Piqray

(Alpelisib)

ApprovedSmall molecule

Alpelisib is used to treat certain types of breast cancer in women, specifically hormone receptor-positive breast cancer that has spread to other parts of the body. It works by blocking a protein that helps cancer cells grow.[2] Piqray is currently approved and in use across 25 indications[4].[1]

Piqray is one of 499 small molecule programs targeting Insulin resistance. It is currently in Approved.

Indications

Total Trials

Active Trials

498

Competitors

FDA Applications

NDA/BLA/ANDA regulatory filings

Patents

Pipeline

Status by Indication[4][1]

Indication

Insulin ResistanceActive, not recruiting

LymphangiomaActive, not recruiting

Capillary MalformationActive, not recruiting

Oropharynx Squamous Cell CarcinomaApproved

Breast NeoplasmActive, not recruiting

Lymphatic MalformationActive, not recruiting

Breast CarcinomaActive, not recruiting

MeningiomaActive, not recruiting

Vascular MalformationActive, not recruiting

HyperglycemiaActive, not recruiting

Insulin ResistancePhase 1

Active, not recruiting

LymphangiomaPreclinical

Active, not recruiting

Capillary MalformationPhase 2

Active, not recruiting

Oropharynx Squamous Cell CarcinomaApproved

Approved

Breast NeoplasmApproved

Active, not recruiting

Lymphatic MalformationPhase 2

Active, not recruiting

Breast CarcinomaApproved

Active, not recruiting

MeningiomaPhase 1

Active, not recruiting

Vascular MalformationPhase 2

Active, not recruiting

HyperglycemiaPreclinical

Active, not recruiting

Showing 10 of 25 indications

Competition

Competitive Landscape

2828 competitors in Breast Cancer

#DrugCompanyPhaseTrials

Piqray

Novartis

Approved

29 2

Trodelvy

Gilead

Preclinical

37 3

Megace

Bristol-Myers Squibb

Preclinical

4 4

Cymbalta

Alnylam Pharmaceuticals

Preclinical

3 5

Zolymbus

AbbVie

Preclinical

1 6

Methylthioninium Chloride

PProvepharm SAS

Preclinical

3 7

Recentin

NNational Cancer Institute (NCI)

Preclinical

2 8

Spravato

WWim Janssens

Preclinical

2 9

Chirocaine

PPurdue Pharma LP

Preclinical

1 10

Acupan

YYonsei University

Preclinical

Ranked by pipeline maturity and clinical activity. Current drug highlighted in teal.

Timeline

Expected Milestones

Q4 2026

Phase 2Active, not recruiting

Breast Cancer

NCT05090358

Phase 2Recruiting

Vascular Malformation

NCT05983159

Phase 1Recruiting

Insulin Resistance

NCT06354088

Phase 3Active, not recruiting

Breast Cancer

NCT05501886

Q1 2027

Phase 3Active, not recruiting

Breast Cancer

NCT04208178

Phase 3Active, not recruiting

Breast Cancer

NCT05038735

Clinical

Trials by Indication[1]

Breast Cancer29 trials

Trastuzumab + Alpelisib +/- Fulvestrant vs Trastuzumab + CT in Patients With PIK3CA Mutated Previously Treated HER2+ Advanced BrEasT Cancer (ALPHABET)

Active, not recruiting·SSpanish Breast Cancer Research Group·Phase 3·NCT05063786·27 enrolled

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

Terminated· Novartis logo

Novartis·Phase 2·NCT04899349·2 enrolled

Phase 1b Study of OP-1250 (Palazestrant) in Combination With Ribociclib, Alpelisib, Everolimus, or Atirmociclib in ER+, HER2- Breast Cancer

Recruiting·OOlema Pharmaceuticals, Inc.·Phase 1·NCT05508906·190 enrolled

Show 26 more trials

Preventing High Blood Sugar in People Being Treated for Metastatic Breast Cancer

Active, not recruiting·MMemorial Sloan Kettering Cancer Center·Phase 2·NCT05090358·15 enrolled

Olaparib and Alpelisib for Treatment of Metastatic Breast Cancer, A ComboMATCH Treatment Trial

Withdrawn·NNational Cancer Institute (NCI)·Phase 2·NCT05967286

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

Terminated· Sanofi logo

Sanofi·Phase 1/2·NCT03284957·136 enrolled

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

Active, not recruiting·UUNICANCER·Phase 2·NCT05625087·162 enrolled

Alpelisib (BYL719) in Combination With Continued Endocrine Therapy Following Progression on Endocrine Therapy in Hormone Receptor Positive, HER2 Negative, PIK3CA Mutant Metastatic Breast Cancer

Active, not recruiting·MMarina N Sharifi·Phase 2·NCT04762979·44 enrolled

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.

