CellCept

(mycophenolic acid)

Phase 3Small molecule

Mycophenolic acid 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 mistakenly attacks the body's own tissues.[1] CellCept is currently being investigated across 15 indications[3], with its most advanced program in Phase 3.[1]

CellCept is one of 424 small molecule programs targeting Systemic Lupus Erythematosus. It is currently in Phase 3.

Indications

Total Trials

Active Trials

423

Competitors

Pipeline

Status by Indication[3][1]

Indication

Systemic Lupus ErythematosusActive, not recruiting

Intermediate UveitisActive, not recruiting

Liver TransplantActive, not recruiting

ToxicityActive, not recruiting

Immune System DiseaseUnknown

Kidney TransplantActive, not recruiting

Pulmonary SarcoidosisActive, not recruiting

Nephrotic SyndromeActive, not recruiting

Crohn's DiseaseUnknown

Myasthenia GravisActive, not recruiting

Systemic Lupus ErythematosusPhase 3

Active, not recruiting

Intermediate UveitisPhase 3

Active, not recruiting

Liver TransplantPhase 3

Active, not recruiting

ToxicityPreclinical

Active, not recruiting

Immune System DiseasePreclinical

Unknown

Kidney TransplantPhase 2

Active, not recruiting

Pulmonary SarcoidosisPhase 3

Active, not recruiting

Nephrotic SyndromePhase 3

Active, not recruiting

Crohn's DiseasePreclinical

Unknown

Myasthenia GravisPreclinical

Active, not recruiting

Showing 10 of 15 indications

Competition

Competitive Landscape

540 competitors in Chronic Kidney Disease

#DrugCompanyPhaseTrials

CellCept

Novartis

Phase 3

27 2

Aranesp

Amgen

Preclinical

40 3

Epogen

Johnson & Johnson Pharmaceutical Research & Development, L.L.C.

Preclinical

16 4

Uloric

Takeda

Preclinical

3 5

Flomax

Activase

Epoetin Beta

5 8

PROCRIT

WWim Janssens

Preclinical

1 9

Verquvo

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

Preclinical

1 10

Genotropin

EMD Serono

Preclinical

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

Timeline

Expected Milestones

Q1 2032

Phase 2/3Recruiting

Prophylaxis

NCT02416388

Clinical

Trials by Indication[1]

Kidney Transplant5 trials

Proportion of CMV Seropositive Kidney Transplant Recipients Who Will Develop a CMV Infection When Treated With an Immunosuppressive Regimen Including Everolimus and Reduced Dose of Cyclosporine Versus an Immunosuppressive Regimen With Mycophenolic Acid and Standard Dose of Cyclosporine A

Completed·UUniversity Hospital, Bordeaux·Phase 4·NCT02328963·186 enrolled

Treg Therapy in Subclinical Inflammation in Kidney Transplantation

Completed·NNational Institute of Allergy and Infectious Diseases (NIAID)·Phase 1/2·NCT02711826·32 enrolled

Efficacy and Safety Study of Everolimus Plus Reduced Cyclosporine Versus Mycophenolic Acid Plus Cyclosporine in Kidney Transplant Recipients

Completed· Novartis logo

Novartis·Phase 3·NCT00251004·833 enrolled

Show 2 more trials

Veloxis de Novo Kidney Transplant ECSWD

Unknown status·SSimon Tremblay, PharmD, PhD·Phase 4·NCT03828682·60 enrolled

Comparison of the Efficacy and Safety of Sirolimus Versus Everolimus Versus Mycophenolate in Kidney Transplantation

Completed·HHospital do Rim e Hipertensão·Phase 4·NCT03468478·1,209 enrolled

Liver Transplant3 trials

Safety and Efficacy of Basiliximab, Delayed Dose Tacrolimus Plus ECMPA (Enteric Coated Mycophenolic Acid) Following Liver Transplantation

Completed·UUniversity of California, Los Angeles·Phase 4·NCT02123108·59 enrolled

Steroid Free Immunosuppression in Liver Transplantation

Completed·TThomas Jefferson University·Phase 4·NCT00296244·40 enrolled

A National Multi-center Randomized, Open Label Study to Evaluate Efficacy and Safety of Everolimus With EC-MPS Compared to Standard Treatment Combination Tacrolimus and EC-MPS in de Novo Liver Transplant Recipients

Completed· Novartis logo

Novartis·Phase 3·NCT01625377·188 enrolled

Toxicity2 trials

Mechanisms and Treatment of Chronic Allograft Injury (CAI) Due to Calcineurin Inhibitor (CNI) Toxicity

Terminated·MMontefiore Medical Center·N/A·NCT01473732·2 enrolled

Conversion From MPA to Zortress (Everolimus) for GI Toxicity Post-renal Transplantation

Terminated·WWashington University School of Medicine·Phase 4·NCT02974686·1 enrolled

Renal Transplant Recipients2 trials

24 Months Follow-up, Two Arm Study to Compare the Cardiovascular Profile in a Regimen With Everolimus + Mycophenolic Acid (MPA) Versus (vs.) a Regimen of CNI+MPA in Maintenance Renal Transplant Recipients

