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Last update 23 Oct 2026

Rosuvastatin Calcium

Last update 23 Oct 2026

Overview

R&D Status

Clinical Result

Translational Medicine

Overview

Basic Info

SummaryRosuvastatin, a drug sold under the trade names of Ezallor and Crestor, is a small molecule that functions as an inhibitor of HMG-CoA reductase, an enzyme responsible for cholesterol synthesis in the liver. By inhibiting the production of cholesterol, rosuvastatin helps to reduce the level of cholesterol and triglycerides in the bloodstream. This drug is primarily used to treat hypercholesterolemia, hyperlipidemias, and heart failure. Although it is available in several countries, including the US, China, Japan, and the Netherlands, it has been granted Priority Review and Orphan Drug status by the FDA. Ongoing research is evaluating the effectiveness of rosuvastatin in treating other conditions, and its active indication is expanding. Nevertheless, rosuvastatin may cause side effects, and patients should be closely monitored during treatment to avoid adverse effects.

Drug Type

Small molecule drug

Synonyms

ORFT, Rosuvastatin, Rosuvastatin calcium (JAN/USAN)

+ [21]

Target

HMGCR

Action

inhibitors

Mechanism

HMG-CoA reductase inhibitors(HMG-CoA reductase inhibitors)

Therapeutic Areas

Nervous System DiseasesCardiovascular DiseasesCongenital Disorders+ [4]

Active Indication

Heterozygous familial hypercholesterolemiaAtherosclerosisDyslipidemias+ [18]

Inactive Indication

AmnesiaAortic DiseasesAortic Valve Stenosis+ [24]

Originator Organization

Active Organization

+ [8]

Inactive Organization

AstraZeneca SAS

Hanmi Pharmaceutical Co., Ltd.

Sun Pharmaceutical Industries Ltd.

License Organization

Kexing Biopharm Co., Ltd.

AstraZeneca PLC

Abbott Laboratories

+ [2]

Drug Highest PhaseApproved

First Approval Date

South Korea (15 Jan 2002),

Homozygous familial hypercholesterolemiaHypercholesterolemiaHyperlipoproteinemia Type III+ [4]

RegulationOrphan Drug (United States), Priority Review (China)

Structure/Sequence

Molecular FormulaC44H56CaF2N6O12S2

InChIKeyGGPPBULYISSAKA-BGRFNVSISA-N

CAS Registry147098-20-2

980

Clinical Trials associated with Rosuvastatin Calcium

NCT07862621

/ Not yet recruitingPhase 1

A 2-period Study to Evaluate the Effects of Multiple Oral Doses of MK-6916 on the Single-dose Pharmacokinetics of Midazolam and Rosuvastatin

Researchers are looking for new treatments for pain. The goal of this trial is to learn if MK-6916 changes what happens to the midazolam and rosuvastatin in healthy participants' bodies. Researchers will compare the amount of midazolam and rosuvastatin in a participant's body over time when they are given with and without MK-6916.

Start Date30 Nov 2026

Sponsor / Collaborator

Merck Sharp & Dohme LLC

NCT07744386

/ Not yet recruitingPhase 1

An Open-label, Fixed-sequence, Non-randomized, Drug-drug Interaction Study to Evaluate the Effect of CHF10196 on the Pharmacokinetics of Dabigatran (P-gp Substrate) and Rosuvastatin (BCRP Substrate) in Healthy Male Participants.

The purpose of this study is to assess the potential drug-drug interaction of CHF10196 (a dipeptidyl peptidase 1 inhibitor) and its metabolite on the pharmacokinetics of dabigatran (a P-glycoprotein substrate) and Rosuvastatin (a breast cancer resistant protein substrate) in healthy male participants.

Start Date27 Oct 2026

Sponsor / Collaborator

CHIESI Farmaceutici SpA

NCT07881224

/ RecruitingPhase 1

A Phase 1, Non-randomized, Fixed-sequence, Multiple-dose Study Investigating the Drug-drug Interaction Potential and QTc Effects of Fosmanogepix in Healthy Adult Subjects

This is a Phase 1, fixed-sequence, multiple-dose study in approximately 42 healthy adult participants. The study will be conducted in two parts. Part 1 will evaluate the effect of fosmanogepix, through exposure to its active moiety manogepix, on selected CYP enzymes and on the concentration-QT interval corrected for heart rate (QTc). Part 2 will evaluate the effect of manogepix on CYP2C8 and on selected drug transporters. The maximum study duration will be approximately 13.5 weeks for participants in Part 1 and approximately 12 weeks for participants in Part 2.

