TheraRadar
Data updated: Sep 20, 2026

MYCOPHENOLATE SODIUM · YICHANG HUMANWELL

Generic · see MYFORTIC
Immunology Approved 2004-02-27

MYCOPHENOLATE SODIUM is FDA-approved to treat 1 condition (same as MYFORTIC).

Source: FDA Label
Jump to: Indications Approvals Trials Competitors Safety Patents
13
Indications
--
Phase 3 Trials
22
Years on Market

Details

Status
Prescription
First Approved
2004-02-27
Routes
ORAL
Dosage Forms
TABLET, DELAYED RELEASE

Companies

YICHANG HUMANWELL RK PHARMA TWI PHARMS Aurobindo Pharma ALKEM LABS LTD CONCORD BIOTECH LTD BIOCON PHARMA ACCORD HLTHCARE Teva Apotex FOSUN WANBANG
Active Ingredient: MYCOPHENOLATE SODIUM

MYCOPHENOLATE SODIUM Approval History

2013
2014
2015
2016
2017
2018
2019
2020
2021
2022
2023
2024
2025
2026
Original
New Indication
New Form
Label Update
148 FDA actions from 2012 to 2026
Aug 2026 SUPPL
Label · Labeling
Jul 2026 SUPPL
Update · REMS
May 2026 SUPPL
Label · Labeling

What MYCOPHENOLATE SODIUM Treats

1 indications

MYCOPHENOLATE SODIUM is approved for 1 conditions since its original approval in 2012. These indications span multiple therapeutic areas including oncology, immunology, and more.

Same approved indications as MYFORTIC (same active ingredient).

Source: FDA Label
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Clinical Trial Registry

11 trials
Trial Sponsor ID Phase Status Title
NCT07412470 FREXERA EFC18554 2025-521521-33-00 Ph 2, Ph 3 recruiting A Study to Investigate the Efficacy and Safety of Frexalimab Versus Tacrolimus in Adults Undergoing Kidney Transplantation
NCT04375631 RG1006914 NCI-2020-02616, RG1006914 Ph 1 recruiting CLAG-M or FLAG-Ida Chemotherapy and Reduced-Intensity Conditioning Donor Stem Cell Transplant for the Treatment of Relapsed or Refractory Acute Myeloid Leukemia, Myelodysplastic Syndrome, or Chronic Myelomonocytic Leukemia
NCT04195633 RG1005742 NCI-2019-07697, 10343 Ph 2 recruiting Donor Stem Cell Transplant With Treosulfan, Fludarabine, and Total-Body Irradiation for the Treatment of Hematological Malignancies
NCT02334488 PROMéTé Ph 3 completed Study Evaluating the Benefit of Two Immunosuppressive Strategies on Renal Function
NCT02953873 results posted 00061221 Ph 4 completed Dosing Requirements of Astagraf XL® in African American Kidney Transplant Recipients
NCT01801280 results posted CERL 080A DE 20 T 2010-021275-92 Ph 4 completed Influence of Pantoprazole on the Bioavailability of MMF and EC-MPS
NCT01410448 NEVERWOUND results posted CRAD001AIT25 2011-002866-19 Ph 3 completed Everolimus in de Novo Kidney Transplant Recipients
NCT00646737 CERL080ABR02 Ph 4 completed Conversion From Mycophenolate Mofetil to Mycophenolate Sodium in Renal Transplant
NCT01822483 AUC-MPA CERL080 CERL080ABR08T Ph 4 completed A Prospective Study to Investigate Mycophenolic Acid (MPA) Exposure Through Area Under the Curve (AUC) in Renal Transplants Recipients Treated With Mycophenolate Mofetil (MMF) and After Conversion to Mycophenolate Sodium (EC-MPS)
NCT01354301 CRAD001ABR18T Ph 4 completed Efficacy and Safety of Induction Strategies Combined With Low Tacrolimus Exposure in Kidney Transplant Recipients Receiving Everolimus or Sodium Mycophenolate
NCT01015456 CONTROL 2009-001 Lupus Research Unit, CRCN Ph 3 terminated The Efficacy of Enteric-coated Mycophenolate Sodium (EC-MPS) (Myfortic) in The Treatment of Relapse or Resistant Proliferative Lupus Nephritis
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Active Pipeline

Pro

Ongoing clinical trials by development phase

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Key Completed Trials

Pro

Completed studies with published results, ranked by significance

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Trial Timeline

ClinicalTrials.gov ↗ Pro

Full development history with FDA approval milestones

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Understanding FDA Approval Types
Count Type What it means
- ORIG Original approval - drug first enters market
- SUPPL - Efficacy New indication (new disease/condition approved)
- SUPPL - Labeling Label text changes (warnings, dosing updates)
- SUPPL - Manufacturing Production changes (new facility)
- SUPPL - Chemistry Formulation changes (new dosage strength)

Green lines in the timeline show ORIG and Efficacy approvals - the clinically meaningful milestones.

MYCOPHENOLATE SODIUM FDA Label Details

Indications & Usage

MYCOPHENOLATE SODIUM is FDA-approved to treat 1 condition — same approved indications as MYFORTIC.

Looking for the branded version?

MYFORTIC

Full clinical data, patents, trials, and competitive landscape for mycophenolate sodium.

See MYFORTIC

Data Sources

FDA Approval: ANDA214376 → Trials: ClinicalTrials.gov →

Data sourced from official FDA and NIH databases. Click links to verify on original sources.