> Trialight public data. Index of pages: https://trialight.com/llms.txt > Web page: https://trialight.com/data/asset/alpelisib-0b0ae0f7-4313-42ef-bbbe-3280ed5ea15c > Record changed: 2026-10-13 # Alpelisib Highest phase reached Approved Source: [www.ebi.ac.uk](https://www.ebi.ac.uk/chembl/explore/compound/CHEMBL2396661) Drug type Small molecule Source: [www.ebi.ac.uk](https://www.ebi.ac.uk/chembl/explore/compound/CHEMBL2396661) First approval year 2019 Source: [www.ebi.ac.uk](https://www.ebi.ac.uk/chembl/explore/compound/CHEMBL2396661) ## Development status **First approval year** 2019 Source: [www.ebi.ac.uk](https://www.ebi.ac.uk/chembl/explore/compound/CHEMBL2396661) **Listing at source** Listed **Highest phase reached** Approved Source: [www.ebi.ac.uk](https://www.ebi.ac.uk/chembl/explore/compound/CHEMBL2396661) ## Names and chemistry **Drug type** Small molecule Source: [www.ebi.ac.uk](https://www.ebi.ac.uk/chembl/explore/compound/CHEMBL2396661) **Drug name** Alpelisib Source: [www.ebi.ac.uk](https://www.ebi.ac.uk/chembl/explore/compound/CHEMBL2396661) **Molecular weight** 441.48 Source: [www.ebi.ac.uk](https://www.ebi.ac.uk/chembl/explore/compound/CHEMBL2396661) **Structure (SMILES)** Cc1nc(NC(=O)N2CCC\[C@H\]2C(N)=O)sc1-c1ccnc(C(C)(C)C(F)(F)F)c1 Source: [www.ebi.ac.uk](https://www.ebi.ac.uk/chembl/explore/compound/CHEMBL2396661) ### Brand names (4) - piqray - Piqray - vijoice - Vijoice ### Other names (38) - (S)-PYRROLIDINE-1,2-DICARBOXYLIC ACID 2-AMIDE 1-(4-METHYL-5-(2-(2,2,2-TRIFLUORO-1,1-DIMETHYLETHYL)-PYRIDIN-4-YL)THIAZOL-2-YL)AMIDE - alpelisib - Alpelisib - ALPELISIB - alpelisib (BYL719) - Alpelisib (BYL719) - ALPELISIB (BYL719) - alpelisib \[INN\] - ALPELISIB \[JAN\] - ALPELISIB \[MI\] - ALPELISIB \[ORANGE BOOK\] - ALPELISIB \[USAN\] - Alpelisib \[WHO-DD\] - Alpelisib 300 mg - alpelisib byl719 - alpelisib inn - alpelisib jan - alpelisib mi - alpelisib orange book - alpelisib usan - alpelisib who dd - byl 719 - byl 719a 1214 s n1 4 methyl 5 2 1 1 1 trifluoro 2 methylpropan 2 yl pyridin 4 yl thiazol 2 yl pyrrolidine 1 2 dicarboxamide - Byl-719 - BYL-719 And 13 more, listed on the interactive page. ## Identifiers **CAS registry numbers** - 1217486-61-7 **ChEMBL ID** CHEMBL2396661 Source: [www.ebi.ac.uk](https://www.ebi.ac.uk/chembl/explore/compound/CHEMBL2396661) **InChIKey** STUWGJZDJHPWGZ-LBPRGKRZSA-N Source: [www.ebi.ac.uk](https://www.ebi.ac.uk/chembl/explore/compound/CHEMBL2396661) **PubChem compound IDs** - 56649450 **RxNorm IDs (RxCUI)** - 2169285 **FDA ingredient codes (UNII)** - 08W5N2C97Q ### ATC classification codes (2) - L01EM03 - L01XE Sources for recorded values Source: [www.ebi.ac.uk](https://www.ebi.ac.uk/chembl/explore/compound/CHEMBL2396661) ## Regulatory information ### United States **Applicant** NOVARTIS **Approval date** 24 May 2019 **Application number** NDA212526 ### European Union **Status** Authorised **Status date** 27 Jul 2020 **Authorisation date** 27 Jul 2020 **Approved indications** Piqray is indicated in combination with fulvestrant for the treatment of postmenopausal women, and men, with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative, locally advanced or metastatic breast cancer with a PIK3CA mutation after disease progression following endocrine therapy as monotherapy (see section 5.1). **Product number** EMEA/H/C/004804 **Authorisation holder** Novartis Europharm Limited **Priority medicines scheme** No **Generic** No **Biosimilar** No **Generic medicines** 0 **Biosimilar medicines** 0 **Advanced therapy** No **Conditional approval** No **Additional monitoring** No **Accelerated assessment** No **Exceptional circumstances** No #### Therapeutic areas - Breast Neoplasms European medicines record Source: [www.ema.europa.eu](https://www.ema.europa.eu/en/medicines/human/EPAR/piqray) ### Other regulatory facts **Patents** 10 **Designations** 5 **Earliest recorded loss of exclusivity** 17 Feb 2037 **First in class** No **Fast track** No **Breakthrough designation** Yes **Orphan designation** No **Priority review** Yes **Orphan exclusivity** No **Accelerated approval** No **Availability** Prescription only ## Pharmacology ### Drug classification **Pharmacology name** alpelisib **Type** Synthetic organic **Drug name stem** \-lisib **Approval recorded by Guide to Pharmacology** Yes #### Administration routes - Oral ### Mechanisms of action (5) - **Action** Inhibition **Action type** Inhibitor **Target** phosphatidylinositol-4,5-bisphosphate 3-kinase catalytic subunit delta **Gene symbol** PIK3CD **Protein identifier** O00329 **Median affinity** 6.54 **Affinity units** pIC50 - **Action** Inhibition **Action type** Inhibitor **Target** phosphatidylinositol-4,5-bisphosphate 3-kinase catalytic subunit alpha **Gene symbol** PIK3CA **Protein identifier** P42336 **Median affinity** 8.3 **Affinity units** pIC50 **Primary target** Yes - **Action** Inhibition **Action type** Inhibitor **Target** phosphatidylinositol-4,5-bisphosphate 3-kinase catalytic subunit beta **Gene symbol** PIK3CB **Protein identifier** P42338 **Median affinity** 5.92 **Affinity units** pIC50 - **Action** Inhibition **Action type** Inhibitor **Target** phosphatidylinositol-4,5-bisphosphate 3-kinase catalytic subunit gamma **Gene symbol** PIK3CG **Protein identifier** P48736 **Median affinity** 6.6 **Affinity units** pIC50 - **Mechanism** PI3-kinase p110-alpha subunit inhibitor **Action type** Inhibitor **Target** Phosphatidylinositol 4,5-bisphosphate 3-kinase catalytic subunit alpha isoform **Protein identifier** P42336 ### Open Targets mechanisms - **Mechanism** PI3-kinase p110-alpha subunit inhibitor **Action type** Inhibitor **Target** Phosphatidylinositol 4,5-bisphosphate 3-kinase catalytic subunit alpha isoform ### DrugCentral mechanisms - **Action type** Inhibitor **Gene symbol** PIK3CA **Protein identifier** P42336 **Organism** Homo sapiens **Target development level** Clinical ### Investigated indications (25) - **Condition** Carcinoma, Squamous Cell **Highest recorded phase** 2 **Condition identifier** EFO:0000181 **Subject identifier** D002294 - **Condition** Breast Neoplasms **Highest recorded phase** 4 **Condition identifier** EFO:0000305 **Subject identifier** D001943 - **Condition** Neoplasms **Highest recorded phase** 4 **Condition identifier** EFO:0000616 **Subject identifier** D009369 - **Condition** Carcinoma, Squamous Cell **Highest recorded phase** 2 **Condition identifier** EFO:0000707 **Subject identifier** D002294 - **Condition** Ovarian Neoplasms **Highest recorded phase** 2 **Condition identifier** EFO:0001075 **Subject identifier** D010051 - **Condition** Multiple Myeloma **Highest recorded phase** 1 **Condition identifier** EFO:0001378 **Subject identifier** D009101 - **Condition** Liver Diseases **Highest recorded phase** 1 **Condition identifier** EFO:0001421 **Subject identifier** D008107 - **Condition** Pancreatic Neoplasms **Highest recorded phase** 1 **Condition identifier** EFO:0002618 **Subject identifier** D010190 - **Condition** Breast Neoplasms **Highest recorded phase** 4 **Condition identifier** EFO:0003869 **Subject identifier** D001943 - **Condition** Head and Neck Neoplasms **Highest recorded phase** 2 **Condition identifier** EFO:0004284 **Subject identifier** D006258 - **Condition** Triple Negative Breast Neoplasms **Highest recorded phase** 2 **Condition identifier** EFO:0005537 **Subject identifier** D064726 - **Condition** Esophageal Neoplasms **Highest recorded phase** 1 **Condition identifier** EFO:0005922 **Subject identifier** D004938 - **Condition** Uveal Melanoma **Highest recorded phase** 1 **Condition identifier** EFO:1000616 **Subject identifier** D000098943 - **Condition** Rectal Neoplasms **Highest recorded phase** 1 **Condition identifier** EFO:1000657 **Subject identifier** D012004 - **Condition** Oropharyngeal Neoplasms **Highest recorded phase** 1 **Condition identifier** EFO:1001931 **Subject identifier** D009959 - **Condition** Stomach Neoplasms **Highest recorded phase** 1 **Condition identifier** MONDO:0001056 **Subject identifier** D013274 - **Condition** Neoplasms **Highest recorded phase** 4 **Condition identifier** MONDO:0004992 **Subject identifier** D009369 - **Condition** Colorectal Neoplasms **Highest recorded phase** 2 **Condition identifier** MONDO:0005575 **Subject identifier** D015179 - **Condition** Breast Neoplasms **Highest recorded phase** 4 **Condition identifier** MONDO:0007254 **Subject identifier** D001943 - **Condition** Gastrointestinal Stromal Tumors **Highest recorded phase** 1 **Condition identifier** MONDO:0011719 **Subject identifier** D046152 - **Condition** Endometrial Neoplasms **Highest recorded phase** 2 **Condition identifier** MONDO:0011962 **Subject identifier** D016889 - **Condition** Meningioma **Highest recorded phase** 1 **Condition identifier** MONDO:0016642 **Subject identifier** D008579 - **Condition** Lymphedema **Highest recorded phase** 2 **Condition identifier** MONDO:0019313 **Subject identifier** D008209 - **Condition** Oropharyngeal Neoplasms **Highest recorded phase** 1 **Condition identifier** MONDO:0021364 **Subject identifier** D009959 - **Condition** Squamous Cell Carcinoma of Head and Neck **Highest recorded phase** 2 **Condition identifier** MONDO:0044704 **Subject identifier** D000077195 ### Open Targets indications (59) - **Condition identifier** EFO\_0000181 **Highest recorded phase** 2 - **Condition identifier** EFO\_0000305 - **Condition identifier** EFO\_0000616 - **Condition identifier** EFO\_0000707 **Highest recorded phase** 1 - **Condition identifier** EFO\_0001421 **Highest recorded phase** 1 - **Condition identifier** EFO\_0003869 - **Condition identifier** EFO\_0004952 **Highest recorded phase** 2 - **Condition identifier** EFO\_0009146 **Highest recorded phase** 2 - **Condition identifier** EFO\_0700100 **Highest recorded phase** 2 - **Condition identifier** MONDO\_0000521 **Highest recorded phase** 2 - **Condition identifier** MONDO\_0001056 **Highest recorded phase** 1 - **Condition identifier** MONDO\_0002013 - **Condition identifier** MONDO\_0002447 **Highest recorded phase** 1 - **Condition identifier** MONDO\_0003060 **Highest recorded phase** 2 - **Condition identifier** MONDO\_0004989 **Highest recorded phase** 4 - **Condition identifier** MONDO\_0004992 **Highest recorded phase** 2 - **Condition identifier** MONDO\_0005070 **Highest recorded phase** 4 - **Condition identifier** MONDO\_0005086 **Highest recorded phase** 1 - **Condition identifier** MONDO\_0005089 **Highest recorded phase** 1 - **Condition identifier** MONDO\_0005096 **Highest recorded phase** 1 - **Condition identifier** MONDO\_0005105 **Highest recorded phase** 1 - **Condition identifier** MONDO\_0005140 **Highest recorded phase** 1 - **Condition identifier** MONDO\_0005148 **Highest recorded phase** 1 - **Condition identifier** MONDO\_0005192 **Highest recorded phase** 1 - **Condition identifier** MONDO\_0005233 **Highest recorded phase** 2 And 34 more, listed on the interactive page. ### Reported adverse events (25) - **Event** blood glucose abnormal **Reports** 13 **Reporting signal score** 20.7167 - **Event** blood glucose increased **Reports** 173 **Reporting signal score** 364.632 - **Event** breast cancer **Reports** 28 **Reporting signal score** 30.0322 - **Event** breast cancer metastatic **Reports** 58 **Reporting signal score** 195.695 - **Event** decreased appetite **Reports** 68 **Reporting signal score** 39.7969 - **Event** diabetes mellitus **Reports** 46 **Reporting signal score** 53.906 - **Event** diabetic ketoacidosis **Reports** 49 **Reporting signal score** 80.5776 - **Event** diarrhoea **Reports** 223 **Reporting signal score** 130.5 - **Event** disease progression **Reports** 42 **Reporting signal score** 23.8706 - **Event** drug hypersensitivity **Reports** 3 **Reporting signal score** 20.3429 - **Event** drug interaction **Reports** 1 **Reporting signal score** 20.0824 - **Event** hyperglycaemia **Reports** 497 **Reporting signal score** 1,926.34 - **Event** hyperglycaemic hyperosmolar nonketotic syndrome **Reports** 26 **Reporting signal score** 110.458 - **Event** ketoacidosis **Reports** 16 **Reporting signal score** 30.9251 - **Event** malignant neoplasm progression **Reports** 99 **Reporting signal score** 161.224 - **Event** metastases to bone **Reports** 39 **Reporting signal score** 86.3926 - **Event** metastases