CellCept

(Mycophenolate Mofetil)

ApprovedSmall molecule

Mycophenolate mofetil is used to prevent the body's immune system from rejecting transplanted organs like kidneys, hearts, or livers. It's also used to treat certain autoimmune diseases where the immune system attacks the body's own tissues.[2] CellCept is currently approved and in use across 90 indications[4].[1]

CellCept is one of 1084 small molecule programs targeting Kidney Transplant. It is currently in Approved.

Indications

621

Total Trials

Active Trials

1,083

Competitors

FDA Applications

NDA/BLA/ANDA regulatory filings

Patents

Pipeline

Status by Indication[4][1]

Indication

Kidney TransplantCompleted

Acute Myeloid LeukemiaTerminated

Liver TransplantTerminated

Iga NephropathyUnknown status

Aplastic AnemiaRecruiting

HepatitisCompleted

LymphomaActive, not recruiting

Bone Marrow TransplantationTerminated

ImmunodeficiencyRecruiting

Systemic SclerosisRecruiting

Kidney TransplantApproved

Completed

Acute Myeloid LeukemiaPhase 3

Terminated

Liver TransplantApproved

Terminated

Iga NephropathyApproved

Unknown status

Aplastic AnemiaPhase 2

Recruiting

HepatitisPhase 2

Completed

LymphomaPhase 2

Active, not recruiting

Bone Marrow TransplantationPhase 2

Terminated

ImmunodeficiencyPhase 2

Recruiting

Systemic SclerosisPhase 2

Recruiting

Showing 10 of 90 indications

Competition

Competitive Landscape

401 competitors in Lymphoma

#DrugCompanyPhaseTrials

CellCept

Roche

Approved

13 2

Zofran

Novartis

Preclinical

2 3

Cabenuva

GSK

Preclinical

1 4

Norvir

AbbVie

Preclinical

1 5

Emend

CCidara Therapeutics Inc., a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA)

Preclinical

1 6

Kenalog

BBausch Health Americas, Inc.

Preclinical

1 7

Nuvigil

NNuvo Research GmbH

Preclinical

1 8

Elitek

AAzienda U.S.L. 1 di Massa e Carrara

Preclinical

—9

Decadron

QQuince Therapeutics S.p.A.

Preclinical

—10

Solu-Medrol

MMassachusetts Eye and Ear Infirmary

Preclinical

—

Ranked by pipeline maturity and clinical activity. Current drug highlighted in teal.

Timeline

Expected Milestones

Q4 2026

N/AActive, not recruiting

Treatment

NCT02936505

Phase 2Active, not recruiting

Malignancy

NCT03674411

Q1 2027

Phase 1Active, not recruiting

Sickle Cell Disease

NCT03249831

Q2 2027

Phase 1/2Recruiting

Bone Marrow Transplantation

NCT04959175

Q4 2027

Phase 1Recruiting

Advanced Hematologic Malignancies

NCT05088356

Clinical

Trials by Indication[1]

Kidney Transplant21 trials

OPERA Study: A Study of Two Dosing Regimens of CellCept (Mycophenolate Mofetil) in Kidney Transplant Patients.

Completed· Roche logo

Roche·Phase 3·NCT02005562·252 enrolled

Dosing Requirements of Astagraf XL® in African American Kidney Transplant Recipients

Completed·MMedical University of South Carolina·Phase 4·NCT02953873·25 enrolled

Validation of Population Pharmacokinetic Model Derived From Healthy Volunteer in Kidney Transplant Recipients

Unknown status·SSeoul National University Hospital··NCT02808065·40 enrolled

Show 18 more trials

Effects of Inhibiting Early Inflammation in Kidney Transplant Patients

Completed·NNational Institute of Allergy and Infectious Diseases (NIAID)·Phase 2·NCT02495077·290 enrolled

Polycystic Liver Disease in Kidney Transplant

Terminated·MMayo Clinic·N/A·NCT00934791·2 enrolled

Evaluating Safety and Efficacy of TOL101 Induction Versus Anti-Thymocyte Globulin to Prevent Kidney Transplant Rejection

Unknown status·TTolera Therapeutics, Inc·Phase 1/2·NCT01154387·85 enrolled

Genetic Drug Study of Mycophenolic Acid (CellCept) in Pediatric Kidney Transplant Patients

Terminated·—·Phase 1·NCT00433953·44 enrolled

Enteric-Coated Mycophenolate Sodium on Quality of Life in Patients With Gastrointestinal Symptoms Related to Mycophenolate Mofetil Therapy After Kidney Transplantation

Completed· Novartis logo

Novartis·Phase 4·NCT00239005·134 enrolled

Risk Factors of Chinese Kidney Transplant Recipients DSA Based on MPA Immunosuppressive Regimen

Unknown status·FFirst Affiliated Hospital Xi'an Jiaotong University·Phase 4·NCT04444843·300 enrolled

A Study of the Impact of an Early Biopsy in Patients Treated With CellCept (Mycophenolate Mofetil) After Kidney Transplantation

Completed· Roche logo

Roche·Phase 4·NCT00817687·66 enrolled

MYREPTIC-N® or MY-REPT® in Stable Patients After Kidney Transplant Recipients

Recruiting· Chong Kun Dang Pharmaceutical logo

Chong Kun Dang Pharmaceutical·Phase 4·NCT06044493·158 enrolled

Kidney Spare the Nephron (STN) Study - A Study of CellCept (Mycophenolate Mofetil) and Rapamune (Sirolimus) in Kidney Transplant Recipients

Completed· Roche logo

Roche·Phase 4·NCT00121810·305 enrolled

Evaluate the Efficacy and Safety of My-Rept® Tablet vs. My-Rept® Capsule in Combination With Tacrolimus in Kidney Transplant Patients

Completed· Chong Kun Dang Pharmaceutical logo

Chong Kun Dang Pharmaceutical·Phase 4·NCT01842269·156 enrolled

A Study to Assess Use of Zenapax (Daclizumab) and CellCept (Mycophenolate Mofetil) to Improve Kidney Function in Kidney Transplant Patients

Completed· Roche logo

Roche·Phase 3·NCT00048152·539 enrolled

A Phase II Study of Belatacept (BMS-224818) With a Steroid-free Regimen in Subjects Undergoing Kidney Transplantation

Completed· Bristol-Myers Squibb logo

Bristol-Myers Squibb·Phase 2·NCT00455013·93 enrolled

Pharmacogenetic Study of CellCept (Mycophenolate Mofetil) in Kidney Transplant Patients.

Completed· Roche logo

Roche·Phase 4·NCT00337493·155 enrolled

A Study of CellCept (Mycophenolate Mofetil) in Kidney Transplant Patients Switched From EC-MPS.

