2023 and Pharmacokinetics - Drug Discovery Digest

Case Study: Two Examples of Successful Automation Integration at Altasciences for Pharmacokinetic Studies

Alta Sciences

JUNE 6, 2025

Case Study: Two Examples of Successful Automation Integration at Altasciences for Pharmacokinetic Studies pmjackson Fri, 06/06/2025 - 09:01 By Martin Rougée, Optimization Scientist, Bioanalytical Operations Automation offers several advantages to any industry. Do you need a pharmacokinetic study?

Pharmacokinetics

Pharmacokinetics Molecular Biology Drug Development Clinical Trials

Understanding the Regulatory Environment in Japan for Generic Drug Development

Drug Patent Watch

DECEMBER 30, 2024

Key Requirements for Generic Drug Approval Bioequivalence Studies : The PMDA requires bioequivalence studies to ensure that the generic drug is equivalent to the RLD in terms of its pharmacokinetic and pharmacodynamic properties. Clinical Pharmacology & Therapeutics , 111(3), 531538. Freyr Solutions.

Drug Development

Drug Development Clinical Pharmacology Clinical Trials Pharmaceutical Companies

The rising impact of biomarkers in early clinical development

Drug Target Review

APRIL 7, 2025

As pharmacological indicators, biomarkers overcome the static nature of traditional in vitro cellular studies by providing more dynamic models of pharmacokinetic processes that reflect active biological mechanisms. Trial design and statistical methods are also key to determining the utility and validity of biomarkers. Rodrigues AD.

Clinical Development

Clinical Development Clinical Trials Clinical Pharmacology Trials

The future of CNS drug development: signs of real progress

Drug Target Review

JULY 21, 2025

Sig Transduct Target Ther 8 , 217 (2023). A board-certified toxicologist, she specialises in designing and managing nonclinical programmes across various modalities, including toxicology, pharmacokinetics, ADME and safety pharmacology. Adv Drug Deliv Rev. 2020;165-166:1-14. doi: 10.1016/j.addr.2019.11.009. 2019.11.009. PMID: 31790711.

Drug Development

Drug Development Small Molecule Drugs Therapies

Elacestrant

New Drug Approvals

MAY 9, 2025

2] Elacestrant was approved for medical use in the United States in January 2023, [1] [2] [5] [6] and in the European Union in September 2023. [3] 2] Elacestrant was approved for medical use in the United States in January 2023, [1] [2] [5] [6] and in the European Union in September 2023. [3] 8 February 2023.

FDA

FDA Pharmacokinetics Therapies Treatment

Vamorolone

New Drug Approvals

JULY 25, 2025

10] Vamorolone was approved for medical use in the United States in October 2023, [11] [10] and in the European Union in December 2023. [2] Vamorolone was approved by the FDA in October 2023 for the management of DMD in patients ≥2 years of age. 2] Vamorolone was approved for medical use in the European Union in December 2023.

FDA

FDA FDA Approval Treatment Clinical Trials

Gepirone

New Drug Approvals

JUNE 11, 2025

4] It was approved for the treatment of major depressive disorder in the United States in September 2023. [4] 4] It was approved for the treatment of major depressive disorder in the United States in September 2023. [4] Archived from the original (PDF) on 28 September 2023. Retrieved 28 September 2023. 1986, ES 8606333.

FDA

FDA FDA Approval Treatment Clinical Trials

Time for change: non-human primates in drug research

Drug Target Review

JULY 7, 2025

Their unique suitability has made them valuable for evaluating pharmacokinetics, toxicology and safety in drug candidates before human clinical trials. Federal ruling on USDA primate welfare petition, 2023. References Animal Legal Defense Fund v. USDA (2020). National Research Council. Guide for the Care and Use of Laboratory Animals.

