Asset profile

Pivekimab Sunirine

Antibody–drug conjugate

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Approvedregulatory verdict

Evidence outlook

Approved: blastic plasmacytoid dendritic cell neoplasm (BPDCN) (FDA)

This approval is for an indication outside this terminal's covered markets; the covered program shown here is investigational. Regulatory approval supersedes design-level evidence grading for the approved use.

Source for the program status

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Competitive landscape

66 competitors in this universe: 6 direct rivals (same mechanism and indication), 0 same-class, 60 same-indication; 30 further along in development.

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DrugStageModalityMechanismEvidence signalReported efficacygraded featured trials
Pivekimab Sunirine: this drugPhase 2/3Antibody–drug conjugateCD123
TagraxofuspPhase 2—CD123
CD123 Targeted CAR-NK CellsPhase 1/2Cell therapyCD123
SAR443579Phase 1/2Biologic (subtype unspecified)CD123
Allo-RevCAR01-TPhase 1—CD123
Anti-CD123 CAR NK CellsPhase 1—CD123
BYON4413Phase 1—CD123
ASTX727ApprovedSmall moleculeDecitabine/cedazuridine fixed combination (DNMT + CDA inhibition)
EnasidenibApprovedSmall moleculeIDH2
Gemtuzumab OzogamicinApprovedAntibody–drug conjugateCD33
GilteritinibApprovedSmall moleculeFLT3
MidostaurinApprovedSmall moleculeFLT3;KIT;PKC;PDGFR
OlutasidenibApprovedSmall moleculeMutant IDH1
QuizartinibApprovedSmall moleculeFLT3
RevumenibApprovedSmall moleculeMenin
Tretinoin (Vesanoid)ApprovedSmall moleculeRARA (retinoic acid receptor alpha); degrades the PML-RARA fusion oncoprotein in APL

…and 51 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)
February 2027 (1)
Phase 1/2Acute Myeloid LeukemiaActive not recruiting
Est. primary completion 2027-02 · NCT04086264 · CT.gov ↗
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2028 (1)
April 2028 (1)
Phase 1Acute Myeloid LeukemiaRecruiting
Est. primary completion 2028-04 · NCT07306832 · CT.gov ↗
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2032 (1)
June 2032 (1)
Phase 2/3Acute Myeloid LeukemiaRecruiting
Est. primary completion 2032-06 · NCT07581002 · 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 2/3 (1)
Phase 1/2 (3)
Phase 1 (2)