Article, Pharmacokinetics and Small Molecule

Metabolism of 2023 FDA Approved Small Molecules – PART 2

Metabolite Tales Blog

APRIL 10, 2024

Table 1: Small molecule drugs approved by the FDA in 2023 with reported involvement of phase II mechanisms In vitro : In vivo differences Incubation of the SGLT2 (sodium-glucose co-transporter-2) inhibitor bexagliflozin in human liver microsomes points to metabolism through both oxidation and glucuronidation to 6 main metabolites.

Small Molecule

Small Molecule FDA Approval FDA Pharmacokinetics

Metabolism of 2023 FDA Approved Small Molecules – PART 1

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. Health Sci Rep. 6(10):e1610.

Small Molecule

Small Molecule FDA Approval FDA Pharmacokinetics

Pharmacokinetics, Pharmacodynamics and Toxicokinetics Demystified

Alta Sciences

JANUARY 31, 2024

Pharmacokinetics, Pharmacodynamics and Toxicokinetics Demystified pmjackson Wed, 01/31/2024 - 14:55 Understanding the effects of a drug, and how it interacts with the body, and vice versa, is critical to ensure it is safe for human use. This is where pharmacokinetic (PK), pharmacodynamic (PD) , and toxicokinetic (TK) analyses step in.

Pharmacokinetics

Pharmacokinetics Clinical Trials Drug Development Trials

The rising impact of biomarkers in early clinical development

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. Trial design and statistical methods are also key to determining the utility and validity of biomarkers.

Clinical Development

Clinical Development Clinical Trials Clinical Pharmacology Trials

A spatial approach to understanding drug dynamics using mass spectrometry imaging

Drug Target Review

JUNE 16, 2025

Unlike traditional pharmacokinetic (PK) studies that rely on plasma measurements alone, MSI, when combined with traditional histology, enables spatial mapping of drug distribution, metabolism and target engagement. This article explores the principles, applications and future potential of MSI in drug development. 2024, Article ASAP.

Drugs

Drugs Organic Chemistry Laboratories Pharmaceuticals

Chemical probes and permeability

Molecular Design

FEBRUARY 7, 2023

The FDH is covered in the S2010 (see Box 1 and 2) and B2013 articles and, given that the targets of small molecule drugs tend to be intracellular, I’ll direct you to the excellent Smith & Rowland perspective on intracellular and intraorgan concentrations of drugs.

Pharmacokinetics

Pharmacokinetics Small Molecule Disease Clinical Trials

Crinecerfont

New Drug Approvals

APRIL 18, 2025

This article incorporates text from this source, which is in the public domain. ^ “Novel Drug Approvals for 2024” U.S. Article ] Yogi A, Kashimada K: Current and future perspectives on clinical management of classic 21-hydroxylase deficiency. Food and Drug Administration (FDA) (Press release). 1 October 2024. PMC 10583973.

FDA

FDA FDA Approval Drugs Trials

Five Promising Treatment Areas in Early-Phase Drug Development in 2024

Alta Sciences

APRIL 17, 2024

In this blog article, we review some of these areas of investigation where Altasciences has robust expertise and solution offerings. According to a 2022 article published in Molecular Psychiatry, treatment resistance affects 20 to 60% of patients with psychiatric disorders. Asia, and Europe.

Drug Development

Drug Development Treatment Drugs FDA Approval

Concert Pharmaceuticals Reports Third Quarter 2020 Financial Results and Provides Company Update

The Pharma Data

NOVEMBER 4, 2020

The article, entitled “Burden of Illness in Alopecia Areata: A Cross-Sectional Online Survey Study,” is available online at: [link]. CTP-692: An Investigational Adjunctive Treatment for Schizophrenia. CTP-692 Phase 2 Enrollment Complete.

Pharmaceuticals

Pharmaceuticals Clinical Trials Trials Treatment

Analysis Life Sciences Thank You Workshop addresses oncology dose optimization across full span of development

Agency IQ

FEBRUARY 23, 2024

Additionally, this approach is generally no longer applicable to new treatments that are more targeted in their effects, such as immunotherapies and targeted small molecule therapies. This has spawned a movement focused on optimizing dose selection in oncology drug development.

