(Eflornithine hydrochloride + sulindac) is under clinical development by Panbela Therapeutics and currently in the 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 (Eflornithine hydrochloride + sulindac)’s likelihood of approval (LoA) and phase transition for Colorectal Cancer took place on 23 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 (Eflornithine hydrochloride + sulindac) Likelihood of Approval (LoA) and Phase Transition Success Rate (PTSR) Report.

(Eflornithine hydrochloride + sulindac) overview

Eflornithine hydrochloride in fixed-dose combination with sulindac (TP-09, CPP- 1X/sul) is under development for the treatment of attenuated familial adenomatous polyposis in pediatrics, colon adenomas, colorectal cancer and pancreatic cancer. The drug candidate is administered orally in the form of tablet. CPP-1X acts by targeting ornithine decarboxylase. Sulindac acts by targeting cyclic guanosine monophosphate-phosphodiesterase 5 (cGMP-PDE) which is involved in the control of apoptosis. Sulindac also controls tumor cell invasion by acting on NF-kappaB-mediated transcription of microRNAs. It affects translocation of NF-kappaB to the nucleus. It was under development for familial adenomatous polyposis in adults.

It was under development for the treatment of attenuated familial adenomatous polyposis, colon cancer and pancreatic cancer.

Panbela Therapeutics overview

Panbela Therapeutics (Panbela), formerly Sun BioPharma Inc is a biopharmaceutical company. It develops disruptive therapeutics for the treatment of pancreatic cancer and pancreatitis. The company’s pipeline products include SBP-101. Its SBP-101 produces superior anti-tumour activity in human cancer cell lines and is used for the treatment of patients with pancreatic ductal adenocarcinoma, and pancreatitis. The company offers clinical trials and drug development services. It partners with institutions, cancer centres universities, and research centres for the development of drugs. Panbela is headquartered in Waconia, Minnesota, the US.

Quick View (Eflornithine hydrochloride + sulindac) LOA Data

Report Segments
  • Innovator
Drug Name
  • (Eflornithine hydrochloride + sulindac)
Administration Pathway
  • Oral
Therapeutic Areas
  • Genetic Disorders
  • Non Malignant Disorders
  • Oncology
Key Developers
Highest Development Stage
  • Filing rejected/Withdrawn

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.