dm+d
Unassigned
New Medicines
Anticoagulation reversal; antidote to oral factor Xa inhibitors, fondaparinux, low molecular weight heparins and unfractionated heparins
Information
New molecular entity
AMAG
AMAG
Development and Regulatory status
None
None
Phase II Clinical Trials
Jan 20Ciraparantag still listed as PII in AMAG pipeline [6].
Mar 19Product recently acquired by new company (AMAG) which plans to hold an end of PII meeting with the FDA later this year to confirm the design of the PIII program, which is expected to include PIIIa trials in healthy volunteers followed by a P3b/4 trial in patients. The company intends to initiate the P3a trials in the second half of 2019 [5]
Category
A water soluble, small molecule that re-establishes normal blood coagulation by directly binding to factor Xa and IIa inhibitors, such as edoxaban, dabigatran and rivaroxaban.
Anticoagulation reversal; antidote to oral factor Xa inhibitors, fondaparinux, low molecular weight heparins and unfractionated heparins
Intravenous
Trial or other data
Sep 21Sep 21: Results from two PII randomized, placebo-controlled, dose-ranging trials (NCT03288454 and NCT03172910) published in European Heart Journal [9]