主要研究目的：本研究以成都倍特药业股份有限公司生产的麦考酚钠肠溶片（0.36g）为受试制剂，以原研厂家 Novartis Pharma Produktions GmbH 生产的麦考酚钠肠溶片（360mg，商品名：Myfortic®）为参比制剂，评价受试制剂和参比制剂在空腹和餐后条件下给药时的生物等效性。次要研究目的：观察受试制剂和参比制剂在健康受试者中的安全性。

[Translation]

Main research purpose: This study uses mycophenolate sodium enteric-coated tablets (0.36g) produced by Chengdu Beite Pharmaceutical Co., Ltd. as the test preparation and mycophenolate sodium enteric-coated tablets (360mg, trade name: Myfortic®) produced by the original manufacturer Novartis Pharma Produktions GmbH as the reference preparation to evaluate the bioequivalence of the test preparation and the reference preparation when administered under fasting and postprandial conditions. Secondary research purpose: Observe the safety of the test preparation and the reference preparation in healthy subjects.

Start Date30 Dec 2023

Sponsor / Collaborator

Brilliant Pharmaceutical Co. Ltd.

CTR20231670 / CompletedNot Applicable

麦考酚钠肠溶片人体生物等效性研究

[Translation] Study on the bioequivalence of mycophenolate sodium enteric-coated tablets in healthy volunteers

考察健康受试者在空腹及餐后条件下，单次口服由浙江美迪深生物医药有限公司持证、华益药业科技（安徽）有限公司生产的麦考酚钠肠溶片（受试制剂，规格：180mg）与相同条件下单次口服由Novartis Pharma GmbH持证的麦考酚钠肠溶片（参比制剂，商品名：Myfortic®，规格：180mg）的药代动力学特征，评价两制剂间的生物等效性和安全性，为该受试制剂注册申请提供依据。

[Translation]

To investigate the pharmacokinetic characteristics of a single oral administration of Mycophenol Sodium Enteric-coated Tablets (test preparation, specification: 180 mg) certified by Zhejiang Medishen Biopharmaceutical Co., Ltd. and produced by Huayi Pharmaceutical Technology (Anhui) Co., Ltd. to healthy subjects under fasting and postprandial conditions, and a single oral administration of Mycophenol Sodium Enteric-coated Tablets (reference preparation, trade name: Myfortic®, specification: 180 mg) certified by Novartis Pharma GmbH under the same conditions, to evaluate the bioequivalence and safety of the two preparations, and to provide a basis for the registration application of the test preparation.

Start Date02 Jun 2023

Sponsor / Collaborator

Zhejiang Meidishen Biomedical Co., Ltd.

ChiCTR2300075403 / CompletedNot ApplicableIIT

Pharmacokinetics and Bioequivalence study of mycophenolate sodium enteric-coated tablets in healthy Chinese volunteers

Start Date02 Jun 2023

Sponsor / Collaborator-

100 Clinical Results associated with Mycophenolate Sodium

100 Translational Medicine associated with Mycophenolate Sodium

100 Patents (Medical) associated with Mycophenolate Sodium

2,325

Literatures (Medical) associated with Mycophenolate Sodium

JAMA network open

Prenatal Care Initiation and Exposure to Teratogenic Medications

Article

Author: Ewig, Celeste ; Smolinski, Nicole E ; Thai, Thuy N ; Wang, Yanning ; Rasmussen, Sonja A ; Winterstein, Almut G

Importance:

With new legal abortion restrictions, timing of prenatal care initiation is critical to allow for discussion of reproductive options among pregnancies exposed to teratogenic medications.

Objective:

To investigate the prevalence of prenatal exposure to teratogenic medications and prenatal care initiation across gestational weeks.

Design, Setting, and Participants:

This descriptive, population-based cross-sectional study used health encounter data from a national sample of individuals with employer-sponsored health insurance. A validated algorithm identified pregnancies among persons identifying as female that ended with a live or nonlive outcome between January 2017 and December 2019. Data were analyzed from December 2022 to December 2023.

