Assessment of Changes in Clinical and Radiological Parameters in Gingival Pockets After Subgingival Application of 1.2% Lovastatin Gel in Combination With SRP Procedure Compared to SRP and Placebo Gel Application in the Treatment of Periodontal Disease in Generally Healthy Non-smokers and Smokers From Central Europe: a Split-mouth Randomized Controlled Trial.

The aim of the study is to evaluate how a gel (1.2% lovastatin) applied under the gum improves the results of classic periodontal treatment (SRP-scaling, root planing).
The study involves two groups of adults diagnosed with periodontitis: the first group consists of generally healthy individuals who do not smoke tobacco. The second group consists of generally healthy individuals who have been smoking for at least 5 years. Before the study begins, each participant will undergo gum health measurements. Changes in these parameters will be monitored throughout the study. Two teeth will be selected for each participant:
* a gel containing the medication will be applied under the gum of one tooth
* a gel that looks similar to the medication but does not contain any medicinal substance will be applied under the gum of the second tooth.
Before applying the gel, each participant will undergo subgingival cleaning (SRP) to remove any debris that may prevent the medicine from working.
The study will last six months.
Expected results:
* all participants will experience an improvement in the condition of their gums after treatment
* the effect of treatment will be better in non-smokers than in smokers
* the treatment outcome will be better in the area where the medicated gel was applied compared to areas where the gel without medicinal substances was applied.

Start Date11 Jul 2025

Sponsor / Collaborator

Medical University of Silesia

NCT06636734

/ RecruitingPhase 2IIT

A Phase II Trial of Lovastatin and Pembrolizumab in Patients with RM HNSCC (LAPP)

This phase II trial tests how well lovastatin and pembrolizumab work in treating patients with head and neck cancer that has come back after a period of improvement (recurrent) or that has spread from where it first started (primary site) to other places in the body (metastatic). Lovastatin is a drug used to lower the amount of cholesterol in the blood and may also cause tumor cell death. In addition, studies have shown that lovastatin may make the tumor cells more sensitive to immunotherapy. Immunotherapy with monoclonal antibodies, such as pembrolizumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Giving lovastatin and pembrolizumab may kill more tumor cells in patients with recurrent or metastatic head and neck cancer.

Start Date09 Dec 2024

Sponsor / Collaborator

Emory University

[+1]

NCT06262685

/ Not yet recruitingPhase 4IIT

A Multicenter, Controlled, Randomized, Single-blind Phase IV Trial Assesses Efficacy, Safety, and Cost of Pre-emptive Genotyping in a Cardiovascular Risk Population Eligible for High/Moderate-intensity Statins

This is a Phase IV multicentre adaptive single-blinded randomized clinical trial if preemptively genotyping populations at risk of cardiovascular disease susceptible of receiving high or moderate doses of statin therapy is efficacious, cost-efficacious, and feasible within the Spanish National Health System when compared to the current standard of care. This trial is nested within the iPHARMGx master protocol

Start Date04 Mar 2024

Sponsor / Collaborator

Instituto de Investigación Hospital Universitario La Paz

[+1]

100 Clinical Results associated with Lovastatin

100 Translational Medicine associated with Lovastatin

100 Patents (Medical) associated with Lovastatin

6,794

Literatures (Medical) associated with Lovastatin

01 Jan 2026·TOXICOLOGY

Statin induces epithelial cell death and tissue barrier damage in renal tubule on chip

Article

Author: Pak, Hyon U ; Wang, Shiquan ; Qin, Jianhua ; Wang, Daqing ; Zhang, Xu ; Zhang, Xiaoqing ; Liu, Yaqi

Although statins are widely used to reduce lipid levels, they can lead to cytotoxicity in various cell types when given at certain dosages. The effects of statins on kidney epithelial cells are speculated based on clinical phenomena but remain unverified in animal models. Here, we described a human renal tubule chip that allows the evaluation of statin-induced cytotoxicity. The renal chip was constructed by co-culturing human proximal tubular epithelial cells and umbilical vein endothelial cells under fluidic flow. In this model, the effects of lovastatin (25 μM) on the cells over 48 h were tested using the CCK-8, lactate dehydrogenase leakage, permeability tests and ROS production assays. Our findings revealed that lovastatin reduced cell viability, increased lactate dehydrogenase leakage, and impaired barrier integrity while elevating ROS levels. Different from what we expected, lovastatin-treated epithelial cells exhibited exacerbated tubular injury and further increased ROS production following the addition of N-acetylcysteine or GSH. In contrast, sodium pyruvate attenuated lovastatin-induced ROS levels and barrier damage in the chip. These findings demonstrate that lovastatin induces oxidative stress via GSH, with ROS-mediated pathways driving tubular injury. This study establishes a platform for the in vitro assessment of drug cytotoxicity and the investigation of statin-related renal side effects.

01 Jan 2026·Translational Oncology

A Glycerophospholipid Metabolism-Based Prognostic Model Guides Osteosarcoma Therapy

Article

Author: Wen, Yong ; Chen, Bolai ; Zhao, Jian ; Yao, Li ; Wang, Hongshen ; Wang, Donglian ; Zhang, Jin

BACKGROUND:

Glycerophospholipid metabolism regulates membrane synthesis, signaling, and cell homeostasis, but its role in osteosarcoma (OS) progression, immunity, and therapy remains unclear.

