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AVP-786-18
AVP-786-18 is a Sigma-1 receptor agonist Small molecule drug developed by Otsuka Pharmaceutical Development & Commercialization, Inc.. It is currently in Phase 3 development for Agitation associated with Alzheimer's disease dementia, Potential indication in other neurodegenerative or neuropsychiatric conditions.
AVP-786 is a combination of deuterated dextromethorphan and quinidine that enhances sigma-1 receptor signaling to reduce neurological symptoms.
AVP-786 is a combination of deuterated dextromethorphan and quinidine that enhances sigma-1 receptor signaling to reduce neurological symptoms. Used for Agitation associated with Alzheimer's disease dementia, Potential indication in other neurodegenerative or neuropsychiatric conditions.
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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 | AVP-786-18 |
|---|---|
| Sponsor | Otsuka Pharmaceutical Development & Commercialization, Inc. |
| Drug class | Sigma-1 receptor agonist |
| Target | Sigma-1 receptor |
| Modality | Small molecule |
| Therapeutic area | Neurology |
| Phase | Phase 3 |
Mechanism of action
The drug combines dextromethorphan (a sigma-1 receptor agonist) with quinidine, which inhibits the metabolism of dextromethorphan and increases its bioavailability. This combination allows for lower doses while maintaining therapeutic efficacy. The sigma-1 receptor modulation is thought to provide neuroprotective and neuromodulatory effects relevant to neurodegenerative and neuropsychiatric conditions.
Approved indications
- Agitation associated with Alzheimer's disease dementia
- Potential indication in other neurodegenerative or neuropsychiatric conditions
Common side effects
- Dizziness
- Headache
- Somnolence
- Nausea
Key clinical trials
- Long Term, Extension Study of the Safety and Efficacy of AVP-786 for the Treatment of Agitation in Patients With Dementia of the Alzheimer's Type (PHASE3)
- Study to Assess the Efficacy, Safety, and Tolerability of AVP-786 for the Treatment of Agitation in Patients With Dementia of the Alzheimer's Type (PHASE3)
- Assessment of the Efficacy, Safety, and Tolerability of AVP-786 for the Treatment of Agitation in Patients With Dementia of the Alzheimer's Type (PHASE3)
- Efficacy, Safety and Tolerability of AVP-786 for the Treatment of Agitation in Patients With Dementia of the Alzheimer's Type (PHASE3)
- Efficacy, Safety, and Tolerability of AVP-786 for the Treatment of Agitation in Participants With Dementia of the Alzheimer's Type (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:
- AVP-786-18 CI brief — competitive landscape report
- AVP-786-18 updates RSS · CI watch RSS
- Otsuka Pharmaceutical Development & Commercialization, Inc. portfolio CI
Frequently asked questions about AVP-786-18
What is AVP-786-18?
How does AVP-786-18 work?
What is AVP-786-18 used for?
Who makes AVP-786-18?
What drug class is AVP-786-18 in?
What development phase is AVP-786-18 in?
What are the side effects of AVP-786-18?
What does AVP-786-18 target?
Related
- Drug class: All Sigma-1 receptor agonist drugs
- Target: All drugs targeting Sigma-1 receptor
- Manufacturer: Otsuka Pharmaceutical Development & Commercialization, Inc. — full pipeline
- Therapeutic area: All drugs in Neurology
- Indication: Drugs for Agitation associated with Alzheimer's disease dementia
- Indication: Drugs for Potential indication in other neurodegenerative or neuropsychiatric conditions
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing