IP Library Granted Patent US 10,745,428
Granted Patent B2
US 10,745,428 · App. 15/781,985 · Granted Aug 18, 2020

Antiviral phosphodiamide prodrugs of tenofovir

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Quick Facts
Patent No.
US 10,745,428
App. No.
15/781,985
Granted
Aug 18, 2020
Kind
B2
Abstract

Compounds of Formula I and pharmaceutically acceptable salts and co-crystals thereof are useful for the inhibition of HIV reverse transcriptase. The compounds may also be useful for the prophylaxis or treatment of infection by HIV and in the prophylaxis, delay in the onset or progression, and treatment of AIDS. The compounds and their salts can be employed as ingredients in pharmaceutical compositions, optionally in combination with other antiviral agents, immunomodulators, antibiotics or vaccines.

Claims (88)

1. A compound of structural Formula I:

or pharmaceutically acceptable salt thereof, wherein:

R A is a D-proline ester residue of formula (ii):

R 3 is

(a) —C 1-10 alkyl unsubstituted or substituted with one to three substituents independently selected from fluoro, chloro, bromo, —OR 7 , —SH, —NR 8 R 9 , —C 3-6 cycloalkyl or spiro—C 3-6 cycloalkyl,

(b) —CH 2 -phenyl unsubstituted or substituted with one to three substituents independently selected from fluoro, chloro, bromo, —OR 10 , —SH, —NR 8 R 9 or —C 1-3 alkyl,

(c) —C 3-8 cycloalkyl unsubstituted or substituted with one to three substituents independently selected from fluoro, chloro, bromo, —OR 10 , —SH, —NR 8 R 9 or —C 1-3 alkyl,

(d) aryl unsubstituted or substituted with one to three substituents independently selected from fluoro, chloro, bromo, —OR 10 , —SH, —NR 8 R 9 or —C 1-3 alkyl,

(e) —C 1-5 alkyl-X—C 1-5 alkyl wherein X is O, S or NH,

(f) heteroaryl unsubstituted or substituted with one to three substituents independently selected from fluoro, chloro, bromo, —OR 10 , —SH, —NR 8 R 9 or —C 1-3 alkyl, or

(g) a heterocyclic ring unsubstituted or substituted with one to three substituents independently selected from fluoro, chloro, bromo, —OR 10 , —SH, —NR 8 R 9 or —C 1-3 alkyl;

R B is a geminally di-substituted amino acid ester residue of formula (iii):

R 4 and R 5 are each independently selected from (a) —C 1-4 alkyl, (b) —C 1-4 alkyl substituted with —OH, —SH, —SCH 3 , —NH 2 , —NH—C(═NH)—NH 2 , (c) —CH 2 -phenyl, (d) —CH 2 -phenol, (e) —(CH 2 ) 1-2 —COOH, (f) —(CH 2 ) 1-2 —CONH 2 , (g) —CH 2 -1H-indole, (h) —CH 2 -imidazole, (i) aryl, or (j) heteroaryl;

or R 4 and R 5 are joined together with the carbon to which they are both attached to form —C 3-6 cycloalkyl or a 4 to 6-membered heterocyclic ring;

R 6 is

(a) —C 1-10 alkyl unsubstituted or substituted with one to three substituents independently selected from fluoro, chloro, bromo, —OR 11 , —SH, —NR 12 R 13 , —C 3-6 cycloalkyl or spiro-C 3-6 cycloalkyl,

(b) —CH 2 -phenyl unsubstituted or substituted with one to three substituents independently selected from fluoro, chloro, bromo, —OR 14 , —SH, —NR 12 R 13 , —C 1-3 alkyl,

(c) —C 3-8 cycloalkyl unsubstituted or substituted with one to three substituents independently selected from fluoro, chloro, bromo, —OR 14 , —SH, —NR 12 R 13 or —C 1-3 alkyl,

(d) aryl unsubstituted or substituted with one to three substituents independently selected from fluoro, chloro, bromo, —OR 14 , —SH, —NR 12 R 13 or —C 1-3 alkyl,

(e) —C 1-5 alkyl-X—C 1-5 alkyl wherein X is O, S or NH;