Terminated· Roche logo

Roche·Phase 4·NCT00420472

Study of Efficacy, Safety, Tolerability, Pharmacokinetic (PK) and Pharmacodynamic (PD) of an Anti-CD40 Monoclonal Antibody, CFZ533, in Kidney Transplant Recipients

Completed· Novartis logo

Novartis·Phase 2·NCT03663335·418 enrolled

12 Month Athena Study: Everolimus vs. Standard Regimen in de Novo Kidney Transplant Patients

Completed· Novartis logo

Novartis·Phase 3·NCT01843348·612 enrolled

Pediatric Kidney Transplant Without Calcineurin Inhibitors

Completed·NNational Institute of Allergy and Infectious Diseases (NIAID)·N/A·NCT00023231·35 enrolled

Study Comparing Effect On Carotid Atherosclerosis Following Conversion From Tacrolimus To Sirolimus Post-Transplant In Kidney Transplant Patients

Terminated· Pfizer logo

Pfizer·Phase 3·NCT00311311·72 enrolled

Stem Cell Transplant9 trials

Cyclophosphamide and/or Mycophenolate Mofetil With or Without Tacrolimus in Treating Patients Who Are Undergoing a Donor Bone Marrow or Peripheral Stem Cell Transplant for Hematologic Cancer

Completed·SSidney Kimmel Comprehensive Cancer Center at Johns Hopkins·Phase 1·NCT00255710·60 enrolled

Donor Peripheral Stem Cell Transplant, Fludarabine, and Busulfan in Treating Patients With Hematologic Cancers

Completed·UUniversity of California, Davis·Phase 2·NCT00619645·8 enrolled

Stem Cell Transplant in Treating Patients With Hematological Cancer or Other Disorders

Unknown status·IInstitut Paoli-Calmettes·Phase 2·NCT00740467·50 enrolled

Show 6 more trials

Busulfan, Fludarabine, and Total-Body Irradiation in Treating Patients Who Are Undergoing a Donor Stem Cell Transplant for Hematologic Cancer

Completed·OOHSU Knight Cancer Institute·Phase 1/2·NCT00245037·147 enrolled

Lupus Immunosuppressive/Immunomodulatory Therapy or Stem Cell Transplant (LIST)

Withdrawn·NNational Institute of Allergy and Infectious Diseases (NIAID)·Phase 2·NCT00230035

Combination Chemotherapy, Donor Stem Cell Transplant, Tacrolimus, Mycophenolate Mofetil, and Cyclophosphamide in Treating Patients With Hematologic Cancer

Completed·NNorthside Hospital, Inc.·Phase 2·NCT00782379·20 enrolled

Peripheral Stem Cell Transplant, White Blood Cell Infusions, Chemotherapy, and Radiation Therapy in Treating Patients With Recurrent Metastatic Cervical or Vaginal Cancer

Completed·FFred Hutchinson Cancer Center·Phase 2·NCT00005941

Donor Stem Cell Transplant, Pentostatin, and Total-Body Irradiation in Treating Patients With Hematological Cancer

Withdrawn·UUniversity of Nebraska·Phase 1/2·NCT00816413

Safety and Efficacy of Pentostatin and Low Dose TBI With Allogenic Peripheral Blood Stem Cell Transplant

Completed·UUniversity of Nebraska·Phase 2·NCT00571662·76 enrolled

Lupus Nephritis7 trials

Efficacy and Safety of Tacrolimus Versus Mycophenolate in Lupus Nephritis

Completed·TThe University of Hong Kong·Phase 3·NCT02630628·130 enrolled

Fixed-dose Versus Concentration-controlled Mycophenolate Mofetil for the Treatment of Active Lupus Nephritis

Terminated·—·Phase 4·NCT03920059·2 enrolled

The Efficacy and Safety of Biologics (Belimumab/ Telitacicept) Induction Therapy in Proliferative Lupus Nephritis Patients for 6 Months Compared With Mycophenolate Mofetil Treatment

Recruiting·NNanjing University School of Medicine·Phase 2·NCT07340463·50 enrolled

Show 4 more trials

Comparing the Efficacy of Tacrolimus and Mycophenolate Mofetil for the Initial Therapy of Active Lupus Nephritis

Completed·TTuen Mun Hospital·Phase 4·NCT00371319·150 enrolled

Efficacy and Safety Study of Abatacept to Treat Lupus Nephritis

Terminated· Bristol-Myers Squibb logo

Bristol-Myers Squibb·Phase 2/3·NCT00430677·423 enrolled

A Study to Evaluate Efficacy of CellCept (Mycophenolate Mofetil) in Patients With Lupus Nephritis

Terminated· Roche logo

Roche·Phase 3·NCT02081183·16 enrolled

A Study of Mycophenolate Mofetil (CellCept) in Management of Patients With Lupus Nephritis.

Completed· Roche logo

Roche·Phase 3·NCT00377637·370 enrolled

Bone Marrow Transplantation6 trials

Phase I/II Study to Reduce Post-transplantation Cyclophosphamide Dosing for Older or Unfit Patients Undergoing Bone Marrow Transplantation for Hematologic Malignancies

Recruiting·NNational Cancer Institute (NCI)·Phase 1/2·NCT04959175·320 enrolled

Cyclophosphamide Plus Bone Marrow Transplantation in Treating Patients With Hematologic Cancer

Completed·SSidney Kimmel Comprehensive Cancer Center at Johns Hopkins·Phase 1·NCT00006042

Gemtuzumab Ozogamicin, Fludarabine, and Total-body Irradiation Followed by Peripheral Stem Cell or Bone Marrow Transplantation in Treating Patients With Advanced Acute Myeloid Leukemia or Myelodysplastic Syndrome

Completed·FFred Hutchinson Cancer Center·Phase 2·NCT00008151

Show 3 more trials

Non-Myeloablative Conditioning and Bone Marrow Transplantation

Unknown status·VVanderbilt-Ingram Cancer Center·N/A·NCT01850108·26 enrolled

Bone Marrow Transplantation of Patients in Remission Using Partially Matched Relative Donor

Completed·SSidney Kimmel Comprehensive Cancer Center at Thomas Jefferson University·Phase 2·NCT01350245·28 enrolled

Reduced-intensity, Related-donor Bone Marrow Transplantation Followed by High-dose Cyclophosphamide for Hematologic Cancers

Terminated·SSidney Kimmel Comprehensive Cancer Center at Johns Hopkins·Phase 2·NCT01135329·15 enrolled

Hematologic Malignancies5 trials

Sirolimus and Mycophenolate Mofetil in Preventing GVHD in Patients With Hematologic Malignancies Undergoing HSCT

Terminated·SStanford University·Phase 1·NCT02728700·1 enrolled

Reduced Intensity Chemotherapy and Radiation Therapy Before Donor Stem Cell Transplant in Treating Patients With Hematologic Malignancies

Completed·SSidney Kimmel Comprehensive Cancer Center at Thomas Jefferson University·Phase 2·NCT02566304·35 enrolled

T-Cell Replete Haploidentical Donor Hematopoietic Stem Cell Plus Natural Killer (NK) Cell Transplantation in Patients With Hematologic Malignancies Relapsed or Refractory Despite Previous Allogeneic Transplant

