Enlicitide chloride

Evogene Ltd. (Nasdaq: EVGN; TASE: EVGN) and ELEO Inc., a private South Korean biotech based in Daejeon, announced a collaboration to discover oral small-molecule inhibitors of the PCSK9 pathway, pairing Evogene’s AI-driven computational chemistry platform with ELEO’s biological discovery work in lipid disease. The collaboration places Evogene among a growing group of companies pursuing orally administered PCSK9 inhibitors, a field that transitioned from an experimental concept to a commercially validated drug class with the recent FDA approval of Merck’s enlicitide. Developing orally available PCSK9 inhibitors has proven challenging because small molecules must disrupt the interaction between PCSK9 and the LDL receptor, a protein-protein interface traditionally considered difficult to target with conventional medicinal chemistry. Under the collaboration, Evogene’s contribution is its computational chemistry platform, which generates and prioritizes candidate structures in silico before wet-lab synthesis. ELEO is providing what the company describes as proprietary biological capabilities relevant to PCSK9 pathway suppression, though neither party has disclosed a specific lead series or nominated compound. No financial specifics were disclosed. The agreement fits a pattern Evogene has run repeatedly over the past year: it has struck a string of similar computational-chemistry tie-ups, including with Unravel Biosciences on demyelinating disease, with Professor Ehud Gazit and Tel Aviv University on metabolic disease, with Systasy and LMU University Hospital Munich on neutrophil-driven inflammation, and with Tel Aviv University’s Blavatnik Center for Drug Discovery on broader AI-driven small-molecule work. Evogene has also been layering AI agent capability into its ChemPass platform through an expanded Google Cloud partnership. The oral PCSK9 field has shifted rapidly from scientific ambition to commercial reality. In July 2026, Merck’s oral macrocyclic peptide PCSK9 inhibitor enlicitide received FDA approval for adults with hypercholesterolemia, becoming the first oral therapy targeting the pathway after demonstrating LDL-C reductions across the Phase III CORALreef program. AstraZeneca’s AZD0780, a conventional oral small molecule rather than a peptide, remains in clinical development following positive Phase IIb PURSUIT data, providing proof that small-molecule chemistry can also engage the historically challenging PCSK9 target. Established injectable therapies—including the monoclonal antibodies evolocumab and alirocumab, the siRNA inclisiran, and LIB Therapeutics’ lerodalcibep—continue to anchor the broader PCSK9 market. Against that backdrop, the Evogene-ELEO collaboration sits at the earliest stage of discovery, with no disclosed lead compound or clinical candidate. Rather than competing directly with established products, the partnership aims to determine whether AI-guided medicinal chemistry can identify differentiated oral small molecules capable of matching or improving on the efficacy, manufacturability or dosing profile of an increasingly crowded PCSK9 field. Access the AllSci platform to explore the science behind the news. Your email address will not be published. Required fields are marked * Comment * Name * Email * Website Privacy Terms About Us Copyright © 2026. AllSci Corp. All rights reserved.

First oral PCSK9 inhibitor provides an additional treatment option for adults with hypercholesterolemia Silver Spring, MD, July 17, 2026 (GLOBE NEWSWIRE) -- The U.S. Food and Drug Administration approved Lipfendra (enlicitide), the first oral inhibitor of proprotein convertase subtilisin/kexin type 9 (PCSK9), as an adjunct to diet and exercise to reduce low-density lipoprotein cholesterol (LDL-C), or “bad” cholesterol, in adults with hypercholesterolemia, including those with heterozygous familial hypercholesterolemia (HeFH). PCSK9 inhibitors have previously been available only as injectable therapies. Lipfendra is administered as a once-daily oral tablet and provides an additional treatment option for adults who require further LDL-C reduction despite existing therapies. The approval also reflects continued advances in the development of therapies for chronic cardiovascular disease management. “Cardiovascular disease remains the leading cause of death in the United States, and elevated LDL cholesterol is one of its most important modifiable risk factors,” said Michael Davis, M.D., Ph.D., Acting Director of the FDA’s Center for Drug Evaluation and Research . “This approval provides an additional treatment option for adults with hypercholesterolemia and reflects the FDA’s broader commitment to supporting meaningful advances in patient access and tackling chronic diseases.” ezstandalone.cmd.push(function () { ezstandalone.showAds(131); }); Hypercholesterolemia occurs when there is too much LDL-C in the blood. Over time, excess LDL-C can accumulate within the walls of arteries, contributing to the formation of plaques that narrow blood vessels and restrict blood flow. If a plaque ruptures, it can trigger the formation of a blood clot, increasing the risk of heart attack or stroke. Because high cholesterol typically causes no symptoms, many people are unaware they have the condition until it is detected through routine blood testing. Diet, physical inactivity, excess body weight, and inherited genetic conditions can all contribute to elevated cholesterol levels. Several classes of medications are available to lower LDL-C, including statins, ezetimibe, and injectable PCSK9 inhibitors. Lipfendra is the first oral therapy to inhibit PCSK9. The efficacy and safety of Lipfendra were evaluated in two randomized, double-blind, placebo-controlled clinical trials involving 3,207 adults with hypercholesterolemia, including patients with and without HeFH, who were receiving maximally tolerated statin therapy. The primary endpoint in both studies was the percent change in LDL-C from baseline to Week 24 compared with placebo. In the first trial, which enrolled adults with established atherosclerotic cardiovascular disease (ASCVD) or those at high risk for ASCVD, participants had a mean baseline LDL-C of 96 mg/dL. Treatment with Lipfendra resulted in an average 56% reduction in LDL-C at Week 24 compared with placebo. In the second trial, which enrolled adults with HeFH, participants had a mean baseline LDL-C of 119 mg/dL. Treatment with Lipfendra resulted in an average 59% reduction in LDL-C at Week 24 compared with placebo. In the first trial, the frequency of adverse reactions was similar between patients treated with Lipfendra and those receiving placebo. In the second trial, the most common adverse reactions occurring more frequently with Lipfendra than placebo were diarrhea and dizziness. Across both trials, discontinuation rates due to adverse reactions were comparable between the Lipfendra-treated and placebo-recipient groups. Lipfendra received Priority Review for this indication. The application was also reviewed under the Commissioner’s National Priority Voucher (CNPV) pilot program, which is intended to help accelerate the review of therapies that address national public health priorities. The approval was granted to Merck Sharp & Dohme LLC. ### The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation’s food supply, cosmetics, dietary supplements, radiation-emitting electronic products, and for regulating tobacco products. Contact Info U.S. Food and Drug Administration FDAPressAlerts@fda.hhs.gov +1 202-690-6343