Gedatolisib is under clinical development by Celcuity and currently in the Phase I and Phase II 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 Gedatolisib’s likelihood of approval (LoA) and phase transition for Metastatic Breast Cancer took place on 16 Feb 2022, which increased the likelihood that the drug progresses to the next phase in its clinical pathway.

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

Gedatolisib overview

Gedatolisib (PF-05212384, PKI-587) is under development for ER+/HER2-negative metastatic breast cancer, HER-2 positive breast cancer and triple-negative breast cancer, head and neck cancer squamous cell carcinoma, small-cell lung cancer, pancreatic cancer, metastatic hormone refractory (castration resistant, androgen-independent) prostate cancer, gynaecological cancer, solid tumor. It is administered as intravenous infusion. The drug candidate acts by targeting dual PI3K/mTOR. It was also under development for endometrial cancer as second and third line therapy, metastatic colorectal cancer, glioblastoma, renal cancer and pancreatic ductal adenocarcinoma.

It was under development for the treatment of relapsed refractory acute myeloid leukemia and myelodysplastic syndrome, non-small cell lung cancer, squamous small cell lung carcinoma, endometrial cancer, metastatic breast cancer, metastaic ovarian cancer, esophagal-gastric cancer, head and neck cancer squamous cell carcinoma and hormone refractory (castration resistant, androgen-independent) prostate cancer, transitional cell cancer (urothelial cell cancer), oropharyngeal cancer, ovarian cancer and pancreatic cancer.

Celcuity overview

Celcuity is a cellular analysis company. It develops companion diagnostic tests to identify new patient populations for targeted therapies. The company’s CELx signaling function diagnostic platform utilizes a patient’s living tumor cells to identify the specific abnormal cellular activity. It also develops CELx multi-pathway (MP) signaling function test for breast cancer which measures HER1, HER2, HER3, and c-Met signaling activity in a patient’s live tumor cells. The company partners with pharmaceutical companies to evaluate the efficacy of targeted therapies in patients diagnosed with cancer. Celcuity is headquartered in Minneapolis, Minnesota, the US.

Quick View Gedatolisib LOA Data

Report Segments
  • Innovator
Drug Name
  • Gedatolisib
Administration Pathway
  • Intravenous
Therapeutic Areas
  • Oncology
  • Undisclosed
Key Developers
  • Sponsor Company: Celcuity
  • Originator: Wyeth
Highest Development Stage
  • Phase III

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.