IP Library Granted Patent US 11,046,728
Granted Patent B2
US 11,046,728 · App. 16/393,396 · Granted Jun 29, 2021

Neuroactive steroids, compositions, and uses thereof

Inventors: Gabriel Martinez Botella (Wayland, MA); Boyd L. Harrison (Princeton Junction, NJ); Albert Jean Robichaud (Boston, MA); Francesco G. Salituro (Marlborough, MA)
Assignee: Sage Therapeutics, Inc.
C07J41/0094A61K31/56A61K31/565A61K31/567A61K45/06C07J1/0011C07J1/0022C07J5/0053C07J11/00C07J21/008C07J31/006C07J51/00C07J71/001
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Quick Facts
Patent No.
US 11,046,728
App. No.
16/393,396
Granted
Jun 29, 2021
Kind
B2
Abstract

Described herein are neuroactive steroids of the Formula (I): or a pharmaceutically acceptable salt thereof; wherein R 1a and R 1b are as defined herein. Such compounds are envisioned, in certain embodiments, to behave as GABA modulators. The present invention also provides pharmaceutical compositions comprising a compound of the present invention and methods of use and treatment, e.g., such for inducing sedation and/or anesthesia.

Claims (39)

1. A compound of Formula (III):

wherein:

one of R 1a and R 1b is halo, hydroxy, alkyl, alkoxy, —C(O)R a , —C(O)N(R b )(R c ), —C(O)OR a , —N(R h )(R i ), —OC(O)N(R b )(R c ), —OC(O)OR a , —OC(O)R a , —S(O) 0-2 R a , —S(O) 0-2 OR a , or —S(O) 0-2 N(R b )(R c ) and the other one is hydrogen; or

R 1a and R 1b are taken together with the carbon to which they are attached to form C(═O);

one of R 2a and R 2b is chloro, fluoro, hydroxy, alkyl, alkoxy, —C(O)R a , —C(O)N(R b )(R c ), —C(O)OR a , —N(R f )(R g ), —OC(O)N(R b )(R c ), —OC(O)OR a , —OC(O)R a , —S(O) 0-2 R a , —S(O) 0-2 OR a , or —S(O) 0-2 N(R b )(R c ), and the other one is hydrogen;

R 3 is hydrogen or C 1 -C 6 alkyl;

each R a is hydrogen or C 1 -C 6 alkyl;

each R b and R c is independently hydrogen or C 1 -C 6 alkyl, or

R b and R c , taken together with the nitrogen atom to which they are attached, form a 3-7-membered heterocyclic ring;

each R f and R g is independently hydrogen or C 1 -C 6 alkyl, or

R f and R g , taken together with the nitrogen atom to which they are attached, form a 3-7-membered heterocyclic ring optionally comprising one additional heteroatom selected from nitrogen and sulfur; and

each R h is unsubstituted C 1 -C 4 alkyl;

each R i is hydrogen, substituted methyl or C 2 -C 6 alkyl, or

R h and R i , taken together with the nitrogen atom to which they are attached, form a 3-7-membered heterocyclic ring.

2. The compound of claim 1 , wherein the compound is a compound of Formula (IIIb):

wherein:

one of R 1a and R 1b is halo, hydroxy, alkyl, alkoxy, —C(O)R a , —C(O)N(R b )(R c ), —C(O)OR a , —N(R h )(R i ), —OC(O)N(R b )(R c ), —OC(O)OR a , —OC(O)R a , —S(O) 0-2 R a , —S(O) 0-2 OR a , or —S(O) 0-2 N(R b )(R c ), and the other one is hydrogen; or

R 1a and R 1b are taken together with the carbon to which they are attached to form C(═O);

one of R 2a and R 2b is chloro, fluoro, hydroxy, alkyl, alkoxy, —C(O)R a , —C(O)N(R b )(R c ), —C(O)OR a , —N(R f )(R g ), —OC(O)N(R b )(R c ), —OC(O)OR a , —OC(O)R a , —S(O) 0-2 R a , —S(O) 0-2 OR a , or —S(O) 0-2 N(R b )(R c ), and the other one is hydrogen;

each R a is hydrogen or C 1 -C 6 alkyl;

each R b and R c is independently hydrogen or C 1 -C 6 alkyl, or

R b and R c , taken together with the nitrogen atom to which they are attached to form a 3-7-membered heterocyclic ring;

each R f and R g is independently hydrogen or C 1 -C 6 alkyl, or

R f and R g , taken together with the nitrogen atom to which they are attached to form a 3-7-membered heterocyclic ring optionally comprising one additional heteroatom selected from nitrogen and sulfur; and

each R h is unsubstituted C 1 -C 4 alkyl;

each R i is hydrogen, substituted methyl or C 2 -C 6 alkyl, or

R h and R i , taken together with the nitrogen atom to which they are attached to form a 3-7-membered heterocyclic ring.

3. The compound of claim 1 , wherein R 1a and R 1b are taken together with the carbon to which they are attached to form C(═O).

4. The compound of claim 1 , wherein R 2a or R 2b is hydroxy, alkyl, or alkoxy.

5. The compound of claim 1 , wherein R 1a and R 1b are taken together with the carbon to which they are attached to form C(═O) and R 2a or R 2b is hydroxy, alkyl, or alkoxy.

6. The compound of claim 1 , wherein R 1a or R 1b is hydroxy, alkyl, or alkoxy.

7. The compound of claim 6 , wherein R 1a is hydroxy.

8. The compound of claim 6 , wherein R 1a is alkoxy.

9. The compound of claim 1 , wherein R 1a or R 1b is hydroxy, alkyl, or alkoxy and R 2a or R 2b is hydroxy, alkyl, or alkoxy.

10. The compound of claim 4 , wherein R 2a is alkyl.

11. The compound of claim 4 , wherein R 2a is alkoxy.

12. The compound of claim 1 , wherein R 3 is C 1 -C 6 alkyl.

13. The compound of claim 1 selected from:

14. A pharmaceutical composition comprising a compound of claim 1 , and a pharmaceutically acceptable excipient.

Assignments (2)
CHANGE OF NAME Recorded Apr 23, 2026
From: SAGE THERAPEUTICS, INC.
To: SAGE THERAPEUTICS, LLC
Reel/Frame 075472/0569 →
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded May 7, 2021
From: BOTELLA, GABRIEL MARTINEZ; HARRISON, BOYD L.; ROBICHAUD, ALBERT JEAN; SALITURO, FRANCESCO G.
To: SAGE THERAPEUTICS, INC.
Reel/Frame 056173/0506 →
Cited By (2)
US 12,534,495 US 12,655,175