2016 Pharmacokinetics Small Molecule 
Drug Target Review
APRIL 7, 2025
Novel mechanisms of action associated with CGTs naturally create dosing effects that apply in very different ways than with traditional small molecule pharmacotherapies. Silver Spring (MD): Food and Drug Administration (US); 2016-. References FDA-NIH Biomarker Working Group. Bagyinszky E, et al. 21(10):3517.
New Drug Approvals
JULY 28, 2025
133 This first-in-class, small molecule,oral,glucokinaseactivator(GKA)wasfirst approved in ChinainSeptember2022foradultpatientswithT2DMasa monotherapy and in combination with metformin (an antidiabetic medication).134 2016, 10, 1619−26. and 2-chlorophenol (18.5). .; 135) Ren, Y.;
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Metabolite Tales Blog
JANUARY 23, 2024
Metabolism of 2023 FDA Approved Small Molecules – PART 1 By Julia Shanu-Wilson 2023 was a fruitful year for drug approvals by the FDA, with a crop of 34 small molecules out of a total of 55 new drugs [1]. References [1] 2023 Novel Small Molecule FDA Drug Approvals. Basic Clin Pharmacol Toxicol.
Drug Target Review
NOVEMBER 1, 2023
2,8-10 However, the number of compounds with satisfying pharmacokinetic parameters (PKD) are limited, with most unable to cross the blood-brain barrier or go sufficiently deep into a malignant tumour. 2016 Jun 23;59(12):5604–21. Structure–Activity Relationships of Small Molecule Autotaxin Inhibitors with a Discrete Binding Mode.
Drug Target Review
SEPTEMBER 25, 2024
Applying our technology has enabled us to develop a new small molecule, TT125-802, and to assign a new role to the epigenetic regulator CBP/p300 as a novel master regulator of non-oncogene resistance. This orally available small molecule binds to the bromodomain of CBP/p300 in a highly specific manner.
New Drug Approvals
OCTOBER 12, 2024
2016 ; Abushakra et al., ALZ-801 is a potent and orally available small-molecule β-amyloid (Aβ) anti-oligomer and aggregation inhibitor, valine-conjugated proagent of Tramiprosate with substantially improved PK properties and gastrointestinal tolerability compared with the parent compound. Clin Pharmacokinet.
The Premier Consulting Blog
JANUARY 31, 2023
Of note, this guidance is specific to small molecule pharmaceuticals; similar guidance for biologics can be found in the ICH’s S6(R1) Preclinical Safety Evaluation for Biotechnology-Derived Pharmaceuticals. Pharmacokinetic and systemic exposure data is also important to consider.
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