Terminated·SSt. Jude Children's Research Hospital·Phase 2·NCT01621477·34 enrolled

Show 2 more trials

Donor Stem Cell Transplant in Treating Patients With Relapsed Hematologic Malignancies or Secondary Myelodysplasia Previously Treated With High-Dose Chemotherapy and Autologous Stem Cell Transplant

Terminated·AAlliance for Clinical Trials in Oncology·Phase 2·NCT01118013·6 enrolled

Allogeneic Transplantation Using Total Lymphoid Irradiation (TLI) and Anti-Thymocyte Globulin (ATG) for Older Patients With Hematologic Malignancies

Completed·SStanford University·Phase 2·NCT00185640·303 enrolled

87 more indications

Acute Graft Versus Host Disease5 trials

Tacrolimus and Mycophenolate Mofetil With or Without Sirolimus in Preventing Acute Graft-Versus-Host Disease in Patients Who Are Undergoing Donor Stem Cell Transplant for Hematologic Cancer

Completed·FFred Hutchinson Cancer Center·Phase 2·NCT00105001·210 enrolled

Acute Graft-versus-Host Disease Treatment (BMT CTN 0802)

Completed·MMedical College of Wisconsin·Phase 3·NCT01002742·236 enrolled

PTCy-ATG vs ATG in Haploidentical HSCT for Acute Graft-versus-host Disease Prophylaxis

Unknown status·NNanfang Hospital, Southern Medical University·Phase 4·NCT03689465·260 enrolled

Show 2 more trials

Rituximab in Preventing Acute Graft-Versus-Host Disease in a Donor Stem Cell Transplant for Hematologic Cancer

Terminated·UUniversity of Nebraska·Phase 2·NCT01044745·20 enrolled

Thymoglobulin, Sirolimus and Mycophenolate Mofetil for Prevention of Acute Graft-Versus-Host Disease (GVHD)

Terminated·MM.D. Anderson Cancer Center·Phase 2·NCT00506948·13 enrolled

Treatment5 trials

Mycophenolate Mofetil and Abacavir Treatment in HIV Patients With Failed Anti-HIV Treatment

Withdrawn·NNational Institute of Allergy and Infectious Diseases (NIAID)·Phase 2·NCT00021489

Clinical Study of MMF in Treatment of IIM-ILD and Its Effect on Peripheral Blood Treg Cells

Unknown status·FFirst Affiliated Hospital Xi'an Jiaotong University·Phase 4·NCT05129410·20 enrolled

Treatment Strategies in IgG4-RD Patients With Re-elevation of Serum IgG4 Level During Maintenance Remission Period

Unknown status·PPeking Union Medical College Hospital·N/A·NCT05974683·108 enrolled

Show 2 more trials

Clinical Study Evaluating Two Treatment Protocols for Immunosuppressive Drugs. Looking at 3-year Incidence of CLAD.

Active, not recruiting·VVastra Gotaland Region·N/A·NCT02936505·249 enrolled

The Research of Standard Diagnosis and Treatment for HSPN in Children

Unknown status·NNanjing Children's Hospital·Phase 2·NCT02532777·100 enrolled

Renal Transplant5 trials

Effect of Everolimus on the Pharmacokinetics of Tacrolimus in Renal Transplant Patients

Completed·NNational Taiwan University Hospital·Phase 4·NCT02077556·14 enrolled

Enteric-coated Mycophenolate Sodium (EC-MPS) and Mycophenolate Mofetil (MMF) in Renal Transplant Patients With Gastrointestinal (GI) Intolerance

Completed· Novartis logo

Novartis·Phase 4·NCT00400400·400 enrolled

Effects of Mycophenolate Mofetil (MMF) On Anti-HLA (Human Leukocyte Antigen)Antibody Levels In Patients Awaiting Cadaveric Renal Transplant.

Completed·UUniversity of Washington·Phase 2·NCT00446459·45 enrolled

Show 2 more trials

Effects of Rituximab and Mycophenolate Mofetil (MMF) on Highly Sensitized Patients Awaiting Renal Transplant

Completed·UUniversity of Washington·Phase 2·NCT00446251·14 enrolled

Concentration Controlled Everolimus With Reduced Dose Cyclosporine Versus Mycophenolate Mofetil With Standard Dose Cyclosporine in de Novo Renal Transplant Adult Recipients Treated With Basiliximab and Corticosteroids

Completed· Novartis logo

Novartis·Phase 3·NCT00658320·122 enrolled

Lymphoma4 trials

Chemotherapy, Radiation Therapy, Rituximab, and Umbilical Cord Blood Transplant in Treating Patients With B-Cell Non-Hodgkin's Lymphoma

Completed·MMemorial Sloan Kettering Cancer Center·Phase 2·NCT00387959·17 enrolled

High-Dose Y-90-Ibritumomab Tiuxetan Added to Reduced-Intensity Allogeneic Stem Cell Transplant Regimen for Relapsed or Refractory Aggressive B-Cell Lymphoma

Terminated·FFred Hutchinson Cancer Center·Phase 2·NCT01434472·20 enrolled

Study Of Two Non-Myeloablative Stem Cell Transplant Strategies For Low-Grade Lymphoma And CLL

Terminated·UUniversity of Texas Southwestern Medical Center·Phase 2·NCT00041288·10 enrolled

Show 1 more trial

Reduced-Intensity Regimen Before Allogeneic Transplant for Patients With Relapsed Non-Hodgkin's or Hodgkin's Lymphoma

Terminated·EEastern Cooperative Oncology Group·Phase 2·NCT00057954·6 enrolled

Transplantation4 trials

Trial Of Double Umbilical Cord Blood Transplantation

Completed·UUniversity of Michigan Rogel Cancer Center·Phase 2·NCT00763490·20 enrolled

Comparison of Triple GVHD Prophylaxis Regimens for Nonmyeloablative or Reduced Intensity Conditioning Unrelated Mobilized Blood Cell Transplantation

Terminated·FFred Hutchinson Cancer Center·Phase 2·NCT03246906·150 enrolled

Phase 2 Study of Autologous Followed by Nonmyeloablative Allogeneic Transplantation Using TLI & ATG

Completed·SStanford University·Phase 2·NCT00899847·9 enrolled

Show 1 more trial

Pilot Study of Unrelated Cord Blood Transplantation

Terminated·KKing's College Hospital NHS Trust·Phase 2·NCT00916045·40 enrolled

Systemic Lupus Erythematosus4 trials

Effectiveness of Mycophenolate Mofetil Combined With Tacrolimus for Steroid Tapering in Systemic Lupus Erythematosus

Recruiting·CChinese SLE Treatment And Research Group·Phase 4·NCT05916781·220 enrolled

Nonmyeloablative Conditioning and Transplantation for Patients With Refractory Systemic Lupus Erythematosus (SLE)

Terminated·SSidney Kimmel Comprehensive Cancer Center at Johns Hopkins·Phase 1/2·NCT02080195·1 enrolled

