IP Library Granted Patent US 9,045,501
Granted Patent B2
US 9,045,501 · App. 14/203,033 · Granted Jun 2, 2015

5-HT3 receptor modulators, methods of making, and use thereof

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Patent No.
US 9,045,501
App. No.
14/203,033
Granted
Jun 2, 2015
Kind
B2
Abstract

Novel 5-HT 3 receptor modulators are disclosed. These compounds are used in the treatment of various disorders, including chemotherapy-induced nausea and vomiting, post-operative nausea and vomiting, and irritable bowel syndrome. Methods of making these compounds are also described in the present invention.

Claims (102)

1. A method of treating irritable bowel syndrome comprising:

selecting a patient with irritable bowel syndrome; and

administering to the patient a therapeutically effective amount of a compound of formula I:

wherein:

represents an optional double bond;

Q is a saturated, bicyclic, heterocyclic amine comprising at least two atoms between the amide nitrogen of the compound of formula I and any amine nitrogen of Q and wherein the saturated, bicyclic, heterocyclic amine is optionally substituted with from 1 to 3 substituents independently selected at each occurrence thereof from the group consisting of C 1 -C 3 alkyl, halogen, —CN, —OR 7 , and —NR 7 R 8 ;

X is CH, CH 2 , CR 2 , C(R 2 ) 2 , N, NH, C═O, or SO 2 ;

Y is CH, CH 2 , CR 2 , C(R 2 ) 2 , N, NH, NR 3 , O, or C═O;

R 1 is individually selected at each location from the group consisting of H, halogen, —OR 4 , —NR 4 R 5 , —NR 4 C(O)R 5 , —NR 4 C(O) 2 R 5 , —NR 5 C(O)NR 5 R 6 , —S(O) q R 5 , —CN, —C(O)R 5 , —C(O)NR 4 R 5 , C 1 -C 6 alkyl, C 2 -C 6 alkenyl, C 2 -C 6 alkynyl, C 3 -C 6 cycloalkyl, C 4 -C 7 cycloalkylalkyl, aryl, and heteroaryl, wherein each of C 1 -C 6 alkyl, C 2 -C 6 alkenyl, C 2 -C 6 alkynyl, C 3 -C 6 cycloalkyl, C 4 -C 7 cycloalkylalkyl, aryl, and heteroaryl is optionally substituted with from 1 to 3 substituents independently selected at each occurrence thereof from C 1 -C 3 alkyl, halogen, —CN, —OR 7 , —NR 7 R 8 , and phenyl which is optionally substituted 1-3 times with halogen, C 1 -C 4 alkyl, C 1 -C 4 haloalkyl, C 1 -C 4 alkoxy, —CN, —OR 7 , or —NR 7 R 8 ;

R 2 is individually selected at each location from the group consisting of H, halogen, —OR 4 , —NR 4 R 5 , —NR 4 C(O)R 5 , —NR 4 C(O) 2 R 5 , —NR 5 C(O)NR 5 R 6 , —S(O) q R 5 , —CN, —C(O)R 5 , —C(O)NR 4 R 5 , C 1 -C 6 alkyl, C 2 -C 6 alkenyl, C 2 -C 6 alkynyl, C 3 -C 6 cycloalkyl, C 4 -C 7 cycloalkylalkyl, aryl, and heteroaryl, wherein each of C 1 -C 6 alkyl, C 2 -C 6 alkenyl, C 2 -C 6 alkynyl, C 3 -C 6 cycloalkyl, C 4 -C 7 cycloalkylalkyl, aryl, and heteroaryl is optionally substituted with from 1 to 3 substituents independently selected at each occurrence thereof from C 1 -C 3 alkyl, halogen, —CN, —OR 7 , —NR 7 R 8 , and phenyl which is optionally substituted 1-3 times with halogen, C 1 -C 4 alkyl, C 1 -C 4 haloalkyl, C 1 -C 4 alkoxy, —CN, —OR 7 , or —NR 7 R 8 ;

