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Alkermes (ALKS)
NASDAQ:ALKS
Alks 2680
Idiopathic Hypersomnia
Phase II
Recruiting
A Study to Evaluate the Safety and Effectiveness of ALKS 2680 in Subjects With Idiopathic Hypersomnia
Feb 21, 2025
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Alks 2680, 4Mg, Alks 2680, 6Mg, Alks 2680, 8Mg, Alks 2680, 10Mg, Alks 2680, 14Mg, Alks 2680, 18Mg
Idiopathic Hypersomnia, Narcolepsy Type 2, Narcolepsy Type 1
Phase II/III
Recruiting
A Long-Term Study of ALKS 2680 in Subjects With Narcolepsy and Idiopathic Hypersomnia
Jan 06, 2025
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Alks 2680
Narcolepsy Type 2
Phase II
Active Not Recruiting
A Study to Evaluate the Safety and Effectiveness of ALKS 2680 in Subjects With Narcolepsy Type 2
Aug 13, 2024
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Alks 2680
Narcolepsy Type 1
Phase II
Completed
A Study to Evaluate the Safety and Effectiveness of ALKS 2680 in Subjects With Narcolepsy Type 1 (ALKS 2680-201)
Apr 02, 2024
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Olanzapine, Olz/Sam
Schizophrenia, Bipolar I Disorder
Phase III
Recruiting
Study to Evaluate Weight Gain as Assessed by Change in BMI Z-score in Pediatric Subjects With Schizophrenia or Bipolar I Disorder
Mar 22, 2022
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Olz/Sam
Schizophrenia, Bipolar I Disorder
Phase III
Enrolling By Invitation
Long-term Safety Extension Study of OLZ/SAM in Pediatric Subjects
Jul 26, 2021
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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 Alkermes (ALKS) have in its pipeline
ALKS is currently developing the following drugs: Alks 2680, Alks 2680, 4Mg, Alks 2680, 6Mg, Alks 2680, 8Mg, Alks 2680, 10Mg, Alks 2680, 14Mg, Alks 2680, 18Mg, Alks 2680. These drug candidates are in various stages of clinical development as the company works toward FDA approval.