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Arimoclomol FDA Approval Status

Last updated by Judith Stewart, BPharm on June 10, 2020.

FDA Approved: No
Generic name: arimoclomol
Company: Orphazyme A/S
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
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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