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For drug development, the clinical phases start with testing for drug safety in a few human subjects, then expand to many study participants (potentially tens of thousands) to determine if the treatment is effective. [1] Clinical research is conducted on drug candidates, vaccine candidates, new medical devices, and new diagnostic assays.
As of October 2024, CYB003 is in phase 3 clinical trials for major depressive disorder and is in the preclinical stage of development for alcoholism and other psychiatric disorders. [1] [3] Two phase 3 clinical trials for major depressive disorder are being initiated in November 2024 and February 2025. [1] [3] The drug is under development by ...
CagriSema entered Phase III clinical trials in 2023. [6] In December 2024, Novo Nordisk announced the results of REDEFINE 1, one of their series of Phase III trials, testing weekly cagrilintide 2.4 mg and semaglutide 2.4 mg individually and together versus placebo in obese or overweight subjects with one or more comorbidities. [7]
Adverse effects have been observed in a significant proportion of participants in the phase 3 clinical trials for lecanemab(45%) and donanemab(89%).
As of May 2024, the vaccine candidate is in Phase 3 clinical trials, with an estimated completion date of late August 2024. [7] Preliminary results from this trial indicated the vaccine produced a strong immune response, especially in patients over 65, who are at greater risk for severe outcomes from COVID-19. [8]
In a 2021 placebo controlled phase II clinical trial, KarXT met the primary endpoint. [11] In March 2023, Karuna Therapeutics announced that KarXT had met its primary endpoint in a phase III trial, EMERGENT-3, and that it was submitting the drug for approval by the US Food and Drug Administration (FDA). [12]
In 2019, Johnson & Johnson announced that its subsidiary, Janssen Vaccines, would launch a Phase 3 clinical trial of a mosaic-based HIV vaccine candidate under the trial name HVTN 706/HPX3002/MOSAICO with a target enrollment of 3800 participants for 55 clinical sites in Argentina, Brazil, Italy, Mexico, Peru, Poland, Spain, and the United ...
This trial failed to show positive results, [18] despite the high expectations. The trial will be finalized in 2020. [17] The Anti-Amyloid Treatment in Asymptomatic Alzheimer’s (A4) study is a phase 3 clinical trial to evaluate whether solanezumab can slow cognitive decline in cognitively unimpaired older adults with elevated levels of ...
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related to: current phase 3 clinical trials