Exposures:

Prenatal exposure to any of 137 teratogenic medications, measured via pharmacy and medical claims. Measurement of prenatal care initiation was adapted from the Children’s Health Care Quality Measures.

Main Outcomes and Measures:

Prevalence of prenatal exposure to teratogens and prenatal care initiation by gestational week. Timing of prenatal teratogenic exposure was compared with timing of prenatal care initiation and legal abortion cutoffs.

Results:

Among 639 994 pregnancies, 472 472 (73.8%; 95% CI, 73.7%-73.9%) had a live delivery (mean [SD] age, 30.9 [5.4] years) and 167 522 (26.2%; 95% CI, 26.1%-26.3%) had a nonlive outcome (mean [SD] age, 31.6 [6.4] years). Of pregnancies with live deliveries, 5.8% (95% CI, 5.7%-5.8%) were exposed to teratogenic medications compared with 3.1% (95% CI, 3.0%-3.2%) with nonlive outcomes. Median time to prenatal care was 56 days (IQR, 44-70 days). By 6 weeks’ gestation, 8186 pregnancies had been exposed to teratogenic medications (25.2% [95% CI, 24.7%-25.7%] of pregnancies exposed at any time during gestation; 1.3% [95% CI, 1.3%-1.3%] of all pregnancies); in 6877 (84.0%; 95% CI, 83.2%-84.8%), prenatal care was initiated after 6 weeks or not at all. By 15 weeks, teratogenic exposures had occurred for 48.9% (95% CI, 48.4%-49.5%) of all teratogen-exposed pregnancies (2.5% [2.4-2.5] of all pregnancies); prenatal care initiation occurred after 15 weeks for 1810 (16.8%; 95% CI, 16.1%-17.5%) with live deliveries and 2975 (58.3%; 95% CI, 56.9%-59.6%) with nonlive outcomes. Teratogenic medications most used within the first 15 gestational weeks among live deliveries included antiinfectives (eg, fluconazole), anticonvulsants (eg, valproate), antihypertensives (eg, lisinopril), and immunomodulators (eg, mycophenolate). For nonlive deliveries, most antihypertensives were replaced by vitamin A derivatives.

Conclusions and Relevance:

In this cross-sectional study, most exposures to teratogenic medications occurred in early pregnancy and before prenatal care initiation, precluding prenatal risk-benefit assessments. Prenatal care commonly occurred after strict legal abortion cutoffs, prohibiting consideration of pregnancy termination if concerns about teratogenic effects arose.

01 Feb 2024·Journal of the American Academy of Dermatology

Executive summary: Guidelines of care for the management of atopic dermatitis in adults with phototherapy and systemic therapies

Review

Author: Davis, Dawn M R ; Darr, Jennifer M ; Alikhan, Ali ; Schwarzenberger, Kathryn ; Cohen, David E ; Frazer-Green, Lindsy ; Silverberg, Jonathan I ; Eichenfield, Lawrence F ; Singh, Anne Marie ; Paller, Amy S ; Sidbury, Robert ; Drucker, Aaron M ; Bercovitch, Lionel ; Wu, Peggy A

BACKGROUND:

The summarized guidelines update the 2014 recommendations for the management of AD with phototherapy and systemic therapies.

METHODS:

A multidisciplinary workgroup conducted a systematic review and applied the GRADE approach for assessing the certainty of the evidence and formulating and grading recommendations.

RESULTS:

The workgroup developed 11 recommendations on the management of AD in adults with phototherapy and systemic therapies, including biologics, oral Janus Kinase inhibitors, and other immunomodulatory medications.

CONCLUSIONS:

The evidence supported strong recommendations for the use of dupilumab, tralokinumab, abrocitinib, baricitinib, and upadacitinib and conditional recommendations in favor of using phototherapy, azathioprine, cyclosporine, methotrexate, and mycophenolate, and against the use of systemic corticosteroids.

