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: Europe
Company Founding Year: 1996
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 ID |
Trial |
Phase |
Trial Status |
Disease |
Primary Completion Date |
Probability of Success |
Latest Trial Update Date |
Data Updated |
|---|---|---|---|---|---|---|---|---|
2017-000764-15 |
ETAL-4 | P3 |
Completed |
Myelodysplastic Syndrome|Acute Myeloid Leukemia |
2023-02-13 |
2025-05-06 |
Primary Completion Date|Study Completion Date|Treatments|Trial Status |
Recent News Events
Date |
Type |
Title |
|---|---|---|
|
01/05/2026 |
News Article |
Appointment of Fiona Sharp to the Board as Chief Financial Officer and Company Secretary |
|
12/18/2025 |
News Article |
Biodexa Announces Pricing of $10 Million Public Offering |
|
12/01/2025 |
News Article |
Biodexa Announces Enrolment of First European Patients into Pivotal Phase 3 Serenta Trial in FAP |
|
11/24/2025 |
News Article |
Biodexa Activates First European Site for Registrational Phase 3 Serenta Trial in FAP |