Drugs / IC14
Trials 14
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 12 trials · 1 met primary | ||||||
| Phase 1 | NCT07481474 | Jan → Jun 2027 expected | osteoarthritis, knee | VA Office of Research and Development | Not yet recruiting | No outcome recorded |
| Phase 1 | NCT03487263 | Oct 2017 → Apr 2018 | amyotrophic lateral sclerosis | Implicit Bioscience | Completed | Met primary |
| Phase 1/23 trials | ||||||
| Phase 1/2 | NCT06678074 | Feb 2025 → Jun 2026 overdue | ST-elevation myocardial infarction | Implicit Bioscience | Active not recruiting | No outcome recorded |
| Phase 1/2 | NCT06556810 | Oct 2024 → Apr 2026 overdue | heart failure | Implicit Bioscience | Active not recruiting | No outcome recorded |
| Phase 1/2 | NCT06275893 | Mar 2024 → Aug 2025 | arrhythmogenic right ventricular dysplasia 1, familial isolated arrhythmogenic ventricular dysplasia, left dominant form | Implicit Bioscience | Completed | No outcome recorded |
| Phase 27 trials · 1 missed | ||||||
| Phase 2 | NCT06513949 | Aug 2025 → Sep 2027 expected | acute lung injury, adult acute respiratory distress syndrome | Implicit Bioscience | Recruiting | No outcome recorded |
| Phase 2 | NCT04488081 | Jul 2020 → Jul 2028 expected | COVID-19 | QuantumLeap Healthcare Collaborative | Active not recruiting | Missed primary |
| Phase 2 | NCT03474263 | Sep 2019 → Apr 2021 | amyotrophic lateral sclerosis | Implicit Bioscience | Withdrawn | No outcome recorded Stop: Enrollment |
| Phase 2 | NCT03017547 | Jun 2019 → Jun 2020 | acute respiratory distress syndrome | Implicit Bioscience | Withdrawn | No outcome recorded Stop: Enrollment |
| Phase 2 | NCT03875560 | May 2019 → Jan 2020 | dengue disease | Implicit Bioscience | Withdrawn | No outcome recorded Stop: Enrollment |
| Phase 2 | NCT00233207 | Sep 2005 → Jun 2007 | adult acute respiratory distress syndrome | University of Washington | Terminated | No outcome recorded Stop: Enrollment |
| Phase 2 | NCT00042588 | May 2002 → ? | infectious disease with sepsis, pneumonia | ICOS Corporation | Completed | No outcome recorded |
| Phase not stated2 trials | ||||||
| — | NCT04346277 | — | COVID-19, acute respiratory distress syndrome | Implicit Bioscience | No longer available | No outcome recorded |
| — | NCT04309604 | — | amyotrophic lateral sclerosis | Implicit Bioscience | No longer available | No outcome recorded |
| Comparator or background therapy1 trial | ||||||
| Phase 2 | NCT03508453 Comparator | Aug 2021 → May 2023 | amyotrophic lateral sclerosis | Implicit Bioscience | Withdrawn | No outcome recorded Stop: Enrollment |
News releases announcing trial results or a regulatory action · 7
| Date | Issuer | Release |
|---|---|---|
| 2026-01-27 | Implicit Bioscience | Regulatory MEDIA | Implicit Bioscience’s IC14 Granted FDA Fast Track Designation for Acute Decompensated Heart Failure implicitbioscience.com ↗
Implicit Bioscience today announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation to IC14 (atibuclimab) for the treatment of patients hospitalized with acute decompensated heart failure (ADHF). |
| 2024-12-01 | Implicit Bioscience | Regulatory Media Release | FDA Approves Implicit Drug for Clinical Study in Heart Failure and First Patient Reported to be Responding Well to Treatment implicitbioscience.com ↗
The US Food & Drug Administration has approved the commencement of a clinical study of Implicit Bioscience’s monoclonal anti-CD14 antibody atibuclimab (IC14) in patients with acute decompensated heart failure (ADHF). |
| 2023-11-24 | Implicit Bioscience | Regulatory Promising New Cardiology Program in Heart-stopping Disease implicitbioscience.com ↗
The FDA has approved commencement of atibuclimab in ACM and designated it as an Orphan Drug for the disease. |
| 2022-06-13 | Implicit Bioscience | Results Heart Attack Data Presented In Berlin implicitbioscience.com ↗
Given as a treatment one hour after blood flow to the heart was restarted, the drug protected between 30% and 70% of critical heart functions. |
| 2021-01-12 | Implicit Bioscience | Regulatory FDA Awards IC14 as Orphan Drug for MND implicitbioscience.com ↗
The FDA has designated Brisbane biotech Implicit Bioscience’s biologic IC14 an Orphan Drug for the treatment of motor neurone disease. |
| 2020-12-15 | Implicit Bioscience | Regulatory FDA Grants Approval for Heart Attack Trial implicitbioscience.com ↗
The US Food and Drug Administration has issued a “Study May Proceed” letter approving the commencement of clinical study with IC14 in patients with the most severe form of heart attack. |
| 2020-06-03 | Implicit Bioscience | Regulatory FDA approves COVID-19 study implicitbioscience.com ↗
On June 3, the US FDA approved an Investigative New Drug (IND) application for IC14 together with remdesivir in 300 COVID-19 patients at risk of acute respiratory distress syndrome (ARDS). |
All press releases naming this drug 13 releases
Evidence & citations 6 cited values
Every value below carries the sentence it was read from. 17 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | IC14 | “The objective of this study is to demonstrate the safety and efficacy of IC14 in the treatment of hospitalized patients with community-acquired pneumonia and sepsis.” NCT00042588 ↗12“Atibuclimab (IC14) is a monoclonal antibody against human cluster of differentiation (CD)14, a key signaling molecule of the innate immune system” NCT06556810 ↗ “Atibuclimab (IC14), 20 mg/kg intravenously, once” NCT06678074 ↗ |
| Known as | atibuclimab | “The primary objective was to demonstrate the safety and tolerability of monoclonal antibody against CD14 (IC14) (atibuclimab) in amyotrophic lateral sclerosis patients.” PMID 34678870 ↗ Oct 20215“IC14 (atibuclimab) is a monoclonal anti-CD14 antibody.” PMID 36533976 ↗ Dec 2022 |
| Action | Inhibit | “to block CD14 medicated cellular activation” NCT00233207 ↗ |
| Modality | Monoclonal antibody | “Recombinant Chimeric Monoclonal Antibody” NCT00042588 ↗ |
| Route | Intravenous | “IC14 4 mg/kg IV on Study Day 1” NCT03017547 ↗ |
| Target | CD14 | “a recombinant chimeric monoclonal antibody (mAb) recognizing CD14” NCT00233207 ↗ |