01 Feb 2024·Annals of the American Thoracic Society

Rituximab in Patients with Systemic Sclerosis–associated Interstitial Lung Disease: A Systematic Review and Meta-Analysis

Review

Author: Herman, Derrick ; Raghu, Ganesh ; Macrea, Madalina ; Hossain, Tanzib ; Silver, Richard M ; Knight, Shandra L ; Barnes, Hayley ; Montesi, Sydney B ; Ghazipura, Marya

Background: The American Thoracic Society convened an international, multidisciplinary panel to develop clinical practice guidelines for the treatment of systemic sclerosis-associated interstitial lung disease (SSc-ILD). Objective: To conduct a systematic review and evaluate the literature to determine whether patients with SSc-ILD should be treated with rituximab. Data Sources: A literature search was conducted across MEDLINE, EMBASE, and Cochrane Central Register of Controlled Trials (CENTRAL) databases through June 2022 for studies using rituximab to treat patients with SSc-ILD. Data Extraction: Disease progression, quality of life, mortality, and adverse event data were extracted. The intervention was rituximab. The standard-of-care comparator group was decided a priori by consensus of the panel as either placebo or mycophenolate. The Grading of Recommendations, Assessment, Development, and Evaluation (GRADE) Working Group approach was used to assess the quality of evidence. Synthesis: Three relevant studies were selected. Rituximab significantly improved the forced vital capacity % predicted (mean difference, 3.13; 95% confidence interval [CI], 0.37 to 5.90) and the modified Rodnan Skin Score (mean difference, -7.01; 95% CI, 11.46 to -2.56) at 24-48 weeks. Conclusions: Rituximab use in patients with SSc-ILD is associated with stabilization of lung function. The quality of evidence for study outcomes was considered to be very low, as defined by the GRADE approach. Additional research on treatment with rituximab is imperative.

News (Medical) associated with Mycophenolate Sodium

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

13 Mar 2024

·www.biospace.com

Surface Ophthalmics Announces New Leadership with Richard Lindstrom, MD, and Renewed Vision for Addressing Critical Unmet Needs of Dry Eye Syndrome Patients

With over 40 years of ophthalmology industry experience, Dr. Lindstrom will lead Surface Ophthalmics into its next stage of growth as it advances its innovative and patented proprietary portfolio for dry eye syndrome. PLEASANTON, Calif.--(BUSINESS WIRE)-- Surface Ophthalmics, a pioneering biopharmaceutical company, dedicated to transforming the management and treatment of dry eye syndrome (DES), today announced the appointment of Richard Lindstrom, MD as Founder & Chairman. A highly acclaimed physician and surgeon in ophthalmology, Dr. Lindstrom is founder and attending surgeon emeritus at Minnesota Eye Consultants, P.A. Dr. Lindstrom will lead in partnership with Surface’s distinguished Board of Directors including Adrienne Graves, Ph.D., (Lead Director); Perry J. Sternberg, Shelley Thunen, and J. Andy Corley. In the US alone, an estimated 38 million people have some form of DES, yet only 17 million are diagnosed and fewer still, 1.7 million, are using a prescription therapy.1,2 With its product portfolio in development, Surface seeks to address the full range of DES, from episodic to chronic by providing eye care professionals targeted therapies to treat the signs, symptoms, and underlying causes of DES, which can be naturally occurring or following ocular surgery.3 “I am honored and thrilled to lead Surface Ophthalmics into its next phase of expansion as we work to advance the company’s innovative and proprietary medicinal candidates for patients suffering from DES,” said Dr. Lindstrom. “Our solutions hold significant potential to meet existing gaps in care, and I’m eager to collaborate with our talented team to introduce these products to the market.” Surface Ophthalmics is advancing two products: Kera Sol™ Tears, an over-the-counter artificial tear solution designed for cell-compatible, short-term, fast-acting, temporary relief of burning and irritation caused by dryness of the eye. Additionally, the company is progressing the clinical program for its investigational drug, Mycosol (Surf-101), a first-in-class prescription eye drop that delivers Mycophenolate in Surface’s proprietary formulation. This combination is designed to provide sustained immunosuppressive action and mucin upregulation at the ocular surface. Richard Lindstrom, MD Dr. Richard Lindstrom is founder and attending surgeon emeritus at Minnesota Eye Consultants P.A., a provider of eye care services, since 1989. Dr. Lindstrom has served as a researcher, teacher, inventor, writer, lecturer and highly acclaimed physician and surgeon in the ophthalmology field. Dr. Lindstrom has served as associate director of the Minnesota Lions Eye Bank from 1987 - 2017. He is a medical advisor for several medical device and pharmaceutical manufacturers and serves on the boards of several public and privately held life sciences companies. Dr. Lindstrom previously served as president of the International Society of Refractive Surgery from 1993 to 1994, the International Intraocular Implant Society from 2002 to 2004, the International Refractive Surgery Club from 2002 to 2004, and the American Society of Cataract and Refractive Surgery from 2007 to 2008. He currently serves on the ASCRS Executive Committee and is a past chair of the ASCRS Foundation. From 1980 to 1989, he served as a professor of ophthalmology at the University of Minnesota, where he is currently an adjunct professor and foundation trustee emeritus. Dr. Lindstrom also chaired the Ophthalmology and Visual Neurosciences Foundation for three decades. About Surface Ophthalmics Surface Ophthalmics is a pioneering biopharmaceutical firm dedicated to the discovery and market introduction of novel treatments for diseases affecting the ocular surface. Our mission is to address critical unmet needs in eye care by harnessing in-depth expertise, a dynamic strategy, operational efficiency, and distinctive clinical advantages. To learn more visit and follow us on LinkedIn. References 1 2019 Dry Eye Products Market Report, Market Scope 2 Symphony Rx Data divided by DES Prevalence Study and validated with Market Scope data 3 Craig JP, et al., TFOS DEWS II Report Executive Summary, The Ocular Surface (2017)

