Sun Pharmaceutical Industries Limited announced on Monday an exclusive licensing agreement with LIB Therapeutics Inc. to commercialise and manufacture lerodalcibep, a PCSK9 inhibitor, outside the US and China.

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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 Market

Lerodalcibep, 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.

Market Growth

The 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 Details

Lerodalcibep 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.

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Patient Benefits

Kirti 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.

Strategic Impact

Evan 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 Approval

In the United States, lerodalcibep is approved by the US FDA under the brand name Lerochol, available in both autoinjector and prefilled-syringe presentations.

Undesirable Effects

The 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.

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