Sun Pharma Inks Global Lerodalcibep Deal, Gets Rights Outside US, China

Lerodalcibep, marketed as Lyrokaul in the European Union, is a once-monthly PCSK9 inhibitor for lowering low-density lipoprotein cholesterol (LDL-C). It received European Union approval on September 21, 2026.

The agreement strengthens Sun Pharma's Innovative Medicines portfolio through access to the PCSK9 inhibitor market outside the United States and China, which was valued at US$3.7 billion in the period ending Q2 2026 and grew at a 38% compound annual growth rate over the preceding two years, according to IQVIA. The global PCSK9 market is approaching US$7 billion in 2026.

Under the agreement, LIB Therapeutics will receive an upfront payment and future milestone payments, together with royalties based on net sales in the licensed territories. Other terms of the agreement are confidential.

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, lerodalcibep is approved by the US Food and Drug Administration under the brand name Lerochol as an adjunct to diet and exercise to reduce LDL-C in adults with hypercholesterolaemia, including heterozygous familial hypercholesterolaemia (HeFH).

The partnership is intended to address a significant unmet need in cardiovascular care. According to the companies, many patients at high or very high cardiovascular risk remain above recently updated and more globally harmonized 2026 guideline-recommended LDL-C goals despite treatment.

In the DA VINCI observational study across 18 European countries, 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. The 2019 goals were applied retrospectively to data collected in 2017-2018, and the 33% figure relates to patients assessed on stable therapy.

Treatment guidelines now emphasize both additional LDL-C reductions and lower targets for patients at high and very high cardiovascular risk, with additional therapies recommended when statins alone are insufficient. PCSK9 inhibitors provide an additional treatment option for achieving these LDL-C goals.

The companies said the gap between treatment goals and real-world control highlights an opportunity to broaden access to lipid-lowering treatment across Europe and Sun Pharma's worldwide 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,” Ganorkar added.

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.”

“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,” Stein added.

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 a 38% CAGR over the preceding two years. Europe alone accounted for a US$2.9 billion PCSK9 inhibitor market in MAT Q2 2026.

Sun Pharma will be responsible for pursuing regulatory approvals in licensed territories where approval has not yet been obtained.

Lerodalcibep is a novel antibody-mimetic biologic and recombinant fusion protein that inhibits proprotein convertase subtilisin/kexin type 9 (PCSK9). It is designed to deliver sustained reductions in LDL-C, often referred to as “bad” cholesterol.

The drug is administered as a once-monthly 300 mg/1.2 mL subcutaneous injection.

Lerodalcibep has received marketing authorization from the 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 presentations.

Therapeutic Indications

Lyrokaul is indicated in adults with primary hypercholesterolaemia, including heterozygous familial hypercholesterolaemia (HeFH) and nonfamilial hypercholesterolaemia, or mixed dyslipidaemia, as an adjunct to diet:

in combination with a statin or a statin with other lipid-lowering therapies in patients unable to reach LDL-C goals with the maximum tolerated dose of a statin; or

alone or in combination with other lipid-lowering therapies in patients who are statin intolerant or for whom a statin is contraindicated.

Contraindications

Lyrokaul is contraindicated in patients with hypersensitivity to the active substance or any of the excipients listed in the package leaflet.

Special Warnings and Precautions

Traceability: To improve the traceability of biological medicinal products, the name and batch number of the administered product should be clearly recorded.

Sodium: Lyrokaul contains less than 1 mmol sodium (23 mg) per dose and is therefore essentially “sodium-free.”

Polysorbate 80: The medicinal product contains 0.24 mg polysorbate 80 (E 433) per dose. Polysorbates may cause allergic reactions.

Renal impairment: Lyrokaul should be used with caution in patients with severe renal impairment or end-stage renal disease. The medicine has not been studied in these populations.

Severe hepatic impairment or active liver disease: Lyrokaul has not been studied in patients with severe hepatic impairment or active liver disease. It should only be used in these patients if the anticipated clinical benefit outweighs the risk.

Drug Interactions

No interaction studies have been performed.

Fertility, Pregnancy and Lactation

Pregnancy: There are no data from the use of lerodalcibep in pregnant women. Animal studies do not indicate direct or indirect harmful effects with respect to reproductive toxicity. As a precautionary measure, it is preferable to avoid the use of Lyrokaul during pregnancy.

Breast-feeding: It is unknown whether lerodalcibep is excreted in human milk. Available pharmacodynamic and toxicological data in animals have shown excretion of lerodalcibep in milk. A risk to newborns and infants cannot be excluded.

A decision must be made whether to discontinue breast-feeding or to discontinue or abstain from Lyrokaul therapy, taking into account the benefit of breast-feeding for the child and the benefit of therapy for the woman.

Fertility: No data are available on the effect of lerodalcibep on human fertility. Animal fertility studies were not performed; however, no effects were seen on surrogate markers of fertility in animal studies.

Effects on Driving and Use of Machines

Lyrokaul has no or negligible influence on the ability to drive and use machines.

Adverse Reactions

The most frequently reported adverse reactions in patients treated with lerodalcibep are 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 treated with lerodalcibep in pivotal studies. The most frequently occurring reactions were injection-site reaction (6.7%), injection-site erythema (3.6%), injection-site pruritis (1.0%) and injection-site bruising (1.6%).

The proportion of patients who discontinued treatment due to injection-site reactions was 1.0%. Adverse reactions were generally mild or moderate in severity. Severe injection-site reactions occurred in 0.2% of cases, were transient and resolved without leading to discontinuation of the study drug.

Immunogenicity

Anti-drug antibody (ADA) responses, including neutralising antibodies (NAb), were low-titer and did not appear to have a clinically meaningful impact on the efficacy or safety of lerodalcibep, except for a higher rate of injection-site reactions in patients with treatment-emergent ADA compared with patients who were ADA-negative.

The excluded China territory comprises mainland China, Hong Kong, Macau and Taiwan.

Worldwide rights under the agreement exclude the United States and China. Certain other excluded territories, limited in number, will be covered through separate agreements between Sun Pharma and LIB.

LIB Therapeutics Inc. is a privately held, commercial-stage biopharmaceutical company focused on developing novel therapies for patients with cardiovascular disease and familial hypercholesterolaemia to help them achieve their LDL-C goals.

LIB was advised and assisted by Greenhill & Co investment bank UK.