Drugs / Landiolol
Landiolol
also known as
ONO-1101 · AOP200704 · landiolol hydrochloride · LDLL600 · Ono 1101 hydrochloride · Onoact · Rapibloc · Rapiblyk
Small molecule targets ADRB1 via inhibition
Regulatory milestones approvals, filings & regulatory actions · 2 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Label expansion | US (FDA) | RAPIBLYK | — | 2026-02-13 | fda.gov ↗ |
| Approved | US (FDA) | RAPIBLYK | — | 2024-11-22 | fda.gov ↗ |
Trials 15
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 11 trial | ||||||
| Phase 1 | NCT01741519 | Dec 2012 → Jan 2013 | — | AOP Orphan Pharmaceuticals AG | Completed | No outcome recorded |
| Phase 1/21 trial | ||||||
| Phase 1/2 | NCT05554978 | Mar 2021 → Dec 2023 | cardiac arrest | Medical University of Vienna | Unknown | No outcome recorded |
| Phase 24 trials | ||||||
| Phase 2 | NCT01313143 | Mar → May 2011 | — | AOP Orphan Pharmaceuticals AG | Completed | No outcome recorded |
| Phase 2 | NCT00560209 | Nov 2007 → Nov 2008 | coronary artery disorder | Ono Pharmaceutical Co., Ltd. | Completed | No outcome recorded |
| Phase 2 | NCT00311038 | Apr 2006 → ? | coronary artery disorder | Ono Pharmaceutical Co., Ltd. | Completed | No outcome recorded |
| Phase 2 | NCT00212680 | Dec 1996 → Apr 2006 | atrial tachycardia | Ono Pharma USA Inc | Completed | No outcome recorded |
| Phase 2/31 trial | ||||||
| Phase 2/3 | NCT00212654 | Jun 2001 → Apr 2006 | atrial tachycardia | Ono Pharmaceutical Co., Ltd. | Completed | No outcome recorded |
| Phase 35 trials · 1 missed | ||||||
| Phase 3 | NCT04931225 | Jul 2022 → Jul 2026 overdue | infectious disease with sepsis | Assistance Publique - Hôpitaux de Paris | Recruiting | No outcome recorded |
| Phase 3 | NCT04748796 | Feb 2021 → Jun 2027 expected | cardiac rhythm disease, infectious disease with sepsis | Centre Hospitalier Universitaire, Amiens | Recruiting | No outcome recorded |
| Phase 3 | NCT04607122 | Jan 2021 → Jun 2023 | atrial fibrillation | CMC Ambroise Paré | Completed | Missed primary |
| Phase 3 | NCT03779178 | Jan → Dec 2019 | atrial fibrillation | Hospices Civils de Lyon | Completed | No outcome recorded |
| Phase 3 | NCT00924586 | Jun 2009 → Feb 2010 | coronary artery disorder | Ono Pharmaceutical Co., Ltd. | Completed | No outcome recorded |
| Phase 42 trials | ||||||
| Phase 4 | NCT07168421 | Apr 2026 → Jan 2028 expected | dysautonomia, myocardial disorder | Insel Gruppe AG, University Hospital Bern | Recruiting | No outcome recorded |
| Phase 4 | NCT06793670 | Jan 2025 → Jun 2027 expected | cardiogenic shock, heart failure | Vita-Salute San Raffaele University | Recruiting | No outcome recorded |
| Phase not applicable1 trial | ||||||
| — | NCT04694092 | Nov 2020 → Dec 2023 | atrial fibrillation, left ventricular failure | Institute for Clinical and Experimental Medicine | Unknown | No outcome recorded |
| Comparator or background therapy2 trials | ||||||
| Phase 3 | NCT05084118 Comparator | Oct 2021 → Nov 2023 | atrial fibrillation | Medical University of Vienna | Unknown | No outcome recorded |
| Phase 4 | NCT04223739 Comparator | Dec 2019 → Jun 2021 | atrial fibrillation | University Hospital, Caen | Unknown | No outcome recorded |
News releases announcing trial results or a regulatory action · 4
| Date | Issuer | Release |
|---|---|---|
