Plinabulin is under clinical development by BeyondSpring and currently in the Phase II and Phase III 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 Plinabulin’s likelihood of approval (LoA) and phase transition for Metastatic Breast Cancer took place on 19 Dec 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.

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

Plinabulin overview

plinabulin (NPI-2358) is under development for the treatment of non-small cell lung cancer (second and third line), metastatic breast cancer, chemotherapy-induced neutropenia and febrile neutropenia (second line), metastatic brain tumor, Merkle cell cancer , melanoma, small cell lung cancer, glioblastoma multiforme, cancer associated with a RAS mutation such as colorectal cancer, multiple myeloma, bladder cancer. The drug is administered as an intravenous infusion. It is is a halimide derivative. It is a new chemical entity and a synthetic analog of NPI-2350, a natural product isolated from Aspergillus species. It binds to the colchicine-binding site of beta tubulin and GEFH1. It was also under development for metastatic pancreatic cancer, advanced solid tumor malignancies or lymphoma.

BeyondSpring overview

BeyondSpring is a clinical stage biopharmaceutical company that develops immune-oncology cancer therapies. The company provides lead compound, Plinabulin, is derived from a natural compound which holds a number of biochemical activities and provides multiple potential therapeutic potentials in various types of cancers; BPI-002, an oral small molecule agent used for the treatment of colon cancer; BPI-003 and BPI-004 against various tumors. Its target areas include non-small cell lung cancer, neutropenia prevention, and plinabulin with opdivo. The company holds a license from the Fred Hutchinson Cancer Research Center and University of Washington for a range of platform technology which concentrates on a novel mechanism to inhibit a various oncogenes. BeyondSpring is headquartered in New York City, New York, the US.

Quick View Plinabulin LOA Data

Report Segments
  • Innovator
Drug Name
  • Plinabulin
Administration Pathway
  • Intravenous
Therapeutic Areas
  • Hematological Disorders
  • Oncology
  • Toxicology
Key Developers
  • Sponsor Company: BeyondSpring
  • Originator: Nereus Pharmaceuticals
Highest Development Stage
  • Pre-Registration

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.