2020, Drugs and Pharmacokinetics - Drug Discovery Digest

Understanding the Regulatory Environment in Japan for Generic Drug Development

Drug Patent Watch

DECEMBER 30, 2024

The regulatory environment in Japan for generic drug development is complex and has undergone significant changes in recent years. Regulatory Authority: Pharmaceuticals and Medical Devices Agency (PMDA) The PMDA is the primary regulatory authority responsible for overseeing the drug approval process in Japan.

Drug Development

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The rising impact of biomarkers in early clinical development

Drug Target Review

APRIL 7, 2025

In a recent survey conducted by ICON, Plc, biomarker selection was identified by 35 percent of respondents as a top challenge among drug developers for phase I trials, second only to navigating regulatory compliance (- 38 percent). To qualify as endpoints, biomarkers used in early phases must be relevant to later stages of drug development.

Clinical Development

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Time for change: non-human primates in drug research

Drug Target Review

JULY 7, 2025

Non-human primates (NHPs), such as macaques and cynomolgus monkeys, have long served as a cornerstone in preclinical drug development due to their close genetic, anatomical and physiological resemblance to humans. Conventional models often fail to predict cardiac side effects, especially with biologics.

Drug Research

Drug Research Research Animal Testing Drugs

Elacestrant

New Drug Approvals

MAY 9, 2025

1] [8] Pharmacokinetics Elacestrant has an oral bioavailability of approximately 10%. [1] 1] [8] Pharmacokinetics Elacestrant has an oral bioavailability of approximately 10%. [1] Food and Drug Administration (FDA). 1] [4] It is taken by mouth. [1] 3] [7] PATENTS Cruskie MP, et al. Retrieved 11 February 2023. 27 January 2023.

FDA

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Vamorolone

New Drug Approvals

JULY 25, 2025

The distinction between it and traditional corticosteroid drugs lies in its capacity to specifically activate particular signaling pathways of corticosteroids. In individuals diagnosed with DMD, the primary mechanism through which corticosteroid drugs exhibit their effectiveness is by exerting anti-inflammatory effects. 70) Keam, S.

FDA

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Navigating Regulatory Hurdles in Drug Development

DrugBank

JUNE 18, 2025

Drug development is a complex and highly regulated process. Food and Drug Administration (FDA), the European Medicines Agency (EMA), and other global counterparts, set rigorous standards to ensure that drugs are safe, effective, and high-quality. Regulatory agencies, such as the U.S.

Drug Development

Drug Development Clinical Trials Compliance Drugs

Crinecerfont

New Drug Approvals

APRIL 18, 2025

2] [3] The US Food and Drug Administration (FDA) considers it to be a first-in-class medication. [4] 1] [2] Adverse effects The US Food and Drug Administration prescription label for crinecerfont has a warning for acute adrenal insufficiency or adrenal crisis. [2] Food and Drug Administration (FDA) (Press release). January 2025.

FDA

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Landiolol

New Drug Approvals

APRIL 19, 2025

4] Landiolol can be used as first-line treatment for acute ventricular rate control in patients with atrial fibrillation (Level I recommendation- 2020 Guidelines of the European Society of Cardiology [15] ). Mode of action The drug acts as an ultra-short-acting 1-selective blocking agent. Food and Drug Administration (FDA).

FDA

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Donafenib

New Drug Approvals

AUGUST 4, 2025

Donafenib , sold under the brand name Zepsun , is a pharmaceutical drug for the treatment of cancer. 3] It is a deuterated derivative of sorafenib with improved pharmacokinetic properties. [4] 3] It is a deuterated derivative of sorafenib with improved pharmacokinetic properties. [4] Drugs 2021, 81, 1915−1920. 229) Li, C.;

Metabolic Stability

Metabolic Stability Pharmacokinetics Treatment Trials

AZVUDINE

New Drug Approvals

JULY 18, 2025

D-ARABINOFURANOSYL)- 4′-C-Azido-2′-deoxy-2′-fluoro-b-D-arabinocytidine Azvudine is an antiviral drug which acts as a reverse transcriptase inhibitor. [3] In addition to its antiviral activity, concentration of the drug in the thymus has suggested immune-targeting activity; this dual function is unique among RdRp inhibitors.8

