Mycophenolate Mofetil
Regulatory milestones approvals, filings & regulatory actions · 6 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Label expansions (4) | US (FDA) | CELLCEPT | — | 1998-02-11 – 2022-06-06 | fda.gov ↗ |
| Approved | EU (EMA) | CellCept | — | 1996-02-14 | europa.eu ↗ |
| Approved | US (FDA) | CELLCEPT | — | 1995-05-03 | fda.gov ↗ |
Trials 248 · started per year
News releases announcing trial results or a regulatory action · 21
| Date | Issuer | Release |
|---|---|---|
| 2025-12-09 | Hoffmann-La Roche | Regulatory European Commission approves Roche’s Gazyva/Gazyvaro for adults with active lupus nephritis roche.com ↗ |
| 2025-10-28 | Hoffmann-La Roche | Results Positive phase III results for Roche’s Gazyva/Gazyvaro in children and young adults with idiopathic nephrotic syndrome roche.com ↗
The study met its primary endpoint, with more people achieving sustained complete remission at one year (week 52) with Gazyva/Gazyvaro compared with mycophenolate mofetil (MMF). |
| 2025-10-27 | Genentech, Inc. | Results Positive Phase III Results for Genentech’s Gazyva in Children and Young Adults With Idiopathic Nephrotic Syndrome gene.com ↗
The study met its primary endpoint, with more people achieving sustained complete remission at one year (week 52) with Gazyva compared with mycophenolate mofetil (MMF). |
| 2025-10-17 | Hoffmann-La Roche | Regulatory CHMP recommends EU approval of Roche’s Gazyva/Gazyvaro for lupus nephritis roche.com ↗
Roche (SIX: RO, ROG; OTCQX: RHHBY) announced today that the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) has recommended the approval of Gazyva®/Gazyvaro® (obinutuzumab) in combination with mycophenolate mofetil (MMF) for the treatment of adult patients with active Class III or IV, with or without concomitant Class V, lupus nephritis. |
| 2025-05-22 | Aurinia Pharmaceuticals Inc. | Results New AURORA 1 Analysis: LUPKYNIS-Based Triple Immunosuppressive Therapy Yields Deep Proteinuria Reduction in Lupus Nephritis auriniapharma.com ↗
Of the 357 patients in AURORA 1, 60.9% in the triple immunosuppressive therapy group (N=109) achieved a UPCR of ≤0.4 g/g at least once during the study compared to 37.1% of patients in the control group (N=66). |
| 2023-04-05 | Aurinia Pharmaceuticals Inc. | Results Aurinia Pharmaceuticals Announces Promising Topline Data from Renal Biopsy Sub-study of the AURORA Trial auriniapharma.com ↗
The patients in the voclosporin treatment arm demonstrated histologic activity improvement with stable chronicity scores similar to the active control arm of MMF and low dose steroids alone over the 18-months average treatment period at the time of repeat biopsy. |
| 2022-03-21 | Zydus Lifesciences Limited | Regulatory Zydus receives Prior Approval Supplement (PAS) approval from USFDA for Mycophenolate Mofetil for Injection USP zyduslife.com ↗
Zydus Lifesciences Limited (formerly known as Cadila Healthcare Ltd.) has received Prior Approval Supplement (PAS) approval from the USFDA to market Mycophenolate Mofetil for Injection USP, 500 mg/vial (US RLD: CellCept injection). |
| 2021-06-25 | Chugai Pharmaceutical | Regulatory Immunosuppressant CellCept, Approved for Additional Indication of Prevention of Graft-Versus-Host Disease in Hematopoietic Stem-Cell Transplantation chugai-pharm.co.jp ↗
Chugai Pharmaceutical Co., Ltd. (TOKYO: 4519) announced that it obtained approval from the Ministry of Health, Labour and Welfare (MHLW) for immunosuppressant CellCept ® Capsules 250, and CellCept ® Powder for Oral Suspension 31.8% (generic name: mycophenolate mofetil) for the additional indication of prevention of graft-versus-host disease (GVHD) in hematopoietic stem-cell transplantation (adults and children). |
