Enlicitide Decanoate
- Generic Name
- Enlicitide Decanoate
LEQVIO Emerges as Leading PCSK9 Inhibitor in Cholesterol Management Across Major Markets
• Novartis's LEQVIO (inclisiran), the first FDA-approved siRNA therapy for LDL-C reduction, is projected to reach USD 2.2 billion in US market size by 2034, offering a novel mechanism with biannual dosing that enhances patient adherence.
• The PCSK9 inhibitor market, valued at USD 2 billion across seven major markets in 2023, is expected to grow substantially due to expanding applications in statin-intolerant patients and preventive cardiovascular strategies.
• Emerging competitors including Lerodalcibep, Merck's oral MK-0616, and Verve Therapeutics' gene-editing candidates are advancing through clinical trials, potentially disrupting LEQVIO's market position after 2027.
MSD and Cyprumed Forge $493 Million Deal to Advance Oral Peptide Therapeutics
• MSD (Merck & Co.) has secured non-exclusive global rights to Cyprumed's oral peptide delivery platform, potentially transforming injectable peptide treatments into convenient tablet formulations.
• The agreement includes up to $493 million in milestone payments and grants MSD options for exclusive licensing of the technology for specific targets, with MSD leading all development and commercialization efforts.
• Cyprumed's innovative tablet formulation technology offers superior bioavailability using approved pharmaceutical excipients, potentially advancing MSD's macrocyclic peptide portfolio including enlicitide decanoate and efinopegdutide.
Verve Therapeutics Expands Base Editing Trial for Cholesterol Treatment into US Following FDA Clearance
• Verve Therapeutics received FDA clearance to expand its VERVE-102 trial into the US, potentially offering a one-time base editing treatment for persistent high cholesterol conditions.
• The company's gene editing approach targets the PCSK9 gene to deliver lifelong cholesterol lowering, distinguishing it from current therapies that require regular injections ranging from bi-weekly to semi-annually.
• Initial safety and efficacy data from the Phase 1b Heart-2 trial is expected by the end of June, with dose escalation data and Phase 2 trial initiation planned for later this year.
AstraZeneca's Oral PCSK9 Inhibitor Shows Promise in Phase 1 Trial
• AstraZeneca's oral PCSK9 inhibitor, AZD0780, demonstrated a 52% reduction in LDL cholesterol when added to statin therapy in a Phase 1 trial.
• The study included treatment-naive participants with hypercholesterolemia, showing a 78% total reduction from baseline in LDL-C levels.
• AZD0780's efficacy appears comparable to injectable PCSK9 inhibitors, with the added convenience of oral administration, unaffected by food intake.
• AstraZeneca plans to advance AZD0780 into a Phase 2 program, joining MSD in the race to provide oral alternatives to injectable cholesterol-lowering drugs.
Verve Therapeutics Advances Pipeline with Focus on Gene Editing for Cardiovascular Disease
• Verve Therapeutics anticipates initial data from the Heart-2 Phase 1b trial of VERVE-102, targeting PCSK9, in Q2 2025, including safety and efficacy data.
• VERVE-301 has been nominated as the development candidate targeting the LPA gene, triggering a milestone payment from Eli Lilly, who will fund Phase 1 development.
• The Pulse-1 Phase 1b trial for VERVE-201, which targets ANGPTL3, is progressing, with an update expected in the second half of 2025.
• Verve's strong financial position, boosted by the Lilly milestone payment, extends the company's cash runway into mid-2027.
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