US 12,213,982 B2
Pharmaceutical compositions comprising sepiapterin and uses thereof
Daniel E. Levy, San Mateo, CA (US)
Assigned to PTC Therapeutics MP, Inc., Warren, NJ (US)
Filed by PTC Therapeutics MP, Inc., South Plainfield, NJ (US)
Filed on Aug. 18, 2023, as Appl. No. 18/235,486.
Application 18/235,486 is a continuation of application No. 16/670,362, filed on Oct. 31, 2019, granted, now 11,752,154.
Application 16/670,362 is a continuation of application No. PCT/US2018/049359, filed on Sep. 4, 2018.
Claims priority of provisional application 62/678,069, filed on May 30, 2018.
Claims priority of provisional application 62/553,603, filed on Sep. 1, 2017.
Prior Publication US 2024/0100054 A1, Mar. 28, 2024
This patent is subject to a terminal disclaimer.
Int. Cl. A61K 31/519 (2006.01); A61K 9/14 (2006.01); A61K 9/20 (2006.01); A61K 38/40 (2006.01); A61P 25/00 (2006.01)
CPC A61K 31/519 (2013.01) [A61K 9/14 (2013.01); A61K 9/20 (2013.01); A61K 38/40 (2013.01); A61P 25/00 (2018.01)] 19 Claims
 
1. A method of treating a tetrahydrobiopterin-related disorder selected from tetrahydrobiopterin deficiency and phenylketonuria in a subject in need thereof, the method comprising administering to the subject an effective amount of a pharmaceutical composition comprising an effective amount of sepiapterin and a pharmaceutically acceptable carrier,
wherein the relative amount of antioxidant to sepiapterin is between 0 and 20% wt/wt;
wherein the antioxidant, when present, is ascorbic acid, an ester of ascorbic acid, or a salt of ascorbic acid; and
wherein from about 2.5 mg sepiapterin per kilogram of body weight of the subject (mg/kg) to about 150 mg/kg is administered.