Floatz Rating
BB70/100
Confidence
Indicative
Sponsor
Dr. Stavroula Rakitzi
Modality
Small molecule
Development Phase
Phase 4 / Approved
Status
Active
Evidence ledger · v0.2
Clinical Evidence
Clinical track record: trial progression, reported outcomes, safety signals, and endpoint quality.
68High confidence
Detailed axis rationale is planned and will be published soon.
| Trial | Phase | Status | N | Primary endpoint | Readout |
|---|---|---|---|---|---|
NCT02893371CT.gov Longitudinal Comparative Effectiveness of Bipolar Disorder Therapies | — | Terminated | — | — | — |
NCT02087579CT.gov Parallel Group, Multiple Dose Pharmacokinetics Study of Five Antipsychotic Medications in Psychiatric Participants | — | Completed | — | — | — |
NCT01498770CT.gov An Observational Drug Utilization Study of Asenapine in the United Kingdom (P08308) | — | Completed | — | — | — |
NCT01211704CT.gov Paliperidone Palmitate Efficacy and Safety in Bipolar Disorder Complicated by Alcoholism | — | Withdrawn | — | — | — |
NCT01181960CT.gov Research and Evaluation of Antipsychotic Treatment in Community Behavioral Health Organizations | — | Completed | — | — | — |
NCT01094249CT.gov A Drug Interaction Study of Valproic Acid and Paliperidone Extended-Release (ER) in Patients With Schizophrenia, Bipolar I Disorder, or Schizoaffective Disorder | — | Completed | — | — | — |
NCT00592358CT.gov Invega (Paliperidone) for the Treatment of Mania in Children and Adolescents Ages 6-17 With Bipolar Disorder | — | Terminated | — | — | — |
NCT00892125CT.gov A Study of the Effect of Carbamazepine on the Pharmacokinetics of Paliperidone Extended Release (ER) in Patients With Schizophrenia or Bipolar I Disorder | — | Completed | — | — | — |
NCT00490971CT.gov A Study to Evaluate the Effectiveness and Safety of Extended-Release (ER) Paliperidone Compared With Placebo in Delaying the Recurrence of Symptoms in Bipolar I Disorder | — | Completed | — | — | — |
NCT00309699CT.gov A Study to Evaluate the Efficacy and Safety of Flexible Doses of Extended-release (ER) Paliperidone Compared With Flexible Doses of Quetiapine and Placebo in Patients With Bipolar I Disorder | — | Completed | — | — | — |
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NCT00309686CT.gov A Study to Evaluate the Efficacy and Safety of Adjustable Doses of Extended-release (ER) Paliperidone Compared With Placebo, in Combination With Lithium or Valproate, to Treat Manic and Mixed Episodes in Patients With Bipolar I Disorder | — | Completed | — | — | — |
NCT00299715CT.gov A Study to Evaluate the Efficacy and Safety of Three Fixed Doses of Extended-release Paliperidone in Subjects With Bipolar I Disorder | — | Completed | — | — | — |
Competitive Position
Competitive setting: how crowded the indication is, class-level failures, and timing against rivals.
73High confidence
Detailed axis rationale is planned and will be published soon.
Same indication · Bipolar Disorder
| Asset | Sponsor | Phase | Rating |
|---|---|---|---|
| Paliperidone (this asset) | Dr. Stavroula Rakitzi | Approved | BB · 70 |
| Asenapine | Dr. Stavroula Rakitzi | P4 | BBB |
| Lamotrigine | Johns Hopkins University | P4 | BBB |
| Quetiapine | First Affiliated Hospital of Zhejiang University | P4 | BBB |
| Paroxetine | Mental Health Centre Copenhagen, Bispebjerg and Frederiksberg Hospital | P4 | BBB |
| Citalopram | University of Texas Southwestern Medical Center | P4 | BBB |
| Escitalopram | First Affiliated Hospital of Zhejiang University | P4 | BBB |
| Lithium, Elemental | University of Aarhus | P4 | BBB |
| Valproic Acid | University of New Mexico | P4 | BBB |
+42 more in the Bipolar Disorder cohort
Other indications for Paliperidone
| Indication | Sponsor | Phase | Rating |
|---|---|---|---|
| Schizoaffective Disorder | — | P4 | BBB · 78 |
| Psychotic Disorder | — | P4 | BBB · 76 |
| Schizophrenia | — | P4 | BBB · 72 |
Scientific Foundation
Strength of the underlying biology: target validation, tractability, modality fit, and how related mechanisms have fared.
NR
Planned for methodology v0.2.
Development Feasibility
How realistically the program can be executed, drawing on modality precedent, enrollment dynamics, and sponsor delivery.
NR
Planned for methodology v0.2.
Commercial Opportunity
Commercial prize: addressable population, unmet need, and the value case for the indication.
NR
Planned for methodology v0.2.
IP & Exclusivity
Exclusivity position, covering patent protection and freedom-to-operate runway.
NR
Planned for methodology v0.2.
Manufacturing & Supply
Manufacturing and supply readiness, driven by modality process and scale-up risk.
NR
Planned for methodology v0.2.
Related assets
Citation
Floatz Terminal. Paliperidone in Bipolar Disorder. Methodology v0.2. Rated under v0.2 effective July 8, 2026. Last refreshed July 8, 2026. Accessed July 14, 2026. https://terminal.floatz.ai/assets/paliperidone-bipolar-disorder
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