Drug profile · INN
nilotinib
TASIGNA
nilotinib (TASIGNA) is a tyrosine-protein kinase abl inhibitor. Associated with Novartis Pharmaceuticals. Current US regulatory status: approved.
Drug details — nilotinib
- US status
- approved
- Class
- Antineoplastic and immunomodulating agents (L01)
- Route
- —
- Patents
- 4
- Programs
- 11
- Data quality
- 0.83
Quick answer
nilotinib (TASIGNA) is a tyrosine-protein kinase abl inhibitor. Associated with Novartis Pharmaceuticals. Current US regulatory status: approved.
Key facts
Mechanism of action
Tyrosine-protein kinase ABL inhibitor
Approval history
| Authority | Status | Date |
|---|---|---|
| FDA | approved | — |
| EMA | approved | — |
| TGA | approved | — |
Recent coverage
FDA Approves Oral Nilotinib Tablets for Ph+ CML: A New Era for Treatment
The FDA has approved oral nilotinib tablets, a significant advancement for patients with Philadelphia chromosome-positive chronic myeloid leukemia (Ph+ CML). This approval offers a new, more convenient treatment option and impacts the competitive dynamics within the CML market.
FDA Approves Orally Disintegrating Nilotinib (Cavhanza) for Chronic Myeloid Leukemia
The FDA has approved Cavhanza, an orally disintegrating tablet (ODT) formulation of nilotinib, for the treatment of select patients with chronic myeloid leukemia (CML). This new formulation enhances patient convenience by allowing co-administration with acid-reducing agents and reducing food-related burdens.
Pipeline programs
Related & competitor drugs
Related patents
Frequently asked questions
What is nilotinib?
nilotinib (TASIGNA) is a tyrosine-protein kinase abl inhibitor. Associated with Novartis Pharmaceuticals. Current US regulatory status: approved.
What is the brand name for nilotinib?
TASIGNA is a marketed brand name for nilotinib. Check FDA Drugs@FDA for the current US label holder and prescribing information.
What is the US approval status of nilotinib?
nilotinib has approved status in the United States according to our Drugs@FDA-derived records. Verify on the official FDA label before clinical or commercial decisions.