Blog, FDA Approval 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 2022 FDA approved small molecule drugs PART 1

Metabolite Tales Blog

JANUARY 26, 2023

Metabolism of 2022 FDA approved small molecule drugs – Part 1 Does CYP3A4 still rule? By Julia Shanu-Wilson It won’t come as much surprise to learn that of the 17 small molecules* approved by the FDA in 2022, CYP3A4 was the major player in drug metabolism. References Iversen et al.,

Small Molecule

Small Molecule FDA Approval FDA Drugs

Metabolism of 2022 FDA approved small molecule drugs PART 2

Metabolite Tales Blog

APRIL 4, 2023

Metabolism of 2022 FDA approved small molecule drugs part 2 Mixing it Up By Julia Shanu-Wilson In Part 1 of this topic we looked at metabolism of the small molecule drugs approved by the FDA in 2022 that were mediated by CYP3A4. Dermavant’s tapinarof is one such friend. Gut 1996; 38: 439-446.

Small Molecule

Small Molecule FDA Approval FDA Drugs

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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.

Small Molecule

Small Molecule FDA Approval FDA Pharmacokinetics

A new drug approval for the vanguard of RNA-targeted small molecules

Dark Matter Blog

AUGUST 27, 2020

A few years ago, at Arrakis Therapeutics, we set out to conquer a strange new territory, drugging RNA structures with small molecules. The agent, onasemnogene abeparvovec, was approved by the FDA in 2019 and is marketed as Zolgensma. But we have not been the only people on this mission.

Small Molecule

Small Molecule RNA Clinical Trials Drugs

Researchers Identify Novel Immunotherapeutic Compound Targeting Key Cancer Pathway

PerkinElmer

NOVEMBER 9, 2022

To date, the only FDA approved immune checkpoint inhibitors targeting the PD-1/PD-L1 pathway are monoclonal antibodies (mAbs). Recent efforts have focused on the development of small-molecule inhibitors as an alternative approach to therapeutically target PD-1 or PD-L1.

Small Molecule

Small Molecule Research Immune Response FDA Approval

Keeping Your Company’s Federal Contracting Options Safe in the Face of Pending BIOSECURE Act Legislation

FDA Law Blog: Biosimilars

MARCH 3, 2024

Effect on FDA approvals— In cases where a biological product or drug needs to change aspects of its manufacturing processes to avoid using a covered equipment or service, will it need to file supplements with FDA for the CMC update?

Small Molecule

Small Molecule Government FDA Approval Regulations

Present Treatments & Hopeful Future Directions for ALS Pharmacotherapies

Conversations in Drug Development Trends

MAY 30, 2024

From drugs previously FDA-approved for gallstone diseases, Parkinson’s disease, and even cancer, researchers are working tirelessly to test and establish whether these pharmacotherapies with well-defined safety profiles may have any potential for efficacy in treating ALS.

Treatment

Treatment Clinical Trials Small Molecule Therapies

Announcing the first biopharma IPNFT Transaction

Molecule Blog

AUGUST 13, 2021

If successful, this work could result in the repurposing of several FDA-approved therapeutics for the purpose of extending the human lifespan, at a lower cost and over faster timelines than conceivably possible with de novo drug discovery. The Scheibye-Knudsen lab has analyzed 1.5 billion prescriptions from 4.8

FDA Approval

FDA Approval DNA Small Molecule FDA

Iptacopan

New Drug Approvals

DECEMBER 16, 2023

Retrieved 10 December 2023. ^ “Novartis receives FDA approval for Fabhalta (iptacopan), offering superior hemoglobin improvement in the absence of transfusions as the first oral monotherapy for adults with PNH” Novartis (Press release). 1 H NMR (400 MHz, methanol-d4) δ 10.73 (s, 1H), 8.23 (d, J = 8.2 Hz, 2H), 7.36−7.31

FDA

FDA Small Molecule FDA Approval Treatment

mRNA Cancer Vaccines and Therapies: An Overview

Advarra

JANUARY 11, 2024

In this blog, we examine how mRNA can impact cancer treatment, the unique challenges associated with working with mRNA, and strategies for researchers proposing mRNA-based cancer trials. Immunomodulatory Proteins Immunomodulators are molecules influencing the pathways regulating the body’s immune system activities.

Vaccine

Vaccine Therapies Clinical Trials Small Molecule

Breaking C-F bonds in drugs

Metabolite Tales Blog

MAY 12, 2023

In 2021, almost one third of FDA approved drugs contained at least one fluorine. Even newer from the pharma benches are 12 small molecule drugs highlighted by Chris de Savi [4], whose structures were first disclosed at the ACS and AACR meetings in Q1 2023. Of these 12 drugs, 9 contain at least one fluorine! Soloshonok.

