Tivozanib hydrochloride is under clinical development by Recordati and currently in the Phase II and 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 Tivozanib hydrochloride’s likelihood of approval (LoA) and phase transition for Bile Duct Cancer (Cholangiocarcinoma) took place on 09 Nov 2022, 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 Tivozanib hydrochloride Likelihood of Approval (LoA) and Phase Transition Success Rate (PTSR) Report.

Tivozanib hydrochloride overview

Tivozanib Hydrochloride (Fotivda) is a quinoline urea derivative and acts as anti neoplastic agent. It is formulated as hard gelatin capsules for oral route of administration. Fotivda is indicated in the treatment of advanced (metastatic) renal cell carcinoma in adult patients and for adult patients who are VEGFR and mTOR pathway inhibitor-naïve following disease progression after one prior treatment with cytokine therapy for advanced RCC.

Tivozanib Hydrochloride is also under development for the treatment of soft tissue sarcoma, gallbladder cancer, neuroendocrine cancer, pancreatic adenocarcinoma, prostate cancer, renal cell carcinoma and metastatic hepatocellular carcinoma and wet age-related macular degeneration, ovarian cancer, fallopian tube cancer, peritoneal cancer and bile duct cancer (Cholangiocarcinoma). It is also administered by ocular route and oral route. It was under development for the treatment of solid tumors, breast cancer, vulvar cancer, metastatic colorectal cancer, hepatocellular cancer, non-small cell lung cancer.

Recordati overview

Recordati, a subsidiary of Fimei SpA, is a pharmaceutical company that researches, develops, manufactures and markets pharmaceuticals. The company offers pharmaceuticals for cardiovascular diseases, central nervous system disorders, dermatology, musculoskeletal disorders and analgesia, and urology diseases. It also offers cosmetics, dietary supplements, pregnancy test products, over-the-counter (OTC) and non-prescription pharmaceuticals, anti-infectives and others. It manufactures pharmaceutical chemicals such as active pharmaceutical ingredients (APIs) and intermediates. The company sells its pharmaceuticals directly in the countries of its operations and through licensees in other places. Recordati is headquartered in Milan, Italy.

Quick View Tivozanib hydrochloride LOA Data

Report Segments
  • Innovator (NME)
Drug Name
  • Tivozanib hydrochloride
Administration Pathway
  • Oral
Therapeutic Areas
  • Oncology
  • Ophthalmology
  • Undisclosed
Key Developers
  • Sponsor Company: Recordati
  • Originator: Kirin Brewery
Highest Development Stage
  • Marketed

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.