IP Library › Granted Patent US 12,497,404
Granted Patent B2
US 12,497,404 · App. 19/182,977 · Granted Dec 16, 2025

Morphic forms of trilaciclib and methods of manufacture thereof

Inventors: Stephen Schneider (Raleigh, NC); Alexander Smith (Apex, NC); Hannah S. White (Chapel Hill, NC); Jay Copeland Strum (Hillsborough, NC); Jaroslaw Mazurek (Amsterdam, NL)
Assignee: Pharmacosmos Holding A/S
C07D487/20A61K9/0019A61K9/08A61K9/19A61K47/02A61K47/12A61K47/26C07B2200/13
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Quick Facts
Patent No.
US 12,497,404
App. No.
19/182,977
Granted
Dec 16, 2025
Kind
B2
Abstract

An advantageous isolated morphic form of trilaciclib which is 2′-((5-(4-methylpiperazin-1-yl)pyridin-2-yl)amino)-7′,8′-dihydro-6′H-spiro[cyclohexane-1,9′-pyrazino[1′,2′:1,5]pyrrolo[2,3-d]pyrimidin]-6′-one, for example in the form of a dihydrochloride salt or a dihydrochloride, dihydrate.

Claims (12)

1 . A crystalline compound of structure:

which is a dihydrochloride characterized by an X-ray powder diffraction (XRPD) pattern comprising at least three 2theta values selected from 8.1±0.2°, 14.8±0.2°, 16.5±0.2°, 18.1±0.2°, 19.7±0.2°, 24.8±0.2°, and 27.7±0.2°.

2 . The crystalline compound of claim 1 , wherein the XRPD pattern comprises at least the 2theta value of 8.1±0.2°.

3 . The crystalline compound of claim 1 , wherein the XRPD pattern comprises at least the 2theta value of 16.5±0.2°.

4 . The crystalline compound of claim 1 , wherein the XRPD pattern comprises at least the 2theta value of 24.8±0.2°.

5 . The crystalline compound of claim 1 , wherein the XRPD pattern comprises at least four 2theta values selected from 8.1±0.2°, 14.8±0.2°, 16.5±0.2°, 18.1±0.2°, 19.7±0.2°, 24.8±0.2°, and 27.7±0.2°.

6 . The crystalline compound of claim 1 , wherein the XRPD pattern comprises at least five 2theta values selected from 8.1±0.2°, 14.8±0.2°, 16.5±0.2°, 18.1±0.2°, 19.7±0.2°, 24.8±0.2°, and 27.7±0.2°.

7 . The crystalline compound of claim 6 , wherein the XRPD pattern comprises at least the 2theta value of 8.1±0.2°.

8 . The crystalline compound of claim 6 , wherein the XRPD pattern comprises at least the 2theta value of 16.5±0.2°.

9 . The crystalline compound of claim 6 , wherein the XRPD pattern comprises at least the 2theta value of 24.8±0.2°.

10 . The crystalline compound of claim 1 , wherein the XRPD pattern comprises at least six 2theta values selected from 8.1±0.2°, 14.8±0.2°, 16.5±0.2°, 18.1±0.2°, 19.7±0.2°, 24.8±0.2°, and 27.7±0.2°.

11 . The crystalline compound of claim 1 , wherein the XRPD pattern comprises the 2theta values 8.1±0.2°, 14.8±0.2°, 16.5±0.2°, 18.1±0.2°, 19.7±0.2°, 24.8±0.2°, and 27.7±0.2°.

Assignments (2)
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Apr 23, 2025
From: PHARMACOSMOS THERAPEUTICS, INC.
To: PHARMACOSMOS A/S
Reel/Frame 071018/0421 →
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Apr 23, 2025
From: PHARMACOSMOS A/S
To: PHARMACOSMOS HOLDING A/S
Reel/Frame 071018/0502 →
Continuity (5)
Continuation 18973646 · Dec 9, 2024
Continuation 17236687 · Apr 21, 2021
Continuation 17097854 · Nov 13, 2020
Provisional Application 63039372 · Jun 15, 2020
Related Publication 20250243213A1 · Jul 31, 2025
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