Tadalafil

Latest step in Grünenthal's strategy to acquire established medicines that serve clear medical needs, leverage its commercial and operational capabilities, and drive growth. Stivarga® (regorafenib) is an established oral treatment for certain advanced cancers, including metastatic colorectal cancer, gastrointestinal stromal tumours (GIST) and hepatocellular carcinoma (liver cancer). It is approved and available in more than 90 markets worldwide. Grünenthal has invested around €2.6 billion in successful M&A transactions since 2017, significantly strengthening its profitability and further funding its innovative research pipeline. AACHEN, Germany, Sept. 21, 2026 /PRNewswire/ -- Grünenthal, a global leader in pain management and research, today announced an agreement with Bayer AG to acquire Stivarga®, an oral treatment for specific advanced cancers, for up to €375 million. The acquisition is subject to customary closing conditions, including approval by the relevant regulatory authorities. The acquisition is expected to close by the end of 2026 or early 2027. Stivarga® (regorafenib) is an oral multkinase inhibitor indicated for metastatic colorectal cancer, hepatocellular carcinoma and gastrointestinal stromal tumours (GIST) in patients who have already been treated with, or who cannot be given, other available treatments. It is approved and available in more than 90 markets worldwide. "This acquisition is a strong strategic fit for Grünenthal and reflects our disciplined M&A strategy of acquiring established medicines that address clear and ongoing medical needs and create long-term value," said Gabriel Baertschi, CEO, Grünenthal. "Stivarga® has a well-established role in patient care and the transaction is immediately accretive to our business. By leveraging the strength of our commercial and operational expertise, we see clear opportunities to maximise the value of the medicine and support Grünenthal's long-term growth." Loss of exclusivity for Stivarga® is anticipated in 2029 in the European Union and in 2030 in the United States (US). Grünenthal estimates that Stivarga® may contribute a positive impact on its consolidated EBITDA of up to approximately €100 million for the year ending 31 December 2027, based on an analysis of the information made available to Grünenthal from Bayer and assuming closing by the end of 2026 or the beginning of 2027, as well as a full-year consolidation. The acquisition is the latest development in Grünenthal's M&A strategy and follows the successful integration of several important medicines across a range of health conditions, including the global rights to Nebido™, the rights to Cialis® in Mexico, Brazil and Colombia, the European rights to Crestor™ and Nexium™, and the global rights to Vimovo™ (ex-US and Japan), Zomig™ (ex-Japan) and Qutenza™. In addition to asset acquisitions, earlier this year, Grünenthal acquired full ownership of Grünenthal Meds, a previously joint venture with Kyowa Kirin International to market its established medicines portfolio, and, in 2024, acquired the US company Valinor Pharma and the product Movantik®. The company has invested around €2.6 billion in successful M&A transactions since 2017. About Stivarga ® Stivarga® is a once-daily, oral prescription medicine for certain advanced cancers. It has treated more than one million patients across more than 90 countries over 10 years. In the EU, Stivarga® is indicated as monotherapy for the treatment of adult patients with metastatic colorectal cancer (mCRC) who have been previously treated with, or are not considered candidates for, available therapies including fluoropyrimidine-based chemotherapy, an anti-VEGF therapy and an anti-EGFR therapy, as well as for the treatment of adult patients with unresectable or metastatic gastrointestinal stromal tumor (GIST) who progressed on or are intolerant to prior treatment with imatinib and sunitinib, and for the treatment of adult patients with hepatocellular carcinoma (HCC) who have been previously treated with sorafenib. In the US, Stivarga® is indicated for the treatment of patients with mCRC who have been previously treated with fluoropyrimidine-, oxaliplatin- and irinotecan-based chemotherapy, an anti-VEGF therapy, and, if RAS wild-type, an anti-EGFR therapy, as well as locally advanced, unresectable or metastatic GIST who have been previously treated with imatinib mesylate and sunitinib malate, and for HCC who have been previously treated with sorafenib. About Grünenthal Grünenthal is a global leader in pain management and related diseases. As a science-based, fully integrated pharmaceutical company, we have a long track record of bringing innovative treatments and state-of-the-art technologies to patients worldwide. Our purpose is to change lives for the better – and innovation is our passion. We focus all our activities and efforts on working towards our vision of a World Free of Pain. Grünenthal is headquartered in Aachen, Germany, and has affiliates in 28 countries across Europe, Latin America, and the U.S. Our products are available in approx. 100 countries. In 2025, Grünenthal employed around 4,100 people and achieved revenues of €1.8 billion. More information: Follow us on LinkedIn & Instagram Advisors Freshfields served as legal counsel to Grünenthal. For further information, please contact: Matt Crabb, Head of Global Communications (Interim), Grünenthal [email protected] SOURCE Grünenthal Group 21% more press release views with Request a Demo

