Granted Patent
B2
US 12,194,039 · App. 17/454,592 · Granted Jan 14, 2025
Methods of treating heart failure by administering omecamtiv mecarbil
View Patent ↗
Loading inventors, assignments & file history…
Abstract
Provided herein are methods of treating heart failure in patients exhibiting one or more additional features, comprising administering to the patient a therapeutically effective amount of omecamtiv mecarbil, or a hydrate, salt, or salt of a hydrate thereof.
Claims (30)
1. A method of treating heart failure in a patient who has a left ventricular ejection fraction (LVEF) of less than or equal to 28% at baseline, comprising administering to the patient a therapeutically effective amount of omecamtiv mecarbil, or a hydrate, a salt, or a salt of a hydrate thereof.
2. The method of claim 1 , wherein the patient does not exhibit atrial fibrillation or atrial flutter.
3. The method of claim 2 , wherein the patient has a pretreatment level of NT-proBNP of at least 2,000 pg/mL.
4. The method of claim 1 , wherein the patient has a pretreatment level of NT-proBNP of at least 2,000 pg/mL.
5. The method of claim 1 , wherein the patient is an inpatient.
6. The method of claim 1 , wherein the patient is an outpatient.
7. The method of claim 1 , wherein the omecamtiv mecarbil, or the hydrate, salt, or salt of the hydrate thereof is administered orally.
8. The method of claim 7 , wherein the omecamtiv mecarbil, or the hydrate, salt, or salt of the hydrate thereof is administered as a tablet.
9. The method of claim 1 , comprising administering to the patient a therapeutically effective amount of omecamtiv mecarbil dihydrochloride hydrate.
10. The method of claim 1 , wherein the omecamtiv mecarbil, or the hydrate, salt, or salt of the hydrate thereof is administered as a modified release matrix tablet.
11. The method of claim 1 , wherein the omecamtiv mecarbil, or the hydrate, salt, or salt of the hydrate thereof is administered in a dosage of 25 mg twice daily, 37.5 mg twice daily, or 50 mg twice daily.
12. The method of claim 1 , wherein the patient has undergone cardiac resynchronization therapy (CRT) prior to treatment.
13. The method of claim 1 , wherein the patient has an implantable cardioverter defibrillator (ICD) device.
14. The method of claim 1 , further comprising administering to the patient a therapeutically effective amount of an angiotensin-converting enzyme inhibitor.
15. The method of claim 1 , further comprising administering to the patient a therapeutically effective amount of a mineralocorticoid receptor antagonist.
16. The method of claim 1 , wherein the patient is not receiving digoxin.
17. The method of claim 2 , wherein the patient is not receiving digoxin.
18. The method of claim 1 , wherein the patient has an LVEF of less than 25%.
19. The method of claim 1 , wherein the patient has an LVEF of less than 22%.
20. A method of treating heart failure in a patient who has low blood pressure, comprising administering to the patient a therapeutically effective amount of omecamtiv mecarbil, or a hydrate, a salt, or a salt of a hydrate thereof.
21. The method of claim 20 , wherein the patient has a systolic blood pressure (SBP) of less than or equal to 100 mmHg.
22. The method of claim 20 , wherein the patient has an LVEF of less than 28%.
23. The method of claim 20 , wherein the patient has an LVEF of less than 25%.
24. The method of claim 20 , wherein the patient has an LVEF of less than 22%.
25. The method of claim 20 , wherein the patient has a pretreatment level of NT-proBNP of at least 2,000 pg/mL.
26. The method of claim 20 , wherein the omecamtiv mecarbil, or the hydrate, salt, or salt of the hydrate thereof is administered orally.
27. The method of claim 26 , wherein the omecamtiv mecarbil, or the hydrate, salt, or salt of the hydrate thereof is administered as a tablet.
28. The method of claim 20 , comprising administering to the patient a therapeutically effective amount of omecamtiv mecarbil dihydrochloride hydrate.
29. The method of claim 20 , wherein the omecamtiv mecarbil, or the hydrate, salt, or salt of the hydrate thereof is administered as a modified release matrix tablet.
30. The method of claim 20 , wherein the omecamtiv mecarbil, or the hydrate, salt, or salt of the hydrate thereof is administered in a dosage of 25 mg twice daily, 37.5 mg twice daily, or 50 mg twice daily.
Assignments (2)
ASSIGNMENT OF ASSIGNOR'S INTEREST
Recorded May 26, 2022
From: HONARPOUR, NARIMON
To: AMGEN INC.
Reel/Frame 060031/0795 →
ASSIGNMENT OF ASSIGNOR'S INTEREST
Recorded May 26, 2022
From: MALIK, FADY
To: CYTOKINETICS, INC.
Reel/Frame 060031/0905 →
Continuity (6)
Provisional Application
63203436
· Jul 22, 2021
Provisional Application
63202873
· Jun 28, 2021
Provisional Application
63187084
· May 11, 2021
Provisional Application
63154077
· Feb 26, 2021
Provisional Application
63112995
· Nov 12, 2020
References Cited (277)
US 4450150A
· Sidman et al.
· 1984
[cited by applicant]
US 6303144B1
· Omura et al.
· 2001
[cited by applicant]
US 7507735B2
· Morgan et al.
· 2009
[cited by applicant]
US 8101617B2
· Morgan et al.
· 2012
[cited by applicant]
US 8110595B2
· Morgan et al.
· 2012
[cited by applicant]
US 8445495B2
· Morgan et al.
· 2013
[cited by applicant]
US 8513257B2
· Morgan et al.
· 2013
[cited by applicant]
US 8871768B2
· Morgan et al.
· 2014
[cited by applicant]
US 8871769B2
· Morgan et al.
· 2014
[cited by applicant]
US 9150564B2
· Morgan et al.
· 2015
[cited by applicant]
US 9643925B2
· Morgan et al.
· 2017
[cited by applicant]
US 9895308B2
· Caldwell et al.
· 2018
[cited by applicant]
US 9951015B2
· Bi et al.
· 2018
[cited by applicant]
US 9988354B2
· Cui et al.
· 2018
[cited by applicant]
US 20070161617A1
· Morgan et al.
· 2007
[cited by applicant]
US 20180312469A1
· Cui et al.
· 2018
[cited by applicant]
US 20200079736A1
· Cui et al.
· 2020
[cited by applicant]
US 20200108076A1
· Scott et al.
· 2020
[cited by applicant]
US 20200331859A1
· Cui et al.
· 2020
[cited by applicant]
US 20210198203A1
· Morgan et al.
· 2021
[cited by applicant]
US 20220324808A1
· Chen et al.
· 2022
[cited by applicant]
US 20230044617A1
· Cui et al.
· 2023
[cited by applicant]
US 20230090391A1
· Bi et al.
· 2023
[cited by applicant]
JP 2020526483A
· 2020
[cited by applicant]
MX 2020000190A
· 2020
[cited by applicant]
WO 199940942A1
· 1999
[cited by applicant]
WO 0032218A1
· 2000
[cited by applicant]
WO 2004033036A2
· 2004
[cited by applicant]
WO 2007133747A2
· 2007
[cited by applicant]
WO 2007141411A1
· 2007
[cited by applicant]
WO 2008130158A1
· 2008
[cited by applicant]
WO 2014152236A1
· 2014
[cited by applicant]
WO 2014152270A1
· 2014
[cited by applicant]
WO 2016210240A1
· 2016
[cited by applicant]
WO 2018144968A1
· 2018
[cited by applicant]
WO 2019006235A1
· 2019
[cited by applicant]
WO 2020011626A1
· 2020
[cited by applicant]
WO 2020014406A1
· 2020
[cited by applicant]
WO 2020020728A1
· 2020
[cited by applicant]
WO 2020180356A1
· 2020
[cited by applicant]
WO 2021053175A1
· 2021
[cited by applicant]
WO 2021053189A1
· 2021
[cited by applicant]
WO 2021070123A1
· 2021
[cited by applicant]
WO 2021070124A1
· 2021
[cited by applicant]
WO 2021092598A1
· 2021
[cited by applicant]
WO 2021123119A1
· 2021
[cited by applicant]
WO 2021136477A1
· 2021
[cited by applicant]
WO 2022103966A1
· 2022
[cited by applicant]
WO 2023205291A2
· 2023
[cited by applicant]
WO 2024081611A1
· 2024
[cited by applicant]
International Search Report and Written Opinion mailed on Feb. 4, 2022, for PCT Application No. PCT/US2021/058988, filed on Nov. 11, 2021, 17 pages.
[cited by applicant]
Liu, C.Y. et al. (Nov. 20, 2015, e-pub. Dec. 19, 2015). “Omecamtiv Mecarbil: A New Cardiac Myosin Activator for the Treatment of Heart Failure,” Expert Opinion on Investigational Drugs 25(1):117-127.
[cited by applicant]
Teerlink, J.R. et al. (Jul. 13, 2021, e-pub. May 17, 2021). “Effect of Ejection Fraction on Clinical Outcomes in Patients Treated With Omecamtiv Mecarbil in GALACTIC-HF,” Journal of the American College of Cardiology 78…
[cited by applicant]
Ahmad, T. et al. (2019, e-pub. Aug. 13, 2019). “Why Has Positive Inotropy Failed in Chronic Heart Failure? Lessons From Prior Inotrope Trials,” Eur J Heart Fail 21:1064-1078.
[cited by applicant]
Allen, L.A. et al. (Apr. 2012). “Decision Making in Advanced Heart Failure: A Scientific Statement From the American Heart Association,” Circulation 125(5):1928-1952.
[cited by applicant]
Allen, L.A. et al. (Mar. 2014). “Hospital Variation in Intravenous Inotrope Use for Patients Hospitalized With Heart Failure: Insights From Get With the Guidelines,” Circ Heart Fail. 7(2):251-260.
[cited by applicant]
Ammar, K.A. et al. (Mar. 27, 2007).“Prevalence and Prognostic Significance of Heart Failure Stages,” Circulation 115(12):1563-1570.
[cited by applicant]
Benjamini, Y. et al. (1995). “Controlling the False Discovery Rate: A Practical and Powerful Approach to Multiple Testing,” Journal of the Royal Statistical Society. Series B Methodological 57(1):289-300.
[cited by applicant]
Biering-Sorensen, T. et al. (Dec. 2020). “Cardiac Myosin Activator Omecamtiv Mecarbil Improves Left Ventricular Myocardial Deformation in Chronic Heart Failure: The COSMIC-HF Trial,” Circ Heart Fail 13(12):e008007, 5 pa…
[cited by applicant]
Burnett, J.C. Jr. (Dec. 2019). “Atrial Natriuretic Peptide, Heart Failure and the Heart as an Endocrine Organ,” Clin Chem. 65(12):1602-1603.
[cited by applicant]
Butler, J. et al. (2020, e-pub. Apr. 2, 2020). “Minimal Clinically Important Difference in Quality of Life Scores for Patients With Heart Failure and Reduced Ejection Fraction,” Eur J Heart Fail 22:999-1005.
[cited by applicant]
Cleland, J.G.F. et al. (2018, e-pub. Oct. 10, 2017). “Beta-Blockers for Heart Failure With Reduced, Mid-Range, and Preserved Ejection Fraction: an Individual Patient-Level Analysis of Double-Blind Randomized Trials,” Eu…
[cited by applicant]
Cleland, J.G.F. et al. (Aug. 20, 2011). “The Effects of the Cardiac Myosin Activator, Omecamtivmecarbil, on Cardiac Function in Systolic Heart Failure: A Double-Blind, Placebo Controlled, Crossover, Dose-Ranging Phase 2…
[cited by applicant]
Cleland, J.G.F. et al. (Mar. 29, 2016). “Acute Treatment With Omecamtiv Mecarbil to Increase Contractility in Acute Heart Failure: The ATOMIC-AHF Study,” J Am Coll Cardiol. 67(12):1444-1455.
[cited by applicant]
Comin-Colet, J. et al. (Jul. 2018). “Efficacy and Safety of Intermittent Intravenous Outpatient Administration of Levosimendan in Patients With Advanced Heart Failure: The Lion-Heart Multicentre Randomised Trial,” Eur J…
[cited by applicant]
Crespo-Leiro M.G. et al. (2018, e-pub. Jul. 17, 2018). “Advanced Heart Failure: A Position Statement of the Heart Failure Association of the European Society of Cardiology,” European Journal of Heart Failure 20:1505-153…
[cited by applicant]
Cui, D. et al. (Jan. 2021). “Levosimendan Can Improve the Level of B-Type Natriuretic Peptide and the Left Ventricular Ejection Fraction of Patients With Advanced Heart Failure: A Meta-Analysis of Randomized Controlled …
[cited by applicant]
Dewan, P. et al. (2020, e-pub. Jun. 15, 2020). Efficacy and Safety of Sodium-Glucose Co-Transporter 2 Inhibition According to Left Ventricular Ejection Fraction in DAPA-HF. Eur J Heart Fail 22:1247-1258.
[cited by applicant]
Ezekowitz, J.A. et al. (Nov. 2020). “N-Terminal Pro-B-Type Natriuretic Peptide and Clinical Outcomes: Vericiguat Heart Failure With Reduced Ejection Fraction Study,” JACC Heart Fail 8(11):931-939.