R 3 is selected from the group consisting of H, C 1 -C 6 alkyl, C 3 -C 6 alkenyl, C 3 -C 6 alkynyl, C 3 -C 6 cycloalkyl, C 4 -C 7 cycloalkylalkyl, aryl, and heteroaryl, wherein each of C 1 -C 6 alkyl, C 3 -C 6 alkenyl, C 3 -C 6 alkynyl, C 3 -C 6 cycloalkyl, C 4 -C 7 cycloalkylalkyl, aryl, and heteroaryl is optionally substituted with from 1 to 3 substituents independently selected at each occurrence thereof from C 1 -C 3 alkyl, halogen, —CN, —OR 7 , —NR 7 R 8 , and phenyl which is optionally substituted 1-3 times with halogen, C 1 -C 4 alkyl, C 1 -C 4 haloalkyl, C 1 -C 4 alkoxy, —CN, —OR 7 , or —NR 7 R 8 ;

R 4 is H, C 1 -C 4 alkyl, C 1 -C 4 haloalkyl, C 1 -C 4 alkoxyalkyl, C 3 -C 6 cycloalkyl, C 4 -C 7 cycloalkylalkyl, —C(O)R 6 , phenyl, or benzyl, wherein phenyl or benzyl is optionally substituted 1 to 3 times with halogen, cyano, C 1 -C 4 alkyl, C 1 -C 4 haloalkyl, or C 1 -C 4 alkoxy;

R 5 is H, C 1 -C 4 alkyl, C 1 -C 4 haloalkyl, C 1 -C 4 alkoxyalkyl, C 3 -C 6 cycloalkyl, C 4 -C 7 cycloalkylalkyl, phenyl, or benzyl, wherein phenyl or benzyl is optionally substituted 1 to 3 times with halogen, cyano, C 1 -C 4 alkyl, C 1 -C 4 haloalkyl, or C 1 -C 4 alkoxy; or

R 4 and R 5 are taken together with the nitrogen to which they are attached to form a five- to seven-membered heterocyclic ring, which comprises from 1 to 2 heteroatoms selected from the group consisting of nitrogen, oxygen, and sulfur, and is optionally substituted from 1 to 4 times with a substituent selected independently at each occurrence thereof from the group consisting of halogen, cyano, C 1 -C 4 alkyl, C 1 -C 4 haloalkyl, and C 1 -C 4 alkoxy;

R 6 is C 1 -C 4 alkyl, C 1 -C 4 haloalkyl, or phenyl;

R 7 and R 8 are each independently H, C 1 -C 4 alkyl, C 1 -C 4 haloalkyl, C 1 -C 4 alkoxyalkyl, C 3 -C 6 cycloalkyl, C 4 -C 7 cycloalkylalkyl, —C(O)R 6 , phenyl, or benzyl, wherein phenyl or benzyl is optionally substituted from 1 to 3 times with a substituent selected independently at each occurrence thereof from the group consisting of halogen, cyano, C 1 -C 4 alkyl, C 1 -C 4 haloalkyl, and C 1 -C 4 alkoxy;

n is 1 or 2;

p is 0, 1, 2, or 3;

q is 0, 1, or 2; and

wherein heteroaryl is an aromatic monocyclic or multi-cyclic ring system of 5 to 14 ring atoms in which one or more atoms in the ring system are nitrogen, oxygen, or sulfur;

or a pharmaceutically acceptable salt thereof.

2. The method according to claim 1 further comprising:

administering to the patient a therapeutically effective amount of a second serotonin 5-HT 3 receptor modulator or a serotonin 5-HT 4 receptor modulator.

3. The method according to claim 2 , wherein the second serotonin 5-HT 3 receptor modulator or serotonin 5-HT 4 receptor modulator is selected from the group consisting of Alosetron, renzapride, cilansetron, Tegaserod, Prucalopride, ondansetron, and combinations thereof.

4. The method according to claim 1 further comprising:

administering to the patient a therapeutically effective amount of a therapeutic agent selected from the group consisting of somatostatin analogs, muscarinic receptor antagonists, laxatives, antispasmodics, antidepressants, antidiarrheal agents, prokinetic agents, peripheral opiate narcotic antagonists, and combinations thereof.

