Daratumumab
As of the edition of 20 October 2026, Daratumumab is an antibody: marketed, first approved in 2015 (US); acts on CD38; US protection ends in 2028.
Sources: FDA Orange Book and Purple Book, other approval registers, ClinicalTrials.gov, ChEMBL.
The drug
- Status
- Marketed; latest approval 2017
- Kind
- Antibody
- Brand name
- Darzalex
- First approved
- 16 November 2015 (US)
- Approvals on record
- 16 in 4 regions
- Holder of the most recent approval
- Johnson & Johnson; 4 holders in all
- Registered trials
- 327, 44 stopped early
- Disease areas
- Cancer; Immune system; Blood and lymph; Heart and blood vessels; Nutrition and metabolism; Urinary and reproductive
US protection
US protection ends in 2028.
The orphan exclusivity ends in 2028 (it covers one use only). The application that gives this date is held by Johnson & Johnson.
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 product4 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
1 company on route B because of this drug.
Companies on route B for this drug
In the product1 company is on route B because of Daratumumab.
See the 1 company on route B for this drug, with the facts behind eachRequest access. Nothing is shown until you do.
Target
| Gene | Protein | UniProt |
|---|---|---|
| CD38 | ADP-ribosyl cyclase/cyclic ADP-ribose hydrolase 1 | P28907 |
Registered trials
| Phase | Trials | Completed | Active | Stopped early |
|---|---|---|---|---|
| Phase not stated | 17 | 5 | 4 | 0 |
| Phase 1 | 56 | 23 | 21 | 11 |
| Phase 2 | 198 | 47 | 101 | 32 |
| Phase 3 | 49 | 16 | 31 | 1 |
| Phase 4 | 7 | 2 | 5 | 0 |
| All trials | 327 |
Who has held its approvals
| Company | Role | Years |
|---|---|---|
| Johnson & Johnson | Applicant and Lead sponsor of trials | 2014 to now |