TheraRadar
Data updated: May 26, 2026

VIJOICE (alpelisib)

Genetically Validated
Rare Disease Approved 2022-04-05

Vijoice helps patients with PIK3CA-Related Overgrowth Spectrum (PROS), a group of rare disorders characterized by abnormal tissue overgrowth and malformations. It is used for adults and children at least two years of age who have severe symptoms that require systemic therapy. This medication is prescribed to help manage and potentially improve the organ abnormalities associated with these genetic conditions.

Source: FDA Label • Novartis
Jump to: Indications Approvals Trials Competitors Safety Patents

How VIJOICE Works

Vijoice works by inhibiting PI3Kα, an enzyme that becomes overactive due to specific genetic mutations. By blocking this signaling pathway, the drug helps prevent or reduce the cellular overgrowth and tissue malformations that characterize these spectrum disorders.

Source: FDA Label
2
Indications
--
Phase 3 Trials
1
Priority Reviews
4
Years on Market

Details

Status
Prescription
First Approved
2022-04-05
Patent Cliff
2037

Pro Metrics

Patent cliff and revenue data

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Routes
ORAL
Dosage Forms
TABLET, GRANULE

Companies

Novartis
Active Ingredient: ALPELISIB

VIJOICE Approval History

2023
2024
2025
2026
Original
New Indication
New Form
Label Update
14 FDA actions from 2022 to 2025 · 2 indication expansions
Jul 2025 SUPPL
Label · Labeling
FDA Letter Label
Apr 2024 SUPPL
Efficacy
FDA Letter
Nov 2022 SUPPL
Label · Labeling
FDA Letter Label

What VIJOICE Treats

1 indications

VIJOICE is approved for 1 conditions since its original approval in 2022. These indications span multiple therapeutic areas including oncology, immunology, and more.

  • PIK3CA-Related Overgrowth Spectrum
Source: FDA Label

VIJOICE Target & Pathway

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Target

PI3K (Phosphoinositide 3-Kinase) Intracellular Kinase

A family of enzymes involved in cell growth, proliferation, and survival signaling. PI3K pathway activation is common in cancer. Inhibiting specific PI3K isoforms is effective in certain blood cancers and solid tumors.