Reappraisal of the Therapies of Refractory Autoimmune Hemolytic Anemia in Systemic Lupus Erythematosus

Unknown status·—·Phase 3·NCT05057481·30 enrolled

Show 1 more trial

A Study of Laquinimod in Participants With Systemic Lupus Erythematosus (SLE) Active Lupus Nephritis

Completed· Teva logo

Teva·Phase 2·NCT01085097·46 enrolled

Liver Transplant4 trials

Donor-Alloantigen-Reactive Regulatory T Cell (darTregs) in Liver Transplantation

Terminated·NNational Institute of Allergy and Infectious Diseases (NIAID)·Phase 1·NCT02188719·15 enrolled

Liver Spare the Nephron (STN) Study - A Study of CellCept (Mycophenolate Mofetil) and Sirolimus in Recipients of a Liver Transplant

Completed· Roche logo

Roche·Phase 4·NCT00118742·293 enrolled

Belatacept in Liver Transplant Recipients

Terminated· Bristol-Myers Squibb logo

Bristol-Myers Squibb·Phase 2·NCT00555321·260 enrolled

Show 1 more trial

Evaluation of Thymoglobulin Induction and Reduced Doses of Calcineurin Inhibitors on Liver Transplant Rejection

Completed· Sanofi logo

Sanofi·Phase 2·NCT00117689·75 enrolled

Renal Transplant Recipients4 trials

Selective CD28 Blockade in Renal Transplant Recipients

Withdrawn·NNational Institute of Allergy and Infectious Diseases (NIAID)·Phase 2·NCT04903054

Calcineurin Free Immunosuppression in Renal Transplant Recipients

Completed·UUniversity Hospital, Basel, Switzerland·Phase 4·NCT00812123·127 enrolled

CellCept® Dose Adjustment Versus Fixed Dose (Standard Care) in Renal Transplant Recipients

Unknown status·RRabin Medical Center·Phase 4·NCT00737659·138 enrolled

Show 1 more trial

Safety/Efficacy of Induction Agents With Tacrolimus, MMF, and Rapid Steroid Withdrawal in Renal Transplant Recipients

Completed· Astellas logo

Astellas·Phase 4·NCT00113269·501 enrolled

Allogeneic Hematopoietic Stem Cell Transplantation3 trials

Allogeneic Hematopoietic Stem Cell Transplantation for Relapsed or Refractory High-Risk NBL.

Withdrawn·NNationwide Children's Hospital·Phase 2·NCT00874315

A Multi-Institutional Pilot Study of Allogeneic Hematopoietic Stem Cell Transplantation for Patients With Malignant Neuro-Epithelial and Other Solid Tumors

Terminated·MMontefiore Medical Center·Phase 1·NCT02653196·1 enrolled

Allogeneic Hematopoietic Stem Cell Transplantation for High-Risk Hematologic Malignancies Using One Haploidentical Donor

Completed·SSidney Kimmel Comprehensive Cancer Center at Thomas Jefferson University·Phase 2·NCT01982682·41 enrolled

Nephrotic Syndrome3 trials

Randomized Trial Evaluating Mycophenolate Mofetil in Children With Nephrotic Syndrome After Rituximab Treatment

Withdrawn·—·Phase 3·NCT04531865

Study of Tacrolimus vs Mycophenolate Mofetil in Pediatric Patients With Nephrotic Syndrome

Completed·TThe Children's Hospital of Zhejiang University School of Medicine·Phase 4·NCT04048161·270 enrolled

Mycophenolate Mofetil in Pediatric Steroid Dependent Nephrotic Syndrome

Completed·SSeoul National University Hospital·Phase 4·NCT01895894·34 enrolled

Immunosuppression3 trials

Phase I/II Thymus Transplantation With Immunosuppression #950

Completed·SSumitomo Pharma Switzerland GmbH·Phase 1/2·NCT00579527·14 enrolled

Steroid-Free Versus Steroid-Based Immunosuppression in Pediatric Renal (Kidney) Transplantation

Completed·NNational Institute of Allergy and Infectious Diseases (NIAID)·Phase 1/2·NCT00141037·130 enrolled

A Trial of Two Steroid-Free Approaches Toward Mycophenolate Mofetil-Based Monotherapy Immunosuppression

Terminated·NNorthwestern University·Phase 4·NCT00166712·40 enrolled

IgA Nephropathy3 trials

Mycophenolate Mofetil Versus Intravenous Cyclophosphamide Pulses in the Treatment of Crescentic IgA Nephropathy

Completed·NNanjing University School of Medicine·N/A·NCT00301600·40 enrolled

Mycophenolate Mofetil (MMF) in Patients With IgA Nephropathy

Terminated·SSt. Joseph's Hospital and Medical Center, Phoenix·Phase 3·NCT00318474·184 enrolled

Mycophenolate Mofetil (MMF) in Patients With IgA Nephropathy (IgAN)

Completed·SSun Yat-sen University·Phase 3·NCT00657059·151 enrolled

De Novo Renal Transplantation3 trials

A Dose Escalation Study of TCD601 Compared to ATG in de Novo Renal Transplantation

Terminated·IITB-Med LLC·Phase 2·NCT06365437·33 enrolled

A Dose Escalation Study in de Novo Renal Transplantation

Completed·IITB-Med LLC·Phase 2·NCT04311632·13 enrolled

CCFZ533X2201 - PoC Study in de Novo Renal Transplantation

Completed· Novartis logo

Novartis·Phase 1/2·NCT02217410·59 enrolled

Chronic Lymphocytic Leukemia2 trials

Chemotherapy, Total-Body Irradiation, Rituximab, and Donor Stem Cell Transplant in Treating Patients With B-Cell Non-Hodgkin's Lymphoma or Chronic Lymphocytic Leukemia

Completed·MMemorial Sloan Kettering Cancer Center·Phase 2·NCT00425802·61 enrolled

Autologous Peripheral Blood Stem Cell Transplant Followed by Donor Bone Marrow Transplant in Treating Patients With High-Risk Hodgkin Lymphoma, Non-Hodgkin Lymphoma, Multiple Myeloma, or Chronic Lymphocytic Leukemia

Completed·FFred Hutchinson Cancer Center·Phase 2·NCT01008462·16 enrolled

Transplant Recipient2 trials

Outcomes in Pediatric Heart Transplant Recipients Receiving Cellcept

Terminated·EEmory University·N/A·NCT00166153·30 enrolled

Heart Spare the Nephron (STN) Study - A Study of CellCept (Mycophenolate Mofetil) and Rapamune (Sirolimus) in Heart Transplant Recipients

Terminated· Roche logo

Roche·Phase 4·NCT00121784·12 enrolled

Stem Cell Transplantation2 trials

Mycophenolate Mofetil, Tacrolimus, Daclizumab, and Donor Peripheral Stem Cell Transplantation in Treating Patients With Hematologic Cancer

Completed·UUniversity of Maryland, Baltimore·Phase 2·NCT00006350

Total-Body Irradiation, Fludarabine, and Peripheral Stem Cell Transplantation in Treating Patients With Hematologic Cancer

Completed·UUniversity of Texas Southwestern Medical Center·Phase 2·NCT00044954

Multiple Myeloma2 trials

Reduced-Intensity Conditioning Followed By Donor Peripheral Blood Stem Cell Transplant in Treating Patients With Multiple Myeloma

Completed·FFred Hutchinson Cancer Center·Phase 1/2·NCT00054353·16 enrolled

Non-myeloablative Allogeneic Transplantation for the Treatment of Multiple Myeloma

Completed·WWen-Kai Weng·Phase 2·NCT00185614·63 enrolled

Severe Aplastic Anemia2 trials

MT2023-20: Hematopoietic Cell Transplant With Reduced Intensity Conditioning and Post-transplant Cyclophosphamide for Severe Aplastic Anemia and Other Forms of Acquired Bone Marrow Failure.

