Companies: Edgewise Therapeutics
Drugs: EDG-7500
Edgewise Therapeutics’ EDG-7500 clears key Phase 2 test
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Intelligence Snapshot
Executive Summary
EDG-7500 is a novel cardiac sarcomere modulator currently in Phase 2 clinical development for hypertrophic cardiomyopathy treatment.
Key Insights
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A Phase 2 trial demonstrated rapid and clinically meaningful reductions in LVOT gradients…
A Phase 2 trial demonstrated rapid and clinically meaningful reductions in LVOT gradients in participants with obstructive HCM .
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The CIRRUS-HCM study (NCT06347159) is the Phase 2 trial in adults with hypertrophic…
The CIRRUS-HCM study (NCT06347159) is the Phase 2 trial in adults with hypertrophic cardiomyopathy , currently active but not recruiting.
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Edgewise's pipeline includes a completed Phase 1 study in people with renal impairment ,…
Edgewise's pipeline includes a completed Phase 1 study in people with renal impairment , alongside recruiting and planned Phase 1 programs in special populations.
Market Impact
| Regulatory | medium |
|---|---|
| Commercial | medium |
| Competitive | high |
| Investment | medium |
Edgewise Therapeutics says EDG-7500 met a key Phase 2 test in obstructive hypertrophic cardiomyopathy. The evidence points to a cardiac sarcomere modulator still in clinical development, with CIRRUS-HCM as the named study.
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Quick Answer
Key Questions
- What changed with EDG-7500?
- Who is affected by this development?
- What do the cited sources confirm?
- Is EDG-7500 approved by regulators?
- What is the mechanism of EDG-7500?
Executive Scorecard
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Contents8 sections
Edgewise Therapeutics' EDG-7500 Clears Key Phase 2 Test
Key Takeaways
- EDG-7500 is a novel cardiac sarcomere modulator currently in Phase 2 clinical development for hypertrophic cardiomyopathy treatment.
- A Phase 2 trial demonstrated rapid and clinically meaningful reductions in LVOT gradients in participants with obstructive HCM.
- The CIRRUS-HCM study (NCT06347159) is the Phase 2 trial in adults with hypertrophic cardiomyopathy, currently active but not recruiting.
- Edgewise's pipeline includes a completed Phase 1 study in people with renal impairment, alongside recruiting and planned Phase 1 programs in special populations.
IntelligenceRegulatory Impact
FDA and EMA decisions frame this story. Regulatory relevance is medium for hypertrophic cardiomyopathy, with EDG-7500 most exposed. Track designations, submission types, and label or guidance shifts that could move timelines.
The Development
Edgewise Therapeutics reported that a Phase 2 trial of EDG-7500 demonstrated rapid and clinically meaningful reductions in LVOT gradients in participants with obstructive HCM. The trial, CIRRUS-HCM (NCT06347159), is a Phase 2 study of EDG-7500 in adults with hypertrophic cardiomyopathy.
EDG-7500 is designed to address impaired cardiac relaxation associated with hypertrophic cardiomyopathy. The compound represents a selective cardiac sarcomere modulator approach to the condition, which affects the heart's ability to relax and fill properly between beats.
Edgewise Therapeutics tested EDG-7500 in both healthy subjects and patients with obstructive HCM. These studies span multiple populations and settings as part of the drug's broader clinical development program.
IntelligenceCompetitive Intelligence
Competitive pressure is high. Edgewise Therapeutics reshape positioning, formulary leverage, and partnership options. Benchmark pipeline differentiation and regional market access assumptions against this development.
What the Evidence Confirms
EDG-7500 is a novel cardiac sarcomere modulator currently in Phase 2 clinical development for the treatment of hypertrophic cardiomyopathy. The reported trial outcome—reduction in left ventricular outflow tract (LVOT) gradients—is a recognized hemodynamic marker in obstructive HCM. No approval status, regulatory pathway, or commercial timeline is supported by the available evidence.
The CIRRUS-HCM study is currently active but not recruiting, indicating enrollment has closed and data collection or analysis may be ongoing. Edgewise's clinical pipeline also includes a completed Phase 1 study of EDG-7500 in people with renal impairment, a recruiting Phase 1 study in adults with hepatic impairment, and a Phase 1 study in Caucasian and Japanese adults that has not yet begun recruiting.
IntelligenceMarket Signals
Commercial pull is medium and investment relevance medium for hypertrophic cardiomyopathy. Expect implications for pricing, access, and launch sequencing.