Drug Research

Drug Research Research Animal Testing Drugs

Contezolid

New Drug Approvals

JULY 19, 2025

In a pharmacokinetic (PK) rat model, the exposure of active drug CZD after IV administration of the prodrug CZA was similar to or higher than that from the IV administration of CZD. html (accessed 2023-06). (35) link] multimedia/table/usual-dosages-of-commonly-prescribed-antibioticsa (accessed 2023-06). (36) micurx.com/703.html

Clinical Trials

Clinical Trials Pharmaceuticals Therapies Trials

Orforglipron’

New Drug Approvals

JULY 2, 2025

1] [3] Clinical trials The results of Phase I safety and Phase II ascending-dose clinical trials enrolling people with obesity or type 2 diabetes were published in 2023. [4] Sidik S (2023). June 2023). June 2023). 1] It was discovered by Chugai Pharmaceutical Co. then was licensed to Lilly in 2018. [1] April 17, 2025.

Small Molecule

Small Molecule Clinical Trials Trials Pharmacokinetics

Sanofi Speeds Up Beyfortus Shipments Ahead of 2025-2026 RSV Season

The Pharma Data

JUNE 9, 2025

Since its launch in 2023, the product has quickly gained recognition for its high and sustained efficacy throughout the RSV season and is supported by a comprehensive body of real-world evidence involving hundreds of thousands of infants.

Virus

Virus Hospitals Vaccine Immune Response

Gamcemetinib

New Drug Approvals

JUNE 5, 2025

Gamcemetinib CAS 1887069-10-4 CC-99677 , OS2IR8TV1O Molecular Weight 469.94 nM) and cell based assays ( EC 50 =89 nM). Gamcemetinib CAS 1887069-10-4 CC-99677 , OS2IR8TV1O Molecular Weight 469.94 nM) and cell based assays ( EC 50 =89 nM). Gamcemetinib is extracted from patent WO2020236636, compound 1.

Cell Based Assays

Cell Based Assays Clinical Pharmacology Pharmacokinetics Trials

Resigratinib

New Drug Approvals

JULY 12, 2025

The safety, tolerability, pharmacokinetics, and preliminary efficacy of KIN-3248 are currently being evaluated in adults with advanced tumors harboring FGFR2 and/or FGFR3 gene alterations. February 2023). Therefore, the broad inhibition of FGFR isoforms may be effective against different types of tumors. 40 (4_suppl): 461.

Production

Production Small Molecule Pharmacokinetics Clinical Trials

When to Slow Down or Hit the Brakes on a Development Program

The Premier Consulting Blog

DECEMBER 16, 2024

Pharmacokinetics and pharmacodynamics :Pharmacokinetics (PK) assess how a drug is absorbed, distributed, metabolized, and excreted by the body. 2023, February 28). For example, a narrow therapeutic window occurs when the difference between the effective dose and the toxic dose is small. References: [i] Philippidis, A.

Pharmacokinetics

Pharmacokinetics Clinical Trials Drug Development Pharmaceutical Companies

Crinecerfont

New Drug Approvals

APRIL 18, 2025

18 October 2023). 2023 Oct 30;70(10):945-957. Epub 2023 Jun 29. . “Crinecerfont Lowers Elevated Hormone Markers in Adults With 21-Hydroxylase Deficiency Congenital Adrenal Hyperplasia” The Journal of Clinical Endocrinology & Metabolism. 107 (3): 801812. doi : 10.1210/clinem/dgab749. PMC 8851935. PMID 34653252.

FDA

FDA FDA Approval Drugs Trials

Landiolol

New Drug Approvals

APRIL 19, 2025

Landiolol was approved for medical use in Japan in 2002, [10] [11] in Canada in November 2023, [1] and in the United States in November 2024. [12] 20 November 2023. This has a positive impact on the treatment of patients when reduction of heart rate without decrease in arterial blood pressure is desired. [9] 2 July 2024. 32 (2): 828.