5. A method of treating emesis comprising:

selecting a patient with emesis; and

administering to the patient a therapeutically effective amount of a compound of formula I:

wherein:

represents an optional double bond;

Q is a saturated, bicyclic, heterocyclic amine comprising at least two atoms between the amide nitrogen of the compound of formula I and any amine nitrogen of Q and wherein the saturated, bicyclic, heterocyclic amine is optionally substituted with from 1 to 3 substituents independently selected at each occurrence thereof from the group consisting of C 1 -C 3 alkyl, halogen, —CN, —OR 7 , and —NR 7 R 8 ;

X is CH, CH 2 , CR 2 , C(R 2 ) 2 , N, NH, C═O, or SO 2 ;

Y is CH, CH 2 , CR 2 , C(R 2 ) 2 , N, NH, NR 3 , O, or C═O;

R 1 is individually selected at each location from the group consisting of H, halogen, —OR 4 , —NR 4 R 5 , —NR 4 C(O)R 5 , —NR 4 C(O) 2 R 5 , —NR 5 C(O)NR 5 R 6 , —S(O) q R 5 , —CN, —C(O)R 5 , —C(O)NR 4 R 5 , C 1 -C 6 alkyl, C 2 -C 6 alkenyl, C 2 -C 6 alkynyl, C 3 -C 6 cycloalkyl, C 4 -C 7 cycloalkylalkyl, aryl, and heteroaryl, wherein each of C 1 -C 6 alkyl, C 2 -C 6 alkenyl, C 2 -C 6 alkynyl, C 3 -C 6 cycloalkyl, C 4 -C 7 cycloalkylalkyl, aryl, and heteroaryl is optionally substituted with from 1 to 3 substituents independently selected at each occurrence thereof from C 1 -C 3 alkyl, halogen, —CN, —OR 7 , —NR 7 R 8 , and phenyl which is optionally substituted 1-3 times with halogen, C 1 -C 4 alkyl, C 1 -C 4 haloalkyl, C 1 -C 4 alkoxy, —CN, —OR 7 , or —NR 7 R 8 ;

R 2 is individually selected at each location from the group consisting of H, halogen, —OR 4 , —NR 4 R 5 , —NR 4 C(O)R 5 , —NR 4 C(O) 2 R 5 , —NR 5 C(O)NR 5 R 6 , —S(O) q R 5 , —CN, —C(O)R 5 , —C(O)NR 4 R 5 , C 1 -C 6 alkyl, C 2 -C 6 alkenyl, C 2 -C 6 alkynyl, C 3 -C 6 cycloalkyl, C 4 -C 7 cycloalkylalkyl, aryl, and heteroaryl, wherein each of C 1 -C 6 alkyl, C 2 -C 6 alkenyl, C 2 -C 6 alkynyl, C 3 -C 6 cycloalkyl, C 4 -C 7 cycloalkylalkyl, aryl, and heteroaryl is optionally substituted with from 1 to 3 substituents independently selected at each occurrence thereof from C 1 -C 3 alkyl, halogen, —CN, —OR 7 , —NR 7 R 8 , and phenyl which is optionally substituted 1-3 times with halogen, C 1 -C 4 alkyl, C 1 -C 4 haloalkyl, C 1 -C 4 alkoxy, —CN, —OR 7 , or —NR 7 R 8 ;

R 3 is selected from the group consisting of H, C 1 -C 6 alkyl, C 3 -C 6 alkenyl, C 3 -C 6 alkynyl, C 3 -C 6 cycloalkyl, C 4 -C 7 cycloalkylalkyl, aryl, and heteroaryl, wherein each of C 1 -C 6 alkyl, C 3 -C 6 alkenyl, C 3 -C 6 alkynyl, C 3 -C 6 cycloalkyl, C 4 -C 7 cycloalkylalkyl, aryl, and heteroaryl is optionally substituted with from 1 to 3 substituents independently selected at each occurrence thereof from C 1 -C 3 alkyl, halogen, —CN, —OR 7 , —NR 7 R 8 , and phenyl which is optionally substituted 1-3 times with halogen, C 1 -C 4 alkyl, C 1 -C 4 haloalkyl, C 1 -C 4 alkoxy, —CN, —OR 7 , or —NR 7 R 8 ;

R 4 is H, C 1 -C 4 alkyl, C 1 -C 4 haloalkyl, C 1 -C 4 alkoxyalkyl, C 3 -C 6 cycloalkyl, C 4 -C 7 cycloalkylalkyl, —C(O)R 6 , phenyl, or benzyl, wherein phenyl or benzyl is optionally substituted 1 to 3 times with halogen, cyano, C 1 -C 4 alkyl, C 1 -C 4 haloalkyl, or C 1 -C 4 alkoxy;

R 5 is H, C 1 -C 4 alkyl, C 1 -C 4 haloalkyl, C 1 -C 4 alkoxyalkyl, C 3 -C 6 cycloalkyl, C 4 -C 7 cycloalkylalkyl, phenyl, or benzyl, wherein phenyl or benzyl is optionally substituted 1 to 3 times with halogen, cyano, C 1 -C 4 alkyl, C 1 -C 4 haloalkyl, or C 1 -C 4 alkoxy; or

R 4 and R 5 are taken together with the nitrogen to which they are attached to form a five- to seven-membered heterocyclic ring, which comprises from 1 to 2 heteroatoms selected from the group consisting of nitrogen, oxygen, and sulfur, and is optionally substituted from 1 to 4 times with a substituent selected independently at each occurrence thereof from the group consisting of halogen, cyano, C 1 -C 4 alkyl, C 1 -C 4 haloalkyl, and C 1 -C 4 alkoxy;

R 6 is C 1 -C 4 alkyl, C 1 -C 4 haloalkyl, or phenyl;

R 7 and R 8 are each independently H, C 1 -C 4 alkyl, C 1 -C 4 haloalkyl, C 1 -C 4 alkoxyalkyl, C 3 -C 6 cycloalkyl, C 4 -C 7 cycloalkylalkyl, —C(O)R 6 , phenyl, or benzyl, wherein phenyl or benzyl is optionally substituted from 1 to 3 times with a substituent selected independently at each occurrence thereof from the group consisting of halogen, cyano, C 1 -C 4 alkyl, C 1 -C 4 haloalkyl, and C 1 -C 4 alkoxy;

n is 1 or 2;

p is 0, 1, 2, or 3;

q is 0, 1, or 2; and

wherein heteroaryl is an aromatic monocyclic or multi-cyclic ring system of 5 to 14 ring atoms in which one or more atoms in the ring system are nitrogen, oxygen, or sulfur;

or a pharmaceutically acceptable salt thereof.

6. The method according to claim 5 further comprising:

administering to the patient a therapeutically effective amount of one or more other anti-emetic compounds.

7. The method according to claim 6 , wherein the one or more other anti-emetic compounds are selected from the group consisting of dexamethasone, alosetron, alprazolam, aprepitant, dimenhydrinate, diphenhydramine, dolasetron, tetrahydrocannabinol, nabilone, dronabinol, droperidol, granisetron, haloperidol, lorazepam, metoclopramide, midazolam, olanzapine, ondansetron, palonosetron, proclorperazine, promethazine, tropisetron, and combinations thereof.

8. A method of treating irritable bowel syndrome comprising:

selecting a patient with irritable bowel syndrome; and

administering to the patient a therapeutically effective amount of a compound of formula II:

wherein:

represents an optional double bond;

Q is a saturated, bicyclic, heterocyclic amine, wherein the saturated, bicyclic, heterocyclic amine is optionally substituted with from 1 to 3 substituents independently selected at each occurrence thereof from the group consisting of C 1 -C 3 alkyl, halogen, —CN, —OR 7 , and —NR 7 R 8 ;

X is CH, CH 2 , CR 2 , C(R 2 ) 2 , N, NH, C═O, or SO 2 ;

Y is CH, CH 2 , CR 2 , C(R 2 ) 2 , N, NH, NR 3 , O, or C═O;

Z is C or N;

R 1 is individually selected at each location from the group consisting of H, halogen, —OR 4 , —NR 4 R 5 , —NR 4 C(O)R 5 , —NR 4 C(O) 2 R 5 , —NR 5 C(O)NR 5 R 6 , —S(O) q R 5 , —CN, —C(O)R 5 , —C(O)NR 4 R 5 , C 1 -C 6 alkyl, C 2 -C 6 alkenyl, C 2 -C 6 alkynyl, C 3 -C 6 cycloalkyl, C 4 -C 7 cycloalkylalkyl, aryl, and heteroaryl, wherein each of C 1 -C 6 alkyl, C 2 -C 6 alkenyl, C 2 -C 6 alkynyl, C 3 -C 6 cycloalkyl, C 4 -C 7 cycloalkylalkyl, aryl, and heteroaryl is optionally substituted with from 1 to 3 substituents independently selected at each occurrence thereof from C 1 -C 3 alkyl, halogen, —CN, 13 OR 7 , —NR 7 R 8 , and phenyl which is optionally substituted 1-3 times with halogen, C 1 -C 4 alkyl, C 1 -C 4 haloalkyl, C 1 -C 4 alkoxy, —CN, —OR 7 , or —NR 7 R 8 ;