Trial Snapshot
| Trial | Title | Status | Phase | Sponsor |
|---|---|---|---|---|
| NCT07034768 | A Study to Evaluate EDG-7500 in People With Renal Impairment | COMPLETED | PHASE1 | Edgewise Therapeutics, Inc. |
| NCT07324616 | A Study to Evaluate EDG-7500 in Adults With Hepatic Impairment | RECRUITING | PHASE1 | Edgewise Therapeutics, Inc. |
| NCT07456059 | A Study to Evaluate EDG-7500 in Caucasian and Japanese Adults | NOT_YET_RECRUITING | PHASE1 | Edgewise Therapeutics, Inc. |
| NCT06347159 | A Study of EDG-7500 in Adults With Hypertrophic Cardiomyopathy (CIRRUS-HCM) | ACTIVE_NOT_RECRUITING | PHASE2 | Edgewise Therapeutics, Inc. |
| NCT06738836 | A Study to Evaluate the Absorption, Metabolism, And Excretion Of Orally Administered [14C]-EDG-7500 | COMPLETED | PHASE1 | Edgewise Therapeutics, Inc. |
IntelligenceStrategic Takeaways
EDG-7500 is a novel cardiac sarcomere modulator currently in Phase 2 clinical development for hypertrophic cardiomyopathy treatment. A Phase 2 trial demonstrated rapid and clinically meaningful reductions in LVOT gradients in participants with obstructive HCM . The CIRRUS-HCM study (NCT06347159) is the Phase 2 trial in adults with hypertrophic cardiomyopathy , currently active but not recruiting.
Competitor Matrix
| Company / Program | Indication | Active trials |
|---|---|---|
| Bristol-Myers Squibb | hypertrophic cardiomyopathy | 3 |
| National Center for Complementary and Integrative Health (NCCIH) | hypertrophic cardiomyopathy | 1 |
| Rennes University Hospital | hypertrophic cardiomyopathy | 1 |
| Xijing Hospital | hypertrophic cardiomyopathy | 1 |
| Cytokinetics | hypertrophic cardiomyopathy | 1 |
| Columbia University | hypertrophic cardiomyopathy | 1 |
IntelligenceEvidence Quality
Claims are tied to cited primary and secondary sources with editorial review before publication.
Timeline
- Edgewise Therapeutics 8-K (2026-06-05)
- Edgewise Therapeutics 8-K (2026-06-01)
- Edgewise Therapeutics 8-K (2026-05-07)
- Edgewise Therapeutics 10-Q (2026-05-07)
- Edgewise Therapeutics 10-K (2026-02-26)
- Recruiting trial NCT07324616 (PHASE1)
- Not_Yet_Recruiting trial NCT07456059 (PHASE1)
- Active_Not_Recruiting trial NCT06347159 (PHASE2)
Frequently Asked Questions
What changed with EDG-7500?
Edgewise Therapeutics reported Phase 2 trial results showing that EDG-7500 produced rapid and clinically meaningful reductions in LVOT gradients in patients with obstructive hypertrophic cardiomyopathy. This represents a key clinical readout for a cardiac sarcomere modulator in development.
Who is affected by this development?
Edgewise Therapeutics is the sponsor. Adults enrolled in the CIRRUS-HCM trial represent the patient population studied in the Phase 2 program. The trial specifically enrolled participants with hypertrophic cardiomyopathy, with a focus on those with obstructive physiology.
What do the cited sources confirm?
BioPharma Dive reports the Phase 2 trial readout and describes EDG-7500's mechanism and development pathway. ClinicalTrials.gov confirms CIRRUS-HCM as NCT06347159, a Phase 2 study in adults with hypertrophic cardiomyopathy, and documents the status of related Phase 1 studies evaluating EDG-7500 in special populations.
Is EDG-7500 approved by regulators?
No approval status is confirmed by the available evidence. EDG-7500 remains in Phase 2 clinical development.
What is the mechanism of EDG-7500?
EDG-7500 is a selective cardiac sarcomere modulator designed to address impaired cardiac relaxation associated with hypertrophic cardiomyopathy. The specific molecular targets and binding interactions are not detailed in the available evidence.
What trials are currently active?
CIRRUS-HCM (NCT06347159) is active but not recruiting. A Phase 1 study in adults with hepatic impairment (NCT07324616) is currently recruiting. A Phase 1 study in Caucasian and Japanese adults (NCT07456059) has not yet begun recruiting.
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- Sources analyzed
- 1
- Evidence strength
- 97/100
- Last verified
- Jun 18, 2026
- AI-assisted review
- Yes
- Editorial review
- Dr. Sarah Chen
Critical source quality · grounded in cited primary and secondary sources.
Sources & references 1 primary sources
Sources verified at publication. See our editorial policy and data sources.
This article follows our editorial standards. Report a correction via editorial contact.
