VIJOICE

Growth

alpelisib

NDAORALGRANULES
Approved
Apr 2024
Lifecycle
Growth
Competitive Pressure
0/100
Clinical Trials
21

Mechanism of Action

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…

Clinical Trials (5)

NCT06997588Phase 2Recruiting

EPIK-P4: A Phase II Single-arm Study to Assess the Efficacy, Safety and Pharmacokinetics of Alpelisib (BYL719) in Pediatric and Adult Patients With PIK3CA-related Overgrowth Spectrum (PROS)

Started Oct 2025
104 enrolled
PIK3CA-related Overgrowth Spectrum (PROS)
NCT05154487Phase 2Active Not Recruiting

A Study of Alpelisib and Fulvestrant to Treat Endometrial Cancer

Started Sep 2024
51 enrolled
Endometroid Endometrial Cancer
NCT05948943Phase 2/3Recruiting

Alpelisib in Pediatric and Adult Patients With Lymphatic Malformations Associated With a PIK3CA Mutation.

Started Nov 2023
232 enrolled
Lymphatic Malformations
NCT05625087Phase 2Active Not Recruiting

Detection of Tumor DNA in the Blood of Patients Receiving Standard Therapy for Hormone Receptor-positive (HR+) Non-HER2 Expressing (HER2-) Metastatic Breast Cancer as a Tool to Select Those Who May Benefit From the Next Course of Fulvestrant in Combination With Alpelisib or Ribociclib

Started Oct 2023
162 enrolled
Breast Cancer Stage IV
NCT05966584Phase 2Terminated

A Study to Prevent Rash in People Starting Alpelisib for the Treatment of Breast Cancer

Started Jul 2023
1 enrolled
Breast Cancer

Loss of Exclusivity

LOE Date
Feb 17, 2037
133 months away
Patent Expiry
Feb 17, 2037

Patent Records (4)

Patent #ExpiryTypeUse Code
8476268
Sep 10, 2029
SubstanceProduct
8227462
Apr 29, 2033
SubstanceProduct
11433059
Feb 17, 2037
U-4359
12427141
Feb 17, 2037
U-4288