To Get Full Access :

NCE-1 Intelligence & Market Opportunity

Lipfendra

Enlicitide Decanoate
Oral PCSK9 Inhibitor
Oral Tablet

PCSK9 inhibitors have transformed cholesterol management, but until now they have largely depended on injections. Lipfendra (enlicitide decanoate) changes that by becoming the first FDA-approved oral PCSK9 inhibitor for lowering LDL cholesterol.

The therapy works by blocking PCSK9, allowing more LDL receptors to remain active on the liver and clear harmful cholesterol from the bloodstream. Delivering this mechanism in a once-daily tablet could improve convenience and potentially increase patient adherence.

As cardiovascular treatment continues to evolve, Lipfendra is likely to become an important benchmark in lipid-management studies. Tracking its commercial adoption and exclusivity period will help clinical trial and regulatory teams stay ahead of emerging opportunities.

Approval Date
15-Jul-26
NCE-1 Date
15-Jul-30
NCE Date
15-Jul-31
Commercial snapshot

Market performance & projections

Revenue ($M)
NA
CAGR (%)
NA
Projected sales, 2026–2032 ($M)
Analyst projection, $M per year
2026
18
2027
305
2028
667
2029
1,346
2030
2,096
2031
2,781
2032
3,488
Molecule profile

Details & specifications

Molecule
Enlicitide Decanoate
Innovator
MERCK SHARP AND DOHME LLC
Dosage Form
Oral Tablet
Strength
EQ 20 mg base
Therapeutic Category
Oral PCSK9 Inhibitor
Usage
To reduce low-density lipoprotein cholesterol
Good to know

Frequently asked questions

Ready to act on this opportunity?

Talk to Spring Bio Solution about sourcing, licensing, and filing support for this molecule.

Why Spring Bio Solution

Supported 1000+ clinical trials globally

Provides services across regulatory, legal & clinical research

Unmatched intelligence on batches, expiry, spacing, and historical data from innovators

Integrated CRO services as part of our offerings

Insights on global pricing for smarter clinical trial supply decisions

Global sourcing capability across US, EU, South Africa, Canada, Japan, Australia, New Zealand, Southeast Asia, and other key markets

Login With

For full access Sign-up / Sign-in using below Methods:

By continuing, you agree to our Terms & Conditions and Privacy Policy. You can review them anytime.

Are you sure want to logout from NCE Grid?