Asset profile

Tafolecimab · Sintbilo

Monoclonal antibody

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Approvedregulatory verdict

Evidence outlook

Approved: Primary hypercholesterolemia and mixed dyslipidemia (SINTBILO) (CN)

This approval is outside the US-scoped market view; the covered program shown here is investigational. Regulatory approval supersedes design-level evidence grading for the approved use.

track record: Reliable signal

Source for the program status

How the evidence outlook works ↗

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
Tafolecimab (Sintbilo): this drugPhase 3Monoclonal antibodyPCSK9
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
SYH2053Phase 3RNA / oligonucleotidePCSK9
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

(8 total)

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

2026 (1)
December 2026 (1)
Early phase / not applicableIschemic Stroke or High-risk TIA (ABCD² ≥ 4)Not yet recruiting
Est. primary completion 2026-12-01 · NCT07341958 · CT.gov ↗
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2027 (5)
May 2027 (2)
Phase 2NSCLC (Advanced Non-small Cell Lung Cancer), Resistance to ImmunotherapyNot yet recruiting
Est. primary completion 2027-05 · NCT07014215 · CT.gov ↗
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Phase 2Lung CancerRecruiting
Est. primary completion 2027-05-30 · NCT06421298 · CT.gov ↗
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August 2027 (1)
Phase 2Extensive-stage Small Cell Lung Cancer (ES-SCLC), Extensive Stage Lung Small Cell Cancer, Extensive-Stage Small-Cell Lung Cancer …Recruiting
Est. primary completion 2027-08-01 · NCT07061535 · CT.gov ↗
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September 2027 (1)
Phase 2Gastric Adenocarcinoma, Esophagogastric Juction Cancer, Proficient Mismatch RepairNot yet recruiting
Est. primary completion 2027-09-01 · NCT07621562 · CT.gov ↗
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November 2027 (1)
Phase 4Acute Myocardial Infarction (AMI)Not yet recruiting
Est. primary completion 2027-11-30 · NCT06683131 · CT.gov ↗
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2028 (1)
June 2028 (1)
Phase 2Bladder Urothelial Carcinoma, Bladder CancerRecruiting
Est. primary completion 2028-06-30 · NCT07717242 · CT.gov ↗
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2030 (1)
January 2030 (1)
Phase 3Local Advanced Rectal Cancer, PD-1 Inhibitor, PCSK9 Inhibitor, RCT, Radiotherapy, Capecitabine, OxaliplatinNot yet recruiting
Est. primary completion 2030-01-01 · NCT07686796 · 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 (5)
Phase 2/3 (2)
Phase 2 (6)
Phase 1 (2)
Phase 4 (1)
Early phase / not applicable (2)