[Translation] A randomized, open-label, four-period, completely repeated crossover design to evaluate the bioequivalence of a single oral dose of mycophenolate sodium enteric-coated tablets in Chinese healthy subjects on an empty stomach

主要目的：以广州市微生物研究所集团股份有限公司持有的麦考酚钠肠溶片为受试制剂（规格：0.18g），按生物等效性试验的有关规定，与Novartis Pharma GmbH持有的麦考酚钠肠溶片（商品名：Myfortic（米芙），规格180mg）为参比制剂，进行生物等效性试验，比较两种制剂在空腹条件下单次给药的生物等效性。次要目的：评估单剂口服受试制剂（麦考酚钠肠溶片，T）和参比制剂（商品名：Myfortic（米芙），R）在中国健康成年受试者中的安全性。

[Translation]

Main purpose: Using mycophenolate sodium enteric-coated tablets (specification: 0.18g) held by Guangzhou Institute of Microbiology Group Co., Ltd. as the test preparation, and mycophenolate sodium enteric-coated tablets (trade name: Myfortic, specification 180mg) held by Novartis Pharma GmbH as the reference preparation, a bioequivalence test was conducted according to the relevant provisions of the bioequivalence test to compare the bioequivalence of the two preparations under fasting conditions after a single dose. Secondary purpose: Evaluate the safety of a single oral dose of the test preparation (mycophenolate sodium enteric-coated tablets, T) and the reference preparation (trade name: Myfortic, R) in healthy adult subjects in China.

Start Date23 Jul 2024

Sponsor / Collaborator

Guangzhou Microorganism Research Institute

ChiCTR2400091632 / RecruitingPhase 4IIT

A Single-center, Single-arm Clinical Study of the Efficacy and Safety of Conversion of Mycophenolate Mofetil to Mycophenolate Sodium Enteric-Coated Tablets in Stable Phase of Kidney Transplant Recipients

Start Date25 Jan 2024

Sponsor / Collaborator

The First Affiliated Hospital of Xi'an Jiaotong University

100 Clinical Results associated with Mycophenolate Sodium

100 Translational Medicine associated with Mycophenolate Sodium

100 Patents (Medical) associated with Mycophenolate Sodium

2,182

Literatures (Medical) associated with Mycophenolate Sodium

01 Mar 2025·JOINT BONE SPINE

Article

Author: Kawka, Lou ; Arnaud, Laurent ; Sauleau, Erik ; Coury, Fabienne ; Fabacher, Thibaut

OBJECTIVES:

To investigate the risk and predictors of severity and mortality of COVID-19 infection in patients with Connective Tissue Diseases (CTDs).

METHODS:

Using the French nationwide claims and hospitalization database, we assembled a nation-wide exhaustive cohort of adult CTD patients with rheumatoid arthritis, systemic lupus, Sjögren's disease, inflammatory myopathies, systemic sclerosis. We analyzed the rates of hospitalization, severe inpatient stays (intensive care unit [ICU] admissions or in-hospital mortality), and in-hospital mortality with COVID-19 from January 1st to December 31st, 2020.

RESULTS:

The study included 329,276 CTD patients (75.5% female, mean age 65.2±15.3 years). Among these, 3,389 (1.03%) were hospitalized, with COVID-19 infection, 973 (0.29%) required admission to ICU and 713 (0.22%) died. Patients who were hospitalized had severe inpatient stays, or died were predominantly male, older and with comorbidities (P<0.0001 for all). The risk of hospitalization, severe inpatient stay, and death was significantly higher in patients treated with glucocorticoids, leflunomide, sulfasalazine, mycophenolate derivatives, and rituximab (P<0.05 for all). TNF inhibitors were associated with reduced hospitalizations and severe inpatient stays (P<0.05 for all) and methotrexate use was associated with decreased mortality (P<0.01).

CONCLUSION:

In CTD patients with COVID-19, use of glucocorticoids, rituximab, and certain immunosuppressants was associated with severity and mortality, while TNF inhibitors and methotrexate were protective. These findings can guide clinical and public health decisions for this highly vulnerable group.

01 Feb 2025·PEDIATRIC NEUROLOGY

Article

Author: Bauchat, Andrea ; Prasad, Vinod K ; Mahadeo, Kris M ; Driscoll, Timothy A ; Kurtzberg, Joanne ; Martin, Paul L ; Stokhuyzen, Andre

BACKGROUND:

Hematopoietic cell transplantation (HCT) is the standard of care treatment for children with Hurler syndrome (HS). This study describes the impact of newborn screening (NBS) on HCT outcomes for these patients.

METHODS:

Retrospective study of HS patients diagnosed through NBS and referred to Duke from 2017 to 2023. Patients received a myeloablative busulfan-based regimen and unrelated umbilical cord blood HCT, with cyclosporine and mycophenolate for graft-versus-host-disease prophylaxis.

