Crizanlizumab
As of the edition of 20 October 2026, Crizanlizumab is an antibody: marketed, first approved in 2019 (US); acts on SELP; US protection ends in 2031.
Sources: FDA Orange Book and Purple Book, other approval registers, ClinicalTrials.gov, ChEMBL.
The drug
- Status
- Marketed; latest approval 2019
- Kind
- Antibody
- Brand name
- Adakveo
- First approved
- 15 November 2019 (US)
- Approvals on record
- 1 in 1 region
- Holder of the most recent approval
- Novartis
- Withdrawn from market
- 3 August 2023 (in some regions)
- Registered trials
- 16, 1 stopped early
- Disease areas
- Blood and lymph; Inherited and neonatal; Infections; Lungs and airways; Urinary and reproductive; Pregnancy and women's health
US protection
US protection ends in 2031.
US protection ends in 2031, computed as 12 years from the first US licence because FDA publishes no date for this product. The application that gives this date is held by Novartis. The date is computed, not published.
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 product2 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 Crizanlizumab.
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 |
|---|---|---|
| SELP | P-selectin | P16109 |
Registered trials
| Phase | Trials | Completed | Active | Stopped early |
|---|---|---|---|---|
| Phase not stated | 1 | 0 | 0 | 0 |
| Phase 2 | 10 | 7 | 2 | 1 |
| Phase 3 | 2 | 0 | 2 | 0 |
| Phase 4 | 3 | 2 | 1 | 0 |
| All trials | 16 |
Who has held its approvals
| Company | Role | Years |
|---|---|---|
| Novartis | Originator and Lead sponsor of trials | 2019 to now |