Mumbai-based Sun Pharmaceutical Industries and US-based LIB Therapeutics Inc. have announced an exclusive licensing agreement granting Sun Pharma rights to commercialise and manufacture lerodalcibep worldwide, excluding the United States and China.
Lyrokaul (lerodalcibep), a once-monthly PCSK9 inhibitor for LDL-C lowering, comes with 6-month EU ambient storage; received EU approval on September 21, 2026.
It strengthens Sun Pharma’s Innovative Medicines portfolio through access to a $3.7 billion PCSK9 market Ex-US and China, growing at 38% CAGR; global PCSK9 market approaching $7 billion in 2026. LIB will receive an upfront and future milestone payments, together with royalties based on net sales in the licensed territories.
Lerodalcibep is approved in the EU under the brand name Lyrokaul for the treatment of adult patients with hypercholesterolaemia and mixed dyslipidaemia. In the United States, it is US FDA-approved under the brand name Lerochol as an adjunct to diet and exercise: to reduce low-density lipoprotein cholesterol (LDL-C) in adults with hypercholesterolemia, including heterozygous familial hypercholesterolemia (HeFH).
Treatment guidelines now emphasise both additional LDL-C reductions and lower targets for patients at high and very high cardiovascular risk, with additional therapies when statins alone are insufficient. PCSK9 inhibitors provide the efficacy and safety to achieve these goals. This gap between treatment goals and real-world control reinforces the opportunity for Sun Pharma and LIB to broaden access to innovative lipid-lowering care across Europe and Sun’s world-wide licensed markets.