Remove 2016 Remove Pharmacokinetics Remove Small Molecule
article thumbnail

Metabolism of 2023 FDA Approved Small Molecules – PART 1

Metabolite Tales Blog

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.

article thumbnail

The rising impact of biomarkers in early clinical development

Drug Target Review

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.

Insiders

Sign Up for our Newsletter

This site is protected by reCAPTCHA and the Google Privacy Policy and Terms of Service apply.

article thumbnail

New molecular insights on medical cannabis

Drug Target Review

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.

article thumbnail

Looking beyond traditional oncogenic pathways to break cancer resistance

Drug Target Review

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.

article thumbnail

VALILTRAMIPROSATE

New Drug Approvals

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.

article thumbnail

Weight-of-Evidence Assessments: Unpacking New Guidance on Carcinogenicity Testing

The Premier Consulting Blog

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.

article thumbnail

ATICAPRANT

New Drug Approvals

14] Pharmacokinetics The oral bioavailability of aticaprant is 25%. [1] 19] As of 2016, aticaprant has reached phase II clinical trials as an augmentation to antidepressant therapy for treatment-resistant depression. [20] 14] Pharmacokinetics The oral bioavailability of aticaprant is 25%. [1] 2] Aticaprant is taken by mouth. [1]