IP Library Granted Patent US 11,440,893
Granted Patent B2
US 11,440,893 · App. 17/101,239 · Granted Sep 13, 2022

Prodrugs of riluzole and their method of use

Inventors: Garry Robert Smith (Royersford, PA); Allen B. Reitz (Lansdale, PA); Mark McDonnell (Lansdale, PA); Suzie Chen (Highland Park, NJ); Matthew D. Vera (Collegeville, PA); Benjamin E. Blass (Eagleville, PA); Jeffrey Claude Pelletier (Lafayette Hill, PA); Venkata N. Velvadapu (Philadelphia, PA); Jay Edward Wrobel (Lawrenceville, NJ)
Assignees: Biohaven Pharmaceutical Holding Company Ltd.; Rutgers, The State University of New Jersey
C07D277/82A61K31/428A61K45/06C07D417/12
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Quick Facts
Patent No.
US 11,440,893
App. No.
17/101,239
Granted
Sep 13, 2022
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 (82)

1. A method for treating cancer, said method comprising administering to a subject an effective amount of

at least one compound having formula (I) below:

including hydrates, solvates, pharmaceutically acceptable salts, and complexes thereof, wherein:

R 1 is OR 2 ,

R 2 is selected from the group consisting of optionally substituted C3-C6 alkyl and CH 2 (CH 2 ) n NR 8a R 8b ,

R 8a is optionally substituted C1-C6 alkyl,

R 8b is optionally substituted C2-C6 alkyl, and

n is 1 or 2;

or

at least one compound having formula (I) below:

including hydrates, solvates, pharmaceutically acceptable salts, and complexes thereof, wherein:

R 1 is CH 2 CH 2 CO 2 R 4 , and

R 4 is selected from the group consisting of hydrogen and optionally substituted C1-C6 alkyl;

or

at least one compound having formula (I) below:

including hydrates, solvates, pharmaceutically acceptable salts, and complexes thereof, wherein:

R 1 is CH 2 CH 2 CONHR 5 ,

R 5 is selected from the group consisting of hydrogen, optionally substituted C1-C6 Alkyl, CH 2 CH 2 NR 10a R 10b , and CH 2 R 11 ,

R 10a and R 10b are each independently selected from the group consisting of hydrogen and optionally substituted C1-C6 alkyl,

or

R 10a and R 10b are taken together with the atom to which they are bound to form an optionally substituted ring having 5 to 6 ring atoms,

or

R 10a and R 10b are taken together with the atom to which they are bound to form an optionally substituted ring having 5 to 6 ring atoms containing an oxygen,

or

R 10a and R 10b are taken together with the atom to which they are bound to form an optionally substituted ring having 5 to 6 ring atoms containing two nitrogen atoms, and

R 11 is selected from the group consisting of optionally substituted phenyl and optionally substituted heteroaryl;

wherein the cancer is ovarian cancer, cervical cancer, breast cancer, prostate cancer, testicular cancer, lung cancer, renal cancer, colorectal cancer, skin cancer, brain cancer, or leukemia.

2. The method of claim 1 , wherein the at least one compound is administered in a composition further comprising at least one excipient and an anticancer agent.

3. A method for treating melanoma, said method comprising administering to a subject an effective amount of

at least one compound having formula (I) below:

including hydrates, solvates, pharmaceutically acceptable salts, and complexes thereof, wherein:

R 1 is OR 2 ,

R 2 is selected from the group consisting of optionally substituted C3-C6 alkyl and CH 2 (CH 2 ) n NR 8a R 8b ,

R 8a is optionally substituted C1-C6 alkyl,

R 8b is optionally substituted C2-C6 alkyl, and

n is 1 or 2;

or

at least one compound having formula (I) below:

including hydrates, solvates, pharmaceutically acceptable salts, and complexes thereof, wherein:

R 1 is CH 2 CH 2 CO 2 R 4 , and

R 4 is selected from the group consisting of hydrogen and optionally substituted C1-C6 alkyl;

or

at least one compound having formula (I) below:

including hydrates, solvates, pharmaceutically acceptable salts, and complexes thereof, wherein:

R 1 is CH 2 CH 2 CONHR 5 ,

R 5 is selected from the group consisting of hydrogen, optionally substituted C1-C6 Alkyl, CH 2 CH 2 NR 10a R 10b , and CH 2 R 11 ,

R 10a and R 10b are each independently selected from the group consisting of hydrogen and optionally substituted C1-C6 alkyl,

or

R 10a and R 10b are taken together with the atom to which they are bound to form an optionally substituted ring having 5 to 6 ring atoms,

or

R 10a and R 10b are taken together with the atom to which they are bound to form an optionally substituted ring having 5 to 6 ring atoms containing an oxygen,

or

R 10a and R 10b are taken together with the atom to which they are bound to form an optionally substituted ring having 5 to 6 ring atoms containing two nitrogen atoms, and

R 11 is selected from the group consisting of optionally substituted phenyl and optionally substituted heteroaryl.

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

5. A composition comprising an effective amount of

at least one compound having formula (I) below:

including hydrates, solvates, pharmaceutically acceptable salts, and complexes thereof, wherein:

R 1 is OR 2 ,

R 2 is selected from the group consisting of optionally substituted C3-C6 alkyl and CH 2 (CH 2 ) n NR 8a R 8b ,

R 8a is optionally substituted C1-C6 alkyl,

R 8b is optionally substituted C2-C6 alkyl, and

n is 1 or 2;

or

at least one compound having formula (I) below:

including hydrates, solvates, pharmaceutically acceptable salts, and complexes thereof, wherein:

R 1 is CH 2 CH 2 CO 2 R 4 , and

R 4 is selected from the group consisting of hydrogen and optionally substituted C1-C6 alkyl;

or

at least one compound having formula (I) below:

including hydrates, solvates, pharmaceutically acceptable salts, and complexes thereof, wherein:

R 1 is CH 2 CH 2 CONHR 5 ,

R 5 is selected from the group consisting of hydrogen, optionally substituted C1-C6 Alkyl, CH 2 CH 2 NR 10a R 10b , and CH 2 R 11 ,

R 10a and R 10b are each independently selected from the group consisting of hydrogen and optionally substituted C1-C6 alkyl,

or

R 10a and R 10b are taken together with the atom to which they are bound to form an optionally substituted ring having 5 to 6 ring atoms,

or

R 10a and R 10b are taken together with the atom to which they are bound to form an optionally substituted ring having 5 to 6 ring atoms containing an oxygen,

or

R 10a and R 10b are taken together with the atom to which they are bound to form an optionally substituted ring having 5 to 6 ring atoms containing two nitrogen atoms, and

R 11 is selected from the group consisting of optionally

substituted phenyl and optionally substituted heteroaryl.

Assignments (4)
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 →
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded May 15, 2023
From: CHEN, SUZIE
To: RUTGERS, THE STATE UNIVERSITY OF NEW JERSEY
Reel/Frame 063639/0235 →
PATENT SECURITY AGREEMENT Recorded Dec 2, 2021
From: BIOHAVEN PHARMACEUTICAL HOLDING COMPANY LTD.
To: SIXTH STREET SPECIALTY LENDING, INC., AS ADMINISTRATIVE AGENT
Reel/Frame 058299/0297 →
Continuity (5)
Continuation 16748354 · Jan 21, 2020
Continuation 15668984 · Aug 4, 2017
Continuation 14385551
Provisional Application 61612210 · Mar 16, 2012
Related Publication 20210078962A1 · Mar 18, 2021