R 2 is individually selected at each location from the group consisting of H, halogen, —OR 4 , —NR 4 R 5 , —NR 4 C(O)R 5 , —NR 4 C(O) 2 R 5 , —NR 5 C(O)NR 5 R 6 , —S(O) q R 5 , —CN, —C(O)R 5 , —C(O)NR 4 R 5 , C 1 -C 6 alkyl, C 2 -C 6 alkenyl, C 2 -C 6 alkynyl, C 3 -C 6 cycloalkyl, C 4 -C 7 cycloalkylalkyl, aryl, and heteroaryl, wherein each of C 1 -C 6 alkyl, C 2 -C 6 alkenyl, C 2 -C 6 alkynyl, C 3 -C 6 cycloalkyl, C 4 -C 7 cycloalkylalkyl, aryl, and heteroaryl is optionally substituted with from 1 to 3 substituents independently selected at each occurrence thereof from C 1 -C 3 alkyl, halogen, —CN, —OR 7 , —NR 7 R 8 , and phenyl which is optionally substituted 1-3 times with halogen, C 1 -C 4 alkyl, C 1 -C 4 haloalkyl, C 1 -C 4 alkoxy, —CN, —OR 7 , or —NR 7 R 8 ;

R 3 is selected from the group consisting of H, C 1 -C 6 alkyl, C 3 -C 6 alkenyl, C 3 -C 6 alkynyl, C 3 -C 6 cycloalkyl, C 4 -C 7 cycloalkylalkyl, aryl, and heteroaryl, wherein each of C 1 -C 6 alkyl, C 3 -C 6 alkenyl, C 3 -C 6 alkynyl, C 3 -C 6 cycloalkyl, C 4 -C 7 cycloalkylalkyl, aryl, and heteroaryl is optionally substituted with from 1 to 3 substituents independently selected at each occurrence thereof from C 1 -C 3 alkyl, halogen, —CN, —OR 7 , —NR 7 R 8 , and phenyl which is optionally substituted 1-3 times with halogen, C 1 -C 4 alkyl, C 1 -C 4 haloalkyl, C 1 -C 4 alkoxy, —CN, —OR 7 , or —NR 7 R 8 ;

R 4 is H, C 1 -C 4 alkyl, C 1 -C 4 haloalkyl, C 1 -C 4 alkoxyalkyl, C 3 -C 6 cycloalkyl, C 4 -C 7 cycloalkylalkyl, —C(O)R 6 , phenyl, or benzyl, wherein phenyl or benzyl is optionally substituted 1 to 3 times with halogen, cyano, C 1 -C 4 alkyl, C 1 -C 4 haloalkyl, or C 1 -C 4 alkoxy;

R 5 is H, C 1 -C 4 alkyl, C 1 -C 4 haloalkyl, C 1 -C 4 alkoxyalkyl, C 3 -C 6 cycloalkyl, C 4 -C 7 cycloalkylalkyl, phenyl, or benzyl, wherein phenyl or benzyl is optionally substituted 1 to 3 times with halogen, cyano, C 1 -C 4 alkyl, C 1 -C 4 haloalkyl, or C 1 -C 4 alkoxy; or

R 4 and R 5 are taken together with the nitrogen to which they are attached to form a five- to seven-membered heterocyclic ring, which comprises from 1 to 2 heteroatoms selected from the group consisting of nitrogen, oxygen, and sulfur, and is optionally substituted from 1 to 4 times with a substituent selected independently at each occurrence thereof from the group consisting of halogen, cyano, C 1 -C 4 alkyl, C 1 -C 4 haloalkyl, and C 1 -C 4 alkoxy;

R 6 is C 1 -C 4 alkyl, C 1 -C 4 haloalkyl, or phenyl;

R 7 and R 8 are each independently H, C 1 -C 4 alkyl, C 1 -C 4 haloalkyl, C 1 -C 4 alkoxyalkyl, C 3 -C 6 cycloalkyl, C 4 -C 7 cycloalkylalkyl, —C(O)R 6 , phenyl, or benzyl, wherein phenyl or benzyl is optionally substituted from 1 to 3 times with a substituent selected independently at each occurrence thereof from the group consisting of halogen, cyano, C 1 -C 4 alkyl, C 1 -C 4 haloalkyl, and C 1 -C 4 alkoxy;

n is 0, 1, or 2, with the provisos that: (1) when Z is N, then n is 1 or 2; and (2) when Z is C, then n is 0, 1, or 2;

p is 0, 1, 2, or 3;

q is 0, 1, or 2; and

wherein heteroaryl is an aromatic monocyclic or multi-cyclic ring system of 5 to 14 ring atoms in which one or more atoms in the ring system are nitrogen, oxygen, or sulfur;

or a pharmaceutically acceptable salt thereof.

