Asset profile

SYH2053

RNA / oligonucleotide

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Phase 3underway

Evidence outlook · registrational

Atherosclerotic Cardiovascular Disease: registrational readout pending

Entered Phase 3 on partial signal mid-stage evidence. Registrational readout expected around 2027-12-31.

NCT07421232: The trial was randomized and participant-blinded, with placebo and inclisiran comparator groups, and enrolled 156 participants. Its primary endpoint was the clinically accepted LDL-C measure, but the outcome comparison cannot yet be assessed because results are not available.

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Competitive landscape

79 competitors in this universe: 18 direct rivals (same mechanism and indication), 1 same-class, 60 same-indication; 18 further along in development.

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DrugStageModalityMechanismEvidence signalReported efficacygraded featured trials
SYH2053: this drugPhase 3RNA / oligonucleotidePCSK9
Alirocumab (Praluent)ApprovedMonoclonal antibodyPCSK9
Evolocumab (Repatha)ApprovedMonoclonal antibodyPCSK9
Inclisiran (Leqvio)ApprovedRNA / oligonucleotidePCSK9
AZD0780Phase 3Small moleculePCSK9
EbronucimabPhase 3Monoclonal antibodyPCSK9
EnlicitidePhase 3PeptidePCSK9
Lerodalcibep (Lerochol)Phase 3Protein / enzyme therapeuticPCSK9
Ongericimab (Junshida)Phase 3Monoclonal antibodyPCSK9
QLC7401Phase 3RNA / oligonucleotidePCSK9
RecaticimabPhase 3Monoclonal antibodyPCSK9
Tafolecimab (Sintbilo)Phase 3Monoclonal antibodyPCSK9
AZD8233Phase 2RNA / oligonucleotidePCSK9
DNV001Phase 2Monoclonal antibodyPCSK9
HRS-1301Phase 2Small moleculePCSK9
COR-1004Phase 1—PCSK9

…and 64 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 (2)
December 2027 (2)
Phase 3Atherosclerotic Cardiovascular DiseaseNot yet recruiting
Est. primary completion 2027-12-31 · NCT07421284 · CT.gov ↗
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Phase 3Atherosclerotic Cardiovascular DiseaseRecruiting
Est. primary completion 2027-12-31 · NCT07421297 · CT.gov ↗
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2028 (1)
February 2028 (1)
Phase 3Atherosclerotic Cardiovascular DiseaseRecruiting
Est. primary completion 2028-02-28 · NCT07465263 · 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.