[cited by applicant]
Fang, J.C. et al. (Jun. 2015, e-pub. May 4, 2015). “Advanced (Stage D) Heart Failure: A Statement From the Heart Failure Society of America Guidelines Committee,” Journal of Cardiac Failure 21(6):519-534.
[cited by applicant]
Grodin, J.L. et al. (Sep. 2019). Prognostic Implications of Changes in Amino-Terminal Pro-B-Type Natriuretic Peptide in Acute Decompensated Heart Failure: Insights From ASCEND-HF. J Card Fail. 25(9):703-711. (Accepted M…
[cited by applicant]
Hardy, R.J. et al. (Mar. 30, 1996). “A Likelihood Approach to Meta-Analysis With Random Effects,” Stat Med 15(6):619-629.
[cited by applicant]
Haybittle, J.L. (Oct. 1971). “Repeated Assessment of Results in Clinical Trials of Cancer Treatment,” Br J Radiol 44(526):793-797.
[cited by applicant]
Hicks, K.A. et al. (Mar. 6, 2018). “2017 Cardiovascular and Stroke Endpoint Definitions for Clinical Trials,” J Am Coll Cardiol 71(9):1021-1034.
[cited by applicant]
Ibrahim, N.E. (May 2020). “Natriuretic Peptides as Inclusion Criteria in Clinical Trials: A JACC: Heart Failure Position Paper,” JACC Heart Fail. 8(5):347-358.
[cited by applicant]
Kotecha, D. et al. (Dec. 20, 2014). “Efficacy of B Blockers in Patients With Heart Failure Plus Atrial Fibrillation: An Individual-Patient Data Meta-Analysis,” The Lancet 384(9961):2235-2243, 44 pages.
[cited by applicant]
Kramer, D.G. et al. (Jul. 27, 2010). “Quantitative Evaluation of Drug or Device Effects on Ventricular Remodeling as Predictors of Therapeutic Effects on Mortality in Patients With Heart Failure and Reduced Ejection Fra…
[cited by applicant]
Kristensen, S.L. et al. (Mar. 2019). “N-Terminal Pro-B-Type Natriuretic Peptide Levels for Risk Prediction in Patients With Heart Failure and Preserved Ejection Fraction According to Atrial Fibrillation Status,” Circ He…
[cited by applicant]
Kristensen, S.L. et al. (Oct. 2017). “Prognostic Value of N-Terminal Pro-B-Type Natriuretic Peptide Levels in Heart Failure Patients With and Without Atrial Fibrillation,” Circ Heart Fail. 10(10):e004409, 9 pages.
[cited by applicant]
Lee, D.S. et al. (Sep. 14, 2005). “Risk Treatment Mismatch in the Pharmacotherapy of Heart Failure,” JAMA 294(10):1240-1247.
[cited by applicant]
Loungani, R.S. (Jul. 2020). “Biomarkers in Advanced Heart Failure: Implications for Managing Patients With Mechanical Circulatory Support and Cardiac Transplantation,” Circ Heart Fail. 13(7):e006840, 10 pages.
[cited by applicant]
Malik, F.I. et al. (Mar. 18, 2011). “Cardiac Myosin Activation: A Potential Therapeutic Approach for Systolic Heart Failure,” Science 331(6023):1439-1443.
[cited by applicant]
Mann, D.L. et al. (Oct. 2020). “Sacubitril/Valsartan in Advanced Heart Failure With Reduced Ejection Fraction,” JACC: Heart Failure 8(10):789-799.
[cited by applicant]
McMurray, J.J.V. et al. (Nov. 21, 2019, e-pub. Sep. 19, 2019). “Dapagliflozin in Patients with Heart Failure and Reduced Ejection Fraction,” N Engl J Med 381(21):1995-2008.
[cited by applicant]
Merck Sharp & Dohme Corp. (Jan. 19, 2021). Verquvo Tablets. Center for Drug Evaluation and Research, Food and Drug Administration. Integrated Review, Application No. 2143770rig1s000, NDA 214377 Vericiguat, 10 pages.
[cited by applicant]
Metra, M. et al. (2007). “Advanced Chronic Heart Failure: A Position Statement From the Study Group on Advanced Heart Failure of the Heart Failure Association of the European Society of Cardiology,” European Journal of …
[cited by applicant]
Metra, M. et al. (2009). “Effects of Low-Dose Oral Enoximone Administration on Mortality, Morbidity, and Exercise Capacity in Patients With Advanced Heart Failure: The Randomized, Double-Blind, Placebo-Controlled, Paral…
[cited by applicant]
Mueller, C. et al. (Jun. 2019). “Heart Failure Association of the European Society of Cardiology Practical Guidance on the Use of Natriuretic Peptide Concentrations,” Eur J Heart Fail. 21(6):715-731.
[cited by applicant]
Najjar, E. et al. (Jun. 2018, e-pub. Feb. 22, 2018). “Haemodynamic Effects of Levosimendan in Advanced But Stable Chronic Heart Failure,” ESC Heart Fail. 5(3):302-308.
[cited by applicant]
Nizamic, T. et al. (Sep. 2018). “Ambulatory Inotrope Infusions in Advanced Heart Failure: A Systematic Review and Meta-Analysis. JACC Heart failure,” 6(9):757-767.
[cited by applicant]
Packer, M. (Oct. 8, 2020, e-pub. Aug. 28, 2020). “Cardiovascular and Renal Outcomes with Empagliflozin in Heart Failure,” N Engl J Med 383(15):1413-1424.
[cited by applicant]
Packer, M. et al. (May 23, 1996). “The Effect of Carvedilol on Morbidity and Mortality in Patients with Chronic Heart Failure,” N Engl J Med. 334(21):1349-1355.
[cited by applicant]
Peto, R. et al. (1976). “Design and Analysis of Randomized Clinical Trials Requiring Prolonged Observation of Each Patient. I. Introduction and Design,” Br J Cancer 34:585-612.
[cited by applicant]
Pitt, B. et al. (Sep. 2, 1999). “The Effect of Spironolactone on Morbidity and Mortality in Patients With Severe Heart Failure. Randomized Aldactone Evaluation Study Investigators,” N Engl J Med. 341(10):709-717.
[cited by applicant]
Planelles-Herrero, V.J. et al. (2017). “Mechanistic and Structural Basis for Activation of Cardiac Myosin Force Production by Omecamtiv Mecarbil,” Nat Commun 8(190):1-10.
[cited by applicant]
Psotka, M.A. et al. (2017). “Direct Myosin Activation by Omecamtiv Mecarbil for Heart Failure with Reduced Ejection Fraction,” Handb Exp Pharmacol 243:465-490, 35 pages.
[cited by applicant]
Psotka, M.A. et al. (May 14, 2019). “Cardiac Calcitropes, Myotropes, and Mitotropes,” J Am Coll Cardiol 73(18):2345-2353.