Completed· Novartis logo

Novartis·Phase 3·NCT02437318·572 enrolled

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)

Active, not recruiting·CCelcuity Inc·Phase 3·NCT05501886·701 enrolled

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

Completed· Novartis logo

Novartis·Phase 2·NCT03056755·383 enrolled

Open-Label Umbrella Study To Evaluate Safety And Efficacy Of Elacestrant In Various Combination In Participants With Metastatic Breast Cancer

Recruiting·SStemline Therapeutics, Inc.·Phase 1/2·NCT05563220·435 enrolled

Clinical Trial of Alpelisb and Tucatinib in Patients With PIK3CA-Mutant HER2+ Metastatic Breast Cancer.

Active, not recruiting·CCriterium, Inc.·Phase 1/2·NCT05230810·40 enrolled

Umbrella Trial of Subtype-Targeted Therapies in ER+/HER2- Breast Cancer

Completed·JJennifer Lee Caswell-Jin·Phase 2·NCT05101564·19 enrolled

Alpelisib And Sacituzumab Govitecan For Treatment Of Breast Cancer

Active, not recruiting·UUniversity of Kansas Medical Center·Phase 1·NCT05143229·18 enrolled

Alpelisib and Enzalutamide in Treating Patients With Androgen Receptor and PTEN Positive Metastatic Breast Cancer

Completed·MM.D. Anderson Cancer Center·Phase 1·NCT03207529·18 enrolled

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

Terminated· Novartis logo

Novartis·Phase 2·NCT04862143·2 enrolled

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

Active, not recruiting· Novartis logo

Novartis·Phase 3·NCT04208178·19 enrolled

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

Active, not recruiting· Novartis logo

Novartis·Phase 2·NCT04544189·69 enrolled

A Phase Ib Dose De-escalation Study With BYL719 in Premenopausal Patients With Locally Advanced or Metastatic Breast Cancer

Completed· Novartis logo

Novartis·Phase 1·NCT02058381·40 enrolled

Managed Access Program to Provide Alpelisib for Patients With HR+ Advanced or Metastatic Breast Cancer

No longer available· Novartis logo

Novartis··NCT03706573

SAFIR-PI3K A Phase II Randomized Maintenance Trial Comparing Alpelisib and Fulvestrant Versus Chemotherapy in PIK3CA Mutated Advanced Breast Cancer

Terminated·UUNICANCER·Phase 2·NCT03386162·31 enrolled

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

Completed· Novartis logo

Novartis·Phase 1·NCT02077933·79 enrolled

Genetically-informed Therapy for ER+ Breast Cancer Post-CDK4/6 Inhibitor

Recruiting·—·Phase 2·NCT05933395·135 enrolled

SEQUence of Endocrine Therapy in Advanced Luminal Breast Cancer (SEQUEL-Breast)

Active, not recruiting·BBorstkanker Onderzoek Groep·Phase 2·NCT05392608·130 enrolled

A Phase IIIb, Open-label, Local, Multicenter Study of the Molecular Features of Postmenopausal Women With Hormone Receptor-positive (HR+) HER2-negative Advanced Breast Cancer on First-line Treatment With Ribociclib Plus Letrozole and, in Patients With a PIK3CA Mutation, on Second-line Treatment With Alpelisib Plus Fulvestrant (BioItaLEE)

Terminated· Novartis logo

Novartis·Phase 3·NCT03439046·287 enrolled

EPIK-B5: A Phase III, Randomized, Double-blind, Placebo-controlled Study of Alpelisib in Combination With Fulvestrant for Men and Postmenopausal Women With HR-positive, HER2-negative Advanced Breast Cancer With a PIK3CA Mutation, Who Progressed on or After Aromatase Inhibitor and a CDK4/6 Inhibitor

