Midostaurin
As of the edition of 20 October 2026, Midostaurin is a small molecule: marketed, first approved in 2017 (US); acts on FLT3, KIT and PDGFRA and 1 more; no US protection is listed.
Sources: FDA Orange Book and Purple Book, other approval registers, ClinicalTrials.gov, ChEMBL.
The drug
- Status
- Marketed; latest approval 2018
- Kind
- Small molecule
- Brand name
- Rydapt
- First approved
- 28 April 2017 (US)
- Approvals on record
- 4 in 4 regions
- Holder of the most recent approval
- NOVARTIS BIOCIENCIAS S.A; 3 holders in all
- Registered trials
- 43, 10 stopped early
- Disease areas
- Cancer; Blood and lymph; Immune system; Inherited and neonatal; Digestive system
US protection
No US protection is listed.
The FDA registers list no drug-substance patent or exclusivity that counts for this drug.
This is the US only.
Companies that need a new molecule because of this drug
1 company-target row on route B because of this drug.
Companies on route B for this drug
In the product1 company-target row is on route B because of Midostaurin.
See the 1 company-target row on route B for this drug, with the facts behind eachRequest access. Nothing is shown until you do.
Targets
Registered trials
| Phase | Trials | Completed | Active | Stopped early |
|---|---|---|---|---|
| Phase not stated | 4 | 1 | 0 | 0 |
| Phase 1 | 12 | 9 | 2 | 1 |
| Phase 2 | 22 | 9 | 3 | 9 |
| Phase 3 | 5 | 3 | 0 | 0 |
| All trials | 43 |
Who has held its approvals
| Company | Role | Years |
|---|---|---|
| Novartis | Originator, Applicant and Lead sponsor of trials | 2017 to now |