Italian global pharmaceutical company founded in 1926 as a family-run pharmacy laboratory in Correggio; headquarters moved to Milan in 1953 and it is now a diversified international pharmaceutical group listed on Borsa Italiana.
Clinical Trials
20
8 active
Approvals
9
Total approvals
Agencies
1
Regulatory bodies
Founded
1926
Active, not recruiting
7
35.0%
Completed
10
50.0%
Not yet recruiting
1
5.0%
Recruiting
1
5.0%
Terminated
1
5.0%
- CVC Capital Partners has offered €52 per share to acquire the remaining 48.2% of Recordati shares, valuing the deal at €10.9 billion. - The acquisition would give CVC full control of the Italian pharmaceutical company, which already holds a 51.8% controlling stake acquired in 2018. - Recordati's strong financial performance in 2025 included 11.8% revenue growth to €2.6 billion, driven primarily by a 29.7% increase in rare disease drug sales. - The proposed takeover comes amid increased pharmaceutical M&A activity, with companies seeking to strengthen pipelines ahead of patent expiries.
- The FDA approved osilodrostat (Isturisa) as a second-line treatment for adults with endogenous Cushing syndrome in April 2025, expanding treatment options for patients unable to undergo surgery. - Relacorilant demonstrated significant cardiometabolic benefits in Phase III trials, showing notable blood pressure reductions of -10.1 mm Hg systolic and -6.3 mm Hg diastolic compared to placebo increases. - Multiple companies including Corcept Therapeutics, Crinetics Pharmaceuticals, and AstraZeneca are developing novel therapies with over 4 investigational treatments in various clinical phases. - The Cushing syndrome pipeline includes diverse therapeutic approaches targeting cortisol synthesis inhibition and glucocorticoid receptor modulation across oral and parenteral administration routes.
- Recordati has acquired exclusive licensing and supply rights to commercialize Vazkepa (icosapent ethyl) across 59 European countries in a deal worth up to $175 million with Amarin. - Vazkepa is the only treatment proven to reduce cardiovascular risk in statin-treated patients with elevated triglycerides, backed by the REDUCE-IT study involving over 8,000 patients. - The drug generated €12 million in net sales across 11 European countries in 2024 and is projected to exceed €40 million in revenues by 2027. - The agreement includes a $25 million upfront payment and potential milestone payments up to $150 million based on sales performance thresholds starting at €100 million annually.
- Novo Nordisk's 25 mg oral semaglutide for chronic weight management received FDA acceptance in May 2025, potentially becoming the first oral GLP-1 therapy approved for obesity treatment. - The FDA cleared Dexcom's G7 15-day CGM system in April 2025, making it the longest-lasting and most accurate CGM approved in the U.S. with 8.0% MARD. - Recordati received FDA approval for expanded osilodrostat indication to treat all adults with endogenous Cushing's syndrome who are not surgical candidates. - Eton Pharmaceuticals gained FDA approval for the first liquid hydrocortisone formulation for pediatric patients aged 5 and older with adrenocortical insufficiency.
- The FDA has approved an expanded indication for osilodrostat (Isturisa) to treat endogenous hypercortisolemia in adults with Cushing's syndrome for whom surgery is not an option or has not been curative. - This regulatory expansion broadens treatment beyond the previous indication limited to Cushing's disease (a subtype of Cushing's syndrome), addressing significant unmet needs for patients with other forms of the syndrome. - Clinical evidence supporting the approval includes data from the LINC studies involving over 350 patients, demonstrating osilodrostat's ability to rapidly normalize cortisol levels and maintain this effect with a manageable safety profile.
• Clinical trial sponsors and CROs must establish optimal oversight balance, with experts warning that both excessive and insufficient monitoring can impede trial success and efficiency. • Industry leaders at Veeva's Clinical Operations Outsourcing 2024 Forum stress the importance of early collaboration agreements and transparent communication between sponsors and CROs. • As clinical trials become increasingly complex, particularly in specialized therapies, the need for efficient sponsor oversight becomes more crucial for ensuring trial quality and regulatory compliance.
- Recordati has secured worldwide rights to Enjaymo, the first and only approved treatment for cold agglutinin disease (CAD), from Sanofi for an upfront payment of $825 million with potential milestone payments of $250 million. - Enjaymo, a humanized monoclonal antibody targeting C1s in the classical complement pathway, has generated approximately €100M in revenue over the past year and is projected to reach peak sales of €250-300M. - The acquisition strengthens Recordati's rare disease portfolio and addresses an unmet medical need, with Enjaymo already approved by regulatory authorities in the US, Europe, and Japan.
- South Korea is implementing reforms to reduce drug reimbursement times from approximately 4 years to align more closely with other advanced nations like the US, Japan, and Germany. - A new pilot program called "Approval-evaluation-negotiation linkage system" allows simultaneous review by health authorities, with Recordati's Qarziba and Ipsen's Bylvay being the first drugs included. - The reforms include risk-sharing agreements, waivers for cost-effectiveness analysis for pediatric, rare disease, and cancer treatments, and reduced price negotiation periods from 60 to 30 days.
• Italy's pharmaceutical market is projected to decline from $25.1 billion in 2012 to $23.5 billion by 2020, driven by government austerity measures and strict drug pricing policies. • The Italian Medicines Agency (AIFA) has implemented stringent pricing controls, refusing reimbursement for manufacturers who don't accept their suggested prices, while promoting generic drug adoption. • Despite having an underdeveloped generics market with only 20% volume share compared to 50% in other EU countries, Italy's recent reforms are expected to significantly boost generic drug usage.
