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Arimoclomol FDA Approval Status

Last updated by Judith Stewart, BPharm on Dec 31, 2023.

FDA Approved: No
Generic name: arimoclomol
Company: Zevra Therapeutics, Inc.
Treatment for: Niemann-Pick Disease

Arimoclomol is an investigational heat shock protein amplifier in development for the treatment of Niemann-Pick disease Type C (NPC).

Development timeline for arimoclomol

DateArticle
Mar  4, 2024Zevra Therapeutics Provides FDA Update On The PDUFA Action Date For Arimoclomol As A Treatment For Niemann-Pick Disease Type C
Dec 27, 2023Zevra Therapeutics Announces Resubmission of Arimoclomol New Drug Application to the U.S. Food and Drug Administration
Feb 11, 2022Orphazyme Provides Update for Planned NDA Resubmission for Arimoclomol for the Treatment of Niemann-Pick Disease Type C in the United States
Jun 18, 2021Orphazyme Provides Regulatory Update from FDA on Arimoclomol for Niemann-Pick Disease Type C
Sep 16, 2020Orphazyme Announces FDA Acceptance and Priority Review of New Drug Application for Arimoclomol for Niemann-Pick Disease Type C
Jul 20, 2020Orphazyme Completes Rolling Submission of New Drug Application To U.S. FDA for Arimoclomol for Niemann-Pick Disease Type C
May 29, 2020Orphazyme Initiates Rolling Submission of New Drug Application for Arimoclomol with US FDA in Niemann-Pick Disease Type C
Jul 21, 2019Orphazyme to Prepare for Filing of Arimoclomol in US for Niemann-Pick Disease Type C (NPC)
Sep 28, 2018Orphazyme Reports Encouraging Arimoclomol Clinical Trial Top-Line Data in Niemann-Pick Disease Type C (NPC)
Aug 10, 2018Orphazyme Announces Enrollment of First Patient in Phase III Clinical Trial of Arimoclomol for ALS

Further information

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