(f) heteroaryl unsubstituted or substituted with one to three substituents independently selected from fluoro, chloro, bromo, —OR 14 , —SH, —NR 12 R 13 or —C 1-3 alkyl, or

(g) a heterocyclic ring unsubstituted or substituted with one to three substituents independently selected from fluoro, chloro, bromo, —OR 14 , —SH, —NR 12 R 13 or —C 1-3 alkyl;

R 7 and R 11 are each independently selected from —H or —C 3-6 cycloalkyl;

R 8 and R 9 are each independently selected from —H, —C 1-3 alkyl or —C 3-6 cycloalkyl;

R 12 and R 13 are each independently selected from —H, —C 1-3 alkyl or —C 3-6 cycloalkyl; and

R 10 and R 14 are each independently selected from —H, —C 1-3 alkyl or —C 3-6 cycloalkyl.

2. A compound which is selected from the following:

or a pharmaceutically acceptable salt thereof.

3. A compound which is selected from the following:

isopropyl2-(((S)-((((R)-1-(6-amino-9H-purin-9-yl)propan-2-yl)oxy)methyl)(((R)-1-(cyclopentyloxy)-1-oxopropan-2-yl)amino)phosphoryl)amino)-2-methylpropanoate;

isopropyl2-(((R)-((((R)-1-(6-amino-9H-purin-9-yl)propan-2-yl)oxy)methyl)(((R)-1-(cyclopentyloxy)-1-oxopropan-2-yl)amino)phosphoryl)amino)-2-methylpropanoate;

hexyl 2-(((S)-((((R)-1-(6-amino-9H-purin-9-yl)propan-2-yl)oxy)methyl)(((R)-1-isopropoxy-1-oxopropan-2-yl)amino)phosphoryl)amino)-2-methylpropanoate;

hexyl 2-(((R)-((((R)-1-(6-amino-9H-purin-9-yl)propan-2-yl)oxy)methyl)(((R)-1-isopropoxy-1-oxopropan-2-yl)amino)phosphoryl)amino)-2-methylpropanoate;

isopropyl 2-(((S)-((((R)-1-(6-amino-9H-purin-9-yl)propan-2-yl)oxy)methyl)(((R)-1-butoxy-1-oxopropan-2-yl)amino)phosphoryl)amino)-2-methylpropanoate;

isopropyl 2-(((R)-((((R)-1-(6-amino-9H-purin-9-yl)propan-2-yl)oxy)methyl)(((R)-1-butoxy-1-oxopropan-2-yl)amino)phosphoryl)amino)-2-methylpropanoate;

isopropyl 2-(((S)-((((R)-1-(6-amino-9H-purin-9-yl)propan-2-yl)oxy)methyl)(((R)-1-isopropoxy-1-oxopropan-2-yl)amino)phosphoryl)amino)-2-methylpropanoate;

isopropyl 2-(((R)-((((R)-1-(6-amino-9H-purin-9-yl)propan-2-yl)oxy)methyl)(((R)-1-isopropoxy-1-oxopropan-2-yl)amino)phosphoryl)amino)-2-methylpropanoate;

isopropyl 2-(((S)-((((R)-1-(6-amino-9H-purin-9-yl)propan-2-yl)oxy)methyl)(((R)-1-isobutoxy-1-oxopropan-2-yl)amino)phosphoryl)amino)-2-methylpropanoate;

isopropyl 2-(((R)-((((R)-1-(6-amino-9H-purin-9-yl)propan-2-yl)oxy)methyl)(((R)-1-isobutoxy-1-oxopropan-2-yl)amino)phosphoryl)amino)-2-methylpropanoate;

isopropyl 2-(((S)-((((R)-1-(6-amino-9H-purin-9-yl)propan-2-yl)oxy)methyl)(((R)-1-(cyclohexyloxy)-1-oxopropan-2-yl)amino)phosphoryl)amino)-2-methylpropanoate;

isopropyl 2-(((R)-((((R)-1-(6-amino-9H-purin-9-yl)propan-2-yl)oxy)methyl)(((R)-1-(cyclohexyloxy)-1-oxopropan-2-yl)amino)phosphoryl)amino)-2-methylpropanoate;

