Asset profile

Zovegalisib

Small molecule

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Phase 3underway

Evidence outlook · registrational

HR+/HER2- Metastatic Breast Cancer: registrational readout pending

Its supporting mid-stage evidence has not yet been graded on this platform. Registrational readout expected around 2028-04-30.

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Competitive landscape

61 competitors in this universe: 1 direct rival (same mechanism and indication), 0 same-class, 60 same-indication; 29 further along in development.

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DrugStageModalityMechanismEvidence signalReported efficacygraded featured trials
Zovegalisib: this drugPhase 3Small moleculePI3K-alpha (mutant-selective)
JS105Phase 3Small moleculePI3K-alpha (mutant-selective)
Abemaciclib (Verzenio)ApprovedSmall moleculeCDK4 and CDK6
Alpelisib (BYL719)ApprovedSmall moleculePI3K-alpha
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

…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

(3 total)

Estimated primary-completion dates from ClinicalTrials.gov. These are registry estimates, never confirmed readout dates; they can move as trials progress.

2027 (1)
April 2027 (1)
Phase 1HR+/HER2- Metastatic Breast CancerRecruiting
Est. primary completion 2027-04-30 · NCT05216432 · CT.gov ↗
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2028 (1)
April 2028 (1)
Phase 3HR+/HER2- Metastatic Breast CancerRecruiting
Est. primary completion 2028-04-30 · NCT06982521 · CT.gov ↗
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2031 (1)
July 2031 (1)
Phase 2PIK3CA-Related Overgrowth Spectrum (PROS), Lymphatic Malformations, Vascular Malformations, PIK3CA Mutation, CLOVES Syndrome …Recruiting
Est. primary completion 2031-07 · NCT06789913 · 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 (1)
Phase 2 (1)
Phase 1 (1)