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neuroinflammation
neuroinflammation is a Small molecule drug developed by National Institute on Alcohol Abuse and Alcoholism (NIAAA). It is currently in Phase 1 development.
-
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).
| 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 | neuroinflammation |
|---|---|
| Sponsor | National Institute on Alcohol Abuse and Alcoholism (NIAAA) |
| Modality | Small molecule |
| Therapeutic area | Neuroscience |
| Phase | Phase 1 |
Approved indications
Common side effects
Key clinical trials
- A Study to Evaluate the Safety, Tolerability and the Effects of Ixodes Ricinus-Contact Phase Inhibitor (Ir-CPI) in Adult Patients With Spontaneous Intracerebral Haemorrhage (PHASE2)
- Imaging of Neuro-Inflammation and the Risk for Post-Traumatic Epilepsy (PHASE1)
- Brain Inflammation and Function in Alcoholism (EARLY_PHASE1)
- Minocycline as Adjunctive Treatment for Treatment Resistant Depression (PHASE3)
- Effect of Dexmedetomidine on Brain Homeostasis and Neurocognitive Outcome (PHASE4)
- Prednisone in Adults With an Immune-Mediated Subtype of Autism Spectrum Disorder (EARLY_PHASE1)
- Is [18F]-DPA-714 PET a Good Marker of Neuroinflammation in Autoimmune Encephalitis? (PHASE2)
- Inflammatory and Infectious Diseases of the Nervous System
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:
- neuroinflammation CI brief — competitive landscape report
- neuroinflammation updates RSS · CI watch RSS
- National Institute on Alcohol Abuse and Alcoholism (NIAAA) portfolio CI
Frequently asked questions about neuroinflammation
What is neuroinflammation?
Who makes neuroinflammation?
What development phase is neuroinflammation in?
Related
- Manufacturer: National Institute on Alcohol Abuse and Alcoholism (NIAAA) — full pipeline
- Therapeutic area: All drugs in Neuroscience
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing