crizanlizumab
crizanlizumab: developed by 1 company · 4 clinical trials tracked · 1 FDA decision.
crizanlizumab evidence translation
What we can confirm
1 FDA record · 4 tracked trials
What it means
What to watch
Prepared research question
How could crizanlizumab → NVS affect its developer, and what evidence supports the link?
Traceable citations · Unknowns marked
See linked entities and source evidence1 indications · 0 study sponsors
Related indications
Study sponsors
No additional listed-company sponsor is linked.
Development Pipeline (1)
| Company | Phase |
|---|---|
| Novartis AG (NVS) | Approved |
Clinical Trials (4)
Managed Access Programs for SEG101, Crizanlizumab
A Phase III, Multicenter, Randomized, Placebo Controlled, Double-blind Study to Assess Efficacy and Safety of Crizanlizumab (5 mg/kg) Versus Placebo, With or Without Hydroxyurea/Hydroxycarbamide Therapy, in Adolescent and Adult Sickle Cell Disease Patients With Frequent Vaso-Occlusive Crises
Primary endpoint: Annualized rate of VOCs that are healthcare professional (HCP)-managed (including VOCs leading to management at a health care facility or those managed via remote consultation) in each treatment arm
An Open-label, Multi-center, Phase IV, Rollover Study for Patients With Sickle Cell Disease Who Have Completed a Prior Novartis-Sponsored Crizanlizumab Study
Primary endpoint: Not Applicable as this protocol is to provide an option for continued access to crizanlizumab for patients with Sickle Cell Disease who have completed a prior Novartis-sponsored Crizanlizumab study
A Phase III, Multicenter, Randomized, Double-blind Study to Assess Efficacy and Safety of Two Doses of Crizanlizumab Versus Placebo, With or Without Hydroxyurea/ Hydroxycarbamide Therapy, in Adolescent and Adult Sickle Cell Disease Patients With Vaso-Occlusive Crises (STAND)
Primary endpoint: Annualized Rate of Vaso-occlusive Crisis (VOC) Events Leading to a Healthcare Visit
FDA Decisions1 records
Frequently asked questions
Who is developing crizanlizumab?
crizanlizumab is being developed by Novartis AG.
How many clinical trials involve crizanlizumab?
BioSniper tracks 4 clinical trials involving crizanlizumab.
What is crizanlizumab's latest FDA decision?
The most recent tracked FDA decision for crizanlizumab is Approval for 1 INDICATIONS AND USAGE ADAKVEO ® is indicated to reduce the frequency of vaso-occlusive crises (VOCs) in adults and pediatric patients aged 16 years and older with sickle cell disease. ADAKVEO is a selectin blocker indicated to reduce the frequency of vasoocclusive crises in adults and pediatric patients aged 16 years and older with sickle cell disease., dated November 15, 2019.