IP Library Granted Patent US 11,926,592
Granted Patent B2
US 11,926,592 · App. 17/929,645 · Granted Mar 12, 2024

Salts and crystal forms of omecamtiv mecarbil

Inventors: Henry Morrison (Thousand Oaks, CA); Sheng Cui (Thousand Oaks, CA); Kyle Quasdorf (Thousand Oaks, CA); Evelyn Yanez (Thousand Oaks, CA); Bin Peter Quan (Thousand Oaks, CA); Ron C. Kelly (Thousand Oaks, CA); Sebastien Caille (Thousand Oaks, CA); Lingyun Xiao (Thousand Oaks, CA); David Pearson (Berwichshire, GB); Jaclyn Raeburn (Milton, CA); Alisa Golightly (Tranent, GB)
Assignee: Amgen Inc.
C07D213/75C07B2200/13
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Quick Facts
Patent No.
US 11,926,592
App. No.
17/929,645
Granted
Mar 12, 2024
Kind
B2
Abstract

Provided herein are free base crystalline forms, crystalline salts, and an amorphous salts of omecamtiv mecarbil.

Claims (25)

1. An omecamtiv mecarbil fumarate crystalline salt form which is any one of the following forms:

i) an omecamtiv mecarbil bis-fumarate crystalline salt form A, characterized by an X-ray powder diffraction (XRPD) pattern comprising peaks at 5.64, 15.76, 22.03, and 23.87±0.2° 2θ using Cu Kα radiation;

ii) an omecamtiv mecarbil bis-fumarate crystalline salt form B, characterized by an X-ray powder diffraction (XRPD) pattern comprising peaks at 5.68, 6.11, 13.13, 18.08, and 22.47±0.2° 2θ using Cu Kα radiation;

iii) an omecamtiv mecarbil bis-fumarate crystalline salt form C, characterized by an X-ray powder diffraction (XRPD) pattern comprising peaks at 5.88, 18.79, 25.41, and 26.86±0.2° 2θ using Cu Kα radiation; or

iv) an omecamtiv mecarbil mono-fumarate crystalline salt form D, characterized by an X-ray powder diffraction (XRPD) pattern comprising peaks at 8.01, 15.20, and 20.02±0.2° 2θ using Cu Kα radiation.

2. The omecamtiv mecarbil fumarate crystalline salt form of claim 1 , wherein the crystalline salt form is omecamtiv mecarbil bis-fumarate crystalline salt form A, characterized by an X-ray powder diffraction (XRPD) pattern comprising peaks at 5.64, 15.76, 22.03, and 23.87±0.2° 2θ using Cu Kα radiation.

3. The omecamtiv mecarbil bis-fumarate crystalline salt form A of claim 2 , further characterized by XRPD pattern peaks at 16.80, 21.55, 21.87, 23.61, 23.87, 26.01, and 27.20±0.2° 2θ using Cu Kα radiation.

4. The omecamtiv mecarbil bis-fumarate crystalline salt form A of claim 2 , further characterized by XRPD pattern peaks at 10.80, 12.04, 15.76, 16.40, 17.94, 18.32, 19.87, 20.61, 22.88, 27.86, 32.73, and 36.54±0.2° 2θ using Cu Kα radiation.

5. The omecamtiv mecarbil bis-fumarate crystalline salt form A of claim 2 , having an XRPD pattern substantially as shown in FIG. 20 .

6. The omecamtiv mecarbil bis-fumarate crystalline salt form A of claim 2 , having a thermogravimetric analysis (TGA) as shown in FIG. 21 .

7. The omecamtiv mecarbil fumarate crystalline salt form of claim 1 , wherein the crystalline salt form is omecamtiv mecarbil bis-fumarate crystalline salt form B, characterized by an X-ray powder diffraction (XRPD) pattern comprising peaks at 5.68, 6.11, 13.13, 18.08, and 22.47±0.2° 2θ using Cu Kα radiation.

8. The omecamtiv mecarbil bis-fumarate crystalline salt form B of claim 7 , further characterized by XRPD pattern peaks at 9.69, 11.43, 12.92, 15.95, 20.81, 22.95, 26.04, 27.01, and 28.43±0.2° 2θ using Cu Kα radiation.

9. The omecamtiv mecarbil bis-fumarate crystalline salt form B of claim 7 , further characterized by XRPD pattern peaks at 19.52, 24.53, 31.37, 32.32, 34.89, 35.89, and 37.16±0.2° 2θ using Cu Kα radiation.

