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Cognitive Remediation
Cognitive Remediation is a Small molecule drug developed by New York State Psychiatric Institute. It is currently in Phase 3 development for Cognitive deficits in schizophrenia, Cognitive impairment in serious mental illness.
Cognitive Remediation is a behavioral intervention that uses structured training and practice to improve cognitive functions such as attention, memory, and executive function in patients with psychiatric or neurological disorders.
Cognitive Remediation is a treatment approach used to study various conditions, including HIV, Cognitive Impairment, Head Trauma, Developmental Dyslexia, and Schizoaffective Disorder, through interventions such as Plasticity-based Adaptive Cognitive Remediation (PACR), therapeutic education, and transcranial Direct Current Stimulation (tDCS). Research on Cognitive Remediation has been conducted through clinical trials, including one titled "Cognitive Training for the Remediation of Functional Brain Health in HIV" at McGill University.
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Baseline phase 3 → approval rate
+58.3pp
Industry-wide phase 3 drugs reach approval ~58.3% 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).
| Regulator | Country | Likely year | Lag vs FDA |
|---|---|---|---|
| FDA | US | 2028–2030 | — |
| EMA | EU | 2029–2031 | +0.7 yr |
| MHRA | GB | 2029–2031 | +0.7 yr |
| Health Canada | CA | 2029–2032 | +0.9 yr |
| TGA | AU | 2029–2032 | +1.2 yr |
| PMDA | JP | 2029–2032 | +1.5 yr |
| NMPA | CN | 2030–2033 | +2.3 yr |
| MFDS | KR | 2029–2032 | +1.4 yr |
| CDSCO | IN | 2029–2033 | +1.8 yr |
| ANVISA | BR | 2030–2033 | +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 | Cognitive Remediation |
|---|---|
| Sponsor | New York State Psychiatric Institute |
| Modality | Small molecule |
| Therapeutic area | Psychiatry/Neurology |
| Phase | Phase 3 |
Mechanism of action
Cognitive Remediation employs targeted exercises and cognitive training strategies to enhance impaired cognitive domains through neuroplasticity and skill acquisition. It is typically delivered as a structured program combining computerized tasks, paper-based exercises, and real-world application to strengthen cognitive abilities and functional outcomes in conditions characterized by cognitive deficits.
Approved indications
- Cognitive deficits in schizophrenia
- Cognitive impairment in serious mental illness
Common side effects
Key clinical trials
- HOme-Based Self-management and COgnitive Training CHanges Lives (HOBSCOTCH) -Post-Traumatic Epilepsy (PTE) (NA)
- Cognitive Remediation and Supported Education in Psychotic Disorders (NA)
- Efficacy of Personalizing Cognitive Remediation for Schizophrenia by Targeting Impairments in Early Auditory Processing (NA)
- Multidisciplinary Day-hospital Versus Waiting List Management of Post-COVID-19 Persistent Symptoms (ECHAP-COVID) (NA)
- Evaluating the Feasibility, Acceptability, and Initial Clinical Effectiveness of Implementing a Cognitive Remediation Program Within Psychiatric Services. (NA)
- Older Adults, Methadone, and Cognitive Function (NA)
- Cognitive Remediation Intervention to Prepare for Transition of Care (PHASE2)
- Enhanced Coordinated Specialty Care for Early Psychosis (NA)
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:
- Cognitive Remediation CI brief — competitive landscape report
- Cognitive Remediation updates RSS · CI watch RSS
- New York State Psychiatric Institute portfolio CI
Frequently asked questions about Cognitive Remediation
What is Cognitive Remediation?
How does Cognitive Remediation work?
What is Cognitive Remediation used for?
Who makes Cognitive Remediation?
What development phase is Cognitive Remediation in?
Related
- Manufacturer: New York State Psychiatric Institute — full pipeline
- Therapeutic area: All drugs in Psychiatry/Neurology
- Indication: Drugs for Cognitive deficits in schizophrenia
- Indication: Drugs for Cognitive impairment in serious mental illness
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing