Data updated: May 26, 2026
PIQRAY (alpelisib)
Genetically Validated
Trial Activity: Growth 24 active trials
Priority Review
Oncology
Approved 2019-05-24
Piqray treats adults with advanced or metastatic breast cancer that is hormone receptor-positive and HER2-negative. It is used for patients whose tumors carry a specific PIK3CA mutation, which is identified through a specialized test. This medication helps patients whose cancer has progressed following previous hormone-based treatments and is used in combination with fulvestrant.
Source: FDA Label • Novartis
How PIQRAY Works
This drug works by blocking PI3K, particularly the alpha subunit that becomes overactive due to genetic mutations and drives tumor growth. By inhibiting this pathway, it reduces the signaling that allows cancer cells to multiply and transform. It also increases estrogen receptor activity, making the combination with fulvestrant more effective at stopping tumor progression than using either drug alone.
Development Insights
Novartis Pharmaceuticals conducting 19 trials (41%)
103 indications explored (Broad Platform)
→ breast cancer (16 trials)
→ advanced breast cancer (6 trials)
→ anatomic stage iii breast cancer ajcc v8 (4 trials)
3
Indications
--
Phase 3 Trials
2
Priority Reviews
7
Years on Market
Details
- Status
- Prescription
- First Approved
- 2019-05-24
- Patent Cliff
- 2033
- Routes
- ORAL
- Dosage Forms
- TABLET
PIQRAY Approval History
2020
2021
2022
2023
2024
2025
2026
Original
New Indication
New Form
Label Update
18 FDA actions from 2019 to 2024 · 2 indication expansions
What PIQRAY Treats
1 indicationsPIQRAY is approved for 1 conditions since its original approval in 2019. These indications span multiple therapeutic areas including oncology, immunology, and more.
- Breast Cancer
Source: FDA Label
PIQRAY Target & Pathway
ProTarget
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.
PIQRAY Competitive Set
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Indication competitors
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What's emerging in PIQRAY's indications
See all emerging drugs →Phase 3 candidates targeting molecules with no FDA-approved drug, in indications PIQRAY treats. First-in-class if their pivotal trials read out positive.
Drugs Similar to PIQRAY
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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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Trial Timeline
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.
PIQRAY FDA Label Details
Indications & Usage
FDA Label (PDF)PIQRAY is indicated for the treatment of Breast Cancer.
View full patent landscape →
2 OB patents · 1 families ·
76 international docs across 51 countries
PIQRAY Patents & Exclusivity
Latest Patent: Apr 2033
Exclusivity: Jan 2027
Exclusivity
I-937
Until Jan 2027
I-937
Until Jan 2027
I-937
Until Jan 2027
I-937
Until Jan 2027
I-937
Until Jan 2027
I-937
Until Jan 2027
I-937
Until Jan 2027
I-937
Until Jan 2027
I-937
Until Jan 2027
Source: FDA Orange Book
Pro Intelligence Preview
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Revenue Insights
- • Quarterly revenue tracking
- • Historical trend analysis
Patent Timeline
- • Cliff: 2033
- • 18 active patents
Trial Analysis
- • 46 total trials
- • Stage: Growth
Competitive Landscape
- • 20 similar drugs
- • Same target/indication analysis
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Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.
How We Calculate These Metrics
Trial Activity Stage
Measures the current development activity pattern based on trial phases, status, and trends. Important: This measures R&D activity, not commercial lifecycle.
Trial statuses: "Active" means recruiting or ongoing. "Completed" means reached planned endpoint. "Terminated" means stopped early—often due to safety, efficacy, or business reasons.
- Growth: High proportion of early-phase trials (Phase 1/2), active development
- Expansion: Significant Phase 3 activity, approaching or pursuing approvals
- Mature: Substantial Phase 4 post-marketing studies
- Stable: Mixed phase distribution, steady development
- Declining: Low active trial ratio, reduced R&D investment