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Moleculin Biotech (MBRX)
NASDAQ:MBRX
Liposomal Annamycin Injection In Combination With Cytarabine Injection, Liposomal Annamycin For Injection In Combination With Cytarabine Injection.
Acute Myeloid Leukaemia (Aml)
Phase II/III
Recruiting
L-Annamycin for Injection in Combination With Cytarabine Injection as Second Line Therapy for Remission Induction in Adult Subjects With Refractory/Relapsed AML
Dec 05, 2024
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Cytarabine, Liposomal Annamycin
Leukemia, Myeloid, Acute
Phase I/II
Completed
Study of Liposomal Annamycin in Combination With Cytarabine for the Treatment of Subjects With Acute Myeloid Leukemia (AML)
Feb 22, 2022
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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 Moleculin Biotech (MBRX) have in its pipeline
MBRX is currently developing the following drugs: Liposomal Annamycin Injection In Combination With Cytarabine Injection, Liposomal Annamycin For Injection In Combination With Cytarabine Injection., Cytarabine, Liposomal Annamycin. These drug candidates are in various stages of clinical development as the company works toward FDA approval.