KalVista Pharmaceuticals, Inc. (DE:4XC1)
NASDAQ:4XC1
Kvd900 600 Mg, Kvd900 300 Mg, Kvd900 150 Mg
Hereditary Angioedema
Phase III
Recruiting
Open-Label Safety, PK, and Efficacy Trial of Sebetralstat (KVD900) in Pediatric Patients (Ages 2-11) With HAE Type I or II
Jun 14, 2024
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Kvd900 600 Mg, Kvd900 300 Mg
Hereditary Angioedema
Phase III
Active 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)
Aug 11, 2022
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Kvd900 600 Mg, Drug: Kvd900 300 Mg
Hereditary Angioedema
Phase III
Active Not Recruiting
PK Subtrial in Adolescent Patients With HAE Type I or II Participating in the KVD900-302 Trial
Aug 11, 2022
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Kvd900 600 Mg, Kvd900 300 Mg
Hereditary Angioedema
Phase III
Completed
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)
Feb 04, 2022
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Kvd900
Hereditary Angioedema
Phase I
Completed
A Single Dose Safety, Tolerability, Pharmacokinetic and Food Effect Study of KVD900 (Sebetralstat) in Healthy Volunteers
Mar 09, 2020
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Kvd900
Hereditary Angioedema
Phase II
Completed
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
Dec 20, 2019
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FAQ
What are the FDA phases for drug approval?
The FDA approval process for new drugs is divided into several phases:
a. Preclinical testing
b. Phase 1 – Safety and dosage
c. Phase 2 – Effectiveness and side effects
d. Phase 3 – Confirmation of effectiveness, monitoring of adverse reactions, and comparison with existing treatments
e. Phase 4 – Post-marketing studies to track long-term safety and effectiveness
a. Preclinical testing
b. Phase 1 – Safety and dosage
c. Phase 2 – Effectiveness and side effects
d. Phase 3 – Confirmation of effectiveness, monitoring of adverse reactions, and comparison with existing treatments
e. Phase 4 – Post-marketing studies to track long-term safety and effectiveness
What is a clinical trial?
A clinical trial is a carefully designed study in which researchers test a drug, treatment, or medical device in people to evaluate its safety, effectiveness, and potential side effects. These trials are essential for determining whether a new treatment should be approved for widespread use.
What drugs does KalVista Pharmaceuticals, Inc. (4XC1) have in its pipeline
4XC1 is currently developing the following drugs: Kvd900 600 Mg, Kvd900 300 Mg, Kvd900 150 Mg, Kvd900 600 Mg, Kvd900 300 Mg, Kvd900 600 Mg, Drug: Kvd900 300 Mg. These drug candidates are in various stages of clinical development as the company works toward FDA approval.