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Amisulpride IV Prevention
Amisulpride IV Prevention is a Dopamine antagonist Small molecule drug developed by Benaroya Research Institute. It is currently in Phase 3 development for Prevention of disease progression (specific indication under investigation in Phase 3). Also known as: Amisulpride IV Treatment.
Amisulpride is a selective dopamine D2/D3 receptor antagonist that blocks dopamine signaling to prevent or reduce disease progression.
Amisulpride is a selective dopamine D2/D3 receptor antagonist that blocks dopamine signaling to prevent or reduce disease progression. Used for Prevention of disease progression (specific indication under investigation in Phase 3).
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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). -
Immunology slight uplift
+1.0pp
Mature endpoint landscape (ACR, DAS28, PASI) makes immunology approvals slightly more predictable.
| 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 | Amisulpride IV Prevention |
|---|---|
| Also known as | Amisulpride IV Treatment |
| Sponsor | Benaroya Research Institute |
| Drug class | Dopamine antagonist |
| Target | Dopamine D2/D3 receptors |
| Modality | Small molecule |
| Therapeutic area | Immunology |
| Phase | Phase 3 |
Mechanism of action
Amisulpride selectively antagonizes dopamine D2 and D3 receptors with preferential activity at limbic over striatal regions. In the context of IV prevention, it is being investigated for its potential to modulate immune or inflammatory pathways, though the exact preventive mechanism in this indication requires further clarification from clinical trial data.
Approved indications
- Prevention of disease progression (specific indication under investigation in Phase 3)
Common side effects
- Extrapyramidal symptoms
- Hyperprolactinemia
- Sedation
- Weight gain
Key clinical trials
- Study of Intravenous Amisulpride for Prophylaxis of Post-operative Nausea and Vomiting (PONV) in Pediatric Patients (PHASE2, PHASE3)
- Efficacy of Adding Oral Amisulpride to Dual Prophylaxis for Postoperative Nausea and Vomiting in Patients at High Risk for Nausea and Vomiting Undergoing Gynecological Surgery (PHASE2)
- A Pilot Study to Evaluate Barhemsys for the Prevention of Postoperative Nausea and Vomiting in the Bariatric Surgery Population (PHASE3)
- A Comparison of the Efficacy of Amisulpride and Placebo in the Prevention of PONV in Patients at Moderate-to-high Risk of PONV. (PHASE3)
- Dose-finding Study of APD403 to Prevent Nausea and Vomiting After Chemotherapy (PHASE2)
- European Phase III Study of APD421 in PONV (PHASE3)
- Phase IIIb Study of APD421 in Combination as PONV Prophylaxis (PHASE3)
- US Phase III Study of APD421 in PONV (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:
- Amisulpride IV Prevention CI brief — competitive landscape report
- Amisulpride IV Prevention updates RSS · CI watch RSS
- Benaroya Research Institute portfolio CI
Frequently asked questions about Amisulpride IV Prevention
What is Amisulpride IV Prevention?
How does Amisulpride IV Prevention work?
What is Amisulpride IV Prevention used for?
Who makes Amisulpride IV Prevention?
Is Amisulpride IV Prevention also known as anything else?
What drug class is Amisulpride IV Prevention in?
What development phase is Amisulpride IV Prevention in?
What are the side effects of Amisulpride IV Prevention?
What does Amisulpride IV Prevention target?
Related
- Drug class: All Dopamine antagonist drugs
- Target: All drugs targeting Dopamine D2/D3 receptors
- Manufacturer: Benaroya Research Institute — full pipeline
- Therapeutic area: All drugs in Immunology
- Indication: Drugs for Prevention of disease progression (specific indication under investigation in Phase 3)
- Also known as: Amisulpride IV Treatment
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing