Product Description
Mycophenolic acid is a member of the class of 2-benzofurans that is 2-benzofuran-1(3H)-one which is substituted at positions 4, 5, 6, and 7 by methyl, methoxy, (2E)-5-carboxy-3-methylpent-2-en-1-yl, and hydroxy groups, respectively. It has a role as an antineoplastic agent, an antimicrobial agent, an EC 1.1.1.205 (IMP dehydrogenase) inhibitor, an immunosuppressive agent, a mycotoxin, a Penicillium metabolite, an environmental contaminant, a xenobiotic and an anticoronaviral agent (Sourced from: https://pubchem.ncbi.nlm.nih.gov/compound/Mycophenolic-acid)
Mechanisms of Action: IMPDH Inhibitor,Calcineurin Inhibitor,Immunosuppressive
Novel Mechanism: No
Modality: Small Molecule
Route of Administration: Oral
FDA Designation: None *
Approval Status: Approved
Approved Countries: Algeria | Argentina | Australia | Austria | Bangladesh | Belgium | Bosnia | Brazil | Bulgaria | Canada | Chile | China | Colombia | Croatia | Cyprus | Czech | Denmark | Dominican Republic | Ecuador | Egypt | Estonia | European Medicines Agency | Finland | France | Germany | Greece | Hong Kong | Hungary | Iceland | India | Indonesia | Ireland | Israel | Italy | Japan | Jordan | Korea | Latvia | Lebanon | Lithuania | Luxembourg | Malaysia | Malta | Mexico | Morocco | Netherlands | New Zealand | Norway | Pakistan | Peru | Philippines | Poland | Portugal | Romania | Russia | Saudi Arabia | Serbia | Singapore | Slovakia | Slovenia | South Africa | Spain | Sri Lanka | Sweden | Switzerland | Taiwan | Thailand | Tunisia | Turkey | Ukraine | United Arab Emirates | United Kingdom | United States | Uruguay | Venezuela | Vietnam
Approved Indications: Kidney Transplant | Transplantation Unspecified | Heart Transplant | Kidney Transplant | Liver Transplant | Transplantation Unspecified
Known Adverse Events: Pain Unspecified | Pain, Postoperative | Insomnia | Anemia | Leukopenia | Constipation | Diarrhea | Dyspepsia | Opportunistic Infections
Company: Novartis
Company Location: BASEL V8 CH 4056
Company CEO: Vasant Narasimhan
Additonal Commercial Interests: None
Clinical Description
Countries in Clinic: China, France, India, United States
Active Clinical Trial Count: 8
Highest Development Phases
Phase 3: Lupus Erythematosus, Systemic|Lupus Nephritis
Phase 2: Dry Eye Disease|Dry Eye Syndromes|Geographic Atrophy|Keratoconjunctivitis Sicca|Lung Diseases, Interstitial|Macular Degeneration|Retinal Degeneration|Scleroderma, Diffuse|Scleroderma, General|Scleroderma, Localized|Scleroderma, Systemic
Phase 1: Acute Lymphoid Leukemia|Acute Monocytic Leukemia|Acute Myeloid Leukemia|Acute Myelomonocytic Leukemia|Chronic Lymphoid Leukemia|Chronic Myeloid Leukemia|Chronic Myelomonocytic Leukemia|Graft vs Host Disease|Juvenile Myelomonocytic Leukemia,|Kidney Transplant|Liver Transplant|Lymphoma, Non-Hodgkin|Myelodysplastic Syndrome|Myeloproliferative Disorders|Precursor Cell Lymphoblastic Leukemia-Lymphoma|Preleukemia|Stem Cell Transplant|Transplantation Unspecified
Trial |
Phase |
Trial Status |
Disease |
Primary Completion Date |
Probability of Success |
|---|---|---|---|---|---|
| OBILUP | P3 |
Recruiting |
Lupus Nephritis|Lupus Erythematosus, Systemic |
2031-12-01 |
|
| PLUMM | P2 |
Recruiting |
Lupus Nephritis |
2025-07-01 |
|
| ERPL-CTP-001 | P2 |
Recruiting |
Geographic Atrophy|Macular Degeneration|Retinal Degeneration |
2025-04-01 |
|
| NCT04473911 | P1 |
Active, not recruiting |
Myeloproliferative Disorders|Acute Myelomonocytic Leukemia|Graft vs Host Disease|Preleukemia|Lymphoma, Non-Hodgkin|Juvenile Myelomonocytic Leukemia,|Myelodysplastic Syndrome|Acute Monocytic Leukemia|Stem Cell Transplant|Chronic Myeloid Leukemia|Chronic Lymphoid Leukemia|Acute Lymphoid Leukemia|Precursor Cell Lymphoblastic Leukemia-Lymphoma|Chronic Myelomonocytic Leukemia|Acute Myeloid Leukemia |
2023-10-22 |