[cited by applicant]
Rorth, R. et al. (Feb. 2020). “Comparison of BNP and NT-proBNP in Patients With Heart Failure and Reduced Ejection Fraction,” Circ Heart Fail. 13(2):e006541, 10 pages.
[cited by applicant]
Shen, Y.T. et al. (Jul. 2010). “Improvement of Cardiac Function by a Cardiac Myosin Activator in Conscious Dogs With Systolic Heart Failure,” Circ Heart Fail 3(4):522-527.
[cited by applicant]
Solomon, S.D. et al. (Dec. 13, 2005). “Influence of Ejection Fraction on Cardiovascular Outcomes in a Broad Spectrum of Heart Failure Patients,” Circulation 112(24):3738-3744, 11 pages.
[cited by applicant]
Solomon, S.D. et al. (Feb. 4, 2020). “Sacubitril/Valsartan Across the Spectrum of Ejection Fraction in Heart Failure,” Circulation 141:352-361.
[cited by applicant]
Solomon, S.D. et al. (Mar. 2016). “Influence of Ejection Fraction on Outcomes and Efficacy of Sacubitril/Valsartan (LCZ696) in Heart Failure with Reduced Ejection Fraction: The Prospective Comparison of ARNI with ACEI t…
[cited by applicant]
Stewart, G.C. et al. (Nov. 9, 2016). “INTERMACS (Interagency Registry for Mechanically Assisted Circulatory Support) Profiling Identifies Ambulatory Patients at High Risk on Medical Therapy After Hospitalizations for He…
[cited by applicant]
Tahhan, A.S. et al. (2018, e-pub. Aug. 22, 2018). “Enrollment of Older Patients, Women, and Racial and Ethnic Minorities in Contemporary Heart Failure Clinical Trials: A Systematic Review,” JAMA Cardiol 3(10):1011-1019.
[cited by applicant]
Teerlink, J.R. et al. (Apr. 2020). “Omecamtiv Mecarbil in Chronic Heart Failure With Reduced Ejection Fraction: Rationale and Design of GALACTIC-HF,” JACC Heart Fail 8(4):329-340.
[cited by applicant]
Teerlink, J.R. et al. (Aug. 20, 2011). “Dose-Dependent Augmentation of Cardiac Systolic Function With the Selective Cardiac Myosin Activator, Omecamtiv Mecarbil: A First-In-Man Study,” Lancet 378(9792):667-675.
[cited by applicant]
Teerlink, J.R. et al. (Dec. 10, 2016). “Chronic Oral Study of Myosin Activation to Increase Contractility in Heart Failure (COSMIC-HF): A Phase 2, Pharmacokinetic, Randomised, Placebo-Controlled Trial,” Lancet 388(10062…
[cited by applicant]
Teerlink, J.R. et al. (Jan. 14, 2021, e-pub. Nov. 13, 2020). “Cardiac Myosin Activation with Omecamtiv Mecarbil in Systolic Heart Failure,” N Engl J Med. 384(2):105-116.
[cited by applicant]
Teerlink, J.R. et al. (Mar. 29, 2016). “Acute Treatment With Omecamtiv Mecarbil to Increase Contractility in Acute Heart Failure: The ATOMIC-AHF Study,” J Am Coll Cardiol 67(12):1444-1455.
[cited by applicant]
Teerlink, J.R. et al. (Nov. 2020, e-pub. Oct. 27, 2020). “Omecamtiv Mecarbil in Chronic Heart Failure With Reduced Ejection Fraction: GALACTIC-HF Baseline Characteristics and Comparison With Contemporary Clinical Trials…
[cited by applicant]
Troughton, R.W. et al. (Jun. 14, 2014, e-pub. Mar. 6, 2014). “Effect of B-type Natriuretic Peptide-Guided Treatment of Chronic Heart Failure on Total Mortality and Hospitalization: An Individual Patient Meta-Analysis,” …
[cited by applicant]
Unroe, K.T. et al. (2011, e-pub. Oct. 11, 2010). “Resource Use in the Last 6 Months of Life Among Medicare Beneficiaries With Heart Failure, 2000-2007,” Archives of Internal Medicine 171(3):196-203.
[cited by applicant]
Vaduganathan, M. et al. (Jul. 2018). “Natriuretic Peptides as Biomarkers of Treatment Response in Clinical Trials of Heart Failure,” JACC Heart Fail. 6(7):564-569.
[cited by applicant]
Wessler, B.S. et al. (2019, e-pub. Mar. 27, 2019). “Relation Between Therapy-Induced Changes in Natriuretic Peptide Levels and Long-Term Therapeutic Effects on Mortality in Patients With Heart Failure and Reduced Ejecti…
[cited by applicant]
Yancy, C.W. et al. (Oct. 15, 2013). “2013 ACCF/AHA Guideline for the Management of Heart Failure: A Report of the American College of Cardiology Foundation/American Heart Association Task Force on Practice Guidelines,” …
[cited by applicant]
Zile, M.R. et al. (Dec. 6, 2016). “Prognostic Implications of Changes in N-Terminal Pro-B-Type Natriuretic Peptide in Patients With Heart Failure,” J Am Coll Cardiol. 68(22):2425-2436.
[cited by applicant]
Adjei, A. et al. (Jun. 7, 1990). “Pulmonary Delivery of Peptide Drugs: Effect of Particle Size on Bioavailability of Leuprolide Acetate in Healthy Male Volunteers,” Pharm Res. 7(6):565-569.
[cited by applicant]
Ambrosy, A. P. et al. (Apr. 1, 2014, e-pub. Feb. 5, 2014). “The Global Health and Economic Burden of Hospitalizations for Heart Failure: Lessons Learned From Hospitalized Heart Failure Registries,” J Am Coll Cardiol. 63…
[cited by applicant]
Anonymous (Apr. 4, 2016). “Cytokinetics Announces Start of Phase 2 Clinical Trial of Omecamtiv Mecarbil in Japanese Subjects With Heart Failure,” Globe Newswire, 5 pages.
[cited by applicant]
Anonymous (Dec. 1, 2016). “Cytokinetics Announces Start of GALACTIC-HF, A Phase 3 Clinical Trial of Omecamtiv Mecarbil,” Globe Newswire, 6 pages.
[cited by applicant]
Anonymous (Mar. 13, 2015). “Cytokinetics Announces Completion of Enrollment in Cosmic-HF,” Cytokinetics, Inc., 7 pages.
[cited by applicant]
Anonymous (May 1, 2017). “Cytokinetics Announces Results From Dose Escalation Phase of Cosmic-HF Presented at Heart Failure 2017,” Globe Newswire, 6 pages.
