Sun Pharma and LIB Therapeutics from the US have signed an exclusive licensing agreement for a cholesterol lowering drug called Lerodalcibep. The deal was announced on 28th September 2026. Along with this, Sun Pharma also shared that the drug has received approval in Europe on 21st September 2026 under the name Lyrokaul. In the US, the same drug is already approved under the name Lerochol.
Under this agreement, Sun Pharma gets the rights to commercialise and manufacture Lerodalcibep in all countries except the US and China. China here includes mainland China, Hong Kong, Macau and Taiwan. Some smaller territories will have separate agreements.
At A Glance - Key Highlights
- Who Is The Deal Between: Sun Pharma and LIB Therapeutics from US
- What Is The Drug: Lerodalcibep, called Lyrokaul in Europe and Lerochol in US
- What Does It Do: It lowers bad cholesterol called LDL-C, it is a PCSK9 inhibitor
- How To Take: One injection of 300 mg in 1.2 mL under the skin, once in a month
- Special Benefit: Can be kept at room temperature up to 25 degree for 6 months, no need to keep in fridge always, easy to carry while traveling
- Where Sun Pharma Can Sell: All over the world except US and China, China includes mainland China, Hong Kong, Macau and Taiwan
- Market Size: As per IQVIA data, market outside US and China is 3.7 billion dollars, growing 38% every year, Europe alone is 2.9 billion dollars, total global market is almost 7 billion dollars
What Is This Deal?
Sun Pharma will now make and sell this drug in many countries except US and China. Sun Pharma will also take regulatory approvals in countries where it is not yet approved.
For this, LIB Therapeutics will get an upfront payment and future milestone payments when certain goals are reached, plus royalty on net sales in the licensed territories. Other terms of the deal are private.
What Is This Drug And Why Is It Needed?
Many people who have heart disease or high risk of heart disease still have high bad cholesterol even after taking normal cholesterol medicines like statins. A big study called DA VINCI in 18 European countries found that only 33% of people reached their cholesterol goals with normal pills.
New health guidelines from 2026 say that such high-risk patients need lower cholesterol goals and need extra medicines when statins are not enough. PCSK9 inhibitors like Lerodalcibep can help reach those goals.
This drug is a new type of biologic. It is made of a small protein piece called adnectin of 11-kDa size that sticks strongly to PCSK9 protein and is joined with human albumin to stay longer in blood. It helps to reduce bad cholesterol for a long time.
It was tested in a big global program called LIBerate with more than 2700 to 2900 patients who have heart disease or high risk, including patients with family high cholesterol called FH. Patients took the drug once a month for up to 52 weeks and more than 2400 patients continued for 72 weeks extra in open label extension.
Who Can Take This Medicine?
As per Europe approval, Lyrokaul is for adults with primary high cholesterol (family type HeFH and non-family) or mixed high fat in blood, along with diet:
- With Statin: For people who cannot reach cholesterol goal even with highest dose of statin, it can be taken with statin or statin plus other fat lowering medicines
- Without Statin: For people who cannot take statin or statin does not suit them, it can be taken alone or with other medicines
It should not be taken if someone is allergic to this drug or its ingredients.
Important Safety Points From Filing
Traceability: Doctors should write the name and batch number of the medicine given, because it is a biologic product.
Ingredients: It has very less sodium, less than 1 mmol or 23 mg per dose, so it is almost sodium free. It has 0.24 mg polysorbate 80 per dose which may cause allergy in some people.
Kidney And Liver: It has not been tested in patients with very bad kidney problems or last stage kidney disease, so use with care. It has also not been tested in patients with very bad liver problem or active liver disease, only use if benefit is more than risk.
Other Medicines: No studies have been done to check interaction with other medicines.
Pregnancy And Breast Feeding: No data in pregnant women, animal studies show no direct harm but as safety, it is better to avoid in pregnancy. It is not known if it goes into human milk, animal data shows it goes into milk, so risk to baby cannot be avoided. Doctor has to decide whether to stop breast feeding or stop medicine based on benefit to child and mother. No data on human fertility, animal studies showed no effect on fertility markers, but fertility studies were not done.
Driving: It has no or very small effect on driving or using machines.
Side Effects: Most common side effects are where injection is given. Injection site reaction in 6.7% patients, redness in 3.6%, bruising in 1.6%, itching in 1.0%. Total injection site reactions happened in 11.6% patients in main studies. 1.0% patients stopped treatment due to injection site reaction. Most reactions were mild or medium, only 0.2% were severe, they went away and did not need to stop drug. Body may make antibodies against drug called ADA including neutralising antibodies Nab, but they were low and did not affect much how drug works or safety, except patients with ADA had more injection site reactions.
What Did Company Leaders Say?
Kirti W Ganorkar, Managing Director of Sun Pharma, said that once monthly dose, strong bad cholesterol reduction, small injection volume and six month room temperature storage makes treatment easy and more convenient for patients. He said this deal is an important step to make Sun Pharma's innovative medicines portfolio stronger, especially in heart care.
Evan Stein, Chief Operating and Scientific Officer and co-founder of LIB Therapeutics, said that LIB is very happy to partner with Sun Pharma, which is a well known global pharma company focusing on new medicines. He said Sun Pharma's global presence and experience makes it a good partner to take this drug to more patients who need extra cholesterol reduction.
Agreement Details In Table
| Point | Details About Agreement |
|---|---|
| Licensor | LIB Therapeutics Inc., US |
| Licensee | Sun Pharmaceutical Industries Limited |
| Territory | Worldwide except US and China, China includes mainland China, Hong Kong, Macau, Taiwan, some small territories will have separate agreements |
| Rights Given | To commercialise and manufacture Lerodalcibep |
| EU Brand | Lyrokaul, approved on 21st September 2026 |
| US Brand | Lerochol, already FDA approved in auto-injector and pre-filled syringe |
| Financial Terms | Upfront payment plus future milestone payments plus royalty on net sales in licensed territories, other terms are private |
| Sun Pharma Responsibility | To take regulatory approvals in licensed countries where not yet approved |
| Market Reference | USD 3.7 billion outside US and China as per IQVIA MAT Q2 2026, 38% CAGR, Europe 2.9 billion, global near 7 billion |
| Advisor | LIB was advised by Greenhill & Co investment bank UK |