isopropyl 2-(((S)-((((R)-1-(6-amino-9H-purin-9-yl)propan-2-yl)oxy)methyl)(((R)-1-(hexyloxy)-1-oxopropan-2-yl)amino)phosphoryl)amino)-2-methylpropanoate;

isopropyl 2-(((R)-((((R)-1-(6-amino-9H-purin-9-yl)propan-2-yl)oxy)methyl)(((R)-1-(hexyloxy)-1-oxopropan-2-yl)amino)phosphoryl)amino)-2-methylpropanoate;

isopropyl 2-(((S)-((((R)-1-(6-amino-9H-purin-9-yl)propan-2-yl)oxy)methyl)(((R)-1-oxo-1-(pentyloxy)propan-2-yl)amino)phosphoryl)amino)-2-methylpropanoate;

isopropyl 2-(((R)-((((R)-1-(6-amino-9H-purin-9-yl)propan-2-yl)oxy)methyl)(((R)-1-oxo-1-(pentyloxy)propan-2-yl)amino)phosphoryl)amino)-2-methylpropanoate;

pentyl 2-(((S)-((((R)-1-(6-amino-9H-purin-9-yl)propan-2-yl)oxy)methyl)(((R)-1-butoxy-1-oxopropan-2-yl)amino)phosphoryl)amino)-2-methylpropanoate;

pentyl 2-(((R)-((((R)-1-(6-amino-9H-purin-9-yl)propan-2-yl)oxy)methyl)(((R)-1-butoxy-1-oxopropan-2-yl)amino)phosphoryl)amino)-2-methylpropanoate;

hexyl 2-(((S)-((((R)-1-(6-amino-9H-purin-9-yl)propan-2-yl)oxy)methyl)(((R)-1-isobutoxy-1-oxopropan-2-yl)amino)phosphoryl)amino)-2-methylpropanoate;

hexyl 2-(((R)-((((R)-1-(6-amino-9H-purin-9-yl)propan-2-yl)oxy)methyl)(((R)-1-isobutoxy-1-oxopropan-2-yl)amino)phosphoryl)amino)-2-methylpropanoate;

hexyl 2-(((S)-((((R)-1-(6-amino-9H-purin-9-yl)propan-2-yl)oxy)methyl)(((R)-1-butoxy-1-oxopropan-2-yl)amino)phosphoryl)amino)-2-methylpropanoate;

hexyl 2-(((R)-((((R)-1-(6-amino-9H-purin-9-yl)propan-2-yl)oxy)methyl)(((R)-1-butoxy-1-oxopropan-2-yl)amino)phosphoryl)amino)-2-methylpropanoate;

hexyl 2-(((S)-((((R)-1-(6-amino-9H-purin-9-yl)propan-2-yl)oxy)methyl)(((R)-1-oxo-1-(pentyloxy)propan-2-yl)amino)phosphoryl)amino)-2-methylpropanoate;

hexyl 2-(((R)-((((R)-1-(6-amino-9H-purin-9-yl)propan-2-yl)oxy)methyl)(((R)-1-oxo-1-(pentyloxy)propan-2-yl)amino)phosphoryl)amino)-2-methylpropanoate;

hexyl 2-(((S)-((((R)-1-(6-amino-9H-purin-9-yl)propan-2-yl)oxy)methyl)(((R)-1-(hexyloxy)-1-oxopropan-2-yl)amino)phosphoryl)amino)-2-methylpropanoate;

hexyl 2-(((R)-((((R)-1-(6-amino-9H-purin-9-yl)propan-2-yl)oxy)methyl)(((R)-1-(hexyloxy)-1-oxopropan-2-yl)amino)phosphoryl)amino)-2-methylpropanoate;

hexyl 2-(((S)-((((R)-1-(6-amino-9H-purin-9-yl)propan-2-yl)oxy)methyl)(((R)-1-(cyclopentyloxy)-1-oxopropan-2-yl)amino)phosphoryl)amino)-2-methylpropanoate;

hexyl 2-(((R)-((((R)-1-(6-amino-9H-purin-9-yl)propan-2-yl)oxy)methyl)(((R)-1-(cyclopentyloxy)-1-oxopropan-2-yl)amino)phosphoryl)amino)-2-methylpropanoate;