Executive Change

06 Nov 2023

·www.prnewswire.com

LRA Highlights Groundbreaking Lupus Research at ACR Convergence 2023

This information is brought to you by the Lupus Research Alliance and Lupus Therapeutics and is not sponsored by, nor a part of, the American College of Rheumatology. 30+ presentations of studies funded by the LRA spanning a broad spectrum of research areas Positive results from Phase 2/3 clinical studies supported by LRA affiliate Lupus Therapeutics point to potential new treatments Lupus Therapeutics' PALS Program helps overcome challenges of diverse lupus patient trial participation SAN DIEGO, Nov. 6, 2023 /PRNewswire/ -- The Lupus Research Alliance (LRA), the largest non-governmental non-profit funder of lupus research worldwide, is pleased to announce results from more than 30 studies supported by the LRA and its clinical research affiliate Lupus Therapeutics will be presented at ACR Convergence 2023, the annual meeting of the American College of Rheumatology. Studies will represent the full continuum of research that the LRA and Lupus Therapeutics support, from innovative foundational research to lupus clinical trials evaluating potential new treatments. "The LRA and Lupus Therapeutics are extremely proud of the tremendous work we have supported that will contribute to the dynamic scientific dialogue at this important rheumatology meeting,' commented LRA President and CEO Albert T. Roy. "We also look forward to many presentations of exciting clinical research, including results from CAR-T cell therapy studies that built on pioneering work funded by the LRA and have the potential to shift the lupus treatment paradigm." FOUNDATIONAL RESEARCH FUNDED BY THE LRA LRA-funded investigators will be presenting their recent breakthroughs across a broad spectrum of lupus research, including the impact of lupus on various organs such as the skin, kidney, and brain, the contribution of the gut microbiome to lupus, dysregulation of a variety of immune cell types underlying lupus, and more. ORAL PRESENTATIONS Sunday, Nov. 12 APOL1 High Risk Genotype in SLE: A Genes in Context Story Abstract # NA, 12:00 PM – Room 11A-B ROCK1 Orchestrates B-cell Differentiation Under Stress Abstract #0729, 2:30 PM – Room 30D-E Lupus Nephritis Flares Linked to Platelet Activation During Gut Pathobiont Blooms Abstract #0851, 5:00 PM, Exhibit Hall A-B Monday, Nov. 13 CXCL13+ T cell differentiation in systemic lupus erythematosus is controlled by opposing effects of aryl hydrocarbon receptor and type I interferon Abstract #1580, 11:15 AM – Exhibit Hall A-B Metabolic Mechanisms that Control Inflammation and Immune-related Disorders Plenary Session II, 12:00 PM – Room 30D-E Keratinocyte VISTA Suppresses Skin IFN-I Production by Regulating DNA Damage Repair and Cytosolic DNA Sensing Abstract #1586, 2:15 PM – Room 32A-B Single-Cell RNA Sequencing Reveals Cellular Drivers of UV-mediated Skin Injury in Cutaneous Lupus Abstract #1599, 2:30 PM – Room 6F/6C Identifying Potential Neuroimaging Biomarkers of Neuropsychiatric Lupus in Children Using Deep Learning Abstract #1625, 3:00 PM – Room 7A-B Tuesday, Nov. 14 Longitudinal Gut Microbiome Analyses and Blooms of Pathogenic Strains during Lupus Disease Flares Abstract #NA, 8:20 AM – Room 6F/6C Development of Engineered Smith-Specific Regulatory T Cells to Treat Lupus Nephritis Abstract #2444, 2:15 PM – Room 26A-B Targeting of Endothelial Dysfunction in Lupus Nephritis: Effect on Human Renal Endothelial Cell Gene Expression and Outcomes in Murine Lupus Nephritis Abstract #2445, 2:30 PM – Room 26A-B UV Light Exposure Induces a Type I Interferon Dependent Activation and Migration of Inflammatory Dendritic Cells to Local Lymph Nodes Abstract #2448, 3:15 PM – Room 26A-B Wednesday, Nov. 15 In Situ Adaptive Immunity in Human Lupus Nephritis Abstract # N/A, 8:30 AM – Room 29A-D POSTER PRESENTATIONS – Poster