NDAINTRAMUSCULARSUSPENSION, EXTENDED RELEASE
Approved
Jul 2009
Lifecycle
Peak
Competitive Pressure
8/100
Clinical Trials
20
Data completeness
6/8 — Strong
Drug data last refreshed 22h ago · AI intelligence enriched 1w ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
INVEGA SUSTENNA is a long-acting intramuscular injection of paliperidone palmitate, an atypical antipsychotic indicated for schizophrenia and schizoaffective disorder. Administered as a monthly or 3-monthly extended-release suspension, it provides sustained dopamine D2 receptor antagonism to manage psychotic symptoms and reduce relapse risk.
$1.8BPart D
PeakStable
4.3 years to LOEMature peak product with substantial installed base (612K+ claims annually) indicates stable commercial infrastructure and mid-to-late-career specialty sales opportunities.
Mechanism of Action
Mechanism of action data is being enriched from DailyMed and FDA sources. Check back soon for updated drug intelligence.
Indications
Indication data is being enriched from DailyMed and FDA labeling. Check back soon for approved therapeutic uses.
Clinical Trials (20)
A Study to Assess the Treatment of Schizophrenia With Paliperidone Palmitate in Rwandan Healthcare Settings
Started Jul 2021
93 enrolled
Schizophrenia
Evaluate the PK of LY03010 Process 1 and Process 2 Drug Product vs INVEGA SUSTENNA After Intramuscular Injection in Schizophrenia Patients
Started Jan 2020
36 enrolled
Schizophrenia Patients
A Study of Paliperidone Palmitate 6-Month Formulation
Started Sep 2019
178 enrolled
Schizophrenia
A Study to Determine Pharmacokinetic Characteristics of LY03010 Versus INVEGA SUSTENNA® in Schizophrenia Patients
Started Dec 2018
48 enrolled
Schizo Affective DisorderSchizophreniaSchizoaffective Disorder
A Survey to Collect Treatment Experience Feedback From Patients, Physicians, Nurses and Carers After Switching to Paliperidone Palmitate 3-monthly
Started Nov 2018
225 enrolled
Schizophrenia
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Data Sources
- Drug label: DailyMed / FDA
- Clinical trials: ClinicalTrials.gov
- Patent data: FDA Orange Book
- Spending data: CMS Medicare
The information on this page is for informational purposes only and should not be used as a substitute for professional medical advice. Drug information is sourced from FDA, DailyMed, and other government databases. Adverse event data from FAERS does not establish causation. Always consult a healthcare professional for medical decisions.