Lerodalcibep is approved in the EU under the brand name Lyrokaul for the treatment of adult patients with hypercholestrolaemia and mixed dyslipidaemia, Sun Pharma said.
In the US, it is USFDA-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), it added.
Sun Pharma, in an exchange filing, stated that it had, with its subsidiaries, entered the agreement with LIB Therapeutics Inc for:
- An exclusive licensing agreement granting Sun Pharma rights to comemrcialisation and manufacture lerodalcibep worldwide, excluding the US and China.
- Lryokaul (lerodalcibep), a once-monthly PCSK9 inhibitor for LDL-C lowering, comes with six-month EU ambient storage. It received EU approval on September 21, 2026.
- Strengthens Sun Pharma’s Innovative Medicines portfolio through access to a $3.7 billion PCSK9 market, excluding US and China, growth at 38% compound annual growth rate (CAGR). The global PCSK9 market is 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.
Sun Pharma said 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.
The partnership helps address a significant global unmet need in cardiovascular care., the filing stated. Many patients at high or very high cardiovascular risk remain the recently-updated and more globally harmonized 2026 guidelines recommended LDL-cholesterol goals despite treatment.
Sun Pharma said treatmenet guidelines now emphasise both additional LDL-C reductions and lower targets for patients at high and very high cardiovascular risk, with additional therapies when statis alone are insufficient. PCSK9 inhibitors provide the efficacy and safety to achieve these goals, it said.
“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,” Sun Pharma managing director Kirti W Ganorkar, said.
Ganorkar added that this agreement marks a significant step in strengthening its global innovative medicines portfolio, particularly in cardiovascular care. The company looks to expand access to the treatment option for patients globally.”Sun Pharma’s international presence and experience in building global innovative brands make it an ideal partner to bring leadership to more patients,” Evan Stein, the MD, PhD, chief operating and scientific officer and co-founder of LIB Therapeutics, said.
Sun Pharma stated that as per IQVIA, the PCSK9 inhibitor market outside the US and China reached $3.7 billion in the period ending the second quarter of 2026, growing at 38% CAGR, over the preceding two years. It said Europe alone accounted for $2.9 billion PCSK9 inhibitor market in moving annual total (MAT) Q2 2026.
Shares of Sun Pharma ended the previous session 0.3% up at ₹1,855.9 apiece. The stock has declined 3.3% in the past month but is up 7.8% this year, so far.
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