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Last update 12 Jun 2026

Alpelisib

Last update 12 Jun 2026

Overview

R&D Status

Clinical Result

Translational Medicine

Overview

Basic Info

Drug Type

Small molecule drug

Synonyms

Alpelisib (JAN/USAN/INN), 阿吡利塞, BYL-719

+ [4]

Target

PI3Kα

Action

inhibitors

Mechanism

PI3Kα inhibitors(Phosphatidylinositol 3 kinase alpha inhibitors)

Therapeutic Areas

NeoplasmsSkin and Musculoskeletal DiseasesOther Diseases+ [6]

Active Indication

Inactive Indication

Adenocarcinoma of LungAdvanced gastric carcinomaAdvanced Lung Non-Small Cell Carcinoma+ [29]

Originator Organization

Novartis Pharma AG

Active Organization

Novartis Pharma Stein AG

Novartis Pharmaceuticals Corp.Novartis Pharma AG

+ [6]

Inactive Organization

AstraZeneca PLC

The University of California, San Francisco

Brown University

License Organization

Kura Oncology, Inc.

Novartis AG

Olema Pharmaceuticals, Inc.

Drug Highest PhaseApproved

First Approval Date

United States (24 May 2019),

PIK3CA mutation/HR-positive/HER2-negative Breast Cancer

RegulationOrphan Drug (United States), Orphan Drug (European Union), Orphan Drug (Australia)

Structure/Sequence

Molecular FormulaC19H22F3N5O2S

InChIKeySTUWGJZDJHPWGZ-LBPRGKRZSA-N

CAS Registry1217486-61-7

112

Clinical Trials associated with Alpelisib

NCT07573696

/ Not yet recruitingPhase 2IIT

A Multicenter, Phase 2 Non-Randomized Study of Unresectable Stage III ALK+ NSCLC Treated With Neoadjuvant Alectinib Plus Chemotherapy Followed by Multidisciplinary Approach for Optimal Local Treatment

This is a multicenter, phase 2 non-randomized study to investigate the clinical feasibility and therapeutic efficacy of employing a MDT-based strategy in unresectable stage III ALK positive NSCLC following neoadjuvant alectinib in combination with platinum-based chemotherapy. Participants in this study must not have received any previous systemic anticancer therapy before enrollment.
The study will consist of a 42-day screening period, a neoadjuvant treatment period, a local radical treatment period, a post-local treatment period, a safety follow-up visit occurring 28 days after the final dose of alectinib, and a survival follow-up period.
In the neoadjuvant treatment period, participants will be provided with alectinib (600mg PO BID for 3 cycles) plus platinum-based chemotherapy for a maximum of 3 cycles (each cycle is 21 days).
Following the completion of neoadjuvant therapy, all participants who are reassessed by MDT to be resectable after neoadjuvant treatment and have adequate lung functions would be provided with definite surgery. Otherwise, patients would be provided with radical radiotherapy through MDT discussion.
For the surgery cohort, participants meet both the R0 resection, the pathological assessment criteria of pCR and have two consecutive landmark ctDNA tests that are negative will receive surveillance after surgery. Participants who do not meet all the above conditions will receive alectinib after surgery, adjuvant treatment should be initiated ideally 4-12 weeks after surgery, or according to local standard of care, treatment will continue until completion of treatment period (24 months), disease recurrence, unacceptable toxicity, death, or withdrawal from the study, whichever occurs first.
For the radical radiotherapy cohort, participants will receive alectinib after radiotherapy, adjuvant treatment should be initiated ideally 4-12 weeks after surgery, or according to local standard of care, the treatment will continue until completion of treatment period (24 months), disease progression, unacceptable toxicity, death, or withdrawal from the study, whichever occurs first.

Start Date15 Jun 2026

Sponsor / Collaborator

Guangdong General Hospital

NCT06997588

/ RecruitingPhase 2

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

This study is designed to demonstrate the efficacy and assess safety and tolerability of oral daily alpelisib in participants with PIK3CA-related overgrowth spectrum (PROS).

Start Date09 Oct 2025

Sponsor / Collaborator

Novartis Pharmaceuticals Canada, Inc.

NCT07543822

/ Active, not recruitingPhase 2

VATCH (Vascular Anomaly Analysis for Therapy Choice): Phase II Study of Alpelisib Treatment in Subjects With TIE2/PIK3CA Pathway Driven Vascular Anomalies

The study will enroll participants 2 months of age up to 30 years of age. The purpose of this study is to assess the effectiveness and safety of Alpelisib (the "Study Drug") in patients with PIK3CA/TIE-2/TEK pathway driven vascular anomalies (VA). Alpelisib has been approved by the U.S. Food and Drug Administration (FDA) for treating adults and children with certain types of breast cancer. Its use in this study is considered experimental because FDA has not approved the study drug for treating people with VAs.
Study participation will last for up to 3 years and will involve regular study visits to Children's Hospital of Philadelphia (CHOP)'s Philadelphia Campus. Participants will need to take the study drug Alpelisib for at least 2 years, or up to 3 years in total if there is a positive response. Participating in this research means you will attend up to 16 clinic visits for the purposes of the study. Most visits will take approximately 30 minutes, but some visits will take approximately 2 hours, because you will be asked to complete questionnaires about your experience. Participating in this research also means taking the study drug, having pictures taken, and completing study drug diaries. There is also an optional portion to this study that involves collecting blood for biomarker testing.

Start Date27 Aug 2025

Sponsor / Collaborator

The Children's Hospital of Philadelphia

[+21]

100 Clinical Results associated with Alpelisib

100 Translational Medicine associated with Alpelisib

100 Patents (Medical) associated with Alpelisib

925

Literatures (Medical) associated with Alpelisib

01 Aug 2026·EUROPEAN JOURNAL OF MEDICINAL CHEMISTRY

Benzothiophene-based, orally active PIK3CA H1047R mutant-selective inhibitors for the treatment of HR+/HER2- breast cancer

Article

Author: Xu, Hang ; Yang, Fanglong ; Jin, Lei ; Wang, Siqin ; Jia, Xiangyu ; Fan, Xing ; Xia, Yuanfeng ; Zhao, Sheng ; Lu, Biao

PI3Kα plays a key role in a variety of cellular processes, and its gene mutations are closely related to the occurrence and development of many types of cancer. Although two orthosteric PI3Kα inhibitors including Alpelisib and Inavolisib have been launched onto market, they often cause toxic and side effects due to insufficient selectivity for PIK3CA mutant protein. The development of allosteric PI3Kα inhibitors provides new ideas for overcoming these problems. Our research focuses on optimizing a novel series of allosteric PI3Kα inhibitors derived from STX-478. By integrating scaffold hopping and comprehensive structural modification strategies, we obtained the lead compound allosteric PI3Kα inhibitor 11f with a benzothiophene scaffold. The inhibitor demonstrates high selectivity for PIK3CA mutant protein, low hERG inhibition, minimal CYP inhibition, excellent in vivo efficacy, good safety and no impact on insulin balance. Collectively, these findings confirm that compound 11f is a highly promising drug candidate for the targeted therapy of PIK3CA H1047R mutant HR+/HER2-breast cancer.

01 Jul 2026·INTERNATIONAL IMMUNOPHARMACOLOGY

Targeting NBL1/PI3K/AKT axis to enhance the chemosensitivity and radiosensitivity of esophageal squamous cell carcinoma

Article

Author: Wang, Bing ; Feng, Bin ; Zeng, Renya ; Lei, Lingli ; Yang, Zhe

BACKGROUND:

The development of radioresistance and chemoresistance remains a huge obstacle for the prognosis of esophageal squamous cell carcinoma (ESCC) patients. When investigating novel therapeutic targets involved in ESCC radioresistance and chemoresistance, we identified that ESCC patients expressing lower levels of neuroblastoma suppression of tumorigenicity 1 (NBL1) tended to have short overall survival. This research aimed to elucidate the functional roles of NBL1 in ESCC progression and further identify its downstream signaling pathway.

METHODS:

The expression level of NBL1 in ESCC tissues and non-tumor tissues was evaluated using enzyme-linked immunosorbent assay (ELISA) and immunohistochemistry (IHC). The correlation between NBL1 expression and patient survival was analyzed using the Kaplan-Meier survival curve method. Knockdown and overexpression of NBL1 in ESCC cells were achieved via short hairpin RNA (shRNA) and lentiviral transduction, respectively. The survival capacity of NBL1-silenced cells under chemotherapy and radiotherapy was assessed through colony formation assay and Cell Counting Kit-8 (CCK-8) assay. Western blotting was employed to identify downstream signaling pathways of NBL1 involved in chemoresistance and radioresistance in ESCC, revealing that the PI3K-AKT (phosphoinositide 3-kinase-AKT signaling) pathway was activated in NBL1-silenced cells. Colony formation and CCK-8 assays were further applied to evaluate cell survival after combined treatment with chemotherapy and PI3K-AKT inhibitors (LY294002 or BYL719) or radiotherapy combined with LY294002/BYL719. Levels of (Bone Morphogenetic Protein) BMP2, 4, 6, and 7 were interfered with using siRNA in NBL1-knockdown cells, followed by qPCR validation and Western blot analysis to determine the expression of PI3K, AKT, and p-AKT proteins. A mouse xenograft model was established to investigate the antitumor efficacy of LY294002 and BYL719 in enhancing chemosensitivity and radiosensitivity in esophageal squamous cell carcinoma.

RESULTS:

Kaplan-Meier survival analysis revealed that ESCC patients with lower NBL1 expression had a shorter overall survival (P = 0.0141), suggesting NBL1 as a potential prognostic biomarker for ESCC. To investigate the functional role of NBL1 in ESCC progression, we performed knockdown of NBL1 expression in ESCC cells for functional assays. The results demonstrated that downregulation of NBL1 significantly promoted cell proliferation and migration, and enhanced resistance to multiple chemotherapeutic agents (chemoresistance) as well as radiotherapy (radioresistance). These phenotypes indicate that NBL1 may function as a tumor suppressor in ESCC. Mechanistically, both in vitro and in vivo studies confirmed that the PI3K-AKT signaling pathway was markedly activated in NBL1-knockdown ESCC cells. Further rescue experiments showed that treatment with PI3K-AKT pathway inhibitors (LY294002 or BYL719) significantly sensitized ESCC cells, particularly NBL1-silenced cells, to chemotherapy and radiotherapy. The qPCR results verified effective reduction in BMP2, 4, 6, and 7 levels following siRNA interference. Western blot analysis indicated that knockdown of BMP7 led to increased expression of PI3K, AKT, and p-AKT proteins. Taken together, these findings suggest that NBL1 may negatively regulate the PI3K-AKT signaling pathway through BMP2,4,7 thereby suppressing malignant progression and therapy resistance in ESCC.

CONCLUSION:

NBL1 functions as a tumor suppressor in ESCC. Its downregulation enhances radioresistance and chemoresistance in ESCC by activating the PI3K-AKT signaling pathway through BMP2,4,7. Inhibition of the PI3K-AKT pathway with LY294002 or BYL719 increases the cytotoxic effects of chemotherapy and radiation, offering a novel therapeutic strategy for ESCC patients, particularly those with low NBL1 expression.

01 Jun 2026·NEOPLASIA

PIK3CA mutant cervical cancer is selectively suppressed by PI3Kα inhibition (Alpelisib/BYL-719 and Inavolisib/GDC-0077) and cooperates with HPV directed T cell therapy

Article

Author: Syracuse, Nick ; Langan, David ; Oberley, Matthew R ; Robinson, Emma ; Xie, Yi ; Kim, Sojung ; Lou, Hong ; Rossi, Nicole M ; Dean, Michael ; Oelke, Mathias ; Rao, Nina ; Murphy, Elisabeth A ; Rodriguez, Isabel ; Joe, Tawnjerae ; Tulsyan, Sonam

Cervical cancer is largely driven by human papillomavirus (HPV) infection, yet clinically actionable molecular subtypes and effective targeted therapies remain limited. Here, we define biologically and clinically relevant subtypes and evaluate targeted therapeutic strategies. Analysis of public datasets, coupled with functional studies in cervical cancer cell lines and immune assays, identified three subtypes: (I) PIK3CA wild-type without YAP1 amplification, (II) PIK3CA-mutant without YAP1 amplification, and (III) PIK3CA wild-type with YAP1 amplification. Notably, YAP1 amplification is associated with poorer patient survival. The PI3Kα-specific inhibitors, Alpelisib (BYL-719) and Inavolisib (GDC-0077), selectively inhibited proliferation in multiple PIK3CA-mutant cervical cancer cell lines but had minimal effect in PIK3CA wild-type cells. Alpelisib further reduced expression of HPV16 E7, PD-L1 (CD274), YAP1, and EGFR specifically in PI3Kα-mutant models. In an HPV16-positive, HLA-A2-positive, PIK3CA-mutant cell line (CaSki), antigen-specific donor T cells (NexImmune) induced cytotoxicity in a dose-dependent manner. Importantly, combining BYL-719 with T-cell therapy enhanced tumor cell killing, with maximal effects observed following drug pretreatment prior to T-cell exposure. These findings identify actionable molecular subtypes of cervical cancer and support targeting PI3Kα in PIK3CA-mutant tumors. Moreover, combining PI3K inhibition with antigen-specific immunotherapy represents a promising strategy to improve outcomes in advanced HPV16-associated cervical cancer.

291

News (Medical) associated with Alpelisib

10 Jun 2026

·allsci.com

Laekna takes stake in ‘new co.’ Vasque Bio, licensing PI3Kα inhibitor in USD 527m deal

Laekna (HKEX: 02105) has licensed its pre-clinical PI3Kα inhibitor LAE118 to US-based Vasque Bio in a deal worth up to USD 527 million. Vasque will serve as a rare-disease-focused channel for the global development of Laekna’s next-generation mutant-selective kinase inhibitor, which has cleared IND review in both the US and China. The LAE118 license agreement, announced on June 9, 2026, grants Vasque Bio exclusive worldwide rights excluding Greater China to develop, manufacture, and commercialize the compound. The deal’s equity component — Laekna’s right to acquire up to a high-teen percentage of Vasque Bio stock at no additional cost — gives the originator direct exposure to any future exit. Under the terms, Laekna receives a USD 10 million non-refundable upfront payment, up to USD 517 million in combined development and sales milestones, and tiered royalties ranging from single-digit to double-digit percentages on any future net sales. A further clause entitles Laekna to up to 50% of the value of any qualifying strategic transaction — such as an acquisition or sublicense — that Vasque Bio enters involving LAE118. That provision is structurally uncommon and suggests Laekna negotiated aggressively to guard against a scenario where Vasque Bio exits cheaply before milestones are earned. Laekna’s PI3Kα inhibitor LAE118 is described by Laekna as a novel PI3Kα pan-mutant selective inhibitor, designed to target the mutant forms of the PI3Kα enzyme while sparing the wild-type protein. First-generation PI3Kα inhibitors, including Novartis’s alpelisib (Piqray/Vijoice), inhibit both mutant and wild-type enzyme, producing on-target toxicities — particularly hyperglycemia — that limit dosing and combination potential. Mutant-selective agents aim to widen the therapeutic window by concentrating activity on disease-driving variants. According to Laekna, LAE118 is being actively developed into clinical studies for PIK3CA-mutant solid tumors in both China and the US. The partnership introduces an unusual indication split. Laekna describes its own development focus as oncology, while Vasque Bio — backed by The Column Group and F-Prime — is described as a company dedicated to rare diseases. PIK3CA gain-of-function mutations drive not only common cancers but also a spectrum of rare overgrowth conditions known as PIK3CA-related overgrowth spectrum disorders, where targeted PI3Kα inhibition has shown biological rationale. Industry and transaction context The LAE118 license agreement arrives in the middle of a concentrated wave of large-pharma and venture capital activity targeting next-generation PI3Kα mutant-selective inhibitors. In March 2026, Novartis agreed to acquire Synnovation Therapeutics’ pan-mutant selective PI3Kα program SNV4818 for up to USD 3 billion, paying USD 2 billion upfront — a transaction that set a high-water mark for the class. The competitive field for pan-mutant selective PI3Kα inhibitors has become notably crowded. Relay Therapeutics’ zovegalisib (RLY-2608), an allosteric pan-mutant isoform-selective inhibitor, is in a Phase III pivotal study in HR+/HER2- breast cancer. Eli Lilly’s tersolisib (STX-478), acquired via Scorpion Therapeutics, has entered a front-line pivotal trial. Celcuity’s gedatolisib, a pan-PI3K/mTOR inhibitor, met the primary endpoint of the Phase III VIKTORIA-1 trial against alpelisib in PIK3CA-mutant breast cancer. LAE118 enters this landscape without clinical efficacy data and with multiple competitors already generating late-stage readouts. The structural features of the Laekna Vasque Bio partnership are worth examining in the context of how Chinese biotech companies have been structuring ex-China deals. The 50% strategic transaction participation right — entitling Laekna to half the value of any qualifying M\&A or sublicense involving LAE118 — goes beyond standard royalty and milestone protections. It functions more like a co-ownership clause than a typical licensor protection, and reflects a pattern seen in other recent China-to-Western deals where originators have sought to retain economic exposure beyond conventional milestone structures. This article was generated with AI assistance and reviewed and edited by the AllSci editorial team Explore more at AllSci News: https://allsci.com/news/ Leave a Reply Cancel reply Your email address will not be published. Required fields are marked * Comment * Name * Email * Website Privacy Terms About Us Copyright © 2026. AllSci Corp. All rights reserved.

07 Jun 2026

·firstwordpharma.com

Celcuity's drug halves risk of disease progression, death versus Novartis' Piqray in PIK3CA-mutant breast cancer

Two regimens containing Celcuity's multi-target PAM inhibitor gedatolisib halved the risk of disease progression or death versus Novartis' PI3Kα inhibitor Piqray (alpelisib) in adults with hormone receptor (HR)-positive, HER2-negative, PIK3CA mutated, locally advanced or metastatic breast cancer. The statistically significant and clinically meaningful findings come from the Phase III VIKTORIA-1 trial, which were presented Tuesday at the American Society of Clinical Oncology (ASCO) annual meeting. “By comprehensively blocking the PI3K/AKT/mTOR, or PAM, pathway, gedatolisib…showed it can offer these patients two times the likelihood of survival without disease progression or death relative to a single-target inhibitor of the PAM pathway," said co-principal investigator Sara Hurvitz. "With these results, the gedatolisib regimens, if approved, represent a new potential standard of care for patients with HR+, HER2-negative, PIK3CA mutant advanced breast cancer whose disease progressed on or after treatment with a CDK4/6 inhibitor.” VIKTORIA-1 already produced positive results in the PIK3CA wild-type cohort, with a progression-free survival (PFS) benefit of 76% for gedatolisib compared to fulvestrant — the FDA is set to decide on approval in this patient population by July 17. And last month, Celcuity said that the study, which enrolled participants who progresed on, or after, treatment with a CDK4/6 inhibitor and an aromatase inhibitor, also hit its primary endpoint against Piqray in the PIK3CA-mutant cohort. Results presented at ASCO showed that a triplet regimen of gedatolisib, fulvestrant and Pfizer's CDK4/6 inhibitor Ibrance (palbociclib) reduced the risk of disease progression or death by 50% versus Piqray plus fulvestrant. Median PFS in the two arms was 11.1 months and 5.6 months, respectively. Meanwhile, the dual regimen of gedatolisib plus fulvestrant reduced the risk of disease progression or death by 49% compared to Piqray plus fulvestrant, with median PFS of 11.3 months. Celcuity added that the gedatolisib triplet regimen demonstrated an objective response rate of 48.9%, which it was 35.7% for the dual regimen, compared to 26% for Piqray plus fulvestrant. Further, the median duration of response was 15.7 months for the gedatolisib triplet regimen, versus 24.2 months for the doublet regimen and 7.5 months for Piqray plus fulvestrant. “Both gedatolisib regimens were well-tolerated with very few VIKTORIA-1 patients discontinuing treatment due to an adverse event," said Igor Gorbatchevsky, Celcuity's chief medical officer. Treatment-related adverse events that led to the discontinuation of study treatment occurred in 2.6% of patients in the gedatolisib-triplet group, 3.8% in the gedatolisib doublet group, and 7.1% in the Piqray plus fulvestrant group. While there was one grade 5 TRAE in the gedatolisib-triplet group, the company noted that this was related to Ibrance — there were no similar events in the gedatolisib-doublet group, versus two in the Piqray plus fulvestrant arm. The content above comes from the network. if any infringement, please contact us to modify.

Clinical ResultASCONDA

03 Jun 2026

·www.biospace.com

Celcuity slides even after ‘practice-changing’ late-stage breast cancer data

iStock, Deagreez Celcuity’s gedatolisib doubled progression-free survival versus standard of care in certain patients with advanced breast cancer. Still, the biotech’s stock dropped more than 25% Tuesday. Celcuity’s breast cancer candidate halved the risk of death or disease progression in a Phase 3 study, setting the drug up to become what analysts called a “practice-changing” treatment in the field. Despite the positive readout, the Minneapolis biotech slid more than 25% to $91.42 per share at the end of Tuesday’s trading session. In the Phase 3 VIKTORIA-1 study , Celcuity enrolled more than 700 patients with HR-positive, HER2-negative advanced or metastatic breast cancer with PIK3CA mutations. Results disclosed Tuesday showed that Celcuity’s drug gedatolisib, when used alongside AstraZeneca’s Faslodex and Pfizer’s Ibrance, resulted in a 50% progression-free survival (PFS) benefit as compared with Faslodex plus Novartis’ Piqray, a current standard-of-care (SOC) schedule in the space. Meanwhile, an investigational doublet consisting of gedatolisib and Faslodex had similar outcomes, cutting the risk of disease progression or death by 49% versus Piqray plus Faslodex. This degree of PFS improvement “is practice-changing in our view,” Jefferies told investors in a note on Tuesday. “The geda triplet arm doubled PFS” versus Piqray controls, the analysts continued, “a meaningful improvement vs SOC that could drive near-term rapid uptake.” The firm also addressed the selloff, attributing Celcuity’s stock weakness to “higher Street expectations on absolute PFS numbers.” Celcuity on Tuesday reported median PFS of 11.1 months the triplet group, versus 5.6 months in controls. Jefferies also noted that another reason for the share slump is that there was “seemingly no PFS benefit” to the gedatolisib triplet over the doublet regimen—the two groups showed very similar PFS outcomes—“making real-world commercial use a little less clear-cut.” On this point, however, the analysts argued that the three-drug combo elicited a higher objective response rate and earlier separation on overall survival, “which may support triplet use in 2L for fitter pts or more broadly.” Overall survival data were immature by the time of Celcuity’s readout. Jefferies remains bullish on gedatolisib overall, contending that the drug “can dominate” in breast cancer, with a “major place” in second-line care and even potentially in the frontline setting. Gedatolisib is already under FDA review for HR-positive, HER2-negative patients with advanced breast cancer who don’t have PIK3CA mutations, with a decision expected on July 17. Celcuity intends to data as a supplement to this application, the company said Tuesday, though it didn’t specify a timeline for this submission. Cancer ASCO: A battle of bispecifics, Eli Lilly’s big win and more Practice-changing data in lung cancer, prostate cancer and more were on display over the weekend at the American Society of Clinical Oncology annual meeting in Chicago. Plus, early readouts on assets that could reshape the cancer landscape. June 1, 2026 · 4 min read · Brianna Abbott Read more

