IP Library › Granted Patent US 12,655,100
Granted Patent B2
US 12,655,100 · App. 18/557,255 · Granted Jun 16, 2026

Method for producing pyrrolidine compound

Inventors: Masatoshi Yamada (Osaka, JP); Sayuri Hirano (Osaka, JP); Osamu Yabe (Osaka, JP); Yuichi Kajita (Osaka, JP); Tsuneo Oda (Kanagawa, JP); Takashi Abe (Kanagawa, JP); Hironori Yamashita (Kanagawa, JP)
Assignee: Takeda Pharmaceutical Limited Company
C07D207/14
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Quick Facts
Patent No.
US 12,655,100
App. No.
18/557,255
Granted
Jun 16, 2026
Kind
B2
Abstract

The present invention provides a method suitable for industrial production of a compound of formula (V): (V) comprising a step of subjecting a compound (IV) to an asymmetric reductive amination reaction in the presence of a metal complex comprising a chiral ligand and subjecting this product to purification using salt formation with N-(4-methylbenzene-1-sulfonyl)-L-phenylalanine. (IV)

Claims (51)

1 . A method for producing a salt of formula (V)

wherein

each R 1 is independently selected from a halogen atom and a trifluoromethanesulfonyl group;

A is an optionally further substituted 4-7 membered N-containing monocyclic saturated heterocyclyl; and

PG is a protecting group,

the process comprising subjecting a compound of formula (IV):

to an asymmetric reductive amination reaction in the presence of a metal complex comprising a chiral ligand and subjecting the resulting product to purification using salt formation with N-(4-methylbenzene-1-sulfonyl)-L-phenylalanine.

2 . The method of claim 1 , further comprising:

(a) reacting a compound of formula (II):

wherein

R 1 is independently selected from a halogen atom and a trifluoromethanesulfonyl group; and

X is a halogen atom,

with an anion of a compound of formula (III):

wherein

PG is a protecting group; and

A is an optionally further substituted 4-7 membered N-containing monocyclic saturated heterocycle;

(b) deprotecting the product of step (a);

(c) reacting the product of step (b) with a racemate of an organic acid; and

(d) introducing a protecting group to the product of step (c);

to provide the compound of formula (IV).

3 . The method of claim 1 , wherein A is selected from pyrrolidine, piperidine, and azetidine, each of which is optionally further substituted.

4 . The method of claims 1 , wherein each R 1 is independently selected from Cl, Br, I, and a trifluoromethanesulfonyl group.

5 . The method of claim 2 , wherein the organic acid is racemic tartaric acid (DL-tartaric acid).

6 . A method for producing N-(4-methylbenzene-1-sulfonyl)-L-phenylalanine salt of (2S,3S)-2-[(3-bromo-2-fluorophenyl) methyl]pyrrolidin-3-amine with a protecting group at the 1-position on the pyrrolidine, which comprises

a step comprising

Step 3a: subjecting 2-[(3-bromo-2-fluorophenyl) methyl]pyrrolidin-3-one with a protecting group at the 1-position on the pyrrolidine to an asymmetric reductive amination reaction in the presence of a metal complex comprising a chiral ligand; and

Step 3b: subjecting the product of Step 3a to purification using salt formation with N-(4-methylbenzene-1-sulfonyl)-L-phenylalanine.

7 . The method of claim 6 , further comprising

Step 1a: reacting 1-bromo-3-(bromomethyl)-2-fluorobenzene and pyrrolidin-3-one with a protecting group at the 1-position on the pyrrolidine;

Step 1b: deprotecting the product of Step 1a and reacting with DL-tartaric acid; and

Step 2: introducing a protecting group to the product of Step 1b to provide 2-[(3-bromo-2-fluorophenyl) methyl] pyrrolidin-3-one with a protecting group at the 1-position on the pyrrolidine.

8 . The method according to claim 1 , wherein the chiral ligand in the metal complex is a BINAP ligand, a phosphine ligand, a ferrocene ligand, or a cyclophane ligand.

9 . The method according to claim 1 , wherein the metal in the metal complex is ruthenium, rhodium, or iridium.

10 . The method according to claim 1 , wherein the metal complex comprising a chiral ligand is a ruthenium complex comprising a chiral BINAP ligand, or a ruthenium complex comprising a chiral cyclophane ligand.

11 . The method according to claim 1 , wherein the metal complex comprising a chiral ligand is a metal complex represented by the formula:

wherein Ligand is (S)-binap, (R)-xylyl-Phanephos or (R)-xylyl-binap.

12 . The method according to claim 1 , wherein the metal complex comprising a chiral ligand is Ru(OAc) 2 {(R)-xylyl-binap}.

13 . The method according to claim 1 , wherein the protecting group is selected from tert-butoxycarbonyl, benzyloxycarbonyl, acetyl, trityl, benzyl, 9-fluorenylmethyloxycarbonyl, 2,2,2-trichloroethoxycarbonyl, and methoxymethyl.

14 . The method according to claim 1 , wherein the protecting group is tert-butoxycarbonyl.

15 . The method according to claim 1 , wherein the purification conditions comprises recrystallization.

16 . The method according to claim 15 , wherein the crystallization comprises a salt formation with N-(4-methylbenzene-1-sulfonyl)-L-phenylalanine, which is conducted in a solvent at a temperature from 60° C. to 78° C., stirring at a temperature from 60° C. to 78° C., for about 0.5 hours, stirring at 15° C. to 35° C. for about 12 to about 48 hours, and filtering the resulting precipitate.

17 . The method according to claim 16 , further comprising recrystallizing the precipitate from a solvent selected from an alcohol, ether, or aromatic hydrocarbon.

18 . The method according to claim 17 , wherein the solvent is ethanol.

19 . The method according to claim 6 , further comprising:

Step 4: subjecting the N-(4-methylbenzene-1-sulfonyl)-L-phenylalanine salt of (2S,3S)-2-[(3-bromo-2-fluorophenyl) methyl]pyrrolidin-3-amine with a protecting group at the 1-position on the pyrrolidine to desalination and reacting with a methanesulfonylating agent;

Step 5: reacting the product of Step 4 with (3,5-difluorophenyl) boronic acid;

Step 6: subjecting the product of Step 5 to deprotection conditions; and

Step 7: subjecting the product of Step 6 to a condensation reaction with 2-hydroxy-2-methylpropanoic acid to give N-{(2S,3S)-1-(2-hydroxy-2-methylpropanoyl)-2-[(2,3′,5′-trifluoro [1,1′-biphenyl]-3-yl)methyl]pyrrolidin-3-yl} methanesulfonamide, or a hydrate thereof, or a solvate thereof.

20 . A compound which is a racemic organic acid salt of

21 . The compound of claim 20 , which is a racemic tartaric acid salt.

22 . The compound of claim 20 , which is

Assignments (3)
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Jan 10, 2025
From: SPERA PHARMA, INC.
To: TAKEDA PHARMACEUTICAL COMPANY LIMITED
Reel/Frame 069822/0710 →
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Jan 10, 2025
From: HIRANO, SAYURI; YABE, OSAMU; YAMADA, MASATOSHI
To: SPERA PHARMA, INC
Reel/Frame 069872/0479 →
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Jan 10, 2025
From: KAJITA, YUICHI; ABE, TAKASHI; YAMASHITA, HIRONORI; ODA, TSUNEO
To: TAKEDA PHARMACEUTICAL COMPANY LIMITED
Reel/Frame 069872/0507 →
Priority Claims (1)
JP 2021-074435 · Apr 26, 2021 · national
Continuity (1)
Related Publication 20240228437A1 · Jul 11, 2024
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