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Pacritinib FDA Approval Status

Last updated by Judith Stewart, BPharm on Oct 19, 2020.

FDA Approved: No
Generic name: pacritinib
Company: CTI BioPharma Corp.
Treatment for: Myelofibrosis

Pacritinib is an investigational oral JAK2/FLT3 multikinase inhibitor in development for the treatment of myelofibrosis patients with severe thrombocytopenia.

Development Timeline for pacritinib

DateArticle
Jun  1, 2021CTI BioPharma Announces Acceptance of NDA Granted with Priority Review of Pacritinib for Treatment of Patients with Myelofibrosis
Mar 31, 2021CTI BioPharma Announces Completion of Rolling Submission of New Drug Application (NDA) for Pacritinib in Myelofibrosis Patients with Severe Thrombocytopenia
Oct 13, 2020CTI BioPharma Initiates Rolling Submission of New Drug Application (NDA) for Pacritinib in Myelofibrosis Patients with Severe Thrombocytopenia
Feb  9, 2016CTI BioPharma Provides Update on Clinical Hold of Investigational Agent Pacritinib and NDA
Jan  5, 2016CTI BioPharma and Baxalta Complete Submission of NDA for Pacritinib for Unmet Medical Need in Myelofibrosis
Nov 23, 2015CTI BioPharma Initiates Rolling Submission of NDA for Pacritinib for the Treatment of Patients with Myelofibrosis
Sep 23, 2015CTI BioPharma To Submit NDA For Pacritinib In Q4 Based Primarily On Data From Single Pivotal Persist-1 Trial

Further information

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