Drugs / Tadekinig alfa

Trials 4

20152016201720182019202020212022202320242025202620272028
PhaseRegistry idDatesIndicationSponsorStatusOutcome
Phase 01 trial
Phase 0 NCT05306080 Apr 2022 → Jan 2028 expected cytokine release syndrome, hemophagocytic syndrome University of Pennsylvania Recruiting No outcome recorded
Phase 21 trial
Phase 2 NCT02398435 Feb 2015 → Jun 2016 adult-onset Still disease AB2 Bio Ltd. Completed No outcome recorded
Phase 32 trials
Phase 3 NCT03512314 Jan 2018 → Apr 2024 X-linked lymphoproliferative disease due to XIAP deficiency, autoinflammatory syndrome AB2 Bio Ltd. Completed No outcome recorded
Phase 3 NCT03113760 Jul 2017 → Oct 2023 X-linked lymphoproliferative disease due to XIAP deficiency, autoinflammatory syndrome AB2 Bio Ltd. Completed No outcome recorded

News releases announcing trial results or a regulatory action · 5

DateIssuerRelease
2023-04-17 Lassen Therapeutics Inc. Results Lassen Therapeutics Presents Data Demonstrating Anti-IL18 Binding Protein Antibody Efficacy and Enhancement of Anti-Tumor Immunity at AACR Annual Meeting lassentherapeutics.com ↗
Lassen’s anti-IL18BP antibodies demonstrated anti-tumor efficacy in a mouse syngeneic tumor model in combination with IL-18, anti-PD-1, and anti-PD-1 plus IL-18.
2019-03-21 AB2 Bio Ltd. Regulatory AB2 Bio announces readiness for recruitment in pivotal Phase 3 trial of Tadekinig alfa, a novel human recombinant interleukin-18 binding protein, in children with genetic diagnosis of NLRC4-MAS mutation or XIAP deficiency, with amended design in the U.S. and Canada. ab2bio.com ↗
a single-arm open label design with a randomized withdrawal phase for its ongoing pivotal Phase 3 trial under an Investigational New Drug (IND) Application for its product candidate Tadekinig alfa, has been accepted
2017-04-03 AB2 Bio Ltd. Regulatory AB2 Bio Ltd’s Tadekinig alfa therapy receives Breakthrough Therapy Designation from the US Food and Drug Administration (FDA) for the treatment of monogenic, Interleukin-18 (IL-18) associated autoinflammatory conditions with ongoing systemic inflammation. ab2bio.com ↗
2016-11-29 AB2 Bio Ltd. Regulatory AB2 Bio Ltd receives Orphan Drug Designation from the European Medicines Agency for the treatment of Haemophagocytic Lymphohistiocytosis (HLH) ab2bio.com ↗
2015-11-09 AB2 Bio Ltd. Results AB2 Bio Ltd achieves a medical breakthrough in the treatment of systemic inflammation ab2bio.com ↗
A critically ill baby girl with major systemic inflammation was successfully treated in summer 2015 with IL -18BP on a compassionate use basis.

All press releases naming this drug 12 releases

DateIssuerRelease

Evidence & citations 9 cited values

Every value below carries the sentence it was read from. 6 sources stand behind the page.

FieldValueCited text
Known as Tadekinig alfa ClinicalTrials.gov intervention name — accepted as the source's own label NCT03113760 ↗
3

NCT03512314 ↗

NCT02398435 ↗

NCT05306080 ↗

Known as IL-18BP “Tadekinig alfa is the drug name for recombinant human interleukin-18 binding protein (IL-18BP).” NCT02398435 ↗
1

“Tadekinig alfa (IL-18BP)” NCT05306080 ↗

Known as Interleukin-18-binding protein ChEMBL registry synonym — accepted as the source's own label CHEMBL2108054 ↗
Known as recombinant human IL-18 binding protein “Tadekinig alfa (recombinant human IL-18 binding protein)” NCT02398435 ↗
Known as recombinant human interleukin-18 binding protein “Tadekinig alfa is the drug name for recombinant human interleukin-18 binding protein (IL-18BP).” NCT02398435 ↗
Action Inhibit “IL-18 inhibition, using the recombinant human IL-18 binding protein, tadekinig alfa” PMID 29472362 ↗ Feb 2018
Modality Protein / enzyme biologic “recombinant human interleukin-18 binding protein” NCT02398435 ↗
Route Subcutaneous “Patients received the study treatment three times a week subcutaneously.” NCT02398435 ↗
Target IL18 “Treatment with IL-18BP will permit to inhibit the pro-inflammatory cascade triggered by IL-18” NCT02398435 ↗