Active, not recruiting· Novartis logo

Novartis·Phase 3·NCT05038735·210 enrolled

A Phase III, Multicenter, Randomized, Open-Label Study Evaluating the Efficacy and Safety of Inavolisib Plus Fulvestrant Versus Alpelisib Plus Fulvestrant in Patients With Hormone Receptor-Positive, HER2-Negative, PIK3CA Mutated, Locally Advanced or Metastatic Breast Cancer Who Progressed During or After CDK4/6 Inhibitor and Endocrine Combination Therapy

Active, not recruiting· Roche logo

Roche·Phase 3·NCT05646862·420 enrolled

EMBER: A Phase 1a/1b Study of LY3484356 Administered as Monotherapy and in Combination With Anticancer Therapies for Patients With ER+ Locally Advanced or Metastatic Breast Cancer and Other Select Non-Breast Cancers

Active, not recruiting· Eli Lilly logo

Eli Lilly·Phase 1·NCT04188548·379 enrolled

Growth3 trials

Managed Access Program (MAP) to Provide Access to Alpelisib (BYL719) for Patients With PIK3CA-Related Overgrowth Spectrum (PROS)

Available· Novartis logo

Novartis··NCT04085653

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)

Active, not recruiting· Novartis logo

Novartis·Phase 2·NCT04980833·41 enrolled

Study Assessing the Efficacy, Safety and PK of Alpelisib (BYL719) in Pediatric and Adult Patients With PIK3CA-related Overgrowth Spectrum

Active, not recruiting· Novartis logo

Novartis·Phase 2·NCT04589650·206 enrolled

Advanced Breast Cancer2 trials

ALPelisib INdia Safety STudy (ALPINIST): A Phase IV, Prospective, Multicenter, Open-label, Non-comparative, Interventional 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 a PIK3CA Mutation, Whose Disease Has Progressed on or After Endocrine Based Treatment.

Completed· Novartis logo

Novartis·Approved·NCT05631795·40 enrolled

A Phase II Open-label, 2-Part, Multi-center Study of BYL719 (Alpelisib) in Combination With Fulvestrant for Men and Postmenopausal Women With PIK3CA Mutation Hormone Receptor (HR) Positive, HER2-negative, Advanced Breast Cancer Which Progressed on or After Aromatase Inhibitor (AI) Treatment in Japan

Active, not recruiting· Novartis logo

Novartis·Phase 2·NCT04524000·24 enrolled

PIK3CA-related Overgrowth Spectrum (PROS)2 trials

Study Assessing the Efficacy, Safety and Pharmacokinetics of Alpelisib in Pediatric and Adult Patients With PIK3CA-related Overgrowth Spectrum (PROS)

Recruiting· Novartis logo

Novartis·Phase 2·NCT06997588·104 enrolled

An Open Label, Multi-center Alpelisib Roll-over Study to Assess Long-term Safety in Participants Who Have Completed a Novartis Sponsored Alpelisib (BYL719) Study and Are Judged by the Investigator to Benefit From Continued Treatment With Alpelisib.

Not yet recruiting· Novartis logo

Novartis·Phase 2·NCT07679269·51 enrolled

Pilot Study1 trial

Safety and Oversight of the Individually Tailored Treatment Approach: A Novel Pilot Study

Terminated·PPeter MacCallum Cancer Centre, Australia·N/A·NCT04801966·3 enrolled

23 more indications

Immunotherapy1 trial

The Rome Trial From Histology to Target: the Road to Personalize Target Therapy and Immunotherapy

Unknown status·FFondazione per la Medicina Personalizzata·Phase 2·NCT04591431·400 enrolled

Treatment1 trial

SMMART Adaptive Clinical Treatment (ACT) Trial

Withdrawn·OOHSU Knight Cancer Institute·Phase 1·NCT05238831

Trial1 trial

The Drug Rediscovery Protocol (DRUP Trial)

Recruiting·TThe Netherlands Cancer Institute·Phase 2·NCT02925234·1,550 enrolled

Observational Study1 trial

Analysis of Therapy Sequence in Women With HR+, HER2 - mBC in Moscow: A Multicenter Retrospective Observational Study.