hexyl 2-(((S)-((((R)-1-(6-amino-9H-purin-9-yl)propan-2-yl)oxy)methyl)(((R)-1-(cyclohexyloxy)-1-oxopropan-2-yl)amino)phosphoryl)amino)-2-methylpropanoate;

hexyl 2-(((R)-((((R)-1-(6-amino-9H-purin-9-yl)propan-2-yl)oxy)methyl)(((R)-1-(cyclohexyloxy)-1-oxopropan-2-yl)amino)phosphoryl)amino)-2-methylpropanoate;

pentyl 2-(((S)-((((R)-1-(6-amino-9H-purin-9-yl)propan-2-yl)oxy)methyl)(((R)-1-oxo-1-(pentyloxy)propan-2-yl)amino)phosphoryl)amino)-2-methylpropanoate;

pentyl 2-(((R)-((((R)-1-(6-amino-9H-purin-9-yl)propan-2-yl)oxy)methyl)(((R)-1-oxo-1-(pentyloxy)propan-2-yl)amino)phosphoryl)amino)-2-methylpropanoate;

pentyl 2-(((S)-((((R)-1-(6-amino-9H-purin-9-yl)propan-2-yl)oxy)methyl)(((R)-1-isopropoxy-1-oxopropan-2-yl)amino)phosphoryl)amino)-2-methylpropanoate;

pentyl 2-(((R)-((((R)-1-(6-amino-9H-purin-9-yl)propan-2-yl)oxy)methyl)(((R)-1-isopropoxy-1-oxopropan-2-yl)amino)phosphoryl)amino)-2-methylpropanoate;

isopropyl 2-((S)-((((R)-1-(6-amino-9H-purin-9-yl)propan-2-yl)oxy)methyl)(((R)-1-cyclobutoxy-1-oxopropan-2-yl)amino)phosphoryl)amino)-2-methylpropanoate;

isopropyl 2-(((R)-((((R)-1-(6-amino-9H-purin-9-yl)propan-2-yl)oxy)methyl)(((R)-1-cyclobutoxy-1-oxopropan-2-yl)amino)phosphoryl)amino)-2-methylpropanoate;

pentyl 2-(((S)-((((R)-1-(6-amino-9H-purin-9-yl)propan-2-yl)oxy)methyl)(((R)-1-cyclobutoxy-1-oxopropan-2-yl)amino)phosphoryl)amino)-2-methylpropanoate;

pentyl 2-(((R)-((((R)-1-(6-amino-9H-purin-9-yl)propan-2-yl)oxy)methyl)(((R)-1-cyclobutoxy-1-oxopropan-2-yl)amino)phosphoryl)amino)-2-methylpropanoate;

isobutyl 2-(((S)-((((R)-1-(6-amino-9H-purin-9-yl)propan-2-yl)oxy)methyl)(((R)-1-cyclobutoxy-1-oxopropan-2-yl)amino)phosphoryl)amino)-2-methylpropanoate;

isobutyl 2-(((R)-((((R)-1-(6-amino-9H-purin-9-yl)propan-2-yl)oxy)methyl)(((R)-1-cyclobutoxy-1-oxopropan-2-yl)amino)phosphoryl)amino)-2-methylpropanoate;

hexyl 2-(((S)-((((R)-1-(6-amino-9H-purin-9-yl)propan-2-yl)oxy)methyl)(((R)-1-cyclobutoxy-1-oxopropan-2-yl)amino)phosphoryl)amino)-2-methylpropanoate;

hexyl 2-(((R)-((((R)-1-(6-amino-9H-purin-9-yl)propan-2-yl)oxy)methyl)(((R)-1-cyclobutoxy-1-oxopropan-2-yl)amino)phosphoryl)amino)-2-methylpropanoate;

propyl 2-(((S)-((((R)-1-(6-amino-9H-purin-9-yl)propan-2-yl)oxy)methyl)(((R)-1-cyclobutoxy-1-oxopropan-2-yl)amino)phosphoryl)amino)-2-methylpropanoate;

propyl 2-(((R)-((((R)-1-(6-amino-9H-purin-9-yl)propan-2-yl)oxy)methyl)(((R)-1-cyclobutoxy-1-oxopropan-2-yl)amino)phosphoryl)amino)-2-methylpropanoate;

butyl 2-(((S)-((((R)-1-(6-amino-9H-purin-9-yl)propan-2-yl)oxy)methyl)(((R)-1-cyclobutoxy-1-oxopropan-2-yl)amino)phosphoryl)amino)-2-methylpropanoate;

butyl 2-(((R)-((((R)-1-(6-amino-9H-purin-9-yl)propan-2-yl)oxy)methyl)(((R)-1-cyclobutoxy-1-oxopropan-2-yl)amino)phosphoryl)amino)-2-methylpropanoate;

pentyl 2-(((S)-((((R)-1-(6-amino-9H-purin-9-yl)propan-2-yl)oxy)methyl)(((R)-1-(cyclopentyloxy)-1-oxopropan-2-yl)amino)phosphoryl)amino)-2-methylpropanoate;

pentyl 2-(((R)-((((R)-1-(6-amino-9H-purin-9-yl)propan-2-yl)oxy)methyl)(((R)-1-(cyclopentyloxy)-1-oxopropan-2-yl)amino)phosphoryl)amino)-2-methylpropanoate;

pentyl 2-(((S)-((((R)-1-(6-amino-9H-purin-9-yl)propan-2-yl)oxy)methyl)(methyl ((R)-1-oxo-1-(pentyloxy)propan-2-yl)amino)phosphoryl)amino)-2-methylpropanoate;

pentyl 2-(((R)-((((R)-1-(6-amino-9H-purin-9-yl)propan-2-yl)oxy)methyl)(methyl((R)-1-oxo-1-(pentyloxy)propan-2-yl)amino)phosphoryl)amino)-2-methylpropanoate;

pentyl (((S)-(((R)-1-(6-amino-9H-purin-9-yl)propan-2-yl)oxy)methyl)((2-methyl-1-oxo-1-(pentyloxy)propan-2-yl)amino)phosphoryl)-D-prolinate;

pentyl (((R)-(((R)-1-(6-amino-9H-purin-9-yl)propan-2-yl)oxy)methyl)((2-methyl-1-oxo-1-(pentyloxy)propan-2-yl)amino)phosphoryl)-D-prolinate;

cyclohexyl 2-(((S)-((((R)-1-(6-amino-9H-purin-9-yl)propan-2-yl)oxy)methyl)(((R)-1-(cyclopentyloxy)-1-oxopropan-2-yl)amino)phosphoryl)amino)-2-methylpropanoate;

cyclohexyl 2-(((R)-((((R)-1-(6-amino-9H-purin-9-yl)propan-2-yl)oxy)methyl)(((R)-1-(cyclopentyloxy)-1-oxopropan-2-yl)amino)phosphoryl)amino)-2-methylpropanoate;

cyclobutyl 2-(((S)-((((R)-1-(6-amino-9H-purin-9-yl)propan-2-yl)oxy)methyl)(((R)-1-(cyclopentyloxy)-1-oxopropan-2-yl)amino)phosphoryl)amino)-2-methylpropanoate;

cyclobutyl 2-(((R)-((((R)-1-(6-amino-9H-purin-9-yl)propan-2-yl)oxy)methyl)(((R)-1-(cyclopentyloxy)-1-oxopropan-2-yl)amino)phosphoryl)amino)-2-methylpropanoate;

a pharmaceutically acceptable salt thereof.

4. The compound of claim 2 which is

or a pharmaceutically acceptable salt thereof.

Assignments (3)
MERGER Recorded Aug 8, 2022
From: MERCK SHARP & DOHME CORP.
To: MERCK SHARP & DOHME LLC
Reel/Frame 061102/0145 →
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Jun 6, 2018
From: RAHEEM, IZZAT TIEDJE; HARTINGH, TIMOTHY J.; SCHREIER, JOHN
To: MERCK SHARP & DOHME CORP.
Reel/Frame 046005/0612 →
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Jun 6, 2018
From: PAPARIN, JEAN-LAURENT
To: IDENIX PHARMACEUTICALS LLC
Reel/Frame 046005/0688 →