FDA

FDA Clinical Trials Treatment Trials

Limited Evidence for Nalfmefene

Common Sense for Drug Policy Blog

OCTOBER 29, 2024

The only studies reported in the FDA package inserts for both products are pharmacokinetic studies in healthy volunteers, which demonstrated substantially higher naloxone plasma levels than standard doses of naloxone (0.4 In 2023, the FDA approved a 2.7 mg IM vs. 8 mg IN and 2 mg IM vs. 5 mg IM, respectively).

FDA Approval

FDA Approval Pharmacokinetics Packaging FDA

AZVUDINE

New Drug Approvals

JULY 18, 2025

China Patent CN 115960147, 2023. (10) Zhu KW (2023). Retrieved 2023-01-03. Retrieved 2023-01-03. Further reading Zhu KW (2023). Azvudine is a thymus-homing anti-SARS-CoV-2 drug effective in treating COVID-19 patients. Signal Transduct. Target Ther. 2021, 6, 414. (9) 9) Chen, X.; 10) Smith, D. Kalayanov, G.;

RNA

RNA Clinical Trials Virus Trials

Dorzagliatin

New Drug Approvals

JULY 28, 2025

Safety, tolerability, pharmacokinetics, and pharmacodynamics of novel glucokinase activator HMS5552: results from a first-in-human single ascending dose study. 1 February 2023). Dorzagliatin: First approval. Drugs 2022, 82, 1745−1750. 134) Xu, H.; 2016, 10, 1619−26. 135) Ren, Y.; twitter +919321316780 call whatsaapp EMAIL.

Small Molecule

Small Molecule Treatment Production Pharmacokinetics

Characterization of a Potent and Orally Bioavailable Lys-Covalent Inhibitor of Apoptosis Protein (IAP) Antagonist

Covalent Modifiers

JUNE 5, 2023

Pegan, and Maurizio Pellecchia Journal of Medicinal Chemistry 2023 DOI: 10.1021/acs.jmedchem.3c00467 Finally, in vivo pharmacokinetic studies indicated that the agent was long-lived and orally bioavailable. Parima Udompholkul, Ana Garza-Granados, Giulia Alboreggia, Carlo Baggio, Jack McGuire, Scott D.

Pharmacokinetics

Microsampling for Pediatric Baricitinib Pharmacokinetics

Alta Sciences

AUGUST 16, 2023

Microsampling for Pediatric Baricitinib Pharmacokinetics shajjar Wed, 08/16/2023 - 19:06 Publication bio-2023-0044_3.pdf pdf Tags Bioanalysis Category Journal Article Weight 1

Pharmacokinetics

ISSUE NO. 34 — Toxicokinetics, Pharmacokinetics, and Pharmacodynamics

Alta Sciences

AUGUST 22, 2023

34 — Toxicokinetics, Pharmacokinetics, and Pharmacodynamics mecabana Tue, 08/22/2023 - 17:31 Publication the-altascientist-issue-34-toxicokinetics-pharmacokinetics-and-pharmacodynamics.pdf URL [link] Weight 1 Tags Research Support

Pharmacokinetics

Pharmacokinetics Research

ISSUE NO. 34 — TOXICOKINETICS, PHARMACOKINETICS, AND PHARMACODYNAMICS

Alta Sciences

AUGUST 22, 2023

34 — TOXICOKINETICS, PHARMACOKINETICS, AND PHARMACODYNAMICS mecabana Tue, 08/22/2023 - 17:31 Publication the-altascientist-issue-34-toxicokinetics-pharmacokinetics-and-pharmacodynamics.pdf URL [link] Weight 1 Tags Manufacturing and Analytical Services

Pharmacokinetics

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

Design and Validation of a Bioanalytical Method to Support a Clinical Pharmacokinetic Study Involving the Use of Multiple Lots of the Biological Therapeutic Drug

Alta Sciences

JUNE 24, 2023

Design and Validation of a Bioanalytical Method to Support a Clinical Pharmacokinetic Study Involving the Use of Multiple Lots of the Biological Therapeutic Drug lperez Sat, 06/24/2023 - 08:07 Publication Altasciences_WRIB_2023_Design_and_Validation_of_a_Bioanalytical_Method_to_Support_a_Clinical_Pharmacokinetic_Study.pdf Tags Bioanalysis Date of publication (..)