Recruiting·MMasonic Cancer Center, University of Minnesota·Phase 2·NCT06412497·60 enrolled

NMA Haplo or MUD BMT for Newly Diagnosed Severe Aplastic Anemia

Completed·SSidney Kimmel Comprehensive Cancer Center at Johns Hopkins·Phase 2·NCT02833805·21 enrolled

Aplastic Anemia2 trials

Donor Stem Cell Transplant in Treating Patients With Hematologic Cancer, Metastatic Kidney Cancer, or Aplastic Anemia

Unknown status·UUniversity of California, San Francisco·N/A·NCT00295997·35 enrolled

Optimizing Haploidentical Aplastic Anemia Transplantation (BMT CTN 1502)

Completed·MMedical College of Wisconsin·Phase 2·NCT02918292·32 enrolled

Kidney Cancer2 trials

Fludarabine Phosphate, Low-Dose Total Body Irradiation, and Donor Stem Cell Transplant in Treating Patients With Hematologic Malignancies or Kidney Cancer

Completed·FFred Hutchinson Cancer Center·N/A·NCT00005799·55 enrolled

Fludarabine and Total-Body Irradiation in Treating Patients Who Are Undergoing a Donor Stem Cell Transplant for Metastatic Kidney Cancer That Cannot Be Removed By Surgery

Terminated·OOHSU Knight Cancer Institute·Phase 2·NCT00243009·1 enrolled

Acute Myeloid Leukemia2 trials

S0125, Chemotherapy, Total-Body Irradiation, and Peripheral Stem Cell Transplantation in Treating Older Patients With Acute Myeloid Leukemia

Terminated·SSWOG Cancer Research Network·Phase 2·NCT00053014·5 enrolled

Clofarabine and Low-Dose Total-Body Irradiation in Treating Patients With Acute Myeloid Leukemia Undergoing Donor Peripheral Blood Stem Cell Transplant

Completed·FFred Hutchinson Cancer Center·Phase 2·NCT01252667·44 enrolled

Interstitial Lung Disease2 trials

Evaluation of Efficacy and Safety of Rituximab With Mycophenolate Mofetil in Patients With Interstitial Lung Diseases

Completed·UUniversity Hospital, Tours·Phase 3·NCT02990286·122 enrolled

Comparison of Therapeutic Regimens for Scleroderma Interstitial Lung Disease (The Scleroderma Lung Study II)

Completed·MMichael Roth·Phase 2·NCT00883129·142 enrolled

Chronic Graft Versus Host Disease2 trials

Evaluation of Rovadicitinib Compared to the Protocol Selected by Researchers in Third Line and Subsequent Studies of Moderate to Severe Chronic Graft-versus-host Disease

Recruiting· Chia Tai Tianqing Pharmaceutical Group Co., Ltd. logo

Chia Tai Tianqing Pharmaceutical Group Co., Ltd.·Phase 3·NCT06682169·182 enrolled

Mycophenolate Mofetil (MMF) for Treatment of Chronic Graft-versus-host Disease (GVHD)

Terminated·MMartin, Paul·Phase 3·NCT00089141·151 enrolled

Sickle Cell Disease2 trials

Nonmyeloablative Conditioning for Mismatched Hematopoietic Stem Cell Transplantation for Severe Sickle Cell Disease

Terminated·WWashington University School of Medicine·Phase 1·NCT02678143·1 enrolled

A Blood Stem Cell Transplant for Sickle Cell Disease

Active, not recruiting·—·Phase 1·NCT03249831·3 enrolled

Graft Versus Host Disease2 trials

Novel Approaches for Graft-versus-Host Disease Prevention Compared to Contemporary Controls (BMT CTN 1203)

Completed·NNational Heart, Lung, and Blood Institute (NHLBI)·Phase 2·NCT02208037·279 enrolled

Graft-Versus-Host Disease Prophylaxis in Treating Patients With Hematologic Malignancies Undergoing Unrelated Donor Peripheral Blood Stem Cell Transplant

Completed·FFred Hutchinson Cancer Center·Phase 3·NCT01231412·174 enrolled

Fasting Conditions2 trials

Mycophenolate Mofetil 250 mg Capsules Under Fasting Conditions

Completed· Teva logo

Teva·Phase 1·NCT00911274·53 enrolled

Mycophenolate Mofetil Tablets Under Fasting Conditions

Completed· Teva logo

Teva·Phase 1·NCT00907907·40 enrolled

Allogeneic Stem Cell Transplantation2 trials

Optimized Cord Blood Transplantation for the Treatment of Patients With High-risk Hematologic Malignancies Who Have Relapsed After First Allogeneic Stem Cell Transplantation

Recruiting·MM.D. Anderson Cancer Center·Phase 2·NCT06807606·35 enrolled

Allogeneic Stem Cell Transplantation for Children With CML

Completed·SSt. Anna Kinderkrebsforschung·Phase 2/3·NCT02707393·13 enrolled

Myeloproliferative Disorder2 trials

Post T-plant Infusion of Allogeneic Cytokine Induced Killer (CIK) Cells as Consolidative Therapy in Myelodysplastic Syndromes/Myeloproliferative Disorders

Completed·EEverett Meyer·Phase 2·NCT01392989·44 enrolled

Fludarabine Phosphate and Total Body Irradiation Followed by a Donor Peripheral Stem Cell Transplant in Treating Patients With Myelodysplastic Syndromes or Myeloproliferative Disorders

Completed·FFred Hutchinson Cancer Center·Phase 2·NCT00397813·77 enrolled

Prophylaxis2 trials

Minitransplants With HLA-matched Donors : Comparison Between 2 GVHD Prophylaxis Regimens

Active, not recruiting·UUniversity of Liege·Phase 2·NCT01428973·200 enrolled

Sirolimus & Mycophenolate Mofetil as GvHD Prophylaxis in Myeloablative, Matched Related Donor HCT

Terminated·SStanford University·Phase 2·NCT01220297·3 enrolled

Heart Transplant2 trials

Optimize Immunosuppressive Therapy Using Everolimus and Low-dose Calcineurin Inhibitors in Heart Transplant Patients in Korea

Not yet recruiting· Chong Kun Dang Pharmaceutical logo

Chong Kun Dang Pharmaceutical·Phase 4·NCT06942156·140 enrolled

A Study Investigating the Renal Tolerability, Efficacy, and Safety of a CNI-free Versus a Standard Regimen in de Novo Heart Transplant (HTx) Recipients

Completed· Novartis logo

Novartis·Phase 4·NCT00862979·162 enrolled

Myasthenia Gravis2 trials

A Continuation Study to Assess the Effect of CellCept in Patients With Myasthenia Gravis.