Unknown status·—··NCT04852081·1,000 enrolled

Hyperglycemia1 trial

Utilizing Continuous Glucose Monitoring to Characterize and Manage Hyperglycemia in Patients Initiating Alpelisib

Active, not recruiting·HHealthPartners Institute··NCT06083038·15 enrolled

Hepatic Impairment1 trial

Pharmacokinetic Study of Alpelisib in Subjects With Hepatic Impairment.

Completed· Novartis logo

Novartis·Phase 1·NCT02624557·23 enrolled

Meningioma1 trial

Combination of Alpelisib and Trametinib in Progressive Refractory Meningiomas

Recruiting·AAssistance Publique Hopitaux De Marseille·Phase 1·NCT03631953·25 enrolled

Ovarian Cancer1 trial

Alpelisib Plus Olaparib in Platinum-resistant/Refractory, High-grade Serous Ovarian Cancer, With no Germline BRCA Mutation Detected

Terminated· Novartis logo

Novartis·Phase 3·NCT04729387·358 enrolled

Solid Tumor Malignancies1 trial

Phase Ib Study of Alpelisib With Cisplatin in Patients With HPV+ Solid Tumor Malignancies

Terminated·PPamela Munster·Phase 1·NCT02620839·28 enrolled

Oropharyngeal Cancer1 trial

Alpelisib in Treating Participants With Transorally Resectable HPV-Associated Stage I-IVA Oropharyngeal Cancer

Terminated·UUniversity of Arizona·Phase 2·NCT03601507·9 enrolled

Gastric Cancer1 trial

Alpelisib and Paclitaxel in PIK3CA-altered Gastric Cancer

Unknown status·SSeoul National University Bundang Hospital·Phase 1/2·NCT04526470·55 enrolled

Head and Neck Squamous Cell Carcinoma1 trial

Combination Trial of Tipifarnib and Alpelisib in Adult Recurrent/ Metastatic Head and Neck Squamous Cell Carcinoma (R/M HNSCC)

Completed·KKura Oncology, Inc.·Phase 1/2·NCT04997902·45 enrolled

Squamous Cell Carcinoma1 trial

Alpelisib in Combination With Carboplatin in Patients With Solid Tumors and HPV-Positive Squamous Cell Carcinoma

Withdrawn·PPamela Munster·Phase 1·NCT05472220

Capillary Malformation1 trial

Assessment of the Efficacy and Safety of Alpelisib (BYL719) in Pediatric and Adult Patients With Megalencephaly-CApillary Malformation Polymicrogyria Syndrome (MCAP)

Recruiting·—·Phase 2·NCT05577754·20 enrolled

Vascular Malformation1 trial

A Trial of Targeted Therapies for Patients With Slow-Flow or Fast-Flow Vascular Malformations

Recruiting·MMurdoch Childrens Research Institute·Phase 2·NCT05983159·50 enrolled

Insulin resistance1 trial

Human Models of Selective Insulin Resistance: Alpelisib, Part I

Recruiting·—·Phase 1·NCT06354088·32 enrolled

Prevention1 trial

Study to Evaluate the Effect of Metformin in the Prevention of HG in HR[+]/HER2[-] PIK3CA-mut Advanced BC Patients

Completed·MMedSIR·Phase 2·NCT04300790·69 enrolled

MPA1 trial

Compassionate Use of BYL 719 Alpelisib

No longer available·NNew Mexico Cancer Research Alliance··NCT03941782

Neoadjuvant Treatment1 trial

Study of Letrozole With or Without BYL719 or Buparlisib, for the Neoadjuvant Treatment of Postmenopausal Women

Completed· Novartis logo

Novartis·Phase 2·NCT01923168·340 enrolled

Advanced Malignant Solid Neoplasm1 trial

Molecular Analysis for Combination Therapy Choice (ComboMATCH)

