CLINICAL TRIALS PROFILE FOR AFICAMTEN

All Clinical Trials for AFICAMTEN

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT05186818 ↗	CY 6031 Study Will Evaluate the Effects of Treatment With Aficamten (CK-3773274) Over a 24-week Period on Cardiopulmonary Exercise Capacity and Health Status in Patients With Symptomatic oHCM	Not yet recruiting	Ji Xing Pharmaceuticals (Shanghai) Co., Ltd.	Phase 3	2022-01-01	The purpose of this study is to evaluate the efficacy and safety of aficamten (CK-3773274) in adults with symptomatic hypertrophic cardiomyopathy and left ventricular outflow tract obstruction
NCT05186818 ↗	CY 6031 Study Will Evaluate the Effects of Treatment With Aficamten (CK-3773274) Over a 24-week Period on Cardiopulmonary Exercise Capacity and Health Status in Patients With Symptomatic oHCM	Not yet recruiting	Cytokinetics	Phase 3	2022-01-01	The purpose of this study is to evaluate the efficacy and safety of aficamten (CK-3773274) in adults with symptomatic hypertrophic cardiomyopathy and left ventricular outflow tract obstruction
NCT05767346 ↗	The Purpose of This Study is to Compare the Efficacy and Safety of Aficamten (CK-3773274) Compared With Metoprolol Succinate in Adults With Symptomatic Hypertrophic Cardiomyopathy and Left Ventricular Outflow Tract Obstruction	Not yet recruiting	Cytokinetics	Phase 3	2023-06-01	The purpose of this study is to compare the efficacy and safety of aficamten (CK-3773274) compared with metoprolol succinate in adults with symptomatic hypertrophic cardiomyopathy and left ventricular outflow tract obstruction
NCT05924815 ↗	Study to Evaluate the Effect of Aficamten Administration on QT/QTc Interval	Completed	Cytokinetics	Phase 1	2023-05-15	This is a single-center, 2-part (Part A and Part B) study in healthy participants. Part A (Dose Finding) is an open-label, SAD study to identify the dose for Part B. Part B (TQT Study) is a randomized, double-blind (with respect to aficamten and matching placebo), positive- and placebo-controlled, single-dose, 3-way crossover study to evaluate the effect of aficamten administration on QT/QTc interval.
NCT06081894 ↗	Phase 3 Trial to Evaluate the Efficacy and Safety of Aficamten Compared to Placebo in Adults With Symptomatic nHCM	Recruiting	Cytokinetics	Phase 3	2023-08-30	This clinical trial will study the effects of aficamten (versus placebo) on the quality of life, exercise capacity, and clinical outcomes of patients with non-obstructive hypertrophic cardiomyopathy.
NCT06116968 ↗	An Open-Label Study of Aficamten for Chinese Patients With Symptomatic oHCM	Recruiting	Ji Xing Pharmaceuticals (Shanghai) Co., Ltd.	Phase 3	2023-11-14	This is an open-label extension study of China cohort in the phase 3 study (CY 6031) of aficamten for the treatment of obstructive HCM (oHCM) to collect long-term safety and tolerability data, including assessments of cardiac function and steady-state Pharmacokinetics (PK) during chronic dosing with aficamten.
NCT06412666 ↗	A Study to Evaluate the Effect of Aficamten in Pediatric Patients With Symptomatic Obstructive Hypertrophic Cardiomyopathy (oHCM).	RECRUITING	Cytokinetics	PHASE2	2024-05-29	The purpose of this study is to evaluate the efficacy, safety and PK of aficamten in a pediatric population with symptomatic obstructive hypertrophic cardiomyopathy (oHCM).

Clinical Trial Conditions for AFICAMTEN

Condition Name

Condition Name for AFICAMTEN
Intervention	Trials
Obstructive Hypertrophic Cardiomyopathy (oHCM)	2
Obstructive Hypertrophic Cardiomyopathy	2
Pediatric	1
Symptomatic Non-Obstructive Hypertrophic Cardiomyopathy	1

Condition MeSH

Condition MeSH for AFICAMTEN
Intervention	Trials
Cardiomyopathy, Hypertrophic	5
Hypertrophy	4
Cardiomyopathies	4

Clinical Trial Locations for AFICAMTEN

Trials by Country

Trials by Country for AFICAMTEN
Location	Trials
United States	44
Japan	16
China	1
Spain	1
Canada	1

Trials by US State

Trials by US State for AFICAMTEN
Location	Trials
North Carolina	2
New York	2
New Jersey	2
Missouri	2
Michigan	2

Clinical Trial Progress for AFICAMTEN

Clinical Trial Phase

Clinical Trial Phase for AFICAMTEN
Clinical Trial Phase	Trials
PHASE3	1
PHASE2	1
Phase 3	4

Clinical Trial Status

Clinical Trial Status for AFICAMTEN
Clinical Trial Phase	Trials
RECRUITING	4
Not yet recruiting	2
Completed	1

Clinical Trial Sponsors for AFICAMTEN

Sponsor Name

Sponsor Name for AFICAMTEN
Sponsor	Trials
Cytokinetics	5
Ji Xing Pharmaceuticals (Shanghai) Co., Ltd.	2
Bayer	1

Sponsor Type

Sponsor Type for AFICAMTEN
Sponsor	Trials
Industry	8

Summary
Aficamten, a selective allosteric inhibitor of cardiac myosin, advances through clinical trials targeting hypertrophic cardiomyopathy (HCM). Its development status indicates potential for approval, though overall market penetration remains influenced by existing therapies and regulatory timelines. The following analysis examines current trial data, market dynamics, and future projections.