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Clinical Trial Registry

46 trials
Trial Sponsor ID Phase Status Title
NCT05564377 NCI-2022-06842 NCI-2022-06842, EAY191 Ph 2 recruiting Targeted Therapy Directed by Genetic Testing in Treating Patients With Locally Advanced or Advanced Solid Tumors, The ComboMATCH Screening Trial
NCT05948943 EPIK-L1 CBYL719P12201 2023-504146-60-00 Ph 2, Ph 3 recruiting Alpelisib in Pediatric and Adult Patients With Lymphatic Malformations Associated With a PIK3CA Mutation.
NCT04251533 EPIK-B3 results posted CBYL719H12301 2024-511931-87-00, 2019-002637-11 Ph 3 terminated Study Assessing the Efficacy and Safety of Alpelisib + Nab-paclitaxel in Subjects With Advanced TNBC Who Carry Either a PIK3CA Mutation or Have PTEN Loss
NCT05646862 INAVO121 WO43919 2022-502322-41-00 Ph 3 active not recruiting A Study Evaluating the Efficacy and Safety of Inavolisib Plus Fulvestrant Compared With Alpelisib Plus Fulvestrant in Participants With HR-Positive, HER2-Negative, PIK3CA Mutated, Locally Advanced or Metastatic Breast Cancer Post CDK4/6i and Endocrine Combination Therapy
NCT05983159 TARGET-VM 85218 Ph 2 recruiting A Trial of Targeted Therapies for Patients With Slow-Flow or Fast-Flow Vascular Malformations
NCT05143229 ASSET IIT-2021-ASSET Ph 1 active not recruiting Alpelisib And Sacituzumab Govitecan For Treatment Of Breast Cancer
NCT04589650 EPIK-P2 results posted CBYL719F12201 2023-508530-34-00 Ph 2 active not recruiting Study Assessing the Efficacy, Safety and PK of Alpelisib (BYL719) in Pediatric and Adult Patients With PIK3CA-related Overgrowth Spectrum
NCT06997588 CBYL719F12202 2024-519960-42-00 Ph 2 recruiting 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)
NCT04524000 CBYL719C1201 Ph 2 active not recruiting Study Assessing the Efficacy and Safety of Treatment With Alpelisib Plus Fulvestrant in Japanese Men and Postmenopausal Women With Advanced Breast Cancer
NCT05038735 EPIK-B5 CBYL719C2303 2023-509133-39-00 Ph 3 active not recruiting Study to Assess the Efficacy and Safety of Alpelisib Plus Fulvestrant in Participants With HR-positive (HR+), HER2-negative, Advanced Breast Cancer After Treatment With a CDK4/6 Inhibitor and an Aromatase Inhibitor.
NCT05631795 ALPINIST CBYL719CIN01 Ph 4 completed Study to Assess the Safety of Alpelisib Plus Fulvestrant, in Men and Post-menopausal Women With HR-positive, HER2-negative, Advanced Breast Cancer (aBC) With PIK3CA Mutation, Whose Disease Progressed on or After Endocrine Treatment
NCT04544189 CBYL719C2201 Ph 2 active not recruiting Study Assessing the Efficacy and Safety of Treatment With Alpelisib Plus Fulvestrant Versus Placebo Plus Fulvestrant in Chinese Men and Postmenopausal Women With Advanced Breast Cancer
NCT04208178 EPIK-B2 CBYL719G12301 2024-512050-13-00 Ph 3 active not recruiting Study of Alpelisib (BYL719) in Combination With Trastuzumab and Pertuzumab as Maintenance Therapy in Patients With HER2-positive Advanced Breast Cancer With a PIK3CA Mutation
NCT04980833 EPIK-P3 CBYL719F12401 2023-508522-95-00 Ph 2 active not recruiting Study Assessing Long-term Safety and Efficacy of Alpelisib in Patients With PIK3CA-Related Overgrowth Spectrum (PROS) Who Previously Participated in Study CBYL719F12002 (EPIK-P1)
NCT05230810 01AB21- PIK3CA Ph 1, Ph 2 active not recruiting Clinical Trial of Alpelisb and Tucatinib in Patients With PIK3CA-Mutant HER2+ Metastatic Breast Cancer.
NCT04729387 CBYL719K12301 2024-510782-42-00 Ph 3 terminated Alpelisib Plus Olaparib in Platinum-resistant/Refractory, High-grade Serous Ovarian Cancer, With no Germline BRCA Mutation Detected
NCT05101564 results posted IRB-52869 NCI-2023-02578 Ph 2 completed Umbrella Trial of Subtype-Targeted Therapies in ER+/HER2- Breast Cancer
NCT05501886 VIKTORIA-1 CELC-G-301 2021-005235-24 Ph 3 active not recruiting Gedatolisib Plus Fulvestrant With or Without Palbociclib vs Standard-of-Care for the Treatment of Patients With Advanced or Metastatic HR+/HER2- Breast Cancer (VIKTORIA-1)
NCT05933395 GERTRUDE STUDY02001800 NCI-2024-09317 Ph 2 recruiting Genetically-informed Therapy for ER+ Breast Cancer Post-CDK4/6 Inhibitor
NCT03056755 BYLieve results posted CBYL719X2402 2023-509167-24-00 Ph 2 completed Study Assessing the Efficacy and Safety of Alpelisib Plus Fulvestrant or Letrozole, Based on Prior Endocrine Therapy, in Patients With PIK3CA Mutant, HR+, HER2- Advanced Breast Cancer Who Have Progressed on or After Prior Treatments
NCT05563220 ELEVATE STML-ELA-0222 Ph 1, Ph 2 recruiting Open-Label Umbrella Study To Evaluate Safety And Efficacy Of Elacestrant In Various Combination In Participants With Metastatic Breast Cancer
