Drug Target Review

APRIL 7, 2025

Susceptibility or risk biomarkers can detect the likelihood of a patient developing a disease or medical condition, which is crucial for treatments that are most effective before the onset of symptoms. A biomarker is a measurable indicator of a biological process, disease state, or response to a treatment.

Clinical Development 69

Clinical Development Clinical Trials Clinical Pharmacology Trials 69

DrugBank

JULY 14, 2025

The complexity of pharmacokinetics and pharmacodynamics, coupled with the variability in patient populations, makes predicting and managing DDI a particularly challenging aspect of drug development.  The most clinically significant pharmacokinetic interactions are often those that influence drug metabolism.

Clinical Development 52

Clinical Development Pharmacokinetics Drugs Clinical Trials 52

Molecular Design

MARCH 31, 2019

Controllability of exposure is the focus of pharmacokinetic optimization and I recently became aware of an exciting new development that will surely reshape the pharmacokinetic field and transform drug discovery beyond all recognition.

Pharmacokinetics 52

Pharmacokinetics Treatment Drugs 52

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

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] Randomization was stratified based on whether the ESR1 mutation was detected or not, prior treatment with fulvestrant, and presence of visceral metastasis.

FDA 62

FDA Pharmacokinetics Therapies Treatment 62

The Pharma Data

JUNE 25, 2025

Designed using the same fundamental mechanism as Biogen’s approved SMA treatment SPINRAZA (nusinersen), salanersen represents a next-generation approach aimed at greater potency and less frequent dosing—potentially requiring only once-yearly administration. Treatment-naïve individuals, to evaluate efficacy as a first-line therapy.

Therapies 52

Therapies Trials RNA Treatment 52

The Pharma Data

JUNE 22, 2025

The study marks a significant step forward in the treatment landscape for haemophilia A, demonstrating not only clinical safety and pharmacokinetic stability, but also strong patient preference for the Mim8 pen-injector delivery system. Throughout the 26-week study period, the investigational therapy was well-tolerated.

Pharmacokinetics 40

Pharmacokinetics Therapies Treatment Trials 40

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

Drug Target Review

JUNE 19, 2025

As the limitations of current treatments become increasingly clear, researchers are exploring new, safer approaches. His focus, however, is on addressing a critical gap in medicine: the lack of safe, non-addictive pain treatments – a challenge that has driven the development of SRP-001. “As From bench to bedside: what is next?

Clinical Trials 52

Clinical Trials Molecular Biology Treatment Trials 52

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

The Pharma Data

JUNE 25, 2025

A Patient-Centered Innovation in B-Cell Cancer Treatment Zanubrutinib, marketed as BRUKINSA, is a next-generation Bruton’s tyrosine kinase (BTK) inhibitor approved for the treatment of various B-cell malignancies.

Packaging 52

Packaging Pharmacokinetics Therapies Marketing 52

Drug Target Review

JUNE 6, 2025

And in the small molecule space, it’s about overcoming pharmacokinetic factors and formulation issues.” Greally explains that this iterative approach allows for more rigorous evaluation of ADC candidates, particularly in relation to pharmacokinetics and in vivo performance.

Small Molecule 52

Small Molecule Pharmacokinetics Packaging Drugs 52

The Pharma Data

JUNE 27, 2025

The trial met both its primary and key secondary endpoints, signaling a potential breakthrough in a condition with few, if any, effective treatment options. It is characterized by early-onset, treatment-resistant seizures, beginning as early as six weeks of age, and profound global neurodevelopmental impairment.

Trials 40

Trials Treatment Therapies Pharmacokinetics 40

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

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

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

JUNE 23, 2025

In tandem with the Phase 2 results, Amgen also shared detailed data from its Phase 1 Pharmacokinetics Low Dose Initiation (PK-LDI) study. This study explored the effects of beginning treatment with lower starting doses of MariTide to improve tolerability while maintaining clinical benefit.

Trials 40

Trials Treatment Pharmacokinetics Clinical Trials 40

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] 4] It was approved for the treatment of major depressive disorder in the United States in September 2023. [4]

FDA 62

FDA FDA Approval Treatment Clinical Trials 62

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.

Clinical Trials 78

Clinical Trials Laboratories Trials Drug Development 78

The Pharma Data

JULY 2, 2025

Promising Results from Phase 1b Trial The Phase 1b study was a multicenter, randomized, double-blind, placebo-controlled clinical trial specifically designed to assess the safety, tolerability, pharmacokinetics (PK), immunogenicity, and preliminary efficacy of ARGX-119 in individuals with DOK7-related CMS. per 1 million.

Clinical Trials 40

Clinical Trials Trials Therapies Disease 40

The Pharma Data

JUNE 11, 2025

This decision represents a pivotal moment in the evolution of treatment convenience for patients with certain B-cell malignancies, while reinforcing BRUKINSA’s stronghold in the BTK inhibitor market. The agency has officially approved a new tablet formulation of BRUKINSA® (zanubrutinib) for all five of its previously approved indications.

FDA Approval 40

FDA Approval FDA Treatment Therapies 40

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 Production 122

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 Production 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

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 Drugs FDA Approval 52

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

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 Pharmaceuticals Clinical Trials Therapies 98