[cited by applicant]
Anonymous (Nov. 30, 2016). “The Lancet Publishes Results From Cosmic-HF Trial Showing Omecamtiv Mecarbil Significantly Improved Cardiac Function in Patients With Chronic Heart Failure,” Globe Newswire, 13 pages.
[cited by applicant]
Anonymous (Oct. 27, 2015). “Amgen and Cytokinetics Announce Positive Top-Line Results From Cosmic-HF, A Phase 2 Trial of Omecamtiv Mecarbil in Patients With Chronic Heart Failure,” Globe Newswire, 11 pages.
[cited by applicant]
Anonymous (Sep. 1, 2016). “Cytokinetics and Amgen to Advance Omecamtiv Mecarbil to Phase 3 Clinical Development,” Globe Newswire, 6 pages.
[cited by applicant]
American Heart Association Editorial Staff (Last Reviewed Jun. 7, 2023). “Classes and Stages of Heart Failure,” American Heart Association, Retrieved from Internet: https://www.heart.org/en/health-topics/heart-failure/w…
[cited by applicant]
Apple, F. S. et al. (Jul. 2009, e-pub. May 28, 2009). “A New Season for Cardiac Troponin Assays: It's Time to Keep a Scorecard,” Clin Chem. 55(7):1303-1306.
[cited by applicant]
Berge, S. et al. (Jan. 1977). “Pharmaceutical Salts,” Journal of Pharmaceutical Sciences 66(1):1-19.
[cited by applicant]
Bhatia, R. S. et al. (Jul. 20, 2006). “Outcome of Heart Failure With Preserved Ejection Fraction in a Population-Based Study,” N Engl J Med. 355(3):260-269.
[cited by applicant]
Biering-Sorensen, T. et al. (Aug. 2015). “Systolic Ejection Time is an Independent Predictor of Incident Heart Failure in a Community Based Cohort Free of Heart Failure,” Journal of Cardiac Failure 21(8 Supplement):S84,…
[cited by applicant]
Braunwald, E. et al. (Nov. 9, 1967). “Mechanisms of Contraction of the Normal and Failing Heart,” N Engl J Med 277(19):1012-1022.
[cited by applicant]
Bretz, F. et al. (Feb. 15, 2009, e-pub. Dec. 2, 2008). “A Graphical Approach to Sequentially Rejective Multiple Test Procedures,” Stat Med. 28(4):586-604.
[cited by applicant]
Chen, P-W. et al. (Apr. 1, 2022). “Population Pharmacokinetic Properties of Omecamtiv Mecarbil in Healthy Subjects and Patients With Heart Failure With Reduced Ejection Fraction,” J Cardiovasc Pharmacol. 79(4):539-548.
[cited by applicant]
Cleland, J. et al. (Aug. 5, 2008). “Predicting the Long-Term Effects of Cardiac Resynchronization Therapy on Mortality From Baseline Variables and the Early Response a Report From the CARE-HF (Cardiac Resynchronization …
[cited by applicant]
Cleland, J. G. F. et al. (Nov. 10, 2009). “Plasma Concentration of Amino-Terminal Pro-Brain Natriuretic Peptide in Chronic Heart Failure: Prediction of Cardiovascular Events and Interaction With the Effects of Rosuvasta…
[cited by applicant]
clincialtrials.gov (Jun. 21, 2017). “History of Changes for Study: NCT02929329: Registrational Study With Omecamtiv Mecarbil/AMG 423 to Treat Chronic Heart Failure With Reduced Ejection Fraction (GALACTIC-HF),” 30 pages.
[cited by applicant]
clincialtrials.gov (May 15, 2017). “History of Changes for Study: NCT02695420: Safety, PK, and Efficacy of Omecamtiv Mercarbil in Japanese Subjects with Heart Failure With Reduced Ejection Fraction,” 6 pages.
[cited by applicant]
clinicaltrials.gov (May 5, 2016 copy attached; downloaded from the web Nov. 19, 2021). “NCT01786512—COSMIC-HF—Chronic Oral Study of Myosin Activation to Increase Contractility in Heart Failure,” 10 pages.
[cited by applicant]
Cytokinetics. (2022). “Empowering Muscle Empowering Lives. Sarcomere Directed Therapies,” Cytokinetics 2022, 58 pages.
[cited by applicant]
Dasgupta, A. et al. (2008). “Analytical Techniques for Measuring Concentrations of Therapeutic Drugs in Biological Fluids,” Chapter 3 in Handbook of Drug Monitoring Methods, Humana Press, pp. 67-86.
[cited by applicant]
Deluca, P. P. et al. (1982). “Parenteral Drug-Delivery Systems,” Chapter 8 in Pharmaceutics and Pharmacy Practice, J. B. Lippincott Company, pp. 238-250, 16 pages.
[cited by applicant]
Dickstein, K. et al. (Oct. 2008, e-pub. Sep. 17, 2008). “ESC Guidelines for the Diagnosis and Treatment of Acute and Chronic Heart Failure 2008: The Task Force for the Diagnosis and Treatment of Acute and Chronic Heart …
[cited by applicant]
Go, A. S. et al. (Jan. 1, 2013, e-pub. Dec. 12, 2012). “Heart Disease and Stroke Statistics—2013 Update: A Report From the American Heart Association,” Circulation 127(1):e6-e245, 489 pages.
[cited by applicant]
Greenberg, B. H. et al. (Jan. 2015, e-pub. Nov. 11, 2014). “Safety and Tolerability of Omecamtiv Mecarbil During Exercise in Patients With Ischemic Cardiomyopathy and Angina,” JACC Heart Fail. 3(1):22-29.
[cited by applicant]
Greene, S. J. et al. (Apr. 2015, e-pub. Feb. 10, 2015). “The Vulnerable Phase After Hospitalization for Heart Failure,” Nat Rev Cardiol. 12(4):220-229.
[cited by applicant]
Hampton, J. R. et al. (Apr. 5, 1997). “Randomised Study of Effect of Ibopamine on Survival in Patients With Advanced Severe Heart Failure. Second Prospective Randomised Study of Ibopamine on Mortality and Efficacy (PRIM…
[cited by applicant]
Hasenfuss, G. et al. (Aug. 2011, e-pub. Mar. 8, 2011). “Cardiac Inotropes: Current Agents and Future Directions,” Eur Heart J. 32(15):1838-1845.
[cited by applicant]
Hicks, K. A. et al. (Jul. 28, 2015, e-pub. Dec. 29, 2014). “2014 ACC/AHA Key Data Elements and Definitions for Cardiovascular Endpoint Events in Clinical Trials: A Report of the American College of Cardiology/American H…
[cited by applicant]
Hilfiker-Kleiner, D. et al. (Nov. 7, 2006). “Molecular Mechanisms in Heart Failure: Focus on Cardiac Hypertrophy, Inflammation, Angiogenesis, and Apoptosis,” J Am Coll Cardiol. 48(9 Suppl. A):A56-A66.
