FT-011 is under clinical development by Certa Therapeutics and currently in Phase II for Systemic Sclerosis (Scleroderma). According to GlobalData, Phase II drugs for Systemic Sclerosis (Scleroderma) have a 24% phase transition success rate (PTSR) indication benchmark for progressing into Phase III. GlobalData’s report assesses how FT-011’s drug-specific PTSR and Likelihood of Approval (LoA) scores compare to the indication benchmarks. Buy the report here.

GlobalData tracks drug-specific phase transition and likelihood of approval scores, in addition to indication benchmarks based off 18 years of historical drug development data. Attributes of the drug, company and its clinical trials play a fundamental role in drug-specific PTSR and likelihood of approval.

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.

For a complete picture of FT-011’s drug-specific PTSR and LoA scores, buy the report here.


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.