Sun Pharmaceutical Industries Limited and LIB Therapeutics Inc have entered into an exclusive licensing agreement for lerodalcibep, a PCSK9 inhibitor used to lower low-density lipoprotein cholesterol (LDL-C). Under the agreement, Sun Pharma will have exclusive rights to commercialise and manufacture lerodalcibep worldwide, except in the United States and China. LIB Therapeutics will receive an upfront payment and future milestone payments, along with royalties based on net sales in the licensed territories. Other financial terms of the agreement are confidential.
Lerodalcibep has been approved in the European Union under the brand name Lyrokaul for the treatment of adults with hypercholesterolaemia and mixed dyslipidaemia. The European approval was received on September 21, 2026. The medicine is a once-monthly PCSK9 inhibitor administered as a 300 mg/1.2 mL subcutaneous injection. The EU approval also allows the product to be stored at room temperature of up to 25°C for up to six months after removal from refrigeration, when kept in its original carton.
In the United States, lerodalcibep is approved by the US Food and Drug Administration under the brand name Lerochol as an addition to diet and exercise to reduce LDL-C in adults with hypercholesterolaemia, including those with heterozygous familial hypercholesterolaemia (HeFH). The agreement adds a cardiovascular medicine to Sun Pharma’s Global Innovative Medicines portfolio. According to IQVIA, the PCSK9 inhibitor market outside the United States and China reached US$3.7 billion for the period ending Q2 2026 and grew at a 38% CAGR over the previous two years. Europe accounted for US$2.9 billion of the market during the same period.
“Once-monthly lerodalcibep dosing, with robust LDL-C reduction and the added benefits of a small-volume injection and six-month ambient storage, simplifies treatment for patients and offers greater convenience,” said Kirti W Ganorkar, Managing Director of Sun Pharma. “This agreement marks a significant step in strengthening our global Innovative Medicines portfolio, particularly in cardiovascular care. With exclusive rights outside the United States and China, we look forward to expanding access to this important treatment option for patients globally.”
Evan Stein, MD, PhD, Chief Operating and Scientific Officer and co-founder of LIB Therapeutics, said, “LIB is extremely pleased to partner with Sun Pharma, a well-established global pharmaceutical company with a growing focus on innovative medicines.” Lerodalcibep is an antibody-mimetic biologic and recombinant fusion protein that inhibits PCSK9. It is designed to provide sustained reductions in LDL-C with once-monthly dosing.
Sun Pharma will be responsible for seeking regulatory approvals for lerodalcibep in licensed territories where approvals have not yet been obtained. Sun Pharma is a global pharmaceutical company with businesses in Innovative Medicines, Generics and Consumer Healthcare. The company has operations and manufacturing facilities across multiple countries and sells medicines in more than 100 countries.
