

ALKS 9072 has been studied in four completed clinical trials for schizophrenia. These include NCT01469039, a Phase 3 efficacy and safety study with 623 participants, and NCT01626456, a long-term safety study with 478 participants. All trials are completed, with no active studies ongoing.

Is ALKS 9072 the same as ARISTADA?

Yes, ALKS 9072 is also known as aripiprazole lauroxil, ALKS 9070, or ARISTADA. Clinical trials for ALKS 9072 explicitly reference these alternative names, indicating they refer to the same drug. This information helps identify the drug across different naming conventions.