Covalent Modifiers

JANUARY 29, 2024

3c01608 Glutathione peroxidase 4 (GPX4) emerges as a promising target for the treatment of therapy-resistant cancer through ferroptosis. However, a majority of reported GPX4 inhibitors utilize chloroacetamide as a reactive electrophilic warhead, and the selectivity and pharmacokinetic properties still need to be improved.

Therapies 173

Therapies Pharmacokinetics Treatment 173

Covalent Modifiers

MARCH 13, 2024

Performing structure-guided modifications of BPV, we developed a picomolar-affinity inhibitor, ML2006a4, with antiviral activity, oral pharmacokinetics, and therapeutic efficacy similar or superior to those of NTV.

Pharmacokinetics 162

Pharmacokinetics Virus Treatment Drugs 162

ASPET

OCTOBER 23, 2024

Neither nimodipine nor NP10679 alter each other's pharmacokinetic profile, suggesting no obvious drug-drug interactions. These results further demonstrate the utility of pH-dependent neuroprotective agents and GluN2B-selective NMDAR inhibitors as potential therapeutic strategies for the treatment of aSAH.

Clinical Development 100

Clinical Development Treatment Pharmacokinetics Drugs 100

ASPET

AUGUST 29, 2023

A single subcutaneous dose of STAR-0215 ({greater than or equal to} 100 mg) was predicted to be active in patients for 3 months or longer, based on simulations using a minimal physiologically based pharmacokinetic (mPBPK) model.

Treatment 100

Treatment Pharmacokinetics Therapies Disease 100

Drug Target Review

JULY 12, 2023

Molecular-level biochemical assays like transcriptomics, genomics and proteomics have emerged as valuable tools for identifying potential targets in cancer treatment through deep cyclic inhibition (DCI). How does the DCI mechanism compare to the design of other drugs for cancer treatment?

Biochemical Assays 98

Biochemical Assays Treatment Bioinformatics Disease 98

ASPET

SEPTEMBER 7, 2023

Awareness of drug interactions involving opioids is critical for patient treatment as they are common therapeutics used in numerous care settings including both chronic and disease related pain. Opioids are the classical pain treatment for patients who suffer from moderate to severe pain.

Pharmacokinetics 100

Pharmacokinetics Drugs Treatment Disease 100

Chemical Biology and Drug Design

DECEMBER 19, 2024

Therefore, the inhibition of this pathway is an important therapeutic target for the treatment of various types of inflammation. ADMET prediction analysis indicated that compounds 5h and 5k showed good pharmacokinetic properties.

Pharmacokinetics 100

Pharmacokinetics Regulations Treatment Drugs 100

ASPET

AUGUST 10, 2023

Pharmacokinetic half-lives ranged from 55 to 100 hours over the clinically relevant dose range, consistent with the expected half-life extension by glycoPEGylation. These findings provide evidence that pegozafermin is a promising candidate molecule for the treatment of patients with NASH or SHTG.

Cell Based Assays 100

Cell Based Assays Pharmacokinetics Regulations Treatment 100

DrugBank

SEPTEMBER 19, 2024

It offers convenience for patients, promotes medication adherence, and improves treatment outcomes. However, translating a promising therapeutic candidate into a successful oral medication presents pharmacokinetic and pharmacodynamic challenges.  This could aid in treatment for diabetic patients who currently rely on injections.

Drugs 98

Drugs Pharmacokinetics Treatment Disease 98

ASPET

SEPTEMBER 16, 2024

We further demonstrate that daily oral treatment with a novel mitofusin activator derived from the natural product piperine can reverse these neurological phenotypes. Here, we describe motor and sensory neuron dysfunction characteristic of clinical CMT type 2A in a CRISPR/Casp-engineered Mfn2 Thr105Met (T105M) mutant knock-in mouse.

Small Molecule 100

Small Molecule Pharmacokinetics Engineering Disease 100

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 52

Pharmacokinetics Treatment Trials Production 52

The Pharma Data

AUGUST 28, 2020

Celltrion Group has announced that the Korean Ministry of Food and Drug Safety has approved the company’s Investigational New Drug application for a Phase 1 trial for their coronavirus antiviral antibody treatment candidate. Conor Kavanagh. Source link.

Trials 52

Trials Treatment Clinical Trials Pharmacokinetics 52

ASPET

OCTOBER 20, 2023

Thus, owing to the significant differences in pharmacokinetics of exogenously administered Pramlintide and insulin, the therapy fails to elicit its action otherwise produced by the endogenous hormones.

Therapies 100

Therapies Pharmacokinetics Treatment Marketing 100

DrugBank

OCTOBER 17, 2024

Computational chemistry and molecular modeling techniques can predict potential drug candidates' binding affinity and pharmacokinetic properties, enabling the selection of the most promising compounds for further development.

Drug Development 98

Drug Development Metabolic Stability Clinical Trials Drugs 98

Conversations in Drug Development Trends

JANUARY 21, 2025

Bioanalysis during clinical development of a drug is an indispensable process where trials obtain critical data pertinent to pharmacokinetics (PK) and pharmacodynamics (PD) and as readouts that are crucial for assessing the safety and efficacy of the drugs.

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Clinical Trials Laboratories Trials Drug Development 78

Elrig

MARCH 25, 2025

Earlier in her career, she held several leadership roles within AstraZeneca, including Senior Director for Drug Metabolism & Pharmacokinetics and Director for Lead Optimisation & Enabling Technologies within medicinal chemistry.

RNA 59

RNA Bioinformatics Science Pharmacokinetics 59

Drug Target Review

OCTOBER 24, 2023

Live Bacterial Products (LBPs) will provide patients with a desirable, credible, safe and effective treatment option. The human microbiome, a complex ecosystem of microorganisms residing within our bodies, has emerged as a promising frontier in the quest for innovative medical treatments.

Treatment 122

Treatment Pharmaceuticals Pharmacokinetics Trials 122

Alta Sciences

APRIL 17, 2024

Five Promising Treatment Areas in Early-Phase Drug Development in 2024 aasimakopoulos Wed, 04/17/2024 - 15:52 Early-phase drug development is an ever-changing landscape, as emerging science leads to new promising areas of research for the treatment of human health issues.

Drug Development 52

Drug Development Treatment FDA Approval Drugs 52

The Pharma Data

AUGUST 19, 2021

The Janssen Pharmaceutical Companies of Johnson & Johnson today announced preliminary data from the Phase 1 CHRYSALIS study evaluating RYBREVANT TM (amivantamab-vmjw) for the treatment of patients with non-small cell lung cancer (NSCLC) with mesenchymal-epithelial transition (MET) exon 14 skipping (METex14) mutations. 4] , [5] , [6].

Treatment 52

Treatment FDA Approval Pharmacokinetics FDA 52

The Pharma Data

MARCH 13, 2021

“Lanadelumab is a fully human monoclonal antibody that specifically binds and decreases plasma kallikrein activity, with a proven efficacy and safety profile as a preventive treatment for HAE attacks. Subject to approval, we are looking forward to providing lanadelumab as a new treatment option for patients in Japan living with HAE.”.

Treatment 52

Treatment Pharmacokinetics Drugs Therapies 52

Alta Sciences

SEPTEMBER 13, 2023

Four Pain Models Altasciences Uses to Assess Treatments During Clinical Trials pmjackson Wed, 09/13/2023 - 17:01 September is pain awareness month, and the importance of pain management and continued research into effective analgesics is integral to helping patients suffering from various pain conditions.

Clinical Trials 52

Clinical Trials Treatment Trials Drug Development 52

The Pharma Data

NOVEMBER 11, 2020

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. SAN DIEGO–( BUSINESS WIRE )– Selva Therapeutics, Inc. announced today that the company has received U.S.

Treatment 52

Treatment Small Molecule Virus Pharmacokinetics 52

Drug Target Review

JULY 1, 2024

As a non-opioid, SRP-001 also eliminates abuse potential, positioning it as a safer and effective drug candidate for the treatment of acute and neuropathic pain and migraine headache. How does SRP-001’s safety profile, especially concerning hepatotoxicity and nephrotoxicity, compare to other common pain medications?

Treatment 59

Treatment Clinical Trials Therapies Molecular Biology 59

New Drug Approvals

OCTOBER 12, 2024

ALZ-801 is an advanced and markedly improved candidate for the treatment of alzheimer’s disease. Clinical Pharmacokinetics and Safety of ALZ-801, a Novel Prodrug of Tramiprosate in Development for the Treatment of Alzheimer’s Disease. Clin Pharmacokinet. 2018; 32(9): 849–861. [2]. Hey JA, et al.

Pharmacokinetics 62

Pharmacokinetics Small Molecule Disease Licensing 62

DrugBank

MARCH 7, 2024

Inspired by its success, pharmaceutical companies are pursuing the development of drugs with similar therapeutic profiles, aiming to expand treatment options. Supply issues have plagued the availability of their weight loss treatments, creating hurdles for patients seeking these medications.

Pharmaceutical Companies 98

Pharmaceutical Companies Clinical Trials Pharmaceuticals Therapies 98

Drug Target Review

SEPTEMBER 25, 2024

4 Another related and well described non-oncogene resistance mechanism is the histological transformation of EGFR-mutated non-small cell lung cancer (NSCLC) to small-cell lung cancer upon treatment with an EGFR inhibitor. Notably, TT125-802 stabilised disease and prevented further outgrowth of tumours resistant to standard-of-care treatment.