[cited by applicant]
International Preliminary Report on Patentability mailed on May 16, 2023, for PCT Application No. PCT/US2021/058988, filed on Nov. 11, 2021, 7 pages.
[cited by applicant]
International Preliminary Report on Patentability, issued on Dec. 31, 2019, for PCT Application No. PCT/US2018/040181, filed on Jun. 29, 2018, 7 pages.
[cited by applicant]
International Search Report and Written Opinion mailed on Feb. 2, 2024, for PCT Application PCT/US2023/076419, filed on Oct. 10, 2023, 14 pages.
[cited by applicant]
International Search Report and Written Opinion of the International Searching Authority, mailed Sep. 27, 2018, for PCT Application No. PCT/US2018/040181, filed on Jun. 29, 2018, 10 pages.
[cited by applicant]
Jencks, S. F. et al. (Apr. 2, 2009). “Rehospitalizations Among Patients in the Medicare Fee-For-Service Program,” N Engl J Med. 360(14):1418-1428.
[cited by applicant]
Jessup, M. et al. (May 15, 2003). “Heart Failure,” N Engl J Med. 348(20):2007-2018.
[cited by applicant]
Kang, J. S. et al. (Mar. 2009). “Overview of Therapeutic Drug Monitoring,” Korean J Intern Med. 24(1):1-10.
[cited by applicant]
Kannankeril, P.J. et al. (Nov. 15, 2002). “Usefulness of Troponin I as a Marker of Myocardial Injury After Pediatric Cardiac Catheterization,” Am J Cardiol. 90(10):1128-1132.
[cited by applicant]
Kawashima, Y. et al. (Nov. 1, 1999). “Pulmonary Delivery of Insulin With Nebulized DL-Lactide/Glycolide Copolymer (PLGA) Nanospheres to Prolong Hypoglycemic Effect,” J Control Release 62(1-2):279-287.
[cited by applicant]
Klinkenberg, L. J. J. et al. (May 6, 2014, e-pub. Feb. 26, 2014). “Circulating Cardiac Troponin T Exhibits A Diurnal Rhythm,” J Am Coll Cardiol. 63(17):1788-1795.
[cited by applicant]
Krum, H. et al. (Aug. 20, 2011). “Medical Therapy for Chronic Heart Failure,” Lancet. 378(9792):713-721.
[cited by applicant]
Levy, W. C. et al. (Mar. 21, 2006, e-pub. Mar. 13, 2006). “The Seattle Heart Failure Model: Prediction of Survival in Heart Failure,” 113(11):1424-1433.
[cited by applicant]
Liu, F. Y. et al. (Feb. 1993). “Pulmonary Delivery of Free and Liposomal Insulin,” Pharm Res. 10(2):228-232.
[cited by applicant]
Lopez-Sendon, J. (Jan. 2011). “The Heart Failure Epidemic,” Medicographia 33(4):363-369.
[cited by applicant]
Malik, F.I. et al. (Oct. 2011, e-pub. May 17, 2011). “Cardiac Myosin Activation Part 1: From Concept to Clinic,” J Mol Cell Cardiol. 51(4):454-461.
[cited by applicant]
McLlvennan, C. K. et al. (Dec. 2014, e-pub. Aug. 20, 2014). “Outcomes in Acute Heart Failure: 30-Day Readmission Versus Death,” Curr Heart Fail Rep. 11(4):445-452.
[cited by applicant]
Mozaffarian, D. et al. (Jul. 24, 2007, e-pub. Jul. 9, 2007). “Prediction of Mode of Death in Heart Failure: the Seattle Heart Failure Model,” Circulation 116(4):392-398.
[cited by applicant]
Nagy, L. et al. (Sep. 2014). “Inotropes and Inodilators for Acute Heart Failure: Sarcomere Active Drugs in Focus,” J Cardiovasc Pharmacol. 64(3):199-208.
[cited by applicant]
Packer, M. (Jul. 15, 1993). “The Search for the Ideal Positive Inotropic Agent,” N Engl J Med. 329(3):201-202.
[cited by applicant]
Packer, M. et al. (Nov. 21, 1991). “Effect of Oral Milrinone on Mortality in Severe Chronic Heart Failure. The Promise Study Research Group,” N Engl J Med. 325(21):1468-1475.
[cited by applicant]
Palaparthy, R. et al. (Mar. 1, 2016, e-pub. Dec. 28, 2015). “Relative Bioavailability, Food, Effect and Safety of the Single-Dose Pharmacokinetics of Omecamtiv Mecarbil Following Administration of Different Modified-Rel…
[cited by applicant]
Ponikowski, P. et al. (Aug. 2016, e-pub. May 20, 2016). “2016 ESC Guidelines for the Diagnosis and Treatment of Acute and Chronic Heart Failure: The Task Force for the Diagnosis and Treatment of Acute and Chronic Heart …
[cited by applicant]
Qian, F. et al. (Jan. 21, 2009, e-pub. Nov. 5, 2008). “Pulmonary Delivery of a GLP-1 Receptor Agonist, BMS-686117,” Int J Pharm 366(1-2):218-220.
[cited by applicant]
Qian, F. et al. (Jun. 5, 2009, e-pub. Mar. 19, 2009). “Sustained Release Subcutaneous Delivery of BMS-686117, a GLP-1 Receptor Peptide Agonist, via a Zinc Adduct,” Int J Pharm. 374(1-2):46-52.
[cited by applicant]
Rahimi, K. et al. (Oct. 2014, e-pub. Sep. 3, 2014). “Risk Prediction in Patients With Heart Failure: A Systematic Review and Analysis,” JACC Heart Fail 2(5):440-446.
[cited by applicant]
Shave, R. et al. (Jul. 13, 2010). “Exercise-Induced Cardiac Troponin Elevation: Evidence, Mechanisms, and Implications,” J Am Coll Cardiol. 56(3):169-176.
[cited by applicant]
Shih, J. H. (Dec. 1995). “Sample Size Calculation for Complex Clinical Trials With Survival Endpoints,” Control Clin Trials. 16(6):395-407.
[cited by applicant]
Solomon, S. D. et al. (Oct. 12, 2004, e-pub. Oct. 4, 2004). “Effect of Candesartan on Cause-Specific Mortality in Heart Failure Patients: The Candesartan in Heart Failure Assessment of Reduction in Mortality and Morbidi…
[cited by applicant]
Solomon, S. D. et al. (Sep. 7, 2010, e-pub. Aug. 23, 2010). “Effect of Cardiac Resynchronization Therapy on Reverse Remodeling and Relation to Outcome: Multicenter Automatic Defibrillator Implantation Trial: Cardiac Res…
[cited by applicant]
Steijns, L. S. W. et al. (Jun. 2002). “Evaluation of Fluorescence Polarization Assays for Measuring Valproic Acid, Phenytoin, Carbamazepine and Phenobarbital in Serum,” Ther Drug Monit. 24(3):432-435.
