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Cytokinetics (CYTK)
NASDAQ:CYTK
Ck-4021586 (150 Mg, 300 Mg, 450 Mg, And 600 Mg)
Symptomatic Heart Failure With Preserved Ejection Fraction (Hfpef)
Phase II
Recruiting
AMBER-HFpEF: Assessment of CK-4021586 in a Multi-Center, Blinded Evaluation of Safety and Tolerability Results in HFpEF
Jan 21, 2025
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Aficamten
Symptomatic Non-Obstructive Hypertrophic Cardiomyopathy
Phase III
Recruiting
Phase 3 Trial to Evaluate the Efficacy and Safety of Aficamten Compared to Placebo in Adults With Symptomatic nHCM
Aug 31, 2023
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Moxifloxacin, Aficamten
Healthy Participants
Phase I
Completed
Study to Evaluate the Effect of Aficamten Administration on QT/QTc Interval
Jun 07, 2023
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Ck-4021586
Healthy Participants
Phase I
Completed
A Single and Multiple Ascending Dose Study of CK-4021586 in Healthy Adult Participants
May 17, 2023
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Aficamten (Ck-3773274) (5 Mg, 10 Mg, 15 Mg And 20 Mg), Metoprolol Succinate (50 Mg, 100 Mg, 150 Mg And 200 Mg)
Obstructive Hypertrophic Cardiomyopathy (Ohcm)
Phase III
Completed
Phase 3 Trial to Evaluate the Efficacy and Safety of Aficamten Compared to Metoprolol Succinate in Adults With Symptomatic oHCM
Mar 02, 2023
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Ck-3828136
Healthy Participants
Phase I
Terminated
A Single and Multiple Ascending Dose Study of CK-3828136 in Healthy Adult Participants
Dec 07, 2022
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Reldesemtiv
Amyotrophic Lateral Sclerosis
Phase III
Terminated
A Phase 3, Open-Label Extension of COURAGE-ALS (CY 5031)
Jun 16, 2022
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Aficamten (5 Mg, 10 Mg, 15 Mg, And 20 Mg)
Obstructive Hypertrophic Cardiomyopathy (Ohcm)
Phase III
Completed
Aficamten vs Placebo in Adults With Symptomatic Obstructive Hypertrophic Cardiomyopathy (SEQUOIA-HCM)
Dec 23, 2021
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FAQ
What are the FDA phases for drug approval?
The FDA approval process for new drugs is divided into several phases:
a. Preclinical testing
b. Phase 1 – Safety and dosage
c. Phase 2 – Effectiveness and side effects
d. Phase 3 – Confirmation of effectiveness, monitoring of adverse reactions, and comparison with existing treatments
e. Phase 4 – Post-marketing studies to track long-term safety and effectiveness
a. Preclinical testing
b. Phase 1 – Safety and dosage
c. Phase 2 – Effectiveness and side effects
d. Phase 3 – Confirmation of effectiveness, monitoring of adverse reactions, and comparison with existing treatments
e. Phase 4 – Post-marketing studies to track long-term safety and effectiveness
What is a clinical trial?
A clinical trial is a carefully designed study in which researchers test a drug, treatment, or medical device in people to evaluate its safety, effectiveness, and potential side effects. These trials are essential for determining whether a new treatment should be approved for widespread use.
What drugs does Cytokinetics (CYTK) have in its pipeline
CYTK is currently developing the following drugs: Ck-4021586 (150 Mg, 300 Mg, 450 Mg, And 600 Mg), Omecamtiv Mecarbil (Om), Aficamten. These drug candidates are in various stages of clinical development as the company works toward FDA approval.