100 Deals associated with Alpelisib

External Link

KEGG	Wiki	ATC	Drug Bank
D11011	Alpelisib	L01XX65	DB12015

R&D Status

Approved

10 top approved records.

to view more data

Indication	Country/Location	Organization	Date
PIK3CA-related overgrowth syndrome	United States	Novartis Pharmaceuticals Corp.	05 Apr 2022
Breast Cancer	Australia	Novartis Oncology, Inc.	20 Mar 2020
Advanced breast cancer	Canada	Novartis Pharmaceuticals Canada, Inc.	11 Mar 2020
Metastatic breast cancer	Canada	Novartis Pharmaceuticals Canada, Inc.	11 Mar 2020
PIK3CA mutation/HR-positive/HER2-negative Breast Cancer	United States	Novartis Pharmaceuticals Corp.	24 May 2019

Developing

10 top R&D records.

to view more data

Indication	Highest Phase	Country/Location	Organization	Date
Lymphatic Abnormalities	Phase 3	Argentina	Novartis Pharmaceuticals Corp.	24 Nov 2023
Lymphatic Abnormalities	Phase 3	Australia	Novartis Pharmaceuticals Corp.	24 Nov 2023
Lymphatic Abnormalities	Phase 3	Belgium	Novartis Pharmaceuticals Corp.	24 Nov 2023
Lymphatic Abnormalities	Phase 3	France	Novartis Pharmaceuticals Corp.	24 Nov 2023
Lymphatic Abnormalities	Phase 3	Germany	Novartis Pharmaceuticals Corp.	24 Nov 2023
Lymphatic Abnormalities	Phase 3	Italy	Novartis Pharmaceuticals Corp.	24 Nov 2023
Lymphatic Abnormalities	Phase 3	Netherlands	Novartis Pharmaceuticals Corp.	24 Nov 2023
Lymphatic Abnormalities	Phase 3	Spain	Novartis Pharmaceuticals Corp.	24 Nov 2023
Lymphatic Abnormalities	Phase 3	Switzerland	Novartis Pharmaceuticals Corp.	24 Nov 2023
HR Positive/HER2 Negative/Node positive breast cancer	Phase 3	Belgium	Novartis Pharmaceuticals Corp.	17 Dec 2021

