Ribociclib succinate is under clinical development by Novartis 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 Ribociclib succinate’s likelihood of approval (LoA) and phase transition for Human Epidermal Growth Factor Receptor 2 Positive Breast Cancer (HER2+ Breast Cancer) took place on 02 Aug 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.

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

Ribociclib succinate overview

Ribociclib succinate (Kisqali, Kryxana) is an antineoplastic agent. It is formulated as film coated tablets for oral route of administration. Ribociclib succinate in combination with an aromatase inhibitor as initial endocrine-based therapy for the treatment of postmenopausal women with hormone receptor positive and HER2 negative advanced or metastatic breast cancer.

Ribociclib succinate is under development for the treatment of hepatocellular carcinoma, endometrial carcinoma (third line therapy), metastatic castrate resistant prostate cancer, lymphoma, malignant rhabdoid tumors, teratoma, recurrent glioblastome multiforme or glioma, ovarian cancer, recurrent head and neck cancer squamous cell carcinoma, metastatic triple-negative breast cancer, peritoneal cancer, ALK-positive non-small cell lung cancer, neuroblastoma,  advanced or metastatic BRAF V600 mutant melanoma, well differentiated and dedifferentiated liposarcomas, mantle cell lymphomas, head and neck cancers, metastatic adenocarcinoma of the pancreas, diffuse intrinsic pontine glioma, high grade glioma, metastatic KRAS-mutant colorectal cancer, well differentiated neuroendocrine tumors of foregut origin such as thymic carcinoma, bronchopulmonary cancer, gastric cancer, duodenal cancer, relapsed and refractory acute lymphocytic leukemia, medulloblastoma, atypical teratoid rhabdoid tumor, malignant rhabdoid tumor, rhabdomyosarcoma, medulloblastoma, anaplastic astrocytoma, anaplastic oligodendroglioma, anaplastic pleomorphic xanthoastrocytoma. Ribociclib in combination with PDR001 is under development for the treatment of metastatic hormone receptor positive breast cancer and metastatic ovarian cancer. It is under development for the treatment of women with hormone receptor positive and HER2 negative locally advanced or metastatic breast cancer in combination with fulvestrant as in women who have received prior endocrine therapy. It was under development for the treatment of teratoma. It was under development for the treatment of teratoma.

Novartis overview

Novartis is a healthcare company that focuses on the discovery, development, manufacture and marketing of prescription and generic pharmaceutical products and eye care products. It provides drugs for the treatment of cancer, cardiovascular diseases, dermatological conditions, neurological disorders, ophthalmic and respiratory diseases, immune disorders, and infections, among others. The company offers generic medicines and biosimilars through Sandoz. Novartis conducts research in various disease areas through The Novartis Institutes for BioMedical Research (NIBR). The company operates through a network of subsidiaries and offices across the Americas, Europe, the Middle East, Africa, and Asia-Pacific. Novartis is headquartered in Basel, Switzerland.

Quick View Ribociclib succinate LOA Data

Report Segments
  • Innovator (NME)
Drug Name
  • Ribociclib succinate
Administration Pathway
  • Oral
Therapeutic Areas
  • Oncology
Key Developers
Highest Development Stage
  • Marketed

GlobalData

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.