Drugs / Crizanlizumab
Regulatory milestones approvals, filings & regulatory actions · 5 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Filed sickle cell S-Lepore disease 1 milestone | |||||
| Filed | US (FDA) | — | sickle cell S-Lepore disease | 2019-07-16 | “Crizanlizumab (SEG101) was filed in the US and Europe for the prevention of vaso-occlusive crises in sickle cell disease.” novartis.com ↗ |
| Withdrawn Indication not stated 4 milestones | |||||
| 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| Withdrawn | EU (EMA) | Adakveo | — | 2023-08-03 | europa.eu ↗ |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
| 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 Stop: Business |
| Phase 28 trials · 1 met primary · 2 missed | ||||||
| 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 | Missed primary |
| Phase 2 | NCT03938454 | Oct 2019 → Mar 2023 | priapism | Novartis Pharmaceuticals | Completed | Missed primary |
| 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 | Met primary |
| Phase 32 trials · 1 missed | ||||||
| Phase 3 | NCT06439082 | Oct 2024 → Jul 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 | Missed primary |
| Phase 43 trials · 1 missed | ||||||
| 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 | Missed primary |
| Phase not stated1 trial | ||||||
| — | NCT03720626 | — | sickle cell disease | Novartis Pharmaceuticals | Available | No outcome recorded |
News releases announcing trial results or a regulatory action · 11
| Date | Issuer | Release |
|---|---|---|
| 2020-10-30 | Novartis Pharmaceuticals | Regulatory Novartis sickle cell medicine Adakveo® approved in Europe to prevent recurrent vaso-occlusive crises novartis.com ↗
Novartis today announced that the European Commission (EC) has approved Adakveo (crizanlizumab) for the prevention of recurrent vaso-occlusive crises (VOCs), or pain crises, in patients with sickle cell disease aged 16 years and older. |
| 2020-07-24 | Novartis Pharmaceuticals | Regulatory Novartis Adakveo® receives positive CHMP opinion for the prevention of recurrent vaso-occlusive crises in patients with sickle cell disease novartis.com ↗
Today’s positive opinion by CHMP means that we are one step closer to potentially having an important new medicine to treat thousands of vulnerable patients. |
| 2019-11-15 | Novartis Pharmaceuticals | Regulatory 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 | Regulatory FDA accepts file and accelerates review of Novartis sickle cell disease medicine crizanlizumab (SEG101) novartis.com ↗
Novartis today announced the US Food and Drug Administration (FDA) accepted the company's Biologics License Application (BLA) and has granted Priority Review for its investigational sickle cell medicine crizanlizumab (SEG101). |
| 2019-01-08 | Novartis Pharmaceuticals | Regulatory Novartis investigational therapy crizanlizumab (SEG101) receives FDA Breakthrough Therapy designation for the prevention of vaso-occlusive crises in sickle cell disease novartis.com ↗
Novartis announced today that the US Food and Drug Administration (FDA) has granted crizanlizumab (SEG101) Breakthrough Therapy designation for the prevention of vaso-occlusive crises (VOCs) in patients of all genotypes with sickle cell disease (SCD). |
| 2018-12-01 | Novartis Pharmaceuticals | Results Novartis announces new crizanlizumab (SEG101) data analysis in sickle cell disease, and investment in SENTRY clinical program novartis.com ↗
New data from a post hoc analysis of the Phase II SUSTAIN study of crizanlizumab -- a once-a-month, humanized anti-P-selectin monoclonal antibody infusion being investigated for the treatment of sickle cell disease (SCD) -- shows greater reductions of vaso-occlusive crises (VOCs) in patients who were adherent to the treatment protocol. |
| 2018-10-09 | Novartis Pharmaceuticals | Results Novartis analysis shows crizanlizumab (SEG101) increased the number of patients free of sickle cell pain crises vs placebo during SUSTAIN study novartis.com ↗
The analysis showed that more patients treated with crizanlizumab did not experience a vaso-occlusive crisis (VOC) vs those treated with placebo (35.8% vs 16.9%), specifically patients with a history of 2-10 VOCs in the previous year. |
| 2018-05-17 | Novartis Pharmaceuticals | Results Novartis data at ASCO and EHA reinforce company's commitment to reimagining cancer novartis.com ↗
Crizanlizumab treatment is not associated with the development of proteinuria and hematuria in patients with sickle cell disease |
| 2017-12-11 | Novartis Pharmaceuticals | Results Novartis drug crizanlizumab shown to prolong time to patients' first sickle cell pain crisis in subgroup analysis of SUSTAIN study novartis.com ↗
The data from a subgroup analysis of the Phase II SUSTAIN study showed that crizanlizumab, at 5.0 mg/kg per month increased the time to SCPC in patients on treatment, including those in high-risk subpopulations and with hydroxyurea use[1]. |
| 2017-05-18 | Novartis Pharmaceuticals | Results Novartis data at ASCO, ICML and EHA meetings demonstrate meaningful advancements in cancer care novartis.com ↗
Crizanlizumab, a P-selectin Inhibitor, Increases the Likelihood of Not Experiencing a Sickle Cell-Related Pain Crisis While on Treatment: Results from the Phase II SUSTAIN Study |
| 2016-12-03 | Novartis Pharmaceuticals | Results Novartis SEG101 (crizanlizumab, formerly SelG1) significantly reduces frequency of sickle cell pain crises in Phase II study novartis.com ↗
The study met its primary endpoint, reduction of the annual rate of SCPC in the high-dose arm by 45.3% vs. placebo (medians of 1.63 vs. 2.98, p=0.010). |
All press releases naming this drug 11 releases
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 ↗ |