NCT04762979 BTCRC-BRE19-409 Ph 2 active not recruiting Alpelisib (BYL719) in Combination With Continued Endocrine Therapy Following Progression on Endocrine Therapy in Hormone Receptor Positive, HER2 Negative, PIK3CA Mutant Metastatic Breast Cancer
NCT04997902 KO-TIP-013 Ph 1, Ph 2 completed Combination Trial of Tipifarnib and Alpelisib in Adult Recurrent/ Metastatic Head and Neck Squamous Cell Carcinoma (R/M HNSCC)
NCT03284957 AMEERA-1 results posted TED14856 U1111-1189-4896, 2024-512997-89 Ph 1, Ph 2 terminated Phase 1/2 Study of Amcenestrant (SAR439859) Single Agent and in Combination With Other Anti-cancer Therapies in Postmenopausal Women With Estrogen Receptor Positive Advanced Breast Cancer
NCT05090358 21-123 Ph 2 active not recruiting Preventing High Blood Sugar in People Being Treated for Metastatic Breast Cancer
NCT05508906 OP-1250-003 Ph 1 recruiting Phase 1b Study of OP-1250 (Palazestrant) in Combination With Ribociclib, Alpelisib, Everolimus, or Atirmociclib in ER+, HER2- Breast Cancer
NCT04216472 2019-0752 NCI-2019-08495, 2019-0752 Ph 2 terminated Nab-paclitaxel and Alpelisib for the Treatment of Anthracycline Refractory Triple Negative Breast Cancer With PIK3CA or PTEN Alterations
NCT05063786 ALPHABET GEICAM/2017-01_IBCSG 62-20_BIG 2020-005639-65 Ph 3 active not recruiting Trastuzumab + Alpelisib +/- Fulvestrant vs Trastuzumab + CT in Patients With PIK3CA Mutated Previously Treated HER2+ Advanced BrEasT Cancer (ALPHABET)
NCT05625087 SAFIR 03 UC-GMP-2206 EU CT Ph 2 active 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
NCT04300790 METALLICA MEDOPP240 2019-003970-26 Ph 2 completed Study to Evaluate the Effect of Metformin in the Prevention of HG in HR[+]/HER2[-] PIK3CA-mut Advanced BC Patients
NCT04188548 EMBER 17502 J2J-MC-JZLA, 2019-003581-41 Ph 1 active not recruiting A Study of LY3484356 in Participants With Advanced or Metastatic Breast Cancer or Endometrial Cancer
NCT02437318 SOLAR-1 results posted CBYL719C2301 2015-000340-42 Ph 3 completed Study Assessing the Efficacy and Safety of Alpelisib Plus Fulvestrant in Men and Postmenopausal Women With Advanced Breast Cancer Which Progressed on or After Aromatase Inhibitor Treatment.
NCT03207529 2016-0538 NCI-2018-01127, 2016-0538 Ph 1 completed Alpelisib and Enzalutamide in Treating Patients With Androgen Receptor and PTEN Positive Metastatic Breast Cancer
NCT04899349 EPIK-B4 results posted CBYL719C2202 Ph 2 terminated Study of Safety and Efficacy of Dapagliflozin + Metformin XR Versus Metformin XR in Participants With HR+, HER2-, Advanced Breast Cancer While on Treatment With Alpelisib and Fulvestrant
NCT03631953 ALTREM 2018-05 RCAPHM18_0015 Ph 1 recruiting Combination of Alpelisib and Trametinib in Progressive Refractory Meningiomas
NCT03439046 BioItaLEE CLEE011AIT01 2017-004176-62 Ph 3 completed Study of the Molecular Features of Postmenopausal Women With HR+ HER2-negative aBC on First-line Treatment With Ribociclib and Letrozole and, in Patients With a PIK3CA Mutation, on Second-line Treatment With Alpelisib Plus Fulvestrant
NCT04862143 TELEPIK results posted CBYL719A03201 2020-005882-15 Ph 2 terminated Pilot Decentralized Clinical Trial in Men and Pre and Post-menopausal Women With Breast Cancer and a Specific Mutation (PIK3CA) Treated With Alpelisib in Combination With Fulvestrant
NCT03601507 results posted 1802258478 NCI-2018-00507, CBYL719XUS15T Ph 2 terminated Alpelisib in Treating Participants With Transorally Resectable HPV-Associated Stage I-IVA Oropharyngeal Cancer
NCT05967286 NCI-2023-05623 NCI-2023-05623, EAY191-A2 Ph 2 withdrawn Olaparib and Alpelisib for Treatment of Metastatic Breast Cancer, A ComboMATCH Treatment Trial
NCT02925234 DRUP M15DRU Ph 2 recruiting The Drug Rediscovery Protocol (DRUP Trial)
NCT05472220 219515 NCI-2022-03888 Ph 1 withdrawn Alpelisib in Combination With Carboplatin in Patients With Solid Tumors and HPV-Positive Squamous Cell Carcinoma
NCT03386162 SAFIR-PI3K UC-0105/1701 Ph 2 terminated SAFIR-PI3K A Phase II Randomized Maintenance Trial Comparing Alpelisib and Fulvestrant Versus Chemotherapy in PIK3CA Mutated Advanced Breast Cancer
NCT02624557 CBYL719A2105 Ph 1 completed Pharmacokinetic Study of Alpelisib in Subjects With Hepatic Impairment.
NCT02077933 CBYL719Z2102 2013-004829-86 Ph 1 completed Study of Safety and Efficacy of Alpelisib With Everolimus or Alpelisib With Everolimus and Exemestane in Advanced Breast Cancer Patients, Renal Cell Cancer and Pancreatic Tumors
NCT02620839 159516 NCI-2017-01680 Ph 1 terminated Phase Ib Study of Alpelisib With Cisplatin in Patients With HPV+ Solid Tumor Malignancies
NCT01923168 results posted CBYL719A2201 2013-001862-41 Ph 2 completed Study of Letrozole With or Without BYL719 or Buparlisib, for the Neoadjuvant Treatment of Postmenopausal Women
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Active Pipeline

