FN-1501
- Generic Name
- FN-1501
- Brand Names
- Cellcept, Myfenax, CellCept, Mycophenolate mofetil Teva, Myclausen
- Drug Type
- Small Molecule
- Chemical Formula
- C22H25N9O
- CAS Number
- 1429515-59-2
- Unique Ingredient Identifier
- 6MC966B505
- Background
Mycophenolate mofetil, also known as MMF or CellCept, is a prodrug of mycophenolic acid, and classified as a reversible inhibitor of inosine monophosphate dehydrogenase (IMPDH). This drug is an immunosuppressant combined with drugs such as Cyclosporine and corticosteroids to prevent organ rejection after hepatic, renal, and cardiac transplants. It is markete...
- Indication
Mycophenolate mofetil is indicated in combination with other immunosuppressants to prevent the rejection of kidney, heart, or liver transplants in adult and pediatric patients ≥3 months old. Mycophenolate mofetil may also be used off-label as a second-line treatment for autoimmune hepatitis that has not responded adequately to first-line therapy. Other off-l...
- Associated Conditions
- Transplanted Organ Rejection
- Associated Therapies
- -
Treatment options for hemophilia A
Hemophilia A, caused by F8 gene mutation, leads to factor VIII deficiency, impairing blood clotting. Treatment includes factor VIII replacement, immunotherapies, and gene therapy, aiming to manage bleeding and prevent inhibitor development.
Lupkynis approved in Japan to treat lupus nephritis
Lupkynis (voclosporin) approved in Japan for lupus nephritis, used with mycophenolate mofetil. Otsuka Pharmaceutical filed for approval in Nov 2023. Aurinia eligible for $10M payment and royalties. Lupkynis also approved in U.K., EU, Switzerland, and U.S. Based on AURORA Clinical Program, Lupkynis better than placebo at stabilizing kidney function.
Significant benefit seen with obinutuzumab in lupus nephritis trial
Positive phase 3 results for obinutuzumab in lupus nephritis showed higher complete renal response rates compared to standard therapy alone, with no new safety concerns.
Approved Therapies Considered for Patients With Graft-Vs-Host Disease
Noah M. Merin discusses approved therapies for acute and chronic graft-vs-host disease (GVHD), emphasizing the shift towards oral treatments like ruxolitinib, ibrutinib, and belumosudil. He notes that less commonly used drugs like infliximab and mycophenolate mofetil can still be beneficial in specific cases, such as acute diarrhea or liver GVHD.
Gazyva/Gazyvaro Shows Improved Complete Renal Response Among Patients with Lupus Nephritis
The Phase III REGENCY trial showed Gazyva/Gazyvaro (obinutuzumab) plus standard therapy achieved higher complete renal response (CRR) in lupus nephritis patients compared to standard therapy alone. The trial also observed significant CRR with reduced corticosteroid use and improved proteinuric response. Gazyva/Gazyvaro could offer a new treatment option for lupus nephritis, potentially delaying end-stage kidney disease.
Roche announces positive results from phase III study of Gazyva/Gazyvaro in people with ...
Roche's phase III REGENCY study showed Gazyva/Gazyvaro plus standard therapy achieved higher complete renal response rates in active lupus nephritis compared to standard therapy alone, with no new safety signals. This could be a significant advancement for patients, potentially preventing end-stage kidney disease.
Positive Phase III Clinical Trial Results Announced for Gazyva for the Treatment of Lupus Nephritis
Genentech announced positive Phase III REGENCY study results for Gazyva (Obinutuzumab) in active lupus nephritis (LN), showing higher complete renal response rates with Gazyva plus standard therapy compared to placebo. Gazyva targets CD20 on B cells to reduce inflammation and kidney damage, potentially preventing end-stage renal disease. The study involved 271 participants and met its primary endpoint. Gazyva is also under study for other conditions and has FDA Breakthrough Therapy designation.
Press Releases | Wednesday, Sep 25, 2024
Genentech announced positive Phase III REGENCY study results for Gazyva, showing it plus standard therapy achieved a higher complete renal response rate in active lupus nephritis patients compared to standard therapy alone, with no new safety signals.
Roche's Gazyva/Gazyvaro Shows Superiority To Standard Therapy In Phase III Lupus
Roche's phase III REGENCY study shows Gazyva/Gazyvaro plus standard therapy achieved higher complete renal response rates in active lupus nephritis patients compared to standard therapy alone, with consistent safety profile and no new concerns.
Drug Development Updates
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