Completed· Roche logo

Roche·Phase 3·NCT00408213·136 enrolled

A Study to Assess the Effect of CellCept (Mycophenolate Mofetil) and Reduced Corticosteroids in Controlling Symptoms of Myasthenia Gravis

Completed· Roche logo

Roche·Phase 3·NCT00683969·136 enrolled

Neuromyelitis Optica2 trials

A Study to Evaluate IMC-002 in Neuromyelitis Optica Spectrum Disorder (NMOSD) Patients

Not yet recruiting·IImmuneCare Biopharmaceuticals (Shanghai) Co., Ltd.·Phase 1/2·NCT06557174·116 enrolled

A Study to Evaluate the Safety and Efficacy of Satralizumab in Participants With Neuromyelitis Optica Spectrum Disorder (NMOSD)

Completed· Roche logo

Roche·Phase 3·NCT04660539·119 enrolled

Combination Therapy2 trials

Combination Therapy Using Cellcept and Rebif in RRMS

Completed·AAaron Boster·Phase 1·NCT00618527·31 enrolled

A Study of CellCept (Mycophenolate Mofetil) in Combination Therapy in Heart Transplant Patients.

Completed· Roche logo

Roche·Phase 3·NCT02091414·36 enrolled

Multiple Sclerosis2 trials

Safety Study of Combination Therapy With Intramuscular Avonex and Oral Cellcept in Patients With Multiple Sclerosis

Completed·UUniversity of Texas Southwestern Medical Center·Phase 2/3·NCT00223301·24 enrolled

Safety and Efficacy of Cellcept and Avonex as Combination Treatment in Multiple Sclerosis

Completed·UUniversity of Texas Southwestern Medical Center·Phase 2·NCT00324506·43 enrolled

Prevention2 trials

Calcineurin Inhibitor-Free GVHD Prevention Regimen After Related Haplo PBSCT

Completed·HH. Lee Moffitt Cancer Center and Research Institute·Phase 1·NCT03018223·32 enrolled

Haplo Peripheral Blood Sct In GVHD Prevention

Completed·ZZachariah Michael DeFilipp·Phase 1·NCT04473911·25 enrolled

Bone Marrow Transplant2 trials

A Two-Step Approach to Bone Marrow Transplant Using Cells From Two Partially-Matched Relatives

Terminated·SSidney Kimmel Comprehensive Cancer Center at Thomas Jefferson University·Phase 2·NCT01532635·4 enrolled

A Two-Step Approach to Bone Marrow Transplant Using Cells From A Partially-Matched Relative

Completed·SSidney Kimmel Comprehensive Cancer Center at Thomas Jefferson University·Phase 1/2·NCT00429143·27 enrolled

Safety and Efficacy2 trials

A Pilot Study Comparing the Safety and Efficacy of Everolimus With Other Medicines in Recipients of ECD/DCD Kidneys

Terminated·MMatthew Cooper·Phase 2/3·NCT01878786·25 enrolled

Study Comparing the Safety and Efficacy of Belatacept With That of Cyclosporine in Patients With a Transplanted Kidney

Completed· Bristol-Myers Squibb logo

Bristol-Myers Squibb·Phase 2·NCT00035555·230 enrolled

Hematologic Malignancy2 trials

Haploidentical Donor Hematopoietic Progenitor Cell and NK Cell Transplantation for Hematologic Malignancy

Completed·SSt. Jude Children's Research Hospital·Phase 2·NCT01807611·82 enrolled

Allo-HSCT With Alternative Donor in Treatment of Hematologic Malignancy

Completed·NNanfang Hospital, Southern Medical University·N/A·NCT02487069·876 enrolled

Leukemia2 trials

Hematopoietic Stem Cell Transplantation in the Treatment of Infant Leukemia

Completed·MMasonic Cancer Center, University of Minnesota·Phase 2·NCT00357565·34 enrolled

Umbilical Cord Blood Transplant With Added Sugar and Chemotherapy and Radiation Therapy in Treating Patients With Leukemia or Lymphoma

Completed·MM.D. Anderson Cancer Center·Phase 2·NCT03096782·6 enrolled

Pulmonary Fibrosis1 trial

Comparing and Combining Bortezomib and Mycophenolate in SSc Pulmonary Fibrosis

Completed·NNorthwestern University·Phase 2·NCT02370693·9 enrolled

AML1 trial

HLA-mismatched MST vs HLA-matched NST for AML in Intermediate-risk

Completed·TThe Affiliated Hospital of the Chinese Academy of Military Medical Sciences·Phase 3·NCT02461121·156 enrolled

Renal Allograft Recipients1 trial

Study Comparing Two Immunosuppressive Regimens in De Novo Renal Allograft Recipients

Completed· Pfizer logo

Pfizer·Phase 4·NCT00261820·160 enrolled

Myelodysplastic Syndromes1 trial

Radiolabeled Monoclonal Antibody Therapy, Fludarabine Phosphate, and Low-Dose Total-Body Irradiation Followed by Donor Stem Cell Transplant and Immunosuppression Therapy in Treating Older Patients With Advanced Acute Myeloid Leukemia or High-Risk Myelodysplastic Syndromes

Completed·FFred Hutchinson Cancer Center·Phase 1·NCT00008177·79 enrolled

GvHD1 trial

In-Vivo Activated T-Cell Depletion to Prevent GVHD

Terminated·IIndiana University·N/A·NCT00594308·10 enrolled

Hepatitis1 trial

Treatment Efficacy of Corticosteroids and Mycophenolate Mofetil in Patients With Immune Related Hepatitis

Unknown status·IInge Marie Svane·Phase 2·NCT04810156·60 enrolled

Cardiac Transplant1 trial

The Effect and Safety Profile of Thymoglobulin® in Primary Cardiac Transplant Recipients

Enrolling by invitation·—·Phase 2·NCT03292861·60 enrolled

HIV infection1 trial

A Study of DAPD Alone Versus DAPD Plus MMF for Treatment of HIV Infection

Completed·NNational Institute of Allergy and Infectious Diseases (NIAID)·Phase 2·NCT00038272·56 enrolled

Tic Disorder1 trial

Stem Cell Transplant for Immunologic or Histiocytic Disorders

Completed·MMasonic Cancer Center, University of Minnesota·Phase 2·NCT00176865·19 enrolled

