Sun Pharma, LIB Therapeutics Sign Global Licensing Deal for Lerodalcibep
Bilkul Bazaar
Mumbai/Cincinnati
Sun Pharmaceutical Industries Ltd and US-based LIB Therapeutics Inc. have entered into an exclusive global licensing, commercialisation and manufacturing agreement for lerodalcibep, a once-monthly PCSK9 inhibitor used to lower LDL cholesterol.
Under the agreement, Sun Pharma will have exclusive rights to commercialise and manufacture lerodalcibep across the world, excluding the United States and China. LIB Therapeutics will receive an upfront payment, future milestone payments and royalties linked to net sales in the licensed territories.
The drug is approved in the European Union under the brand name Lyrokaul for adults with hypercholesterolaemia and mixed dyslipidaemia. The European approval was granted on September 21, 2026. In the US, lerodalcibep is approved as Lerochol.
Lerodalcibep is administered as a once-monthly 300 mg/1.2 mL subcutaneous injection and is designed to provide sustained reductions in LDL cholesterol, commonly referred to as “bad” cholesterol. The EU label also permits storage at room temperature of up to 25°C for as long as six months after removal from refrigeration.
Sun Pharma said the agreement will strengthen its Innovative Medicines portfolio and expand its presence in cardiovascular care. According to IQVIA data cited in the announcement, the PCSK9 inhibitor market outside the US and China was valued at US$3.7 billion in the 12 months ended June 2026, recording a 38% compound annual growth rate over the preceding two years. Europe accounted for US$2.9 billion of that market.
The companies said the partnership aims to improve access to LDL-lowering treatment for patients who remain above recommended cholesterol targets despite existing therapies. Sun Pharma will also be responsible for seeking regulatory approvals in licensed markets where lerodalcibep has not yet been approved.
Under the EU indication, Lyrokaul can be used alongside statins or other lipid-lowering therapies in patients who do not reach LDL-C goals with the maximum tolerated statin dose. It can also be used alone or with other lipid-lowering medicines in patients who cannot tolerate statins or for whom statins are contraindicated.
Sun Pharma Managing Director Kirti W. Ganorkar said the once-monthly dosing, LDL-C reduction, small-volume injection and six-month ambient storage could offer greater convenience to patients. LIB Therapeutics said Sun Pharma’s international presence and experience with innovative medicines would help expand access to lerodalcib