Hall Sunday, Nov. 12 Elevated Serum Levels of S100A8/A9 Discriminate Systemic Lupus Erythematosus Patients with Cognitive Impairment from Patients Without Impairment Abstract #0558, 9:00 AM Comparison of Plasma Protein Profiles and Endothelial Function in Patients with Pediatric-Onset Systemic Lupus Erythematosus and Healthy Controls Abstract #0568, 9:00 AM Monday, Nov. 13 Specificity of Brain-Intrinsic and Hematopoietic-Derived Mechanisms in Mediating Neuropsychiatric Symptoms of Systemic Lupus Erythematosus Abstract #0890, 9:00 AM Adverse Childhood Experiences in a Paediatric Systemic Lupus Erythematosus Cohort Abstract #1241, 9:00 AM Agreement Between Parent- and Self-Report of Executive Function in Adolescents with Childhood-Onset Systemic Lupus Erythematosus Abstract #1242, 9:00 AM Proinflammatory Neutrophils and NETs Mediate Skin and Kidney Inflammation During Lupus Flare in Asymptomatic Lupus-prone Mice Triggered by UVB Abstract #0920, 9:00 AM IL-4 Acts Through Aryl Hydrocarbon Receptor to Antagonize TLR7-induced Double Negative 2 B Cells in Lupus Abstract #0925, 9:00 AM Examining the Relationship Between Socioenvironmental Factors and Cognitive Functioning in Youth with Childhood-Onset Systemic Lupus Erythematosus Abstract #1226, 9:00 AM Longitudinal Assessment of Self-reported Executive Function in Youth with Childhood-Onset Lupus Abstract #1229, 9:00 AM Complement Deposition on Extracellular Mitochondria Induces Platelet Activation in Vitro Abstract #0900, 9:00 AM The Cellular and Spatial Type I Interferon Response Following Skin Exposure to Ultraviolet Light Abstract #0894, 9:00 AM Tuesday, Nov. 14 Brain Activity Patterns and Behavioural Performance in SLE Patients During a Spatial Working Memory and Sustained Attention Task Abstract #2258, 9:00 AM The Effects of Systematic Lupus Erythematosus Related Cognitive Impairments on Activities of Daily Living and Life Role Participation: A Qualitative Framework Study Abstract #2259, 9:00 AM Association of Mycophenolate and Azathioprine Use with Cognitive Function in Systemic Lupus Using a Bayesian Longitudinal Item-response Theory Model Abstract #2290, 9:00 AM CLINICAL TRIALS SUPPORTED BY LUPUS THERAPEUTICS As the clinical research affiliate of the LRA, Lupus Therapeutics collaborates with biotechnology and pharmaceutical companies, as well as lupus experts from their Lupus Clinical Investigators Network (LuCIN) to help design and conduct high-quality, patient-centric, and diverse lupus studies, including several with results being presented at ACR Convergence 2023. ORAL PRESENTATIONS Tuesday, Nov. 14 Efficacy and Safety of ABBV-599 High Dose (Elsubrutinib 60 mg and Upadacitinib 30 mg) and Upadacitinib Monotherapy for the Treatment of Systemic Lupus Erythematosus: A Phase 2, Double-blind, Placebo-controlled Trial Abstract #2488, 2:00 PM – Ballroom 20D Phase 2 Safety and Efficacy of Subcutaneous (s.c.) Dose Ianalumab (VAY736; Anti-BAFFR mAb) Administered Monthly over 28 Weeks in Patients Abstract #2487, 2:00 PM – Ballroom 20D POSTER PRESENTATIONS – Poster Hall Monday, Nov. 13 Treatment with Upadacitinib in Patients with Systemic Lupus Erythematosus Results in the Inhibition of B-Cell–related Biomarkers: Analysis of the M19-130 (SLEek) Phase 2 Study Abstract #1489, 9:00 AM Disease Course and Complement as Predictors of Response to Standard of Care Plus Placebo in Patients with SLE: A Post Hoc Analysis of Dapirolizumab Pegol and Epratuzumab Clinical Trial Data Abstract #1503, 9:00 AM Steroid-sparing Effects of Afimetoran (BMS-986256), an Equipotent Toll-like Receptor (TLR)7 and TLR8 Antagonist, in a Lupus Mouse Model Abstract #0897, 9:00 AM Transcriptomic Analysis of the Impact of Iberdomide on Patients with SLE Abstract #1694, 4:00 PM Tuesday, Nov. 14 Dapirolizumab Pegol Impacts Important Immunologic Pathways in SLE: Pharmacodynamic Analysis of B Cell and Type I Interferon