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: *
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: None
Known Adverse Events: None
Company: Novartis
Company Location: BASEL V8 CH 4056
Company CEO: Vasant Narasimhan
Additional Commercial Interests: None
Clinical Description
Countries in Clinic:
Active Clinical Trial Count: 1
Recent & Upcoming Milestones
Highest Development Phases
Phase 3: Acute Myeloid Leukemia|Myelodysplastic Syndrome
Trial |
Phase |
Trial Status |
Disease |
Primary Completion Date |
Probability of Success |
Latest Trial Update Date |
Data Updated |
|---|---|---|---|---|---|---|---|
| ETAL-4 | P3 |
Completed |
Acute Myeloid Leukemia|Myelodysplastic Syndrome |
2023-02-13 |
2025-05-06 |
Primary Completion Date|Study Completion Date|Treatments|Trial Status |
Recent News Events
Date |
Type |
Title |
|---|---|---|
|
06/25/2025 |
News Article |
Biodexa Announces Activation of First Clinical Study Site for Phase 3 Serenta Trial in Familial Adenomatous Polyposis (FAP) |
|
06/23/2025 |
News Article |
Biodexa Unveils "Serenta" as the Name of its Upcoming Phase 3 Study In Familial Adenomatous Polyposis (FAP) |
|
06/11/2025 |
News Article |
Result of General Meeting |
|
06/04/2025 |
News Article |
Biodexa Announces Recruitment of First Patient in Phase 2 Study of Tolimidone in Type 1 Diabetes |