MYCOPHENOLATE MOFETIL
Mycophenolate mofetil (MMF) is indicated for the prophylaxis of organ rejection, in adult and pediatric recipients 3 months of age and older of allogeneic kidney [see Clinical Studies ] , heart [see Clinical Studies ] or liver transplants [see Clinical Studies ], in combination with other immunosuppressants.
Details
- Status
- Prescription
- First Approved
- 2008-07-29
- Routes
- ORAL
- Dosage Forms
- CAPSULE, FOR SUSPENSION, TABLET
Companies
MYCOPHENOLATE MOFETIL Approval History
What MYCOPHENOLATE MOFETIL Treats
29 FDA approvalsOriginally approved for its first indication in 2008 . Covers 29 distinct patient populations.
- Other (29)
Other
(29 approvals)- • Approved indication (Jul 2008)Label Letter
- • Approved indication (Oct 2008)
- • Approved indication (Apr 2009)
- • Approved indication (May 2009)
- • Approved indication (May 2009)
- • Approved indication (Dec 2009)
- • Approved indication (Jun 2010)
- • Approved indication (Jul 2010)
- • Approved indication (Sep 2010)
- • Approved indication (Oct 2011)
- • Approved indication (Nov 2011)
- • Approved indication (Jun 2013)
- • Approved indication (Nov 2014)
- • Approved indication (Dec 2014)
- • Approved indication (Nov 2017)
- • Approved indication (Nov 2017)
- • Approved indication (Jan 2019)
- • Approved indication (Feb 2019)
- • Approved indication (Jul 2020)
- • Approved indication (Jul 2021)
- • Approved indication (Nov 2021)
- • Approved indication (Jan 2022)
- • Approved indication (Aug 2023)
- • Approved indication (Sep 2023)
- • Approved indication (Jan 2024)
- • Approved indication (Feb 2024)
- • Approved indication (Sep 2024)
- • Approved indication (Oct 2024)
- • Approved indication (Nov 2024)
MYCOPHENOLATE MOFETIL Boxed Warning
EMBRYOFETAL TOXICITY, MALIGNANCIES and SERIOUS INFECTIONS Use during pregnancy is associated with increased risks of first trimester pregnancy loss and congenital malformations. Avoid if safer treatment options are available. Females of reproductive potential must be counseled regarding pregnancy prevention and planning [see Warnings and Precautions (5.1) , Use in Special Populations (8.1 , 8.3) ] . Increased risk of development of lymphoma and other malignancies, particularly of the skin [see W...
WARNING: EMBRYOFETAL TOXICITY, MALIGNANCIES and SERIOUS INFECTIONS Use during pregnancy is associated with increased risks of first trimester pregnancy loss and congenital malformations. Avoid if safer treatment options are available. Females of reproductive potential must be counseled regarding pregnancy prevention and planning [see Warnings and Precautions (5.1) , Use in Special Populations (8.1 , 8.3) ] . Increased risk of development of lymphoma and other malignancies, particularly of the skin [see Warnings and Precautions (5.2) ] . Increased susceptibility to bacterial, viral, fungal and protozoal infections, including opportunistic infections and viral reactivation of hepatitis B and C, which may lead to hospitalizations and fatal outcomes [see Warnings and Precautions (5.3) ] . WARNING: EMBRYOFETAL TOXICITY, MALIGNANCIES and SERIOUS INFECTIONS See full prescribing information for complete boxed warning Use during pregnancy is associated with increased risks of first trimester pregnancy loss and congenital malformations. Avoid if safer treatment options are available. Females of reproductive potential must be counseled regarding pregnancy prevention and planning [see Warnings and Precautions (5.1) ]. Increased risk of development of lymphoma and other malignancies, particularly of the skin [see Warnings and Precautions (5.2) ] . Increased susceptibility to infections, including opportunistic infections and severe infections with fatal outcomes [see Warnings and Precautions (5.3) ].
