Myfortic

(Mycophenolate)

ApprovedSmall molecule

Novartis

Myfortic is one of 217 small molecule programs targeting Liver Transplant. It is currently in Approved.

Indications

Total Trials

Active Trials

216

Competitors

FDA Application

NDA/BLA/ANDA regulatory filings

Pipeline

Status by Indication[3][1]

Indication

Liver TransplantActive, not recruiting

Rheumatic DiseaseRecruiting

Skin CancerActive, not recruiting

Kidney TransplantActive, not recruiting

Lupus NephritisActive, not recruiting

TransplantActive, not recruiting

Atopic DermatitisNot yet recruiting

Liver TransplantPreclinical

Active, not recruiting

Rheumatic DiseasePhase 2

Recruiting

Skin CancerApproved

Active, not recruiting

Kidney TransplantApproved

Active, not recruiting

Lupus NephritisApproved

Active, not recruiting

TransplantPhase 2

Active, not recruiting

Atopic DermatitisApproved

Not yet recruiting

Competition

Competitive Landscape

127 competitors in Atopic Dermatitis

#DrugCompanyPhaseTrials

Myfortic

Novartis

Approved

1 2

Fludara

Sanofi

Phase 3

1 3

Cytosar

Teva

Phase 3

1 4

Adtralza

LEO Pharma

Phase 3

16 5

Amlitelimab

Sanofi

Phase 3

2 6

Certolizumab

Johnson & Johnson

Phase 3

1 7

DUPIXENT

Regeneron

Phase 3

1 8

Jaktinib

SSuzhou Zelgen Biopharmaceuticals Co.,Ltd

Phase 3

4 9

ICP-332

BBeijing InnoCare Pharma Tech Co., Ltd.

Phase 3

2 10

VC005

JJiangsu vcare pharmaceutical technology co., LTD

Phase 3

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

Timeline

Expected Milestones

Q4 2026

Phase 2Active, not recruiting

Transplant

NCT05156710

Q1 2028

Phase 2Recruiting

Rheumatic Disease

NCT07138898

Q2 2030

Post-ApprovalNot yet recruiting

Atopic Dermatitis

NCT07352566

Clinical

Trials by Indication[1]

Lupus Nephritis2 trials

Comparison between2 Drugs in Lupus Nephritis

Completed·—·Phase 4·NCT04424602·40 enrolled

Evaluating the Safety of Myfortic (Mycophenolate Sodium) in Patients With Lupus Nephritis: a 12 Month, Single-arm, Observational Study in Taiwan Population

Completed· Novartis logo

Novartis··NCT04645589·69 enrolled

Graft Versus Host Disease2 trials

Addition of Etanercept and Extracorporeal Photopheresis (ECP) to Standard Graft-Versus-Host Disease (GVHD) Prophylaxis in Stem Cell Transplant

Completed·UUniversity of Michigan Rogel Cancer Center·Phase 2·NCT00639717·48 enrolled

Vorinostat to Prevent Graft Versus Host Disease Following Reduced Intensity, Related Donor Stem Cell Transplant

Completed·—·Phase 1/2·NCT00810602·61 enrolled

Renal Transplant Recipients2 trials

Efficacy and Safety of a Reduced Immunosuppression vs. Standard Triple Therapy in Senior Renal Transplant Recipients

Unknown status·KKlemens Budde·Phase 4·NCT02453867·400 enrolled

Belatacept Compared to Tacrolimus in Deceased Donor Renal Transplant Recipients

Completed·—·Phase 4·NCT02152345·57 enrolled

Pulmonary Sarcoidosis1 trial

Mycophenolate for Pulmonary Sarcoidosis

Terminated·MMedical University of South Carolina·Phase 3·NCT00262132·20 enrolled

Mucous Membrane Pemphigoid1 trial

Baricitinib for the Treatment of Ocular Mucous Membrane Pemphigoid

Terminated·WWashington University School of Medicine·Phase 2·NCT05263505·2 enrolled