Start Date01 Oct 2026

Sponsor / Collaborator

Basilea Pharmaceutica AG

[+1]

100 Clinical Results associated with Rosuvastatin Calcium

100 Translational Medicine associated with Rosuvastatin Calcium

100 Patents (Medical) associated with Rosuvastatin Calcium

4,743

Literatures (Medical) associated with Rosuvastatin Calcium

15 Dec 2026·SCANDINAVIAN JOURNAL OF PRIMARY HEALTH CARE

Changes in LDL-C levels among primary health care patients with hypertension, coronary artery disease, and diabetes during a 36-month follow-up

Article

Author: Valkonen, Petra ; Tusa, Nina ; Kautiainen, Hannu ; Mäntyselkä, Pekka ; Mikkonen, Ulla

BACKGROUND AND AIMS:

Low-density lipoprotein cholesterol (LDL-C) level is one important modifiable risk factor for cardiovascular diseases. This study aimed to describe the characteristics of primary health care patients with hypertension, coronary artery disease, or diabetes according to their LDL-C levels and to observe changes in these levels and medications during the 36-month follow-up.

METHODS:

This study was based on a clinical trial, conducted in a health centre in Siilinjärvi, Finland, between 2017 and 2021. A total of 507 patients with hypertension, coronary artery disease, or diabetes were divided into four groups based on their baseline LDL-C levels to align with the dyslipidaemia guideline risk categories as follows: LDL-C (mmol/L) in Group 0 (< 1.4), Group 1 (1.4-1.8), Group 2 (>1.8-2.6), and Group 3 (> 2.6).

RESULTS:

The mean age at baseline was 69 years (58% females). All patients in Groups 0 and 1 already used lipid-lowering medication. A lower LDL-C level at baseline was statistically significantly associated with higher age, lower blood pressureand lower alcohol consumption. There were changes in the pharmacologically active substances prescribed in all groups. During the 36-month follow-up, the mean LDL-C values decreased statistically significantly in group 3 (-0.76 mmol/L, 95% CI -0.90 to -0.62, -21%, p < .001: [ANCOVA]). The highest increase in lipid-lowering medication prescriptions occurred within this group.

CONCLUSIONS:

This study provides a perspective on real-word treatment patterns and changes in medications prescribed as the recommendations change over time. During a period of increasing pharmacotherapeutic opportunities, this study, conducted in everyday clinical practice suggests that common lipid-lowering medications (atorvastatin and rosuvastatin) are most frequently used for primary health care patients, and are associated with a significant decrease in LDL-C levels. A greater decrease was observed among patients with higher baseline LDL-C values. Despite decreases in LDL-C, this study suggests that the gap remains between guideline-recommended treatment targets and achieved LDL-C levels.

01 Dec 2026·EUROPEAN JOURNAL OF PHARMACEUTICAL SCIENCES

Novel inhibitors of BCRP found among drugs used in the treatment of cancer

Article

Author: Deng, Feng ; Niemi, Mikko ; Tornio, Aleksi ; Hirvensalo, Päivi ; Filppula, Anne M ; Timonen, Martina

Breast cancer resistance protein (BCRP) is an ATP-binding cassette transporter involved in clinically relevant drug-drug interactions. We aimed to identify new BCRP inhibitors among drugs used in cancer treatment. Accordingly, 133 drugs were screened at 50 µM for inhibition of BCRP using vesicular transport assay. Half-maximal inhibitory concentrations (IC₅₀) were predicted, and compounds showing the highest inhibitory potencies relative to their systemic (I₁) or intestinal (I₂) concentrations were selected for experimental IC₅₀ determination. A mechanistic static model was used to predict potential interactions with the BCRP substrate rosuvastatin in humans. Food and Drug Administration Adverse Event Reporting System (FAERS) was searched for signals of rosuvastatin-induced rhabdomyolysis during co-administration with the investigated drugs. Of the 133 drugs screened, 42 had a predicted IC₅₀ value over 0.1 × I₁ and 61 over 10 × I₂, suggesting potential inhibition in humans. IC₅₀ values were experimentally determined for 24 selected drugs. Cabozantinib and midostaurin were the strongest inhibitors, with IC₅₀ values of 0.65 and 0.69 µM, respectively. Moreover, the model suggested that midostaurin, cabozantinib, and alpelisib could almost fully inhibit intestinal BCRP, nearly doubling rosuvastatin exposure (1.83- to 1.94-fold). Entrectinib, alpelisib, flutamide, abiraterone, and capecitabine were predicted to increase rosuvastatin exposure by 1.45- to 1.63-fold through BCRP inhibition. FAERS analysis indicated a higher frequency of rhabdomyolysis reports when abiraterone was co-administered with rosuvastatin compared with all reports without abiraterone, with a reporting odds ratio of 17.3. This study identified multiple previously unrecognized BCRP inhibitors, highlighting the potential for clinically relevant BCRP‑mediated drug-drug interactions in oncology patients.

