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Clinical Trials
40
12 active
Approvals
2
Total approvals
Agencies
1
Regulatory bodies
Founded
1998
Active, not recruiting
12
30.0%
Completed
24
60.0%
Recruiting
4
10.0%
FDA
Food and Drug Administration
- The novel hypercholesterolemia drugs market is projected to grow from USD 17.6 billion in 2026 to USD 42.8 billion by 2036, a 9.3% CAGR. - PCSK9 inhibitors are forecast to hold a 42.0% drug-class share in 2026, spanning monoclonal antibodies, inclisiran-based siRNA, and the new oral enlicitide. - Merck's Lipfendra (enlicitide) gained FDA approval in July 2026 as the first once-daily oral PCSK9 inhibitor for adults with hypercholesterolemia. - Injectable therapies lead with a 57.0% route-of-administration share, while gene-editing programs from Verve, CRISPR Therapeutics, and Eli Lilly advance toward one-time treatment.
