Friday, July 10, 2026

Drug profile · INN

alpelisib

alpelisib (VIJOICE) is a pi3-kinase p110-alpha subunit inhibitor. Route of administration: oral. Current US regulatory status: approved.

FDA: approved EMA: approved Antineoplastic and immunomodulating agents (L01) L01EM03
US status approved
Patents linked 0
Pipeline programs 7
News articles 1
Drug details — alpelisib
US status
approved
Class
Antineoplastic and immunomodulating agents (L01)
Route
ORAL
Patents
0
Programs
7
Data quality
0.84

Quick answer

alpelisib (VIJOICE) is a pi3-kinase p110-alpha subunit inhibitor. Route of administration: oral. Current US regulatory status: approved.

Key facts

INN alpelisib
Brand VIJOICE
Mechanism PI3-kinase p110-alpha subunit inhibitor
Target Phosphatidylinositol 4,5-bisphosphate 3-kinase catalytic subunit alpha isoform
Therapeutic class Antineoplastic and immunomodulating agents (L01)
Route ORAL
Formulation GRANULE
ATC code L01EM03

Mechanism of action

PI3-kinase p110-alpha subunit inhibitor

Primary target: Phosphatidylinositol 4,5-bisphosphate 3-kinase catalytic subunit alpha isoform

Approval history

Authority Status Date
FDA approved
EMA approved

Recent coverage

Pipeline programs

  1. ALPELISIB for PIK3CA mutated HER2+ advanced o… Phase 3 · Ningbo Cancer Hospital · PIK3CA mutated HER2+ advanced or relapsed breast cancer (BC)
  2. CBYL719C2303 Phase 3 · Novartis India · Hormone receptor positive, HER2-negative advanced breast can
  3. CBYL719K12301 Phase 3 · Novartis India · Platinum-resistant or refractory, high-grade serous ovarian
  4. Alpelisib Phase 2 · United Therapeutics Europe · Breast Cancer
  5. CBYL719X2402 Phase 2 · Novartis India · Adult patients with PIK3CA mutant, HR-positive, HER2-negativ
  6. CLEE011X2107 Phase 2 · Novartis India · Advanced HR+ breast cancer
  7. Piqray 50 mg and 200 mg film-coated tablets Phase 2 · Createrna Science and · metasatic breast cancer, hormon positive, her 2 negative

Related & competitor drugs

  1. abiraterone acetate Antineoplastic and immunomodulating agents (L02)
  2. anagrelide Antineoplastic and immunomodulating agents (L01)
  3. apremilast Antineoplastic and immunomodulating agents (L04)
  4. arsenic trioxide Antineoplastic and immunomodulating agents (L01)
  5. axitinib Antineoplastic and immunomodulating agents (L01)
  6. azacitidine Antineoplastic and immunomodulating agents (L01)

Frequently asked questions

What is alpelisib?

alpelisib (VIJOICE) is a pi3-kinase p110-alpha subunit inhibitor. Route of administration: oral. Current US regulatory status: approved.

What is the brand name for alpelisib?

VIJOICE is a marketed brand name for alpelisib. Check FDA Drugs@FDA for the current US label holder and prescribing information.

What is the US approval status of alpelisib?

alpelisib has approved status in the United States according to our Drugs@FDA-derived records. Verify on the official FDA label before clinical or commercial decisions.