Granted Patent
B2
US 12,637,465 · App. 17/059,887 · Granted May 26, 2026
Pharmaceutically acceptable salts of sepiapterin
Inventors:
Daniel E. Levy (San Mateo, CA); Neil Smith (Cary, NC); Jonathan Reis (Brookline, MA); Hiroshi Yoshino (Narashino, JP); Taichi Komoda (Narashino, JP); Yuichi Shiro (Narashino, JP); Shunichi Murata (Narashino, JP); Takayoshi Matsumoto (Narashino, JP); Kaito Kishimoto (Narashino, JP)
Assignee:
PTC Therapeutics MP, Inc.
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Abstract
The present invention relates to new pharmaceutical salts and/or co-crystals of sepiapterin which exhibit improved properties. In particular, the invention relates to salts of sepiapterin with improved stability. The invention also relates to pharmaceutical compositions including a pharmaceutically effective amount of one or more salts and/or co-crystals of sepiapterin, as well as methods of treating tetrahydrobiopterin-related disorders including administration of a sepiapterin salt and/or co-crystal of the invention to a subject in need thereof.
Claims (8)
1 . A pharmaceutically acceptable salt of sepiapterin, wherein the pharmaceutically acceptable salt is a nicotinate salt, a 1:1 tartrate salt, or a 2:1 tartrate salt.
2 . The pharmaceutically acceptable salt of claim 1 , wherein the pharmaceutically acceptable salt is a nicotinate salt.
3 . The pharmaceutically acceptable salt of claim 1 , wherein the pharmaceutically acceptable salt is a 1:1 tartrate salt or a 2:1 tartrate salt.
4 . The pharmaceutically acceptable salt of claim 3 , wherein the pharmaceutically acceptable salt is a 1:1 tartrate salt.
5 . The pharmaceutically acceptable salt of claim 3 , wherein the pharmaceutically acceptable salt is a 2:1 tartrate salt.
6 . The pharmaceutically acceptable salt of claim 1 wherein the salt is crystalline.
7 . The pharmaceutically acceptable salt of claim 6 comprising less than 40% by weight of amorphous compound.
8 . A pharmaceutical composition comprising the pharmaceutically acceptable salt of claim 1 and a pharmaceutically acceptable excipient.
Assignments (6)
TERMINATION AND RELEASE OF PATENT SECURITY AGREEMENT @ REEL 061584 AND FRAME 0377
Recorded Oct 23, 2023
From: WILMINGTON TRUST, NATIONAL ASSOCIATION, AS ADMINISTRATIVE AGENT
To: PTC THERAPEUTICS MP, INC.
Reel/Frame 065321/0025 →
SECURITY INTEREST
Recorded Oct 28, 2022
From: PTC THERAPEUTICS MP, INC.
To: WILMINGTON TRUST, NATIONAL ASSOCIATION
Reel/Frame 061584/0377 →
ASSIGNMENT OF ASSIGNOR'S INTEREST
Recorded Apr 28, 2021
From: YOSHINO, HIROSHI; KOMODA, TAICHI; SHIRO, YUICHI; MURATA, SHUNICHI; MATSUMOTO, TAKAYOSHI; KISHIMOTO, KAITO
To: SHIRATORI PHARMACEUTICALS CO., LTD.
Reel/Frame 056071/0423 →
ASSIGNMENT OF ASSIGNOR'S INTEREST
Recorded Apr 28, 2021
From: LEVY, DANIEL E.; SMITH, NEIL; REIS, JONATHAN
To: CENSA PHARMACEUTICALS INC.
Reel/Frame 056078/0351 →
ASSIGNMENT OF ASSIGNOR'S INTEREST
Recorded Apr 28, 2021
From: SHIRATORI PHARMACEUTICALS CO., LTD.
To: CENSA PHARMACEUTICALS INC.
Reel/Frame 056078/0354 →
CHANGE OF NAME
Recorded Apr 28, 2021
From: CENSA PHARMACEUTICALS INC.
To: PTC THERAPEUTICS MP, INC.
Reel/Frame 056078/0408 →
Priority Claims (1)
GC 2019/37661
· May 28, 2019
· regional
Continuity (4)
Provisional Application
62822336
· Mar 22, 2019
Provisional Application
62726612
· Sep 4, 2018
Provisional Application
62678025
· May 30, 2018
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