Asset profile

Inavolisib

Small molecule

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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.

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Competitive landscape

61 competitors in this universe: 1 direct rival (same mechanism and indication), 0 same-class, 60 same-indication.

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DrugStageModalityMechanismEvidence signalReported efficacygraded featured trials
Inavolisib: this drugApprovedSmall moleculePI3K-alpha
Alpelisib (BYL719)ApprovedSmall moleculePI3K-alpha
Abemaciclib (Verzenio)ApprovedSmall moleculeCDK4 and CDK6
AnastrozoleApprovedSmall moleculeAromatase
CapecitabineApprovedSmall moleculeFluoropyrimidine (antimetabolite)
CapivasertibApprovedSmall moleculeAKT (inhibitor)
Datopotamab DeruxtecanApprovedAntibody–drug conjugateTROP2
DenosumabApprovedMonoclonal antibodyRANKL
DocetaxelApprovedSmall moleculeMicrotubules (tubulin)
ElacestrantApprovedSmall moleculeEstrogen receptor
Eribulin MesylateApprovedSmall moleculeTubulin / microtubules
EverolimusApprovedSmall moleculemTOR kinase, mTOR (mTORC1) (inhibitor)
ExemestaneApprovedSmall moleculeAromatase
Fulvestrant (Faslodex)ApprovedSmall moleculeEstrogen receptor
GedatolisibApprovedSmall moleculePI3K (class I isoforms) and mTORC1/mTORC2
GemcitabineApprovedSmall moleculeribonucleotide reductase / DNA polymerase (dCTP competition)

…and 46 more. Research shows the complete landscape.

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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.

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 (5)
November 2026 (2)
Phase 3HR+/HER2- Metastatic Breast CancerRecruiting
Est. primary completion 2026-11-13 · NCT05646862 · CT.gov ↗
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Phase 1Hepatic ImpairmentRecruiting
Est. primary completion 2026-11-16 · NCT07144111 · CT.gov ↗
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December 2026 (3)
Phase 2HR+/HER2- Metastatic Breast CancerNot yet recruiting
Est. primary completion 2026-12-15 · NCT07245797 · CT.gov ↗
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Phase 1HR+/HER2- Metastatic Breast CancerActive not recruiting
Est. primary completion 2026-12-31 · NCT03006172 · CT.gov ↗
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Phase 3HR+/HER2- Metastatic Breast CancerRecruiting
Est. primary completion 2026-12-31 · NCT05894239 · CT.gov ↗
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2027 (4)
January 2027 (1)
Phase 2HER2-positive Breast CancerRecruiting
Est. primary completion 2027-01 · NCT05306041 · CT.gov ↗
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July 2027 (2)
Phase 1PIK3CA-Mutated CancersActive not recruiting
Est. primary completion 2027-07-21 · NCT06496568 · CT.gov ↗
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Phase 2HR+/HER2- Metastatic Breast CancerRecruiting
Est. primary completion 2027-07-31 · NCT07054190 · CT.gov ↗
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December 2027 (1)
Phase 1Non-Small Cell Lung Cancer, Colorectal Cancer, Advanced Solid TumorsActive not recruiting
Est. primary completion 2027-12-31 · NCT04449874 · CT.gov ↗
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2028 (8)
February 2028 (1)
Phase 2Ovarian CancerActive not recruiting
Est. primary completion 2028-02-28 · NCT04931342 · CT.gov ↗
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March 2028 (2)
Phase 2TNBC - Triple-Negative Breast Cancer, TNBCNot yet recruiting
Est. primary completion 2028-03-15 · NCT07441512 · CT.gov ↗
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Phase 2Metastatic Castration-Resistant Prostate CancerRecruiting
Est. primary completion 2028-03-31 · NCT07287150 · CT.gov ↗
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June 2028 (2)
Phase 2Pancreatic Ductal Adenocarcinoma (PDAC)Not yet recruiting
Est. primary completion 2028-06-29 · NCT07694973 · CT.gov ↗
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Phase 2HR+/HER2- Metastatic Breast CancerActive not recruiting
Est. primary completion 2028-06-30 · NCT05708235 · CT.gov ↗
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October 2028 (1)
Phase 2HR+/HER2- Metastatic Breast CancerRecruiting
Est. primary completion 2028-10-31 · NCT07368998 · CT.gov ↗
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December 2028 (2)
Phase 2HR+/HER2- Metastatic Breast CancerNot yet recruiting
Est. primary completion 2028-12 · NCT07618390 · CT.gov ↗
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Phase 2HR+/HER2- Metastatic Breast CancerRecruiting
Est. primary completion 2028-12-19 · NCT07405801 · CT.gov ↗
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2029 (2)
May 2029 (1)
Phase 1/2HR+/HER2- Metastatic Breast CancerRecruiting
Est. primary completion 2029-05-30 · NCT04802759 · CT.gov ↗
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June 2029 (1)
Phase 2HR+/HER2- Metastatic Breast CancerNot yet recruiting
Est. primary completion 2029-06-15 · NCT07748208 · CT.gov ↗
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2030 (4)
March 2030 (1)
Phase 2HR+/HER2- Metastatic Breast CancerRecruiting
Est. primary completion 2030-03 · NCT05332561 · CT.gov ↗
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May 2030 (1)
Phase 2Endometrial CancerNot yet recruiting
Est. primary completion 2030-05 · NCT07522697 · CT.gov ↗
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August 2030 (1)
Phase 1Metastatic Colorectal CancerRecruiting
Est. primary completion 2030-08-31 · NCT04929223 · CT.gov ↗
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September 2030 (1)
Phase 1/2HR+/HER2- Metastatic Breast CancerRecruiting
Est. primary completion 2030-09-30 · NCT03424005 · CT.gov ↗
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2032 (2)
January 2032 (1)
Phase 3HR+/HER2- Metastatic Breast CancerRecruiting
Est. primary completion 2032-01-31 · NCT06790693 · CT.gov ↗
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September 2032 (1)
Phase 2Solid TumorsActive not recruiting
Est. primary completion 2032-09-25 · NCT04589845 · CT.gov ↗
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2033 (1)
March 2033 (1)
Phase 3CancerRecruiting
Est. primary completion 2033-03-01 · NCT05862285 · CT.gov ↗
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See the full readout calendar ↗

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.

Phase 3 (4)
Phase 2/3 (1)
Phase 2 (19)
Phase 1/2 (3)
Phase 1 (5)