Drugs / ENIBARCIMAB
Trials 4
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 23 trials · 1 met primary | ||||||
| Phase 2 | NCT05156671 | Oct 2022 → Aug 2023 | COVID-19 | University Medical Center Hamburg-Eppendorf | Terminated | No outcome recorded Stop: Enrollment |
| Phase 2 | NCT04252937 | Dec 2019 → Dec 2021 | heart failure | GREAT Network Italy | Unknown | No outcome recorded |
| Phase 2 | NCT03085758 | Dec 2017 → Dec 2019 | infectious disease with sepsis | Adrenomed AG | Completed | Met primary |
| Phase 2/31 trial · 1 missed | ||||||
| Phase 2/3 | NCT03989531 | Apr 2019 → Apr 2021 | cardiogenic shock | Dr. med. Mahir Karakas | Completed | Missed primary |
| Comparator or background therapy2 trials | ||||||
| Phase 1 | NCT03083171 Comparator | Jan → May 2017 | — | Adrenomed AG | Completed | No outcome recorded |
| Phase 1 | NCT02991508 Comparator | May → Sep 2016 | — | Radboud University Medical Center | Completed | No outcome recorded |
News releases announcing trial results or a regulatory action · 12
| Date | Issuer | Release |
|---|---|---|
| 2025-05-20 | Adrenomed AG | Results Journal of Critical Care publishes positive results from prespecified, biomarker-guided subgroup analysis of AdrenoMed’s Phase II AdrenOSS-2 trial in septic shock adrenomed.com ↗ |
| 2023-09-08 | Adrenomed AG | Results Adrenomed presents new findings on its precision medicine treatment for septic shock with enibarcimab during Weimar Sepsis Update adrenomed.com ↗
Adrenomed AG, the vascular integrity company, today announced new findings on the biomarker-guided treatment of septic shock with enibarcimab. |
| 2022-04-11 | Adrenomed AG | Regulatory PEI Regulatory Approval Received for Government Funded (€ 7.4 Million) Clinical Trial Investigating Adrenomed’s Adrecizumab in Treating Endothelial Barrier Dysfunction in Hospitalized COVID-19 Patients adrenomed.com ↗
The University Medical Center Eppendorf (UKE) Hamburg and Adrenomed will receive funds to conduct an investigator initiated Phase II clinical trial with Adrecizumab in hospitalized patients with moderate to severe COVID-19, which has received regulatory approval by the German federal agency, Paul Ehrlich Institute (PEI). |
| 2020-12-02 | Adrenomed AG | Results Efficacy Data from Adrenomed’s AdrenOSS-2 Phase II trial evaluating Adrecizumab (HAM8101) in Septic Shock presented at DIVI adrenomed.com ↗
In the biomarker-guided post-hoc analysis, in particular early treatment with Adrecizumab after ICU admission resulted in a significant and fast improvement of mean fluid balance, a surrogate endpoint for vascular leakage. |
| 2020-11-30 | Adrenomed AG | Results Adrenomed closes EUR 22 million equity financing to accelerate development of Adrecizumab (HAM8101) and provides business update adrenomed.com ↗
Based on the detailed findings of the Phase II study AdrenOSS-2, which have been extensively explored over the past months, the Company is developing a personalized, biomarker-guided clinical trial strategy. |
| 2020-09-16 | Adrenomed AG | Results Positive Results from Adrenomed’s AdrenOSS-2 Phase II trial evaluating Adrecizumab (HAM8101) in Septic Shock presented during e-ISICEM adrenomed.com ↗ |
| 2020-08-24 | Adrenomed AG | Results Targeting endothelial barrier function in critically ill COVID-19 patients: Adrecizumab shows beneficial effects adrenomed.com ↗ |
| 2020-02-21 | Adrenomed AG | Results Adrenomed Announces Positive Top-Line AdrenOSS-2 Phase II Results with Adrecizumab in Septic Shock adrenomed.com ↗
The study achieved its primary endpoint: Adrecizumab demonstrated a favorable safety profile and was well tolerated. |
| 2019-03-21 | Adrenomed AG | Results Adrenomed’s Adrecizumab successfully passes interim analysis in early septic shock study AdrenOSS-II adrenomed.com ↗
Adrenomed AG, the vascular integrity company, announced today that the phase II AdrenOSS-II trial, evaluating Adrecizumab in patients with early septic shock, will continue as intended after successful completion of a planned interim analysis for 50 % (n= 150) of randomized patients. |
| 2018-06-14 | Adrenomed AG | Results Adrenomed AG reveals Adrecizumab mode of action adrenomed.com ↗
Data generated in two animal models for sepsis and in humans with systemic inflammation show that Adrecizumab restores the impaired vascular barrier function that causes hemodynamic instability in sepsis and leads to edema formation, organ failure and shock. |
| 2017-08-11 | Adrenomed AG | Regulatory Adrenomed AG receives approval to conduct proof of concept study with Adrecizumab to treat patients with early septic shock adrenomed.com ↗
German corporation Adrenomed AG today announced that it received the favorable opinion of the Central Ethics Committee of the University of Aachen for its Phase-II study ADR-02 (AdrenOSS-2). |
| 2017-03-08 | Adrenomed AG | Results Adrecizumab is safe, well tolerated and shows additional therapeutic potential in acute heart failure adrenomed.com ↗
Adrenomed AG announces the successful completion of a first-in-human study (Phase-I) that demonstrates excellent safety and tolerability of Adrecizumab in healthy volunteers. |
All press releases naming this drug 19 releases
Evidence & citations 8 cited values
Every value below carries the sentence it was read from. 8 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | ENIBARCIMAB | ChEMBL registry synonym — accepted as the source's own label CHEMBL4650434 ↗ |
| Known as | Adrecizumab | ClinicalTrials.gov intervention name — accepted as the source's own label NCT03085758 ↗ |
| Known as | HAM8101 | “A Randomized Double-blind Placebo-controlled Phase I Study on the Safety, Tolerability and Pharmacokinetics/-Dynamics of Escalating Single Intravenous Doses of ADRECIZUMAB...” NCT03083171 ↗3“A Randomized Double-blind Placebo-controlled Phase 1 Study on the Safety, Tolerability and Pharmacokinetics/-Dynamics of Escalating Single Intravenous Doses of ADRECIZUMAB...” NCT02991508 ↗ “Safety and tolerability of non-neutralizing adrenomedullin antibody adrecizumab (HAM8101) in septic shock patients: the AdrenOSS-2 phase 2a biomarker-guided trial.” PMID 34605947 ↗ Oct 2021 “Adrecizumab (HAM 8101) on top of standard of care.” NCT05156671 ↗ |
| Known as | HAM8101 (Adrecizumab) | “HAM8101 (Adrecizumab) is a humanized IgG1 monoclonal antibody (mAb).” NCT04252937 ↗ |
| Action | Inhibit | “only partially inhibits the bioactivity of ADM” NCT02991508 ↗ |
| Modality | Monoclonal antibody | “monoclonal adrenomedullin antibody” PMID 34605947 ↗ Oct 2021 |
| Route | Intravenous | “single Intravenous Doses” NCT02991508 ↗ |
| Target | ADM | “antibody against the N-terminus of ADM” NCT02991508 ↗ |