RNA

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Dorzagliatin

New Drug Approvals

JULY 28, 2025

1] Unlike other diabetes drugs, it is intended to increase insulin sensitivity. [2] Drugs 2022, 82, 1745−1750. Safety, tolerability, pharmacokinetics, and pharmacodynamics of novel glucokinase activator HMS5552: results from a first-in-human single ascending dose study. Drugs 2020, 80, 467−475. 134) Xu, H.;

Small Molecule

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The Role of Scientific Expertise in Generic Drug Development

Drug Patent Watch

DECEMBER 10, 2024

Generic drug development is a complex process that involves not only scientific and medical expertise but also adherence to strict legal and ethical standards. Scientific expertise plays a crucial role in ensuring that generic drugs are held to the same standards of quality, safety, and efficacy as their brand-name counterparts.

Drug Development

Drug Development Pharmacokinetics Compliance Drugs

Vertex Bags Experimental Drug for Rare Liver Disease after Disappointing Phase 2 Results | 2020-10-15

The Pharma Data

OCTOBER 15, 2020

Vertex Pharmaceuticals has decided to give up on its experimental VX-814, a small molecule drug for the rare genetic disease Alpha-1 antitrypsin deficiency (AATD), canning the drug’s development after seeing lackluster results from an early phase 2 trial.

Disease

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PureTech’s LYT-100 (Deupirfenidone) Demonstrates Tolerability and Pharmacokinetic Proof-of-Concept in Phase 1 Multiple Ascending Dose and Food Effect Study

The Pharma Data

NOVEMBER 17, 2020

The study demonstrated favorable proof-of-concept for LYT-100’s tolerability and pharmacokinetic (PK) profile, which will also enable twice-a-day (BID) dosing of LYT-100 in future studies. The therapeutic dose of pirfenidone approved by the US Food and Drug Administration (FDA) for the treatment of IPF is 801 mg three times a day.

Pharmacokinetics

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

The Pharma Data

NOVEMBER 4, 2020

5, 2020 11:00 UTC. NASDAQ: CNCE) today reported financial results for the third quarter of 2020. Our team has diligently and effectively executed on our plan, and I’m pleased that we have achieved our stated 2020 pipeline milestones. Initiated CTP-543 THRIVE-AA1 Phase 3 Trial in November 2020. LEXINGTON, Mass.–(

Pharmaceuticals

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New molecular insights on medical cannabis

Drug Target Review

NOVEMBER 1, 2023

3 Another recent development is the implication of ATX in neurological diseases, 6,7 as ATX levels are related to metabolic disorders in Alzheimer disease, and thus might be an interesting biomarker and drug target for this devasting pathology. 2020 Jan 1;57(1):372–92. He is a researcher at University of Oldenburg, Germany.

Clinical Trials

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United Therapeutics Corporation Reports Third Quarter 2020 Financial Results

The Pharma Data

OCTOBER 27, 2020

28, 2020 /PRNewswire/ — United Therapeutics Corporation (Nasdaq: UTHR) today announced its financial results for the quarter ended September 30, 2020. ” THIRD QUARTER 2020 FINANCIAL RESULTS. .” ” THIRD QUARTER 2020 FINANCIAL RESULTS. 2020. 2020.

FDA

FDA Production Licensing Licensing

Game-changing pan-TEAD inhibitor for solid tumours

Drug Target Review

JUNE 12, 2023

TEAD proteins are crucial for tumour progression and drug resistance, making them an attractive focus for therapeutic interventions. Leveraging AI-guided structure-based drug design, Insilico’s research and development team generated an impressive portfolio of over 6,000 molecules and identified three highly promising hit series.

Metabolic Stability

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Looking beyond traditional oncogenic pathways to break cancer resistance

Drug Target Review

SEPTEMBER 25, 2024

While these approaches often produce encouraging initial results, the development of drug resistance remains a major obstacle for long-term patient survival. Classically, rational drug combinations are designed to target two nodes in the same oncogenic signalling pathway.