Science

Science FDA Trials Clinical Pharmacology

Analysis Life Sciences Thank You FDA’s new guidance on postapproval manufacturing changes for biosimilars focuses on current practice, new dosage forms

Agency IQ

JULY 26, 2024

in equipment) for products that are more complex or aren’t as well-characterized, such as antibody drug conjugates or recombinant DNA products, will be considered higher risk than they would if the change was made to the production of standard, small molecule products. Any CMC changes (e.g.,

Biosimilars

Biosimilars Science FDA Production

Case Study: How Altasciences Overcame Pharmacological Challenges in a GLP-1 IND-Enabling Study

Alta Sciences

APRIL 24, 2025

Altasciences was chosen by a client for an IND-enabling study of a small-molecule GLP-1 receptor agonist in canines. This presents a challenge when evaluating the test article for potential toxicological effects, since the test article is designed to produce decreased food consumption and body weight loss.

Small Molecule

Small Molecule Pharmacokinetics Treatment Compliance

Analysis Life Sciences Thank You FDA finalizes new guidance on nonclinical assessment of potential immunotoxicity

Agency IQ

JUNE 9, 2023

However, this guideline is primarily intended to provide recommendations on evaluating the immune system’s response to small molecule drugs. The guidance contains recommendations for small molecule drugs, as well as any biological products that fall within CDER’s purview.

FDA

FDA Science Small Molecule Immune Response

Codon Digest: Injected Gene Editors

Codon

APRIL 2, 2023

This is Codon Digest, a weekly roundup of research papers, news articles, and industry highlights about engineered biology. Read Small-molecule aptamer for regulating RNA functions in mammalian cells and animals. Thanks for skimming. ❤️ Subscribe to support human writers. Ricciardi M.J. Cell Systems. Fukunaga K.

DNA

DNA RNA Engineering Licensing

Analysis Life Sciences Thank You The FDA and oncology: 2023 year in review

Agency IQ

DECEMBER 11, 2023

In 2015, the FDA, along with the American Association for Cancer Research (AACR), held a workshop on dose optimization for small molecules. For a more complete discussion of endpoints in oncology clinical trials, see this recent AgencyIQ article. Read AgencyIQ’s analysis of that paper, and the larger issues, here.

FDA

FDA Science Clinical Trials Trials

Major biotransformation routes of aficamten

Metabolite Tales Blog

NOVEMBER 13, 2024

References [1] Pharmacokinetics, disposition, and biotransformation of the cardiac myosin inhibitor aficamten in humans. 2] Pharmacokinetics, mass balance, tissue distribution, metabolism, and excretion of [14C]aficamten following single oral dose administration to rats. Drug Metab Pharmacokinet. Drug Hunter article.

Pharmacokinetics

Pharmacokinetics Small Molecule Production Drugs

Building better drugs: how 3D models are shaping pre-clinical development

Drug Target Review

APRIL 25, 2025

3 These models are pivotal for offering key predictive insights into the clearance of metabolically stable small molecules, maintaining phase I and II metabolic activities for up to four weeks. 9,10 According to IQ-MPS recommendations, liver-on-chip systems can differentiate between toxic and non-toxic small molecule analogues.

Clinical Development

Clinical Development Small Molecule Drugs FDA Approval

Omaveloxolone

New Drug Approvals

MAY 11, 2025

This article incorporates text from this source, which is in the public domain. ^ “Reata Pharmaceuticals Announces FDA Approval of Skyclarys (Omavaloxolone), the First and Only Drug Indicated for Patients with Friedreich’s Ataxia” Reata Pharmaceuticals Inc. 2] [5] It is taken by mouth. [2] 2] [5] It is taken by mouth. [2]

FDA

FDA FDA Approval Disease Production

Drug Discovery Digest

Metabolism of 2023 FDA Approved Small Molecules – PART 2

Metabolism of 2023 FDA Approved Small Molecules – PART 1

Trending Sources

Pharmacokinetics, Pharmacodynamics and Toxicokinetics Demystified

The rising impact of biomarkers in early clinical development

A spatial approach to understanding drug dynamics using mass spectrometry imaging

Chemical probes and permeability

Crinecerfont

Five Promising Treatment Areas in Early-Phase Drug Development in 2024

Concert Pharmaceuticals Reports Third Quarter 2020 Financial Results and Provides Company Update

Analysis Life Sciences Thank You Workshop addresses oncology dose optimization across full span of development

Analysis Life Sciences Thank You FDA’s new guidance on postapproval manufacturing changes for biosimilars focuses on current practice, new dosage forms

Case Study: How Altasciences Overcame Pharmacological Challenges in a GLP-1 IND-Enabling Study

Analysis Life Sciences Thank You FDA finalizes new guidance on nonclinical assessment of potential immunotoxicity

Codon Digest: Injected Gene Editors

Analysis Life Sciences Thank You The FDA and oncology: 2023 year in review

Major biotransformation routes of aficamten

Building better drugs: how 3D models are shaping pre-clinical development

Omaveloxolone

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