Small Molecule 105

Small Molecule Therapies Regulations Treatment 105

The Premier Consulting Blog

MAY 31, 2023

While the type, number, and design of these studies vary based on product-specific characteristics, IND-enabling packages submitted to the FDA generally include key information about the pharmacology, pharmacokinetics, and toxicology of the product. All these studies need to be performed under GLP.

Packaging 52

Packaging Pharmacokinetics Small Molecule Clinical Trials 52

PPD

JULY 29, 2024

The benefits of utilizing AI in clinical research Patient recruitment and diversity AI is increasingly being utilized in the recruitment process for clinical trials , aiming to connect individuals with potential benefits from investigational treatments.

Clinical Research 98

Clinical Research Clinical Trials Research Trials 98

Drug Target Review

DECEMBER 11, 2024

For these studies, a comprehensive approach to drug metabolism and pharmacokinetics (DMPK), along with immunogenicity is essential, drawing on expertise from multiple disciplines. Special attention is required when dealing with antibody-based therapeutics due to their high susceptibility to biotransformation.

International 52

International Laboratories Drugs Pharmacokinetics 52

The Pharma Data

DECEMBER 29, 2020

an international research-focused healthcare Group (Chiesi Group), today announced final study results from the BRIDGE Phase III Open-Label, Switch-Over Clinical Trial Evaluating Pegunigalsidase Alfa for the Treatment of Fabry Disease. galactosidase-A product candidate under development for the treatment of Fabry disease.

Clinical Trials 52

Clinical Trials Disease Treatment Trials 52

The Pharma Data

NOVEMBER 26, 2020

Food and Drug Administration (FDA) has extended the Prescription Drug User Fee Act (PDUFA) date for review of the Company’s Biologics License Application (BLA) seeking accelerated approval of pegunigalsidase alfa (PRX–102) for the proposed treatment of adult patients with Fabry disease. About Pegunigalsidase Alfa.

Disease 52

Disease Treatment Clinical Trials FDA 52

The Pharma Data

JANUARY 3, 2021

Nasdaq: INZY), a clinical-stage biopharmaceutical company developing novel therapeutics for the treatment of rare diseases of abnormal mineralization impacting the vasculature, soft tissue and skeleton, today announced that the U.S. BOSTON, Jan. 04, 2021 (GLOBE NEWSWIRE) — Inozyme Pharma, Inc. About Inozyme Pharma.

Clinical Trials 52

Clinical Trials Trials Treatment FDA 52

Drug Target Review

JUNE 12, 2023

With 13 preclinical candidates and three AI-designed drugs currently undergoing clinical trials, Insilico is spearheading a revolution in cancer treatment and beyond. Can you provide a summary of the key findings and implications of the preclinical studies on ISM6331 for the treatment of advanced solid tumours?

Metabolic Stability 92

Metabolic Stability Clinical Trials Small Molecule Therapies 92

The Pharma Data

JULY 12, 2021

These data include results from a late-breaking presentation from a Phase 2a study evaluating the safety and pharmacokinetics (PK) of once-monthly (QM) oral islatravir for pre-exposure prophylaxis (PrEP) through 24 weeks. “We An overview of the islatravir treatment and prevention development program is available here. Abstract 2361.

Pharmacokinetics 52

Pharmacokinetics Clinical Trials Trials Treatment 52

The Pharma Data

DECEMBER 17, 2020

San Diego-based Janux Therapeutics forged a strategic collaboration with pharma giant Merck potentially worth more than $1 billion to develop next-generation T cell engager immunotherapies for the treatment of cancer. Janux believes it has overcome these limitations with its TRACTr technology.

Immune Response 52

Immune Response Pharmacokinetics Engineering Licensing 52

The Pharma Data

OCTOBER 15, 2020

The study, which involves approximately 50 patients with the rare liver and lung disease, raised concerns about the experimental treatment’s safety and pharmacokinetic profile.

Disease 52

Disease Small Molecule Pharmacokinetics Licensing 52

The Pharma Data

JUNE 7, 2022

RIABNI is already approved for the treatment of adult patients with Non-Hodgkin’s Lymphoma (NHL), Chronic Lymphocytic Leukemia (CLL), Granulomatosis with Polyangiitis (GPA) (also called Wegener’s Granulomatosis) and Microscopic Polyangiitis (MPA). Safety, pharmacokinetics and immunogenicity of RIABNI were similar to rituximab RP.

Biosimilars 52

Biosimilars FDA Approval FDA Pharmacokinetics 52