RESULTS:

Patients (N =9) were transplanted at a median age of 5.2 months and median weight of 7.8 kg. Median reinfused total nucleated cell was 14.8 × 10⁷/kg. The median times to neutrophil and platelet engraftment were 17 and 48 days, respectively. No primary graft failures or rejections were observed. Post-HCT complications included sinusoidal obstructive syndrome, microangiopathy and autoimmune hemolytic anemia. At median follow-up of 29.1 months (range 4.1-72.2), 8 of 9 patients were alive with normal alpha-L-iduronidase (IDUA) levels, Lansky scores of 90-100%, and developing milestones. One patient died due to autoimmune hemolytic anemia on day +139 (with normal IDUA level and >98% donor chimerism at day +100).

CONCLUSIONS:

Early umbilical cord blood transplant during infancy of HS patients diagnosed through NBS is safe, feasible, and corrects IDUA enzyme deficiency. Follow-up studies will ascertain the long-term benefits of this approach.

01 Jan 2025·JOURNAL FRANCAIS D OPHTALMOLOGIE

État des lieux de la prise en charge de l’orbitopathie dysthyroidïenne modérée à sévère active en France à partir de 28 centres experts métropolitains

Article

Author: Lebranchu, P ; Drui, D. ; Ghoufi, A ; Soethoudt, M ; Mouriaux, F. ; Ben Miloud, N. ; Mouriaux, F ; Soethoudt, M. ; Bienvenu, B. ; Lebranchu, P. ; Ghoufi, A. ; Ben Miloud, N ; Drui, D ; Bienvenu, B

INTRODUCTION:

This study investigates the management of Graves'orbitopathy (GO) in France, at 26 university medical centers (CHU) as well as the Rothschild Foundation and the Quinze-Vingts national eye hospital in Paris.

METHODS:

The 28 metropolitan university medical centers were contacted by telephone or e-mail. The authors devised a 5-item questionnaire that explored the scheduling of multidisciplinary meetings, the existence or lack of a dedicated Graves' consultation service, the place of hospitalization, and first- and second-line treatments.

RESULTS:

Eighty-nine percent of hospital departments had a dedicated service for patients with GO, with 36% organizing multidisciplinary meetings. Intravenous corticosteroid therapy is still used as first-line treatment, while mycophenolate is used much less (14.3%), despite the new EUGOGO (European Group on Graves' orbitopathy) 2021 recommendations. For second-line treatment, tocilizumab is most commonly used (64%). Teprotumumab is available in France only on a compassionate basis, and its use is limited (18%).

CONCLUSION:

This study highlights the variability in practices and the importance of a multidisciplinary approach, while calling for national standardization of practices. Despite disparities in the application of recommendations, the emergence of second-line treatments such as tocilizumab and teprotumumab indicates a steady evolution in therapeutic options, although obstacles in terms of accessibility and cost remain.

News (Medical) associated with Mycophenolate Sodium

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

06 May 2024

·www.prnewswire.com

AZURITY PHARMACEUTICALS, INC. ANNOUNCES FDA APPROVAL OF MYHIBBIN™ (mycophenolate mofetil oral suspension)

WOBURN, Mass., May 6, 2024 /PRNewswire/ -- Azurity Pharmaceuticals, a pharmaceutical company focused on developing innovative dose forms and formulations of products to serve the needs of overlooked patients, announced today that the U.S. Food and Drug Administration (FDA) has approved Myhibbin™, the only ready-to-use mycophenolate mofetil oral suspension. Mycophenolate mofetil is an antimetabolite immunosuppressant used to protect a donated organ from being rejected from the body's immune response. In 2023, there were over 46,000 transplants in the US and these patients need to take medication every day to fight against rejection. Myhibbin is indicated for the prophylaxis of organ rejection in adult and pediatric recipients 3 months of age and older of allogeneic kidney, heart, or liver transplants, in combination with other immunosuppressants. "We are very pleased that adult and pediatric organ transplant recipients will soon have access to the only FDA-approved ready-to-use oral liquid formulation of mycophenolate," said Richard Blackburn, CEO of Azurity Pharmaceuticals. "Patients are our priority, and our purpose is to bring them new formulations that help them benefit from established medicines. Myhibbin's ready-to-use formulation provides patients, pharmacists, and caregivers an alternative to other mycophenolate dosage forms." It is expected that Myhibbin will become commercially available in pharmacies nationwide in Q2 2024. For full prescribing information including black box warning, please go to . About Azurity Pharmaceuticals, Inc. Azurity specializes in providing innovative, high-quality medicines that serve overlooked patients. We supply a large number of products to treat a wide range of medical conditions. These include cardiovascular, central nervous system, endocrine, gastro-intestinal, anti-infective and oncology medicines. Many of our medicines are dose-form innovations for patients with needs that are not met by other available products. Our medicines have benefited millions of people. For more information, visit . SOURCE Azurity Pharmaceuticals

Drug ApprovalImmunotherapy

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.