METHODS:

We integrated bulk transcriptome data from TARGET (n = 85) and GEO cohorts (n = 124) with single-cell RNA-seq data (GSE162454, six OS samples). Glycerophospholipid metabolism activity was quantified using five algorithms to generate a GAS score. Prognostic genes were identified via univariate Cox regression, followed by Lasso-Cox modeling. Downstream analyses included cell communication, immune infiltration, mutation profiling, drug sensitivity, and immunotherapy response.

RESULTS:

Twelve cell types were identified; malignant OS cells showed the lowest glycerophospholipid metabolism. Nine genes correlated with GAS (r=±0.2, p < 0.01), six were used to construct the model, which outperformed 42 published signatures (C-index>0.7). High GAS patients exhibited elevated immune gene expression and copy number alterations (p < 0.05). GAS remained an independent prognostic factor (HR=3.58, 95 %CI:2.23-5.74, p < 0.001). Drug prediction highlighted lovastatin, simvastatin, and tamatinib for high-risk patients, and higher GAS associated with poor immunotherapy response (p < 0.01).

CONCLUSION:

GAS-based stratification not only robustly predicts OS prognosis but also reveals interactions between glycerophospholipid metabolism and tumor immunity, guiding personalized therapeutic strategies and highlighting novel drug candidates for high-risk patients.

31 Dec 2025·JOURNAL OF DERMATOLOGICAL TREATMENT

CHILD syndrome combined linear porokeratosis in a patient with a good response to the topical lovastatin/cholesterol ointment

Article

Author: Chen, Qiang ; Su, Fei ; Chen, Kai ; Hu, Bin ; Chen, Liu-Qing

BACKGROUND:

Congenital hemidysplasia with ichthyosiform nevus and limb defects (CHILD) syndrome is a rare X-linked dominant disorder characterized by a peculiar ichthyosiform nevus and limb defects. Linear porokeratosis (LP) is a distinct subtype of porokeratosis with hyperkeratotic nevus typically found on the extremities and linearly arranged along the lines of Blaschko. To our knowledge, the combination of CHILD syndrome and LP in a patient presenting inflammatory nevus on the limbs has never been reported.

PATIENTS AND METHODS:

A fourteen-year-old Chinese girl presented with CHILD syndrome without limb abnormalities but with coexisting LP on her left leg and opisthenar. Clinical and laboratory examination, and Whole-Genome Sequencing (WGS) analysis of the NSDHL and PMVK gene were performed. The topical application of a compounded 2% lovastatin and 2% cholesterol ointment to skin lesions twice daily for up to 4 weeks, and treatment response was evaluated every week.

RESULTS:

Our patient presented with both of the clinical features of CHILD syndrome and LP. Further WGS revealed a genetic deletion in NSDHL (c.123delA, p.V42*) and a compound heterozygous mutation in the PMVK (c.88C > T, p.Q30*) gene, confirming the clinical diagnosis of our patient. Moreover, after 4 weeks of treatment, the skin lesion of the patient had displayed a good therapeutic response to the pathogenesis-directed therapy, and we didn't observe any adverse events.

CONCLUSIONS:

We report, for the first time in China, a case of a patient with both CHILD syndrome and LP with inflammatory nevi on the limbs. Furthermore, we provide evidence of the effectiveness of a topical lovastatin/cholesterol-based therapy for this patient.

News (Medical) associated with Lovastatin

07 Jan 2026

·www.biospace.com

The World’s First Quantum AIDD Benchmark for FIC Drug Discovery Is Released: From 10% Success Rate to Deterministic Design

In AI-driven drug discovery, artificial intelligence has been widely applied across multiple stages of R&D, including target identification, virtual screening, molecular generation, and synthesis route planning. However, in real-world drug design—particularly when addressing first-in-class targets, difficult-to-drug targets such as pan-mutant KRAS, or other settings where microscopic-level research information are limited—existing AI methods continue to face clear limitations. By contrast, quantum computing is based on first-principles approaches and simulates molecular systems by following the laws of quantum mechanics at the microscopic scale, providing drug discovery teams with an alternative technical pathway at the level of fundamental molecular information. Quantum computing has demonstrated significant research value in the biomedical field, yet the transition from technical exploration to practical application continues to face a critical challenge: the lack of a unified and comparable evaluation standard. At present, core quantum algorithms—most notably the variational quantum eigensolver (VQE)—have primarily been applied to small reference molecular systems, such as H₂, H₂O, LiH, and BeH₂, or have been limited to case-specific studies involving individual drug-like compounds. By contrast, there remains no widely adopted benchmark framework capable of systematically evaluating the performance of different quantum algorithms and hardware configurations at the scale of realistic drug-like molecules. Recently, the world ’ s first benchmark for quantum computing – based drug design was released. The benchmark was jointly developed by QureGenAI together with China Pharmaceutical University, Ningbo University of Technology and Hun-Dun Quantum Experimental Platform of China Mobile (Benchmark link: ). Designed for practical application scenarios in real world drug discovery, the benchmark provides open-source code and test datasets and aims to offer a fair and comparable evaluation framework to support the continued iteration of quantum computing applications in biology and pharmaceutical industry, as well as for cross-platform comparisons across different quantum hardware approaches. The core innovation of the benchmark lies in the establishment, for the first time, of a standardized evaluation framework that connects quantum algorithms with realistic drug-like molecules. For drug discovery researchers, its immediate value lies in being readily usable in practice and in reducing the need for extensive empirical exploration. VQE benchmark workflow of QureGenAI This work establishes the first systematic VQE benchmarking framework driven by active space selection. At the methodological level, the benchmark defines a clear set of evaluation criteria, including heuristic classification based on chemically grounded metrics , diverse molecular benchmark suite—such as lovastatin and oseltamivir, employ both UCCSD (unitary coupled-cluster with singles and doubles) and HEA (hardware-efficient ansatz) ansatze and it adopts a multi-dimensional evaluation that integrates both chemistry metrics and architecture metrics. Most importantly, by performing computations on real superconducting quantum processing unit (QPU), the benchmark achieves a critical step from simulation-based validation to empirical evaluation. The research team performed hardware-level validation on two superconducting quantum processors with different qubit counts, using three representative molecules (H₂O, aspirin, and benzene). The experiments evaluated two superconducting quantum processors with different numbers of qubits, two basis sets (STO-3G and 6-31G(d)), and a two-qubit hardware-efficient ansatz (HEA). Across these settings, the resulting converged energy values exhibited stable convergence behavior. These results are essential for assessing the practical relevance of quantum computing in drug discovery and provide empirical evidence supporting hardware–algorithm co-design. The release of the benchmark addresses key practical application pain points in quantum drug discovery, providing pharmaceutical companies and research organizations with technical guidance that can be directly applied. Based on this benchmark, drug development teams can more efficiently identify VQE parameter configurations aligned with their specific needs, thereby reducing repeated trial-and-error costs in parameter selection and experimental setup. Similarly, the establishment of the benchmark helps advance the standardization of technologies in the field of Quantum AIDD, enabling result comparison and collaboration across different research teams and companies, and thereby improving the efficiency of technology iteration. In addition, its open-source design lowers the barrier to applying quantum computing in drug discovery, allowing more organizations to pursue research based on a validated benchmark without starting from low-level parameter exploration. Overall, as quantum hardware performance continues to improve and benchmark frameworks of this kind are further refined, quantum computing is expected to develop closer synergies with AI-driven drug discovery in the future. Such synergy may, to a certain extent, help alleviate long-standing challenges in traditional drug discovery—including limitations in precision and the scarcity of high-quality data—while exploring new technical pathways that could potentially support gains in drug R&D efficiency. About QureGenAI QureGenAI is a drug discovery company operating under a drug pipeline development and licensing business model, integrating quantum computing and AI technologies in its R&D approach(aka Quantum AIDD). The company currently has nine first-in-class (FIC) assets in development, including two at the Pre-IND stage and four at the PCC stage. Its research focus spans multiple therapeutic areas, including novel targets for androgenetic alopecia (AGA), pan-KRAS inhibitors, and HIF-2α agonists.

12 Dec 2024

·www.businesswire.com

Corcept Announces Positive Results in Treatment Phase of CATALYST Trial in Patients With Hypercortisolism (Cushing’s Syndrome) and Difficult-to-Control Diabetes

REDWOOD CITY, Calif.--( BUSINESS WIRE )--Corcept Therapeutics Incorporated (NASDAQ: CORT), a commercial-stage company engaged in the discovery and development of medications to treat severe endocrinologic, oncologic, metabolic and neurologic disorders by modulating the effects of the hormone cortisol, today announced that the primary endpoint was met in the treatment phase of CATALYST, a randomized, double-blind, placebo-controlled study of Korlym ® in patients with hypercortisolism (Cushing’s syndrome) and difficult-to-control type 2 diabetes. CATALYST is a prospective, Phase 4 study with two parts. The first part assessed the prevalence of hypercortisolism by screening 1057 patients with difficult-to-control type 2 diabetes, defined as hemoglobin A1c greater than 7.5 percent despite receiving optimal therapies, including GLP-1 agonists. Of these patients, 23.8 percent were identified as having hypercortisolism and were eligible to enter CATALYST’s treatment phase, in which 136 patients were randomized, 2:1, to receive either Korlym or placebo for 24 weeks. The primary endpoint was the reduction in hemoglobin A1c between these groups. CATALYST met its primary endpoint. Patients who received Korlym exhibited a clinically meaningful and statistically significant improvement in hemoglobin A1c, with a decrease from baseline of 1.47 percent as compared to a decrease of 0.15 percent in patients who received placebo (placebo-adjusted reduction of 1.32 percent; p-value: < 0.0001). The safety profile of Korlym in this study was consistent with the medication’s label and no new side effects or adverse events were identified. Complete results from CATALYST will be presented at a medical conference next year. “CATALYST’s first part showed that hypercortisolism is much more common than previously assumed. The results announced today show that Korlym is a safe and effective treatment option,” said Ralph DeFronzo, MD, chief of the Diabetes Division and professor of medicine at UT Health San Antonio and CATALYST study investigator. “Reductions in hemoglobin A1c of this magnitude are of great clinical benefit. They are particularly compelling, given that the patients in CATALYST had been receiving our best therapies – but continued to experience serious disease. These findings should prompt expanded screening for hypercortisolism, more effective treatment and better health outcomes for patients who are struggling today.” “The results of the CATALYST study will enable physicians to more accurately diagnose and treat patients with hypercortisolism - a serious and deadly disease,” said Bill Guyer, PharmD, Corcept’s Chief Development Officer. “One in four patients with difficult-to-control type 2 diabetes have hypercortisolism and Korlym, a cortisol modulator, was highly effective in controlling hyperglycemia in this patient population.” About Hypercortisolism (Cushing’s Syndrome) Hypercortisolism is caused by excessive activity of the hormone cortisol. Symptoms vary, but most patients experience one or more of the following manifestations: hypertension, central obesity, elevated blood sugar and difficult-to-control type 2 diabetes, severe fatigue and weak muscles. Irritability, anxiety, depression and cognitive disturbances are common. Hypercortisolism can affect every organ system and can be lethal if not treated effectively. Important information about Korlym follows, and full Prescribing Information, including BOXED WARNING , and a Medication Guide are available at www.korlym.com . IMPORTANT SAFETY INFORMATION INDICATIONS AND USAGE Korlym (mifepristone) is a cortisol receptor blocker indicated to control hyperglycemia secondary to hypercortisolism in adult patients with endogenous Cushing’s syndrome who have type 2 diabetes mellitus or glucose intolerance and have failed surgery or are not candidates for surgery. IMPORTANT LIMITATIONS OF USE Do not use for the treatment of type 2 diabetes mellitus unrelated to endogenous Cushing’s syndrome. BOXED WARNING: TERMINATION OF PREGNANCY Mifepristone is a potent antagonist of progesterone and cortisol via the progesterone and glucocorticoid (GR-II) receptors, respectively. The antiprogestational effects will result in the termination of pregnancy. Pregnancy must therefore be excluded before the initiation of treatment with Korlym and prevented during treatment and for one month after stopping treatment by the use of a nonhormonal medically acceptable method of contraception unless the patient has had a surgical sterilization, in which case no additional contraception is needed. Pregnancy must also be excluded if treatment is interrupted for more than 14 days in females of reproductive potential. DOSAGE AND ADMINISTRATION Obtain a negative pregnancy test prior to initiating treatment with Korlym in females of reproductive potential, or if treatment is interrupted for more than 14 days. Administer once daily orally with a meal. The recommended starting dose is 300 mg once daily. Renal impairment: Do not exceed 600 mg once daily. Mild-to-moderate hepatic impairment: Do not exceed 600 mg once daily. Do not use in severe hepatic impairment. Based on clinical response and tolerability, the dose may be increased in 300-mg increments to a maximum of 1200 mg once daily. Do not exceed 20 mg/kg per day. Concomitant use of Korlym with a strong CYP3A inhibitor resulted in a 38% increase in mean plasma concentration of mifepristone. For patients already being treated with a strong CYP3A inhibitor, start with a Korlym dose of 300 mg per day and titrate to a maximum of 900 mg per day if clinically indicated. When a strong CYP3A inhibitor is administered to patients already receiving Korlym, adjust the dose as follows: for patients receiving a daily dose of 600 mg, reduce dose to 300 mg. For patients receiving a daily dose of 900 mg, reduce dose to 600 mg. For patients receiving a daily dose of 1200 mg, reduce dose to 900 mg. Titrate if clinically indicated and do not exceed a Korlym dose of 900 mg in combination with a strong CYP3A inhibitor. CONTRAINDICATIONS Pregnancy; patients taking simvastatin or lovastatin and CYP3A substrates with narrow therapeutic ranges; patients receiving systemic corticosteroids for lifesaving purposes; women with a history of unexplained vaginal bleeding or endometrial hyperplasia with atypia or endometrial carcinoma; patients with known hypersensitivity to mifepristone or to any of the product components. WARNINGS AND PRECAUTIONS Adrenal insufficiency: Patients should be closely monitored for signs and symptoms of adrenal insufficiency. Hypokalemia: Hypokalemia should be corrected prior to treatment and monitored for during treatment. Vaginal bleeding and endometrial changes: Women may experience endometrial thickening or unexpected vaginal bleeding. Use with caution if the patient also has a hemorrhagic disorder or is on anticoagulant therapy. QT interval prolongation: Avoid use with QT interval-prolonging drugs, or in patients with potassium channel variants resulting in a long QT interval. Use of strong CYP3A inhibitors: Concomitant use increases mifepristone plasma levels. Adjust Korlym dose as described in Dosage and Administration . Use only when necessary and do not exceed a Korlym dose of 900 mg. ADVERSE REACTIONS Most common adverse reactions in Cushing’s syndrome (≥20%): nausea, fatigue, headache, decreased blood potassium, arthralgia, vomiting, peripheral edema, hypertension, dizziness, decreased appetite, endometrial hypertrophy. DRUG INTERACTIONS Drugs metabolized by CYP3A: Administer drugs that are metabolized by CYP3A at the lowest dose when used with Korlym. CYP3A inhibitors: Caution should be used when Korlym is used with strong CYP3A inhibitors. Adjust Korlym dose as described in Dosage and Administration . Use only when necessary, and do not exceed a Korlym dose of 900 mg. CYP3A inducers: Do not use Korlym with CYP3A inducers. Drugs metabolized by CYP2C8/2C9: Use the lowest dose of CYP2C8/2C9 substrates when used with Korlym. Drugs metabolized by CYP2B6: Use of Korlym should be done with caution with bupropion and efavirenz. Hormonal contraceptives: Do not use with Korlym. USE IN SPECIFIC POPULATIONS Lactation: Mifepristone is present in human milk, however, there are no data on the amount of mifepristone in human milk, the effects on the breastfed infant, or the effects on milk production during long term use of mifepristone. About Corcept Therapeutics For over 25 years, Corcept’s focus on cortisol modulation and its potential to treat patients with a wide variety of serious disorders has led to the discovery of more than 1,000 proprietary selective cortisol modulators. Corcept is conducting advanced clinical trials in patients with hypercortisolism, solid tumors, ALS and liver disease. In February 2012, the company introduced Korlym, the first medication approved by the U.S. Food and Drug Administration for the treatment of patients with endogenous hypercortisolism. Corcept is headquartered in Redwood City, California. For more information, visit Corcept.com. Forward-Looking Statements Statements in this press release, other than statements of historical fact, are forward-looking statements based on our current plans and expectations and are subject to risks and uncertainties that might cause our actual results to differ materially from those such statements express or imply. These risks and uncertainties are set forth in our SEC filings, which are available at our website and the SEC’s website. In this press release, forward-looking statements include those concerning the full results of CATALYST and the date and manner of their publication; changes in medical practice, including in the frequency and clinical outcome of screening patients for hypercortisolism; the adoption of Korlym as a treatment for patients with hypercortisolism and difficult-to-control diabetes; and Korlym’s commercial prospects. We disclaim any intention or duty to update forward-looking statements made in this press release.

Clinical ResultPhase 3Drug ApprovalPhase 2

15 Apr 2024

·www.biospace.com

Fresenius Accelerates Momentum in its (Bio)Pharma Business and Launches Tyenne®, its Third Approved Biosimilar in the U.S.

Tyenne® is the first tocilizumab biosimilar by Fresenius Kabi, an operating company of Fresenius SE, with an intravenous and subcutaneous formulation approved by the FDA. The tocilizumab biosimilar provides increased access and an affordable, high-quality, and safe treatment option for U.S. patients. Excellent performance of the (Bio)Pharma business in 2024 so far, also driven by Tyenne® which became the first tocilizumab biosimilar available in Europe in November 2023. The launch of the tocilizumab biosimilar contributes directly to growing Fresenius’ (Bio)Pharma platform, a substantial cornerstone of the #FutureFresenius strategy. BAD HOMBURG, Germany--(BUSINESS WIRE)-- Fresenius, via its operating company Fresenius Kabi, announced today the immediate U.S. availability of Tyenne® (tocilizumab-aazg), a biosimilar of Actemra® (tocilizumab). Tyenne®, for use in the treatment of chronic autoimmune diseases, is available in an intravenous (IV) formulation. This press release features multimedia. View the full release here: Fresenius Kabi announced that Tyenne® (tocilizumab-aazg), a biosimilar of Actemra® (tocilizumab) is now available in the U.S. in an IV presentation. Tyenne tocilizumab-aazg) is for use in the treatment of chronic autoimmune diseases. (Photo: Business Wire) Michael Sen, CEO of Fresenius: “With the launch of Tyenne® in the U.S., we have reached another important milestone in accelerating our strong (Bio)Pharma momentum. Growing this platform is a substantial cornerstone of our #FutureFresenius journey. Overall, we have seen an excellent performance of our (Bio)Pharma business in 2024 so far. We are particularly happy with the good progress of our majority-owned biotechnology company mAbxience and the traction of Tyenne®, the first tocilizumab biosimilar available in Europe since November 2023.” Tyenne® is the first tocilizumab biosimilar with an intravenous and subcutaneous formulation approved by the FDA. The biosimilar received FDA approval on March 5, 2024. Tyenne® is Fresenius’ third approved biosimilar available in the U.S. and the second within its immunology portfolio. The biologic medicine is indicated for the treatment of several autoimmune diseases, including rheumatoid arthritis, giant cell arteritis, polyarticular juvenile idiopathic arthritis, and systemic juvenile idiopathic arthritis. Pierluigi Antonelli, CEO of Fresenius Kabi: “Tyenne® will impact the treatment landscape for inflammatory and immune diseases in the U.S. Reaching ever more patients with our state-of-the-art biopharma portfolio signals a clear growth path in a highly promising market segment. We will continue to roll out our comprehensive pipeline of autoimmune and oncology biosimilars with several molecules in late-stage development.” Supported by Fresenius Kabi’s support program for health care professionals and patients, the company’s biologic medicine provides wider access to more treatment options and contributes to the viability of health care systems. Next to its two available biosimilars, Idacio® (adalimumab) and Stimufend® (pegfilgrastim), Fresenius Kabi has a growing pipeline of autoimmune and oncology biosimilars with several molecules in late-stage development. To learn more about how Fresenius Kabi provides comprehensive patient support for Tyenne® in the U.S. please click here. With #FutureFresenius, Fresenius successfully set the course last year to become a leading therapy-focused company. In line with the strategy, Fresenius has simplified its structure, is sharpening its focus by concentrating on its operating companies Fresenius Kabi and Fresenius Helios and is continuously enhancing its performance. About Tyenne®, a Tocilizumab Biosimilar Tyenne® (tocilizumab-aazg), a biosimilar to Actemra® (tocilizumab), is a prescription medicine called an Interleukin-6 (IL-6) receptor antagonist. It was developed by Fresenius Kabi using advanced analytical and manufacturing technologies for use in the treatment of several autoimmune diseases, including rheumatoid arthritis, giant cell arteritis, polyarticular juvenile idiopathic arthritis, and systemic juvenile idiopathic arthritis. Serious infections leading to hospitalization or death including tuberculosis (TB), bacterial, invasive fungal, viral, and other opportunistic infections have occurred in patients receiving the product. Tyenne is contraindicated in patients with known hypersensitivity to tocilizumab products. For more information about Tyenne, please see the full prescribing information for the U.S. here. IMPORTANT SAFETY INFORMATION RISK OF SERIOUS INFECTIONS Patients treated with TYENNE® (tocilizumab-aazg) are at increased risk for developing serious infections that may lead to hospitalization or death, including tuberculosis (TB), bacterial, invasive fungal, viral, or other opportunistic infections. If a serious infection develops, interrupt TYENNE until the infection is controlled. Reported infections include: Active tuberculosis, which may present with pulmonary or extrapulmonary disease. Patients should be tested for latent tuberculosis before TYENNE use and during therapy. Treatment for latent infection should be initiated prior to TYENNE use. Invasive fungal infections, including candidiasis, aspergillosis, and pneumocystis. Patients with invasive fungal infections may present with disseminated, rather than localized, disease. Bacterial, viral and other infections due to opportunistic pathogens. The risks and benefits of treatment with TYENNE should be carefully considered prior to initiating therapy in patients with chronic or recurrent infection. Patients should be closely monitored for the development of signs and symptoms of infection during and after treatment with TYENNE, including the possible development of tuberculosis in patients who tested negative for latent tuberculosis infection prior to initiating therapy. CONTRAINDICATION TYENNE is contraindicated in patients with known hypersensitivity to tocilizumab products. WARNINGS AND PRECAUTIONS Gastrointestinal Perforations Events of gastrointestinal (GI) perforation have been reported in clinical trials, primarily as complications of diverticulitis in patients treated with tocilizumab. Use TYENNE with caution in patients who may be at increased risk for GI perforation. Promptly evaluate patients presenting with new-onset abdominal symptoms for early identification of GI perforation. Hepatotoxicity Serious cases of hepatic injury have been observed in patients taking intravenous or subcutaneous tocilizumab products. Some of these cases have resulted in liver transplant or death. Time to onset for cases ranged from months to years after treatment initiation. Most cases presented with marked elevations of transaminases (> 5 times ULN), and some cases presented with signs or symptoms of liver dysfunction and only mildly elevated transaminases. Treatment with tocilizumab was associated with a higher incidence of transaminase elevations; increased frequency and magnitude of these elevations were observed when tocilizumab was used in combination with potentially hepatotoxic drugs (e.g., methotrexate). It is not recommended to initiate TYENNE treatment in RA, GCA, PJIA, and SJIA patients with elevated transaminases ALT or AST greater than 1.5x ULN. In patients who develop elevated ALT or AST greater than 5x ULN discontinue TYENNE. Measure liver tests promptly in patients who report symptoms that may indicate liver injury. If the patient is found to have abnormal liver tests, TYENNE treatment should be interrupted. TYENNE should only be restarted in patients with another explanation for the liver test abnormalities after normalization of the liver tests. Laboratory Parameters Laboratory monitoring is recommended due to potential consequences of treatment-related laboratory abnormalities in neutrophils, platelets, lipids, and liver function tests. Dosage modifications may be required. Neutropenia: Treatment with tocilizumab products was associated with a higher incidence of neutropenia. It is not recommended to initiate TYENNE treatment in RA, GCA, PJIA, and SJIA patients with a low neutrophil count i.e., absolute neutrophil count (ANC) less than 2000 per mm3. In patients who develop an ANC less than 500 per mm3 treatment is not recommended. Thrombocytopenia: Treatment with tocilizumab products was associated with a reduction in platelet counts. It is not recommended to initiate TYENNE in RA, GCA, PJIA, and SJIA patients with a platelet count below 100,000 per mm3. In patients who develop a platelet count less than 50,000 per mm3, treatment is not recommended. Elevated Liver Enzymes: It is not recommended to initiate TYENNE treatment in patients with elevated transaminases ALT or AST >1.5x ULN. In patients who develop elevated ALT or AST >5x ULN, treatment is not recommended. Lipid Abnormalities: Treatment with tocilizumab products was associated with increases in lipid parameters such as total cholesterol, triglycerides, LDL cholesterols, and/or HDL cholesterol. Immunosuppression The impact of treatment with tocilizumab products on the development of malignancies is not known, but malignancies were observed in clinical studies with tocilizumab. TYENNE is an immunosuppressant, and treatment with immunosuppressants may result in an increased risk of malignancies. Hypersensitivity Reactions Hypersensitivity reactions, including anaphylaxis, have been reported in association with tocilizumab products and anaphylactic events with a fatal outcome have been reported with intravenous infusion of tocilizumab products. TYENNE for intravenous use should only be infused by a healthcare professional with appropriate medical support to manage anaphylaxis. For TYENNE subcutaneous injection, advise patients to seek immediate medical attention if they experience any symptoms of a hypersensitivity reaction. If anaphylaxis or other hypersensitivity reaction occurs, stop administration of TYENNE immediately and discontinue TYENNE permanently. Do not administer TYENNE to patients with known hypersensitivity to tocilizumab products. Demyelinating Disorders The impact of treatment with tocilizumab products on demyelinating disorders is not known, but multiple sclerosis and chronic inflammatory demyelinating polyneuropathy were reported rarely in clinical studies. Monitor patients for signs and symptoms of demyelinating disorders. Prescribers should exercise caution in considering the use of TYENNE in patients with preexisting or recent onset demyelinating disorders. Active Hepatic Disease and Hepatic Impairment Treatment with TYENNE is not recommended in patients with active hepatic disease or hepatic impairment. Vaccinations Avoid use of live vaccines concurrently with TYENNE. No data are available on the secondary transmission of infection from persons receiving live vaccines to patients receiving TYENNE or on the effectiveness of vaccination in patients receiving TYENNE. Patients should be brought up to date on all recommended vaccinations prior to initiation of TYENNE therapy, if possible. ADVERSE REACTIONS Most common adverse reactions (incidence of at least 5%): upper respiratory tract infections, nasopharyngitis, headache, hypertension, increased