Clinical Result

Indication

Phase

Evaluation

View All Results

Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT04729387 (CTgov)	Phase 3	Ovarian Serous Adenocarcinoma \| Platinum-Resistant Ovarian Carcinoma	358	Olaparib+Alpelisib (Alpelisib 200mg + Olaparib 200mg)	pjbgfjkyph(zvuvpbdmvc) = xtoxahthhi hqygirjrxd (jxwmycquwf, subdvglndg - hwlfxpbgle) View more	-	04 Jun 2026
				Pegylated Liposomal Doxorubicin (PLD)+Paclitaxel (Paclitaxel or Pegylated Liposomal Doxorubicin (PLD))	pjbgfjkyph(zvuvpbdmvc) = kwdigraywj hqygirjrxd (jxwmycquwf, qbgzqffpnp - fpwktyoxbr) View more
AACR2026	Phase 2/3	Hormone receptor positive HER2 negative breast cancer HR Positive \| HER2 Negative	16	Imlunestrant alone	ybmdsoicuh(iamfkztzsh) = kzidnvrrcm nhtciwybsd (adernohrjq ) View more	Positive	21 Apr 2026
				Camizestrant 75mg	ybmdsoicuh(cbmogmpjbt) = nvbioujpwx iqybdhztyh (jkfciyqowh ) View more
NCT05101564 (CTgov)	Phase 2	ER-positive/HER2-negative Breast Cancer \| HER2-negative breast cancer \| Estrogen receptor positive breast cancer	19	Fulvestrant+Zotatifin (Cohort 2: Zotatifin in Combination With Fulvestrant (Treatment Arm))	yjmrnpmwbn(xorttwkawk) = viqttrjlvq okyciyhltr (pnnxvgxumc, afdzctbcmi - xezpecaqsk) View more	-	22 Jan 2026
				Fulvestrant (Cohort 2: Fulvestrant (Control Arm))	yjmrnpmwbn(xorttwkawk) = ltrdubjgys okyciyhltr (pnnxvgxumc, xrnzfxdwji - rvlfbcyuur) View more
SABCS2025	Not Applicable	Hormone receptor positive breast cancer PIK3CA \| ESR1	107	alpelisib+fulvestrant	maopgppmkg(gydubcbzog) = One patient with alpelisib experienced treatment interruption and dose reduction due to skin toxicity, while Elacestrant was well-tolerated without major adverse effects. edyjhjexmq (lxpekajwtf )	Positive	10 Dec 2025
				capivasertib+fulvestrant
SABCS2025	Not Applicable	Hormone receptor positive HER2 negative breast cancer HR+ \| HER2- \| PI3K/AKT/PTEN pathway alterations	72	≥2 pathway inhibitors sequentially	agqaplhebb(ntmonrmqcm) = kloxiynzuf idlqbaozjf (xowosjsmtk, 9 - 28)	Positive	10 Dec 2025
				alpelisib alone	agqaplhebb(ntmonrmqcm) = avkutyqkzp idlqbaozjf (xowosjsmtk, 5 - 8)
NCT05143229 (phase I study of alpelisib and sacituzumab govitecan (SG) in patients with HER2-negative metastatic breast cancer (MBC), ASCO2025)	Phase 1	Metastatic HER2-Negative Breast Carcinoma HER2-negative \| TNBC \| HR-positive	12	Alpelisib 250 mg + SG 8 mg/kg	gfyhnxgjxs(vwdofmorok) = G3 17%, G4 0% ghsvugjdsw (uptghpihav ) View more	Positive	30 May 2025
NCT03056755 (BYLieve, Pubmed \| Lancet Oncol)	Phase 2	Advanced breast cancer PIK3CA mutation	127	Alpelisib 300 mg/day + Fulvestrant 500 mg	cmjgaktrqo(attpkvaqrw) = 37 (29%) of 127 patients uxgdedsfib (lkmhmvzice ) View more	Positive	01 Dec 2024
NCT04753203 (ALCAP, ESMO2024) Manual	Phase 2	Metastatic Colorectal Carcinoma Third line	26	Alpelisib capecitabine	csimzaebyt(nbklpqgyhf) = rgbxvhltpz hleurcedtf (ymagfshuwb, 0.7 - 9.3) View more	Positive	16 Sep 2024
NCT05966584 (CTgov)	Phase 2	Exanthema \| PIK3CA mutant Breast Cancer	1	fulvestrant+alpelisib+Benralizumab	kfhsacmgku = bsovnggemb qwknnrlizy (kqihspxasq, sxrltkggdm - vlivtiwscz) View more	-	29 Aug 2024
NCT04251533 (EPIK-B3, CTgov)	Phase 3	Advanced Triple-Negative Breast Carcinoma	137	nab-paclitaxel+alpelisib (Part A: Alpelisib + Nab-paclitaxel)	zlmmsyfxip(fdufuknimb) = zuhaglgzav cifuosqfat (fugmdlprhe, yupxuigocw - neznccgugn) View more	-	31 Jul 2024
				placebo+nab-paclitaxel (Part A: Placebo + Nab-paclitaxel)	zlmmsyfxip(fdufuknimb) = lsvrsjsdjl cifuosqfat (fugmdlprhe, nutybidftp - glnwjjptta) View more

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