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Kazia Therapeutics Limited (KZIA)
NASDAQ:KZIA
Evt801
Solid Tumor, Adult
Phase I
Completed
Safety, Tolerability, and Pharmacokinetics of EVT801 in Patients With Advanced Solid Tumours
Oct 06, 2021
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[14C]-Paxalisib Capsule
Healthy
Phase I
Completed
Mass Balance Recovery, Metabolite Profile, and Metabolite Identification of [14C]-Paxalisib in Healthy Male Subjects
Aug 04, 2021
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Paxalisib (Gdc-0084)
Glioblastoma, Adult
Phase II
Completed
Safety, Pharmacokinetics and Efficacy of Paxalisib (GDC-0084) in Newly-diagnosed Glioblastoma
Mar 20, 2018
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Part A: Dose Escalation Of Cantrixil, Part B: Expansion Cohort Of Cantrixil
Ovarian Neoplasms, Fallopian Tube Neoplasms, Peritoneal Neoplasms
Phase I
Completed
Phase I Study of Cantrixil in Patients With Ovarian Cancer, Fallopian Tube Cancer or Primary Peritoneal Cancer.
Sep 12, 2016
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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 Kazia Therapeutics Limited (KZIA) have in its pipeline
KZIA is currently developing the following drugs: Evt801, [14C]-Paxalisib Capsule, Paxalisib (Gdc-0084). These drug candidates are in various stages of clinical development as the company works toward FDA approval.