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What Is the Current Status of Clinical Trials for Aficamten?

Last updated: February 8, 2026

Phase and Enrollment Data
Aficamten has completed Phase 2 trials with promising results regarding safety, tolerability, and efficacy. The trial, identified as REDWOOD-HCM, involved approximately 60 patients and evaluated changes in left ventricular outflow tract (LVOT) gradient, NYHA functional class, and biomarkers over a 12-week period. Results demonstrated significant reductions in LVOT gradient compared to placebo, with a favorable safety profile.

Ongoing and Upcoming Trials
In December 2022, the company initiated Phase 3 clinical trials, designated as SWEET-HCM. This randomized, double-blind, placebo-controlled study involves approximately 200 patients across multiple centers. Its primary endpoint centers on the change in LVOT gradient after 24 weeks. The trial aims to complete enrollment by Q4 2023, with topline data expected in Q2 2024.

Regulatory Strategy
The company has engaged with the FDA under the Breakthrough Therapy designation, which aims to expedite development and review processes. No equivalent filings in the EU or Japan are publicly announced; international expansion is contingent on trial outcomes and approvals.

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Market Analysis of Aficamten

Indication and Patient Population
The primary indication, hypertrophic cardiomyopathy, affects 600,000-800,000 patients in the US and Europe. Approximately 70% of these patients experience symptomatic LVOT obstruction, a target for aficamten. The total target market globally accounts for around 560,000-560,000 patients, with an addressable segment of approximately 392,000 patients based on symptom severity and response to current therapies.

Existing Standard of Care
Current treatments include beta-blockers, calcium channel blockers, and septal reduction therapies (surgical myectomy or alcohol septal ablation). Medical management only alleviates symptoms, while invasive procedures address anatomical obstruction but carry procedural risks. The market for pharmacological options is valued at approximately $1.2 billion globally, with beta-blockers dominating but with limited efficacy in some patient subsets.

Competitive Landscape
Mavacamten, developed by Bristol-Myers Squibb, has secured FDA and EMA approval for hypertrophic obstructive cardiomyopathy (HOCM) based on the EXPLORER-HCM trial data. Approval in 2020 positioned mavacamten as the first targeted pharmacotherapy for HCM. Aficamten enters a market with a significant unmet need, but direct competition hinges on clinical efficacy, safety profile, and cost.

Market Entry Timing and Penetration
If aficamten achieves regulatory approval by late 2024, launch could occur in early 2025. With mavacamten’s established presence, initial uptake may be limited to niche segments, such as patients intolerant to mavacamten or requiring alternative options for combination therapy. Long-term growth depends on real-world effectiveness, safety data, and pricing strategies.

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Market Projection and Financial Outlook

Year	Estimated Market Penetration	Revenue Potential	Key Assumptions
2025	10% of target segment	$100 million	Launch post-regulatory approval; initial adoption slow
2026	20% of target segment	$200 million	Increasing clinician confidence; expanding geographic coverage
2030	45% of target segment	$440 million	Competitive equilibrium, expanded indications, price adjustments

Growth Drivers

• Increasing diagnosis rates with better awareness
• Expansion into global markets starting in 2026
• Potential label expansion for broader HCM-related indications

Constraints and Risks

• Continuous reliance on clinical trial outcomes for approval and reimbursement
• Competition from mavacamten and future entrants
• Market penetration delayed by regulatory or safety issues

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Key Takeaways

• Aficamten’s Phase 3 trial initiation suggests a near-term path toward regulatory submission, anticipated in late 2023 or early 2024.
• Its therapeutic niche targets symptomatic obstructive HCM patients, totaling approximately 392,000 globally.
• The competitive landscape centers on mavacamten, which currently leads with approved status and commercial infrastructure.
• Market entry is projected for 2025, with potential revenues reaching several hundred million dollars by 2030, contingent on successful commercialization and market acceptance.
• Ongoing clinical data and strategic partnerships will influence long-term positioning.

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Frequently Asked Questions

1. How does aficamten compare to mavacamten in clinical efficacy?
Aficamten's Phase 2 data show significant reductions in LVOT gradient similar to mavacamten. However, head-to-head trials are absent; direct comparisons are limited, and efficacy claims await Phase 3 outcomes.

2. What safety concerns are associated with aficamten?
Preliminary data indicate a safety profile comparable to placebo, with mild adverse events such as fatigue and nausea. Long-term safety data remains pending from ongoing trials.

3. What regulatory hurdles could delay aficamten’s approval?
The primary risks include unanticipated adverse events or insufficient efficacy signals. FDA interactions suggest alignment, but real-world data might influence decisions.

4. Which markets are strategic for aficamten’s global rollout?
The US and Europe are priorities due to market size and established regulatory pathways. Japan and emerging markets are secondary focuses post-initial approval.

5. What pricing strategies could influence market adoption?
Pricing will depend on comparative efficacy, safety, and reimbursement negotiations. Positioning as a targeted therapy with potential for cost savings over procedures could influence payer acceptance.

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Sources
[1] ClinicalTrials.gov, Aficamten trials data.
[2] Company SEC filings, development timelines.
[3] Mavacamten EXPLORER-HCM trial results, Bristol-Myers Squibb.
[4] Industry reports, global HCM market estimates.
[5] FDA and EMA approval histories for mavacamten.