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Details:
Submission seeks approval for LDLL600 (landiolol) for the short-term reduction of ventricular rate in patients with supraventricular tachycardia, including atrial fibrillation and atrial flutter.
Lead Product(s): Landiolol Hydrochloride
Therapeutic Area: Cardiology/Vascular Diseases Product Name: LDLL600
Highest Development Status: Phase IIIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable June 01, 2022
Details:
Landiolol is a short-acting, ultra-high selective beta-1 adrenoceptor blocker developed by AOP Health that has a selective effect on heart rate over cardiac contractility.
Lead Product(s): Landiolol Hydrochloride
Therapeutic Area: Cardiology/Vascular Diseases Product Name: LDLL600
Highest Development Status: Phase IIIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable January 31, 2022
Details:
The Company will support the submission of a new drug application to the U.S. FDA seeking approval for Landiolol for the short-term reduction of ventricular rate in patients with supraventricular tachycardia, including atrial fibrillation and atrial flutter.
Lead Product(s): Landiolol Hydrochloride
Therapeutic Area: Cardiology/Vascular Diseases Product Name: LDLL600
Highest Development Status: Phase IIIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Eagle Pharmaceuticals
Deal Size: Undisclosed Upfront Cash: $5.0 million
Deal Type: Licensing Agreement August 09, 2021
Details:
This approval is based on the result of a multi-center, randomized, open-label, parallel-group, late Phase Ⅱ / Ⅲ study (J-Land 3S study: ONO-1101-32) conducted in Japan, in patients with tachyarrhythmia associated with sepsis.
Lead Product(s): Landiolol Hydrochloride
Therapeutic Area: Cardiology/Vascular Diseases Product Name: Onoact
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable June 29, 2020
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