[cited by applicant]
Tacon, C. L. et al. (Mar. 2012, e-pub. Dec. 8, 2011). “Dobutamine for Patients With Severe Heart Failure: A Systematic Review and Meta-Analysis of Randomised Controlled Trials,” Intensive Care Med. 38(3):359-367.
[cited by applicant]
Teerlink, J.R. et al. (2016). “Online Appendix: Acute Treatment With Omecamtiv Mecarbil to Increase Contractility in Acute Heart Failure: the ATOMIC AHF Study,” J. Am. Coll. Cardiol. 67:1444-1455, Appendix, 16 pages.
[cited by applicant]
Teerlink, J.R. et al. (May 2014). “Chronic Oral Study of Myosin Activation to Increase Contractility in Heart Failure (COSMIC-HF): Improved Contractility and Evolution of Ventricular Remodelling Through Time,” European …
[cited by applicant]
Thygesen, K. et al. (Oct. 16, 2012, e-pub. Sep. 5, 2012). “Third Universal Definition of Myocardial Infarction,” J Am Coll Cardiol 60(16):1581-1598.
[cited by applicant]
Trissel, L. A. et al. (1986). “Intravenous Infusion Solutions,” ASHP Handbook on Injectable Drugs, 4th ed., pp. 622-630.
[cited by applicant]
U.S. Appl. No. 15/898,303, filed Feb. 16, 2018, by William Brett Caldwell et al. (U.S. Patent Application is not submitted herewith pursuant to the waiver of 37 C.F.R. § 1.98(a)(2)(iii) issued by the Office on Sep. 21, …
[cited by applicant]
U.S. Appl. No. 17/176,003, filed Feb. 15, 2021, by Sheng Cui et al. (U.S. Patent Application is not submitted herewith pursuant to the waiver of 37 C.F.R. § 1.98(a)(2)(iii) issued by the Office on Sep. 21, 2004.).
[cited by applicant]
U.S. Appl. No. 18/342,387, filed Jun. 27, 2023, by Fady Malik et al. (U.S. Patent Application is not submitted herewith pursuant to the waiver of 37 C.F.R. § 1.98(a)(2)(iii) issued by the Office on Sep. 21, 2004.).
[cited by applicant]
U.S. Appl. No. 18/416,741, filed Jan. 18, 2024, by Henry Morrison et al. (U.S. Patent Application is not submitted herewith pursuant to the waiver of 37 C.F.R. § 1.98(a)(2)(iii) issued by the Office on Sep. 21, 2004.).
[cited by applicant]
U.S. Appl. No. 18/421,849, filed Jan. 24, 2024, by Shang Cui et al. (U.S. Patent Application is not submitted herewith pursuant to the waiver of 37 C.F.R. § 1.98(a)(2)(iii) issued by the Office on Sep. 21, 2004.).
[cited by applicant]
U.S. Appl. No. 18/531,424, filed Dec. 6, 2023, by Mingda Bi et al. (U.S. Patent Application is not submitted herewith pursuant to the waiver of 37 C.F.R. § 1.98(a)(2)(iii) issued by the Office on Sep. 21, 2004.).
[cited by applicant]
Vu, T. et al. (Nov. 2015, e-pub. Jul. 14, 2015). “Population Pharmacokinetic-Pharmacodynamic Modeling of Omecamtiv Mecarbil, a Cardiac Myosin Activator, in Healthy Volunteers and Patients With Stable Heart Failure,” J C…
[cited by applicant]
Waldenstrom, A. et al. (Jan. 17, 2014). “Role of Exosomes in Myocardial Remodeling,” Circ Res. 114(2):315-324.
[cited by applicant]
Wang, G-F. et al. (Nov. 2008). “Measurement of Plasma Concentration and Bioavailability of Nolatrexed Dihydrochloride in Mice,” J South Med Univ 28(11):1993-1995, with English Abstract.
[cited by applicant]
Weissler, A. M. et al. (Feb. 1968). “Systolic Time Intervals in Heart Failure in Man,” Circulation 37(2):149-159.
[cited by applicant]
Wu, S-N. et al. (2022). “Omecamtiv Mecarbil Treatment Improves Post-Resuscitation Cardiac Function and Neurological Outcome in a Rat Model,” Plos One 17(2):e0264165, 12 pages.
[cited by applicant]
Yancy, C. W. et al. (Oct. 15, 2013, e-pub. Jun. 5, 2013). “2013 ACCF/AHA Guideline for the Management of Heart Failure: A Report of the American College of Cardiology Foundation/American Heart Association Task Force on …
[cited by applicant]
Yancy, C. W. et al. (Sep. 27, 2016, e-pub. May 20, 2016). “2016 ACC/AHA/HFSA Focused Update on New Pharmacological Therapy for Heart Failure: An Update of the 2013 ACCF/AHA Guideline for the Management of Heart Failure:…
[cited by applicant]
Biering-Sorensen, T. et al. (Nov. 11, 2019). “The Effect of the Cardiac Myosin Activator, Omecamtiv Mecarbil, on Diastolic Filling and Function in Chronic Systolic Heart Failure (COSMIC-HF)”, Circ. 140(Suppl1): A14405, …
[cited by applicant]
Butzner, M. et al. (May 2020). “Medical Therapy Side Effects Across Heart Failure Patients With Reduced Ejection Fraction: A Systematic Literature Review”, Value in Health 23(Suppl1):S91, 1 page.
[cited by applicant]
Chen, P. et al. (Sep. 6, 2021). “Model-based Analysis of Omecamtiv Mecarbil Pharmacokinetics Properties,” Presented at 2021 Annual Meeting American College of Clinical Pharmacology, Sep. 13, 2021, Poster 100, Clin Pharm…
[cited by applicant]
Cohen, S.S. et al. (Oct. 2020). “Characteristics and Outcomes of a Real-world Population with Heart Failure with Reduced Ejection Fraction Representative of Clinical Trial Patients”, J Card. Fail. 26(10):S82, p. 1.
[cited by applicant]
Desai, N.R. et al. (Mar. 8, 2022). “Healthcare Resource Use, Intensity and Costs Among Patients with Heart Failure with Reduced Ejection Fraction Treated with Omecamtiv Mecarbil in GALACTIC-HF”, J. Am. Coll Cardiol. 79(…
[cited by applicant]
Desai, N.R. et al. (Oct. 30, 2022). “Healthcare Resource Use, Early Benefit and Cost for North American Patients With HFrEF Most Likely to Benefit From Omecamtiv Mecarbil”, Circ. 146(Suppl1):Abstract 11481, 2 pages.