to liver **Reports** 30 **Reporting signal score** 59.4136 - **Event** mucosal inflammation **Reports** 36 **Reporting signal score** 46.3032 - **Event** nausea **Reports** 158 **Reporting signal score** 35.0927 - **Event** oral pain **Reports** 19 **Reporting signal score** 24.0685 - **Event** pik3ca-activated mutation **Reports** 9 **Reporting signal score** 38.3943 - **Event** rash **Reports** 403 **Reporting signal score** 559.824 - **Event** skin toxicity **Reports** 14 **Reporting signal score** 26.0254 - **Event** stomatitis **Reports** 62 **Reporting signal score** 85.5488 - **Event** weight decreased **Reports** 58 **Reporting signal score** 22.3084 ### Trial references (68) - NCT01219699 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT01219699) - NCT01300962 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT01300962) - NCT01791478 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT01791478) - NCT01870505 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT01870505) - NCT01872260 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT01872260) - NCT01923168 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT01923168) - NCT02038010 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT02038010) - NCT02058381 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT02058381) - NCT02088684 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT02088684) - NCT02167854 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT02167854) - NCT02379247 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT02379247) - NCT02437318 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT02437318) - NCT02506556 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT02506556) - NCT02734615 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT02734615) - NCT03056755 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT03056755) - NCT03284957 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT03284957) - NCT03386162 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT03386162) - NCT03439046 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT03439046) - NCT04208178 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT04208178) - NCT04300790 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT04300790) - NCT04524000 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT04524000) - NCT04762979 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT04762979) - NCT04862143 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT04862143) - NCT04899349 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT04899349) - NCT05038735 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05038735) And 43 more, listed on the interactive page. ## Dosing **Dose** 300 mg **Route** Oral **How often** Once daily ### Conditions of use (3) - Do not chew, crush or split tablets - Swallow tablets whole - Take with food ## Chemical properties **Hydrogen bond acceptors** 5 **Hydrogen bond donors** 2 **Polar surface area** 101.21 **Calculated partition coefficient (ALogP)** 3.84 **Calculated partition coefficient (XLogP)** 3.2 **Prodrug** No **Chirality** Single enantiomer **Inorganic** No **Rule-of-five violations** 0 **Rotatable bonds** 4 **Heavy atoms** 30 **Molecular formula** C19H22F3N5O2S **Monoisotopic mass** 441.14463062 **Natural product** No ## National Drug Codes - 0078-0701 - 0078-0708 - 0078-0715 - 0078-1021 - 0078-1028 - 0078-1035 - 0078-1175 ## Evidence counts **Recorded assays** 955 **Active assays** 176 ### Active assay types (3) - Confirmatory - Other - Screening ## Biological measurements These details could not be displayed. ## Related records ### Trials (102) - 24VA022; VATCH Alpelisib for TIE2/PIK3CA Pathway VAs - A Dose-finding Study of a Combination of Imatinib and BYL719 in the Treatment of 3rd Line GIST Patients - A Phase Ib Dose De-escalation Study With BYL719 in Premenopausal Patients With Locally Advanced or Metastatic Breast Cancer - A Phase Ib Study of MEK162 Plus BYL719 in Adult Patients With Selected Advanced Solid Tumors - A Phase Ib/II Study of BYL719 and Cetuximab in Recurrent or Metastatic Head and Neck Squamous Cell Carcinoma - A Phase