Product Description
Panobinostat is a potent oral deacetylase inhibitor that alters gene expression through epigenetic mechanisms and inhibits protein degradation. It was recently approved by the FDA and EMA for use in combination with bortezomib and dexamethasone in patients with multiple myeloma who have received ≥2 prior regimens, including bortezomib and an immunomodulatory drug. (Sourced from: https://pubmed.ncbi.nlm.nih.gov/26362997/)
Mechanisms of Action: HDAC Inhibitor
Novel Mechanism: No
Modality: Small Molecule
Route of Administration: Oral
FDA Designation: None *
Approval Status: Approved
Approved Countries: Austria | Belgium | Chile | Croatia | Czech | Denmark | Dominican Republic | Estonia | European Medicines Agency | Finland | France | Germany | Greece | Hungary | Iceland | India | Ireland | Italy | Japan | Latvia | Lithuania | Luxembourg | Netherlands | Norway | Poland | Portugal | Romania | Russia | Singapore | Slovakia | Slovenia | Spain | Sweden | Switzerland | Taiwan | United Kingdom | United States
Approved Indications: Multiple Myeloma
Known Adverse Events: Gastrointestinal Hemorrhage | Anemia | Leukopenia | Lymphopenia | Thrombocytopenia | Neutropenia | Hypokalemia | Hyponatremia | Hypophosphatemia | Pregnancy Outcomes | Pulmonary Edema | Diarrhea | Edema
Company: Novartis
Company Location: BASEL V8 CH 4056
Company CEO: Vasant Narasimhan
Additonal Commercial Interests: None
Clinical Description
Countries in Clinic: Germany, Korea, Netherlands, Spain, Taiwan, United Kingdom, United States
Active Clinical Trial Count: 3
Highest Development Phases
Phase 2: HIV Infections|Multiple Myeloma
Phase 1: Adenocarcinoma|Colorectal Cancer|Kidney Cancer|Non-Small-Cell Lung Cancer|Renal Cell Carcinoma|Triple Negative Breast Cancer
Trial |
Phase |
Trial Status |
Disease |
Primary Completion Date |
Probability of Success |
|---|---|---|---|---|---|
| ACTIVATE | P2 |
Completed |
HIV Infections |
2022-08-01 |
|
| LBH589 | P1 |
Completed |
Triple Negative Breast Cancer|Kidney Cancer|Colorectal Cancer|Non-Small-Cell Lung Cancer|Renal Cell Carcinoma|Adenocarcinoma |
2022-02-22 |
44% |
| LBH589 | P1 |
Completed |
Triple Negative Breast Cancer|Kidney Cancer|Colorectal Cancer|Non-Small-Cell Lung Cancer|Renal Cell Carcinoma|Adenocarcinoma |
2022-02-22 |
44% |
| 2015-001564-19 | P2 |
Active, not recruiting |
Multiple Myeloma |
2021-10-26 |