There is currently no FDA-approved treatment for Lp(a). This market resolves YES if at least one medication specifically designed to lower Lp(a) receives FDA approval by December 31, 2027. The medication must be approved for the indication of lowering Lp(a) levels, not merely as a secondary effect of another approved drug. Resolution will be verified through the FDA's official approval announcements or the FDA's drug database at https://www.fda.gov/drugs/novel-drug-approvals-fda.
Must be a medication. Lipoprotein apheresis does not count.
Background
Lp(a) is estimated to affect 64 million people in the United States and 1.4 billion people worldwide. Unlike other types of cholesterol particles, Lp(a) levels are 80-90% genetically determined, and lifestyle patterns such as diet and exercise have no effect on circulating lipoprotein(a), and traditional lipid-lowering agents, including statins and fibrates, have proven unsuccessful at lowering this lipid.
Pelacarsen, an antisense oligonucleotide discovered by Ionis Pharmaceuticals and licensed to Novartis, is furthest ahead in development. Olpasiran is another siRNA investigational agent currently in a phase 3 trial. Eli Lilly announced positive Phase 2 results for muvalaplin, an investigational once-daily oral medication that significantly reduced elevated Lp(a) levels in adults, with placebo-adjusted reductions up to 85.8%.
Considerations
Phase 3 trials will be crucial in determining the viability of lowering Lp(a) with such therapies and improving cardiovascular outcomes. While multiple candidates show strong efficacy in reducing Lp(a) levels, FDA approval requires not only demonstration of safety and efficacy in lowering Lp(a), but also evidence that this reduction translates to meaningful clinical benefit. Pelacarsen's owning company has indicated that they may begin regulatory submissions in the second half of 2026.
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@0xseraphim I don’t think this is a death knell for LPA reduction as a therapy in the long-term. I think it’s still likely that LPA reduction helps at least somewhat especially for patients without pre-existing CVD.
but the trials that show that will take a long time, and this is definitely a big hit to short term approval odds.
Disappointing for my 151 nmol/L rate :/
@Sketchy yeah it's surprising given how confident the scientists are at this point between the causal relationship between LP(a) and atherosclerosis. Maybe there's more going on here than previously thought. Especially since this made it all the way to phase 3 etc.
Fortunately there's all this coming through the pipeline!
I wouldn't worry too much for now tbh, this is just one trial/drug among many. With a high LP(a) I'd just do everything to keep my cholesterol super low and keep any lesions stabilised with statins and that's it. Science doesn't provide any better solutions for now 🤷 (but it probably will in 5-10 years time...)
I think for all the lipid reduction therapies outside LP(a) we've already got all the low hanging fruit with PCSK9 inhibitors. For the next 10 years in atherosclerosis therapies I'd happily bet on something surprising and significant coming up that goes after another target. Maybe something like 7-ketocholesterol with what Cyclarity is doing. That's the complexity of the disease, we still don't really know what we should be targeting in the first place, especially once the process gets going (which is basically everyone past the age of 30 🤣)
@Sketchy thought this was interesting (on the pelacarsen trial): Sam Tsimikas, MD (@Lpa_Doc) on X
NO ~47% — The critical dependency is pelacarsen (Novartis/Ionis) HORIZON trial, with data expected H1 2026 and regulatory submission planned H2 2026. This would be the first cardiovascular outcomes trial proving that lowering Lp(a) actually reduces MACE events — the Lp(a) hypothesis has strong Mendelian randomization support but has never been confirmed in a randomized trial. Even if HORIZON is positive, the timeline to FDA approval by Dec 2027 is tight (submission ~Sep 2026 + 8-12 month review = May-Sep 2027). Olpasiran (Amgen) OCEAN(a) completes Dec 2026, making it unlikely to be approved by end 2027. My estimate: ~42% YES.