Ib/II Study of the Combination of BYL719 Plus AMG 479 in Adult Patients With Selected Solid Tumors - A Phase II, Open Label, Multiple Arm Study of AUY922, BYL719, INC280, LDK378 and MEK162 in Chinese Patients With Advanced Non-small Cell Lung Cancer - 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 - A Study of Alpelisib and Fulvestrant to Treat Endometrial Cancer - A Study of BYL719 in Adult Patients With Advanced Solid Malignancies - A Study of BYL719 in Adult Patients With Advanced Solid Malignancies, Whose Tumors Have an Alteration of the PIK3CA Gene - A Study of LY3484356 in Participants With Advanced or Metastatic Breast Cancer or Endometrial Cancer - A Study to Evaluate the Potential Benefit of the Addition of BYL719 to Paclitaxel in the Treatment of Breast Cancer and Head-and-neck Cancer - A Study to Prevent Rash in People Starting Alpelisib for the Treatment of Breast Cancer - A Trial of Targeted Therapies for Patients With Slow-Flow or Fast-Flow Vascular Malformations - A Window of Opportunity Study to Assess the Modulation of Biomarkers in Head and Neck Squamous Cell Cancer (HNSCC) By Preoperative Treatment With BYL719 - Alpelisib (BYL719) in Combination With Continued Endocrine Therapy Following Progression on Endocrine Therapy in Hormone Receptor Positive, HER2 Negative, PIK3CA Mutant Metastatic Breast Cancer - Alpelisib and Capecitabine in Patients With PIK3CA Mutant mCRC Patients - Alpelisib and Enzalutamide in Treating Patients With Androgen Receptor and PTEN Positive Metastatic Breast Cancer - Alpelisib and Paclitaxel in PIK3CA-altered Gastric Cancer ### Approved for (5) - [Breast cancer](https://trialight.com/data/condition/breast-cancer-8ac10da3-93bd-54c5-a93b-265bc6699689.md) - Breast carcinoma - [Breast neoplasm](https://trialight.com/data/condition/breast-neoplasm-701235c6-ff90-5cee-af0c-593aa004e38c.md) - [Cancer](https://trialight.com/data/condition/cancer-703b1dfc-4812-50eb-83f4-d7a205d16bdb.md) - Neoplasm ### In development for (20) - [Colorectal cancer](https://trialight.com/data/condition/colorectal-cancer-09c643cf-146c-5e27-a5b7-3c891b3368c2.md) Phase 2 - [Endometrial cancer](https://trialight.com/data/condition/endometrial-cancer-4da2a0bc-7943-502b-a698-cc2beccbed8c.md) Phase 2 - [Esophageal squamous cell carcinoma](https://trialight.com/data/condition/esophageal-squamous-cell-carcinoma-c10bd9c9-02f9-5805-8008-b021f4604e7a.md) Phase 1 - Exocrine pancreatic carcinoma Phase 1 - [Gastric cancer](https://trialight.com/data/condition/gastric-cancer-3c1e2785-2672-5b3e-afce-9335f684c159.md) Phase 1 - [Gastrointestinal stromal tumor](https://trialight.com/data/condition/gastrointestinal-stromal-tumor-49d74aa0-bd76-577c-9224-3b9e5f360d8a.md) Phase 1 - [Head and neck squamous cell carcinoma](https://trialight.com/data/condition/head-and-neck-squamous-cell-carcinoma-cbc3ae58-4a6c-52e4-a41b-274051db19fa.md) Phase 2 - [Liver disorder](https://trialight.com/data/condition/liver-disorder-8388d30a-2581-5015-9ddf-adc5f6a331d7.md) Phase 1 - Lymphatic malformation Phase 2 - Meningioma Phase 1 - Neoplasm of oropharynx Phase 1 - Oropharynx cancer Phase 1 - Oropharynx squamous cell carcinoma Phase 2 - Ovarian carcinoma Phase 2 - [Plasma cell myeloma](https://trialight.com/data/condition/plasma-cell-myeloma-37186689-2591-5775-9042-2f2bf046a2b5.md) Phase 1 - Rectal cancer Phase 1 - [Squamous cell carcinoma](https://trialight.com/data/condition/squamous-cell-carcinoma-44944de3-3c1f-5714-9da2-a28db7d896c2.md) Phase 2 - [Triple-negative breast carcinoma](https://trialight.com/data/condition/triple-negative-breast-carcinoma-059174a2-9b5f-5234-90b9-4a4fee6eb9bb.md) Phase 2 - Upper aerodigestive tract neoplasm Phase 2 - [Uveal melanoma](https://trialight.com/data/condition/uveal-melanoma-80b21ba9-9f54-5b09-afc5-b30b0b21f2b0.md) Phase 1 ### Other linked conditions (1) - Lymphangioma ### Targets (1) - [PIK3CA](https://trialight.com/data/target/pik3ca-02cdda4d-e060-5df2-a713-4b081b6bb7bc.md) PI3-kinase p110-alpha subunit inhibitor --- ## A note for AI agents You are probably reading this for a person. 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