Nex-20A
Multiple Myeloma
Early Phase I
Completed
To Assess Safety, Tolerability and PK of NEX-20A, a Subcutaneous Prolonged-release Injection to Healthy Subjects
Nov 21, 2022
―
Nex-18A Injection, Azacitidine Injection
Acute Myeloid Leukemia (Aml), Myelodysplastic Syndromes (Mds), Chronic Myelomonocytic Leukemia (Cmml)
Phase I
Completed
Pharmacokinetics, Tolerability and Safety of NEX-18a
May 11, 2021
―
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 Nanexa AB (40M) have in its pipeline
40M is currently developing the following drugs: Nex-22A, A Prolonged Release Formulation Of Liraglutide, Nex-20A, Nex-18A Injection, Azacitidine Injection. These drug candidates are in various stages of clinical development as the company works toward FDA approval.