Alpelisib
Also known as Piqray
NOVARTIS AG NVS NVSEF · Breast Cancer; Advanced HER2+Breast Cancer; Lymphatic Malformations; Ovarian Cancer; Triple Negative Breast Neoplasms
Key figures
Next catalyst
None scheduled
Only dates with a source are listed
Phase
Approved
Not recorded
Linked trials
7
From ClinicalTrials.gov
Latest FDA action
Approved
NDA215039,
Recalls, shortages, patents and EU status at a glance
Key information
- Sponsor
- NOVARTIS AG NVS NVSEF Source: Company record for NOVARTIS AG (opens in a new tab)
- Indications
- Breast Cancer; Advanced HER2+Breast Cancer; Lymphatic Malformations; Ovarian Cancer; Triple Negative Breast Neoplasms Source: Conditions from ClinicalTrials.gov (opens in a new tab)
- Applications
- NDA 215039 · Priority review Source: Drugs@FDA via openFDA (opens in a new tab) · Action letter for NDA 215039 (opens in a new tab)
- NDA 218466 · Standard review Source: Drugs@FDA via openFDA (opens in a new tab) · Action letter for NDA 218466 (opens in a new tab)
- NDA 212526 · Priority review Source: Drugs@FDA via openFDA (opens in a new tab) · Action letter for NDA 212526 (opens in a new tab)
- Designations
- None recorded
- Next catalyst
- None scheduled
Development timeline
- Preclinical Completed
- Phase 1 Completed
- Phase 2 CompletedFirst trial start 24 Nov 20231 linked trial
- Phase 3 CompletedFirst trial start 23 Jul 20157 linked trials
- Filed Completed
- Approved Current stageFirst approval 24 May 2019
Overview
- Mechanism
- Not recorded
- Route
- Not recorded
- Modality
- Not recorded
- Specialties
- Not recorded
Overview text is written by HealthTrade editors.
Key dates
No catalysts yet. Editors add each date together with its source.
FDA designations
No FDA designations are on record for Alpelisib. Editors add each one with its source.
Filed application
No filed application is on record for Alpelisib. Approvals are listed under FDA actions.
FDA advisory committees
No FDA advisory committee meetings are on record for Alpelisib.
Clinical trials
| Trial | Title | Phase | Status | Enrollment | Primary completion | Results posted |
|---|---|---|---|---|---|---|
| NCT05948943ClinicalTrials.gov record for NCT05948943 (opens in a new tab)EPIK-L1 | Alpelisib in Pediatric and Adult Patients With Lymphatic Malformations Associated With a PIK3CA Mutation. | Phase 2/3 | Recruiting | 232 (estimated) | 31 May 2028 (estimated) | No |
| NCT05038735ClinicalTrials.gov record for NCT05038735 (opens in a new tab)EPIK-B5 | 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. | Phase 3 | Active, not recruiting | 210 (actual) | 28 Jan 2027 (estimated) | No |
| NCT04729387ClinicalTrials.gov record for NCT04729387 (opens in a new tab) | Alpelisib Plus Olaparib in Platinum-resistant/Refractory, High-grade Serous Ovarian Cancer, With no Germline BRCA Mutation Detected | Phase 3 | Terminated | 358 (actual) | 21 Apr 2023 (actual) | Yes First posted Results on ClinicalTrials.gov for NCT04729387 (opens in a new tab) |
Posted results on ClinicalTrials.gov for NCT04729387
Serious adverse events (Adverse events (AEs) were collected from the first dose of study treatment through 30 days after the last dose (on-treatment period), for up to approximately 39 months with alpelisib or olaparib, 45 months with paclitaxel, and 23 months with pegylated liposomal doxorubicin (PLD). Deaths occurring the post-treatment period were collected through study completion, including an additional follow-up period of approximately 14, 8, and 30 months, respectively.): Alpelisib 200mg + Olaparib 200mg (On-Treatment) 98 of 180; Paclitaxel or Pegylated Liposomal Doxorubicin (PLD) (On-Treatment) 52 of 164; Alpelisib 200mg + Olaparib 200mg (Post-Treatment) 0 of 0; Paclitaxel or Pegylated Liposomal Doxorubicin (PLD) (Post-Treatment) 0 of 0 Source: ClinicalTrials.gov results for NCT04729387 (opens in a new tab)· imported Posted results as ClinicalTrials.gov prints them: primary outcome analyses and serious adverse event totals only. Registry facts, not reviewed by HealthTrade and not investment advice; filing-derived results are listed separately. Publications listing NCT04729387 (1), newest first
Citations from PubMed, U.S. National Library of Medicine; abstracts are not stored. A publication lists this study’s NCT number and may be a review that cites many studies. | ||||||
| NCT04208178ClinicalTrials.gov record for NCT04208178 (opens in a new tab)EPIK-B2 | 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 | Phase 3 | Active, not recruiting | 19 (actual) | 26 Feb 2027 (estimated) | No |
| NCT04251533ClinicalTrials.gov record for NCT04251533 (opens in a new tab)EPIK-B3 | 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 | Phase 3 | Terminated | 137 (actual) | 31 May 2023 (actual) | Yes First posted Results on ClinicalTrials.gov for NCT04251533 (opens in a new tab) |
Posted results on ClinicalTrials.gov for EPIK-B3
