Sun Pharma signs global licensing deal for PCSK9 inhibitor lerodalcibep

Lerodalcibep is a once-monthly PCSK9 inhibitor used to reduce low-density lipoprotein cholesterol (LDL-C) and treat adult patients with hypercholesterolaemia and mixed dyslipidaemia

Mumbai: Sun Pharmaceutical Industries Limited on Monday announced a global licensing and commercialisation agreement with LIB Therapeutics Inc. for lerodalcibep, a PCSK9 inhibitor used to lower LDL-C.EU Approval and MarketLerodalcibep, branded Lyrokaul, received EU approval on 21 September 2026 for treating adult patients with hypercholesterolaemia and mixed dyslipidaemia. The company said this strengthens its innovative medicines portfolio with access to a PCSK9 market valued at approximately ₹30,900 crore (US$3.7 billion) outside the US and China.Sun Pharma Secures Ratings Boost From Moody’s, S&P on $11.75-Billion Organon Acquisition Bid Market GrowthThe PCSK9 inhibitor market in these territories grew at a 38% Compound Annual Growth Rate (CAGR) over the past two years, reaching ₹30,900 crore (US$3.7 billion) by Q2 2026. Europe alone accounted for approximately ₹24,170 crore (US$2.9 billion) of this market in Q2 2026, according to IQVIA.Lerodalcibep DetailsLerodalcibep is a novel antibody-mimetic biologic that inhibits PCSK9, delivering sustained reductions in low-density lipoprotein cholesterol (LDL-C). It is administered as a once-monthly 300 mg/1.2 mL subcutaneous injection.Patient BenefitsKirti Ganorkar, managing director of Sun Pharma, said once-monthly lerodalcibep dosing, with its LDL-C reduction, small-volume injection, and six-month ambient storage, simplifies treatment and offers greater convenience for patients.Sun Pharma Agrees to MFN Drug Pricing In US To Delay Tariffs On Innovative Medicines Strategic ImpactEvan Stein, chief operating and scientific officer and co-founder of LIB Therapeutics, said Sun Pharma’s international presence and experience in building global innovative brands makes it an ideal partner to expand patient access to lerodalcibep globally.US ApprovalIn the United States, lerodalcibep is approved by the US FDA under the brand name Lerochol, available in both autoinjector and prefilled-syringe presentations.Undesirable EffectsThe most frequently reported adverse reactions include injection site reaction (6.7%), injection site erythema (3.6%), and injection site bruising (1.6%). Injection site reactions occurred in 11.6% of patients in pivotal studies.Disclaimer: This story is based on company exchange filings and is for informational purposes only. Investors should evaluate risks before making decisions.