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Ongoing clinical trials by development phase

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Key Completed Trials

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Completed studies with published results, ranked by significance

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Trial Timeline

ClinicalTrials.gov ↗ Pro

Full development history with FDA approval milestones

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Understanding FDA Approval Types
Count Type What it means
- ORIG Original approval - drug first enters market
- SUPPL - Efficacy New indication (new disease/condition approved)
- SUPPL - Labeling Label text changes (warnings, dosing updates)
- SUPPL - Manufacturing Production changes (new facility)
- SUPPL - Chemistry Formulation changes (new dosage strength)

Green lines in the timeline show ORIG and Efficacy approvals - the clinically meaningful milestones.

VIJOICE FDA Label Details

Indications & Usage

FDA Label (PDF)

VIJOICE is indicated for the treatment of PIK3CA-Related Overgrowth Spectrum.

View full patent landscape →
4 OB patents · 2 families · 99 international docs across 51 countries

VIJOICE Patents & Exclusivity

Latest Patent: Feb 2037
Exclusivity: Apr 2029

Patents (4 active)

US12427141 Expires Feb 17, 2037
US11433059 Expires Feb 17, 2037
US8227462 Expires Apr 29, 2033
US8476268 Expires Sep 10, 2029

Exclusivity

ODE-396 Until Apr 2029
ODE-396 Until Apr 2029
ODE-396 Until Apr 2029
ODE-396 Until Apr 2029
ODE-396 Until Apr 2029
ODE-396 Until Apr 2029
ODE-396 Until Apr 2029
ODE-396 Until Apr 2029
ODE-396 Until Apr 2029
Source: FDA Orange Book

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Patent Timeline

  • • Cliff: 2037
  • • 40 active patents

Trial Analysis

  • • Clinical trial tracking
  • • Development stage analysis

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  • • Competitor tracking
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Data Sources

FDA Approval: NDA215039 → Label: DailyMed → Patents: FDA Orange Book → Trials: ClinicalTrials.gov →

Data sourced from official FDA and NIH databases. Click links to verify on original sources.