Amdizalisib is under clinical development by Hutchison MediPharma 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 Amdizalisib’s likelihood of approval (LoA) and phase transition for Extranodal Marginal Zone B-Cell Lymphoma (Mucosa-Associated Lymphoid Tissue or MALT-Lymphoma) took place on 25 Nov 2022, which increased the likelihood that the drug progresses to the next phase in its clinical pathway and increased the likelihood of final approval for this indication.

In addition, the same event on 25 Nov 2022 increased Amdizalisib’s LoA and PTSR for Nodal Marginal Zone B-Cell Lymphoma.

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

Amdizalisib overview

HMPL-689 (amdizalisib) is under development for the treatment of hematological B cell malignancies including chronic lymphocytic leukemia (CLL), indolent non-hodgkin lymphoma, small lymphocytic lymphoma (SLL), follicular lymphoma (FL), marginal zone B-cell lymphoma (MZL), Waldenstrom macroglobulinemia (WM), peripheral T-cell lymphomas (PTCL) and mantle cell lymphoma (MCL). It is administered orally. The drug candidate is a small molecule that targets PI3K Delta. HMPL-689 was also under development for the treatment of  hematological malignancies  diffuse large B-cell lymphoma (DLBCL), Burkitt lymphoma. The drug candidate is a new molecular entity (NME).

Hutchison MediPharma overview

Hutchison MediPharma (HMPL) carries out discovery, development and commercialization of therapeutics in oncology and autoimmune diseases. The company’s products include savolitinib, fruquintinib, sulfatinib, HMPL-523, epitinib, theliatinib, HMPL-453, HMPL-689 and HMPL-004. It develops drug discovery technologies in molecular and cell biology, high throughput screening, genomics and informatics to support research and development projects. HMPL’s research and development programs comprise gene-targeted and cell-based screening assays, ligand-dependent screening assays and signal transduction pathway screening assays. The company’s products serve in the fields of medicinal chemistry, pharmacology, oncology, cardiovascular and respiratory diseases, and antiviral treatments. It operates through its two offices in Pudong, China. HMPL is headquartered in Pudong, China.

Quick View Amdizalisib LOA Data

Report Segments
  • Innovator
Drug Name
  • Amdizalisib
Administration Pathway
  • Oral
Therapeutic Areas
  • Oncology
Key Developers
Highest Development Stage
  • Phase II

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.