landiolol
Approved
Nov 22, 2024
Landiolol, sold under the brand names Onoact and Rapiblyk among others, is a medication used for the treatment of tachycardia, atrial fibrillation, and atrial flutter. It is a beta-adrenergic blocker; an ultra short-acting, β1-superselective intravenous adrenergic antagonist, which decreases the heart rate effectively with less negative effect on blood pressure or myocardial contractility. In comparison to other beta blockers, landiolol has the shortest elimination half-life, ultra-rapid onset of effect, and predictable effectiveness with inactive metabolites. The pure S-enantiomer structure of landiolol is believed to develop less hypotensive side effects in comparison to other β-blockers. This has a positive impact on the treatment of patients when reduction of heart rate without decrease in arterial blood pressure is desired. It is used as landiolol hydrochloride. — Wikipedia
Clinical trial activity
16 trials · 38 clinical orgs · 1 marketing orgs
Earliest trial started Dec 1, 1996 (NCT00212680)
Timeline
1990s
- Jan 1, 1996
Earliest Phase 2 Sponsor(trial)
2000s
- Jan 1, 2009
Earliest Phase 3 Sponsor(trial)
2010s
- Jan 1, 2012
AOP Orphan Pharmaceuticals AG — Earliest Phase 1 Sponsor(trial)
2020s
- Nov 22, 2024
AOP Orphan Pharmaceuticals AG — Earliest FDA Approval
- Nov 22, 2024
AOP Orphan Pharmaceuticals AG — NDA Organization
Indications
Approved for
Studied for
- Anesthesia and Analgesia · Phase 4
- Atrial Fibrillation · Phase 4
- Autonomic Nervous System Diseases · Phase 4
- Cardiac Output, Low · Phase 4
- Coronary Artery Disease · Phase 3
- General Surgery · Phase 4
- Healthy Volunteers · Phase 1
- Heart Arrest · Phase 1/Phase 2
- Heart Failure · Phase 4
- Myocardial Infarction · Phase 4
- Postoperative Complications · Phase 3
- Shock, Septic · Phase 3
- Thoracic Surgery · Phase 4
Mechanism of action
- Beta-1 adrenergic receptorANTAGONIST
ADRB1 antagonist
Approval history
- approvedNov 22, 2024
Chemistry & pharmacology
SMILES
CC1(C)OC[C@@H](COC(=O)CCc2ccc(OC[C@@H](O)CNCCNC(=O)N3CCOCC3)cc2)O1- Mol. weight
- 509.6 g/mol
- Lipinski Ro5
- 1 violation(s)
- Rule of 3
- No
- Chirality
- Single Stereoisomer
- Inorganic
- No
- Polymer
- No
- Delivery
- Parenteral
- Availability
- Prescription Only
Oral
No
Parenteral
Yes
Topical
No
Sources
- WikipediaLandiolol ↗
- ChEMBLCHEMBL1742466 ↗
Also known as
- landiolol
- landiolol
- landiolol
- landiolol
- landiolol
- landiolol
- landiolol
- landiolol hcl
- landiolol hydrochloride
- landiolol hydrochloride
- ldll600
- ono 1101
- ono-1101
- ono-1101
- ono-1101
Clinical trials
| NCT ID | Phase | Start date | Sponsor(s) |
|---|---|---|---|
| NCT07168421 | Phase 4 | Oct 31, 2025 | University of Bern |
| NCT06793670 | Phase 4 | Jan 28, 2025 | Vita-Salute University of Milano. Italy |
| NCT05084118 | Phase 3 | Oct 21, 2021 | Medical University of Vienna |
| NCT04931225 | Phase 3 | Jul 31, 2021 | Assistance Publique - Hôpitaux de Paris |
| NCT05554978 | Phase 1/Phase 2 (Phase 2) | Mar 3, 2021 | Medical University of Vienna |
| NCT04748796 | N/A | Feb 1, 2021 | Centre Guillaume le Conquerant LE HAVRE France, Centre Hospitalier COMPIEGNE, Centre Hospitalier d'Arras, Centre Hospitalier de Beauvais, Centre Hospitalier de Béthune, Centre Hospitalier de Calais, Centre Hospitalier de Cherbourg, Centre Hospitalier de Dieppe, Centre Hospitalier de Douai, Centre Hospitalier de Laon, Centre Hospitalier de Lens, Centre Hospitalier de Roubaix, Centre Hospitalier de Tourcoing, Centre Hospitalier Intercommunal Elbeuf-Louviers / Val de Reuil, Centre Hospitalier Universitaire de Nīmes, CH Montreuil, CHU AMBROISE PARE, CHU Edouard Herriot, CHU Henri Mondor, Hôpital Saint Philibert, Lomme, Hospital Avicenne, Sorbonne University, University of Caen-Normandie, University of Lille, University of Montpellier, University of Picardie Jules Verne, University of Western Brittany, Valenciennes Hospital Centre |
| NCT04607122 | Phase 3 | Dec 28, 2020 | CHU AMBROISE PARE, Hôpital Privé Jacques Cartier, Massy, France |
| NCT04694092 | N/A | Nov 5, 2020 | Charles University |
| NCT04223739 | Phase 4 | Dec 13, 2019 | University of Caen-Normandie |
| NCT03779178 | Phase 3 | Jan 17, 2019 | University of Lyon |
| NCT01741519 | Phase 1 | Dec 1, 2012 | AOP Orphan Pharmaceuticals AG, Cepha s.r.o |
| NCT00924586 | Phase 3 | Jun 1, 2009 | Ono Pharmaceuticals |
| NCT00560209 | Phase 2 | Nov 1, 2007 | Ono Pharmaceuticals |
| NCT00311038 | Phase 2 | Apr 1, 2006 | Ono Pharmaceuticals |
| NCT00212654 | Phase 2/Phase 3 (Phase 3) | Jun 1, 2001 | Ono Pharmaceuticals |
| NCT00212680 | Phase 2 | Dec 1, 1996 | Ono Pharmaceuticals |
Organizations
Research & Development (38)
Marketing (1)
| Organization | Org type | Relationship | Date |
|---|---|---|---|
| AOP Orphan Pharmaceuticals AG | For profit | NDA | Nov 22, 2024 |