| 2021-06-07 | Aurinia Pharmaceuticals Inc. | Results Aurinia Announces Additional Analysis of its AURORA 1 Phase 3 Study Data Presented at ERA-EDTA 2021 Congress auriniapharma.com ↗
This examination demonstrated that patients treated with voclosporin in addition to mycophenolate mofetil (MMF) and low-dose steroids achieved statistically significant increased renal response rates regardless of the level of UPCR, including at an even more stringent ≤0.3 mg/mg target. |
| 2020-12-29 | Lupin Limited | Regulatory Lupin launches Mycophenolate Mofetil Tablets USP lupin.com ↗
Mumbai, Baltimore: Lupin Limited (Lupin), global pharmaceutical company, announced today the launch of Mycophenolate Mofetil Tablets USP, 500 mg, after Lupin’s alliance partner Concord Biotech Limited (Concord) received an approval for its ANDA from the United States Food and Drug Administration. |
| 2020-11-09 | Aurinia Pharmaceuticals Inc. | Results Aurinia Presents Integrated Time to Renal Response Data from the AURA-LV and AURORA Trials, along with Voclosporin Drug-Drug Interaction Data at ACR Convergence 2020 auriniapharma.com ↗
The study demonstrated for the first time that voclosporin does not have a meaningful drug-drug interaction when administered with MMF. |
| 2020-10-22 | Aurinia Pharmaceuticals Inc. | Results Aurinia Presents Voclosporin Efficacy and Pharmacokinetic Data from Integrated Analysis of AURA-LV and AURORA Pivotal Trials at ASN Kidney Week 2020 auriniapharma.com ↗
Integrated analysis confirms statistically superior efficacy and safety of voclosporin in combination with MMF and steroids over standard-of-care |
| 2020-08-06 | Lupin Limited | Regulatory Lupin’s Alliance Partner Concord Receives U.S. FDA Approval for Mycophenolate Mofetil Tablets USP lupin.com ↗
Mumbai, Baltimore: Pharma major Lupin Limited (Lupin) in alliance with Concord Biotech Limited (Concord) announced that it has received approval from the United States Food and Drug Administration (U.S. FDA) for Mycophenolate Mofetil Tablets USP, 500 mg, to market a generic version of CellCept® Tablets of Roche Palo Alto LLC (Roche). |
| 2019-11-11 | Hoffmann-La Roche | Results Roche’s Gazyva (obinutuzumab), in combination with standard of care, more than doubles the percentage of lupus nephritis patients achieving complete renal response, compared to standard of care alone roche.com ↗
The study met the primary endpoint with Gazyva, in combination with standard of care (mycophenolate mofetil or mycophenolic acid and corticosteroids), demonstrating superiority compared to placebo plus standard of care. |
| 2019-10-14 | Hoffmann-La Roche | Results Phase III PEMPHIX study shows Roche’s MabThera/Rituxan (rituximab) superior to mycophenolate mofetil in patients with pemphigus vulgaris roche.com ↗
The study met the primary endpoint at Week 52 and demonstrated that MabThera/Rituxan is superior to MMF, with 40.3% of patients treated with MabThera/Rituxan achieving sustained complete remission (CR) without the use of steroids for 16 consecutive weeks or more, compared to 9.5% in the MMF arm (p<0.0001). |
| 2019-10-13 | Genentech, Inc. | Results Phase III PEMPHIX Study Shows Genentech’s Rituxan (Rituximab) Superior to Mycophenolate Mofetil in Patients With Pemphigus Vulgaris gene.com ↗
The PEMPHIX study showed that 40% of people in the study could achieve complete remission from painful blistering without the need for corticosteroids for 16 weeks or more and that Rituxan may be a superior treatment option to mycophenolate mofetil. |
