Drugs / AC01
Trials 2
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 1/21 trial | ||||||
| Phase 1/2 | NCT05642507 | Feb 2023 → Oct 2025 | symptomatic heart failure | AnaCardio AB | Completed | No outcome recorded |
| Phase 21 trial | ||||||
| Phase 2 | NCT07584967 | Aug 2026 → Apr 2028 expected | systolic heart failure | AnaCardio AB | Not yet recruiting | No outcome recorded |
News releases announcing trial results or a regulatory action · 10
| Date | Issuer | Release |
|---|---|---|
| 2026-06-24 | AnaCardio AB | Results AnaCardio´s Phase 1b/2a GOAL-HF1 study in patients with Heart Failure and Reduced Ejection Fraction (HFrEF) published in The Lancet anacardio.com ↗
AnaCardio, a clinical stage biopharmaceutical company developing novel drugs to treat heart failure, today announced the publication in The Lancet of results from its Phase 1b/2a GOAL-HF1 study evaluating AC01, a first-in-class, oral calcium-sensitising contractile agent, in patients with heart failure with reduced ejection fraction (HFrEF). |
| 2026-05-11 | AnaCardio AB | Results AnaCardio Announces Phase 1b/2a GOAL-HF1 Results of AC01 Demonstrating Favorable Safety and Sustained Improvements in Cardiac Function on Top of Standard-of-Care Therapy in HFrEF at Late-Breaking Session at HFA 2026 anacardio.com ↗
AnaCardio today announced detailed results from its Phase 1b/2a GOAL-HF1 study evaluating AC01 in patients with heart failure with reduced ejection fraction (HFrEF), presented in a Late-Breaking Science session at the European Society of Cardiology (ESC) Heart Failure Association (HFA) Congress 2026 in Barcelona, Spain. |
| 2026-03-26 | AnaCardio AB | Results AnaCardio’s AC01 Phase 1b/2a HFrEF Study Selected for Late-Breaking Science Presentation at the Heart Failure 2026 Congress anacardio.com ↗
AC01 demonstrated a favorable safety and tolerability profile, achieved target engagement and exhibited promising signals of improved systolic function. |
| 2025-12-10 | AnaCardio AB | Results AnaCardio Reports Strong Phase 2a Topline Results for AC01 in patients with heart failure and reduced ejection fraction (HFrEF); Paving the Way for Rapid Advancement to Phase 2b anacardio.com ↗
AnaCardio, a clinical-stage biopharmaceutical company developing novel contractile agents for heart failure, today announces strong topline results from the Phase 2a portion of its GOAL-HF1 clinical study program evaluating AC01 in patients with heart failure and reduced ejection fraction (HFrEF). |
| 2025-07-17 | AnaCardio AB | Regulatory AnaCardio announces positive scientific advice from the FDA and EMA, establishing a favourable development path for AC01 treatment of chronic HFrEF anacardio.com ↗
The guidance provided was well aligned across agencies and supports a lean and straightforward development path to satisfy both the FDA and EMA recommendations. |
| 2025-03-13 | AnaCardio AB | Regulatory AnaCardio receives patent grant in Europe for AC01 anacardio.com ↗
today announced that European patent EP4346820 has been issued by the European Patent Office (EPO), securing the use of AC01/HM01 as an inotropic agent. |
| 2025-01-09 | AnaCardio AB | Results AnaCardio raises USD 19 million to advance first-in-class drug candidate AC01 for heart failure anacardio.com ↗
In the present study, AC01 was well-tolerated with no Treatment Emergent Adverse Event (TEAE) resulting in treatment discontinuation, and no severe TEAEs. |
| 2024-09-17 | AnaCardio AB | Results AnaCardio successfully completes first part of AC01 HFrEF study and provides a clinical update anacardio.com ↗
All 24 participants completed the study; AC01 was safe and well-tolerated under both fed and fasted conditions. |
| 2023-08-17 | AnaCardio AB | Regulatory AnaCardio receives IND approval from the FDA for AC01 to Start a Clinical Pharmacology Study anacardio.com ↗
AnaCardio, a Swedish clinical-stage biopharmaceutical company focussing on developing novel contractile agents to treat patients with heart failure, today announced that the U.S. Food and Drug Administration (FDA) has granted the company’s Investigational New Drug (IND) application for the investigational drug AC01. |
| 2022-11-17 | AnaCardio AB | Regulatory AnaCardio Receives Regulatory Approval to Start a Phase 1b/2a Clinical Study in Heart Failure with AC01 in the EU and UK anacardio.com ↗
AnaCardio today announces approval for the GOAL-HF1 Phase 1b/2a study from the competent authorities and ethics committes in Sweden, The Netherlands, Italy and the United Kingdom. |
All press releases naming this drug 16 releases
Evidence & citations 3 cited values
Every value below carries the sentence it was read from. 3 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | AC01 | ClinicalTrials.gov intervention name — accepted as the source's own label NCT05642507 ↗ |
| Action | Activate | “ghrelin receptor agonist” PMID 42341796 ↗ Jun 2026 |
| Route | Oral | “patients were given AC01 orally twice daily for seven days.” NCT05642507 ↗ |