By: IPP Bureau
Last updated : September 28, 2026 7:35 pm
Under the agreement, LIB Therapeutics will receive upfront and milestone payments, plus net sales royalties
Sun Pharmaceutical Industries Limited has entered into an exclusive licensing pact with US-based LIB Therapeutics Inc. The agreement grants Sun Pharma the sole rights to manufacture and commercialise lerodalcibep on a global scale, explicitly excluding the US and Chinese markets.
The drug—a once-monthly PCSK9 inhibitor designed for LDL-C lowering—secured EU approval on September 21, 2026, and features a highly convenient 6-month ambient storage capability in Europe. Under the agreement, LIB Therapeutics will receive upfront and milestone payments, plus net sales royalties. Meanwhile, Sun Pharma significantly expands its Innovative Medicines portfolio, gaining entry to an international PCSK9 market valued at US$3.7 billion (ex-US/China) that is expanding at a 38% CAGR.
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).
This partnership addresses a major global gap in heart health. Despite ongoing treatment, many high-risk patients fail to reach the stricter, newly harmonized 2026 international guidelines for LDL cholesterol lowering. This challenge is highlighted by the multi-country DA VINCI study, which revealed that only 33% of European patients on stable oral therapies successfully reached their target LDL 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.
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.