A large study of nearly 74,000 men suggests that long-term use of tadalafil, best known as Cialis, may be linked to a higher risk of glaucoma and other eye pressure problems. Men prescribed the drug for urinary symptoms caused by an enlarged prostate were 22% more likely to develop glaucoma, 32% more likely to develop ocular hypertension, and 33% more likely to be diagnosed with primary open-angle glaucoma or start glaucoma treatment over five years.A widely used erectile dysfunction medication may be associated with a greater risk of glaucoma when taken long-term to relieve urinary symptoms caused by an enlarged prostate, according to a large comparative study published online in the British Journal of Ophthalmology. The findings suggest that men who use tadalafil (Cialis) over extended periods for these symptoms may benefit from closer monitoring of their eye health. Researchers say this may be especially important for people who already have glaucoma risk factors, including a family history of the disease or elevated pressure within the eye (ocular hypertension). Tadalafil and Eye Health Tadalafil belongs to a group of medications known as phosphodiesterase type 5 inhibitors (PDE5i), the same drug class that includes sildenafil (Viagra). These medications are widely used for erectile dysfunction, while tadalafil is also prescribed for urinary problems associated with an enlarged prostate. Previous research has connected PDE5i medications with several types of eye problems, including disorders involving the optic nerve and the macula, which is the area of the retina responsible for detailed central vision. However, researchers say the evidence surrounding glaucoma has remained inconsistent. In particular, relatively little is known about glaucoma risk when tadalafil is used for lower urinary tract symptoms, a treatment that commonly involves taking the medication every day over a long period. To investigate this question more closely, the researchers examined whether tadalafil, a long-acting PDE5i, was associated with an increased risk of glaucoma when prescribed for urinary tract symptoms related to an enlarged prostate (benign prostatic hyperplasia). Nearly 74,000 Men Included in the Study The team analyzed anonymized health information from 73,854 men aged 40 or older in the TriNetX Analytics Network (Global Collaborative Network). Half had been prescribed tadalafil or another PDE5i for up to 5 years (between January 2012 and December 2022) to manage their symptoms, while the other half had not received these medications. Researchers then compared the two groups to determine how often participants developed glaucoma or ocular hypertension and how frequently they began treatment for glaucoma after 5 years. To make the comparison more meaningful, men in the two groups were matched according to a range of factors that could potentially influence the results. These included age, ethnicity, smoking, alcohol related disorders, prescribed medications, and underlying health conditions such as cardiovascular disease, diabetes, cancer, high cholesterol, kidney function, obesity, and chronic obstructive pulmonary disease (COPD). Glaucoma Risk Was 22% Higher The analysis found that men prescribed tadalafil were significantly (22%) more likely to develop glaucoma than men who had not received the medication. They were also more likely to develop several related conditions. Ocular hypertension was 32% more common, while primary open-angle glaucoma, the most common form of glaucoma, was 33% more likely. Men prescribed tadalafil were also 33% more likely to begin glaucoma treatment. Additional analyses showed that the associations remained among men who developed glaucoma within 1, 3, or 6 months after beginning tadalafil treatment. The same pattern was consistently seen among patients aged 50+, White participants, and people with several of the underlying medical conditions considered in the analysis. Study Cannot Prove Cialis Causes Glaucoma The researchers caution that the findings do not establish that tadalafil directly causes glaucoma. Because this was an observational study, it can identify associations but cannot determine cause and effect. There were also several limitations. For example, the researchers could not account for changes in medication prescriptions or actual medication use over time, nor could they fully track the development of additional underlying health conditions during the study period. Most participants were White, which means the findings may not necessarily apply to men from other ethnic backgrounds. Even so, the researchers say the results warrant further investigation into how long-term PDE5i use might affect the eyes. They write: "These findings suggest that chronic PDE5 inhibition may influence ocular physiology, warranting further mechanistic investigation." Researchers Recommend Eye Monitoring for Higher Risk Patients Importantly, the researchers are not advising patients to stop using tadalafil. Instead, they suggest that people taking the medication for extended periods may need appropriate eye screening and follow-up, particularly when other glaucoma risk factors are already present. They emphasize: "These findings do not contraindicate tadalafil use but highlight the importance of baseline ophthalmic assessment and regular follow-up, particularly in patients with pre-existing glaucoma, ocular hypertension, a family history of glaucoma, high myopia [short-sightedness], or those requiring long-term therapy."