Completed· Novartis logo

Novartis·Phase 4·NCT01169701·71 enrolled

Study to Evaluate the Efficacy, Safety and Tolerability of Everolimus in de Novo Renal Transplant Recipients Participating in the Eurotransplant Senior Program

Terminated· Novartis logo

Novartis·Phase 4·NCT00956293·207 enrolled

Systemic Sclerosis2 trials

Allogeneic Hematopoietic Cell Transplantation for Severe Systemic Sclerosis

Completed·FFred Hutchinson Cancer Center·Phase 1/2·NCT00622895·3 enrolled

Mycophenolate Mofetil Pharmacokinetics in Systemic Sclerosis

Completed·RRegion Skane··NCT03678987·35 enrolled

13 more indications

Sts1 trial

Treg Modulation With CD28 and IL-6 Receptor Antagonists

Completed·NNational Institute of Allergy and Infectious Diseases (NIAID)·Phase 1/2·NCT04066114·24 enrolled

Myasthenia Gravis1 trial

Trial of Mycophenolic Acid Versus Azathioprine in the Treatment of Corticosteroid-refractory Myasthenia Gravis

Unknown status·QQualitix Clinical Research Co., Ltd.·N/A·NCT00997412·40 enrolled

Renal Allograft Recipients1 trial

Evaluate Efficacy Study of Combination Therapy of Everolimus and Low Dose Tacrolimus in Renal Allograft Recipients

Unknown status·SSeoul St. Mary's Hospital·Phase 4·NCT02036554·234 enrolled

Efficacy and Safety1 trial

Efficacy and Safety of AEB071 Plus Tacrolimus (Converted to Mycophenolic Acid After 3 Months), in Renal Transplant Patients

Completed· Novartis logo

Novartis·Phase 1/2·NCT00403416·215 enrolled

Completed·UUniversity of Cincinnati·Phase 4·NCT00374803·45 enrolled

Prophylaxis1 trial

Study to Improve OS in 18 to 60 Year-old Patients, Comparing Daunorubicin Versus High Dose Idarubicin Induction Regimens, High Dose Versus Intermediate Dose Cytarabine Consolidation Regimens, and Standard Versus MMF Prophylaxis of GvHD in Allografted Patients in First CR

Recruiting·UUniversity Hospital, Angers·Phase 2/3·NCT02416388·3,100 enrolled

Transplantation1 trial

Mycophenolic Acid Monotherapy in Recipients of HLA-identical Living-Related Transplantation

Terminated·UUniversity of Wisconsin, Madison·Phase 2·NCT01053221·16 enrolled

GIST1 trial

The Mechanisms and Significances of Synergistic Effects of Mycophenolic Acid and LPS on IL-1β Secretion by Mononuclear

Unknown status·—··NCT02435368·10 enrolled

Tics1 trial

Pharmacokinetics of Mycophenolate Mofetil in Healthy Volunteers

Completed·NNational Institutes of Health Clinical Center (CC)·Phase 1·NCT00128947·130 enrolled

Acute Lymphoblastic Leukemia1 trial

Crohn's Allogeneic Transplant Study

Terminated·FFred Hutchinson Cancer Center·Phase 2·NCT01570348·2 enrolled

Unspecified1 trial

Evaluate Effects and Safety of Pre-load Myfortic® in Transplant Patients

Completed·UUniversity of Cincinnati·Phase 4·NCT01336296·61 enrolled

Sources

References

[1]
ClinicalTrials.gov — 27 trial records for mycophenolic acid. U.S. National Library of Medicine, National Institutes of Health.
[2]
ChEMBL — mycophenolic acid compound record. European Bioinformatics Institute (EMBL-EBI).
[3]
Open Targets Platform — Drug–disease associations for mycophenolic acid. EMBL-EBI & Wellcome Sanger Institute.
[4]
SEC EDGAR — Novartis company filings. U.S. Securities and Exchange Commission.

Details

Drug Info

Quick Facts

Mechanism of Action: Inosine-5'-Monophosphate Dehydrogenase (IMPDH) Inhibitor[2]
Modality: Small molecule[2]
Highest Phase: Phase 3[1]
Company: Novartis

CellCept

Status by Indication[3][1]

Competitive Landscape

Expected Milestones

Q1 2032

Trials by Indication[1]

Kidney Transplant5 trials

Liver Transplant3 trials

Toxicity2 trials

Renal Transplant Recipients2 trials

Systemic Sclerosis2 trials

Sts1 trial

Myasthenia Gravis1 trial

Renal Allograft Recipients1 trial

Efficacy and Safety1 trial

Medication1 trial

Tolerance1 trial

Withdrawal1 trial

Prophylaxis1 trial

Transplantation1 trial

GIST1 trial

Tics1 trial

Acute Lymphoblastic Leukemia1 trial

Unspecified1 trial

References

Drug Info

Quick Facts

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