IP Library Granted Patent US 12,213,965
Granted Patent B2
US 12,213,965 · App. 17/367,484 · Granted Feb 4, 2025

Riluzole prodrugs and their use

Inventors: Jay Edward Wrobel (Lawrenceville, NJ); Allen B. Reitz (Lansdale, PA); Jeffery Claude Pelletier (Lafayette Hill, PA); Garry Robert Smith (Royersford, PA); Haiyan Bian (Princeton, NJ)
Assignee: Biohaven Therapeutics Ltd.
A61K31/428A61K9/006A61K9/1617A61K9/2004A61K31/454A61K31/496A61K31/506A61K31/5377A61K31/541A61K38/05A61K38/06A61K39/4636A61K45/06A61P25/00A61P25/28A61P35/00C07D277/82C07D417/12C07K5/06026C07K5/0806C07K5/0808C07K5/0812A61K9/0056A61K9/2018A61K9/2063A61K9/485A61K9/4858A61K9/4866A61K2300/00
View Patent ↗
Loading inventors, assignments & file history…
Monitor This Case
Get email alerts when status or documents change.
Order Certified Copies
Most orders are placed with the USPTO same day — all within 24 business hours.
Order via The Patent Place →
Pre-filled with this patent's details
Quick Facts
Patent No.
US 12,213,965
App. No.
17/367,484
Granted
Feb 4, 2025
Kind
B2
Abstract

Pharmaceutical compositions of the invention include substituted riluzole prodrugs useful for the treatment of cancers including melanoma, breast cancer, brain cancer, and prostate cancer through the release of riluzole. Prodrugs of riluzole have enhanced stability to hepatic metabolism and are delivered into systemic circulation by oral administration, and then cleaved to release riluzole in the plasma via either an enzymatic or general biophysical release process.

Claims (19)

1. A method of attenuating presynaptic glutamate release, the method comprising administering to a subject an effective amount of at least one compound having formula:

wherein R 23 is selected from the group consisting of H, CH 3 , CH 2 CH 3 , CH 2 CH 2 CH 3 , CH 2 CCH, CH(CH 3 ) 2 , CH 2 CH(CH 3 ) 2 , CH(CH 3 ) CH 2 CH 3 , CH 2 OH, CH 2 OCH 2 Ph, CH 2 CH 2 OCH 2 Ph, CH(OH) CH 3 , CH 2 Ph, CH 2 (cyclohexyl), CH 2 (4-OH-Ph), (CH 2 ) 4 NH 2 , (CH 2 ) 3 NHC(NH 2 ) NH, CH 2 (3-indole), CH 2 (5-imidazole), CH 2 CO 2 H, CH 2 CH 2 CO 2 H, CH 2 CONH 2 , and CH 2 CH 2 CONH 2 ;

or an enantiomer, diastereomer, hydrate, solvate, pharmaceutically acceptable salt, or complex thereof.

2. The method according to claim 1 , wherein the compound is selected from the group consisting of:

(S)-2-amino-N-(2-(methyl (2-oxo-2-((6-(trifluoromethoxy)benzo[d]thiazol-2-yl)amino) ethyl)amino)-2-oxoethyl) propanamide;

(R)-2-amino-N-(2-(methyl (2-oxo-2-((6-(trifluoromethoxy)benzo[d]thiazol-2-yl)amino) ethyl)amino)-2-oxoethyl) propanamide;

(S)-2-amino-3-methyl-N-(2-(methyl (2-oxo-2-((6-(trifluoromethoxy)benzo[d]thiazol-2-yl)amino) ethyl)amino)-2-oxoethyl) butanamide;

(R)-2-amino-3-methyl-N-(2-(methyl (2-oxo-2-((6-(trifluoromethoxy)benzo[d]thiazol-2-yl)amino) ethyl)amino)-2-oxoethyl) butanamide;

(S)-2-amino-N-(2-(methyl (2-oxo-2-((6-(trifluoromethoxy)benzo[d]thiazol-2-yl)amino) ethyl)amino)-2-oxoethyl)-3-phenylpropanamide;

(R)-2-amino-N-(2-(methyl (2-oxo-2-((6-(trifluoromethoxy)benzo[d]thiazol-2-yl)amino) ethyl)amino)-2-oxoethyl)-3-phenylpropanamide;

(S)-2-amino-4-methyl-N-(2-(methyl (2-oxo-2-((6-(trifluoromethoxy)benzo[d]thiazol-2-yl)amino) ethyl)amino)-2-oxoethyl) pentanamide;

(R)-2-amino-4-methyl-N-(2-(methyl (2-oxo-2-((6-(trifluoromethoxy)benzo[d]thiazol-2-yl)amino) ethyl)amino)-2-oxoethyl) pentanamide;

(S)-2-amino-3-hydroxy-N-(2-(methyl (2-oxo-2-((6-(trifluoromethoxy)benzo[d]thiazol-2-yl)amino) ethyl)amino)-2-oxoethyl) propanamide;

(R)-2-amino-3-hydroxy-N-(2-(methyl (2-oxo-2-((6-(trifluoromethoxy)benzo[d]thiazol-2-yl)amino) ethyl)amino)-2-oxoethyl) propanamide; and

2-(2-aminoacetamido)-N-methyl-N-(2-oxo-2-((6-(trifluoromethoxy)benzo[d]thiazol-2-yl)amino) ethyl) acetamide;

or a pharmaceutically acceptable form thereof.

3. The method of claim 1 , wherein the effective amount of at least one compound is administered in a composition further comprising at least one excipient.

4. The method of claim 1 , wherein the attenuating presynaptic glutamate release comprises an inhibitory effect on glutamate release, inactivation of voltage-dependent sodium channels, ability to interfere with intracellular events that follow transmitter binding at excitatory amino acid receptors, or a combination thereof.

5. The method of claim 1 , wherein R 23 is H.

Assignments (3)
SECURITY INTEREST Recorded May 1, 2025
From: BIOHAVEN THERAPEUTICS LTD
To: BEETLEJUICE SA LLC, AS PURCHASER AGENT
Reel/Frame 071147/0260 →
RELEASE OF SECURITY INTEREST Recorded Apr 27, 2025
From: SIXTH STREET SPECIALTY LENDING, INC.
To: BIOHAVEN PHARMACEUTICAL HOLDING COMPANY LTD.; BIOHAVEN THERAPEUTICS LTD.; BIOHAVEN PHARMACEUTICAL IRELAND DESIGNATED ACTIVITY COMPANY
Reel/Frame 071083/0330 →
PATENT SECURITY AGREEMENT Recorded Dec 2, 2021
From: BIOHAVEN THERAPEUTICS LTD.
To: SIXTH STREET SPECIALTY LENDING, INC., AS ADMINISTRATIVE AGENT
Reel/Frame 058299/0273 →
Continuity (5)
Continuation 16689150 · Nov 20, 2019
Continuation 16449948 · Jun 24, 2019
Continuation 15549154
Provisional Application 62127684 · Mar 3, 2015
Related Publication 20230017637A1 · Jan 19, 2023
References Cited (14)
US 9725427B2 · Smith et al. · 2017 [cited by applicant]
US 10357497B2 · Reitz et al. · 2019 [cited by applicant]
US 10485791B2 · Wrobel et al. · 2019 [cited by applicant]
US 10905681B2 · Wrobel · 2021 [cited by examiner]
US 20180037557A1 · Wrobel et al. · 2018 [cited by applicant]
US 20180318268A1 · Marfat · 2018 [cited by applicant]
US 20190209532A1 · Pelletier et al. · 2019 [cited by applicant]
US 20210228549A1 · Wrobel · 2021 [cited by examiner]
WO WO2016140878A2 · 2016 [cited by examiner]
WO 2019094851A1 · 2019 [cited by applicant]
Pelletier et al. “Dipeptide Prodrugs of the Glutamate Modulator Riluzole”, ACS Medicinal Chemistry Letters 2018, 9, 752-756. [cited by applicant]
International Search Report dated Aug. 18, 2016 issued for the corresponding application PCT/US2016/019787 (4 pages). [cited by applicant]
Written Opinion dated Aug. 18, 2016 issued for the corresponding application PCT/US2016/019787 (5 pages). [cited by applicant]
International Preliminary Report on Patentability dated Sep. 5, 2017 issued for the corresponding application PCT/US2016/019787 (6 pages). [cited by applicant]