MYCOPHENOLATE MOFETIL Target & Pathway
ProTarget
Clinical Trial Registry
259 trials| Trial | Sponsor ID | Phase | Status | Title |
|---|---|---|---|---|
| NCT07524530 | 10002233 002233-C | Ph 2 | not yet recruiting | Stem Cell Transplantation for Participants With Germline RUNX1 Associated Blood Cancers |
| NCT06996119 | 23822 NCI-2025-03603, 23822 | Ph 1 | recruiting | Emapalumab With Post-Transplant Cyclophosphamide, Tacrolimus and Mycophenolate Mofetil for the Prevention of Graft-versus-Host Disease After Donor Reduced-Intensity Hematopoietic Cell Transplant |
| NCT07566377 | 26-168 | Ph 2 | recruiting | Cord Blood Transplantation in Children and Young Adults With Blood Cancer |
| NCT04888741 MoTD | RG_19-116 | Ph 2 | recruiting | Methods of T Cell Depletion Trial (MoTD) |
| NCT05039619 POSTERITY | WA42985 2021-000097-29, 2023-505825-15-00 | Ph 2 | recruiting | A Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of Obinutuzumab in Adolescents With Active Class III or IV Lupus Nephritis and the Safety and PK of Obinutuzumab in Pediatric Participants |
| NCT03670966 | RG1003349 10060, P30CA015704 | Ph 1, Ph 2 | recruiting | 211At-BC8-B10 Followed by Donor Stem Cell Transplant in Treating Patients With Relapsed or Refractory High-Risk Acute Leukemia or Myelodysplastic Syndrome |
| NCT01231412 results posted | 2448.00 NCI-2010-02035, 2448.00 | Ph 3 | completed | Graft-Versus-Host Disease Prophylaxis in Treating Patients With Hematologic Malignancies Undergoing Unrelated Donor Peripheral Blood Stem Cell Transplant |
| NCT05327023 | 10000489 000489-C | Ph 1, Ph 2 | recruiting | Donor Lymphocyte Infusion After Allogeneic Hematopoietic Cell Transplantation for High-Risk Hematologic Malignancies |
| NCT07162038 | 10001785 001785-C | Ph 1 | recruiting | Phase I Trial Integrating HLA-Haploidentical Anti-CD19 CAR-T Cells With Post-Transplantation Cyclophosphamide-Based HLA-Haploidentical Hematopoietic Cell Transplantation |
| NCT04959175 | 10000359 000359-C | Ph 1, Ph 2 | recruiting | Phase I/II Study to Reduce Post-transplantation Cyclophosphamide Dosing for Older or Unfit Patients Undergoing Bone Marrow Transplantation for Hematologic Malignancies |
| NCT06807606 | 2024-1605 NCI-2025-00794 | Ph 2 | recruiting | Optimized Cord Blood Transplantation for the Treatment of Patients With High-risk Hematologic Malignancies Who Have Relapsed After First Allogeneic Stem Cell Transplantation |
| 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 |
| NCT07548983 | STUDY00028015 NCI-2025-09157, STUDY00028015 | Ph 1 | not yet recruiting | Ruxolitinib With Azacitidine Maintenance for the Treatment of Patients With Acute Myeloid Leukemia Undergoing Reduced Intensity Allogeneic Stem Cell Transplantation |
| NCT06973668 | 2024-1940 NCI-2025-03239 | Ph 2 | recruiting | A Randomized Study to Compare Post-transplant Cyclophosphamide, Sirolimus, Ruxolitinib and Post-transplant Cyclophosphamide, Sirolimus, Mycophenolate Mofetil to Prevent Graft Versus Host Disease |
| NCT07493538 | 2025LS162 | Ph 2 | recruiting | MT2025-35 Allogeneic Hematopoietic Stem Cell Transplantation Using Reduced Intensity Conditioning Treosulfan and Fludarabine, With Post-Transplant Cytoxan (PTCy) for the Treatment of Hematological Diseases |
| NCT07349771 | MC230810 24-009803 | Ph 2 | not yet recruiting | Axatilimab Plus Standard of Care Therapy for the Prevention of Graft Versus Host Disease Following Allogeneic Hematopoietic Stem Cell Transplantation in Patients With Hematologic Cancer, ABRAXAS Trial |
| NCT01384513 results posted | 11D.247 2011-31, JT 1795 | Ph 2 | completed | A Two-Step Approach to Reduced Intensity Bone Marrow Transplant for Patients With Hematological Malignancies |