Small Molecule

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Roche presents new data from multiple Phase III studies of Tecentriq in triple-negative breast cancer at ESMO Virtual Congress 2020

The Pharma Data

SEPTEMBER 19, 2020

Basel, 19 September 2020 – Roche (SIX: RO, ROG; OTCQX: RHHBY) today announced that it presented the latest results from three Phase III studies from the Tecentriq® (atezolizumab) clinical development programme in triple-negative breast cancer (TNBC) at the European Society for Medical Oncology (ESMO) Virtual Congress 2020.

Treatment

Treatment Disease Therapies Pharmaceuticals

Release of ChEMBL 33

The ChEMBL-og

JUNE 13, 2023

References to primary literature are indicated in the ACTIVITY_PROPERTIES table (TEXT_VALUE AND STANDARD_TEXT_VALUE fields).

FDA Approval

FDA Approval Pharmacokinetics International Production

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. Tapinarof is metabolised by multiple pathways including oxidation, glucuronidation, and sulfation.

Small Molecule

Small Molecule FDA Approval FDA Drugs

Metabolism of 2023 FDA Approved Small Molecules – PART 2

Metabolite Tales Blog

APRIL 10, 2024

Where data was publicly available, the routes of human metabolism for each of the drugs in this subset is listed in Table 1. Metabolites found in humans are also observed in monkeys, and all metabolites were found to possess <10% of the activity of the parent drug. of the administered radiolabel in the human ADME study.

Small Molecule

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AlgoTherapeutix Receives Regulatory Approval to Initiate Clinical Development of ATX01

The Pharma Data

DECEMBER 14, 2020

15, 2020 07:15 UTC. The trial, which will explore the pharmacokinetics and safety of ATX01 in healthy volunteers, is due to start in January 2021. AlgoTherapeutix recently raised a 12M€ Series A that will fund the Phase 1 and 2 clinical development of ATX01.

Clinical Development

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ATICAPRANT

New Drug Approvals

SEPTEMBER 13, 2024

8] [9] [10] The drug has been found to dose-dependently block fentanyl -induced miosis at 25 mg and 60 mg in humans (with minimal to no blockade at doses of 4 to 10 mg), suggesting that the drug significantly occupies and antagonizes the MOR at a dose of at least 25 mg but not of 10 mg or less. [10] 2] Aticaprant is taken by mouth. [1]

Treatment

Treatment Clinical Trials Pharmacokinetics Pharmaceuticals

Aptorum Group Announces Submission of Clinical Trial Application for ALS-4, an Orally Administered Small Molecule Drug for the Treatment of Infections caused by Staphylococcus aureus including Methicillin-resistant Staphylococcus aureus (MRSA)

The Pharma Data

DECEMBER 20, 2020

21, 2020 11:00 UTC. Pending Health Canada’s approval, the Phase 1 trial is designed to test the safety, tolerability and pharmacokinetics of ALS-4 in healthy volunteers. The secondary objective is to assess the pharmacokinetic profile of SAD and MAD of ALS-4 administered orally to healthy subjects. About ALS-4.

Small Molecule

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Combining precision bispecific antibodies with targeted radiotherapy

Drug Target Review

OCTOBER 8, 2024

The OncoOne team is engineering antibodies to optimize pharmacokinetics, biodistribution, tumour retention, and target specificity. Oxidized macrophage migration inhibitory factor is a potential new tissue marker and drug target in cancer. 2020 Aug 21;48(3):874–82. 2020 Aug 1;61(8):1205–11. Molecular Cancer Therapeutics.

Pharmacokinetics

Pharmacokinetics Engineering Treatment Science

Aptorum Group Receives Clearance from Health Canada to Initiate a Phase 1 Clinical Trial for ALS-4, a Small Molecule Drug for Infections Caused by Staphylococcus aureus including Methicillin-resistant Staphylococcus aureus (MRSA)

The Pharma Data

JANUARY 19, 2021

Dr. Clark Cheng, Chief Medical Officer and Executive Director of Aptorum Group, commented, “The clearance of our CTA application for ALS-4 drug represents a significant milestone for the company and one of a number of targeted strategic goals for 2021. About ALS-4.

