Asset profile

Serabelisib

Small molecule

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Weakdesign only

Evidence outlook · results not reported

NCT04073680 · Breast Cancer, Endometrial Cancer, Lung Cancer, Colo-rectal Cancer, Head and Neck Cancer

The lead study uses a design that frequently fails to replicate under controlled conditions, and its results have not been reported. This tier describes the design, not an outcome.

NCT04073680: This is a small, uncontrolled, open-label dose-finding study with no randomization or comparator arm, testing serabelisib in combination with another drug across escalating doses and mutation-specific expansion cohorts. Its main purpose is establishing safety and dosing, and no results are posted, so it provides no evidence of a clinical treatment effect.

Featured evidence outside covered markets:NCT06463028 · Endometrial Cancer · Phase 2 · ungraded

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Competitive landscape

60 competitors in this universe: 0 direct rivals (same mechanism and indication), 0 same-class, 60 same-indication; 58 further along in development.

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DrugStageModalityMechanismEvidence signalReported efficacygraded featured trials
Serabelisib: this drugPhase 2Small moleculePI3K alpha (inhibitor)
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
GemcitabineApprovedSmall moleculeribonucleotide reductase / DNA polymerase (dCTP competition)

…and 45 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

(2 total)

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

2028 (1)
September 2028 (1)
Phase 2Endometrial CancerRecruiting
Est. primary completion 2028-09 · NCT06463028 · CT.gov ↗
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2029 (1)
May 2029 (1)
Phase 1/2HR+/HER2- Metastatic Breast CancerRecruiting
Est. primary completion 2029-05 · NCT07558733 · CT.gov ↗
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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 2 (1)
Phase 1/2 (2)
Phase 1 (1)
Appears in other studies (1)