EKTERLY

LaunchSM

sebetralstat

NDAORALTABLET
Approved
Jul 2025
Lifecycle
Launch
Competitive Pressure
0/100
Clinical Trials
7

Mechanism of Action

Kallikrein Inhibitors

Pharmacologic Class:

Plasma Kallikrein Inhibitor

Clinical Trials (5)

NCT06467084Phase 3Completed

Open-Label Safety, PK, and Efficacy Trial of Sebetralstat (KVD900) in Pediatric Patients (Ages 2-11) With HAE Type I or II

Started Jun 2024
NCT05505916Phase 3Active Not Recruiting

An Open-label Extension Trial to Evaluate the Long-term Safety of KVD900 (Sebetralstat) for On-Demand Treatment of Angioedema Attacks in Adolescent and Adult Patients With Hereditary Angioedema (HAE)

Started Oct 2022
NCT05259917Phase 3Completed

A Phase III, Crossover Trial Evaluating the Efficacy and Safety of KVD900 (Sebetralstat) for On-Demand Treatment of Angioedema Attacks in Adolescent and Adult Patients With Hereditary Angioedema (HAE)

Started Feb 2022
NCT04208412Phase 2Completed

A Phase II, Cross-over Clinical Trial Evaluating the Efficacy and Safety of KVD900 (Sebetralstat) in the On-demand Treatment of Angioedema Attacks in Adult Subjects With Hereditary Angioedema Type I or II

Started Jul 2019
NCT04349800Phase 1Completed

A Single Dose Safety, Tolerability, Pharmacokinetic and Food Effect Study of KVD900 (Sebetralstat) in Healthy Volunteers

Started Jan 2018

Loss of Exclusivity

LOE Date
Jan 26, 2039
157 months away
Patent Expiry
Jan 26, 2039
Exclusivity Expiry
Jul 3, 2030

Patent Records (5)

Patent #ExpiryTypeUse Code
10364238
Nov 26, 2035
SubstanceProduct
10611758
Nov 26, 2035
U-4223
11001578
Nov 26, 2035
SubstanceProduct
11084809
Nov 26, 2035
SubstanceProduct
U-4223
11198691
Nov 26, 2035
U-4223