Pathways from a Phase 2b Trial Abstract #2333, 9:00 AM Modulation of B Cell and Interferon Pathways by Ianalumab in Patients with Systemic Lupus Erythematosus: Findings from a Phase 2 Clinical Trial Abstract #2342, 9:00 AM WORK CONDUCTED THROUGH THE LUPUS THERAPEUTICS PALS PROGRAM Patient Advocates for Lupus Studies (PALS) is a peer support program that aims to improve participation in lupus clinical trials through increased education and availability of information about clinical trials. Individuals living with lupus who have clinical research act as peer educators, or PALs, to deliver educational sessions to others living with lupus. The PALS program was piloted from 2019-2021 and demonstrated significant increases in knowledge about, attitudes toward, and intentions to participate in lupus clinical trials among program participants. POSTER PRESENTATION – Poster Hall Sunday, Nov. 12 Barriers and Facilitators to Recruiting Underrepresented Participants for Clinical Trials: Insights from the Lupus Clinical Investigators Network (LuCIN) Abstract #0183, 9:00 AM WORK CONDUCTED BY THE ACCELERATING MEDICINES PARTNERSHIP The LRA is a partner in Accelerating Medicines Partnership® Autoimmune Mediated Disease (AMP® AIM), which brings together 20 organizations from the public, private, and nonprofit sectors to accelerate the identification and validation of new therapeutic targets by reconstructing shared immune response pathways through spatial and multi-omics technologies. The project is managed by the FNIH and builds on the success of AMP RA/SLE in which LRA was also a partner. The presentation of results from an AMP® AIM lupus study is noted below. ORAL PRESENTATION Monday, Nov. 13 Single Cell Transcriptomics in Kidney Tissue from African American Patients Enrolled in the Accelerating Medicines Partnership (AMP) Implicates Tubular Cells in the Pathogenesis of APOL1 Associated Lupus Nephritis Abstract #1695, 4:30 PM – Room 6F/6C About Lupus Lupus is a chronic, complex autoimmune disease that affects millions of people worldwide. More than 90 percent of people with lupus are women, often striking during the childbearing years of 15-45. Blacks/African Americans, Hispanics, Asians, and Native Americans are at two to three times greater risk than Caucasians for developing lupus. In lupus, the immune system, meant to defend against infections, produces antibodies that mistakenly recognize the body's own cells as foreign, prompting other immune cells to attack and potentially damage organs such as the kidneys, brain, heart, lungs, blood, skin, and joints. About Lupus Research Alliance The Lupus Research Alliance is the largest non-governmental, non-profit funder of lupus research worldwide. The organization aims to transform treatment by funding the most innovative lupus research, fostering diverse scientific talent, and driving discovery toward better diagnostics, improved treatments and ultimately, cure for lupus. Because the Lupus Research Alliance's Board of Directors funds all administrative and fundraising costs, 100% of all donations goes to support lupus research programs. About Lupus Therapeutics Lupus Therapeutics, the clinical research affiliate of the Lupus Research Alliance, aims to accelerate the development of curative treatments for all patients living with lupus. Lupus Therapeutics collaborates with academic institutions, biotechnology, and pharmaceutical partners through the unprecedented Lupus Clinical Investigators Network (LuCIN) to drive rapid and meaningful progress in the treatment of lupus patients. The organization elevates the patient voice, engages community stakeholders, and strives for representation of the diverse lupus community in the clinical research process with the most innovative and renowned experts throughout North America. Visit lupustherapeutics.org for more information. SOURCE Lupus Research Alliance

