Drugs / GRASPA

Regulatory milestones approvals, filings & regulatory actions · 1 recorded

MilestoneJurisdictionBrandIndicationDateSentence it was read from
Approved EU (EMA) Graspa 2018-06-27 europa.eu

Trials 10 · a red edge is where a trial was stopped

PhaseRegistry idDatesIndicationSponsorStatusOutcome
Phase 11 trial
Phase 1 NCT04292743 Dec 2020 → Jan 2023 pancreatic ductal adenocarcinoma Georgetown University Completed No outcome recorded
Phase 1/21 trial
Phase 1/2 NCT00723346 Jan 2006 → Aug 2008 acute lymphoblastic leukemia ERYtech Pharma Completed No outcome recorded
Phase 24 trials
Phase 2 NCT03267030 Aug 2017 → Aug 2020 acute lymphoblastic leukemia Birgitte Klug Albertsen Completed No outcome recorded
Phase 2 NCT02195180 Jul 2014 → Feb 2017 pancreatic adenocarcinoma ERYtech Pharma Completed No outcome recorded
Phase 2 NCT01810705 Feb 2013 → Nov 2017 acute myeloid leukemia ERYtech Pharma Completed No outcome recorded
Phase 2 NCT01523782 Apr 2009 → Jan 2011 acute lymphoblastic leukemia ERYtech Pharma Completed No outcome recorded
Phase 2/32 trials
Phase 2/3 NCT03674242 Jun 2019 → Mar 2022 triple-negative breast carcinoma ERYtech Pharma Terminated No outcome recorded
Phase 2/3 NCT01518517 Dec 2009 → Sep 2014 acute lymphoblastic leukemia ERYtech Pharma Completed No outcome recorded
Phase 31 trial
Phase 3 NCT03665441 Sep 2018 → Aug 2021 pancreatic ductal adenocarcinoma ERYtech Pharma Completed No outcome recorded
Phase not stated1 trial
NCT02197650 acute lymphoblastic leukemia ERYtech Pharma No longer available No outcome recorded

Evidence & citations 7 cited values

Every value below carries the sentence it was read from. 13 sources stand behind the page.

FieldValueCited text
Known as GRASPA ClinicalTrials.gov intervention name — accepted as the source's own label NCT01518517
4

NCT01810705

NCT00723346

NCT03267030

NCT01523782

Known as ERY001 ClinicalTrials.gov intervention name — accepted as the source's own label NCT02195180
Known as eryaspase “The protocol aims at adding GRASPA (L-asparaginase encapsulated in red blood cells, eryaspase) to standard chemotherapy (low-dose cytarabine) to treat patients older than 65...” NCT01810705
5

“PURPOSE: Eryaspase is composed of l-asparaginase encapsulated in erythrocytes and has demonstrated significant efficacy in a randomized phase II trial.” PMID 32605910 Jun 2020

eryaspaseNCT02197650

NCT03674242

NCT04292743

NCT03665441

Known as erysapase “Considering the promising results of ASNase for AML treatment and the better safety profile offered by GRASPA (L-aspariginase encapsulated in red blood cells, erysapase), a...” NCT01810705
Known as erythrocyte-encapsulated asparaginase “This Phase IIb (NCT02195180) open-label study evaluated erythrocyte-encapsulated asparaginase (eryaspase) in combination with chemotherapy in second-line advanced pancreatic...” PMID 31760314 Nov 2019
Modality Protein / enzyme biologic “Erythrocytes Encapsulating L-asparaginase (GRASPA)” NCT01518517
Route Intravenous “eryaspase 100 U/kg intravenously on days 1 and 15” PMID 41187298 Nov 2025