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Ipsen Biopharmaceuticals: New FDA Orphan Drug Designation For Huntington’s Disease

March 18, 2015


Ipsen Biopharmaceuticals receives FDA ODD for Huntington’s Disease on March 16th. Currently, the company is recruiting for a Phase II clinical trial (“Study exploring safety, pharmacokinetic and pharmacodynamics of BN82451 in Male Huntington’s Disease Patients”; NCT02231580) of BN8245B versus placebo after oral administration twice daily for 28 days in patients with HD.

FDA ODD Database Record For Ipsen Biopharmaceuticals

Generic Name: Phenol, 4-[2-(aminomethyl)-4-thiazolyl]-2,6-bis (1,1-dimethyethyl) monohydrochloride
Trade Name: n/a
Date Designated: 03-16-2015
Orphan Designation: Huntington’s Disease
Orphan Designation Status: Designated
FDA Orphan Approval Status: Not FDA Approved for Orphan Indication
Sponsor: Ipsen Biopharmaceuticals, Inc. 106 Allen Road 3rd Floor Basking Ridge, NJ 07920


Please Note: “Cambio de color a diferente pHs” by Rubashkyn (Own work) [CC-BY-SA-3.0] | Wikimedia Commons.

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