2011 Clinical Pharmacology Disease 
The Pharma Data
NOVEMBER 1, 2020
Mission Therapeutics is an early-stage drug development company targeting the ubiquitin pathway for the treatment of kidney disease, neurodegenerative disease, rare mitochondrial diseases and fibrosis. The Company is managed by a team with broad international, commercial and clinical-science experience.
New Drug Approvals
SEPTEMBER 13, 2024
2] As of July 2022, it is in phase 3 clinical trials for major depressive disorder. [2] 2] Like other kappa opioid antagonists currently under clinical investigation for the treatment of major depression, its efficacy may be compromised by the countervailing activation of pro-inflammatory cytokines in microglia within the CNS. [7]
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Agency IQ
SEPTEMBER 15, 2023
FDA’s clinical pharmacology analysis challenged previous in vitro estimates of bioavailability for orally administered phenylephrine. Since the 2007 NDAC meeting, several clinical trials have been conducted by industry to assess new phenylephrine doses and formulations—consistently failing to outperform placebo.
Agency IQ
OCTOBER 6, 2023
Taking a closer look, nearly half of the products were reviewed by the Office of Oncologic Diseases. The largest portion of reviews after that were 14% (3 NMEs) each with the Office of Neuroscience and the Office of Rare Diseases, Pediatrics, Urologic and Reproductive Medicine. of all NME approvals this year.
The Pharma Data
FEBRUARY 8, 2021
ACIS is a Phase 3 randomized, double-blind, placebo-controlled, multicenter clinical study evaluating the efficacy and safety of ERLEADA ® and ZYTIGA ® plus prednisone compared to placebo and ZYTIGA ® plus prednisone in 982 patients with chemotherapy-naïve mCRPC disease who received ADT. FDA on February 8, 2018. [vi]
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