01 Dec 2026·INTERNATIONAL JOURNAL OF PHARMACEUTICS

Food-associated pharmacokinetic differences and variability of a rosuvastatin/ezetimibe fixed-dose combination in replicated bioequivalence studies

Article

Author: Fu, Yingli ; Liao, Hui ; Bai, Lu ; Li, Qian ; Li, Rongshan ; Liu, Xingwei

BACKGROUND /OBJECTIVES:

Rosuvastatin/ezetimibe fixed-dose combinations target cholesterol synthesis and intestinal absorption, but pharmacokinetics may differ by analyte, endpoint, and fasted/fed state. This study characterized food-associated pharmacokinetic differences, reference-product within-subject variability, and bioequivalence decision pathways.

METHODS:

Data were integrated from two independently conducted, single-center, randomized, open-label, single-dose, two-sequence, four-period, fully replicated crossover bioequivalence trial parts in healthy Chinese adults (ChiCTR2500110429). Free and total ezetimibe and rosuvastatin were evaluated in fasted and fed states. Bioequivalence was assessed separately in each trial part, while exploratory food-associated comparisons used reference-product data averaged across replicated periods within participants.

RESULTS:

Food-associated patterns differed by analyte and endpoint. Fed-to-fasted geometric mean ratios (GMRs) for free ezetimibe were 258.8% for maximum plasma concentration (Cmax), 125.9% for area under the concentration-time curve from time zero to the last measurable concentration (AUC0-t), and 127.1% for area under the concentration-time curve from time zero to infinity (AUC0-∞). For total ezetimibe, the Cmax GMR was 152.4%, whereas AUC shifts were smaller than the free ezetimibe. Rosuvastatin GMRs were 47.7%, 59.2%, and 60.8% for Cmax, AUC0-t, and AUC0-∞, respectively. Within-subject coefficients of variation (CVW%) differed by analyte, endpoint, and state. All primary endpoints met average bioequivalence (ABE) or reference-scaled average bioequivalence (RSABE) criteria in both states. No serious or grade ≥ 2 adverse events or adverse-event-related withdrawals occurred.

CONCLUSIONS:

Food-associated pharmacokinetic differences were analyte- and endpoint-dependent, whereas formal bioequivalence was demonstrated in both states. These findings support separate interpretation of food-associated pharmacokinetics, reference-product variability, and bioequivalence in multi-analyte fixed-dose combination evaluation.

125

News (Medical) associated with Rosuvastatin Calcium

06 Oct 2026

·www.biospace.com

Akebia Therapeutics Announces Late-Breaking VOICE Trial Presentation and Posters on Akebia’s Rare Kidney Pipeline at ASN Kidney Week 2026

Additional poster presentations highlight Vafseo® (vadadustat) clinical and economic data WALTHAM, Mass., Oct. 06, 2026 (GLOBE NEWSWIRE) -- Akebia Therapeutics®, Inc. (Nasdaq: AKBA), a biopharmaceutical company with the purpose to better the lives of people impacted by kidney disease, today announced upcoming presentations at the American Society of Nephrology Kidney Week 2026 (ASN Kidney Week), which will take place in Denver, CO from October 21-25, 2026. U.S. Renal Care will present the results of the VOICE trial evaluating the safety of three-times-weekly vadadustat compared with an erythropoiesis-stimulating agent (ESA) in patients receiving in-center hemodialysis as a late-breaking presentation. Additionally, Akebia will have multiple poster presentations featuring its rare kidney disease pipeline, including a poster highlighting preclinical research of praliciguat in focal segmental glomerulosclerosis (FSGS), the Phase 2 trial evaluating praliciguat in FSGS, and the Phase 2 basket trial of ebribafusp alfa in complement-mediated kidney diseases. Akebia will also present posters evaluating clinical and economic outcomes associated with Vafseo® (vadadustat). ASN Kidney Week attendees can visit Akebia at Booth #682 in the Exhibit Hall. Late-breaking presentation by U.S. Renal Care details: Vadadustat Three Times Weekly for the Treatment of Anemia in Patients Receiving Hemodialysis Presenter: Geoffrey A. Block, M.D., FASN, Associate Chief Medical Officer and Senior Vice President, Clinical Research & Medical Affairs for U.S. Renal Care Date and Time: October 23, 2026; 12:00 to 12:15 PM MT Akebia-supported posters to be presented in the Exhibit Hall Posters related to rare kidney disease pipeline: Renal-Protective Effects of Praliciguat in Preclinical Models of Focal Segmental Glomerulosclerosis Poster #: TH-PO0380 Date and Time: October 22, 2026; 10:00 AM to 12:00 PM MT A Phase 2 Trial of Praliciguat Therapy in Patients with FSGS Poster #: INFO18-SA Date and Time: October 24, 2026; 10:00 AM to 12:00 PM MT Tissue-Targeted Complement Inhibition in Rare Kidney Disease: A Phase 2 Open-Label Basket Trial of Ebribafusp Alfa Poster #: INFO12-SA Date and Time: October 24, 2026; 10:00 AM to 12:00 PM MT Posters related to Vafseo® (vadadustat): Cost Analysis of Hospitalizations for Vadadustat vs. Darbepoetin Alfa Based on the Phase 3 INNO 2 VATE Trials Poster #: FR-PO0609 Date and Time: October 23, 2026; 10:00 AM to 12:00 PM MT Comparison of Major Adverse Cardiovascular Events with Once-Daily vs. Three-Times-Weekly Vadadustat Dosing in Patients with Dialysis-Dependent CKD Poster #: SA-PO1096 Date and Time: October 24, 2026; 10:00 AM to 12:00 PM Comparison Between Vadadustat Exposure (Cmax) and Major Adverse Cardiovascular Events in Patients with Dialysis-Dependent CKD Poster #: SA-PO1097 Date and Time: October 24, 2026; 10:00 AM to 12:00 PM MT About Akebia Therapeutics Akebia Therapeutics, Inc. is a fully integrated biopharmaceutical company with the purpose to better the lives of people impacted by kidney disease. Akebia was founded in 2007 and is headquartered in Waltham, Massachusetts. For more information, please visit our website at , which does not form a part of this release. About Vafseo® (vadadustat) tablets Vafseo® (vadadustat) tablets is a once-daily oral hypoxia-inducible factor prolyl hydroxylase inhibitor that activates the physiologic response to hypoxia to stimulate endogenous production of erythropoietin, increasing hemoglobin and red blood cell production to manage anemia. Vafseo is approved for use in 37 countries. INDICATION VAFSEO is indicated for the treatment of anemia due to chronic kidney disease (CKD) in adults who have been receiving dialysis for at least three months. Limitations of Use VAFSEO has not been shown to improve quality of life, fatigue, or patient well-being. VAFSEO is not indicated for use: As a substitute for red blood cell transfusions in patients who require immediate correction of anemia. In patients with anemia due to CKD not on dialysis. IMPORTANT SAFETY INFORMATION about VAFSEO (vadadustat) tablets WARNING: INCREASED RISK OF DEATH, MYOCARDIAL INFARCTION, STROKE, VENOUS THROMBOEMBOLISM, and THROMBOSIS OF VASCULAR ACCESS. VAFSEO increases the risk of thrombotic vascular events, including major adverse cardiovascular events (MACE). Targeting a hemoglobin level greater than 11 g/dL is expected to further increase the risk of death and arterial and venous thrombotic events, as occurs with erythropoietin stimulating agents (ESAs), which also increase erythropoietin levels. No trial has identified a hemoglobin