Small Molecule

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Selva Therapeutics Announces First Dosing in Phase 1 Clinical Study of SLV213, a Potential Oral Treatment for COVID-19

The Pharma Data

NOVEMBER 11, 2020

12, 2020 14:00 UTC. Food and Drug Administration (FDA) clearance of an Investigational New Drug (IND) application for SLV213 for the treatment of COVID-19 and has dosed the first subjects in a Phase 1 clinical study. Preclinical data show SLV213 is a potent inhibitor of SARS-CoV-2 infection. About SLV213.

Treatment

Treatment Small Molecule Virus Pharmacokinetics

First Subject Dosed with Gannex’s FXR Agonist ASC42 in a U.S. Phase I Trial

The Pharma Data

DECEMBER 27, 2020

27, 2020 /PRNewswire/ — Gannex , a wholly owned company of Ascletis Pharma Inc. HKEX: 1672) and fully dedicated to the R&D and commercialization of new drugs in the field of NASH, announces today dosing of first subject with its NASH drug candidate ASC42, a Farnesoid X Receptor (FXR) agonist, in a U.S. SHANGHAI , Dec.

Trials

Trials Pharmacokinetics Clinical Trials Therapies

Zelatriazin

New Drug Approvals

SEPTEMBER 10, 2024

. “In Vitro Metabolism of Slowly Cleared G Protein–Coupled Receptor 139 Agonist TAK-041 Using Rat, Dog, Monkey, and Human Hepatocyte Models (HepatoPac): Correlation with In Vivo Metabolism” Drug Metabolism and Disposition. 49 (2): 121–132. doi : 10.1124/dmd.120.000246. 120.000246. PMID 33273044. S2CID 227282766. “S180. .

Clinical Pharmacology

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Protalix BioTherapeutics and Chiesi Global Rare Diseases Announce Final Results of BRIDGE Phase III Open-Label, Switch-Over Clinical Trial Evaluating Pegunigalsidase Alfa for the Treatment of Fabry Disease

The Pharma Data

DECEMBER 29, 2020

30, 2020 /PRNewswire/ — Protalix BioTherapeutics, Inc. Topline results from the BRIDGE study were announced in May 2020. As announced in May 2020 , in the study, the mean annualized eGFR slope of the study participants improved from -5.90 The treatment period of the BRIGHT study was completed in July 2020.

Clinical Trials

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SCYNEXIS Announces Advancement of Ibrexafungerp’s Intravenous Formulation to Clinical Stage and Provides Further Updates on its Clinical Studies in Patients with Life-Threatening Fungal Infections

The Pharma Data

DECEMBER 9, 2020

The first trial will be conducted as a Phase 1, randomized, double-blind, placebo-controlled study to evaluate the safety, tolerability, and pharmacokinetics of the intravenous liposomal formulation of ibrexafungerp in healthy subjects. JERSEY CITY, N.J., 1) L iposomal IV formulation of ibrexafungerp entering Phase 1 study.

Hospitals

Hospitals Pharmacokinetics Treatment Trials

Etrasimod

New Drug Approvals

OCTOBER 24, 2023

3] [4] [5] [6] [7] [8] Society and culture Legal status Velsipity was approved by the US Food and Drug Administration (FDA) in October 2023. [1] Food and Drug Administration (FDA). April 2020). “FDA Approves New Drug for Ulcerative Colitis” Medscape. 11] SYN ACS Med. twitter +919321316780 call whatsaapp EMAIL.

