Amisulpride is under clinical development by Eagle Pharmaceuticals and currently in the Phase I in clinical pathway. The characteristics of the clinical trial as well as other attributes related to the drug, regulations, and company play a fundamental role in ensuring the likelihood of transition that the drug moves from its current development stage to next.

According to GlobalData, the latest event to affect Amisulpride’s likelihood of approval (LoA) and phase transition for End-Stage Kidney Disease (End-Stage Renal Disease or ESRD) took place on 13 Jun 2022, which decreased the likelihood that the drug progresses to the next phase in its clinical pathway and decreased the likelihood of final approval for this indication.

GlobalData uses proprietary data and analytics to provide a complete picture of this assessment in their Amisulpride Likelihood of Approval (LoA) and Phase Transition Success Rate (PTSR) Report.

Amisulpride overview

Amisulpride (APD-421, ACA-1421, Barhemsys) is a benzamide derivative. It is formulated as solution for intravenous route of administration. Barhemsys is indicated in adults for prevention of postoperative nausea and vomiting (PONV), either alone or in combination with an antiemetic of a different class. It is indicated for the treatment of prevention of postoperative nausea and vomiting (PONV) in patients who have received antiemetic prophylaxis with an agent of a different class or have not received prophylaxis.

Amisulpride (APD-421) is under development for the treatment of end-stage kidney disease (end-stage renal disease or ESRD), post operative nausea and vomiting . It is administered through oral route or as an intravenous injection.  It is a small molecule which acts by targeting dopamine D2/D3 receptor. APD-421 was also under development for chemotherapy induced nausea and vomiting (CINV).

Eagle Pharmaceuticals overview

Eagle Pharmaceuticals (Eagle), is a specialty pharmaceutical company that offers proprietary pharmaceutical injectables in the therapy areas of critical care, oncology, and various orphan diseases. The company’s key commercial products encompass pharmaceutical injectables, including Ryanodex for exertional heatstroke; Bendeka, and Belrapzo, both for the treatment of chronic lymphocytic leukemia (CLL), and indolent B-cell non-Hodgkin’s lymphoma (NHL). Pipeline products of the company include EP-4104 (dantrolene sodium) for exertional heat stroke (EHS) and nerve agent exposure; EGL-5385-C-1701 (fulvestrant) and Vasopressin injection for blood pressure. The company’s products cater to patients and healthcare professionals in the areas of critical care, orphan diseases, and oncology. Eagle Pharmaceuticals is headquartered in Woodcliff Lake, New Jersey, the US.

Quick View Amisulpride LOA Data

Report Segments
  • Innovator (NME)
Drug Name
  • Amisulpride
Administration Pathway
  • Intravenous
Therapeutic Areas
  • Gastrointestinal
  • Genito Urinary System And Sex Hormones
  • Toxicology
Key Developers
Highest Development Stage
  • Marketed

GlobalData, the leading provider of industry intelligence, provided the underlying data, research, and analysis used to produce this article.

GlobalData’s Likelihood of Approval analytics tool dynamically assesses and predicts how likely a drug will move to the next stage in its clinical pathway (PTSR), as well as how likely the drug will be approved (LoA). This is based on a proprietary algorithm built from the drugs’ sales forecast, regulatory milestones, cost forecasts, WACC rate and other proprietary data sources found on GlobalData’s Pharmaceutical Intelligence Center.