[cited by applicant]
Docherty, K.F. et al. (Mar. 8, 2022). “The Effect of Omecamtiv Mecarbil in Hospitalized Patients as Compared with Outpatients: a Prespecified Analysis of GALACTIC-HF,” J. Am. Coll. Cardiol. 79(9):310, Abstract, 1 page.
[cited by applicant]
European Examination Report dated Apr. 17, 2024, for European Examination No. 18745732.0, filed on Jan. 17, 2020, 4 pages.
[cited by applicant]
Morgan, B. et al. (Aug. 19, 2018). “Discovery and Development of Omecamtiv Mecarbil—a Novel Cardiac Myosin Activator for the Potential Treatment of Systolic Heart Failure,” Abstract, ACS Fall 2018, as posted on https://…
[cited by applicant]
Pabon, M et al. (Oct. 30, 2022). “Sex Differences in Heart Failure with Reduced Ejection Fraction in the GALACTIC-HF Trial,” Circ. 146(Suppl1): Abstract 13640, 1 page.
[cited by applicant]
Riskin, D. et al. (Nov. 12, 2020). “Enabling Advanced Real-world Evidence in Heart Failure: A Pilot Study Defining Preferred Approaches to Electronic Health Record Data Use,” Circ. 142(Suppl3): Abstract 13797, 2 pages.
[cited by applicant]
Teerlink, J.R. et al. (Dec. 21, 2021). “The Effect of Omecamtiv Mecarbil on Stroke in Patients With Heart Failure and Reduced Ejection Fraction in GALACTIC-HF,” Circ. 144(25):e582, Abstract 16605, 1 page.
[cited by applicant]
Teerlink, J.R. et al. (Jan. 14, 2021, e-pub. Nov. 13, 2020). “Supplementary Appendix. Cardiac Myosin Activation with Omecamtiv Mecarbil in Systolic Heart Failure,” N Engl J Med. 384(2):1-55.
[cited by applicant]
Teerlink, J.R. et al. (Mar. 12, 2019). “Effect of Omecamtiv Mecarbil in Patients with Atrial Fibrillation and Heart Failure with Reduced Ejection Fraction: Results from COSMIC-HF,” JACC 73(9):691.
[cited by applicant]
Trivedi, A. et al. (Sep. 6, 2021). “Effect of Varying Degrees of Hepatic Impairment on the Pharmacokinetics of Omecamtiv Mecarbil,” Presented at 2021 Annual Meeting American College of Clinical Pharmacology, Sep. 13, 20…
[cited by applicant]
Trivedi, A. et al. (Sep. 6, 2021). “Effect of Varying Degrees of Renal Impairment on the Pharmacokinetics of Omecamtiv Mecarbil,” Presented at 2021 Annual Meeting American College of Clinical Pharmacology, Sep. 13, 2021…
[cited by applicant]
Trivedi, A. et al. (Sep. 6, 2021). “Omecamtiv Mecarbil Does Not Prolong QTc Intervals at Therapeutic Concentrations,” Presented at 2021 Annual Meeting American College of Clinical Pharmacology, Sep. 13, 2021, Poster 021…
[cited by applicant]
Trivedi, A. et al. (Sep. 6, 2021). “Pharmacokinetic Drug-Drug Interaction Study of Ome-camtiv Mecarbil With MATE1/MATE2-K Substrate Metformin in Healthy Subjects,” Presented at 2021 Annual Meeting American College of Cl…
[cited by applicant]
Trivedi, A. et al. (Sep. 6, 2021). “Pharmacokinetic Drug-Drug Interaction Study of Omecamtiv Mecarbil With Amiodarone in Healthy Subjects,” Presented at 2021 Annual Meeting American College of Clinical Pharmacology, Sep…
[cited by applicant]
Trivedi, A. et al. (Sep. 6, 2021). “Pharmacokinetic Drug-Drug Interaction Study of Omecamtiv Mecarbil with Breast Cancer Resistance Protein Substrate, Rosuvastatin, in Healthy Subjects,” Presented at 2021 Annual Meeting…
[cited by applicant]
Trivedi, A. et al. (Sep. 6, 2021). “Pharmacokinetic Drug-Drug Interaction Study of Omecamtiv Mecarbil With Midazolam, a CYP3A4 Sensitive Index Substrate, in Healthy Subjects,” Presented at 2021 Annual Meeting American C…
[cited by applicant]
Trivedi, A. et al. (Sep. 6, 2021). “Pharmacokinetic Drug-Drug Interaction Study of Omecamtiv Mecarbil with P-glycoprotein Substrate Digoxin in Healthy Subjects,” Presented at 2021 Annual Meeting American College of Clin…
[cited by applicant]
Trivedi, A. et al. (Sep. 6, 2021). “Pharmacokinetic Drug-Drug Interaction Study of Omecamtiv Mecarbil With Proton Pump Inhibitor, Omeprazole in Healthy Subjects,” Presented at 2021 Annual Meeting American College of Cli…
[cited by applicant]
Trivedi, A. et al. (Sep. 6, 2021). “Pharmacokinetics, Disposition & Biotransformation of [14C]-Omecamtiv Mecarbil in Healthy Male Subjects After a Single Intravenous or Oral Dose,” Presented at 2021 Annual Meeting Ameri…
[cited by applicant]
Trivedi, A. et al. (Sep. 6, 2021). “Relative Bioavailability of Omecamtiv Mecarbil Pediatric Minitablet Formulations in Healthy Subjects,” Presented at 2021 Annual Meeting American College of Clinical Pharmacology, Sep.…
[cited by applicant]
Trivedi, A. et al. (Sep. 6, 2021). “Switchability & Minimal Effect of Food on Pharmacokinetics of Modified-release Tablet Strengths of Omecamtiv Mecarbil, a Cardiac Myosin Activator,” Presented at 2021 Annual Meeting Am…
[cited by applicant]
U.S. Appl. No. 18/642,005, filed Apr. 22, 2024, by Fady Malik et al. (U.S. Patent Application is not submitted herewith pursuant to the waiver of 37 C.F.R. § 1.98(a)(2)(iii) issued by the Office on Sep. 21, 2004.).
[cited by applicant]
International Search Report mailed on Jul. 19, 2024, for PCT Application No. PCT/US2024/025668, filed on Apr. 22, 2024, 15 pages.
[cited by applicant]
MSD Manual Editorial Staff. “New York Heart Association (NYHA) Classification of Heart Failure,” XP93180881, MSD Manual Professional Version, Retrieved from Internet: https://www.msdmanuals.com/professional/multimedia/t…
[cited by applicant]
Cited By (3)