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Indication	Country/Location	Organization	Date
Acute rejection of renal transplant	FR	Novartis Pharma SAS	07 Feb 2004
Renal transplant rejection	CH	Novartis Pharma Schweiz AG	24 Oct 2002

Developing

10 top R&D records.

to view more data

Indication	Highest Phase	Country/Location	Organization	Date
Uveitis, Intermediate	Phase 3	DE	Novartis Pharmaceuticals Corp.	01 Mar 2010
Nephrosis, Lipoid	Phase 3	FR	Novartis AG	01 Oct 2009
Nephrotic Syndrome	Phase 3	FR	Novartis AG	01 Oct 2009
Systemic Lupus Erythematosus	Phase 3	NL	Novartis Pharmaceuticals Corp.	01 Jul 2007
Signs and Symptoms, Digestive	Phase 3	CA	Novartis AG	01 May 2007
Autoimmune Diseases	Phase 3	DE	Novartis Pharmaceuticals Corp.	01 Jun 2006
Hepatitis C	Phase 3	-	Novartis Pharmaceuticals Corp.	01 Apr 2004
Kidney Diseases	Phase 3	-	Novartis Pharmaceuticals Corp.	01 Apr 2004
Heart Diseases	Phase 3	-	Novartis Pharmaceuticals Corp.	01 Apr 2003
Transplant glomerulopathy	Phase 3	-	Novartis AG	01 Oct 2002

Clinical Result

Indication

Phase

Evaluation

View All Results

Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


EULAR2024	Not Applicable	Lupus Nephritis	-	Azathioprine	dbtkfqqqpe(qsuggnbgae) = xnrbuvumbd ovsfgtgvrd (dpaeiimmag )	-	05 Jun 2024
ATS2024	Not Applicable	-	110	Mycophenolate mofetil (MMF)	dkoowwfcex(oskvbsicyv) = 56% qudaotvbhm (vqwwebckyf ) View more	Positive	19 May 2024
Pubmed \| Blood Adv	Not Applicable	Graft vs Host Disease	-	Tacrolimus/MTX	czfcoqqsmz(arrdyfnhmt) = veghkpofgi jadpvsjxjc (zhlpxnlgdi ) View more	-	23 Jun 2023
				Tac/mini-MTX/MMF	czfcoqqsmz(arrdyfnhmt) = jqavryrsxb jadpvsjxjc (zhlpxnlgdi ) View more
ISN WCN2023	Not Applicable	COVID-19	251	MMF cessation	uhhhaxvgby(tmpolggujz) = gcmuafbuqj nwuwjxtkht (hpzvglhipy ) View more	Negative	01 Mar 2023
				MMF reduction/no manipulation	uhhhaxvgby(tmpolggujz) = ovbxvycwyz nwuwjxtkht (hpzvglhipy ) View more
Tandem Meetings ASTCT and CIBMTR2023	Not Applicable	-	75	PTCy/MMF/TAC	qhaamodnto(hdbyzlaapj): 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)	vqpaoviomv(tvnkshdudf) = ijsioskqmi dpkwbecdxj (hvrnyfivgz )	Positive	04 Nov 2022
				Lower MMF group (500 mg BID)	vqpaoviomv(tvnkshdudf) = kznsnhlkfv dpkwbecdxj (hvrnyfivgz )
BLISS LN trial (BLNT) (ASN2022)	Not Applicable	Lupus Nephritis	20	Mycophenolate + Placebo	fqjnpszwhy(ybcrgxczjd) = kkczapmmtp wpnrzojshg (gdtstyjvrm ) View more	Positive	03 Nov 2022
				Mycophenolate + Belimumab	fqjnpszwhy(ybcrgxczjd) = jmcnktbnpt wpnrzojshg (gdtstyjvrm ) View more
ATS2021	Not Applicable	Progressive fibrotic interstitial lung disease	-	Mycophenolate (MMF)	pyuvxmvpas(gkxvsidgww) = 5% of patients taking MMF experienced constitutional symptoms, which were also a common reason for medication discontinuation (14% of those who stopped MMF) silihnspzf (xbiiafdvrx ) View more	-	03 May 2021
				Azathioprine (AZA)
P614 (EBMT2020)	Not Applicable	-	17	Cyclosporine and mycophenolate plus low doses of ATG	fspoiywigv(tchbyrozzw) = xvsitqzhqc unvirprvqq (fbckbetdiy ) View more	-	29 Aug 2020
NCT00574197 (CTgov)	Phase 4	-	11	Mycophenolate Sodium	smfxujvvbr(hqpkacvbzc) = uhthtyjxfj znuwildscv (tpcwxvabjf, zvzloaqpet - aqwdqzmjlh) View more	-	08 Jul 2020

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