FDA

FDA FDA Approval International Pharmacokinetics

Protalix BioTherapeutics and Chiesi Global Rare Diseases Announce Extension of PDUFA Date for Pegunigalsidase Alfa for the Proposed Treatment of Fabry Disease

The Pharma Data

NOVEMBER 26, 2020

27, 2020 /PRNewswire/ — Protalix Biotherapeutics, Inc. Protein sub-units are covalently bound via chemical cross-linking using short PEG moieties, resulting in a molecule with unique pharmacokinetic parameters. . CARMIEL, Israel , Nov. Galactosidase-A enzyme.

Disease

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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]. 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

Positive Phase 1 results in high-dose setanaxib trial

The Pharma Data

JANUARY 17, 2021

18, 2021 /PRNewswire/ — Genkyotex SA , a subsidiary of Calliditas Therapeutics AB (publ) (“Calliditas”) (Nasdaq OMX – CALTX; NASDAQ – CALT), today announced positive Phase 1 data demonstrating a favorable safety and pharmacokinetic profile of high-dose setanaxib, Genkyotex’s lead asset. STOCKHOLM , Jan.

Trials

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Keys to Success in Vaccine Development for Special Populations

PPD

MAY 11, 2023

The global COVID-19 pandemic increased awareness of the importance of vaccine development — both for drug developers and the public. The minimum age standards vary by country, and drug developers must be knowledgeable of the expectations in countries in which they conduct trials.

Vaccine

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SRP-001: redefining pain treatment with a safer, non-opioid analgesic

Drug Target Review

JULY 1, 2024

Can you explain the mechanism of action of SRP-001 and how it differs from traditional analgesics like acetaminophen (ApAP) and non-steroidal anti-inflammatory drugs (NSAIDs) in treating acute, chronic and neuropathic pain? We set out to improve health by developing a novel non-opioid that avoids potential abuse.

Treatment

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Hepion Pharmaceuticals Completes 75 mg CRV431 Dosing, Initiates 225 mg Dosing in Phase 2a ‘AMBITION’ Clinical Trial for NASH

The Pharma Data

DECEMBER 9, 2020

EDISON, NJ / ACCESSWIRE / December 10, 2020 / Hepion Pharmaceuticals, Inc. “All patients will now be observed for a 14-day follow-up period, which is scheduled to be completed by December 16, 2020. The Company’s lead drug candidate, CRV431, is a potent inhibitor of cyclophilins, which are involved in many disease processes.

Clinical Trials

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NorthSea Therapeutics doses first patient in Phase 1 trial of SEFA-1024 in dyslipidemia and further expands its clinical pipeline

The Pharma Data

NOVEMBER 18, 2020

19, 2020 09:00 UTC. This Phase 1 trial will evaluate the safety, tolerability, and pharmacokinetics of SEFA-1024 in 96 otherwise healthy volunteers with elevated plasma triglyceride levels.

Trials

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Donanemab data that demonstrated relationship between reduction of amyloid plaque and slowing of cognitive decline

The Pharma Data

JULY 29, 2021

Food and Drug Administration (FDA) had granted Breakthrough Therapy designation for donanemab based on the Phase 2 data. Additionally, pharmacokinetic/pharmacodynamic modeling showed that greater relative amyloid plaque clearance was correlated with greater clinical benefit. In June 2021, Lilly announced the U.S.

Disease

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Molecular Partners Doses First Cohort in Phase 1 Trial of COVID-19 DARPin(R) Therapeutic Candidate MP0420

The Pharma Data

NOVEMBER 22, 2020

Following strong preclinical data supporting the anti-COVID-19 program candidates, in October 2020 the Company entered into a collaboration with Novartis AG in the form of an option and license agreement to develop, manufacture and commercialize Molecular Partners’ anti-COVID-19 DARPin® program. About Molecular Partners AG.

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Evotec Expands Oxfordshire Site into a Fully-Integrated R&D Centre Named ‘Dorothy Crowfoot Hodgkin Campus’

The Pharma Data

NOVEMBER 11, 2020

CREATES CENTRE OF EXCELLENCE FOR STRUCTURE-BASED DRUG DESIGN. INCREASES GLOBAL CAPACITY FOR HIGH-VALUE INTEGRATED DRUG DISCOVERY AND COMMERCIAL DEVELOPMENT OFFERING. . ADDS IN VITRO PHARMACOLOGY AND EXPANDS PROTEIN SCIENCES.

