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Paliperidone, LAI
Paliperidone, LAI is a Small molecule drug developed by Janssen Research & Development, LLC. It is currently in Phase 1 development. Also known as: INVEGA®.
Paliperidone, administered as a long-acting injectable (LAI), is a small molecule antagonist that targets the dopamine D2 receptor. It is used to treat various conditions, including schizophrenia, psychotic disorders, bipolar disorder, depressive disorder, and schizoaffective disorder.
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Baseline phase 1 → approval rate
+9.6pp
Industry-wide phase 1 drugs reach approval ~9.6% of the time (BIO/Informa 2023 industry benchmark across all therapeutic areas). -
Big-pharma sponsor
+3.0pp
Janssen Research & Development, LLC is a top-20 pharma sponsor — historical approval rates run ~3pp above average due to scale, regulatory experience, and trial-design quality.
| Regulator | Country | Likely year | Lag vs FDA |
|---|---|---|---|
| FDA | US | 2033–2036 | — |
| EMA | EU | 2034–2037 | +0.7 yr |
| MHRA | GB | 2034–2037 | +0.7 yr |
| Health Canada | CA | 2034–2038 | +0.9 yr |
| TGA | AU | 2034–2038 | +1.2 yr |
| PMDA | JP | 2034–2038 | +1.5 yr |
| NMPA | CN | 2035–2039 | +2.3 yr |
| MFDS | KR | 2034–2038 | +1.4 yr |
| CDSCO | IN | 2034–2039 | +1.8 yr |
| ANVISA | BR | 2035–2039 | +2.3 yr |
Hover any row for the lag rationale. Lag estimates are reduced when the drug has FDA Breakthrough or EMA PRIME designation (sponsors file globally in parallel).
Estimate based on the BIO/Informa industry phase transition rates plus per-drug modifiers for therapeutic area, sponsor type, FDA designations, mechanism, and trial design. Per-jurisdiction lags from Tufts CSDD international approval studies. Not investment, clinical or regulatory advice. Methodology: /methodology#likelihood.
At a glance
| Generic name | Paliperidone, LAI |
|---|---|
| Also known as | INVEGA® |
| Sponsor | Janssen Research & Development, LLC |
| Modality | Small molecule |
| Phase | Phase 1 |
Approved indications
Common side effects
Key clinical trials
- Risk of Breakthrough Symptoms With Long-Acting Injectable Medications
- A Concierge Model of CAE Plus LAI in Individuals With Schizophrenia at Risk for Treatment Non-adherence and Homelessness (NA)
- Aripiprazole, Abilify Maintena Collaborative Clinical Protocol (PHASE4)
- The Effect of a Community-based LAI-treated Management Model on the Violence Risk of Patients With Schizophrenia (PHASE4)
- Parallel Group, Multiple Dose Pharmacokinetics Study of Five Antipsychotic Medications in Psychiatric Participants (PHASE1)
- A Comparative Study of Paliperidone Palmitate and Risperidone Long Acting Injection (LAI) in Participants With Schizophrenia (PHASE3)
Primary sources
Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.
| Source | Used for |
|---|---|
| ClinicalTrials.gov | Trial enrolment, design, endpoints, results |
Competitive intelligence
For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:
- Paliperidone, LAI CI brief — competitive landscape report
- Paliperidone, LAI updates RSS · CI watch RSS
- Janssen Research & Development, LLC portfolio CI
Frequently asked questions about Paliperidone, LAI
What is Paliperidone, LAI?
Who makes Paliperidone, LAI?
Is Paliperidone, LAI also known as anything else?
What development phase is Paliperidone, LAI in?
Related
- Manufacturer: Janssen Research & Development, LLC — full pipeline
- Also known as: INVEGA®
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing