Everolimus 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 Everolimus’s likelihood of approval (LoA) and phase transition for Acute Myelocytic Leukemia (AML, Acute Myeloblastic Leukemia) took place on 06 Jun 2022, which increased the likelihood that the drug progresses to the next phase in its clinical pathway.

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

Everolimus overview

Everolimus (Afinitor, Votubia, RAD001) is an ester of the macrocytic immunosuppressive agent and acts as an anti-neoplastic agent. It is formulated as tablets for oral route of administration. It is indicated for the treatment of postmenopausal women with advanced hormone receptor-positive, HER2­negative breast cancer in combination with exemestane after failure of treatment with letrozole or anastrozole, adults with progressive neuroendocrine tumors of pancreatic origin (PNET) and adults with progressive, well-differentiated, non-functional neuroendocrine tumors (NET) of gastrointestinal (GI) or lung origin that are unresectable, locally advanced or metastatic, adults with advanced renal cell carcinoma (RCC) after failure of treatment with sunitinib or sorafenib, adults with renal angiomyolipoma and tuberous sclerosis complex (TSC), not requiring immediate surgery, and for the treatment of adult and pediatric patients aged 1 year and older with TSC who have subependymal giant cell astrocytoma (SEGA) that requires therapeutic intervention but cannot be curatively resected.

The drug candidate is under development for the treatment of endometrial cancer, diffuse large B-cell lymphoma,  low grade glioma, high-grade glioma (HGG), medulloblastoma, CNS embryonal tumor, ependymoma, diffuse intrinsic pontine glioma (DIPG), metastatic castrate-resistant prostate cancer, radioiodine-refractory thyroid cancer (papillary, follicular, medullary Hurthle cell), peripheral nerve sheath tumor, acute lymphocytic leukemia, relapsed or refractory acute myelocytic leukemia, myelodysplastic syndrome. It was also under development for the treatment of metastatic renal cell carcinoma, HER2 positive breast cancer, hepatocellular carcinoma, gastric cancer, chronic myelocytic leukemia (chronic myeloid leukemia), gastrointestinal stromal tumor, glioblastoma multiforme, non-small cell lung cancer, myeloblastic syndrome, metastatic colorectal cancer, urothelial cell cancer, progressive intracranial meningioma, relapsed or refractory cutaneous T-cell lymphoma, relapsed and refractory seminomatous, non-seminomatous germ cell cancers and advanced nonfunctional neuroendocrine tumors of gastrointestinal or lung origin and cervical cancer advanced squamous cell carcinoma of head and neck, ovarian cancer, peritoneal cancer, fallopian cancer. It was also underdevelopment for bone or soft tissue sarcoma including liposarcoma, synovial sarcoma, malignant paraganglioma, fibrosarcoma, gastrointestinal stromal tumor, leiomyosarcoma, angiosarcoma including haemangiopericytoma, miscellaneous sarcoma including mixed mesodermal tumors of the uterus osteosarcoma, Ewing's sarcoma, refractory, rhabdomyosarcoma, alveolar soft part sarcoma (ASPS) and Waldenstrom macroglobulinemia. It was also under development for the treatment of epilepsy in children with Sturge-Weber Syndrome (SWS).

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 Everolimus LOA Data

Report Segments
  • Innovator (NME)
Drug Name
  • Everolimus
Administration Pathway
  • Oral
Therapeutic Areas
  • Central Nervous System
  • Genetic Disorders
  • Non Malignant Disorders
  • Oncology
Key Developers
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.