Drugs / Otlertuzumab

Trials 4

20082009201020112012201320142015201620172018201920202021202220232024202520262027
PhaseRegistry idDatesIndicationSponsorStatusOutcome
Phase 13 trials
Phase 1 NCT01644253 Sep 2012 → Feb 2020 B-cell chronic lymphocytic leukemia, peripheral T-cell lymphoma, not otherwise specified Aptevo Therapeutics Terminated No outcome recorded Stop: Business
Phase 1 NCT01317901 May 2011 → Apr 2013 chronic lymphocytic leukemia/small lymphocytic lymphoma Aptevo Therapeutics Completed No outcome recorded
Phase 1 NCT00614042 Jan 2008 → Dec 2011 B-cell chronic lymphocytic leukemia Aptevo Therapeutics Completed No outcome recorded
Phase 1/21 trial
Phase 1/2 NCT01188681 Sep 2010 → Dec 2014 chronic lymphocytic leukemia/small lymphocytic lymphoma Aptevo Therapeutics Completed No outcome recorded

News releases announcing trial results or a regulatory action · 3

DateIssuerRelease
2013-01-02 Emergent BioSolutions Regulatory Emergent’s TRU-016 for CLL Receives Orphan Medicinal Product Designation from European Commission emergentbiosolutions.com ↗
2011-12-01 Emergent BioSolutions Regulatory Emergent BioSolutions Receives Orphan Drug Designation for Its TRU-016 Protein Therapeutic for the Treatment of Chronic Lymphocytic Leukemia emergentbiosolutions.com ↗
2010-12-06 Emergent BioSolutions Results Emergent BioSolutions Presents Positive Data from Its TRU-016 Program at American Society of Hematology Meeting emergentbiosolutions.com ↗
In an oral presentation given yesterday, results from the study show that TRU-016 demonstrates favorable response rates and is generally well-tolerated in patients with chronic lymphocytic leukemia (CLL).

All press releases naming this drug 14 releases

DateIssuerRelease

Evidence & citations 6 cited values

Every value below carries the sentence it was read from. 5 sources stand behind the page.

FieldValueCited text
Known as Otlertuzumab “Otlertuzumab (TRU-016) is a novel humanized anti-CD37 protein therapeutic.” PMID 25146490 ↗ Aug 2014
Known as TRU-016 “Otlertuzumab (TRU-016) is a novel humanized anti-CD37 protein therapeutic.” PMID 25146490 ↗ Aug 2014
3

NCT01644253 ↗

NCT01317901 ↗

NCT01188681 ↗

Modality Monoclonal antibody — CHEMBL3039539 ↗
Modality Protein / enzyme biologic “Otlertuzumab (TRU-016) is a novel humanized anti-CD37 protein therapeutic.” PMID 25146490 ↗ Aug 2014
Route Intravenous “TRU-016 at 20 mg/kg, weekly by IV infusion x 2 cycles” NCT01188681 ↗
Target CD37 “Otlertuzumab (TRU-016) is a novel humanized anti-CD37 protein therapeutic.” PMID 25146490 ↗ Aug 2014