IP Library › Granted Patent US 12,521,374
Granted Patent B1
US 12,521,374 · App. 19/244,143 · Granted Jan 13, 2026

Combination therapy for a dopamine agonist

Inventors: Kathleen E. Clarence-Smith (Washington, DC); Thomas N. Chase (Washington, DC)
Assignee: Alto Neuroscience, Inc.
A61K31/4178A61K31/428A61P1/08
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Quick Facts
Patent No.
US 12,521,374
App. No.
19/244,143
Granted
Jan 13, 2026
Kind
B1
Abstract

The application describes a method of reducing emesis caused by a dopamine agonist in a patient with depression who is treated with a dopamine agonist, comprising administering ondansetron in combination with the dopamine agonist.

Claims (19)

1 . A method for treating a patient suffering from major depressive disorder, comprising administering to the patient a daily dose of 1 μg to 300 mg of ondansetron, or a pharmaceutically acceptable salt or solvate thereof, and a daily dose of about 0.5 mg to about 6 mg of pramipexole, or a pharmaceutically acceptable salt thereof.

2 . The method of claim 1 , comprising administering to the patient a daily dose of about 1 mg to about 6 mg of pramipexole, or a pharmaceutically acceptable salt thereof.

3 . The method of claim 1 , wherein the pramipexole is pramipexole dihydrochloride monohydrate.

4 . The method of claim 3 , wherein the method comprises administering to the patient a daily dose of pramipexole dihydrochloride monohydrate from 0.5 mg to 6 mg.

5 . The method of claim 3 , wherein the method comprises administering to the patient a daily dose of pramipexole dihydrochloride monohydrate from 1 mg to 6 mg.

6 . The method of claim 3 , wherein the method comprises administering to the patient a daily dose of pramipexole dihydrochloride monohydrate from 2 mg to 6 mg.

7 . The method of claim 1 , wherein ondansetron, or a pharmaceutically acceptable salt or solvate thereof, and pramipexole, or a pharmaceutically acceptable salt, are formulated in separate pharmaceutical compositions.

8 . The method of claim 7 , wherein the separate pharmaceutical compositions are administered to the patient concurrently.

9 . The method of claim 7 , wherein the separate pharmaceutical compositions are administered to the patient sequentially.

10 . The method of claim 1 , wherein the ondansetron is ondansetron hydrochloride dihydrate.

11 . The method of claim 1 , wherein the method comprises administering to the patient about 6 mg to about 32 mg ondansetron or an equivalent dose of ondansetron hydrochloride dihydrate.

12 . The method of claim 1 , wherein the method comprises administering to the patient about 8 mg ondansetron or an equivalent dose of ondansetron hydrochloride dihydrate.

13 . The method of claim 1 , wherein the method comprises administering to the patient a daily dose of about 1 mg pramipexole, or a pharmaceutically acceptable salt thereof.

14 . The method of claim 1 , wherein the method comprises administering to the patient a daily dose of about 1.5 mg pramipexole, or a pharmaceutically acceptable salt thereof.

15 . The method of claim 1 , wherein the method comprises administering to the patient a daily dose of about 2.0 mg pramipexole, or a pharmaceutically acceptable salt thereof.

16 . The method of claim 1 , wherein the method comprises administering to the patient a daily dose of about 2.5 mg pramipexole, or a pharmaceutically acceptable salt thereof.

17 . The method of claim 1 , wherein the method comprises administering to the patient a daily dose of about 3.0 mg pramipexole, or a pharmaceutically acceptable salt thereof.

18 . The method of claim 1 , wherein the method comprises administering to the patient a daily dose of about 4.0 mg pramipexole, or a pharmaceutically acceptable salt thereof.

19 . The method of claim 1 , wherein the method comprises administering to the patient a daily dose of about 4.5 mg pramipexole, or a pharmaceutically acceptable salt thereof.

Assignments (2)
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Nov 25, 2025
From: CLARENCE-SMITH, KATHLEEN E.; CHASE, THOMAS N.
To: ALTO NEUROSCIENCE, INC.
Reel/Frame 073027/0853 →
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Jun 24, 2025
From: CLARENCE-SMITH, KATHLEEN E.; CHASE, THOMAS N.
To: ALTO NEUROSCIENCE, INC.
Reel/Frame 071509/0532 →
Continuity (2)
Continuation 16607252
Provisional Application 62489016 · Apr 24, 2017
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