Autoimmune Hepatitis1 trial

Mycophenolate Mofetil Versus Azathioprine in Treatment Naive Autoimmune Hepatitis

Unknown status·RRadboud University Medical Center·Phase 4·NCT02900443·70 enrolled

Nephropathy1 trial

The Effects of Mycophenolate Mofetil (MMF) on Renal Outcomes in Advanced Immunoglobulin A (IgA) Nephropathy Patients

Completed·FFan Fan Hou·N/A·NCT01854814·238 enrolled

Immune Thrombocytopenia1 trial

Rituximab and Dexamethasone Followed by Mycophenolate Mofetil or Placebo in Patients With Immune Thrombocytopenia

Withdrawn·WWeill Medical College of Cornell University·Phase 3·NCT02649504

Renal Transplantation1 trial

Belatacept With Early Steroid Withdrawal rATG and Everolimus in Renal Transplantation (BETTER Trial)

Unknown status·UUniversity of Cincinnati·Phase 4·NCT04849533·120 enrolled

Efficacy and Safety1 trial

Efficacy and Safety of Human Lipoprotein Lipase (LPL)[S447X] Expressed by an Adeno-Associated Viral Vector in LPL-deficient Subjects

Completed·AAmsterdam Molecular Therapeutics·Phase 2/3·NCT00891306·5 enrolled

Total Body Irradiation1 trial

Total Body Irradiation and Astatine-211-Labeled BC8-B10 Monoclonal Antibody for the Treatment of Nonmalignant Diseases

Recruiting·FFred Hutchinson Cancer Center·Phase 1/2·NCT04083183·40 enrolled

Primary Biliary Cholangitis1 trial

Mycophenolate Mofetil Versus Cyclosporin A in the Treatment of Primary Biliary Cholangitis-autoimmune Hepatitis Overlap Syndrome Due to Nonresponse to Standard Therapy

Unknown status·WWest China Hospital·Phase 4·NCT04376528·89 enrolled

Natural Killer Cell1 trial

Donor Umbilical Cord Blood Natural Killer Cells, Aldesleukin and Umbilical Cord Blood Transplant in Patients With Refractory Hematologic Cancers.

Terminated·MMasonic Cancer Center, University of Minnesota·Phase 2·NCT00354172·16 enrolled

Hematological Malignancies1 trial

Donor Atorvastatin Treatment in Preventing Severe Acute GVHD After Nonmyeloablative Peripheral Blood Stem Cell Transplant in Patients With Hematological Malignancies

Completed·FFred Hutchinson Cancer Center·Phase 2·NCT01527045·47 enrolled

Trial1 trial

Trial of GVHD Prophylasxis With PTCy or Thymoglobulin in Unrelated SCT

Terminated·SSt. Petersburg State Pavlov Medical University·Phase 2·NCT02627573·32 enrolled

Chronic Myelogenous Leukemia1 trial

Natural Killer Cells Before and After Donor Stem Cell Transplant in Treating Patients With Acute Myeloid Leukemia, Myelodysplastic Syndrome, or Chronic Myelogenous Leukemia

Completed·MM.D. Anderson Cancer Center·Phase 1/2·NCT01904136·54 enrolled

Pancreatic Cancer1 trial

Study of CellCept for Advanced Pancreatic Cancer

Completed·—·Phase 1·NCT00997958·12 enrolled

Acute Lymphoblastic Leukemia1 trial

Busulfan and Cyclophosphamide Followed By ALLO BMT

Terminated·MMasonic Cancer Center, University of Minnesota·N/A·NCT01685411·5 enrolled

Histiocytosis1 trial

Combination Chemotherapy Followed By Donor Stem Cell Transplant in Treating Patients With Hemophagocytic Lymphohistiocytosis

Unknown status·CChildren's Cancer and Leukaemia Group·Phase 3·NCT00334672·288 enrolled

CIDP1 trial

Interest of Mycophenolate for CIDP Weaning

Completed·AAssistance Publique - Hôpitaux de Paris·Phase 3·NCT02494505·40 enrolled

Completed·MMasonic Cancer Center, University of Minnesota·Phase 1/2·NCT00630253·31 enrolled

Systemic Sclerosis1 trial

Treatment Outcome in Early Diffuse Cutaneous Systemic Sclerosis

Completed·UUniversity of Manchester··NCT02339441·320 enrolled

Non-myeloablative Conditioning1 trial

Non-Myeloablative Conditioning for Unrelated Donor Umbilical Cord Blood Transplant

Completed·MMasonic Cancer Center, University of Minnesota·Phase 2·NCT00305682·295 enrolled

Hematological Malignancy1 trial

Adoptive Immunotherapy in Relapsed Hematological Malignancy: Early GVHD Prophylaxis

Completed·VVirginia Commonwealth University·Phase 2·NCT02593123·31 enrolled

Tics1 trial

Study to Evaluate the Pharmacokinetic Characteristics of CKD-4101 (Mycophenolate Mofetil) Tablet

Completed· Chong Kun Dang Pharmaceutical logo

Chong Kun Dang Pharmaceutical·Phase 1·NCT01016626·28 enrolled

Excretion1 trial

Effects of an Immunosuppressant Mycophenolate Mofetil or MMF on the Urinary Sodium Excretion Response to Mental Stress

Unknown status·—·Phase 1/2·NCT02432339·50 enrolled

Hematopoietic Cell Transplantation1 trial

Total Body Irradiation +/- Total Lymphoid Irradiation & Anti-Thymocyte Globulin in Non-myeloablative Hematopoietic Cell Transplantation

Completed·SStanford University·Phase 2·NCT03734601·22 enrolled

Withdrawal1 trial

MMF and Calcineurin Inhibitor Withdrawal in CAN

Terminated·UUniversity Hospital Muenster·N/A·NCT00204230·86 enrolled

Fed1 trial

Bioequivalence Study of Mycophenolate Mofetil 250 mg Capsule Under Fed Condition

Completed·PPanacea Biotec Ltd·N/A·NCT01080417·84 enrolled

Limited Cutaneous Systemic Sclerosis1 trial

Mycophenolate in Limited Cutaneous Systemic Sclerosis (MINIMISE-Pilot)

Unknown status·UUniversity College, London·Phase 2·NCT04927390·120 enrolled

Conditioning1 trial

Allogeneic HCT Using Nonmyeloablative Host Conditioning With TLI & ATG vs SOC in AML

Terminated·SStanford University·Phase 3·NCT00568633·58 enrolled

Scleroderma1 trial

Scleroderma Lung Study III - Combining Pirfenidone With Mycophenolate

Completed·MMichael Roth·Phase 2·NCT03221257·51 enrolled

Allogeneic Hematopoietic Cell Transplant1 trial

Optimizing GVHD Prophylaxis After Allogeneic Hematopoietic Cell Transplantation

Recruiting·UUniversity of Nebraska·Phase 2·NCT06799195·126 enrolled

Malignancies1 trial

Fludarabine and Intermediate-dose TBI Followed by PTCy in Patients Undergoing Allo Transplant for Heme Malignancies

