Sirolimus albumin-bound is under clinical development by Aadi Bioscience and currently in Phase II for Neuroendocrine Gastroenteropancreatic Tumors (GEP-NET). According to GlobalData, Phase II drugs for Neuroendocrine Gastroenteropancreatic Tumors (GEP-NET) have a 53% phase transition success rate (PTSR) indication benchmark for progressing into Phase III. GlobalData’s report assesses how Sirolimus albumin-bound’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.

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), esophagogastric (GE) Junction carcinoma, hepatobiliary system tumor,  leiomyosarcoma, 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, neuroendocrine tumors (NETs) of the gastrointestinal tract, lung, or pancreas (neuroendocrine gastroenteropancreatic 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 osteosarcoma, relapsed/refractory multiple myeloma. It is being developed based on nanoparticle albumin-based (nab) platform.

Aadi Bioscience overview

Aadi Bioscience, formerly Aerpio Pharmaceuticals Inc, is a clinical-stage biopharmaceutical company that focuses on developing and commercializing precision therapies for genetically defined cancers with alterations in mTOR pathway genes. The company’s lead drug product, FYARROTM, (nab-sirolimus) is a form of sirolimus bound to albumin. It also focused on 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

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

This content was updated on 16 July 2024

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GlobalData’s Likelihood of Approval analytics tool dynamically assesses and predicts how likely a drug will move to the next stage in clinical development (PTSR), as well as how likely the drug will be approved (LoA). This is based on a combination of machine learning and a proprietary algorithm to process data points from various databases found on GlobalData’s Pharmaceutical Intelligence Center.