(Cedazuridine + decitabine) is under clinical development by Otsuka Pharmaceutical and currently in Phase II for Acute Myelocytic Leukemia (AML, Acute Myeloblastic Leukemia). According to GlobalData, Phase II drugs for Acute Myelocytic Leukemia (AML, Acute Myeloblastic Leukemia) have a 30% phase transition success rate (PTSR) indication benchmark for progressing into Phase III. GlobalData’s report assesses how (Cedazuridine + decitabine)’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.

(Cedazuridine + decitabine) overview

Cedazuridine and Decitabine (Inqovi, Inaqovi) is a fixed dose combination, acts as an anti-neoplastic agent. It is formulated as film coated tablets for oral route of administration. It is indicated for the treatment of adult patients with myelodysplastic syndrome with French, American, British subtypes refractory anemia with ringed sideroblast, refractory anemia with excess blasts and chronic myelomonocytic leukemia, adult patients with newly diagnosed acute myeloid leukaemia (AML) who are ineligible for standard induction chemotherapy.

ASTX-727 (fixed dose combination of decitabine and cedazuridine (E-7727)) is under development for the treatment of metastatic mucosal melanoma, metastatic castrate resistant prostate cancer (mCRPC), newly diagnosed acute myeloid leukemia (AML), BAP1 cancer predisposition syndrome and subclinical, early-stage mesothelioma, newly diagnosed chronic myeloid leukemia, relapsed and refractory acute myeloid leukemia, peripheral nerve sheath tumor (neurofibrosarcoma), low grade gliomas, triple negative breast cancer and hormone resistant/HER2-negative metastatic breast cancer, myelodysplastic syndrome, chronic myelomonocytic leukemia (CMML), recurrent or metastatic squamous cell carcinoma of the head and neck, acute myeloid leukemia (AML), myeloproliferative neoplasms, relapsed and refractory overlap syndromes and solid tumors. The drug candidate formulated as tablet and is administered orally in the form of tablet. Decitabine is a cytidine antimetabolite analogue that inhibits DNA methyltransferase-1. E-7727 is a new molecular entity (NME) that inhibits cytidine deaminase (CDA) activity. It is developed based on Pyramid technology.

Otsuka Pharmaceutical overview

Otsuka Pharmaceutical (OPC), a subsidiary of Otsuka Holdings Co Ltd, is a manufacturer and supplier of pharmaceuticals, food products, clinical testing, and medical equipment. The company develops formulations for the diagnosis and treatment of central nervous system, oncology, cardiovascular and renal, gastrointestinal, ophthalmology disorders and infectious diseases through its pharmaceutical business. Its nutraceutical segment offers rehydration, nutrition, vitamin supplements and cosmetics. OPC is investigating drugs for psychiatry and neurology; oncology; cardiovascular and other therapeutic indications in collaboration with academia and venture companies. The company operates branch offices, research facilities and factories in Japan. OPC is headquartered in Chiyoda-ku, Tokyo, Japan.

For a complete picture of (Cedazuridine + decitabine)’s drug-specific PTSR and LoA scores, buy the report here.

This content was updated on 20 May 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.