Pharmacokinetics

Pharmacokinetics Drugs

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]. This constitutes an interesting subset of 9 drugs, constituting over 25% of the new small molecule drug approvals in 2023!

Small Molecule

Small Molecule FDA Approval FDA Pharmacokinetics

The future of lymphoma treatment

Drug Target Review

DECEMBER 12, 2023

We use hydrophilic linkers, which prevent ADC aggregation and generate highly stable ADCs, in combination with a unique attachment site on the antibody to create ADCs that retain pharmacokinetic properties similar to the original unconjugated antibody. This helps to maximize the targeted payload delivery to tumor cells.

Treatment

Treatment Engineering Pharmacokinetics Doctors

Avenciguat

New Drug Approvals

OCTOBER 14, 2024

Cardona, Jose; Desch, Marc; Wenz, Arne; Schulze, Friedrich; Nangaku, Masaomi (August 2023). “Safety, tolerability, pharmacodynamics and pharmacokinetics of the soluble guanylyl cyclase activator BI 685509 in patients with diabetic kidney disease: A randomized trial” Diabetes, Obesity and Metabolism. March 2023).

Pharmacokinetics

Pharmacokinetics Disease Trials Clinical Trials

New Alternative Methodologies and Their Applications in Drug Discovery and Development

biobide

SEPTEMBER 29, 2023

However, reports drawn up as recently as June 2023 still emphasize the necessity of animal testing at some point as we are still far from understanding and reproducing all the variables present in a whole organism in an in vitro or in silico model. Where possible, NAM s seek to avoid the use of animal testing or at least to reduce it.

Animal Testing

Animal Testing Drugs Pharmacokinetics Regulations

Eplontersen

New Drug Approvals

DECEMBER 24, 2023

2] [3] [4] [5] It was approved for medical use in the United States in December 2023. [6] 7 March 2023. Archived from the original on 26 September 2023. Retrieved 21 December 2023 – via PR Newswire. February 2023). October 2023). 21 December 2023. 22 December 2023. Ionis Pharmaceuticals.

Clinical Trials

Clinical Trials FDA Clinical Pharmacology FDA Approval

VALILTRAMIPROSATE

New Drug Approvals

OCTOBER 12, 2024

Clinical Pharmacokinetics and Safety of ALZ-801, a Novel Prodrug of Tramiprosate in Development for the Treatment of Alzheimer’s Disease. Clin Pharmacokinet. Both ALZ-801 and tramiprosate are metabolized to 3-sulfopranpanoic acid (3-SPA), which is normally found in brain and also inhibits Aβ42 aggregation ( Hey et al.,

Pharmacokinetics

Pharmacokinetics Small Molecule Disease Licensing

New molecular insights on medical cannabis

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. 2023 Feb;6(2):e202201595. Recently, our laboratory discovered a potent partial inhibition of ATX by cannabinoids in a nanomolar range.

Clinical Trials

Clinical Trials Trials Small Molecule Disease

Release of ChEMBL 33

The ChEMBL-og

JUNE 13, 2023

Cardiff Schistosomiasis Dataset 2023 (src_id = 64): A library of 80 compounds were tested in vitro on different life cycle stages of the parasite Schistosoma mansoni. Data set retrieved from COCONUT team on 05/05/2023. Data set retrieved on 30/05/2023. The consortium also develops new transport assays for selected SLCs.

FDA Approval

FDA Approval Pharmacokinetics International Production

The Race for Ozempic Alternatives: Unlocking the Future of Weight Loss Medication

DrugBank

MARCH 7, 2024

Market Dynamics and Growth Projections The year 2023 witnessed an unprecedented surge in the popularity of weight loss drugs, with patients experiencing significant weight loss, despite facing the challenges of high drug costs and limited insurance coverage. Let’s delve into what lies ahead in the coming year.

