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14C-paliperidone
14C-paliperidone is a Atypical antipsychotic Small molecule drug developed by Johnson & Johnson Pharmaceutical Research & Development, L.L.C.. It is currently in Phase 1 development for Schizophrenia.
Dopamine D2 receptor antagonist
14C-paliperidone is a radiolabeled form of paliperidone, which is used to study plasma concentrations, metabolism, and excretion after a single oral dose. It has been studied in clinical trials for the condition of schizophrenia.
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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). -
CNS / neurology attrition
-3.0pp
CNS drugs have historically high Phase 3 failure rates (notably in Alzheimer disease + major depression). -
Big-pharma sponsor
+3.0pp
Johnson & Johnson Pharmaceutical Research & Development, L.L.C. 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 | 14C-paliperidone |
|---|---|
| Sponsor | Johnson & Johnson Pharmaceutical Research & Development, L.L.C. |
| Drug class | Atypical antipsychotic |
| Target | Dopamine D2 receptor |
| Modality | Small molecule |
| Therapeutic area | Neurology |
| Phase | Phase 1 |
Mechanism of action
Paliperidone is a second-generation (atypical) antipsychotic that acts as a selective dopamine D2 receptor antagonist, which is thought to contribute to its therapeutic effects in schizophrenia.
Approved indications
- Schizophrenia
Common side effects
- Orthostatic hypotension
- Weight gain
- Somnolence
Key clinical trials
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:
- 14C-paliperidone CI brief — competitive landscape report
- 14C-paliperidone updates RSS · CI watch RSS
- Johnson & Johnson Pharmaceutical Research & Development, L.L.C. portfolio CI
Frequently asked questions about 14C-paliperidone
What is 14C-paliperidone?
How does 14C-paliperidone work?
What is 14C-paliperidone used for?
Who makes 14C-paliperidone?
What drug class is 14C-paliperidone in?
What development phase is 14C-paliperidone in?
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What does 14C-paliperidone target?
Related
- Drug class: All Atypical antipsychotic drugs
- Target: All drugs targeting Dopamine D2 receptor
- Manufacturer: Johnson & Johnson Pharmaceutical Research & Development, L.L.C. — full pipeline
- Therapeutic area: All drugs in Neurology
- Indication: Drugs for Schizophrenia
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing