[Translation] A single-dose, randomized, open-label, two-dose, repeated crossover, four-period, fasting and fed human bioequivalence study of mycophenolate sodium enteric-coated tablets in healthy subjects

主要目的：以重庆迈川医药科技有限公司的麦考酚钠肠溶片（规格：以麦考酚酸（（C17H20O6）计0.18g）为受试制剂，以诺华制药（Novartis Pharma GmbH）的麦考酚钠肠溶片（商品名：Myfortic®/米芙®，规格：180mg）为参比制剂，按生物等效性试验的有关规定，考察两制剂在健康人体内的生物等效性。次要目的：观察受试制剂和参比制剂在健康受试者中的安全性。

[Translation]

Main purpose: Using the Mycophenol Sodium Enteric-coated Tablets (specification: 0.18 g based on mycophenolic acid ((C17H20O6)) of Chongqing Maichuan Pharmaceutical Technology Co., Ltd. as the test preparation and the Mycophenol Sodium Enteric-coated Tablets (trade name: Myfortic®/Mifu®, specification: 180 mg) of Novartis Pharma GmbH as the reference preparation, the bioequivalence of the two preparations in healthy humans was investigated according to the relevant provisions of the bioequivalence test. Secondary purpose: To observe the safety of the test preparation and the reference preparation in healthy subjects.

Start Date17 Feb 2025

Sponsor / Collaborator

Chongqing Maichuan Medical Technology Co., Ltd.

CTR20250065

/ Active, not recruitingNot Applicable

麦考酚钠肠溶片空腹及餐后人体生物等效性研究

[Translation] Study on the bioequivalence of mycophenolate sodium enteric-coated tablets in fasting and fed subjects

以山东新时代药业有限公司的麦考酚钠肠溶片为受试制剂，Novartis Pharmaceuticals Corporation持证的麦考酚钠肠溶片（Myfortic®）为参比制剂，考察两制剂在空腹及餐后状态下单次给药吸收速度和程度的差异，评价两制剂是否生物等效。

[Translation]

Mycophenolate sodium enteric-coated tablets produced by Shandong Xinshidai Pharmaceutical Co., Ltd. were used as the test preparation, and mycophenolate sodium enteric-coated tablets (Myfortic®) certified by Novartis Pharmaceuticals Corporation were used as the reference preparation. The differences in the absorption rate and extent of single-dose administration of the two preparations in the fasting and postprandial states were investigated to evaluate whether the two preparations were bioequivalent.

Start Date12 Feb 2025

Sponsor / Collaborator

Shandong New Time Pharmaceutical Co. Ltd.

100 Clinical Results associated with Mycophenolate Sodium

100 Translational Medicine associated with Mycophenolate Sodium

100 Patents (Medical) associated with Mycophenolate Sodium

5,584

Literatures (Medical) associated with Mycophenolate Sodium

01 Jul 2025·JOURNAL OF PHARMACEUTICAL AND BIOMEDICAL ANALYSIS

Analytical validation and pilot clinical application of a UPLC-MS/MS method for determining intracellular mycophenolic acid and metabolites in kidney transplant recipients

Article

Author: Xu, Huan ; Wang, Xueqaio ; Liu, Hanjing ; Chen, Chunxia ; Bai, Yangjuan ; Shi, Yunying ; Chen, Xiaomei ; Li, Yi ; Dai, Xinhua ; Zou, Yuangao

There is no consensus on the strategy for therapeutic drug monitoring of the immunosuppressive drug mycophenolic acid (MPA) in organ transplant recipients. The present study proposes the utilization of ultra-performance liquid chromatography-tandem mass spectrometry (UPLC-MS/MS) for determining the concentrations of MPA and its metabolites: 7-O-mycophenolic acid glucuronide (MPAG) and acyl mycophenolic acid glucoside (AcMPAG) in peripheral blood mononuclear cells (PBMCs). We aimed to assess the potential application of monitoring MPA and its metabolite concentrations in PBMCs in the infection after transplantation in Chinese kidney transplant recipients (KTRs). The UPLC-MS/MS method we developed demonstrated good linearity in the quantitative ranges of 0.05-50.00 ng/mL for MPA, 0.50-50.00 ng/mL for MPAG, and 0.10-20.00 ng/mL for AcMPAG. AcMPAG in PBMCs was unstable, degrading significantly after 48 h of storage at -80°C or after 3 freeze-thaw cycles. MPA and MPAG concentrations in KTRs' PBMCs exhibited high inter-individual variability, and the MPA concentration in PBMCs was poorly correlated with that in plasma (rs = 0.206, p = 0.117). Compared with the stable group, the infected group had significantly higher MPA concentration in PBMCs at 2 and 4 h post-dosing and in plasma at 4 h post-dosing (p < 0.05). The receiver operating characteristic (ROC) analysis for post-transplantation infection revealed that PBMCs MPA-C4 and PBMCs-MPA-C2 possessed much better diagnostic efficiency than Plasma-MPA-C4. This method is easy-to-use and reliable, making it a promising clinical quantitative tool for MPA, MPAG, and AcMPAG in PBMCs. PBMC-MPA monitoring may be a potential biomarker for infection monitoring for KTRs.

01 Jun 2025·FOOD CONTROL

Simultaneous broad-spectrum detection of over 50 mycotoxins in maize silage via liquid chromatography-tandem mass spectrometry: Method development and application

Author: Sun, Yucui ; Huang, Jin ; Feng, Shoushuai ; Yang, Hailin ; Luan, Yujing ; Zhou, Xueting ; Sun, Bo ; Zhang, Dawei

For a comprehensive assessment of mycotoxin contamination in maize silage, a novel method using high-performance liquid chromatog.-tandem mass spectrometry (LC-MS/MS) that can simultaneously detect 53 mycotoxins in maize silage was developed.The method streamlines the extraction and purification processes with a simplified dilute-and-shoot sample pretreatment step.After extraction with acetonitrile/water/formic acid (70:30:0.1, volume/volume/v) followed by the LC-MS/MS detection.Furthermore, isotope internal standards were employed to eliminate matrix effects.The method was validated by linearity, matrix effects, selectivity, recovery, repeatability, limits of detection (LOD), limits of quantification (LOQ) and measurement uncertainties.The LODs ranged from 0.3 to 162.2 μg/kg and the LOQs from 0.9 to 535.4 μg/kg.The method developed enables the effective quant. anal. of 51 out of 53 mycotoxins, with mean recoveries for 51 qual. determinable analytes applicable to this method ranging from 33.20% to 119.50% and relative standard deviations of less than 13.33%; all 53 mycotoxins could be qual. analyzed, and the method was successfully applied for analyzing 63 maize silage samples from China.Most of the mycotoxins detected were attributed to the Fusarium species. highlighting the prevalence of this genus in maize silage contamination.The developed LC-MS/MS method provides an excellent anal. performance for detecting multiple mycotoxins, marking it as the first report of such broad-spectrum detection in silage, and offers an effective tool for the accurate assessment of the true mycotoxin content in maize silage and the precise evaluation of feed quality.

01 May 2025·FOOD CONTROL

Use of Penicillium roqueforti in plant-based veined-blue cheese: A source of mycotoxin hazards?

Author: Khireddine, Rayan ; Gallegos, Nathalie ; Richard-Forget, Florence ; Gauthier, Oriane ; Bernillon, Stephane ; Chassard, Christophe ; Callon, Cecile ; Saupique, Capucine

While the consumer demand for plant-based cheese is increasingly growing, there is insufficient knowledge to allow anticipating potential hazards related to mycotoxins in these new products and notably in plant-based blue veined cheese inoculated with Penicillium roqueforti.Actually plant-based matrixes, characterized by a higher C/N ratio than dairy milk, are likely to promote the yield of mycotoxins by P. roqueforti.This study aims to provide first scientific insights to fulfill this gap of knowledge.As a first step, the capacity of 15 P. roqueforti strains belonging to the Roquefort and Non-Roquefort populations to yield mycotoxins was assessed.The medium used allowed to evidence a significant higher production of roquefortine C and a lower yield of andrastin A by strains of the Non-Roquefort group compared to those of the Roquefort one.In a second step a microbiol. challenge testing approach was implemented using five matrixes of plant (almond, cashew and soy) and animal (cow and sheep) origin.Results suggested that animal matrixes were more prone to contamination with andrastin A while cashew and soy matrixes promoted the yield of roquefortine C and mycophenolic acid, and in a less extent of fumigaclavin A.Besides, while warning on the mycotoxin risk associated with some plant matrixes, our results also evidenced that the risk was strongly dependent on choice of the combination P. roqueforti strain/matrix.

News (Medical) associated with Mycophenolate Sodium

15 Jan 2025

·www.biospace.com

Pharmacy Benefits Managers Netted Extra $7.3B by Inflating Drug Prices: FTC

Pictured: Entrance of the FTC in Washington, DC iStock, hapabapa A report published Tuesday shows hundreds and thousands of percent markups on HIV, hypertension and cancer drugs for Medicare and commercial claims alike. Tuesday, the U.S. Federal Trade Commission published a report finding that the “Big 3 PBMs”, Caremark Rx, Express Scripts and OptumRx, have been marking up the prices of drugs by hundreds and thousands of percents, bringing in an additional $7.3 billion in revenue. The 60-page report alleges the three pharmacy benefit managers (PBMs) employed a number of tactics to increase profits, from markups on specialty generic drugs at affiliated pharmacies, steering more profitable specialty drugs toward those affiliated pharmacies and away from unaffiliated ones, and billing plan sponsors more than they were reimbursing pharmacies for the cost of drugs, a practice called “spread pricing.” “The FTC staff’s second interim report finds that the three major pharmacy benefit managers hiked costs for a wide range of lifesaving drugs, including medications to treat heart disease and cancer,” FTC Chair Lina Khan said in a statement . The report notes that PBMs—middlemen that buy directly from drug manufacturers and reimburse pharmacies for the costs of drugs—were deriving excess profits as patient costs continued to soar. “We also found that this problem is growing at an alarming rate, which means there is an urgent need for policymakers to address it,” Hannah Garden-Monheit, director of the FTC’s Office of Policy Planning, added in the same press release. The report shared data showing that over the last three years, these markups have been steadily increasing. Some were on drugs like Epivir, an HIV drug marked up 276% in 2022, Tobi, an inhaled medication for cystic fibrosis marked up 339%, and Myfortic, an immunosuppressant taken by organ transplant patients marked up 693%. The biggest moneymakers, however, were drugs for hypertension (up 7,736%), multiple sclerosis (up to 2,435%) and cancer chemotherapies. Gleevec, the landmark leukemia drug, was marked up 4,154% for Medicare plans and 5,232% for commercial ones. The report published Tuesday follows one released last summer , which showed how vertical integration and concentration had enabled the three largest PBMs in the U.S. to manage about 80% of all prescriptions filled nationwide, and the six largest up to 95%. In the past, both PBMs and drug makers themselves have played the blame game , accusing one another of being at fault for soaring drug prices. The FTC in September sued Caremark, Express Scripts and Optum for their roles in inflating drug prices, accusing them of anticompetitive and unfair rebating practices, ultimately reducing patient access to life-saving medications.

Patent Infringement

29 Oct 2024

·endpts.com

Two type 1 diabetes patients are insulin-free after Eledon's immunosuppressant and an islet transplant

Eledon Pharmaceuticals’ experimental immunosuppressant helped two patients with type 1 diabetes go insulin-free following an islet cell transplant, the company announced Tuesday. The company’s stock $ELDN rose about 12% on Tuesday morning after Eledon announced the data and an $85 million offering . It said the investigator-initiated trial, which is being conducted by researchers at UChicago Medicine Transplant Institute, could have produced the first results showing that two patients became insulin-independent after undergoing treatment with an anti-CD40L monoclonal antibody and without taking tacrolimus, which is the current standard of care to prevent transplant rejections. Tacrolimus, a type of immunosuppressant, comes with a laundry list of toxicity issues, including kidney and beta cell toxicity, post-transplant new-onset diabetes, hypertension, brain fog and tremors, according to Eledon CEO David-Alexandre Gros. “We’re trying to get people off insulin, and yet, right when we’re giving them new islet cells, we’re giving them a drug that is going to harm,” Gros told Endpoints News . “We’re looking to develop a new generation of immunomodulator, one that will be both more effective as well as safer than the current standard of care.” Gros pointed to Vertex’s work in stem cell-derived islet cell therapy — the company announced over the summer that three of its patients had gone insulin-free using VX-880 — but patients also have to be on chronic immunosuppressive therapy. Vertex is working on VX-264, which is designed to treat patients without immunosuppressants, but Gros thinks there will be a place for Eledon’s drug, called tegoprubart, if VX-264 fails. “What we’re hoping to do is to unlock this market if tegoprubart can provide as good or better protection but without all of the side effects,” Gros said. “And so far, the data is very encouraging.” In the study, patients received islet transplants combined with induction therapy — mycophenolate mofetil plus tegoprubart — every three weeks by an IV infusion. The company said treatment with tegoprubart was “generally well-tolerated” in all subjects, with no unexpected adverse events, graft rejection or hypoglycemic episodes. A third patient decreased their insulin use by more than 60% three days after the transplant procedure. Along with achieving insulin independence at approximately three months and six months post-transplant, the first two patients also recorded normal HbA1c levels. All three patients saw improved islet engraftment — engraftment was three to five times higher than three comparable subjects who received only tacrolimus — and Eledon said this suggests that tegoprubart is “less toxic” to transplanted islets and led to improved graft survival and function. Back in 2020, Eledon bought tegoprubart through its acquisition of Anelixis, though the ALS Therapy Development Institute had discovered the drug. Eledon first ran a Phase 2 trial with the drug in ALS patients before pivoting to transplant rejection. It still has plans to develop the drug in ALS. The company is continuing the trial in islet cell transplant, which is designed for up to nine patients, and it has three ongoing trials in kidney transplantation. Editor’s note: This story has been updated with the name of the UChicago Medicine Transplant Institute.

Clinical ResultCell TherapyPhase 2AcquisitionImmunotherapy

07 Oct 2024

·www.prnewswire.com

The Positive Topline Results From Phase III Study of UCB/Biogen's Dapirolizumab Pegol Brings a Ray of Hope in Systemic Lupus Erythematosus Therapeutic Space | DelveInsight

UCB and Biogen reported encouraging topline findings from the Phase III PHOENYCS GO trial, which assessed dapirolizumab pegol, a novel Fc-free anti-CD40L drug candidate, in individuals with moderate-to-severe SLE. The promising outcomes with dapirolizumab pegol signify significant advancements in creating treatments that can enhance the quality of life for individuals with lupus, a condition that continues to have considerable unmet medical needs, particularly impacting women. LAS VEGAS, Oct. 7, 2024 /PRNewswire/ -- Systemic lupus erythematosus is a long-lasting autoimmune disorder that can impact various areas of the body. Lupus arises when the immune system, typically responsible for defending against infections and illnesses, mistakenly targets the body's own tissues. This misguided response leads to inflammation and, in some instances, lasting damage to tissues, potentially affecting a wide range of organs including the skin, joints, heart, lungs, kidneys, blood cells, and brain. As per the estimates, the prevalence of systemic lupus erythematosus in the United States is approximately 500K cases in 2023. In females, prevalence rates are observed to be much greater than that of males, constituting more than 90% of the total prevalent cases in the US. In 2023, among the treated SLE patients, nearly 40% of patients became relapsed or refractory after the first line of therapy. The main goals of SLE treatment are to alleviate symptoms, prevent or reduce organ damage and disease flare-ups, minimize drug toxicity, and improve the patient's overall quality of life. The SLE treatment plan primarily includes antimalarial medications (like hydroxychloroquine), glucocorticoids (such as prednisone or similar), immunosuppressive drugs (including methotrexate, azathioprine, or mycophenolate), and biologics, in addition to nonsteroidal anti-inflammatory drugs (NSAIDs) for managing inflammation and pain. Biologics are specifically used for patients who do not respond to standard treatments or for those with severe, organ-threatening diseases. Currently, the biologics approved by the US FDA as adjunct therapies for SLE patients are BENLYSTA and SAPHNELO. In contrast, the use of rituximab for treating SLE is considered off-label. Learn more about the FDA-approved SLE drugs @ Drugs for Systemic Lupus Erythematosus Treatment BENLYSTA (belimumab) is a fully human monoclonal antibody that targets and inhibits BLyS (B-lymphocyte stimulator), a protein found at elevated levels in patients with systemic autoimmune diseases such as systemic lupus erythematosus and lupus nephritis. By binding to soluble BLyS, BENLYSTA prevents the prolonged survival of B cells, including autoreactive B cells, and reduces their differentiation into plasma cells that produce immunoglobulins. However, BENLYSTA does not directly bind to B cells. First approved by the US FDA in 2011, it is the only biologic therapy approved for the treatment of active SLE and LN in more than 50 years, including for pediatric patients. SAPHNELO (anifrolumab) is a fully human monoclonal antibody and the first of its kind, targeting subunit 1 of the type I interferon (IFN) receptor to inhibit type I IFN activity. Type I IFNs, including IFN-alpha, IFN-beta, and IFN-kappa, are cytokines that play a role in the inflammatory pathways associated with systemic lupus erythematosus. Most adults with SLE exhibit increased type I IFN signaling, which correlates with greater disease activity and severity. SAPHNELO has been approved for the treatment of SLE in over 60 countries, including the US, EU, and Japan, with ongoing reviews in additional regions. To know more about SLE treatment options, visit @ New Treatment for Systemic Lupus Erythematosus SLE pipeline possesses some drugs in mid and late-stage developments to be approved in the near future. The emerging landscape holds a diverse range of therapeutic alternatives for treatment, including Litifilimab (Biogen), Ianalumab (Novartis), Cenerimod (Idorsia/Viatris), Dapirolizumab pegol (UCB/Biogen), Telitacicept (RC18) (RemeGen), and others in different lines of treatment. The expected launch of these therapies shall further create a positive impact on the market. Discover which therapies are expected to grab major SLE market share @ Systemic Lupus Erythematosus Market Report Dapirolizumab pegol is a novel investigational treatment, consisting of a humanized, Fc-free antigen-binding (Fab') fragment conjugated with polyethylene glycol (PEG). It works by inhibiting CD40L signaling, which has been shown to reduce B cell activation, decrease autoantibody production, limit type 1 interferon (IFN) secretion, and suppress the activation of T cells and antigen-presenting cells (APCs). In September 2024, UCB and Biogen announced that the Phase III PHOENYCS GO trial achieved its primary goal, showing clinical improvements in patients with moderate-to-severe systemic lupus erythematosus. Additionally, key secondary endpoints, assessing disease activity and flare-ups, also demonstrated clinical improvements. Following the positive results from the PHOENYCS GO study, UCB and Biogen are launching a second Phase 3 trial of dapirolizumab pegol in 2024, named PHOENYCS FLY. Participants from the PHOENYCS GO study will continue to be monitored in a long-term open-label extension. Biogen is working on developing Litifilimab (BIIB059), an experimental humanized monoclonal antibody. This antibody specifically targets and binds to blood dendritic cell antigen 2 (BDCA2), a receptor found on plasmacytoid dendritic cells (pDCs). When BDCA2 is engaged, it inhibits the production of type I interferons (IFN-I) and other inflammatory molecules. BDCA2 is exclusively expressed on the surface of human pDCs. Litifilimab acts as an inhibitor of B-cell lymphocyte stimulator. Currently, Biogen is conducting Phase III clinical trials to evaluate its use for treating SLE. Ianalumab, developed by Novartis, is an antibody aimed at the B-cell activating factor receptor (BAFF-R). It is designed to inhibit BAFF-R signaling and deplete B cells through antibody-dependent cellular cytotoxicity. The drug is currently undergoing a Phase III clinical trial for systemic lupus erythematosus, with the company expecting to submit it for approval by 2027, according to a recent presentation. Cenerimod is an oral, once-daily tablet that acts as a highly selective modulator of the sphingosine-1-phosphate receptor 1 (S1P1). Although the exact cause of systemic lupus erythematosus is not fully understood, T and B lymphocytes are believed to be the primary immune cells involved in the disease's progression. These cells express the S1P1 receptor on their surface. In February 2024, Idorsia Pharmaceuticals formed a major global research and development partnership with Viatris to advance and commercialize two Phase III assets, selatogrel and cenerimod, on a global scale. Discover more about drugs for SLE in development @ Systemic Lupus Erythematosus Clinical Trials The anticipated launch of these emerging therapies for SLE are poised to transform the market landscape in the coming years. As these cutting-edge therapies continue to mature and gain regulatory approval, they are expected to reshape the SLE market landscape, offering new standards of care and unlocking opportunities for medical innovation and economic growth. DelveInsight estimates that the market size for SLE is expected to grow from USD 3.2 billion in 2023 with a significant CAGR by 2034. This growth is mainly driven by ongoing clinical research and better diagnostic tools that might improve the prognosis of the disease. DelveInsight's latest published market report titled as Systemic Lupus Erythematosus Market Insight, Epidemiology, and Market Forecast – 2034 will help you to discover which market leader is going to capture the largest market share. The report provides comprehensive insights into the SLE country-specific treatment guidelines, patient pool analysis, and epidemiology forecast to help understand the key opportunities and assess the market's underlying potential. The SLE market report proffers epidemiological analysis for the study period 2020–2034 in the 7MM segmented into: Total SLE Diagnosed Prevalent Cases Total SLE Diagnosed Prevalent Cases by Gender Total SLE Diagnosed Prevalent Cases by Age SLE Severity-Based Diagnosed Prevalent Cases Total SLE Treated Cases The report provides an edge while developing business strategies by understanding trends shaping and driving the 7MM SLE market. Highlights include: 11-year Forecast 7MM Analysis Epidemiology-based Market Forecasting Historical and Forecasted Market Analysis upto 2034 Emerging Drug Market Uptake Peak Sales Analysis Key Cross Competition Analysis Industry Expert's Opinion Access and Reimbursement Download this SLE market report to assess the epidemiology forecasts, understand the patient journeys, know KOLs' opinions about the upcoming treatment paradigms, and determine the factors contributing to the shift in the SLE market. Also, stay abreast of the mitigating factors to improve your market position in the SLE therapeutic space. Related Reports Systemic Lupus Erythematosus Pipeline Systemic Lupus Erythematosus Pipeline Insight – 2024 report provides comprehensive insights about the pipeline landscape, pipeline drug profiles, including clinical and non-clinical stage products, and the key myasthenia gravis companies, including Yake Biotechnology, UCB, Sorrento Therapeutics, SinoMab Bioscience Ltd, Shanghai Junshi Biosciences, Sareum, Sanofi, Roche, Rheos Medicine, Resolve, Provention Bio, Pfizer, Novartis, Neovacs, Merck, Medsenic, Landos Biopharma, Kezar Life Sciences, Kangpu Biopharmaceuticals, Janssen Research & Development, Janssen, InnoCare, ImmuPharma, I-MAB Biopharma, ILTOO, Idorsia Pharmaceuticals, Horizon Therapeutics, Genovax, Exinda Thearapeutics, Equillium, Eli Lilly and Company, Eisai, Daiichi Sankyo Company, Corestem, Corbus Pharmaceuticals, Citryll BV, Chipscreen Biosciences, Carna Bioscience, Bristol-Myers Squibb, Brickell Biotech, Boston Pharmaceuticals, Biogen, Athos Therapeutics, Asahi Kasei Pharma, Aria Pharmaceuticals, Antengene Therapeutics, Amgen, Alpine Immune Sciences, Akeso Biopharma, AbbVie, among others. Systemic Lupus Erythematosus Epidemiology Systemic Lupus Erythematosus Epidemiology Forecast – 2032 report delivers an in-depth understanding of the disease, historical, and forecasted SLE epidemiology in the 7MM. Lupus Nephritis Market Lupus Nephritis Market Insights, Epidemiology, and Market Forecast – 2034 report delivers an in-depth understanding of the disease, historical and forecasted epidemiology, as well as the market trends, market drivers, market barriers, and key lupus nephritis companies, including NOVARTIS, MORPHOSYS, ASTRAZENECA, ROCHE, KEZAR LIFE SCIENCES, ALEXION PHARMACEUTICALS, NOVARTIS, CABALETTA BIO, among others. Lupus Nephritis Pipeline Lupus Nephritis Pipeline Insight – 2024 report provides comprehensive insights about the pipeline landscape, pipeline drug profiles, including clinical and non-clinical stage products, and the key lupus nephritis companies, including Inflection Biosciences, Equillium, Roche, Horizon Therapeutics, BeiGene, Janssen Research & Development, ImmPACT Bio, among others. About DelveInsight DelveInsight is a leading Business Consultant and Market Research firm focused exclusively on life sciences. It supports pharma companies by providing comprehensive end-to-end solutions to improve their performance. Get hassle-free access to all the healthcare and pharma market research reports through our subscription-based platform PharmDelve . Contact Us Shruti Thakur [email protected] +14699457679 Logo: SOURCE DelveInsight Business Research, LLP WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

Phase 3Drug Approval

100 Deals associated with Mycophenolate Sodium

External Link

KEGG	Wiki	ATC	Drug Bank
-	Mycophenolate Sodium	L04AA06	DB01024

R&D Status

Approved

10 top approved records.

to view more data

Indication	Country/Location	Organization	Date
Acute rejection of renal transplant	Austria	Novartis Pharma SAS	07 Feb 2004
Acute rejection of renal transplant	Belgium	Novartis Pharma SAS	07 Feb 2004
Acute rejection of renal transplant	Cyprus	Novartis Pharma SAS	07 Feb 2004
Acute rejection of renal transplant	Czechia	Novartis Pharma SAS	07 Feb 2004
Acute rejection of renal transplant	Denmark	Novartis Pharma SAS	07 Feb 2004
Acute rejection of renal transplant	Finland	Novartis Pharma SAS	07 Feb 2004
Acute rejection of renal transplant	France	Novartis Pharma SAS	07 Feb 2004
Acute rejection of renal transplant	Germany	Novartis Pharma SAS	07 Feb 2004
Acute rejection of renal transplant	Greece	Novartis Pharma SAS	07 Feb 2004
Acute rejection of renal transplant	Hungary	Novartis Pharma SAS	07 Feb 2004
Acute rejection of renal transplant	Iceland	Novartis Pharma SAS	07 Feb 2004
Acute rejection of renal transplant	Ireland	Novartis Pharma SAS	07 Feb 2004
Acute rejection of renal transplant	Italy	Novartis Pharma SAS	07 Feb 2004
Acute rejection of renal transplant	Luxembourg	Novartis Pharma SAS	07 Feb 2004
Acute rejection of renal transplant	Malta	Novartis Pharma SAS	07 Feb 2004
Acute rejection of renal transplant	Netherlands	Novartis Pharma SAS	07 Feb 2004
Acute rejection of renal transplant	Norway	Novartis Pharma SAS	07 Feb 2004
Acute rejection of renal transplant	Poland	Novartis Pharma SAS	07 Feb 2004
Acute rejection of renal transplant	Portugal	Novartis Pharma SAS	07 Feb 2004
Acute rejection of renal transplant	Slovakia	Novartis Pharma SAS	07 Feb 2004

Developing

10 top R&D records.

to view more data

Indication	Highest Phase	Country/Location	Organization	Date
Uveitis, Intermediate	Phase 3	Germany	Novartis Pharmaceuticals Corp.	01 Mar 2010
Nephrosis, Lipoid	Phase 3	France	Novartis AG	01 Oct 2009
Nephrotic Syndrome	Phase 3	France	Novartis AG	01 Oct 2009
Systemic Lupus Erythematosus	Phase 3	Netherlands	Novartis Pharmaceuticals Corp.	01 Jul 2007
Signs and Symptoms, Digestive	Phase 3	Canada	Novartis AG	01 May 2007
Chronic graft-versus-host disease	Phase 3	France	Novartis AG	01 Sep 2006
Chronic graft-versus-host disease	Phase 3	Germany	Novartis AG	01 Sep 2006
Chronic graft-versus-host disease	Phase 3	Italy	Novartis AG	01 Sep 2006
Chronic graft-versus-host disease	Phase 3	Netherlands	Novartis AG	01 Sep 2006
Chronic graft-versus-host disease	Phase 3	Spain	Novartis AG	01 Sep 2006

Clinical Result

Indication

Phase

Evaluation

View All Results

Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT04734197 (CTgov)	Phase 2	Secondary Sjögren's syndrome \| Dry Eye Syndromes	349	Mycophenolic Acid 0.1% (Mycophenolic Acid 0.1%)	rvlpavotto = iveijzezru tnxythpcey (eyviuntork, pwigubkhjm - rfkhymlgyx) View more	-	18 Mar 2025
				Mycophenolic Acid 0.3% (Mycophenolic Acid 0.3%)	rvlpavotto = epvmnjokld tnxythpcey (eyviuntork, ehjxbkofxz - qflzykapwl) View more
EULAR2024	Not Applicable	Lupus Nephritis	-	Azathioprine	oujbnaeiey(htmnwqhwos) = dcnulpsmwn safqkmlzql (asjpudqjgb )	-	05 Jun 2024
ATS2024	Not Applicable	-	110	Mycophenolate mofetil (MMF)	thnojfnnvv(zbjznneufr) = 56% ibbnkyxlrr (ougmlhtdhg ) View more	Positive	19 May 2024
ISN WCN2023	Not Applicable	COVID-19	251	MMF cessation	nrwmhowhzn(veivpsnyqe) = szytlajbpm xfiqmwjcux (fypodtibjp ) View more	Negative	01 Mar 2023
				MMF reduction/no manipulation	nrwmhowhzn(veivpsnyqe) = szyxrtnehi xfiqmwjcux (fypodtibjp ) View more
Tandem Meetings ASTCT and CIBMTR2023	Not Applicable	-	75	PTCy/MMF/TAC	npbgcknnqo(tijqyxneuy): HR = 0.39 (95% CI, 0.16 - 0.94), P-Value = 0.037	Positive	01 Feb 2023
				MTX/TAC
ASN2022	Not Applicable	-	-	Higher MMF group (750 mg BID)	trksufxmkh(ljvvdiwhvn) = wpioyikogm liksukdopl (wkpuopqxzq )	Positive	04 Nov 2022
				Lower MMF group (500 mg BID)	trksufxmkh(ljvvdiwhvn) = dsozynihht liksukdopl (wkpuopqxzq )
BLISS LN trial (BLNT) (ASN2022)	Not Applicable	Lupus Nephritis	20	Mycophenolate + Placebo	jcwwdtsphn(sffoicfnll) = qrpjiuhovo ggxnbpynyr (fggvvvhkad ) View more	Positive	03 Nov 2022
				Mycophenolate + Belimumab	jcwwdtsphn(sffoicfnll) = qdxmaxaewr ggxnbpynyr (fggvvvhkad ) View more
ATS2021	Not Applicable	Progressive fibrotic interstitial lung disease	-	Mycophenolate (MMF)	eirnczuefc(umjqqqyygs) = 5% of patients taking MMF experienced constitutional symptoms, which were also a common reason for medication discontinuation (14% of those who stopped MMF) snynkpvhvn (jtgvdawtry ) View more	-	03 May 2021
				Azathioprine (AZA)
P614 (EBMT2020)	Not Applicable	-	17	Cyclosporine and mycophenolate plus low doses of ATG	texrkbcqhz(mgdeuvyqne) = uopfogrpyr osvrukexgt (hrlvpgsant ) View more	-	29 Aug 2020
NCT00574197 (CTgov)	Phase 4	-	11	Mycophenolate Sodium	qygxbvlpfl(foguusnmlo) = gzmawenbvv rvitqxqnee (vmvviytqxl, 15.49) View more	-	08 Jul 2020

Translational Medicine

Boost your research with our translational medicine data.

view full example data

Deal

Boost your decision using our deal data.

view full example data

Core Patent

Boost your research with our Core Patent data.

view full example data

Clinical Trial

Identify the latest clinical trials across global registries.

view full example data

Approval

Accelerate your research with the latest regulatory approval information.

view full example data

Regulation

Understand key drug designations in just a few clicks with Synapse.

view full example data

Chat with Hiro

Get started for free today!

Accelerate Strategic R&D decision making with Synapse, PatSnap’s AI-powered Connected Innovation Intelligence Platform Built for Life Sciences Professionals.

Start your data trial now!

Synapse data is also accessible to external entities via APIs or data packages. Empower better decisions with the latest in pharmaceutical intelligence.

Bio

Bio Sequences Search & Analysis

Chemical

Chemical Structures Search & Analysis