| 2019-06-12 | Genentech, Inc. | Results Phase III PEMPHIX Study Showed That Genentech’s Rituxan (Rituximab) is Superior to Standard of Care in Achieving Sustained Remission in Patients with Pemphigus Vulgaris gene.com ↗
The study met the primary endpoint, and demonstrated that Rituxan is superior to MMF in achieving sustained complete remission. |
| 2017-08-24 | Zydus Lifesciences Limited | Regulatory Zydus receives final approval from the USFDA for Mycophenolate Mofetil for Injection USP zyduslife.com ↗
Zydus Cadila has received the final approval from the USFDA to market Mycophenolate Mofetil for Injection USP , 500 mg/vial. |
| 2016-05-13 | Chugai Pharmaceutical | Regulatory Immunosuppressant “CellCept ® ” Obtained Approval for Additional Indication of “Lupus Nephritis” chugai-pharm.co.jp ↗
Chugai filed an application for this additional indication on August 24, and thus obtained a supplemental approval. |
| 2009-05-05 | Zydus Lifesciences Limited | Regulatory Zydus receives approval for Mycophenolate Mofetil tablets and capsules zyduslife.com ↗ |
| 2009-03-11 | Biogen | Results Phase III Study of Rituxan in Lupus Nephritis Did Not Meet Primary Endpoint biogen.com ↗
Genentech, Inc. (NYSE:DNA) and Biogen Idec (Nasdaq:BIIB) announced today that a Phase III study of Rituxan ® (rituximab) plus mycophenolate mofetil (MMF) and corticosteroids in patients with lupus nephritis did not meet its primary endpoint of significantly reducing disease activity at 52 weeks. |
All press releases naming this drug 24 releases
Evidence & citations 23 cited values
Every value below carries the sentence it was read from. 859 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | mycophenolate mofetil | “The BAT in this study was identified by the investigator prior to patient randomization among the following treatments currently used in this setting: anti-thymocyte globulin...” NCT02913261 ↗799“The BAT in this study will freely be identified by the Investigator prior to patient randomization and may include treatments such as: anti-thymocyte globulin (ATG),...” NCT04118556 ↗ “Specifically, this study is designed to determine the ability of Mycophenolate Mofetil (MMF/CellCept) used alone, or in combination with Daclizumab (DZB/Zenapax) to see if it...” NCT00100178 ↗ “BACKGROUND: To reduce long-term nephrotoxic calcineurin inhibitor dosage, adjunctive sirolimus or mycophenolate mofetil (MMF) was used in a 150-patient, randomized, three-armed...” PMID 14742989 ↗ Jan 2004 “Methylprednisolone (500 mg), thymoglobulins (2.5 mg/Kg/die, beginning 1 hour before transplant) and Mycophenolate mofetil (1000 mg) and no immunosuppressive therapy for the...” NCT01640743 ↗ “The CNI-based prophylaxis regimen will be identified by the investigator before the subject's enrollment and will consist of the combination of tacrolimus/methotrexate,...” NCT03320642 ↗ “Evaluation of the Interest of Therapeutic Drug Monitoring of Immunosuppressants (Tacrolimus, Mycophenolate Mofetil) Based on Bayesian Estimation During the Three First Years...” NCT00975663 ↗ “We conducted a single-arm, phase 2 clinical trial that investigated the addition of tocilizumab, an interleukin-6 receptor blocker, to cyclosporine-A (CSA) and mycophenolate...” PMID 40423982 ↗ May 2025 “To compare the safety and efficacy of cyclosporine (CsA) + mycophenolate mofetil (MMF) + corticosteroids © to CsA + Rapamune + Cs with CsA elimination in the Rapamune arm with...” NCT01601821 ↗ “High-dose, post-transplantation cyclophosphamide (PTCy) 25-50 mg/kg on days +3 and +4, sirolimus 6 mg on days +5 through +90, and mycophenolate mofetil (MMF) on days +5 through...” NCT02579967 ↗ “As specified in the protocol, one of the following drugs at a stable dose is required as monotherapy for baseline treatment during the double-blind period: azathioprine (AZA);...” NCT02028884 ↗ |