9 more indications

Hematopoietic Cell Transplantation (HCT)1 trial

Nonmyeloablative Hematopoietic Cell Transplantation (HCT) for Patients With Hematologic Malignancies Using Related, HLA-Haploidentical Donors: A Pilot Trial of Peripheral Blood Stem Cells (PBSC) as the Donor Source

Completed·—·Phase 1·NCT02167958·28 enrolled

Liver Transplant1 trial

Long-term Benefit of MPA in Liver Transplantation

Unknown status·TThird Affiliated Hospital, Sun Yat-Sen University··NCT05707520·500 enrolled

Outcome1 trial

Outcomes of Patients After Allo-HSCT With Decitabine and NAC

Unknown status·TThe First Affiliated Hospital of Soochow University·Phase 3·NCT04945096·100 enrolled

Stem Cell Transplantation1 trial

Zevalin-Containing Nonmyeloablative Conditioning for Stem Cell Transplantation (SCT)

Completed·MM.D. Anderson Cancer Center·Phase 2·NCT01490723·20 enrolled

Atopic Dermatitis1 trial

Utilization of a Microdevice for Psoriasis and Atopic Dermatitis

Not yet recruiting·UUniversity of California, San Francisco·Phase 4·NCT07352566·10 enrolled

Kidney Transplant1 trial

Sirolimus Associated With Tacrolimus at Low Doses in Elderly Kidney Transplant Patients

Completed·AAssociação Médico Espírita de Botucatu·Phase 4·NCT02683291·48 enrolled

Skin Cancer1 trial

Prevention of Skin Cancer in High Risk Patients After Conversion to a Sirolimus-based Immunosuppressive Protocol

Terminated·—·Phase 4·NCT00866684·44 enrolled

Transplant1 trial

A Multi-cohort, Randomized, Phase 2, Open-label Study to Assess the Preliminary Efficacy, Safety, and Pharmacokinetics of BIVV020 for Prevention and Treatment of Antibody-mediated Rejection in Adult Kidney Transplant Recipients.

Active, not recruiting· Sanofi logo

Sanofi·Phase 2·NCT05156710·48 enrolled

Rheumatic Disease1 trial

Immunosuppressant Management in Rheumatology Patients Undergoing Elective Total Shoulder Arthroplasty

Recruiting·NNYU Langone Health·Phase 2·NCT07138898·80 enrolled

Regulatory

FDA Approval Timeline[4]

Feb 27, 2004

MYFORTIC

NDA NDA050791

Sources

References

[1]
ClinicalTrials.gov — 17 trial records for Mycophenolate. U.S. National Library of Medicine, National Institutes of Health.
[2]
ChEMBL — Mycophenolate compound record. European Bioinformatics Institute (EMBL-EBI).
[3]
Open Targets Platform — Drug–disease associations for Mycophenolate. EMBL-EBI & Wellcome Sanger Institute.
[4]
OpenFDA — FDA approval records (NDA NDA050791). U.S. Food & Drug Administration.
[5]
SEC EDGAR — Novartis company filings. U.S. Securities and Exchange Commission.

Details

Drug Info

Quick Facts

Modality: Small molecule[2]
Highest Phase: Approved[1]
Company: Novartis

Myfortic

Status by Indication[3][1]

Competitive Landscape

Expected Milestones

Q4 2026

Q1 2028

Q2 2030

Trials by Indication[1]

Lupus Nephritis2 trials

Graft Versus Host Disease2 trials

Renal Transplant Recipients2 trials

Pulmonary Sarcoidosis1 trial

Mucous Membrane Pemphigoid1 trial

Hematopoietic Cell Transplantation (HCT)1 trial

Liver Transplant1 trial

Outcome1 trial

Stem Cell Transplantation1 trial

Atopic Dermatitis1 trial

Kidney Transplant1 trial

Skin Cancer1 trial

Transplant1 trial

Rheumatic Disease1 trial

FDA Approval Timeline[4]

References

Drug Info

Quick Facts

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