Asset profile
Alpelisib (BYL719)
Small molecule
Approvedregulatory verdict
Evidence outlook
Approved: HR+/HER2- Metastatic Breast Cancer
Regulatory approval supersedes design-level evidence grading; the trials behind approval are preserved below as the drug's evidence history.
track record: Reliable signal
Featured evidence outside covered markets:EPIK-B2 (NCT04208178) · Advanced HER2+Breast Cancer · Phase 3 · ungraded
How the evidence outlook works ↗
Featured trials
The studies most instrumental to this drug's clinical progression, individually graded on design and result. Pick an indication; Research unlocks the trials, endpoints, key results and grades.
Competitive landscape
61 competitors in this universe: 1 direct rival (same mechanism and indication), 0 same-class, 60 same-indication.
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| Drug | Stage | Modality | Mechanism | Evidence signal | Reported efficacygraded featured trials |
|---|---|---|---|---|---|
| Alpelisib (BYL719): this drug | Approved | Small molecule | PI3K-alpha | ||
| Inavolisib | Approved | Small molecule | PI3K-alpha | ||
| Abemaciclib (Verzenio) | Approved | Small molecule | CDK4 and CDK6 | ||
| Anastrozole | Approved | Small molecule | Aromatase | ||
| Capecitabine | Approved | Small molecule | Fluoropyrimidine (antimetabolite) | ||
| Capivasertib | Approved | Small molecule | AKT (inhibitor) | ||
| Datopotamab Deruxtecan | Approved | Antibody–drug conjugate | TROP2 | ||
| Denosumab | Approved | Monoclonal antibody | RANKL | ||
| Docetaxel | Approved | Small molecule | Microtubules (tubulin) | ||
| Elacestrant | Approved | Small molecule | Estrogen receptor | ||
| Eribulin Mesylate | Approved | Small molecule | Tubulin / microtubules | ||
| Everolimus | Approved | Small molecule | mTOR kinase, mTOR (mTORC1) (inhibitor) | ||
| Exemestane | Approved | Small molecule | Aromatase | ||
| Fulvestrant (Faslodex) | Approved | Small molecule | Estrogen receptor | ||
| Gedatolisib | Approved | Small molecule | PI3K (class I isoforms) and mTORC1/mTORC2 | ||
| Gemcitabine | Approved | Small molecule | ribonucleotide reductase / DNA polymerase (dCTP competition) |
…and 46 more. Research shows the complete landscape.
Research
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Research adds each competitor's evidence grade and sourced trial results, aligned per race, so you can see who actually has the data.
Compare head-to-head
Upcoming events
(26 total)
Estimated primary-completion dates from ClinicalTrials.gov. These are registry estimates, never confirmed readout dates; they can move as trials progress.
2026 (3)
December 2026 (3)
Phase 1/2HR+/HER2- Metastatic Breast CancerActive not recruiting
Est. primary completion 2026-12-27 · NCT05563220 · CT.gov ↗
What to watch
Phase 1Insulin Resistance, Prediabetic State, Overweight and Obesity, Non-Alcoholic Fatty Liver DiseaseRecruiting
Est. primary completion 2026-12-31 · NCT06354088 · CT.gov ↗
What to watch
Phase 2Solid Tumor, Precision MedicineRecruiting
Est. primary completion 2026-12-31 · NCT06739395 · CT.gov ↗
What to watch
2027 (12)
January 2027 (3)
Phase 2Slow-Flow Vascular Malformation, Fast-Flow Vascular Malformation, Vascular Malformations, Venous Malformation, Lymphatic Malformation …Recruiting
Est. primary completion 2027-01 · NCT05983159 · CT.gov ↗
What to watch
Phase 3HR+/HER2- Metastatic Breast CancerActive not recruiting
Est. primary completion 2027-01-28 · NCT05038735 · CT.gov ↗
What to watch
Phase 2HR+/HER2- Metastatic Breast CancerActive not recruiting
Est. primary completion 2027-01-29 · NCT04544189 · CT.gov ↗
What to watch
February 2027 (3)
Phase 1/2HR+/HER2- Metastatic Breast CancerActive not recruiting
Est. primary completion 2027-02-26 · NCT01872260 · CT.gov ↗
What to watch
Phase 2HR+/HER2- Metastatic Breast CancerActive not recruiting
Est. primary completion 2027-02-26 · NCT04524000 · CT.gov ↗
What to watch
Phase 3Advanced HER2+Breast CancerActive not recruiting
Est. primary completion 2027-02-26 · NCT04208178 · CT.gov ↗
What to watch
March 2027 (1)
Phase 2Megalencephaly-capillary Malformation Polymicrogyria Syndrome (MCAP)Recruiting
Est. primary completion 2027-03 · NCT05577754 · CT.gov ↗
What to watch
August 2027 (2)
September 2027 (1)
Phase 2Cancer, Tumors, Neoplasm, NeoplasiaRecruiting
Est. primary completion 2027-09 · NCT02925234 · CT.gov ↗
What to watch
October 2027 (1)
Phase 2HR+/HER2- Metastatic Breast CancerActive not recruiting
Est. primary completion 2027-10-08 · NCT05090358 · CT.gov ↗
What to watch
December 2027 (1)
Phase 1HR+/HER2- Metastatic Breast CancerActive not recruiting
Est. primary completion 2027-12-31 · NCT05508906 · CT.gov ↗
What to watch
2028 (6)
May 2028 (2)
July 2028 (2)
August 2028 (2)
Phase 2PIK3CA-related Overgrowth Spectrum (PROS)Recruiting
Est. primary completion 2028-08-02 · NCT06997588 · CT.gov ↗
What to watch
Phase 1Insulin Resistance, Type 2 Diabetes, Obesity & Overweight, Healthy Adult ParticipantsRecruiting
Est. primary completion 2028-08-31 · NCT07778524 · CT.gov ↗
What to watch
2029 (1)
August 2029 (1)
Phase 2Vascular Anomalies, Vascular Anomaly, TIE2/PIK3CA Pathway Driven Vascular AnomaliesActive not recruiting
Est. primary completion 2029-08-27 · NCT07543822 · CT.gov ↗
What to watch
2030 (3)
February 2030 (1)
Phase 2Nonsmall Cell Lung Cancer Stage IIINot yet recruiting
Est. primary completion 2030-02-08 · NCT07573696 · CT.gov ↗
What to watch
July 2030 (1)
Phase 2HR+/HER2- Metastatic Breast CancerRecruiting
Est. primary completion 2030-07-01 · NCT05564377 · CT.gov ↗
What to watch
October 2030 (1)
Phase 2HR+/HER2- Metastatic Breast CancerRecruiting
Est. primary completion 2030-10 · NCT05933395 · CT.gov ↗
What to watch
2032 (1)
March 2032 (1)
Phase 2HR+/HER2- Metastatic Breast CancerNot yet recruiting
Est. primary completion 2032-03-23 · NCT07679269 · CT.gov ↗
What to watch
All registered studies
Every ClinicalTrials.gov study of this drug's own program, grouped by indication and phase. Research unlocks the studies themselves: titles, statuses, dates and featured-trial cross-links.