Approved regulatory verdict
Evidence outlook
Approved: Atherosclerotic Cardiovascular Disease (label: clinical ASCVD, plus adults with primary hyperlipidemia and patients 12 and older with heterozygous...)
Regulatory approval supersedes design-level evidence grading; the trials behind approval are preserved below as the drug's evidence history.
track record: Partial signal
How the evidence outlook works ↗
Featured trials The studies most instrumental to this drug's clinical progression, individually graded on design and result. Pick an indication; Research unlocks the trials, endpoints, key results and grades.
Atherosclerotic Cardiovascular Disease · approved · Featured evidence · 3 ASCVD, Risk Factor, Cardiovascular, Elevated Cholesterol · not a covered market · Outside covered markets · 1 approved Featured evidence · 3
Competitive landscape 79 competitors in this universe: 18 direct rivals (same mechanism and indication), 1 same-class, 60 same-indication.
Unlock with Research ↗ Drug Stage Modality Mechanism Evidence signal Reported efficacygraded featured trials Inclisiran (Leqvio): this drug Approved RNA / oligonucleotide PCSK9 Alirocumab (Praluent)Approved Monoclonal antibody PCSK9 Evolocumab (Repatha)Approved Monoclonal antibody PCSK9 AZD0780 Phase 3 Small molecule PCSK9 Ebronucimab Phase 3 Monoclonal antibody PCSK9 Enlicitide Phase 3 Peptide PCSK9 Lerodalcibep (Lerochol)Phase 3 Protein / enzyme therapeutic PCSK9 Ongericimab (Junshida)Phase 3 Monoclonal antibody PCSK9 QLC7401 Phase 3 RNA / oligonucleotide PCSK9 Recaticimab Phase 3 Monoclonal antibody PCSK9 SYH2053 Phase 3 RNA / oligonucleotide PCSK9 Tafolecimab (Sintbilo)Phase 3 Monoclonal antibody PCSK9 AZD8233 Phase 2 RNA / oligonucleotide PCSK9 DNV001 Phase 2 Monoclonal antibody PCSK9 HRS-1301 Phase 2 Small molecule PCSK9 COR-1004 Phase 1 — PCSK9
…and 64 more. Research shows the complete landscape.
Research Unlock the full comparison Research adds each competitor's evidence grade and sourced trial results, aligned per race, so you can see who actually has the data.
Unlock with Research ↗ Compare head-to-head
12 further head-to-head pairs are tracked; the rosters on each shared mechanism and indication page list every rival in the race.
Upcoming events (22 total) Estimated primary-completion dates from ClinicalTrials.gov. These are registry estimates, never confirmed readout dates; they can move as trials progress.
2026 (6) October 2026 (1) Phase 3 Atherosclerotic Cardiovascular Disease Active not recruiting
Est. primary completion 2026-10-26 ·
NCT05360446 ·
CT.gov ↗ What to watch November 2026 (1) Phase 4 Atherosclerotic Cardiovascular Disease Recruiting
Est. primary completion 2026-11-27 ·
NCT06501443 ·
CT.gov ↗ What to watch December 2026 (4) Phase 1 Inclisiran Formulation Recruiting
Est. primary completion 2026-12-21 ·
NCT07626281 ·
CT.gov ↗ What to watch Phase 4 Atherosclerotic Cardiovascular Disease Recruiting
Est. primary completion 2026-12-30 ·
NCT06865885 ·
CT.gov ↗ What to watch Phase 4 Plaque, Atherosclerotic Active not recruiting
Est. primary completion 2026-12-30 ·
NCT06372925 ·
CT.gov ↗ What to watch Phase 4 Atherosclerotic Cardiovascular Disease Active not recruiting
Est. primary completion 2026-12-31 ·
NCT06249165 ·
CT.gov ↗ What to watch 2027 (7) February 2027 (2) Phase 3 Atherosclerotic Cardiovascular Disease Recruiting
Est. primary completion 2027-02-11 ·
NCT07102628 ·
CT.gov ↗ What to watch Phase 4 Atherosclerotic Cardiovascular Disease Not yet recruiting
Est. primary completion 2027-02-28 ·
NCT07684469 ·
CT.gov ↗ What to watch April 2027 (2) Phase 2 Atherosclerotic Cardiovascular Disease Recruiting
Est. primary completion 2027-04-28 ·
NCT07610278 ·
CT.gov ↗ What to watch Phase 4 Atherosclerotic Cardiovascular Disease Active not recruiting
Est. primary completion 2027-04-30 ·
NCT06941792 ·
CT.gov ↗ What to watch May 2027 (2) Phase 4 Atherosclerotic Cardiovascular Disease Recruiting
Est. primary completion 2027-05 ·
NCT07581808 ·
CT.gov ↗ What to watch Phase 3 Atherosclerotic Cardiovascular Disease Active not recruiting
Est. primary completion 2027-05-10 ·
NCT05030428 ·
CT.gov ↗ What to watch December 2027 (1) Early phase / not applicable Melanoma Recruiting
Est. primary completion 2027-12 ·
NCT07704918 ·
CT.gov ↗ What to watch 2028 (4) February 2028 (2) Phase 2 Atherosclerotic Cardiovascular Disease Recruiting
Est. primary completion 2028-02 ·
NCT07803822 ·
CT.gov ↗ What to watch Phase 3 Atherosclerotic Cardiovascular Disease Recruiting
Est. primary completion 2028-02-03 ·
NCT06813911 ·
CT.gov ↗ What to watch March 2028 (2) Phase 3 Atherosclerotic Cardiovascular Disease Recruiting
Est. primary completion 2028-03-21 ·
NCT06597019 ·
CT.gov ↗ What to watch Phase 3 Atherosclerotic Cardiovascular Disease Recruiting
Est. primary completion 2028-03-21 ·
NCT06597006 ·
CT.gov ↗ What to watch 2029 (3) April 2029 (1) Phase 3 Atherosclerotic Cardiovascular Disease Active not recruiting
Est. primary completion 2029-04-16 ·
NCT05739383 ·
CT.gov ↗ What to watch September 2029 (1) Phase 4 Atherosclerotic Cardiovascular Disease Not yet recruiting
Est. primary completion 2029-09 ·
NCT07799779 ·
CT.gov ↗ What to watch October 2029 (1) Phase 4 Percutaneous Coronary Intervention, Peripheral Endovascular Intervention Recruiting
Est. primary completion 2029-10 ·
NCT06909565 ·
CT.gov ↗ What to watch 2032 (2) March 2032 (1) Phase 3 Atherosclerotic Cardiovascular Disease Recruiting
Est. primary completion 2032-03-25 ·
NCT05682378 ·
CT.gov ↗ What to watch June 2032 (1) Phase 3 Atherosclerotic Cardiovascular Disease Recruiting
Est. primary completion 2032-06-30 ·
NCT06494501 ·
CT.gov ↗ What to watch 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.
All indications (52) Atherosclerotic Cardiovascular Disease (46) Other / comorbidity (6)
Phase 3 (23) Phase 2 (6) Phase 1 (4) Phase 4 (16) Early phase / not applicable (3) Used as active comparator (2)