Rapiblyk

(Landiolol)

ApprovedSmall molecule

AAultman Health Foundation

Rapiblyk is one of 89 small molecule programs targeting Septic Shock. It is currently in Approved.

Indications

Total Trials

Active Trials

Competitors

FDA Application

NDA/BLA/ANDA regulatory filings

Patents

Pipeline

Status by Indication[3][1]

Indication

Septic ShockRecruiting

TachycardiaNot yet recruiting

Atrial FibrillationCompleted

Mitral Valve SurgeryRecruiting

Septic ShockPhase 3

Recruiting

TachycardiaApproved

Not yet recruiting

Atrial FibrillationApproved

Completed

Mitral Valve SurgeryApproved

Recruiting

Competition

Competitive Landscape

137 competitors in Atrial Fibrillation

#DrugCompanyPhaseTrials

Rapiblyk

AAultman Health Foundation

Approved

3 2

Calquence

AstraZeneca

Preclinical

1 3

Rituxan

Coumadin

3 5

Brukinsa

BBeOne Medicines

Preclinical

1 6

Imbruvica

PPharmacyclics LLC.

Preclinical

1 7

Versed

CConrado Roberto Hoffmann Filho

Preclinical

1 8

Ondexxya

UUnion Hospital, Tongji Medical College, Huazhong University of Science and Technology

Preclinical

1 9

Romazicon

CConrado Roberto Hoffmann Filho

Preclinical

1 10

Statin

Bristol-Myers Squibb

Preclinical

Ranked by pipeline maturity and clinical activity. Current drug highlighted in teal.

Timeline

Expected Milestones

Q3 2027

Phase 3Recruiting

Septic Shock

NCT04748796

Q4 2027

Post-ApprovalRecruiting

Mitral Valve Surgery

NCT06793670

Q1 2028

Post-ApprovalNot yet recruiting

Tachycardia

NCT07168421

Clinical

Trials by Indication[1]

Atrial Fibrillation3 trials

Prevention of Atrial Fibrillation by Low-dose Landiolol Administration After Cardiac Surgery

Completed·CCMC Ambroise Paré·Phase 3·NCT04607122·400 enrolled

Comparison of Two Strategies for the Management of Atrial Fibrillation After Cardiac Surgery

Unknown status·UUniversity Hospital, Caen·Phase 4·NCT04223739·380 enrolled

Landiolol in Postoperative Atrial Fibrillation

Completed·HHospices Civils de Lyon·Phase 3·NCT03779178·58 enrolled

Tachycardia1 trial

LANdiolol to Avoid TAchycardia in Patients at Risk for Cardiovascular Events Undergoing Major Non-cardiac Surgery

Not yet recruiting·IInsel Gruppe AG, University Hospital Bern·Phase 4·NCT07168421·114 enrolled

Mitral Valve Surgery1 trial

Landiolol in Mitral Valve Surgery

Recruiting·UUniversità Vita-Salute San Raffaele·Phase 4·NCT06793670·1,500 enrolled

Septic Shock1 trial

Comparison of Landiolol Versus Standard of Care for Prevention of Mortality in Patients Hospitalized for a Septic Shock With Hypercontractility

Recruiting·—·Phase 3·NCT04748796·360 enrolled

Cardiac Arrest1 trial

Beta-blockade With Landiolol in Out-of-hospital Cardiac Arrest

Unknown status·MMedical University of Vienna·Phase 1/2·NCT05554978·32 enrolled

1 more indication

Unspecified1 trial

LANdiolol MIcrocirculatory Effects During Septic chOc (MILANOS)

Recruiting·AAssistance Publique - Hôpitaux de Paris·Phase 3·NCT04931225·44 enrolled

Regulatory

FDA Approval Timeline[4]

Nov 22, 2024

RAPIBLYK

NDA NDA217202

Sources

References

[1]
ClinicalTrials.gov — 8 trial records for Landiolol. U.S. National Library of Medicine, National Institutes of Health.
[2]
ChEMBL — Landiolol compound record. European Bioinformatics Institute (EMBL-EBI).
[3]
Open Targets Platform — Drug–disease associations for Landiolol. EMBL-EBI & Wellcome Sanger Institute.
[4]
OpenFDA — FDA approval records (NDA NDA217202). U.S. Food & Drug Administration.
[5]
FDA Orange Book — Patent and exclusivity data for Rapiblyk. U.S. Food & Drug Administration.
[6]
SEC EDGAR — Aultman Health Foundation company filings. U.S. Securities and Exchange Commission.

Details

Drug Info

Quick Facts

Modality: Small molecule[2]
Highest Phase: Approved[1]
Company: AAultman Health Foundation

Patent Landscape[5]

Patent Cliff

Apr 25, 2034

Earliest patent expiration — generic entry possible after this date

Patent #Expires

10722516Apr 25, 2034

Rapiblyk

Status by Indication[3][1]

Competitive Landscape

Expected Milestones

Q3 2027

Q4 2027

Q1 2028

Trials by Indication[1]

Atrial Fibrillation3 trials

Tachycardia1 trial

Mitral Valve Surgery1 trial

Septic Shock1 trial

Cardiac Arrest1 trial

Unspecified1 trial

FDA Approval Timeline[4]

References

Drug Info

Quick Facts

Patent Landscape[5]

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