Cyclosporine CR is under clinical development by Sublimity Therapeutics HoldCo 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 Cyclosporine CR’s likelihood of approval (LoA) and phase transition for Ulcerative Colitis took place on 10 May 2021, which decreased the likelihood that the drug progresses to the next phase in its clinical pathway and decreased the likelihood of final approval for this indication.

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

Cyclosporine CR overview

Cyclosporine (ST-0529) is under development for the treatment of mild to moderate ulcerative colitis,Crohn's disease and pouchitis. It is a controlled release formulation. The drug candidate is administered orally formulated as a presolubilized, lipid-based formulation. The drug candidate acts by targeting calcineurin. The drug candidate is developed based on single-multiple pill (SmPill) technology. It was also under development for the treatment of psoriasis and multiple sclerosis.

Sublimity Therapeutics HoldCo overview

Sublimity Therapeutics HoldCo (Sublimity Therapeutics), formerly Sigmoid Pharma focuses on identifying and developing medicines for the treatment of gastrointestinal and immunological diseases. The company’s lead product candidate, ST-0529 is an oral calcineurin inhibitor being developed for the treatment of moderate to severe ulcerative colitis. Sublimity Therapeutics utilizes its proprietary drug delivery system, SmPill (single-multiple pill) to enable the precise delivery of an oral cyclosporine directly into diseased tissue in the colon. The company works in collaboration with Dr. Falk Pharma GmbH and Pharmascience Inc for development and commercialization of its pipeline products in Europe and Canada respectively. Sublimity is headquartered in Dublin, Ireland.

Quick View Cyclosporine CR LOA Data

Report Segments
  • Innovator
Drug Name
  • Cyclosporine CR
Administration Pathway
  • Oral
Therapeutic Areas
  • Central Nervous System
  • Gastrointestinal
  • Immunology
Key Developers
  • Sponsor Company: Sublimity Therapeutics HoldCo
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.