Science

Science Small Molecule Pharmacokinetics Disease

Understanding the Regulatory Environment in Japan for Generic Drug Development

The rising impact of biomarkers in early clinical development

Trending Sources

Time for change: non-human primates in drug research

Elacestrant

Vamorolone

Navigating Regulatory Hurdles in Drug Development

Crinecerfont

Landiolol

Donafenib

AZVUDINE

Dorzagliatin

The Role of Scientific Expertise in Generic Drug Development

Vertex Bags Experimental Drug for Rare Liver Disease after Disappointing Phase 2 Results | 2020-10-15

PureTech’s LYT-100 (Deupirfenidone) Demonstrates Tolerability and Pharmacokinetic Proof-of-Concept in Phase 1 Multiple Ascending Dose and Food Effect Study

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

New molecular insights on medical cannabis

United Therapeutics Corporation Reports Third Quarter 2020 Financial Results

Game-changing pan-TEAD inhibitor for solid tumours

Looking beyond traditional oncogenic pathways to break cancer resistance

Roche presents new data from multiple Phase III studies of Tecentriq in triple-negative breast cancer at ESMO Virtual Congress 2020

Release of ChEMBL 33

Metabolism of 2022 FDA approved small molecule drugs PART 2

Metabolism of 2023 FDA Approved Small Molecules – PART 2

AlgoTherapeutix Receives Regulatory Approval to Initiate Clinical Development of ATX01

ATICAPRANT

Aptorum Group Announces Submission of Clinical Trial Application for ALS-4, an Orally Administered Small Molecule Drug for the Treatment of Infections caused by Staphylococcus aureus including Methicillin-resistant Staphylococcus aureus (MRSA)

Combining precision bispecific antibodies with targeted radiotherapy

Aptorum Group Receives Clearance from Health Canada to Initiate a Phase 1 Clinical Trial for ALS-4, a Small Molecule Drug for Infections Caused by Staphylococcus aureus including Methicillin-resistant Staphylococcus aureus (MRSA)

Selva Therapeutics Announces First Dosing in Phase 1 Clinical Study of SLV213, a Potential Oral Treatment for COVID-19

First Subject Dosed with Gannex’s FXR Agonist ASC42 in a U.S. Phase I Trial

Zelatriazin

Protalix BioTherapeutics and Chiesi Global Rare Diseases Announce Final Results of BRIDGE Phase III Open-Label, Switch-Over Clinical Trial Evaluating Pegunigalsidase Alfa for the Treatment of Fabry Disease

SCYNEXIS Announces Advancement of Ibrexafungerp’s Intravenous Formulation to Clinical Stage and Provides Further Updates on its Clinical Studies in Patients with Life-Threatening Fungal Infections

Etrasimod

Protalix BioTherapeutics and Chiesi Global Rare Diseases Announce Extension of PDUFA Date for Pegunigalsidase Alfa for the Proposed Treatment of Fabry Disease

Metabolism of 2023 FDA Approved Small Molecules – PART 1

Positive Phase 1 results in high-dose setanaxib trial

Keys to Success in Vaccine Development for Special Populations

SRP-001: redefining pain treatment with a safer, non-opioid analgesic

Hepion Pharmaceuticals Completes 75 mg CRV431 Dosing, Initiates 225 mg Dosing in Phase 2a ‘AMBITION’ Clinical Trial for NASH

NorthSea Therapeutics doses first patient in Phase 1 trial of SEFA-1024 in dyslipidemia and further expands its clinical pipeline

Donanemab data that demonstrated relationship between reduction of amyloid plaque and slowing of cognitive decline

Molecular Partners Doses First Cohort in Phase 1 Trial of COVID-19 DARPin(R) Therapeutic Candidate MP0420

Evotec Expands Oxfordshire Site into a Fully-Integrated R&D Centre Named ‘Dorothy Crowfoot Hodgkin Campus’

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