Alpelisib is a Small Molecule owned by Novartis, and is involved in 70 clinical trials, of which 30 were completed, 35 are ongoing, and 5 are planned.

Alpelisib is an inhibitor of phosphatidylinositol-3-kinase (PI3K) with inhibitory activity predominantly against PI3Kα. Gain-of-function mutations in the gene encoding the catalytic α-subunit of PI3K (PIK3CA) lead to activation of PI3Kα and Akt-signaling, cellular transformation and the generation of tumors in in vitro and in vivo

In breast cancer cell lines, alpelisib inhibited the phosphorylation of PI3K downstream targets, including Akt and showed activity in cell lines harboring a PIK3CA mutation. In vivo, alpelisib inhibited the PI3K/Akt signaling pathway and reduced tumor growth in xenograft models, including models of breast cancer.

Alpelisib (BYL-719) is a phosphatidylinositol 3-kinase (PI3K) alpha inhibitor. BYL719 strongly and selectively inhibits the PI3K alpha isoform of PI3K. Its biological activity correlates with inhibition of various downstream signaling components of the PI3K/Akt pathway and it inhibits the proliferation of breast cancer cell lines harboring PIK3CA mutations.

The revenue for Alpelisib is expected to reach a total of $6.1bn through 2038. This change impacts the valuation of this asset and is an important factor to understand the current value of the drug in a clinical process. GlobalData uses proprietary data and analytics to provide a complete picture of this assessment in their Alpelisib NPV Report.

Alpelisib is originated and owned by Novartis.

Alpelisib Overview

Alpelisib (Piqray, Pivikto) is a proline or derivative acts as an antineoplastic agent. It is formulated as film coated tablets for oral route of administration. Alpelisib is indicated in combination with fulvestrant for the treatment of postmenopausal women, and men, with hormone receptor positive and HER2 negative, PIK3CA mutated, advanced or metastatic breast cancer.

Alpelisib (BYL-719) is under development for the treatment of advanced HER2+breast cancer, metastatic breast cancer, HER2 negative metastatic breast cancer, triple negative breast cancer, endometrial cancer, PIK3CA-related overgrowth spectrum disorder, ovarian cancer, fallopian tube cancer, peritoneal cancer, HPV+ squamous cell carcinoma and epithelial ovarian cancer. The drug candidate is administered orally and targets phosphatidylinositol 3-kinase (PI3K) alpha.

It was also under development for metastatic uveal melanoma, recurrent or metastatic head and neck squamous cell carcinoma, esophageal squamous cell carcinoma (ESCC), HPV-associated oropharyngeal squamous cell carcinoma, ovarian carcinoma, gastroesophageal (GE) junction carcinomas, gastrointestinal stromal tumor, non-small cell lung cancer, advanced or metastatic pancreatic cancer, renal cell carcinoma, pancreatic neuroendocrine tumors (pNETs), metastatic colorectal cancer, acute myelocytic leukemia (AML), metastatic gastric cancer and relapsed or refractory multiple myeloma, myelodysplastic syndrome.

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.

The company reported revenues of (US Dollars) US$52,877 million for the fiscal year ended December 2021 (FY2021), an increase of 6% over FY2020. In FY2021, the company’s operating margin was 22.1%, compared to an operating margin of 20.3% in FY2020. In FY2021, the company recorded a net margin of 45.4%, compared to a net margin of 16.2% in FY2020. The company reported revenues of US$12,842 million for the third quarter ended September 2022, a decrease of 1.9% over the previous quarter.

Quick View – Alpelisib

Report Segments
  • Innovator (NME)
Drug Name
  • Alpelisib
Administration Pathway
  • Oral
Therapeutic Areas
  • Gastrointestinal
  • Genetic Disorders
  • Oncology
Key Companies
Highest Development Stage
  • Marketed

GlobalData, the leading provider of industry intelligence, provided the underlying data, research, and analysis used to produce this article.

To create this model, GlobalData takes into account factors including patent law, known and projected regulatory approval processes, cash flows, potential applicable patients, drug margins, company expenses, and pricing estimates. Combining these data points with GlobalData’s world class analysis creates high value models that companies can use to help in evaluation processes for each drug or company.

The rNPV method integrates the probability of a drug reaching a clinical stage into the cash flow at that time, which provides a more accurate rNPV, as it considers the probability that the drug never makes it through the clinical pathway to commercialization. GlobalData’s rNPV model uses proprietary likelihood of approval (LoA)and phase transition success rate(PTSR) data for the indication in the highest development stage, which can be found on GlobalData’s Pharmaceutical Intelligence Center.