Paclitaxel is under clinical development by DAE HWA Pharmaceutical 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 Paclitaxel’s likelihood of approval (LoA) and phase transition for Hormone Sensitive Breast Cancer took place on 18 Feb 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 Paclitaxel Likelihood of Approval (LoA) and Phase Transition Success Rate (PTSR) Report.

Paclitaxel overview

Paclitaxel (DHP-107, Liporaxel) is a taxane derivative, acts as anti-neoplastic agent. It is formulated as a liposomal solution for oral route of administration. Paclitaxel is indicated for the treatment of metastatic and locally recurrent gastric cancer.

Paclitaxel is under development for the treatment of metastatic HER2 negative and hormone sensitive breast cancer, knee cancer, oesophagal cancer, ovarian cancer angiosarcoma, bladder cancer, cervical cancer, head and neck cancer, Kaposi's sarcoma and lung cancer. The drug candidate is developed based on DaeHwa lipid-based self-emulsification delivery (DH-LASED) technology. 

DAE HWA Pharmaceutical overview

DAE HWA Pharmaceutical (DAE HWA) is a biotechnology company that develops, manufactures and markets prescription, over-the-counter and finished pharmaceutical products. The company’s products comprise analgesics, injections, anti-inflammatory enzymes, vitamins and tonics, plaster, antihistamines, skeletal muscle relaxants, expectorants and mucolytics among others. DAE HWA also offers drugs for liver diseases, drugs for hemorrhoid disease, gastro-intestinal drugs, anti-inflammatory drugs, topical drugs, cardiovascular drugs and drugs for the central nervous system. The company owns a cGMP manufacturing facility and conducts research on transdermal drug delivery system technology. DAE HWA is headquartered in Seoul, South Korea.

Quick View Paclitaxel LOA Data

Report Segments
  • Innovator (Non-NME)
Drug Name
  • Paclitaxel
Administration Pathway
  • Oral
Therapeutic Areas
  • Infectious Disease
  • Oncology
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.