Asciminib
As of the edition of 20 October 2026, Asciminib is a small molecule: marketed, first approved in 2021 (US); acts on ABL1; US protection ends in 2040.
Sources: FDA Orange Book and Purple Book, other approval registers, ClinicalTrials.gov, ChEMBL.
The drug
- Status
- Marketed; latest approval 2022
- Kind
- Small molecule
- Brand name
- Scemblix
- First approved
- 29 October 2021 (US)
- Approvals on record
- 9 in 4 regions
- Holder of the most recent approval
- Novartis; 2 holders in all
- Registered trials
- 39, 4 stopped early
- Disease areas
- Cancer; Blood and lymph; Immune system; Lungs and airways; Infections; Nervous system
US protection
US protection ends in 2040.
The last listed US drug-substance patent ends in 2040. The application that gives this date is held by Novartis.
This is the US only, and it is not the date generics or biosimilars can enter.
The exact date and the listings behind it
In the product25 listings count towards this date. The exact date and each listing are in the product.
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Target
| Gene | Protein | UniProt |
|---|---|---|
| ABL1 | Tyrosine-protein kinase ABL1 | P00519 |
Registered trials
| Phase | Trials | Completed | Active | Stopped early |
|---|---|---|---|---|
| Phase not stated | 1 | 0 | 0 | 0 |
| Phase 1 | 8 | 4 | 4 | 0 |
| Phase 2 | 22 | 2 | 17 | 3 |
| Phase 3 | 6 | 3 | 2 | 1 |
| Phase 4 | 2 | 1 | 1 | 0 |
| All trials | 39 |
Who has held its approvals
| Company | Role | Years |
|---|---|---|
| Novartis | Originator, Applicant and Lead sponsor of trials | 2021 to now |