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Crizanlizumab

Not yet reviewed: Listed from FDA or ClinicalTrials.gov records; an editor has not checked it yetListed from FDA or ClinicalTrials.gov records; an editor has not checked it yet.

Also known as Adakveo, Crizanlizumab-tmca

NOVARTIS AG NVS NVSEF · Sickle Cell Disease; Sickle Cell Disease (SCD)

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Key figures

  • Next catalyst

    None scheduled

    Only dates with a source are listed

  • Phase

    Approved

    Not recorded

  • Linked trials

    2

    From ClinicalTrials.gov

  • Latest FDA action

    Approved

    BLA761128,

Recalls, shortages, patents and EU status at a glance

Key information

Sponsor
NOVARTIS AG NVS NVSEF Source: Company record for NOVARTIS AG (opens in a new tab)
Indications
Sickle Cell Disease; Sickle Cell Disease (SCD) Source: Conditions from ClinicalTrials.gov (opens in a new tab)
Application
BLA 761128 · Priority review Source: Drugs@FDA via openFDA (opens in a new tab) · Action letter for BLA 761128 (opens in a new tab)
Designations
None recorded
Next catalyst
None scheduled

Development timeline

  1. Preclinical Completed
  2. Phase 1 Completed
  3. Phase 2 Completed
  4. Phase 3 CompletedFirst trial start 26 Jul 20192 linked trials
  5. Filed Completed
  6. Approved Current stageFirst approval 15 Nov 2019

Overview

Mechanism
Not recorded
Route
Not recorded
Modality
Not recorded
Specialties
Not recorded

Overview text is written by HealthTrade editors.

Key dates

No catalysts yet. Editors add each date together with its source.

FDA designations

No FDA designations are on record for Crizanlizumab. Editors add each one with its source.

Filed application

No filed application is on record for Crizanlizumab. Approvals are listed under FDA actions.

FDA advisory committees

No FDA advisory committee meetings are on record for Crizanlizumab.

Clinical trials

Trials linked to Crizanlizumab
TrialTitlePhaseStatusEnrollmentPrimary completionResults posted
NCT06439082ClinicalTrials.gov record for NCT06439082 (opens in a new tab)SPARKLEA Study to Investigate the Efficacy and Safety of Crizanlizumab (5 mg/kg) Compared With Placebo in Adolescent and Adult Sickle Cell Disease Patients Who Experience Frequent Vaso-Occlusive Crises (SPARKLE)Phase 3Recruiting354 (estimated)2 Jul 2029 (estimated) No
NCT03814746ClinicalTrials.gov record for NCT03814746 (opens in a new tab)STANDStudy of Two Doses of Crizanlizumab Versus Placebo in Adolescent and Adult Sickle Cell Disease PatientsPhase 3Active, not recruiting253 (actual)31 Aug 2022 (actual) Yes First posted Results on ClinicalTrials.gov for NCT03814746 (opens in a new tab)

Posted results on ClinicalTrials.gov for STAND

  • Annualized Rate of Vaso-occlusive Crisis (VOC) Events Leading to a Healthcare Visit (number of events per year)
    • Crizanlizumab (SEG101) at 5.0 mg/kg vs Placebo: Rate ratio 1.08 (95% CI 0.76 to 1.55), p-value > 0.999, negative binomial regression model, superiority
    • Crizanlizumab (SEG101) at 7.5 mg/kg vs Placebo: Rate ratio 0.89 (95% CI 0.62 to 1.27), p-value > 0.999, negative binomial regression model, superiority

Serious adverse events (This primary analysis report includes data with a cut-off date 31-Aug-2022. Adverse events and deaths were collected from first dose of study treatment to105 days post-last infusion (defined as on-treatment), up to max on-treatment period of approx. 5 years.): Crizanlizumab (SEG101) at 5.0 mg/kg (On-treatment) 35 of 84; Crizanlizumab (SEG101) at 7.5 mg/kg (On-treatment) 22 of 83; Placebo (On-treatment) 26 of 85

Source: ClinicalTrials.gov results for NCT03814746 (opens in a new tab)· imported

Posted results as ClinicalTrials.gov prints them: primary outcome analyses and serious adverse event totals only. Registry facts, not reviewed by HealthTrade and not investment advice; filing-derived results are listed separately.

Publications listing STAND (2), newest first

  1. Crizanlizumab with or without hydroxyurea in patients with sickle cell disease (STAND): primary analyses from a placebo-controlled, randomised, double-blind, phase 3 trial.

    The Lancet. Haematology · 2025 Apr

    PubMed 40088922 (opens in a new tab)DOI 10.1016/S2352-3026(24)00384-3 (opens in a new tab)

  2. Emerging Therapies and Advances in Sickle Cell Disease with a Focus on Renal Manifestations.

    Kidney360 · 2023 Jul 1

    PubMed 37254256 (opens in a new tab)DOI 10.34067/KID.0000000000000162 (opens in a new tab)

Citations from PubMed, U.S. National Library of Medicine; abstracts are not stored. A publication lists this study’s NCT number and may be a review that cites many studies.

Source: ClinicalTrials.gov, U.S. National Library of Medicine. Posted results are shown as ClinicalTrials.gov prints them; results from company and journal sources are entered by editors and listed separately. Full result tables are on ClinicalTrials.gov.

Trial quality

About CT-VCA

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FDA actions

Original approvals and new-indication supplements for Crizanlizumab, newest first
ApplicationActionDateOutcomeReviewSource
BLA761128Action letter for BLA761128 (opens in a new tab) Supplement 6 EfficacyApprovedstandardDrugs@FDA via openFDA (opens in a new tab)
BLA761128Action letter for BLA761128 (opens in a new tab) Original 1 Type 1 - New Molecular EntityApprovedpriorityDrugs@FDA via openFDA (opens in a new tab)

Data provided by the U.S. Food and Drug Administration.

FDA recalls load here.

FDA drug shortages load here.

Orange Book patents load here.

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EU status (EMA)

RevokedConditional

Adakveo (EMEA/H/C/004874)

Authorised
Therapeutic area
Anemia, Sickle Cell
Marketing authorisation holder
Novartis Europharm Limited
Active substance (INN)
crizanlizumab
ATC code
B06AX01
Latest EMA decision
Withdrawn

Matched by active substance: EMA's INN or active substance equals this drug's name.

EMA page for Adakveo (opens in a new tab)EMA medicine data (opens in a new tab)

Source: European Medicines Agency (EMA), medicines data download. Licence: EMA re-use with acknowledgement. EMA medicines report 2026-10-26.

Related news

No recent headlines mention this drug.

Sources

Record updated .

Dates come from company and FDA disclosures and can change. Nothing on this page is investment advice.