Recruiting·HHackensack Meridian Health·Phase 2·NCT07214688·209 enrolled

Toxicity1 trial

Pharmacologic Pretransplant Immunosuppression (PTIS) + Reduced Toxicity Conditioning (RTC) Allogeneic Stem Cell Transplantation in Inherited Hematologic Disorders

Withdrawn·MM.D. Anderson Cancer Center·Phase 2·NCT05293509

Phase 21 trial

Phase 2 Poor Risk DLBCL of TLI and ATG Followed by Matched Allogeneic HT as Consolidation to Autologous HCT

Terminated·SStanford University·Phase 2·NCT00482053·3 enrolled

Advanced Hematologic Malignancies1 trial

Reduced Intensity Allogeneic HCT in Advanced Hematologic Malignancies w/T-Cell Depleted Graft

Recruiting·SStanford University·Phase 1·NCT05088356·60 enrolled

Malignancy1 trial

Trial Evaluating MGTA-456 in Patients With High-Risk Malignancy

Active, not recruiting·MMasonic Cancer Center, University of Minnesota·Phase 2·NCT03674411·22 enrolled

Infusion1 trial

Infusion of Expanded Cord Blood T Cells

Withdrawn·MM.D. Anderson Cancer Center·Phase 1·NCT00972101

Graft Vs Host Disease1 trial

Vorinostat for Graft vs Host Disease Prevention in Children, Adolescents and Young Adults Undergoing Allogeneic Blood and Marrow Transplantation

Active, not recruiting·UUniversity of Michigan Rogel Cancer Center·Phase 1/2·NCT03842696·43 enrolled

Pterygium1 trial

Treatment of IgAN With Multi-glycoside of Tripterygium Wilfordii HOOK. f.

Unknown status·SSecond Xiangya Hospital of Central South University·Phase 3·NCT02187900·300 enrolled

Unspecified3 trials

Influence of Pantoprazole on the Bioavailability of MMF and EC-MPS

Completed·KKlemens Budde·Phase 4·NCT01801280·20 enrolled

SCHEDULE Follow Up Visit 5-7 yr

Completed· Novartis logo

Novartis·Phase 4·NCT02864706·95 enrolled

Regimen Optimization Study

Completed· Bristol-Myers Squibb logo

Bristol-Myers Squibb·Phase 2·NCT02137239·58 enrolled

Regulatory

FDA Approval Timeline[5]

May 3, 1995

CELLCEPT

NDA NDA050722

Jun 19, 1997

CELLCEPT

NDA NDA050723

Aug 12, 1998

CELLCEPT

NDA NDA050758

Oct 1, 1998

CELLCEPT

NDA NDA050759

May 1, 2024

MYHIBBIN

NDA NDA216482

Sources

References

[1]
ClinicalTrials.gov — 621 trial records for Mycophenolate Mofetil. U.S. National Library of Medicine, National Institutes of Health.
[2]
MedlinePlus Drug Information — CellCept drug information. U.S. National Library of Medicine, National Institutes of Health.
[3]
ChEMBL — Mycophenolate Mofetil compound record. European Bioinformatics Institute (EMBL-EBI).
[4]
Open Targets Platform — Drug–disease associations for Mycophenolate Mofetil. EMBL-EBI & Wellcome Sanger Institute.
[5]
OpenFDA — FDA approval records (NDA NDA216482). U.S. Food & Drug Administration.
[6]
FDA Orange Book — Patent and exclusivity data for CellCept. U.S. Food & Drug Administration.
[7]
SEC EDGAR — Roche company filings. U.S. Securities and Exchange Commission.

Details

Drug Info

Quick Facts

Mechanism of Action: Inosine-5'-Monophosphate Dehydrogenase (IMPDH) Inhibitor[3]
Modality: Small molecule[3]
Highest Phase: Approved[1]
Company: Roche

Patent Landscape[6]

Patent Cliff

Aug 16, 2039

Earliest patent expiration — generic entry possible after this date

Patent #Expires

12194143Aug 16, 2039

12097285Aug 16, 2039

12226526Aug 16, 2039

11931455Aug 16, 2039

12097284Aug 16, 2039

CellCept

Status by Indication[4][1]

Competitive Landscape

Expected Milestones

Q4 2026

Q1 2027

Q2 2027

Q4 2027

Trials by Indication[1]

Kidney Transplant21 trials

Stem Cell Transplant9 trials

Lupus Nephritis7 trials

Bone Marrow Transplantation6 trials

Hematologic Malignancies5 trials

Acute Graft Versus Host Disease5 trials

Treatment5 trials

Renal Transplant5 trials

Lymphoma4 trials

Transplantation4 trials

Systemic Lupus Erythematosus4 trials

Liver Transplant4 trials

Renal Transplant Recipients4 trials

Allogeneic Hematopoietic Stem Cell Transplantation3 trials

Nephrotic Syndrome3 trials

Immunosuppression3 trials

IgA Nephropathy3 trials

De Novo Renal Transplantation3 trials

Chronic Lymphocytic Leukemia2 trials

Transplant Recipient2 trials

Stem Cell Transplantation2 trials

Multiple Myeloma2 trials

Severe Aplastic Anemia2 trials

Aplastic Anemia2 trials

Kidney Cancer2 trials

Acute Myeloid Leukemia2 trials

Interstitial Lung Disease2 trials

Chronic Graft Versus Host Disease2 trials

Sickle Cell Disease2 trials

Graft Versus Host Disease2 trials

Fasting Conditions2 trials

Allogeneic Stem Cell Transplantation2 trials

Myeloproliferative Disorder2 trials

Prophylaxis2 trials

Heart Transplant2 trials

Myasthenia Gravis2 trials

Neuromyelitis Optica2 trials

Combination Therapy2 trials

Multiple Sclerosis2 trials

Prevention2 trials

Bone Marrow Transplant2 trials

Safety and Efficacy2 trials

Hematologic Malignancy2 trials

Leukemia2 trials

Pulmonary Fibrosis1 trial

AML1 trial

Renal Allograft Recipients1 trial

Myelodysplastic Syndromes1 trial

GvHD1 trial

Hepatitis1 trial

Cardiac Transplant1 trial

HIV infection1 trial

Tic Disorder1 trial

Autoimmune Hepatitis1 trial

Nephropathy1 trial

Immune Thrombocytopenia1 trial

Renal Transplantation1 trial

Efficacy and Safety1 trial

Total Body Irradiation1 trial

Primary Biliary Cholangitis1 trial

Natural Killer Cell1 trial

Hematological Malignancies1 trial

Trial1 trial

Chronic Myelogenous Leukemia1 trial

Pancreatic Cancer1 trial

Acute Lymphoblastic Leukemia1 trial

Histiocytosis1 trial

CIDP1 trial

Hematologic Cancer1 trial

Medication1 trial

Fanconi Anemia1 trial