ALT, injection site reactions. DRUG INTERACTIONS In GCA patients, no effect of concomitant corticosteroid on tocilizumab exposure was observed. Cytochrome P450s in the liver are down-regulated by infection and inflammation stimuli including cytokines such as IL-6. Inhibition of IL-6 signaling in RA patients treated with tocilizumab products may restore CYP450 activities to higher levels than those in the absence of tocilizumab products leading to increased metabolism of drugs that are CYP450 substrates. Exercise caution when coadministering TYENNE with CYP3A4 substrate drugs where decrease in effectiveness is undesirable, e.g., oral contraceptives, lovastatin, atorvastatin, etc. USE IN PREGNANCY The limited available data with tocilizumab products in pregnant women are not sufficient to determine whether there is a drug-associated risk for major birth defects and miscarriage. You may report side effects to the FDA at (800) FDA-1088 or . You may also report side effects to Fresenius Kabi at (800) 551-7176. Please see additional Important Safety Information in full Prescribing Information, including Boxed Warning. INDICATIONS TYENNE is indicated for the treatment of adult patients with moderately to severely active rheumatoid arthritis (RA) who have had an inadequate response to one or more Disease-Modifying Anti-Rheumatic Drugs (DMARDs). TYENNE is indicated for the treatment of giant cell arteritis (GCA) in adult patients. TYENNE is indicated for the treatment of active polyarticular juvenile idiopathic arthritis (PJIA) in patients 2 years of age and older. TYENNE is indicated for the treatment of active systemic juvenile idiopathic arthritis (SJIA) in patients 2 years of age and older. Tyenne® demonstrates Fresenius Kabi’s commitment to providing access to affordable and cost-effective biosimilars to more patients living with autoimmune diseases around the world while enabling savings for health care systems. KabiCare, Fresenius Kabi’s comprehensive patient support program, will be available to patients and health care providers in the U.S. from launch. About Fresenius SE Fresenius SE & Co. KGaA (Frankfurt/Xetra: FRE) is a global healthcare company headquartered in Bad Homburg v. d. Höhe, Germany. In the 2023 fiscal year, Fresenius generated €22.3 billion in annual revenue with its more than 190,000 employees. Fresenius offers solutions to the social challenges posed by a growing and ageing population and the resulting need for affordable, high-quality healthcare. The Fresenius Group comprises the operating companies Fresenius Kabi and Fresenius Helios as well as the investment companies Fresenius Vamed and Fresenius Medical Care. With 140 hospitals and countless outpatient facilities, Fresenius Helios is the leading private hospital operator in Germany and Spain, treating around 26 million patients every year. Fresenius Kabi’s product portfolio includes a range of highly complex biopharmaceuticals, clinical nutrition, medical technology, and generic intravenous drugs. Fresenius was established in 1912 by the Frankfurt pharmacist Dr. Eduard Fresenius. After his death, Else Kröner took over management of the company in 1952. She laid the foundations for a global enterprise that today pursues the goal of improving people’s health. The largest shareholder is the non-profit Else Kröner-Fresenius Foundation, which is dedicated to advancing medical research and supporting humanitarian projects. For more information visit the company website at . Follow us on social media: . About Fresenius Kabi Fresenius Kabi is a global healthcare company that specializes in lifesaving medicines and technologies for infusion, transfusion and clinical nutrition. The company’s products and services are used for the therapy and care of critically and chronically ill patients. Its product portfolio comprises a range of highly complex biopharmaceuticals, clinical nutrition, medical technologies, and I.V. generic drugs. Within biopharmaceuticals, Fresenius Kabi offers, among others, biosimilar drugs with a focus on autoimmune diseases and oncology. The company’s clinical nutrition offering includes a wide selection of enteral and parenteral nutrition products. In the segment of medical technologies, its offering includes vital disposables, infusions pumps, apheresis machines, cell therapy devices, and more. Fresenius Kabi puts essential medicines and technologies in the hands of people who help patients and finds the best answers to the challenges they face. Following its strategy “Vision 2026”, which is a key part of the #FutureFresenius program of the Fresenius healthcare group, the company is furthermore committed to increase efficiencies in the therapy and care of patients and improve access to high-quality healthcare around the globe. Fresenius Kabi aspires to be leading globally in its product segments – all for the benefit of patients, its customers, and its stakeholders. Actemra® is a registered trademark of Chugai Seiyaku Kabushiki Kaisha Corp., a member of the Roche Group. Tyenne® is a registered trademark of Fresenius Kabi Deutschland GmbH. Idacio® and Stimufend® are registered trademarks of Fresenius Kabi Deutschland GmbH in selected countries. View source version on businesswire.com: Contacts Matt Kuhn (847) 220-3033 matt.kuhn@fresenius-kabi.com Source: Fresenius Kabi Smart Multimedia Gallery Photo Fresenius Kabi announced that Tyenne® (tocilizumab-aazg), a biosimilar of Actemra® (tocilizumab) is now available in the U.S. in an IV presentation. Tyenne tocilizumab-aazg) is for use in the treatment of chronic autoimmune diseases. (Photo: Business Wire) Logo View this news release and multimedia online at:

Drug Approval

100 Deals associated with Lovastatin

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KEGG	Wiki	ATC	Drug Bank
D00359	Lovastatin	C10AA02	DB00227

R&D Status

Approved

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Indication	Country/Location	Organization	Date
Hyperlipidemias	United States	Covis Pharma Holdings BV	26 Jun 2002
Coronary Disease	United States	Merck Research Laboratories Massachusetts LLC	31 Aug 1987
Hypercholesterolemia	United States	Merck Research Laboratories Massachusetts LLC	31 Aug 1987

Developing

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Indication	Highest Phase	Country/Location	Organization	Date
Atherosclerosis	Phase 3	United States	Merck Sharp & Dohme Corp.	01 Jun 1985
Coronary Artery Disease	Phase 3	United States	Merck Sharp & Dohme Corp.	01 Jun 1985

Clinical Result

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT02998151 (CTgov)	Early Phase 1	Fragile X Syndrome	29	placebo (Placebo)	flbmdqrmwr(kzrwlcpegy) = qvsidpmrvu etblzijnlj (stzcohdeoh, .0265) View more	-	24 Nov 2021
NCT02998151 (CTgov)	Early Phase 1	Fragile X Syndrome	29	Acamprosate (Acamprosate)	flbmdqrmwr(kzrwlcpegy) = jtxwkwrroi etblzijnlj (stzcohdeoh, 0.0252) View more	-	24 Nov 2021
NCT02642653 (CTgov)	Phase 4	Fragile X Syndrome	30	Lovastatin (Lovastatin and PILI)	rdqftzaldv(rdqzjoymwj) = gbrbkousyy tdjqtqyyvc (mkgsppfjzl, 32.41) View more	-	11 Sep 2019
NCT02642653 (CTgov)	Phase 4	Fragile X Syndrome	30	Placebo (Placebo and PILI)	rdqftzaldv(rdqzjoymwj) = bqahekeyyu tdjqtqyyvc (mkgsppfjzl, 18.60) View more	-	11 Sep 2019
NCT02563860 (Statins, CTgov)	Phase 2	Rett Syndrome	20	Lovastatin	cyrnhhgyqa(tdeufgikru) = opddfpscte ubdkempreu (memcnnjath, itetoxeagd - qokstmsptw) View more	-	07 May 2019
NCT00584012 (CTgov)	Phase 1	Breast Cancer	9	Lovastatin+Docetaxel	phbekkfcmo(jyizctrukb) = snthkztnkj mdyfopxyjk (zjyukwwmix, vlldkmhpej - rqqvnpfcyg) View more	-	19 Oct 2018
NCT01361217 (FLUOXETINE, CTgov)	Not Applicable	Medication interactions	10	Lovastatin+Omeprazole+midazolam+caffeine+Fluoxetine+dextromethorphan	junracccuc(bziwqssviw) = ljxmrbitiw xtdlfnzzfv (bpafrxjdoy, inxocxveuz - uofvydrgpx) View more	-	29 Jun 2018
NCT00853580 (STARS, CTgov)	Phase 2	Neurofibromatosis 1	146	Lovastatin (Lovastatin)	bfuthnmvpp(nrscqjtmaa) = ztvunesmax pdtuhylwyn (dejhdatiae, 22.4) View more	-	12 Mar 2018
NCT00853580 (STARS, CTgov)	Phase 2	Neurofibromatosis 1	146	lovastatin+placebo (Placebo)	bfuthnmvpp(nrscqjtmaa) = oodyfjyyjj pdtuhylwyn (dejhdatiae, 15.4) View more	-	12 Mar 2018
NCT00583102 (CTgov)	Phase 1/2	Acute Myeloid Leukemia \| Refractory acute myeloid leukemia	23	Lovastatin+Cytarabine	oppxyfvlyc = swmacamyvv fojngiktir (bfeelzjrly, xyyvleihaz - cmagxzsxxs) View more	-	05 Jan 2018
NCT00585052 (CTgov)	Phase 2	Recurrent ovarian cancer	11	Lovastatin+Paclitaxel	bouzuwszwq(logqutofbn) = tohaojonvb oilmjyjxln (oveotyrnsx, 0.202) View more	-	05 Jan 2018
NCT00580970 (CTgov)	Phase 2	Prostatic Cancer \| Radiation-induced Rectal Injury \| Adenocarcinoma of prostate	73	Lovastatin (Supportive Care (Lovastatin) (Evaluable))	ezfgkmoicz = fgxikcadsp rjrsanavuy (gehdmmnxsm, uxvmzmpajx - bhcnjauqvb)	-	18 Nov 2016
NCT00580970 (CTgov)	Phase 2		73	Lovastatin (Supportive Care (Lovastatin))	uniljwgudb(hioalybjjr) = qrzzigmzrh heggdcthdt (dzlhyydtjx, lmxziszyjk - pvlydamqep) View more	-	18 Nov 2016
NCT00580970 (ASCO_GU2016)	Phase 2	Prostatic Cancer	73	Lovastatin	spacxbfvwl(rnvsvyhhga) = qpqyrfbhgg ltdbhnvfra (mbsguxthto )	Positive	10 Jan 2016

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