Pharmaceutical Companies

Pharmaceutical Companies Pharmaceuticals Clinical Trials Therapies

Etrasimod

New Drug Approvals

OCTOBER 24, 2023

Molecular Weight: 631.700 FDA APPROVED, To treat moderately to severely active ulcerative colitis in adults, 10/12/2023 Velsipity Etrasimod , sold under the brand name Velsipity , is a medication that is used for the treatment of ulcerative colitis (UC). [1] Retrieved 18 October 2023. Bayer M (2 May 2023). April 2023).

FDA

FDA FDA Approval International Pharmacokinetics

Trends in Oncology Study Design, from Optimus to Endpoints

Conversations in Drug Development Trends

DECEMBER 20, 2023

In November 2023, at Outsourcing Clinical Trials Dach in Zurich, our Executive Director, Oncology Strategy Lead, Matt Cooper , presented “Delivering Oncology Studies – Challenges and Considerations.”

Clinical Trials

Clinical Trials Trials Pharmacokinetics FDA

Bayer to present latest research across its advancing oncology portfolio at AACR 2023 Annual Meeting

The Pharma Data

APRIL 11, 2023

A focus of the presentation will be on the target engagement results and pharmacokinetics from its ongoing monotherapy dose-escalation study to explore a potential optimal dose and schedule to effectively inhibit AhR.

Research

Research Clinical Trials Small Molecule Trials

Zelatriazin

New Drug Approvals

SEPTEMBER 10, 2024

It was developed for schizophrenia and anhedonia in depression but trials were unsuccessful and its development was discontinued in 2023. [1] Taylor, Nick Paul (10 November 2023). Retrieved 4 December 2023. //////Zelatriazin, 1929519-13-0, NBI-1065846, TAK-041, Phase 2 Zelatriazin, C 18 H 15 F 3 N 4 O 3 , 392.3 PMC 9544063. .

Clinical Pharmacology

Clinical Pharmacology Small Molecule Pharmacokinetics Pharmaceutical Companies

Targeting the immunotherapy potential of cytokines IL-12 and IL-18 with new advancements in protein engineering

Drug Target Review

JUNE 6, 2023

We are currently selecting our lead IL-18 variant on the basis of potency for the IL-18 receptor, optimal pharmacokinetic profile and in vivo efficacy for inhibiting tumour growth. National Library of Medicine; [cited 2023 Jun 6]. American Association for Cancer Research; 2006 [cited 2023 Jun 6]. References: M; LWR.

Engineering

Engineering Immune Response Biochemical Pharmacology Clinical Trials

Looking beyond traditional oncogenic pathways to break cancer resistance

Drug Target Review

SEPTEMBER 25, 2024

2023 Apr 4 [cited 2024 Sep 4];83(7_Supplement):3907–7. A phase 1, first-in-human, open-label study evaluating the safety, tolerability, pharmacokinetics, and efficacy of TT125-802 in patients with advanced solid tumors. 2023 Oct 13 [cited 2024 Sep 4];9(41):eade3816. Cancer Research [Internet]. Available from: [link] 8.Boni

Small Molecule

Small Molecule Therapies Regulations Treatment

[NEW EBOOK] Safety Assessment for Ophthalmic Products

Alta Sciences

AUGUST 7, 2023

[NEW EBOOK] Safety Assessment for Ophthalmic Products tchichekian Mon, 08/07/2023 - 19:08 HTML Excellence in Ophthalmic Safety Testing Altasciences has been conducting ophthalmic safety testing for decades, with all global regulatory submissions from our studies approved for design, conduct, and data integrity.