10. The omecamtiv mecarbil bis-fumarate crystalline salt form B of claim 7 , having an XRPD pattern substantially as shown in FIG. 22 .

11. The omecamtiv mecarbil bis-fumarate crystalline salt form B of claim 7 , having a thermogravimetric analysis (TGA) as shown in FIG. 23 .

12. The omecamtiv mecarbil fumarate crystalline salt form of claim 1 , wherein the crystalline salt form is omecamtiv mecarbil bis-fumarate crystalline salt form C, characterized by an X-ray powder diffraction (XRPD) pattern comprising peaks at 5.88, 18.79, 25.41, and 26.86±0.2° 2θ using Cu Kα radiation.

13. The omecamtiv mecarbil bis-fumarate crystalline salt form C of claim 12 , further characterized by XRPD pattern peaks at 12.74, 13.56, 17.15, 17.63, 20.29, 21.47, 21.77, 22.21, 22.92, 23.58, 24.15, 25.41, 26.78, and 27.83±0.2° 2θ using Cu Kα radiation.

14. The omecamtiv mecarbil bis-fumarate crystalline salt form C of claim 12 , having an XRPD pattern substantially as shown in FIG. 24 .

15. The omecamtiv mecarbil bis-fumarate crystalline salt form C of claim 12 , having a thermogravimetric analysis (TGA) as shown in FIG. 25 .

16. The omecamtiv mecarbil fumarate crystalline salt form of claim 1 , wherein the crystalline salt form is omecamtiv mecarbil mono-fumarate crystalline salt form D, characterized by an X-ray powder diffraction (XRPD) pattern comprising peaks at 8.01, 15.20, and 20.02±0.2° 2θ using Cu Kα radiation.

17. The omecamtiv mecarbil mono-fumarate crystalline salt form D of claim 16 , further characterized by XRPD pattern peaks at 12.11, 12.67, 14.46, 16.01, 16.57, 17.04, 17.63, 20.51, 21.75, 22.86, 24.25, 24.97, 25.84, 26.17, 27.10, 27.97, and 29.21±0.2° 2θ using Cu Kα radiation.

18. The omecamtiv mecarbil mono-fumarate crystalline salt form D of claim 16 , having an XRPD pattern substantially as shown in FIG. 26 .

19. The omecamtiv mecarbil mono-fumarate crystalline salt form D of claim 16 , having an endothermic transition at 110° C. to 130° C., as measured by differential scanning calorimetry.

20. The omecamtiv mecarbil mono-fumarate crystalline salt form D of claim 16 , wherein the endothermic transition is at 125° C.±3° C.

21. The omecamtiv mecarbil mono-fumarate crystalline salt form D of claim 16 , having a thermogravimetric analysis (TGA) as shown in FIG. 28 .

Assignments (7)
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Nov 21, 2023
From: MORGAN, BRADLEY; PETERSON, MATTHEW
To: CYTOKINETICS, INC.
Reel/Frame 065638/0379 →
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Nov 21, 2023
From: EBERLIN, ALEX; OBLEZOV, ALEXANDER
To: JOHNSON MATTHEY PLC
Reel/Frame 065638/0488 →
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Nov 21, 2023
From: PEARSON, DAVID; RAEBURN, JACLYN; GOLIGHTLY, ALISA
To: SOLID FORM SOLUTIONS LTD
Reel/Frame 065638/0535 →
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Nov 21, 2023
From: JOHNSON MATTHEY PLC
To: MACFARLAN SMITH LIMITED
Reel/Frame 065638/0578 →
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Nov 21, 2023
From: MACFARLAN SMITH LIMITED
To: CYTOKINETICS, INC.
Reel/Frame 065638/0609 →
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Nov 21, 2023
From: SOLID FORM SOLUTIONS LTD
To: AMGEN INC.
Reel/Frame 065638/0749 →
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Nov 21, 2023
From: MORRISON, HENRY; CUI, SHENG; QUASDORF, KYLE; YANEZ, EVELYN; QUAN, BIN PETER; KELLY, RON C.; CAILLE, SEBASTIEN; XIAO, LINGYUN
To: AMGEN INC.
Reel/Frame 065659/0090 →
Continuity (3)
Division 17263224
Provisional Application 62765090 · Aug 17, 2018
Related Publication 20230108971A1 · Apr 6, 2023
Cited By (7)
US 12,221,417 US 12,264,133 US 12,269,811 US 12,275,704 US 12,442,027 US 12,583,821 US 12,612,366