Sirolimus albumin-bound is under clinical development by Aadi Bioscience 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 Sirolimus albumin-bound’s likelihood of approval (LoA) and phase transition for Head And Neck Cancer took place on 12 Dec 2022, which increased the likelihood that the drug progresses to the next phase in its clinical pathway and increased the likelihood of final approval for this indication.

In addition, the same event on 12 Dec 2022 increased Sirolimus albumin-bound’s LoA and PTSR for Uterine Cancer.

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

Sirolimus albumin-bound overview

Sirolimus protein-bound particles for injectable suspension (Fyarro) is a macrolide lactams derivative drug belongs to immunosuppressive agent and an anti-neoplastic agent. It is formulated as powder for solution for intravenous route of administration. Fyarro is indicated for the treatment of adult patients with locally advanced unresectable or metastatic malignant perivascular epithelioid cell tumor (PEComa), hepatobiliary system tumor, melanoma, thyroid cancer, non-small cell lung cancer, esophageal cancer, pancreatic cancer, prostate cancer, colorectal tumor. It is also under development for solid tumors including hepatobiliary system tumor, melanoma, thyroid cancer, non-small cell lung cancer, esophageal cancer, pancreatic cancer, colorectal tumor with pathogenic inactivating alterations in TSC1 and TSC2 genes.e2. It was also under development for the treatment of relapsed/refractory multiple myeloma.

Aadi Bioscience overview

Aadi Bioscience, formerly Aerpio Pharmaceuticals Inc, is a clinical-stage biopharmaceutical company that focused on the developing and commercializing precision therapies for genetically defined cancers with alterations in mTOR pathway genes. The company lead drug product, FYARROTM, (nab-sirolimus) is a form of sirolimus bound to albumin. It also focuswd on the drug discovery and development. The company’s FYARRO is an mTOR inhibitor indicated for the treatment of adult patients with advanced unresectable or metastatic perivascular epithelioid cell tumor (PEComa). The company serves patients in the United States. Aadi Bioscience is headquartered in Los Angeles, California, the US

Quick View Sirolimus albumin-bound LOA Data

Report Segments
  • Innovator (Non-NME)
Drug Name
  • Sirolimus albumin-bound
Administration Pathway
  • Intravenous
  • Intravesical
Therapeutic Areas
  • Cardiovascular
  • Central Nervous System
  • Genetic Disorders
  • Oncology
Key Developers
  • Sponsor Company: Aadi Bioscience
  • Originator: Abraxis BioScience
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.