Fadraciclib is under clinical development by Cyclacel Pharmaceuticals and currently in Phase I for Myelodysplastic Syndrome. According to GlobalData, Phase I drugs for Myelodysplastic Syndrome have a 76% phase transition success rate (PTSR) indication benchmark for progressing into Phase II. GlobalData’s report assesses how Fadraciclib’s drug-specific PTSR and Likelihood of Approval (LoA) scores compare to the indication benchmarks. Buy the report here.
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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.
Fadraciclib overview
CYC-065 is under development for the treatment of hematological malignancies including relapsed or refractory acute myeloid leukemia, chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL), myelodysplastic syndrome, relapsed and refractory chronic lymphocytic leukemia, multiple myelomas, diffuse large B-cell lymphoma, B-cell lymphoma, T-cell lymphoma (CTCL and PTCL) and solid tumors including laryngeal cancer, endometrial cancer, neuroblastoma, ovarian, pancreatic cancer, lung cancer, metastatic breast cancer, hormone receptor positive breast cancer, triple negative and HER2 negative breast cancer, hepatocellular carcinoma, colorectal cancer (including KRAS mutant), lymphomas and uterine cancers. It is a small molecule administered orally and intravenously. CYC065 is a potent derivative of seliciclib. It is a cell cycle kinase inhibitor (CDK 2 and CDK9). CYC065 targets the CDK/cyclin complexes. It was also under development for the treatment of inflammation in COVID-19 patients.
Cyclacel Pharmaceuticals overview
Cyclacel Pharmaceuticals (Cyclacel) is a biopharmaceutical company that develops oral therapies. The company develops small molecule drugs that target various phases of cell cycle control for the treatment of cancer and other serious diseases. Its products include sapacitabine, seliciclib, PLK inhibitor and CDK inhibitor. Cyclacel’s sapacitabine is the drug candidate used to treat the patients with acute myeloid leukemia. The company’s seliciclib is an orally available, cyclin dependent kinase inhibitor. It offers products for the treatment of anti-infective, autoimmune, cardiovascular, ophthalmic and other non-oncology indications. The company operates in the US and the UK. Cyclacel is headquartered in Berkeley Heights, New Jersey, the US.
For a complete picture of Fadraciclib’s drug-specific PTSR and LoA scores, buy the report here.
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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 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.
