Drugs / Ninerafaxstat
Trials 5
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 2 | NCT07023614 | Oct 2025 → Dec 2026 expected | hypertrophic cardiomyopathy | Imbria Pharmaceuticals, Inc. | Recruiting | No outcome recorded |
| Phase 2 | NCT04826185 | Jun 2021 → Sep 2023 | hypertrophic cardiomyopathy | Imbria Pharmaceuticals, Inc. | Completed | Met primary |
| Phase 2 | NCT04826172 | Apr 2021 → Sep 2023 | coronary artery disorder, ischemic disease | Imbria Pharmaceuticals, Inc. | Completed | Met primary |
| Phase 2 | NCT04826159 | Apr 2021 → Aug 2024 | cardiomyopathy, heart failure, type 2 diabetes mellitus | Imbria Pharmaceuticals, Inc. | Completed | Met primary |
| Phase 2 | NCT04306237 | May 2020 → Feb 2025 | intermediate coronary syndrome | Imbria Pharmaceuticals, Inc. | Withdrawn | No outcome recorded |
News releases announcing trial results or a regulatory action · 9
| Date | Issuer | Release |
|---|---|---|
| 2026-06-24 | Imbria Pharmaceuticals, Inc. | Regulatory Imbria Pharmaceuticals Receives FDA Orphan Drug Designation for Ninerafaxstat for Symptomatic Non-Obstructive Hypertrophic Cardiomyopathy imbria.com ↗
Imbria Pharmaceuticals, Inc. (Imbria), a clinical-stage company developing innovative therapeutics for cardiovascular diseases, today announced that the U.S. Food and Drug Administration (FDA) has granted Orphan Drug Designation to ninerafaxstat for the treatment of symptomatic non-obstructive hypertrophic cardiomyopathy (nHCM). |
| 2026-01-07 | Imbria Pharmaceuticals, Inc. | Results Imbria Pharmaceuticals Announces Publication of IMPROVE-DiCE Phase 2a Data in Circulation, Demonstrating Ninerafaxstat as a Potential First-in-Class Therapy Targeting Cardiac Energetics in Cardiometabolic Disease imbria.com ↗
The peer-reviewed data demonstrated that treatment with ninerafaxstat was associated with improvements in myocardial energy metabolism, enhanced cardiac function, and favorable tolerability in patients with type 2 diabetes mellitus (T2DM), obesity, and heart failure with preserved ejection fraction (HFpEF). |
| 2025-03-29 | Imbria Pharmaceuticals, Inc. | Results Imbria Presents Positive Clinical Data from Phase 2 IMPROVE-DiCE Trial of Ninerafaxstat in Patients with Cardiometabolic HFpEF at ACC.25 imbria.com ↗
Ninerafaxstat improves cardiac energetics, cardiac reserve capacity, 6-minute walk distance and heart failure-related health status (KCCQ) in cardiometabolic HFpEF |
| 2024-08-30 | Imbria Pharmaceuticals, Inc. | Results Imbria to Present Results from Phase 2 IMPROVE-ISCHEMIA Trial of Ninerafaxstat in Patients with Angina and Chronic Coronary Syndrome at the European Society of Cardiology Congress 2024 imbria.com ↗
Ninerafaxstat was well tolerated and showed no impact on systemic hemodynamics in patients with stable angina and chronic coronary syndrome |
| 2024-04-08 | Imbria Pharmaceuticals, Inc. | Results Positive Results for Patients with Non-obstructive Hypertrophic Cardiomyopathy Treated with Ninerafaxstat in the Phase 2 IMPROVE-HCM Trial Presented During a Late-Breaking Clinical Trial Session at ACC.24 imbria.com ↗
Improvements in both patient-reported symptoms of heart failure and ventilatory efficiency during exercise testing were demonstrated |
| 2023-11-12 | Imbria Pharmaceuticals, Inc. | Results Imbria Reports Positive Topline Results for Investigational New Drug Ninerafaxstat in Patients with Cardiac Ischemia and Chronic Stable Angina imbria.com ↗ |
| 2023-11-07 | Imbria Pharmaceuticals, Inc. | Results Imbria Reports Positive Topline Results for Investigational New Drug Ninerafaxstat in Patients with Non-obstructive Hypertrophic Cardiomyopathy imbria.com ↗
At 12-weeks, treatment with ninerafaxstat showed a statistically significant improvement in a robust functional cardiopulmonary exercise test (CPET) measure of established prognostic significance in patients with nHCM and heart failure with preserved ejection fraction (HFpEF). |
| 2022-08-26 | Imbria Pharmaceuticals, Inc. | Results Imbria Presents Positive Clinical Data for Ninerafaxstat from IMPROVE-DiCE at the European Society of Cardiology Congress 2022 imbria.com ↗
Imbria Pharmaceuticals, Inc., a clinical stage, cardiometabolic company developing novel therapies designed to enhance cellular energetics, today announced positive clinical results from the Phase 2, IMPROVE-DiCE trial demonstrating that ninerafaxstat in patients with T2DM and obesity normalized cardiac energetic, reduced cardiac steatosis and improved diastolic function. |
| 2021-05-17 | Imbria Pharmaceuticals, Inc. | Results Imbria Pharmaceuticals Presents Phase 1 and Preclinical Data of IMB-1018972 (IMB-101), an Investigational Cardiac Mitotrope, at the American College of Cardiology 70th Annual Scientific Session & Expo imbria.com ↗
In a separate preclinical study, IMB-101 improved cardiac remodeling and function in a clinically relevant disease model of heart failure (murine permanent coronary artery ligation). |
All press releases naming this drug 21 releases
Evidence & citations 4 cited values
Every value below carries the sentence it was read from. 7 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | ninerafaxstat | “a 2-part open-label, phase 2a trial evaluating the safety and effectiveness of ninerafaxstat, a novel therapeutic designed to enhance cardiac energetics.” PMID 41410037 ↗ Dec 2025 |
| Known as | IMB-1018972 | ClinicalTrials.gov intervention name — accepted as the source's own label NCT04826159 ↗ |
| Modality | Small molecule | — CHEMBL5095242 ↗ |
| Route | Oral | “IMB-1018972 200 mg tablet for oral administration” NCT04306237 ↗ |