target level, dose of VAFSEO, or dosing strategy that does not increase these risks. Use the lowest dose of VAFSEO sufficient to reduce the need for red blood cell transfusions. CONTRAINDICATIONS Known hypersensitivity to VAFSEO or any of its components Uncontrolled hypertension WARNINGS AND PRECAUTIONS Increased Risk of Death, Myocardial Infarction (MI), Stroke, Venous Thromboembolism, and Thrombosis of Vascular Access A rise in hemoglobin (Hb) levels greater than 1 g/dL over 2 weeks can increase these risks. Avoid in patients with a history of MI, cerebrovascular event, or acute coronary syndrome within the 3 months prior to starting VAFSEO. Targeting a Hb level of greater than 11 g/dL is expected to further increase the risk of death and arterial and venous thrombotic events. Use the lowest effective dose to reduce the need for red blood cell (RBC) transfusions. Adhere to dosing and Hb monitoring recommendations to avoid excessive erythropoiesis. Hepatotoxicity Hepatocellular injury attributed to VAFSEO was reported in less than 1% of patients, including one severe case with jaundice. Elevated serum ALT, AST, and bilirubin levels were observed in 1.8%, 1.8%, and 0.3% of CKD patients treated with VAFSEO, respectively. Measure ALT, AST, and bilirubin before treatment and monthly for the first 6 months, then as clinically indicated. Discontinue VAFSEO if ALT or AST is persistently elevated or accompanied by elevated bilirubin. Not recommended in patients with cirrhosis or active, acute liver disease. Hypertension Worsening of hypertension was reported in 14% of VAFSEO and 17% of darbepoetin alfa patients. Serious worsening of hypertension was reported in 2.7% of VAFSEO and 3% of darbepoetin alfa patients. Cases of hypertensive crisis, including hypertensive encephalopathy and seizures, have also been reported in patients receiving VAFSEO. Monitor blood pressure. Adjust anti-hypertensive therapy as needed. Seizures Seizures occurred in 1.6% of VAFSEO and 1.6% of darbepoetin alfa patients. Monitor for new-onset seizures, premonitory symptoms, or change in seizure frequency. Gastrointestinal (GI) Erosion Gastric or esophageal erosions occurred in 6.4% of VAFSEO and 5.3% of darbepoetin alfa patients. Serious GI erosions, including GI bleeding and the need for RBC transfusions, were reported in 3.4% of VAFSEO and 3.3% of darbepoetin alfa patients. Consider this risk in patients at increased risk of GI erosion. Advise patients about signs of erosions and GI bleeding and urge them to seek prompt medical care if present. Serious Adverse Reactions in Patients with Anemia Due to CKD and Not on Dialysis The safety of VAFSEO has not been established for the treatment of anemia due to CKD in adults not on dialysis and its use is not recommended in this setting. In large clinical trials in adults with anemia of CKD who were not on dialysis, an increased risk of mortality, stroke, MI, serious acute kidney injury, serious hepatic injury, and serious GI erosions was observed in patients treated with VAFSEO compared to darbepoetin alfa. Malignancy VAFSEO has not been studied and is not recommended in patients with active malignancies. Malignancies were observed in 2.2% of VAFSEO and 3.0% of darbepoetin alfa patients. No evidence of increased carcinogenicity was observed in animal studies. ADVERSE REACTIONS The most common adverse reactions (occurring at ≥ 10%) were hypertension and diarrhea. DRUG INTERACTIONS Iron supplements and iron-containing phosphate binders: Administer VAFSEO at least 1 hour before products containing iron. Non-iron-containing phosphate binders : Administer VAFSEO at least 1 hour before or 2 hours after non-iron-containing phosphate binders. BCRP substrates : Monitor for signs of substrate adverse reactions and consider dose reduction. Statins : Monitor for statin-related adverse reactions. Limit the daily dose of simvastatin to 20 mg and rosuvastatin to 5 mg. USE IN SPECIFIC POPULATIONS Pregnancy: May cause fetal harm. A pregnancy exposure registry is available to monitor outcomes in women exposed to VAFSEO during pregnancy. Report pregnancies to 1-844-445-3799. Lactation: Breastfeeding not recommended until two days after the final dose. Hepatic Impairment : Not recommended in patients with cirrhosis or active, acute liver disease. Please note that this information is not comprehensive. Please click here for the Full Prescribing Information, including BOXED WARNING and Medication Guide. Akebia Therapeutics® and Vafseo® are registered trademarks of Akebia Therapeutics, Inc. Akebia Therapeutics Contact Mercedes Carrasco mcarrasco@akebia.com

Drug ApprovalPhase 2Clinical ResultPhase 3

21 Sep 2026

·www.prnewswire.com

Grünenthal acquires cancer treatment Stivarga®

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

AcquisitionDrug Approval

13 Sep 2026

·www.biospace.com

Cosmos Health Secures Additional 2.5 Million Units Under New Five-Year Contract Manufacturing Agreement with Viofar; Total Orderbook Surpasses 27.5 Million Units

500,000 contracted units of ROSARTIA annually / 2.5 million over five years through a new long-term agreement at wholly owned subsidiary Cana Laboratories Expands Cosmos Health's manufacturing presence in cardiovascular pharmaceuticals , adding production of statin-based lipid-lowering therapies to Cana's growing contract manufacturing portfolio Cumulative contract manufacturing orderbook increases to more than 27.5 million units , up from over 25 million units reported in June 2026 Further strengthens recurring cash flow visibility and expands Cana's long-term manufacturing relationships with established pharmaceutical companies CHICAGO, IL / ACCESS Newswire / September 11, 2026 / Cosmos Health Inc. ("Cosmos Health" or the "Company") ( NASDAQ:COSM ), a diversified, vertically integrated global healthcare group, today announced that its wholly owned subsidiary, Cana Laboratories S.A. ("Cana"), has secured a new five-year contract manufacturing agreement with Viofar covering approximately 2.5 million units of ROSARTIA. The agreement represents approximately 500,000 contracted units annually and increases Cana's cumulative contract manufacturing orderbook to more than 27.5 million units, up from over 25 million units reported in June 2026. The new agreement further expands Cana's long-term pharmaceutical manufacturing base and strengthens visibility into future production volumes and associated cash flows. Viofar Agreement Adds 2.5 Million Units of ROSARTIA, Expanding Cana's Cardiovascular Pharmaceutical Manufacturing Under the five-year agreement with Viofar, Cana will manufacture approximately 500,000 units annually of ROSARTIA, representing approximately 2.5 million units over the five-year term, across the 5 mg, 10 mg, 20 mg and 40 mg strengths. ROSARTIA contains rosuvastatin, a lipid-lowering medicine belonging to the statin class and classified as an HMG-CoA reductase inhibitor. Rosuvastatin is used in the management of elevated cholesterol and other lipid disorders and, in appropriate patients, to reduce cardiovascular risk. The agreement expands Cana's contract manufacturing presence in cardiovascular pharmaceuticals and adds a significant recurring production program to its existing manufacturing base. Contract Manufacturing Orderbook Surpasses 27.5 Million Units The addition of the Viofar agreement increases Cana's cumulative contract manufacturing orderbook to more than 27.5 million units, compared with over 25 million units reported in June 2026. The expanded orderbook provides greater visibility into future production volumes and associated cash flows while further diversifying Cana's manufacturing activity across pharmaceutical products and therapeutic categories. Cana's growing base of multi-year manufacturing agreements also supports deeper relationships with established pharmaceutical companies and reinforces the Company's strategy of developing contract manufacturing as a recurring component of its vertically integrated healthcare platform. Scaling Cana's Manufacturing Platform Cana operates Cosmos Health's wholly owned 54,000-square-foot manufacturing facility in Athens, Greece, which is licensed under European Good Manufacturing Practices (GMP) and certified by the European Medicines Agency (EMA). Cosmos Health has invested approximately $5.5 million in upgrading and modernizing the facility, including investments in manufacturing equipment, IT infrastructure, quality management systems and production capabilities. The continued expansion of Cana's contract manufacturing orderbook supports greater utilization of the Company's manufacturing infrastructure while complementing the production of Cosmos Health's proprietary pharmaceutical, nutraceutical and healthcare brands. Greg Siokas, CEO of Cosmos Health, stated: "Securing an additional 2.5 million contracted units under a five-year agreement represents another important step in the continued expansion of Cana's contract manufacturing business. With our cumulative orderbook now surpassing 27.5 million units, we are building greater long-term visibility across our manufacturing operations and further strengthening the recurring cash flow pro the division. The addition of ROSARTIA expands our contract manufacturing activity into an important cardiovascular product line and further demonstrates our ability to convert Cana's manufacturing capabilities into long-term relationships with established pharmaceutical companies. We continue to see meaningful opportunities to expand our orderbook, increase utilization of our infrastructure and scale Cana's contribution to Cosmos Health." About Cosmos Health Inc. Cosmos Health Inc. (NASDAQ: COSM), incorporated in 2009 in Nevada, is a diversified, vertically integrated global healthcare group. The Company owns a portfolio of proprietary pharmaceutical and nutraceutical brands, including Sky Premium Life®, Mediterranation®, bio-bebe®, C-Sept® and C-Scrub®. Through its subsidiary Cana Laboratories S.A., licensed under European Good Manufacturing Practices (GMP) and certified by the European Medicines Agency (EMA), it manufactures pharmaceuticals, food supplements, cosmetics, biocides, and medical devices within the European Union. Cosmos Health also distributes a broad line of pharmaceuticals and parapharmaceuticals, including branded generics and OTC medications, to retail pharmacies and wholesale distributors through its subsidiaries in Greece and the UK. Furthermore, the Company has established R&D partnerships targeting major health disorders such as obesity, diabetes, and cancer, enhanced by artificial intelligence drug repurposing technologies, and focuses on the R&D of novel patented nutraceuticals, specialized root extracts, proprietary complex generics, and innovative OTC products. Cosmos Health has also entered the telehealth space through the acquisition of ZipDoctor, Inc., based in Texas, USA. With a global distribution platform, the Company is currently expanding throughout Europe, Asia, and North America, and has offices and distribution centers in Thessaloniki and Athens, Greece, and in Harlow, UK. More information is available at , , , , , as well as LinkedIn and X . Forward-Looking Statements With the exception of the historical information contained in this news release, the matters described herein may contain forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. Words such as "believes," "expects," "anticipates," "intends," "projects," "estimates," "plans," and similar expressions, or future or conditional verbs such as "will," "should," "would," "may," and "could," generally identify forward-looking statements, although not all forward-looking statements contain these words. These statements involve risks and uncertainties that may individually or materially affect the matters discussed herein for a variety of reasons outside the Company's control, including, but not limited to: the Company's ability to raise sufficient financing to implement its business plan; the effectiveness of its digital asset strategies, including accumulation and yield-generating activities; the impact of the war in Ukraine and ongoing conflicts in the Middle East and other regions on the Company's business, operations, and the economy in general; the Company's ability to successfully develop and commercialize its proprietary products and technologies; changes in interest rates; changes in foreign currency exchange rates, commodity or other price inflation and deflation; our ability to issue debt on terms and at rates acceptable to us; the impact and expected outcome of investigations, inquiries, claims, and litigation; the challenges of operating in international markets; the adequacy of insurance coverage; the effect of accounting charges and of adopting certain accounting standards; the impact of legal and regulatory changes, including changes to tax laws and regulations; guidance for fiscal 2026 and beyond and financial outlook. Forward-looking statements are based on currently available information and our current assumptions, expectations and projections about future events. You should not rely on our forward-looking statements. These statements are not guarantees of future performance and are subject to future events, risks and uncertainties - many of which are beyond our control, dependent on the actions of third parties, or currently unknown to us - as well as potentially inaccurate assumptions that could cause actual results to differ materially from our historical experience and our expectations and projections. These risks and uncertainties include, but are not limited to, those described from time to time in our periodic reports filed with the SEC and available at the SEC's website ( ). There also may be other factors that we cannot anticipate or that are not described herein, generally because we do not currently perceive them to be material. Such factors could cause results to differ materially from our expectations. Forward-looking statements speak only as of the date they are made, and we do not undertake to update these statements other than as required by law. You are advised, however, to review any further disclosures we make on related subjects in our filings with the Securities and Exchange Commission and in our other public statements. Investor Relations Contact: BDG Communications cosm@bdgcommunications.com SOURCE: Cosmos Health Inc. View the original press release on ACCESS Newswire

Acquisition

100 Deals associated with Rosuvastatin Calcium

External Link

KEGG	Wiki	ATC	Drug Bank
D01915	Rosuvastatin Calcium	C10AA07	DB01098

R&D Status

Approved

10 top approved records.

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Indication	Country/Location	Organization	Date
Primary Hyperlipidemia	United States	Sun Pharmaceutical Industries Ltd.	04 Aug 2023
Heterozygous familial hypercholesterolemia	Brazil	Libbs Farmacêutica Ltda.	12 Nov 2012
Atherosclerosis	United States	AstraZeneca UK Ltd.	08 Nov 2007
Dyslipidemias	United States	AstraZeneca UK Ltd.	08 Nov 2007
Hyperlipidemias	United States	AstraZeneca UK Ltd.	08 Nov 2007
Hypertriglyceridemia	United States	AstraZeneca UK Ltd.	08 Nov 2007
Hypercholesterolemia, Familial	Japan	Shionogi & Co., Ltd.	19 Jan 2005
Hypercholesterolemia, Familial	Japan	AstraZeneca KK	19 Jan 2005
Hyperlipidemia Type IIa	United States	AstraZeneca UK Ltd.	12 Aug 2003
Hyperlipoproteinemia Type IIb	United States	AstraZeneca UK Ltd.	12 Aug 2003
Hyperlipoproteinemia Type IV	United States	AstraZeneca UK Ltd.	12 Aug 2003
Complex dyslipidemia	Austria	Grünenthal GmbH	07 Mar 2003
Complex dyslipidemia	Belgium	Grünenthal GmbH	07 Mar 2003
Complex dyslipidemia	Denmark	Grünenthal GmbH	07 Mar 2003
Complex dyslipidemia	Finland	Grünenthal GmbH	07 Mar 2003
Complex dyslipidemia	France	Grünenthal GmbH	07 Mar 2003
Complex dyslipidemia	Germany	Grünenthal GmbH	07 Mar 2003
Complex dyslipidemia	Greece	Grünenthal GmbH	07 Mar 2003
Complex dyslipidemia	Ireland	Grünenthal GmbH	07 Mar 2003
Complex dyslipidemia	Italy	Grünenthal GmbH	07 Mar 2003

Developing

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Pulmonary Embolism	Phase 3	-	AstraZeneca PLC	01 Feb 2011
Recurrent deep vein thrombosis	Phase 3	-	AstraZeneca PLC	01 Feb 2011
Ischemic stroke	Phase 3	South Korea	AstraZeneca PLC	01 Aug 2010
Coronary Disease	Phase 3	Chile	AstraZeneca PLC	01 Aug 2007
Coronary Disease	Phase 3	Colombia	AstraZeneca PLC	01 Aug 2007
Coronary Disease	Phase 3	Lithuania	AstraZeneca PLC	01 Aug 2007
Coronary Disease	Phase 3	Peru	AstraZeneca PLC	01 Aug 2007
Coronary Disease	Phase 3	Venezuela	AstraZeneca PLC	01 Aug 2007
ST Elevation Myocardial Infarction	Phase 3	Estonia	AstraZeneca SAS	06 Dec 2006
Non ST segment elevation acute coronary syndrome	Phase 3	United States	AstraZeneca PLC	01 Dec 2003