Drugs

Drugs Small Molecule FDA Approval Metabolic Stability

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 an article published in Frontiers in Pharmacology , as of October 2023, there were 15 FDA-approved ADCs on the market, and more than one hundred in clinical development in the U.S.A.,

Drug Development

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Navigating the 505(b)(2) Pathway: No Two Drugs Are Alike

The Premier Consulting Blog

SEPTEMBER 11, 2024

The 505(b)(2) new drug application (NDA) pathway offers a unique opportunity for small molecule developers to bring innovative products to market more efficiently by leveraging existing data they do not own or have right of reference to.

Drugs

Drugs Clinical Pharmacology Packaging Small Molecule

DNA Barcodes Could Streamline Search for New Drugs to Combat Cancer

NIH Director's Blog: Drug Discovery

MARCH 8, 2016

With PRISM, it’s now feasible to screen entire small molecule libraries across large panels of cancer cell lines. The approach might also be put to use for optimizing drug candidates or for discovering new uses for cancer drugs that have already been FDA approved.

DNA

DNA Drugs Small Molecule FDA Approval

Adagrasib

New Drug Approvals

JANUARY 3, 2023

Adagrasib Formula C32H35ClFN7O2 cas 2326521-71-3 Mol weight 604.1174 Antineoplastic Disease Non-small cell lung cancer 2022/12/12 FDA APPROVED, KRAZATI (Mirati Therapeutics) MRTX-849 MRTX849 KRAS G12C inhibitor MRTX849 Adagrasib , sold under the brand name Krazati , is an anticancer medication used to treat non-small cell lung cancer. [1]

FDA

FDA Clinical Trials FDA Approval Treatment

Another Milestone in the Cystic Fibrosis Journey

NIH Director's Blog: Drug Development

JULY 20, 2017

The first major advance in molecularly targeted drug treatment for the disease came in 2012, when the Food and Drug Administration (FDA) approved ivacaftor (Kalydeco). About 30,000 Americans have CF. As exciting as that was, we knew it represented just the first step on a challenging road to helping all people with CF.

Clinical Trials

Clinical Trials Small Molecule Therapies Disease

FDA Knows Its Own Strength—and It Includes Concentration

FDA Law Blog: Biosimilars

FEBRUARY 26, 2024

FDA concluded, its “use of the terms ‘strength’ and ‘concentration’ in different places in its BE regulations reflects the Agency’s view that ‘concentration’ is an element of strength for certain products (e.g., solid oral dosage forms),” which, FDA posits, suggests “that the terms have overlapping meanings.”

FDA

FDA Biosimilars Production Regulations

Codon Digest: Injected Gene Editors

Codon

APRIL 2, 2023

Read Small-molecule aptamer for regulating RNA functions in mammalian cells and animals. Read The FDA is reviewing a “controversial cell therapy for ALS,” developed by BrainStorm Cell Therapeutics. Cell Systems. Fukunaga K. Read Random Stuff Prime factorization via localized tile assembly in a DNA origami framework.

DNA

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Zavegepant

New Drug Approvals

JULY 10, 2023

If FDA approved, it will join other previously-approved “-gepant” drugs [ rimegepant ] and [ ubrogepant ] as an additional treatment alternative for patients with migraine, particularly those for whom traditional triptan therapy has proven ineffective. The clinical trial is expected to complete in September 2020.

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Metabolism of 2024 FDA Approved Small Molecules – PART 1

Metabolite Tales Blog

JANUARY 22, 2025

Metabolism of 2024 FDA approved small molecules part 1 By Julia Shanu-Wilson Involvement of active metabolites The number of small molecules approved by the FDA in 2024 totaled 31 out of 50 NMEs with 56% (28) of these comprising small molecule therapies. What’s next?

Small Molecule

Small Molecule FDA Approval FDA Pharmacokinetics

Drug Discovery Digest

Metabolism of 2023 FDA Approved Small Molecules – PART 2

Metabolism of 2022 FDA approved small molecule drugs PART 1

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Metabolism of 2022 FDA approved small molecule drugs PART 2

Webinars

Metabolism of 2023 FDA Approved Small Molecules – PART 1

A new drug approval for the vanguard of RNA-targeted small molecules

Researchers Identify Novel Immunotherapeutic Compound Targeting Key Cancer Pathway

Keeping Your Company’s Federal Contracting Options Safe in the Face of Pending BIOSECURE Act Legislation

Present Treatments & Hopeful Future Directions for ALS Pharmacotherapies

Announcing the first biopharma IPNFT Transaction

Iptacopan

mRNA Cancer Vaccines and Therapies: An Overview

Breaking C-F bonds in drugs

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

Navigating the 505(b)(2) Pathway: No Two Drugs Are Alike

DNA Barcodes Could Streamline Search for New Drugs to Combat Cancer

Adagrasib

Another Milestone in the Cystic Fibrosis Journey

FDA Knows Its Own Strength—and It Includes Concentration

Codon Digest: Injected Gene Editors

Zavegepant

Metabolism of 2024 FDA Approved Small Molecules – PART 1

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