Adakveo

(crizanlizumab)

Phase 3Monoclonal antibody

Novartis

Adakveo is one of 215 small molecule programs targeting Anemia. It is currently in Phase 3.

Indications

Total Trials

Active Trials

214

Competitors

FDA Application

NDA/BLA/ANDA regulatory filings

Pipeline

Status by Indication[3][1]

Indication

AnemiaActive, not recruiting

EncephalopathyActive, not recruiting

MyelofibrosisActive, not recruiting

GlioblastomaActive, not recruiting

COVID-19Active, not recruiting

Sickle Cell DiseaseActive, not recruiting

Sickle Cell Disease (SCD)Active, not recruiting

AnemiaPhase 1/Phase 2

Active, not recruiting

EncephalopathyPhase 2

Active, not recruiting

MyelofibrosisPhase 1/Phase 2

Active, not recruiting

GlioblastomaPhase 2

Active, not recruiting

COVID-19Phase 2

Active, not recruiting

Sickle Cell DiseasePhase 3

Active, not recruiting

Sickle Cell Disease (SCD)Phase 3

Active, not recruiting

Competition

Competitive Landscape

1931 competitors in COVID-19

#DrugCompanyPhaseTrials

Adakveo

Novartis

Phase 3

2 2

Spikevax

Moderna

Preclinical

21 3

Stivarga

Bayer

Preclinical

1 4

Aimovig

Amgen

Preclinical

1 5

Aldactone

Pfizer

Preclinical

1 6

Nexavar

Bayer

Preclinical

1 7

Calciferol

Alnylam Pharmaceuticals

Activella

Precedex

MMcNeil Consumer & Specialty Pharmaceuticals, a Division of McNeil-PPC, Inc.

Preclinical

1 10

Tricor

JJagotec

Preclinical

Ranked by pipeline maturity and clinical activity. Current drug highlighted in teal.

Timeline

Expected Milestones

Q4 2026

Phase 3Active, not recruiting

Sickle Cell Disease (SCD)

NCT03814746

Q3 2029

Phase 1/2Not yet recruiting

Anemia

NCT05469828

Q2 2030

Phase 3Recruiting

Sickle Cell Disease

NCT06439082

Q3 2030

Phase 2Recruiting

Glioblastoma

NCT05909618

Clinical

Trials by Indication[1]

Sickle Cell Disease7 trials

MAP to Provide Access to Crizanlizumab, for Sickle Cell Disease Patients

Available· Novartis logo

Novartis··NCT03720626

An Indian Multi-centric Phase IV Study to Assess the Safety of Crizanlizumab in Sickle Cell Disease Patients

Completed· Novartis logo

Novartis·Phase 4·NCT04662931·140 enrolled

Rollover Study for Patients With Sickle Cell Disease Who Have Completed a Prior Novartis-Sponsored Crizanlizumab Study

Recruiting· Novartis logo

Novartis·Phase 4·NCT04657822·130 enrolled

Show 4 more trials

Pharmacokinetics and Pharmacodynamics Study of SEG101 (Crizanlizumab) in Sickle Cell Disease (SCD) Patients With Vaso- Occlusive Crisis (VOC)

Completed· Novartis logo

Novartis·Phase 2·NCT03264989·57 enrolled

A Study to Evaluate the Safety and Efficacy of Crizanlizumab in Sickle Cell Disease Related Priapism

Completed· Novartis logo

Novartis·Phase 2·NCT03938454·36 enrolled

Study of Dose Confirmation and Safety of Crizanlizumab in Pediatric Sickle Cell Disease Patients

Completed· Novartis logo

Novartis·Phase 2·NCT03474965·117 enrolled

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

Recruiting· Novartis logo

Novartis·Phase 3·NCT06439082·315 enrolled

COVID-192 trials

Crizanlizumab for Treating COVID-19 Vasculopathy

Completed·JJohns Hopkins University·Phase 2·NCT04435184·54 enrolled

Accelerating COVID-19 Therapeutic Interventions and Vaccines 4 ACUTE

Completed·MMatthew Neal MD·Phase 4·NCT04505774·3,591 enrolled

Glioblastoma1 trial

Crizanlizumab Alone or in Combination With Nivolumab for Glioblastoma and Melanoma With Brain Metastases

Recruiting·SSheba Medical Center·Phase 2·NCT05909618·33 enrolled

Anemia1 trial

Crizanlizumab Improves Tissue Oxygen Supply Demand Matching in Patients With Sickle Cell Anemia

Not yet recruiting·—·Phase 1/2·NCT05469828·30 enrolled

Myelofibrosis1 trial

Platform Study of Novel Ruxolitinib Combinations in Myelofibrosis Patients

Terminated· Novartis logo

Novartis·Phase 1/2·NCT04097821·45 enrolled

2 more indications

Encephalopathy1 trial

Crizanlizumab for Treatment of Retinal Vasculopathy With Cerebral Leukoencephalopathy (RVCL)

Active, not recruiting·WWashington University School of Medicine·Phase 2·NCT04611880·20 enrolled

Sickle Cell Disease (SCD)1 trial

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)

Active, not recruiting· Novartis logo

Novartis·Phase 3·NCT03814746·255 enrolled

Regulatory

FDA Approval Timeline[4]

Nov 15, 2019

ADAKVEO

BLA BLA761128

Sources

References

[1]
ClinicalTrials.gov — 14 trial records for crizanlizumab. U.S. National Library of Medicine, National Institutes of Health.
[2]
ChEMBL — crizanlizumab compound record. European Bioinformatics Institute (EMBL-EBI).
[3]
Open Targets Platform — Drug–disease associations for crizanlizumab. EMBL-EBI & Wellcome Sanger Institute.
[4]
OpenFDA — FDA approval records (BLA BLA761128). U.S. Food & Drug Administration.
[5]
SEC EDGAR — Novartis company filings. U.S. Securities and Exchange Commission.

Details

Drug Info

Quick Facts

Modality: Monoclonal antibody[2]
Highest Phase: Phase 3[1]
Company: Novartis

Adakveo

Status by Indication[3][1]

Competitive Landscape

Expected Milestones

Q4 2026

Q3 2029

Q2 2030

Q3 2030

Trials by Indication[1]

Sickle Cell Disease7 trials

COVID-192 trials

Glioblastoma1 trial

Anemia1 trial

Myelofibrosis1 trial

Encephalopathy1 trial

Sickle Cell Disease (SCD)1 trial

FDA Approval Timeline[4]

References

Drug Info

Quick Facts

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