Carfilzomib
As of the edition of 20 October 2026, Carfilzomib is a protein: marketed, first approved in 2012 (US); acts on PSMB5; US protection ends in 2028.
Sources: FDA Orange Book and Purple Book, other approval registers, ClinicalTrials.gov, ChEMBL.
The drug
- Status
- Marketed; latest approval 2016
- Kind
- Protein
- Brand name
- Kyprolis
- First approved
- 20 July 2012 (US)
- Approvals on record
- 12 in 5 regions
- Holder of the most recent approval
- Amgen; 4 holders in all
- Registered trials
- 229, 36 stopped early
- Disease areas
- Cancer; Immune system; Blood and lymph; Heart and blood vessels; Urinary and reproductive; Lungs and airways
US protection
US protection ends in 2028.
The last listed US exclusivity ends in 2028. The application that gives this date is held by Amgen.
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 product9 listings count towards this date. The exact date and each listing are in the product.
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Companies that need a new molecule because of this drug
2 companies on route B because of this drug.
Companies on route B for this drug
In the product2 companies are on route B because of Carfilzomib.
See the 2 companies on route B for this drug, with the facts behind eachRequest access. Nothing is shown until you do.
Target
| Gene | Protein | UniProt |
|---|---|---|
| PSMB5 | Proteasome subunit beta type-5 | P28074 |
Registered trials
| Phase | Trials | Completed | Active | Stopped early |
|---|---|---|---|---|
| Phase not stated | 9 | 3 | 2 | 0 |
| Phase 1 | 56 | 31 | 11 | 12 |
| Phase 2 | 138 | 58 | 48 | 23 |
| Phase 3 | 22 | 9 | 12 | 1 |
| Phase 4 | 4 | 2 | 2 | 0 |
| All trials | 229 |
Who has held its approvals
| Company | Role | Years |
|---|---|---|
| Amgen | Originator, Applicant and Lead sponsor of trials | 2012 to now |
| Ono Pharmaceutical | Applicant | 2016 to now |