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APD421- Amisulpride for IV injection
APD421 is an intravenous formulation of amisulpride, a dopamine D2/D3 receptor antagonist that blocks dopamine signaling to prevent postoperative nausea and vomiting.
APD421 is an intravenous formulation of amisulpride, a dopamine D2/D3 receptor antagonist that blocks dopamine signaling to prevent postoperative nausea and vomiting. Used for Prevention of postoperative nausea and vomiting (PONV).
At a glance
| Generic name | APD421- Amisulpride for IV injection |
|---|---|
| Also known as | Amisulpride for IV injection |
| Sponsor | Acacia Pharma Ltd |
| Drug class | Dopamine antagonist / Antiemetic |
| Target | Dopamine D2 receptor, Dopamine D3 receptor |
| Modality | Small molecule |
| Therapeutic area | Gastroenterology / Perioperative Medicine |
| Phase | Phase 3 |
Mechanism of action
Amisulpride selectively antagonizes dopamine D2 and D3 receptors in the chemoreceptor trigger zone and gastrointestinal tract, which are key pathways involved in nausea and vomiting. By blocking these receptors, it prevents the emetic signal from reaching the vomiting center in the brain. The IV formulation allows for rapid onset of action in the perioperative setting.
Approved indications
- Prevention of postoperative nausea and vomiting (PONV)
Common side effects
- Headache
- Dizziness
- Restlessness / Akathisia
- Extrapyramidal symptoms
Key clinical trials
- 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)
- Study of APD421 as PONV Treatment (Prior Prophylaxis) (PHASE3)
- Study of APD421 as PONV Treatment (no Prior Prophylaxis) (PHASE3)
Primary sources
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| Source | Used for |
|---|---|
| ClinicalTrials.gov | Trial enrolment, design, endpoints, results |