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.
Strengthens Sun Pharma’s Innovative Medicines portfolio through access to a US$3.7 billion PCSK9 market Ex-US and China, growing at 38% CAGR; global PCSK9 market approaching US$7 billion in 2026.1
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).
The partnership helps address a significant global unmet need in cardiovascular care. Many patients at high or very high cardiovascular risk remain above recently updated and more globally harmonized 2026 guideline-recommended LDL-cholesterol (LDL-C) goals despite treatment. In the DA VINCI observational study across 18 European countries, only 33% of patients assessed on stable oral lipid-lowering therapy achieved their risk-based 2019 European Society of Cardiology/European Atherosclerosis Society (ESC/EAS) LDL-C goals.
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.4 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.
“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.”
“LIB is extremely pleased to partner with Sun Pharma, a well-established global pharmaceutical company with a growing focus on innovative medicines,” said Evan Stein, MD, PhD, Chief Operating and Scientific Officer and co-founder of LIB Therapeutics. “Sun Pharma’s international presence and experience in building global innovative brands make it an ideal partner to bring lerodalcibep to more patients. Together, we aim to expand access for patients with cardiovascular disease, or at high cardiovascular risk, who need substantial additional LDL-cholesterol reductions despite existing treatment.”
The agreement establishes a significant new growth platform for Sun Pharma in a large and rapidly expanding market. According to IQVIA, the PCSK9 inhibitor market outside the United States and China reached US$ 3.7 billion in the period ending Q2 2026 (MAT Q2 2026), growing at 38% CAGR over the preceding two years. Europe alone accounted for US$ 2.9 billion PCSK9 inhibitor market in MAT Q2 2026.
Agreement terms
LIB will receive an upfront and future milestone payments, together with royalties based on net sales in the licensed territories. Other terms of the agreement are confidential. Sun Pharma will be responsible for pursuing regulatory approvals in licensed territories where approval has not yet been obtained.
About lerodalcibep
Lerodalcibep is a novel antibody-mimetic biologic and recombinant fusion protein that inhibits proprotein convertase subtilisin/kexin type 9 (PCSK9). It helps deliver sustained reductions in low-density lipoprotein cholesterol (LDL-C), often called “bad” cholesterol, with once monthly 300 mg/1.2 mL subcutaneous injection.
Recently, lerodalcibep has received marketing authorisation from European Medicines Agency under the brand name Lyrokaul. The EU label permits storage in the original carton at room temperature up to 25°C for up to six months after removal from refrigeration, offering flexibility for patients at home and while travelling.
In the United States, lerodalcibep is approved by the US FDA under the brand name Lerochol in both autoinjector and prefilled-syringe (PFS) presentations.