| NCT04384692 | RG1006507 NCI-2020-01626, 10093 | Ph 2 | active not recruiting | Peritransplant Ruxolitinib for Patients With Primary and Secondary Myelofibrosis |
| NCT03192397 results posted | I 44417 NCI-2017-01069, I 44417 | Ph 1, Ph 2 | active not recruiting | Chemotherapy, Total Body Irradiation, and Post-Transplant Cyclophosphamide in Reducing Rates of Graft Versus Host Disease in Patients With Hematologic Malignancies Undergoing Donor Stem Cell Transplant |
| NCT04547049 | NFD-001 | Ph 3 | active not recruiting | A Study Comparing Haploidentical Hematopoietic Stem Cell Transplantations (HSCTs) From Young Non-first-degree and Older First-degree Donors in Hematological Malignancies |
| NCT05736419 | 23-009 | Ph 2 | recruiting | A Study of Immune Suppression Treatment for People With Sickle Cell Disease or β-Thalassemia Who Are Going to Receive an Allogeneic Hematopoietic Cell Transplantation (HCT) |
| NCT02333162 | IRB14-0709 NCI-2014-02469, IRB14-0709 | Ph 1 | suspended | Intensity Modulated Total Marrow Irradiation, Fludarabine Phosphate, and Melphalan in Treating Patients With Relapsed Hematologic Cancers Undergoing a Second Donor Stem Cell Transplant |
| NCT02251821 results posted | 9033 NCI-2014-01882, 9033 | Ph 2 | completed | JAK Inhibitor Before Donor Stem Cell Transplant in Treating Patients With Primary or Secondary Myelofibrosis |
| NCT01659606 | 12-950 IRB-P00003466 | Ph 2 | active not recruiting | Radiation- and Alkylator-free Bone Marrow Transplantation Regimen for Patients With Dyskeratosis Congenita |
| NCT05538208 PLUMM | ML42264 1R01AR079124-01A1 | Ph 2 | recruiting | The Pediatric Lupus Nephritis Mycophenolate Mofetil (PLUMM) Study |
| NCT04904588 ACCESS | ACCESS | Ph 2 | active not recruiting | HLA-Mismatched Unrelated Donor Hematopoietic Cell Transplantation With Post-Transplantation Cyclophosphamide |
| NCT04644016 | 20-480 | Ph 2 | recruiting | Cord Blood Transplant in Children and Young Adults With Blood Cancers and Non-malignant Disorders |
| NCT05622318 | PRO00046962 | Ph 2 | active not recruiting | De-escalated Cyclophosphamide (PTCy) and Ruxolitinib for Graft-versus-Host Disease (GVHD) Prophylaxis |
| NCT06752694 | RG1124040 NCI-2024-06524, 20575 | Ph 2 | recruiting | Ruxolitinib Based GVHD Prophylaxis Regimen Before, During, and After Hematopoietic Cell Transplantation in Older Adult Patients With Acquired Aplastic Anemia |
| NCT06872333 | 2024LS140 | Ph 2 | recruiting | Allo HSCT for High Risk Hemoglobinopathies |
| 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 |
| NCT03249831 | 16453 | Ph 1 | active not recruiting | A Blood Stem Cell Transplant for Sickle Cell Disease |
| NCT06055608 ADVANTage | DAIT CTOT-41 | Ph 2 | recruiting | Advancing Transplantation Outcomes in Children |
| 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 |
| NCT05170828 | PRESERVE | Ph 1 | withdrawn | Cryopreserved MMUD BM With PTCy for Hematologic Malignancies |
| NCT01203722 results posted | J1055 NA_00039823, P01CA015396 | Ph 1, Ph 2 | completed | Reduced Intensity, Partially HLA Mismatched BMT to Treat Hematologic Malignancies |
| NCT07359859 | 25-212 | Ph 2 | recruiting | A Study of Ruxolitinib for Preventing Graft-Versus-Host Disease in People With a Hematologic Malignancy Who Will Receive a Stem Cell Transplant |
| NCT05193565 | B110_02KT2103 | Ph 4 | active not recruiting | Study to Compare the Efficacy and Safety After Conversion to RaparoBell® or My-Rept® in Kidney Transplant Patients |
| NCT02861417 | 2016-0137 NCI-2017-00614, 2016-0137 | Ph 2 | active not recruiting | Busulfan, Fludarabine Phosphate, and Post-Transplant Cyclophosphamide in Treating Patients With Blood Cancer Undergoing Donor Stem Cell Transplant |