Clinical Result

Indication

Phase

Evaluation

View All Results

Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT03532139 (CTgov)	Phase 2	Ovarian Cancer	24	Enoxaparin (Enoxaparin)	ipyvdvwpyb(lgygojgrrz) = nucbfwdqff kunjzuicvo (prmxzqfbkz, 11237.9) View more	-	09 Oct 2026
				Rosuvastatin+Enoxaparin (Enoxaparin + Rosuvastatin)	ipyvdvwpyb(lgygojgrrz) = kdkqvhtfpe kunjzuicvo (prmxzqfbkz, 18181.1) View more
ESC2026	Not Applicable	Acute Coronary Syndrome	426	Rosuvastatin-Ezetimibe-Bempedoic Acid	sdkzfnmdla(dpqiiflmid) = tmadgrpjgz edadxcpjza (ivflprpgse )	Negative	28 Aug 2026
NCT04098003 (INGEST, CTgov)	Phase 4	-	45	Rosuvastatin (Rosuvastatin)	otctqvypow(pfoysitrrg) = yaggubvgqp rgjivfuyqz (cxuhurvgms, 0.129) View more	-	09 Jul 2026
				Placebo (Placebo)	otctqvypow(pfoysitrrg) = hwvteclvre rgjivfuyqz (cxuhurvgms, 0.091) View more
NCT04826354 (SaveSAMS, Pubmed \| J Am Heart Assoc)	Phase 4	Atherosclerosis	318	High-intensity statin monotherapy (rosuvastatin 20 mg)	rpswzipzai(urucydgche) = sttipfhjtf uogzfielww (ajtkrrmcfq ) View more	Positive	07 Jul 2026
				Moderate-intensity statin plus ezetimibe (rosuvastatin 5 mg/ezetimibe 10 mg)	rpswzipzai(urucydgche) = nryauulanp uogzfielww (ajtkrrmcfq ) View more
NCT05514938 (POLY-ACS, CTgov)	Phase 2	Acute Coronary Syndrome \| Coronary Artery Disease \| Lipid Metabolism Disorders	140	Polypill (Polypill)	omgbywgzbo(hjdbwvpvkc) = mvujesmekc obdifureqb (aqbbpfirok, hvfvscuuww - njdjqhcflz) View more	-	14 May 2026
				Usual Care (individual medications prescribed by primary cardiologist) (Usual Care (Individual Medications Prescribed by Primary Cardiologist))	omgbywgzbo(hjdbwvpvkc) = jzvlazwicg obdifureqb (aqbbpfirok, vwwczcdelv - vwexbdmnhp) View more
NCT06820086 (EE-PRS, Pubmed \| BMJ Open)	Phase 4	Cardiovascular Diseases	2,700	Rosuvastatin 20 mg	mecnjvulsi(uratanlcec) = mpbkklvvom jfpomwttzq (mvvfzqwedh, 5 - 13)	Positive	01 May 2026
				Current standard of care	ktwsssarha(pwlowuqrrf) = hmgvkrergq nbrgbpmjzu (tsehqmbohn, 45 - 67) View more
ESC2026	Not Applicable	Acute Coronary Syndrome	102	Rosuvastatin 40 mg + Ezetimibe 10 mg	wzssfvyeks(hndqbgjmqv) = dydpbmrjce qqhmxvbfoj (marllssvye ) View more	Positive	20 Mar 2026
ESC2025	Not Applicable	Dyslipidemias \| Hypertension	1,955	Losartan+amlodipine+rosuvastatin+ezetimibe	gyasgrdxby(btvaqupjvl) = jhbaxnleum mcugdrlbca (yjzegnizom ) View more	Positive	30 Aug 2025
NCT01935674 (SOS, CTgov)	Phase 4	HIV Infections \| Hypercholesterolemia	43	ritonavir-boosted PI (PI/r Switch Group)	qupmymxvss(ozkdmufatr) = nvwsdpyxtp gupkgnkmcr (osauienjoz, 10.8) View more	-	16 Jul 2025
				Rosuvastatin (Rosuvastatin)	qupmymxvss(ozkdmufatr) = wlrngwbtlr gupkgnkmcr (osauienjoz, 19.2) View more
NCT06105060 (Pubmed \| Clin Ther)	Early Phase 1	Metabolic Dysfunction Associated Steatohepatitis malondialdehyde \| NOD-like receptor-associated protein 3 inflammasome \| tumor necrosis factor-α ... View more	90	Vitamin E 400 IU	ltyvjdsmgn(rhhraortwe) = xfazsekbfm dovwhfnvev (oghxcqyouz ) View more	Positive	01 Jun 2025
				N-acetyl cysteine (NAC) 1200 mg + Rosuvastatin (RSV) 20 mg	esctxrhnsf(fvzbctetjh) = svngbmltuz dalbkurrvb (ymlerdoods ) View more

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