Phase 2Clinical Result

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
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
Acute rejection of renal transplant	Phase 3	-	Novartis AG	01 Mar 2004
Heart Diseases	Phase 3	-	Novartis Pharmaceuticals Corp.	01 Apr 2003

Clinical Result

Indication

Phase

Evaluation

View All Results

Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


Pubmed	Not Applicable	Graft vs Host Disease	-	Tacrolimus/MTX	wyslwxqgka(ucunruzqrp) = gowyvkeenu nnrxyfojuk (cyjurmbhcp ) View more	-	23 Jun 2023
				Tac/mini-MTX/MMFTac/mini-MTX/MMF	wyslwxqgka(ucunruzqrp) = qkjqmgfefa nnrxyfojuk (cyjurmbhcp ) View more
ASN2022	Not Applicable	Lupus Nephritis	20	Mycophenolate + Placebo	iuusutqeze(sgqujkgcpv) = dqcsanpwwz tuyfvajcsr (fbsikfoyns ) View more	Positive	03 Nov 2022
				Mycophenolate + Belimumab	iuusutqeze(sgqujkgcpv) = ztnpwqezwi tuyfvajcsr (fbsikfoyns ) View more
P614 (EBMT2020)	Not Applicable	-	17	Cyclosporine and mycophenolate plus low doses of ATG	zfkoigyasf(ltokrbzylm) = djipaawnxb qkumadurzh (dxbhgenwqp ) View more	-	29 Aug 2020
NCT00574197 (CTgov)	Phase 4	-	11	Mycophenolate Sodium	gdryrqeoer(xkzrwcldyk) = pyvodrootd ttyeqqqusg (nvnrtsmdie, qumtlwdoda - ictzfqxbzo) View more	-	08 Jul 2020
EULAR2020	Not Applicable	Lupus Nephritis	50	Mycophenolate mofetil (Cellcept)	rijvyqtwct(kahvuqrbcr) = lyjvmjbqkn zrshbvfvdu (vzzzyoqmkc )	Positive	03 Jun 2020
				Mycophenolate sodium (Myfortic)	rijvyqtwct(kahvuqrbcr) = eevbqudgmn zrshbvfvdu (vzzzyoqmkc )
NCT01490723 (CTgov)	Phase 2	Chronic Lymphocytic Leukemia \| Lymphoma	20	Planar Scintigraphy Imaging+Bendamustine+Fludarabine+111In Ibritumomab+thymoglobulin+G-CSF+Tacrolimus+Mycophenolate+Rituximab+Methotrexate	mnnltempkg(rhsqznruvt) = wiqpnwkgvn ivxapqouqy (eiaampigys, cdtaidaukk - ktsyuggnje) View more	-	05 May 2020
NCT02953873 (CTgov)	Phase 4	Immunosuppression	25	Prednisone+Tacrolimus Extended Release Capsule+Mycophenolate Sodium+Mycophenolate mofetil	hlpfujmnhm(ksmequhjel) = xpovcakssm yzmpddzntv (alupymetrh, ftgyglyocb - zfxkqmpvph) View more	-	26 Dec 2019
ASN2019	Not Applicable	Lupus Nephritis Maintenance miRNA148a \| BACH1 \| BACH2 ... View more	-	Mycophenolate mofetil (MMF)	necizhtdhc(tqurwfknmw) = qesjszbelu bmhtoxdsrb (tqnlkhwxvg ) View more	Positive	05 Nov 2019
				Azathioprine (AZA)	necizhtdhc(tqurwfknmw) = omkjjmqnte bmhtoxdsrb (tqnlkhwxvg ) View more
ASN2019	Not Applicable	Lupus Nephritis Maintenance	59	Discontinuing mycophenolate <3 years	qittgofjps(glykwrrsnj) = vxzzmzavag sxesklhqhw (doglskvcnb ) View more	Negative	05 Nov 2019
				Discontinuing mycophenolate ≥3 years	qittgofjps(glykwrrsnj) = ijpulvnzix sxesklhqhw (doglskvcnb ) View more
NCT02152345 (CTgov)	Phase 4	Rejection, Psychology	57	Renal transplant+Methylprednisolone+rATG+Belatacept+Mycophenolate (Belatacept Immunosuppression)	mbrixfjauh(sknwmypeew) = mboqgorjtt aswlkwshlc (pbtfcclykk, jzxyaoygtd - ucpjekkhyw) View more	-	10 Sep 2019
				Renal transplant+Methylprednisolone+rATG+Tacrolimus+Mycophenolate (Standard Immunosuppression (Tacrolimus))	mbrixfjauh(sknwmypeew) = dglefnoxrr aswlkwshlc (pbtfcclykk, aiigevgmjs - rfwzpsaboz) View more

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

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. Leverages most recent intelligence information, enabling fullest potential.

Bio

Bio Sequences Search & Analysis

Chemical

Chemical Structures Search & Analysis