Drugs / Crizanlizumab
Regulatory milestones approvals, filings & regulatory actions · 4 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Label expansion | US (FDA) | ADAKVEO | — | 2024-06-26 | fda.gov ↗ |
| Withdrawn | EU (EMA) | Adakveo | — | 2023-08-03 | europa.eu ↗ |
| Approved · conditional | EU (EMA) | Adakveo | — | 2020-10-28 | europa.eu ↗ |
| Approved | US (FDA) | ADAKVEO | — | 2019-11-15 | fda.gov ↗ |
Trials 16 · a red edge is where a trial was stopped
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 1/22 trials | ||||||
| Phase 1/2 | NCT05469828 | Jul 2024 → Jul 2028 expected | sickle cell disease | Children's Hospital Los Angeles | Not yet recruiting | No outcome recorded |
| Phase 1/2 | NCT04097821 | Sep 2019 → May 2023 | myelofibrosis | Novartis Pharmaceuticals | Terminated | No outcome recorded |
| Phase 28 trials | ||||||
| Phase 2 | NCT05909618 | Jul 2023 → Jul 2028 expected | glioblastoma, metastatic melanoma | Sheba Medical Center | Recruiting | No outcome recorded |
| Phase 2 | NCT04611880 | Jan 2021 → Apr 2025 | retinal vasculopathy with cerebral leukoencephalopathy and systemic manifestations | Washington University School of Medicine | Completed | No outcome recorded |
| Phase 2 | NCT04435184 | Jul → Nov 2020 | COVID-19 | Johns Hopkins University | Completed | No outcome recorded |
| Phase 2 | NCT04053764 | Dec 2019 → Mar 2023 | sickle cell disease | Novartis Pharmaceuticals | Completed | No outcome recorded |
| Phase 2 | NCT03938454 | Oct 2019 → Mar 2023 | priapism | Novartis Pharmaceuticals | Completed | No outcome recorded |
| Phase 2 | NCT03474965 | Oct 2018 → Nov 2024 | sickle cell disease | Novartis Pharmaceuticals | Completed | No outcome recorded |
| Phase 2 | NCT03264989 | Dec 2017 → Jun 2023 | sickle cell disease | Novartis Pharmaceuticals | Completed | No outcome recorded |
| Phase 2 | NCT01895361 | Jul 2013 → Mar 2016 | sickle cell disease | Reprixys Pharmaceutical Corporation | Completed | No outcome recorded |
| Phase 32 trials | ||||||
| Phase 3 | NCT06439082 | Oct 2024 → Mar 2029 expected | sickle cell disease | Novartis Pharmaceuticals | Recruiting | No outcome recorded |
| Phase 3 | NCT03814746 | Jul 2019 → Aug 2022 overdue | sickle cell disease | Novartis Pharmaceuticals | Active not recruiting | No outcome recorded |
| Phase 43 trials | ||||||
| Phase 4 | NCT04662931 | Jul 2021 → Feb 2024 | sickle cell disease | Novartis Pharmaceuticals | Completed | No outcome recorded |
| Phase 4 | NCT04657822 | Jun 2021 → Jun 2031 expected | sickle cell disease | Novartis Pharmaceuticals | Recruiting | No outcome recorded |
| Phase 4 | NCT04505774 | Sep 2020 → Aug 2023 | COVID-19 | Matthew Neal MD | Completed | No outcome recorded |
| Phase not stated1 trial | ||||||
| — | NCT03720626 | — | sickle cell disease | Novartis Pharmaceuticals | Available | No outcome recorded |
Press releases naming this drug 9 releases
| Date | Issuer | Release |
|---|---|---|
| 2020-10-30 | Novartis Pharmaceuticals | Novartis sickle cell medicine Adakveo® approved in Europe to prevent recurrent vaso-occlusive crises novartis.com ↗ |
| 2020-07-24 | Novartis Pharmaceuticals | Novartis Adakveo® receives positive CHMP opinion for the prevention of recurrent vaso-occlusive crises in patients with sickle cell disease novartis.com ↗ |
| 2019-11-15 | Novartis Pharmaceuticals | New Novartis medicine Adakveo® (crizanlizumab) approved by FDA to reduce frequency of pain crises in individuals living with sickle cell disease novartis.com ↗ |
| 2019-07-16 | Novartis Pharmaceuticals | FDA accepts file and accelerates review of Novartis sickle cell disease medicine crizanlizumab (SEG101) novartis.com ↗ |
| 2019-01-08 | Novartis Pharmaceuticals | Novartis investigational therapy crizanlizumab (SEG101) receives FDA Breakthrough Therapy designation for the prevention of vaso-occlusive crises in sickle cell disease novartis.com ↗ |
| 2018-12-01 | Novartis Pharmaceuticals | Novartis announces new crizanlizumab (SEG101) data analysis in sickle cell disease, and investment in SENTRY clinical program novartis.com ↗ |
| 2018-10-09 | Novartis Pharmaceuticals | Novartis analysis shows crizanlizumab (SEG101) increased the number of patients free of sickle cell pain crises vs placebo during SUSTAIN study novartis.com ↗ |
| 2017-12-11 | Novartis Pharmaceuticals | Novartis drug crizanlizumab shown to prolong time to patients' first sickle cell pain crisis in subgroup analysis of SUSTAIN study novartis.com ↗ |
| 2016-12-03 | Novartis Pharmaceuticals | Novartis SEG101 (crizanlizumab, formerly SelG1) significantly reduces frequency of sickle cell pain crises in Phase II study novartis.com ↗ |
Evidence & citations 10 cited values
Every value below carries the sentence it was read from. 20 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | Crizanlizumab | “Crizanlizumab is an anti-P-selectin monoclonal antibody indicated to reduce the frequency/prevent recurrence of vaso-occlusive crises (VOCs) in patients with sickle cell...” PMID 36355805 ↗ Mar 202314“Crizanlizumab is a concentrate for solution for infusion, i.v. use.” NCT04053764 ↗ |
| Known as | ADAKVEO | “Crizanlizumab-Tmca 10 MG/1 ML Intravenous Solution [ADAKVEO]” NCT05909618 ↗ |
| Known as | Crizanlizumab-Tmca | ClinicalTrials.gov intervention name — accepted as the source's own label NCT05909618 ↗ |
| Known as | NVP-LXI-262 | ChEMBL registry synonym — accepted as the source's own label CHEMBL4297734 ↗ |
| Known as | SEG101 | “All participants will receive crizanlizumab (SEG101) at the same dose/schedule as in the parent study.” NCT04657822 ↗1“Crizanlizumab (SEG101) is a concentrate for solution for infusion, i.v. use.” NCT03474965 ↗ |
| Known as | SEL-G1 | ChEMBL registry synonym — accepted as the source's own label CHEMBL4297734 ↗ |
| Action | Inhibit | “Crizanlizumab is a novel inhibitor of P-selectin, a key player in multicellular adhesion and inflammatory signaling, that leads to vaso-occlusion in sickle cell disease (SCD).” PMID 39497751 ↗ Nov 20241“P-selectin blocker” CHEMBL4297734 ↗ |
| Modality | Monoclonal antibody | “Crizanlizumab is a humanized monoclonal antibody against P-selectin for the prevention of vaso-occlusive crises in sickle cell disease (SCD).” PMID 36529836 ↗ Dec 2022 |
| Route | Intravenous | “administered intravenously” PMID 27959701 ↗ Dec 2016 |
| Target | SELP | “P-selectin blocker” CHEMBL4297734 ↗ |