Tivanisiran is under clinical development by Sylentis SAU 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 Tivanisiran’s likelihood of approval (LoA) and phase transition for Keratoconjunctivitis Sicca (Dry Eye) took place on 21 Oct 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 Tivanisiran Likelihood of Approval (LoA) and Phase Transition Success Rate (PTSR) Report.

Tivanisiran overview

Tivanisiran (SYL-1001) is under development for the treatment of dry eye syndrome associated with Sjogren’s syndrome, contact lens wears discomfort or exacerbated corneal sensitivity after refractive surgery. The drug candidate is administered through ophthalmic route as eye drops. Tivanisiran acts by targeting capsaicin receptor TrpV1. The drug candidate is developed based on SIRFINDER technology.

Sylentis SAU overview

Sylentis SAU (Sylentis), a subsidiary of Pharma Mar SA, is a biotechnology company that researches and develops new medicaments based on RNA interference gene silencing technology. The company develops products, which include bamosiran and SYL1001. It offers products for various therapeutic areas such as glaucoma, ocular allergies, dry eye syndrome and neurodegenerative diseases. Sylentis also conducts research on ophthalmology, inflammation, central nervous system, formulations and medications. The company collaborates with various pharmaceutical companies and institutions to markets its products. Sylentis is headquartered in Madrid, Spain.

Quick View Tivanisiran LOA Data

Report Segments
  • Innovator
Drug Name
  • Tivanisiran
Administration Pathway
  • Ophthalmic
Therapeutic Areas
  • Ophthalmology
Key Developers
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.