Aura Biosciences Inc (AURA)
NASDAQ:AURA
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Suprachoroidal Microinjector, Bel-Sar, Infrared Laser, Sham Infrared Laser, Sham Microinjector
Uveal Melanoma, Ocular Melanoma, Choroidal Melanoma, Indeterminate Lesions
Phase III
Recruiting
A Phase 3 Randomized, Masked, Controlled Trial to Evaluate Efficacy and Safety of Belzupacap Sarotalocan (AU-011) Treatment Compared to Sham Control in Subjects With Primary Indeterminate Lesions or Small Choroidal Melanoma
Aug 17, 2023
Au-011, Au-011 In Combination With Medical Laser Adminstration, Au-011 In Combination With Medical Laser Administration
Non-Muscle-Invasive Bladder Cancer, Nmibc, Urothelial Carcinoma Bladder, Non-Muscle Invasive Bladder Cancer (&Amp;#34;Nmibc&Amp;#34;) Unresponsive/Intolerant To Bcg, Non-Muscle Invasive Bladder Carcinoma, Non-Muscle Invasive Bladder Neoplasms, Non-Muscle Invasive Bladder Urothelial Carcinoma
Phase I
Recruiting
A Phase 1, Open-label Trial of Belzupacap Sarotalocan (AU-011) in Bladder Cancer
Jul 20, 2022
Au-011, Suprachoroidal Microinjector, Pdt Laser
Ocular Melanoma, Uveal Melanoma, Choroidal Melanoma
Phase II
Completed
Phase 2 Trial to Evaluate Belzupacap Sarotalocan (AU-011) Via Suprachoroidal Administration in Subjects With Primary Indeterminate Lesions and Small Choroidal Melanoma
Jun 02, 2020
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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 Aura Biosciences Inc (AURA) have in its pipeline
AURA is currently developing the following drugs: Au-011, Scs Microinjector, Laser, Suprachoroidal Microinjector, Bel-Sar, Infrared Laser, Sham Infrared Laser, Sham Microinjector, Au-011, Au-011 In Combination With Medical Laser Adminstration, Au-011 In Combination With Medical Laser Administration. These drug candidates are in various stages of clinical development as the company works toward FDA approval.