Asset profile

HRS-5346

Small molecule

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Partialdesign only

Evidence outlook · results not reported

NCT06816264 · Treatment of Lipoprotein Disorder

The lead study's design has limits that temper confidence (see the rationale below), and its results have not been reported. This tier describes the design, not an outcome.

NCT06816264: The trial randomly assigned 120 participants to three HRS-5346 dose groups or placebo and used quadruple masking of participants, care providers, investigators, and outcome assessors. Its primary endpoint was a laboratory measure of lipoprotein(a), rather than a clinical cardiovascular or endoscopic outcome, and the treatment comparison cannot yet be judged because results are not posted.

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Competitive landscape

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

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DrugStageModalityMechanismEvidence signalReported efficacygraded featured trials
HRS-5346: this drugPhase 2Small moleculeLipoprotein(a) [Lp(a)] formation
Alirocumab (Praluent)ApprovedMonoclonal antibodyPCSK9
Bempedoic Acid (Nexletol)ApprovedSmall moleculeAdenosine Triphosphate-Citrate Lyase Inhibitor, ATP citrate lyase
Bempedoic Acid / EzetimibeApprovedSmall moleculeATP citrate lyase (ACLY, bempedoic acid) and NPC1L1 (ezetimibe)
Cangrelor (Kengreal)ApprovedSmall moleculeP2Y12 receptor
Colchicine (cardiovascular) (Lodoco)ApprovedSmall moleculeMicrotubule/inflammasome (tubulin)
Dapagliflozin (Farxiga / Forxiga)ApprovedSmall moleculeSGLT2
Dulaglutide (Trulicity)ApprovedPeptideGLP-1 receptor
Evolocumab (Repatha)ApprovedMonoclonal antibodyPCSK9
Icosapent Ethyl (Vascepa)ApprovedSmall moleculeOmega-3 fatty acid (EPA)
Inclisiran (Leqvio)ApprovedRNA / oligonucleotidePCSK9
Liraglutide (Saxenda / Victoza)ApprovedPeptideGLP-1 receptor
Lomitapide (Juxtapid)ApprovedSmall moleculeMTP
NexlizetApproved——
Olezarsen (Tryngolza)ApprovedRNA / oligonucleotideAPOC3
Orforglipron (Foundayo)ApprovedSmall moleculeGLP-1 receptor

…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.

2027 (2)
February 2027 (1)
Phase 2Atherosclerotic Cardiovascular DiseaseNot yet recruiting
Est. primary completion 2027-02 · NCT07767513 · CT.gov ↗
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October 2027 (1)
Phase 2Atherosclerotic Cardiovascular DiseaseRecruiting
Est. primary completion 2027-10-12 · NCT07614984 · 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 (3)
Phase 1 (3)