Serious adverse events (Adverse events were collected up to approximately 28 months (Part A) or up to approximately 17 months (Part B1). Deaths were collected in the post-treatment survival follow-up from 31 days after last dose of study medication until the data cut-off date, up to approximately 7 additional months (Part A) or approximately 9 additional months (Part B1). These were not considered AEs.): Part A: Alpelisib + Nab-paclitaxelEdit 22 of 52; Part A: Placebo + Nab-paclitaxelEdit 15 of 50; Part B1: Alpelisib + Nab-paclitaxelEdit 14 of 35; Part A: Alpelisib + Nab-paclitaxel (Post-treatment Survival Follow-up) 0 of 0; Part A: Placebo + Nab-paclitaxel (Post-treatment Survival Follow-up) 0 of 0; Part B1: Alpelisib + Nab-paclitaxel (Post-treatment Survival Follow-up) 0 of 0 Source: ClinicalTrials.gov results for NCT04251533 (opens in a new tab)· imported Posted results as ClinicalTrials.gov prints them: primary outcome analyses and serious adverse event totals only. Registry facts, not reviewed by HealthTrade and not investment advice; filing-derived results are listed separately. | ||||||
| NCT03439046ClinicalTrials.gov record for NCT03439046 (opens in a new tab)BioItaLEE | 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 | Phase 3 | Terminated | 287 (actual) | 11 Dec 2023 (actual) | Yes First posted Results on ClinicalTrials.gov for NCT03439046 (opens in a new tab) |
Posted results on ClinicalTrials.gov for BioItaLEE Serious adverse events (Adverse events were reported from first dose of study treatment until end of study treatment plus 30 days post treatment, up to a maximum duration of approximately 5.8 years in the core phase and 1.7 years in the extension phase.): Ribociclib+Letrozole (Core Phase) 79 of 287; Alpelisib+Fulvestrant (Extension Phase) 6 of 21 Source: ClinicalTrials.gov results for NCT03439046 (opens in a new tab)· imported Posted results as ClinicalTrials.gov prints them: primary outcome analyses and serious adverse event totals only. Registry facts, not reviewed by HealthTrade and not investment advice; filing-derived results are listed separately. | ||||||
| NCT02437318ClinicalTrials.gov record for NCT02437318 (opens in a new tab)SOLAR-1 | 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. | Phase 3 | Completed | 572 (actual) | 12 Jun 2018 (actual) | Yes First posted Results on ClinicalTrials.gov for NCT02437318 (opens in a new tab) |
Posted results on ClinicalTrials.gov for SOLAR-1
Serious adverse events (All-cause mortality: from randomization up to approx. 6.5 years, including post-treatment survival follow up period. Serious and Other Adverse Events: from first dose of study treatment until 30 days after last dose up to approx. 6.5 years): Alpelisib + Fulvestrant 110 of 284; Placebo + Fulvestrant 54 of 287; Alpelisib + Fulvestrant (Post-treatment Survival Follow-up) 0 of 0; Placebo + Fulvestrant (Post-treatment Survival Follow-up) 0 of 0 Source: ClinicalTrials.gov results for NCT02437318 (opens in a new tab)· imported Posted results as ClinicalTrials.gov prints them: primary outcome analyses and serious adverse event totals only. Registry facts, not reviewed by HealthTrade and not investment advice; filing-derived results are listed separately. Publications listing SOLAR-1 (6), newest first
All 6 publications for NCT02437318 Citations from PubMed, U.S. National Library of Medicine; abstracts are not stored. A publication lists this study’s NCT number and may be a review that cites many studies. | ||||||
Source: ClinicalTrials.gov, U.S. National Library of Medicine. Posted results are shown as ClinicalTrials.gov prints them; results from company and journal sources are entered by editors and listed separately. Full result tables are on ClinicalTrials.gov.
Trial quality
About CT-VCALoading trial quality…
FDA actions
Data provided by the U.S. Food and Drug Administration.
FDA recalls load here.
FDA drug shortages load here.
Orange Book patents load here.
FAERS adverse event counts load here.
Papers and preprints load here.
Community discussion loads here.
EU status (EMA)
Authorised
Piqray (EMEA/H/C/004804)
- Authorised
- Therapeutic area
- Breast Neoplasms
- Marketing authorisation holder
- Novartis Europharm Limited
- Active substance (INN)
- alpelisib
- ATC code
- L01XE
- Latest EMA decision
Matched by active substance: EMA's INN or active substance equals this drug's name. EMA lists 2 other products with this substance, such as generics.
EMA page for Piqray (opens in a new tab)EMA medicine data (opens in a new tab)
Source: European Medicines Agency (EMA), medicines data download. Licence: EMA re-use with acknowledgement. EMA medicines report 2026-10-26.
Related news
No recent headlines mention this drug.
Sources
- Drugs@FDA 212526 (opens in a new tab) Licence: public-domain. Official registry record this listing came from
- ClinicalTrials.gov NCT05948943 (opens in a new tab) Licence: public-domain. Fetched
- ClinicalTrials.gov NCT05038735 (opens in a new tab) Licence: public-domain. Fetched
- ClinicalTrials.gov NCT04729387 (opens in a new tab) Licence: public-domain. Fetched
- ClinicalTrials.gov NCT04208178 (opens in a new tab) Licence: public-domain. Fetched
- ClinicalTrials.gov NCT04251533 (opens in a new tab) Licence: public-domain. Fetched
- ClinicalTrials.gov NCT03439046 (opens in a new tab) Licence: public-domain. Fetched
- ClinicalTrials.gov NCT02437318 (opens in a new tab) Licence: public-domain. Fetched
- Drugs@FDA via openFDA NDA215039 (opens in a new tab) Licence: cc0. Fetched
- Drugs@FDA via openFDA NDA218466 (opens in a new tab) Licence: cc0. Fetched
- Drugs@FDA via openFDA NDA212526 (opens in a new tab) Licence: cc0. Fetched
Record updated .
Dates come from company and FDA disclosures and can change. Nothing on this page is investment advice.