| NCT03504241 TEACH | DAIT ITN062ST UM1AI109565, NIAID CRMS ID#: 20676 | Ph 1 | completed | Tolerance by Engaging Antigen During Cellular Homeostasis |
| NCT06001385 OPTIMIZE | OPTIMIZE | Ph 2 | active not recruiting | HLA-Mismatched Unrelated Donor Peripheral Blood Stem Cell Transplantation With Reduced Dose Post Transplantation Cyclophosphamide GvHD Prophylaxis |
| NCT04877288 | IM103-402 2022-501677-39 | Ph 3 | recruiting | A Study to Evaluate the Benefits and Risks of Conversion of Existing Adolescent Kidney Transplant Recipients Aged 12 to <18 Years to a Belatacept-based Immunosuppressive Regimen as Compared to Continuation of a Calcineurin Inhibitor-based Regimen, and Their Adherence to Immunosuppressive Medications |
| NCT00882895 | 09-0042 / 201101864 | Ph 2 | active not recruiting | Tandem Stem Cell Transplantation for Non-Hodgkin's Lymphoma |
| NCT03032783 | 16D.606 JT 9551 | Ph 2 | completed | A Two Step Approach to Allogeneic Hematopoietic Stem Cell Transplantation for Patients With Hematologic Malignancies-Increasing GVT Effects Without Increasing Toxicity |
| NCT04262843 | 19518 NCI-2019-08984, 19518 | Ph 2 | active not recruiting | Total Marrow and Lymphoid Irradiation as Conditioning Regimen Before Hematopoietic Cell Transplantation in Patients With Myelodysplastic Syndrome or Acute Leukemia |
| NCT03121001 | 2016-1152 | Ph 2 | recruiting | Study of HLA-Haploidentical Stem Cell Transplantation to Treat Clinically Aggressive Sickle Cell Disease |
| NCT06013423 | RG1123652 NCI-2023-05598, FHIRB0020219 | Ph 2 | recruiting | Cord Blood Transplant, Cyclophosphamide, Fludarabine, and Total-Body Irradiation in Treating Patients With High-Risk Hematologic Diseases |
| NCT03292861 | ATG Pilot Study | Ph 2 | enrolling by invitation | The Effect and Safety Profile of Thymoglobulin® in Primary Cardiac Transplant Recipients |
| NCT05236036 | NU 21C01 NCI-2021-12424, STU00215766 | Ph 1 | active not recruiting | Mycophenolate Mofetil in Combination With Standard of Care for the Treatment of Glioblastoma |
| NCT04022239 | 2018-0972 NCI-2019-03900, 2018-0972 | Ph 1, Ph 2 | recruiting | Bendamustine With or Without Cyclophosphamide in Preventing GVHD in Patients Undergoing Stem Cell Transplant |
Showing 50 of 259 trials
Active Pipeline
Ongoing clinical trials by development phase
Key Completed Trials
Completed studies with published results, ranked by significance
Trial Timeline
Full development history with FDA approval milestones
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 MOFETIL FDA Label Details
Indications & Usage
FDA Label (PDF)Mycophenolate mofetil (MMF) is indicated for the prophylaxis of organ rejection, in adult and pediatric recipients 3 months of age and older of allogeneic kidney [see Clinical Studies ] , heart [see Clinical Studies ] or liver transplants [see Clinical Studies ], in combination with other immunosuppressants. Mycophenolate mofetil is an antimetabolite immunosuppressant indicated for the prophylaxis of organ rejection in adult and pediatric recipients 3 months of age and older of allogeneic kidney, heart or liver transplants, in combination with other immunosuppressants
WARNING: EMBRYOFETAL TOXICITY, MALIGNANCIES and SERIOUS INFECTIONS Use during pregnancy is associated with increased risks of first trimester pregnancy loss and congenital malformations. Avoid if safer treatment options are available. Females of reproductive potential must be counseled regarding pre...
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Full clinical data, patents, trials, and competitive landscape for mycophenolate mofetil.
Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.