Asset profile

Palazestrant

Small molecule

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Phase 3underway

Evidence outlook · registrational

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

Entered Phase 3 on weak signal mid-stage evidence. Registrational readout expected around 2026-10-31.

NCT04505826: The study was nonrandomized, unblinded, and single-arm, with participants receiving OP-1250 at sequential dose levels and no placebo or active comparator. Its results were descriptive rather than a formal comparative test: dose-limiting toxicities were 0/42 during dose escalation, while confirmed partial responses included 4/62 participants at 120 mg once daily; therefore, the primary outcomes were not formally met or missed against a control.

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Competitive landscape

67 competitors in this universe: 7 direct rivals (same mechanism and indication), 0 same-class, 60 same-indication; 29 further along in development.

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DrugStageModalityMechanismEvidence signalReported efficacygraded featured trials
Palazestrant: this drugPhase 3Small moleculeEstrogen receptor
ElacestrantApprovedSmall moleculeEstrogen receptor
Fulvestrant (Faslodex)ApprovedSmall moleculeEstrogen receptor
ImlunestrantApprovedSmall moleculeEstrogen receptor
TamoxifenApprovedSmall moleculeEstrogen receptor
VepdegestrantApprovedSmall moleculeEstrogen receptor
CamizestrantPhase 3Small moleculeEstrogen receptor
GiredestrantPhase 3Small moleculeEstrogen receptor
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)

…and 52 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.

2026 (1)
October 2026 (1)
Phase 3HR+/HER2- Metastatic Breast CancerActive not recruiting
Est. primary completion 2026-10-31 · NCT06016738 · CT.gov ↗
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2027 (1)
December 2027 (1)
Phase 1HR+/HER2- Metastatic Breast CancerActive not recruiting
Est. primary completion 2027-12-31 · NCT05508906 · CT.gov ↗
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2028 (1)
December 2028 (1)
Phase 3HR+/HER2- Metastatic Breast CancerRecruiting
Est. primary completion 2028-12 · NCT07085767 · 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 (2)
Phase 1/2 (1)
Phase 1 (2)
Studied as part of a combination product (1)