Aripiprazole lauroxil
Also known as Aristada
Alkermes plc. ALKS · Schizophrenia
Key figures
Next catalyst
None scheduled
Only dates with a source are listed
Phase
Approved
Not recorded
Linked trials
1
From ClinicalTrials.gov
Latest FDA action
Approved
NDA209830,
Recalls, shortages, patents and EU status at a glance
Key information
- Sponsor
- Alkermes plc. ALKS Source: Company record for Alkermes plc. (opens in a new tab)
- Indication
- Schizophrenia Source: Conditions from ClinicalTrials.gov (opens in a new tab)
- Applications
- NDA 209830 · Standard review Source: Drugs@FDA via openFDA (opens in a new tab) · Action letter for NDA 209830 (opens in a new tab)
- NDA 207533 · Standard review Source: Drugs@FDA via openFDA (opens in a new tab) · Action letter for NDA 207533 (opens in a new tab)
- Designations
- None recorded
- Next catalyst
- None scheduled
Development timeline
- Preclinical Completed
- Phase 1 Completed
- Phase 2 Completed
- Phase 3 CompletedFirst trial start 15 Nov 20171 linked trial
- Filed Completed
- Approved Current stageFirst approval 5 Oct 2015
Overview
- Mechanism
- Not recorded
- Route
- Not recorded
- Modality
- Not recorded
- Specialties
- Not recorded
Overview text is written by HealthTrade editors.
Key dates
No catalysts yet. Editors add each date together with its source.
FDA designations
No FDA designations are on record for Aripiprazole lauroxil. Editors add each one with its source.
Filed application
No filed application is on record for Aripiprazole lauroxil. Approvals are listed under FDA actions.
FDA advisory committees
No FDA advisory committee meetings are on record for Aripiprazole lauroxil.
Clinical trials
| Trial | Title | Phase | Status | Enrollment | Primary completion | Results posted |
|---|---|---|---|---|---|---|
| NCT03345979ClinicalTrials.gov record for NCT03345979 (opens in a new tab) | A Study of Aripiprazole Lauroxil or Paliperidone Palmitate for the Treatment of Schizophrenia | Phase 3 | Completed | 200 (actual) | 12 Mar 2019 (actual) | Yes First posted Results on ClinicalTrials.gov for NCT03345979 (opens in a new tab) |
Posted results on ClinicalTrials.gov for NCT03345979
Serious adverse events (Adverse event data was collected over 25 weeks.): Aripiprazole Lauroxil 8 of 99; Paliperidone Palmitate 7 of 101 Source: ClinicalTrials.gov results for NCT03345979 (opens in a new tab)· imported Posted results as ClinicalTrials.gov prints them: primary outcome analyses and serious adverse event totals only. Registry facts, not reviewed by HealthTrade and not investment advice; filing-derived results are listed separately. Publications listing NCT03345979 (4), newest first
Citations from PubMed, U.S. National Library of Medicine; abstracts are not stored. A publication lists this study’s NCT number and may be a review that cites many studies. | ||||||
Source: ClinicalTrials.gov, U.S. National Library of Medicine. Posted results are shown as ClinicalTrials.gov prints them; results from company and journal sources are entered by editors and listed separately. Full result tables are on ClinicalTrials.gov.
Trial quality
About CT-VCALoading trial quality…
FDA actions
| Application | Action | Date | Outcome | Review | Source |
|---|---|---|---|---|---|
| NDA209830Action letter for NDA209830 (opens in a new tab) | Original 1 Type 5 - New Formulation or New Manufacturer | Approved | standard | Drugs@FDA via openFDA (opens in a new tab) | |
| NDA207533Action letter for NDA207533 (opens in a new tab) | Supplement 4 Efficacy | Approved | standard | Drugs@FDA via openFDA (opens in a new tab) | |
| NDA207533Action letter for NDA207533 (opens in a new tab) | Original 1 Type 1 - New Molecular Entity | Approved | standard | Drugs@FDA via openFDA (opens in a new tab) |
Data provided by the U.S. Food and Drug Administration.
FDA recalls load here.
FDA drug shortages load here.
Orange Book patents load here.
FAERS adverse event counts load here.
Papers and preprints load here.
Community discussion loads here.
EU status (EMA)
EMA's medicines data lists no human medicine with the same active substance as Aripiprazole lauroxil.
Source: European Medicines Agency (EMA), medicines data download.
Related news
No recent headlines mention this drug.
Sources
- Drugs@FDA 207533 (opens in a new tab) Licence: public-domain. Official registry record this listing came from
- ClinicalTrials.gov NCT03345979 (opens in a new tab) Licence: public-domain. Fetched
- Drugs@FDA via openFDA NDA209830 (opens in a new tab) Licence: cc0. Fetched
- Drugs@FDA via openFDA NDA207533 (opens in a new tab) Licence: cc0. Fetched
Record updated .
Dates come from company and FDA disclosures and can change. Nothing on this page is investment advice.