Data updated: May 26, 2026
MYCOPHENOLATE SODIUM
Immunology
Approved 2012-08-21
13
Indications
--
Phase 3 Trials
13
Years on Market
Details
- Status
- Discontinued
- First Approved
- 2012-08-21
- Routes
- ORAL
- Dosage Forms
- TABLET, DELAYED RELEASE
Companies
Teva YICHANG HUMANWELL FOSUN WANBANG ACCORD HLTHCARE TWI PHARMS Aurobindo Pharma ALKEM LABS LTD RK PHARMA CONCORD BIOTECH LTD BIOCON PHARMA Apotex
Active Ingredient: MYCOPHENOLATE SODIUM
Website: ↗
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
122 FDA actions from 2012 to 2026
May 2026 SUPPL
Label · Labeling
Jan 2026 SUPPL
Label · Labeling
Dec 2024 SUPPL
Label · Labeling
Aug 2024 SUPPL
Update
May 2024 ORIGINAL
Update
Feb 2024 ORIGINAL
Update
Nov 2023 ORIGINAL
Update
Nov 2023 SUPPL
Label
May 2023 SUPPL
Label
Mar 2023 SUPPL
Label
Jan 2023 SUPPL
Label
Jan 2023 SUPPL
Label
Nov 2021 ORIGINAL
Update
Nov 2021 ORIGINAL
Update
Sep 2021 ORIGINAL
Update
Aug 2021 SUPPL
Update
Apr 2021 SUPPL
Update
Feb 2021 ORIGINAL
Update
Jan 2021 SUPPL
Update
Dec 2019 SUPPL
Label
Dec 2019 ORIGINAL
Update
Nov 2019 SUPPL
Label
Aug 2017 ORIGINAL
Update
Nov 2015 SUPPL
Update
Oct 2014 ORIGINAL
Update
Aug 2014 ORIGINAL
Update
Jun 2014 SUPPL
Label
Sep 2013 SUPPL
Update
Sep 2012 SUPPL
Update
Aug 2012 ORIGINAL
Update
What MYCOPHENOLATE SODIUM Treats
13 FDA approvalsOriginally approved for its first indication in 2012 . Covers 13 distinct patient populations.
- Other (13)
Other
(13 approvals)- • Approved indication (Aug 2012)
- • Approved indication (Jan 2014)Letter
- • Approved indication (Aug 2014)
- • Approved indication (Oct 2014)
- • Approved indication (Aug 2017)
- • Approved indication (Dec 2019)
- • Approved indication (Feb 2021)
- • Approved indication (Sep 2021)
- • Approved indication (Nov 2021)
- • Approved indication (Nov 2021)
- • Approved indication (Nov 2023)
- • Approved indication (Feb 2024)
- • Approved indication (May 2024)
📋
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 |
🔬
Pro Active Pipeline
Ongoing clinical trials by development phase
Loading...
⭐
Pro Key Completed Trials
Completed studies with published results, ranked by significance
Loading...
📊
Trial Timeline
Full development history with FDA approval milestones
|
Loading...
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
Looking for the branded version?
MYFORTIC
Full clinical data, patents, trials, and competitive landscape for mycophenolate sodium.
Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.