| Known as | Cellcept | “In this context, we propose a randomized controlled non-inferiority study to demonstrate that in liver transplant recipients, an immunosuppressive strategy based on single...” NCT06354179 ↗59“Specifically, this study is designed to determine the ability of Mycophenolate Mofetil (MMF/CellCept) used alone, or in combination with Daclizumab (DZB/Zenapax) to see if it...” NCT00100178 ↗ “The objective of this study was to compare the oral availability of a test product of Mycophenolate Mofetil 250 mg capsule to an equivalent oral dose of the commercially...” NCT00910663 ↗ “maintenance immunosuppressive treatment regimen consisting of a combination of orally administered drugs (tacrolimus (Prograf®), sirolimus (Rapamune®), mycophenolate mofetil...” NCT01309022 ↗ “CellCept (Mycophenolate Mofetil, MMF) Maintenance Immunosuppression in Liver Transplant Recipients With Long-term Follow-up Post-transplantation for Non-Autoimmune Liver...” NCT00206076 ↗ “The proposed study is designed to evaluate the safety and efficacy of mycophenolate mofetil (CellCept) for the treatment of symptomatic pulmonary alveolitis due to systemic...” NCT00333437 ↗ “The drugs that are often used to treat lupus nephritis include prednisone (steroids), cyclophosphamide (Cytoxan), azathioprine (AZA or Imuran), and mycophenolate mofetil (MMF...” NCT00447265 ↗ “Regimens are adapted based on patient age and underlying disease characteristics using the following agents: Campath, Fludarabine, Melphalan, Cyclosporine, Cellcept (MMF).” NCT01050855 ↗ “The dosage of mycophenolate mofetil (CellCept) will be decided by the investigator and should be adjusted according to clinical response or therapeutic drug monitoring.” NCT04444843 ↗ “mycophenolate mofetil stable dose from 1000 - 3000 mg daily tablet 500 mg or 250 mg regardless of the preparation (Mycofit, CellCept, Mycophenolate mofetil, Myfenax)” NCT06297096 ↗ “The Relationships Between Mycophenolic Acid Levels, T-Cell Subsets and Outcomes in Pediatric Heat Transplant Recipients Receiving Mycophenolate Mofetil (Cellcept)” NCT00166153 ↗ |
| Known as | Cellcept for Mycophenolate Mofetil | “Cellcept for Mycophenolate Mofetil” NCT05063513 ↗ |
| Known as | CKD-4101 | “CKD-4101 (Mycophenolate Mofetil) Tablet” NCT01016626 ↗ |
| Known as | MMF | “The BAT in this study will freely be identified by the Investigator prior to patient randomization and may include treatments such as: anti-thymocyte globulin (ATG),...” NCT04118556 ↗208“Specifically, this study is designed to determine the ability of Mycophenolate Mofetil (MMF/CellCept) used alone, or in combination with Daclizumab (DZB/Zenapax) to see if it...” NCT00100178 ↗ “The FSGS Clinical Trial is a multi-center, prospective, controlled, open label randomized trial designed to determine if treatment with mycophenolate mofetil (MMF) in...” NCT00135811 ↗ “The purpose of this study is to evaluate in lung or heart-lung transplant patients on tacrolimus and mycophenolate the impact of optimized mofetil (MMF) therapeutic drug...” NCT00975663 ↗ “BACKGROUND: To reduce long-term nephrotoxic calcineurin inhibitor dosage, adjunctive sirolimus or mycophenolate mofetil (MMF) was used in a 150-patient, randomized, three-armed...” PMID 14742989 ↗ Jan 2004 “BACKGROUND: We compared protection of mycophenolate mofetil (MMF) and azathioprine (AZA) against acute cellular rejection (ACR) and chronic allograft nephropathy (CAN) in...” PMID 34166370 ↗ Jun 2021 “Although the half-life of mycophenolic acid (MPA), the active moiety of mycophenolate mofetil (MMF) is compatible with once-daily administration, no published randomized...” NCT06354179 ↗ “We conducted a single-arm, phase 2 clinical trial that investigated the addition of tocilizumab, an interleukin-6 receptor blocker, to cyclosporine-A (CSA) and mycophenolate...” PMID 40423982 ↗ May 2025 “To compare the safety and efficacy of cyclosporine (CsA) + mycophenolate mofetil (MMF) + corticosteroids © to CsA + Rapamune + Cs with CsA elimination in the Rapamune arm with...” NCT01601821 ↗ “High-dose, post-transplantation cyclophosphamide (PTCy) 25-50 mg/kg on days +3 and +4, sirolimus 6 mg on days +5 through +90, and mycophenolate mofetil (MMF) on days +5 through...” NCT02579967 ↗ “As specified in the protocol, one of the following drugs at a stable dose is required as monotherapy for baseline treatment during the double-blind period: azathioprine (AZA);...” NCT02028884 ↗ |
| Known as | MPM | “This study will compare the safety and effectiveness of two drugs-methotrexate and mycophenolate mofetil (MPM)-in preventing disease recurrence in patients with Wegener's...” NCT00004567 ↗1“This study will examine the safety and effectiveness of the drug mycophenolate mofetil (MPM) in treating Wegener's granulomatosis and related inflammatory vessel diseases.” NCT00001764 ↗ |
| Known as | My-rept capsule | “assistant is My-rept capsule®(Mycophenolate Mofetil)” NCT02075242 ↗ |
| Known as | Mycofenolate Mofetil | “Mycofenolate mofetil (MMF) (for Group A)” NCT02540395 ↗ |
| Known as | Mycofit | “mycophenolate mofetil stable dose from 1000 - 3000 mg daily tablet 500 mg or 250 mg regardless of the preparation (Mycofit, CellCept, Mycophenolate mofetil, Myfenax)” NCT06297096 ↗ |
| Known as | mycophenolat mofetil | “Aplication of mycophenolat mofetil from day +1 to day +28 in a dose of 2 x 1g per day” NCT00785330 ↗ |
| Known as | mycophenolate mofetil (Cellcept) | “mycophenolate mofetil (Cellcept)” NCT01005706 ↗3“Mycophénolate mofétil = Cellcept” NCT00538265 ↗ “mycophenolate mofetil (Cellcept)” NCT00132691 ↗ “mycophenolate mofetil / CellCept” NCT00299221 ↗ |
| Known as | mycophenolate mofetil (MMF) | “mycophenolate mofetil (MMF)” NCT01707004 ↗ |
| Known as | Mycophenolate Mofetil Dispersible tablets（CYCOPIN） | “Mycophenolate Mofetil Dispersible tablets（CYCOPIN®）” NCT04048161 ↗ |
| Known as | Mycophenolate Mofetil Hydrochloride | ClinicalTrials.gov intervention name — accepted as the source's own label NCT04469842 ↗ |
| Known as | Mycophenolate mofetil, CellCept(R) | “Mycophenolate mofetil, CellCept(R)” NCT00360685 ↗ |
| Known as | Mycophenolate Mofetil/Sodium | ClinicalTrials.gov intervention name — accepted as the source's own label NCT06478017 ↗ |
| Known as | mycophenylate mofetil | “In addition to T -cell depletion of the donor product, Mycophenylate mofetil was provided over several months as prophylaxis for GVHD” NCT00143559 ↗ |
| Known as | Myfenax | “mycophenolate mofetil stable dose from 1000 - 3000 mg daily tablet 500 mg or 250 mg regardless of the preparation (Mycofit, CellCept, Mycophenolate mofetil, Myfenax)” NCT06297096 ↗ |
| Known as | Myfortic | “Mycophenolate mofetil (CellCept or Myfortic) belongs to a class of medications known as immunosuppressives.” NCT02370693 ↗ |
| Known as | ◦Drug: Mycophenolate mofetil | “◦Drug: Mycophenolate mofetil” NCT01983761 ↗ |
| Action | Inhibit | “In this study we try to inhibit the activation of the immune system with mycophenolate mofetil (MMF).” NCT00120419 ↗ |
| Modality | Small molecule | “a morpholinoethyl ester of mycophenolic acid” NCT05113004 ↗ |
| Route | Oral | “Patients with active disease will be given MPM and prednisone, both in tablet form.” NCT00001764 ↗ |