| 2026-04-15 | AOP Orphan Pharmaceuticals AG | Regulatory Rapiblyk® (landiolol) is available for Pediatric Patients with SVT aop-health.com ↗
AOP Health US, LLC today announced that the U.S. Food and Drug Administration (FDA) has approved RAPIBLYK® (landiolol) for use in pediatric patients (from birth to <18 years of age) with supraventricular tachycardia (SVT). |
| 2024-11-27 | AOP Orphan Pharmaceuticals AG | Regulatory U.S. FDA approves AOP Health’s Rapiblyk™ aop-health.com ↗
U.S. FDA approves AOP Health’s Rapiblyk™ (landiolol) for ventricular rate control in adults with supraventricular tachycardia including atrial fibrillation and atrial flutter in the critical care setting. |
| 2022-08-24 | Ono Pharmaceutical Co., Ltd. | Regulatory A Short-Acting Selective β 1 Blocker, Onoact® for Intravenous Infusion 50mg/150mg Approved for Additional Indication of Tachyarrhythmia in Pediatric Patients with Low Cardiac Function in Japan ono-pharma.com ↗
ONO received an approval of Onoact® (generic name: landiolol hydrochloride) for Intravenous Infusion 50mg/150mg (“Onoact”) |
| 2021-10-28 | Ono Pharmaceutical Co., Ltd. | Regulatory ONO Submits an Application of ONOACT® for Intravenous Infusion 50mg/150mg, a Short-Acting Selective β 1 Blocker, in Japan for Additional Indication of Tachyarrhythmia in Pediatric Patients with Low Cardiac Function for a Partial Change in Approved Items of Manufacturing and Marketing Approval ono-pharma.com ↗
it submitted an application of ONOACT® for Intravenous Infusion 50mg/150mg |
All press releases naming this drug 8 releases
Evidence & citations 13 cited values
Every value below carries the sentence it was read from. 19 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | Landiolol | ClinicalTrials.gov intervention name — accepted as the source's own label NCT04931225 ↗ |
| Known as | AOP200704 | ClinicalTrials.gov intervention name — accepted as the source's own label NCT01313143 ↗ |
| Known as | landiolol hydrochloride | “A randomized, double-blind, placebo-controlled, phase II dose-finding study of the short acting β1-blocker, landiolol hydrochloride, in patients with suspected ischemic cardiac disease.” PMID 23784548 ↗ Jun 2013 |
| Known as | LDLL600 | ClinicalTrials.gov intervention name — accepted as the source's own label NCT01741519 ↗ |
| Known as | Ono 1101 hydrochloride | ChEMBL registry synonym — accepted as the source's own label CHEMBL1742466 ↗ |
| Known as | ONO-1101 | ClinicalTrials.gov intervention name — accepted as the source's own label NCT00924586 ↗ |
| Known as | Onoact | ChEMBL registry synonym — accepted as the source's own label CHEMBL1742466 ↗ |
| Known as | Rapibloc | “Landiolol (Rapibloc)'s perfusion will be started at T0 at 0.5 mcg/kg/min and increased by 0.5 mcg/kg/min every 30 minutes in order to achieve a 15% (T1) decrease in HR, within...” NCT04931225 ↗ |
| Known as | Rapiblyk | ChEMBL registry synonym — accepted as the source's own label CHEMBL1742466 ↗ |
| Action | Inhibit | “Beta-1 adrenergic receptor antagonist” CHEMBL1742466 ↗1“short-acting β1-receptor blocker” PMID 23784548 ↗ Jun 2013 |
| Modality | Small molecule | — CHEMBL1742466 ↗ |
| Route | Intravenous | “0.06 mg/kg for 1 minute IV” NCT00560209 ↗ |
| Target | ADRB1 | “Beta-1 adrenergic receptor antagonist” CHEMBL1742466 ↗ |