9. The method according to claim 8 further comprising:

administering to the patient a therapeutically effective amount of a second serotonin 5-HT 3 receptor modulator or a serotonin 5-HT 4 receptor modulator.

10. The method according to claim 9 , wherein the second serotonin 5-HT 3 receptor modulator or serotonin 5-HT 4 receptor modulator is selected from the group consisting of Alosetron, renzapride, cilansetron, Tegaserod, Prucalopride, ondansetron, and combinations thereof.

11. The method according to claim 8 further comprising:

administering to the patient a therapeutically effective amount of a therapeutic agent selected from the group consisting of somatostatin analogs, muscarinic receptor antagonists, laxatives, antispasmodics, antidepressants, antidiarrheal agents, prokinetic agents, peripheral opiate narcotic antagonists, and combinations thereof.

12. A method of treating emesis comprising:

selecting a patient with emesis; and

administering to the patient a therapeutically effective amount of a compound of formula II:

wherein:

represents an optional double bond;

Q is a saturated, bicyclic, heterocyclic amine, wherein the saturated, bicyclic, heterocyclic amine is optionally substituted with from 1 to 3 substituents independently selected at each occurrence thereof from the group consisting of C 1 -C 3 alkyl, halogen, —CN, —OR 7 , and —NR 7 R 8 ;

X is CH, CH 2 , CR 2 , C(R 2 ) 2 , N, NH, C═O, or SO 2 ;

Y is CH, CH 2 , CR 2 , C(R 2 ) 2 , N, NH, NR 3 , O, or C═O;

Z is C or N;

R 1 is individually selected at each location from the group consisting of H, halogen, —OR 4 , —NR 4 R 5 , —NR 4 C(O)R 5 , —NR 4 C(O) 2 R 5 , —NR 5 C(O)NR 5 R 6 , —S(O) q R 5 , —CN, —C(O)R 5 , —C(O)NR 4 R 5 , C 1 -C 6 alkyl, C 2 -C 6 alkenyl, C 2 -C 6 alkynyl, C 3 -C 6 cycloalkyl, C 4 -C 7 cycloalkylalkyl, aryl, and heteroaryl, wherein each of C 1 -C 6 alkyl, C 2 -C 6 alkenyl, C 2 -C 6 alkynyl, C 3 -C 6 cycloalkyl, C 4 -C 7 cycloalkylalkyl, aryl, and heteroaryl is optionally substituted with from 1 to 3 substituents independently selected at each occurrence thereof from C 1 -C 3 alkyl, halogen, —CN, —OR 7 , —NR 7 R 8 , and phenyl which is optionally substituted 1-3 times with halogen, C 1 -C 4 alkyl, C 1 -C 4 haloalkyl, C 1 -C 4 alkoxy, —CN, —OR 7 , or —NR 7 R 8 ;

R 2 is individually selected at each location from the group consisting of H, halogen, —OR 4 , —NR 4 R 5 , —NR 4 C(O)R 5 , —NR 4 C(O) 2 R 5 , —NR 5 C(O)NR 5 R 6 , —S(O) q R 5 , —CN, —C(O)R 5 , —C(O)NR 4 R 5 , C 1 -C 6 alkyl, C 2 -C 6 alkenyl, C 2 -C 6 alkynyl, C 3 -C 6 cycloalkyl, C 4 -C 7 cycloalkylalkyl, aryl, and heteroaryl, wherein each of C 1 -C 6 alkyl, C 2 -C 6 alkenyl, C 2 -C 6 alkynyl, C 3 -C 6 cycloalkyl, C 4 -C 7 cycloalkylalkyl, aryl, and heteroaryl is optionally substituted with from 1 to 3 substituents independently selected at each occurrence thereof from C 1 -C 3 alkyl, halogen, —CN, —OR 7 , —NR 7 R 8 , and phenyl which is optionally substituted 1-3 times with halogen, C 1 -C 4 alkyl, C 1 -C 4 haloalkyl, C 1 -C 4 alkoxy, —CN, —OR 7 , or —NR 7 R 8 ;

R 3 is selected from the group consisting of H, C 1 -C 6 alkyl, C 3 -C 6 alkenyl, C 3 -C 6 alkynyl, C 3 -C 6 cycloalkyl, C 4 -C 7 cycloalkylalkyl, aryl, and heteroaryl, wherein each of C 1 -C 6 alkyl, C 3 -C 6 alkenyl, C 3 -C 6 alkynyl, C 3 -C 6 cycloalkyl, C 4 -C 7 cycloalkylalkyl, aryl, and heteroaryl is optionally substituted with from 1 to 3 substituents independently selected at each occurrence thereof from C 1 -C 3 alkyl, halogen, —CN, —OR 7 , —NR 7 R 8 , and phenyl which is optionally substituted 1-3 times with halogen, C 1 -C 4 alkyl, C 1 -C 4 haloalkyl, C 1 -C 4 alkoxy, —CN, —OR 7 , or —NR 7 R 8 ;

R 4 is H, C 1 -C 4 alkyl, C 1 -C 4 haloalkyl, C 1 -C 4 alkoxyalkyl, C 3 -C 6 cycloalkyl, C 4 -C 7 cycloalkylalkyl, —C(O)R 6 , phenyl, or benzyl, wherein phenyl or benzyl is optionally substituted 1 to 3 times with halogen, cyano, C 1 -C 4 alkyl, C 1 -C 4 haloalkyl, or C 1 -C 4 alkoxy;

R 5 is H, C 1 -C 4 alkyl, C 1 -C 4 haloalkyl, C 1 -C 4 alkoxyalkyl, C 3 -C 6 cycloalkyl, C 4 -C 7 cycloalkylalkyl, phenyl, or benzyl, wherein phenyl or benzyl is optionally substituted 1 to 3 times with halogen, cyano, C 1 -C 4 alkyl, C 1 -C 4 haloalkyl, or C 1 -C 4 alkoxy; or

R 4 and R 5 are taken together with the nitrogen to which they are attached to form a five- to seven-membered heterocyclic ring, which comprises from 1 to 2 heteroatoms selected from the group consisting of nitrogen, oxygen, and sulfur, and is optionally substituted from 1 to 4 times with a substituent selected independently at each occurrence thereof from the group consisting of halogen, cyano, C 1 -C 4 alkyl, C 1 -C 4 haloalkyl, and C 1 -C 4 alkoxy;

R 6 is C 1 -C 4 alkyl, C 1 -C 4 haloalkyl, or phenyl;

R 7 and R 8 are each independently H, C 1 -C 4 alkyl, C 1 -C 4 haloalkyl, C 1 -C 4 alkoxyalkyl, C 3 -C 6 cycloalkyl, C 4 -C 7 cycloalkylalkyl, —C(O)R 6 , phenyl, or benzyl, wherein phenyl or benzyl is optionally substituted from 1 to 3 times with a substituent selected independently at each occurrence thereof from the group consisting of halogen, cyano, C 1 -C 4 alkyl, C 1 -C 4 haloalkyl, and C 1 -C 4 alkoxy;

n is 0, 1, or 2, with the provisos that: (1) when Z is N, then n is 1 or 2; and (2) when Z is C, then n is 0, 1, or 2;

p is 0, 1, 2, or 3;

q is 0, 1, or 2; and

wherein heteroaryl is an aromatic monocyclic or multi-cyclic ring system of 5 to 14 ring atoms in which one or more atoms in the ring system are nitrogen, oxygen, or sulfur;

or a pharmaceutically acceptable salt thereof.

13. The method according to claim 12 further comprising:

administering to the patient a therapeutically effective amount of one or more other anti-emetic compounds.

14. The method according to claim 13 , wherein the one or more other anti-emetic compounds are selected from the group consisting of dexamethasone, alosetron, alprazolam, aprepitant, dimenhydrinate, diphenhydramine, dolasetron, tetrahydrocannabinol, nabilone, dronabinol, droperidol, granisetron, haloperidol, lorazepam, metoclopramide, midazolam, olanzapine, ondansetron, palonosetron, proclorperazine, promethazine, tropisetron, and combinations thereof.

Assignments (9)
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Dec 3, 2025
From: CURIA GLOBAL, INC.
To: CURIA BUFFALO R&D, LLC
Reel/Frame 073096/0462 →
ASSIGNMENT OF SECURITY INTEREST IN INTELLECTUAL PROPERTY, RECORDED ON SEPTEMBER 1, 2017, AT REEL/FRAME 043746/0621 Recorded Mar 17, 2025
From: BARCLAYS BANK PLC, AS EXISTING AGENT
To: APOLLO ADMINISTRATIVE AGENCY LLC, AS SUCCESSOR AGENT
Reel/Frame 070531/0279 →
RELEASE OF SECURITY INTEREST Recorded Oct 29, 2020
From: MORGAN STANLEY SENIOR FUNDING, INC., AS COLLATERAL AGENT
To: ALBANY MOLECULAR RESEARCH, INC.; AMRI BURLINGTON, INC.; CEDARBURG PHARMACEUTICALS, INC.; EUTICALS INC.; OSO BIOPHARMACEUTICALS MANUFACTURING, LLC
Reel/Frame 054252/0687 →
CORRECTIVE ASSIGNMENT TO CORRECT THE INCORRECT PATENT NO. 7541537 PREVIOUSLY RECORDED AT REEL: 034045 FRAME: 0951. ASSIGNOR(S) HEREBY CONFIRMS THE SECURITY INTEREST. Recorded Aug 14, 2018
From: ALBANY MOLECULAR RESEARCH, INC.; ALO ACQUISITION LLC; AMRI BURLINGTON, INC.; AMRI RENSSELAER, INC.; CEDARBURG PHARMACEUTICALS, INC.; OSO BIOPHARMACEUTICALS MANUFACTURING, LLC
To: BARCLAYS BANK PLC, AS THE COLLATERAL AGENT
Reel/Frame 046796/0352 →
SECOND LIEN SECURITY AGREEMENT Recorded Sep 1, 2017
From: ALBANY MOLECULAR RESEARCH, INC.; AMRI BURLINGTON, INC.; CEDARBURG PHARMACEUTICALS, INC.; EUTICALS INC.; OSO BIOPHARMACEUTICALS MANUFACTURING LLC-BY ITS SOLE MEMBER:ALO ACQUISITION LLC
To: MORGAN STANLEY SENIOR FUNDING, INC.
Reel/Frame 043746/0657 →
FIRST LIEN SECURITY AGREEMENT Recorded Sep 1, 2017
From: ALBANY MOLECULAR RESEARCH, INC.; AMRI BURLINGTON, INC.; CEDARBURG PHARMACEUTICALS, INC.; EUTICALS INC.; OSO BIOPHARMACEUTICALS MANUFACTURING, LLC-BY ITS SOLE MEMBER: ALO ACQUISITION LLC
To: BARCLAYS BANK, PLC AS COLLATERAL AGENT
Reel/Frame 043746/0621 →
RELEASE OF SECURITY INTEREST Recorded Aug 31, 2017
From: BARCLAYS BANK PLC, AS COLLATERAL AGENT
To: ALBANY MOLECULAR RESEARCH, INC.; ALO ACQUISITION LLC; AMRI BURLINGTON, INC.; AMRI RENSSELAER, INC.; CEDARBURG PHARMACEUTICALS, INC.; OSO BIOPHARMACEUTICALS MANUFACTURING, LLC; AMRI SSCI, LLC; EUTICALS INC.
Reel/Frame 043742/0085 →
SECURITY INTEREST Recorded Aug 5, 2015
From: ALBANY MOLECULAR RESEARCH, INC.; AMRI SSCI, LLC
To: BARCLAYS BANK PLC, AS THE COLLATERAL AGENT
Reel/Frame 036257/0914 →
SECURITY INTEREST Recorded Oct 24, 2014
From: ALBANY MOLECULAR RESEARCH, INC.; ALO ACQUISITION LLC; AMRI BURLINGTON, INC.; AMRI RENSSELAER, INC.; CEDARBURG PHARMACEUTICALS, INC.; OSO BIOPHARMACEUTICALS MANUFACTURING, LLC
To: BARCLAYS BANK PLC, AS THE COLLATERAL AGENT
Reel/Frame 034045/0951 →