FT-011 is under clinical development by Certa Therapeutics 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 FT-011’s likelihood of approval (LoA) and phase transition for Systemic Sclerosis (Scleroderma) took place on 27 Dec 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 FT-011 Likelihood of Approval (LoA) and Phase Transition Success Rate (PTSR) Report.

FT-011 overview

FT-011 (SHP-627) is under development for the treatment of focal segmental glomerulosclerosis, diabetic nephropathy, systemic sclerosis, idiopathic pulmonary fibrosis, chronic kidney disease and glaucoma. The drug candidate is a new chemical entity (NCE). It is an orally active anti-fibrotic agent. The drug candidate targets transforming growth factor-beta (TGF-beta) and platelet-derived growth factor (PDGF). It was also under development for diabetic cardiomyopathy associated with cardiac fibrosis and hypertrophy.

Certa Therapeutics overview

Certa Therapeutics is focused on the emerging field of medical science which uses genetic information to identify which patients will best respond to a specific treatment, commonly referred to as precision medicine. Certa is initially targeting kidney disease, where fibrosis (scarring) of the kidney leads to kidney failure and ultimately dialysis or kidney transplantation. Certa’s novel drugs block a receptor that is a key driver of this fibrosis. Certa is able to use genetic analysis to identify those patients that are most likely to benefit from the therapy, addressing a market worth around US$5 billion per annum.

Quick View FT-011 LOA Data

Report Segments
  • Innovator
Drug Name
  • FT-011
Administration Pathway
  • Oral
Therapeutic Areas
  • Cardiovascular
  • Genito Urinary System And Sex Hormones
  • Immunology
  • Metabolic Disorders
  • Ophthalmology
  • Respiratory
Key Developers
  • Sponsor Company: Certa Therapeutics
  • Originator: University of Melbourne
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.