Recruiting·NNational Cancer Institute (NCI)·Phase 2·NCT05564377·2,900 enrolled

Triple Negative Breast Neoplasms1 trial

A Phase III, Multicenter, Randomized, Double-blind, Placebo-controlled Study to Assess the Efficacy and Safety of Alpelisib (BYL719) in Combination With Nab-paclitaxel in Patients With Advanced Triple Negative Breast Cancer With Either Phosphoinositide-3-kinase Catalytic Subunit Alpha (PIK3CA) Mutation or Phosphatase and Tensin Homolog Protein (PTEN) Loss Without PIK3CA Mutation

Terminated· Novartis logo

Novartis·Phase 3·NCT04251533·137 enrolled

Anatomic Stage I Breast Cancer AJCC v81 trial

A Phase-2, Two-Cohort Trial of Neoadjuvant Nab-Paclitaxel and Alpelisib in Anthracycline Refractory Triple Negative Breast Cancer With PIK3CA or PTEN Alterations

Terminated·MM.D. Anderson Cancer Center·Phase 2·NCT04216472·6 enrolled

Lymphatic Malformation1 trial

A Two-stage Double-blind, Randomized, Placebo-controlled Study to Assess the Efficacy, Safety and Pharmacokinetics of Alpelisib in Pediatric and Adult Patients With Lymphatic Malformations Associated With a PIK3CA Mutation.

Recruiting· Novartis logo

Novartis·Preclinical·NCT05948943·232 enrolled

Regulatory

FDA Approval Timeline[5]

May 24, 2019

PIQRAY

NDA NDA212526

Apr 5, 2022

VIJOICE

NDA NDA215039

Apr 24, 2024

VIJOICE

NDA NDA218466

Sources

References

[1]
ClinicalTrials.gov — 60 trial records for Alpelisib. U.S. National Library of Medicine, National Institutes of Health.
[2]
MedlinePlus Drug Information — Piqray drug information. U.S. National Library of Medicine, National Institutes of Health.
[3]
ChEMBL — Alpelisib compound record. European Bioinformatics Institute (EMBL-EBI).
[4]
Open Targets Platform — Drug–disease associations for Alpelisib. EMBL-EBI & Wellcome Sanger Institute.
[5]
OpenFDA — FDA approval records (NDA NDA218466). U.S. Food & Drug Administration.
[6]
FDA Orange Book — Patent and exclusivity data for Piqray. U.S. Food & Drug Administration.
[7]
SEC EDGAR — Novartis company filings. U.S. Securities and Exchange Commission.

Details

Drug Info

Quick Facts

Mechanism of Action: PI3-Kinase P110-Alpha Subunit Inhibitor[3]
Modality: Small molecule[3]
Highest Phase: Approved[1]
Company: Novartis

Patent Landscape[6]

Patent Cliff

Sep 10, 2029

Earliest patent expiration — generic entry possible after this date

Patent #Expires

8476268Sep 10, 2029

8227462Apr 29, 2033

12427141Feb 17, 2037

11433059Feb 17, 2037

Piqray

Status by Indication[4][1]

Competitive Landscape

Expected Milestones

Q4 2026

Q1 2027

Trials by Indication[1]

Breast Cancer29 trials

Growth3 trials

Advanced Breast Cancer2 trials

PIK3CA-related Overgrowth Spectrum (PROS)2 trials

Pilot Study1 trial

Immunotherapy1 trial

Treatment1 trial

Trial1 trial

Observational Study1 trial

Hyperglycemia1 trial

Hepatic Impairment1 trial

Meningioma1 trial

Ovarian Cancer1 trial

Solid Tumor Malignancies1 trial

Oropharyngeal Cancer1 trial

Gastric Cancer1 trial

Head and Neck Squamous Cell Carcinoma1 trial

Squamous Cell Carcinoma1 trial

Capillary Malformation1 trial

Vascular Malformation1 trial

Insulin resistance1 trial

Prevention1 trial

MPA1 trial

Neoadjuvant Treatment1 trial

Advanced Malignant Solid Neoplasm1 trial

Triple Negative Breast Neoplasms1 trial

Anatomic Stage I Breast Cancer AJCC v81 trial

Lymphatic Malformation1 trial

FDA Approval Timeline[5]

References

Drug Info

Quick Facts

Patent Landscape[6]

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