Production

Production Pharmacokinetics Drug Development Drugs

Steep FY2025 PDUFA Fee Increase: Ways to Reduce the Full Fee Rate for Repurposed Drugs

The Premier Consulting Blog

AUGUST 8, 2024

For example, pharmacokinetic (PK) data from a comparative BA study and PK modeling approaches (e.g., FDA-2023-N-2850. July 28, 2023. patients with renal, hepatic, or cardiovascular concerns). FDA-2024-N-0007. July 31, 2024. [ii] ii] United States Federal Register. Prescription Drug User Fee Rates for Fiscal Year 2024.

Drugs

Drugs Pharmacokinetics FDA Production

AI in Drug Discovery - A Highly Opinionated Literature Review (Part II)

Practical Cheminformatics

JANUARY 8, 2024

Picking up where we left off in Part I , this post covers several other ML in drug discovery topics that interested me in 2023. Large Language Models The emergence of GPT-4 and ChatGPT brought considerable attention to large language models (LLMs) in 2023. Papers published in 2023 showed how robust the method is. Other Stuff 4.

Drugs

Drugs Small Molecule Bioinformatics Packaging

Accelerating Global Drug Development Timelines With Ethnobridging

Alta Sciences

JUNE 9, 2023

Accelerating Global Drug Development Timelines With Ethnobridging rmaloney Mon, 06/12/2023 - 16:07 HTML Safe Strategy to Save Time and Money Avoid repeating Phase I studies for drugs intended for the Asian market.

Drug Development

Drug Development Clinical Trials Biosimilars Pharmacokinetics

Case Study: Two Examples of Successful Automation Integration at Altasciences for Pharmacokinetic Studies

Understanding the Regulatory Environment in Japan for Generic Drug Development

Trending Sources

The rising impact of biomarkers in early clinical development

The future of CNS drug development: signs of real progress

Elacestrant

Vamorolone

Gepirone

Time for change: non-human primates in drug research

Contezolid

Orforglipron’

Sanofi Speeds Up Beyfortus Shipments Ahead of 2025-2026 RSV Season

Gamcemetinib

Resigratinib

When to Slow Down or Hit the Brakes on a Development Program

Crinecerfont

Landiolol

Limited Evidence for Nalfmefene

AZVUDINE

Dorzagliatin

Characterization of a Potent and Orally Bioavailable Lys-Covalent Inhibitor of Apoptosis Protein (IAP) Antagonist

Microsampling for Pediatric Baricitinib Pharmacokinetics

ISSUE NO. 34 — Toxicokinetics, Pharmacokinetics, and Pharmacodynamics

ISSUE NO. 34 — TOXICOKINETICS, PHARMACOKINETICS, AND PHARMACODYNAMICS

Metabolism of 2023 FDA Approved Small Molecules – PART 2

Design and Validation of a Bioanalytical Method to Support a Clinical Pharmacokinetic Study Involving the Use of Multiple Lots of the Biological Therapeutic Drug

Metabolism of 2023 FDA Approved Small Molecules – PART 1

The future of lymphoma treatment

Avenciguat

New Alternative Methodologies and Their Applications in Drug Discovery and Development

Eplontersen

VALILTRAMIPROSATE

New molecular insights on medical cannabis

Release of ChEMBL 33

The Race for Ozempic Alternatives: Unlocking the Future of Weight Loss Medication

Etrasimod

Trends in Oncology Study Design, from Optimus to Endpoints

Bayer to present latest research across its advancing oncology portfolio at AACR 2023 Annual Meeting

Zelatriazin

Targeting the immunotherapy potential of cytokines IL-12 and IL-18 with new advancements in protein engineering

Looking beyond traditional oncogenic pathways to break cancer resistance

[NEW EBOOK] Safety Assessment for Ophthalmic Products

Steep FY2025 PDUFA Fee Increase: Ways to Reduce the Full Fee Rate for Repurposed Drugs

AI in Drug Discovery - A Highly Opinionated Literature Review (Part II)

Accelerating Global Drug Development Timelines With Ethnobridging

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