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US Food and Drug Administration/Conformit Europe-approved absorbable nerve conduits for clinical repair of peripheral and cranial nerves.

Several absorbable nerve conduits are approved by the US Food and Drug Administration (FDA) and Conformit Europe (CE) for clinical repair of peripheral and cranial nerves. Surgeons are often not aware of the different (bio)materials of these conduits when performing nerve repair. An overview of these FDA- and CE-approved absorbable nerve conduits for clinical use is presented. PubMed, MEDLINE, and the companies selling the conduits were consulted. The available FDA and CE absorbable nerve conduits for peripheral and cranial nerve repair are 2 collagen- and 2 synthetic-polyester-based conduits.

Viagra's rise above women's health issues: an analysis of the social and political influences on drug approvals in the United States and Japan.

In the United States, Viagra was approved in less than 6 months of its application to the Food and Drug Administration, while the medical ab … which objective decisions arise from science and clinical investigations. Analyses of these recent drug approvals demonstrate that conclusions may not have been based simply on science and health concerns. Instead, agency actions and application of pharmaceutical law appear to have been influenced by social and political pressures surrounding the products unde …

Rituximab pediatric drug development: Pharmacokinetic and pharmacodynamic modeling to inform regulatory approval for rituximab treatment in patients with granulomatosis with polyangiitis or microscopic polyangiitis.

Anti-neutrophil cytoplasmic antibody-associated vasculitides granulomatosis with polyangiitis (GPA) and microscopic polyangiitis (MPA) are rare, potentially organ- and life-threatening autoimmune conditions affecting adult and pediatric patients. An open-label phase II study was conducted to determine safe and effective dosing regimens of rituximab in pediatric patients with GPA/MPA. To determine the selection of an appropriate dose regimen in children for induction and maintenance, a population pharmacokinetic approach was used (nonlinear mixed-effect modeling), combining pediatric data with

Structure-based drug repurposing for CDK6: Molecular docking and molecular dynamics characterization of FDA-approved non-oncological compounds.

Cyclin-dependent kinase 6 (CDK6) contributes to G1-to-S cell-cycle progression and represents an established therapeutic target in hormone receptor-positive breast cancer. However, adverse effects and acquired resistance associated with current CDK4/6 inhibitors support continued investigation of alternative chemical scaffolds. In this study, a total of 319 FDA-approved non-oncological drugs were screened by molecular docking against the ATP-binding site of a predicted human CDK6-Cyclin D1 complex. The three highest-ranked compounds, dutasteride, danazol, and azelastine, were subsequently subj

Repurposing FDA approved drugs targeting IL-6 associated signalling for the management of rheumatoid arthritis: an in silico and experimental approach.

Rheumatoid arthritis (RA) is a chronic autoimmune inflammatory disease that is mediated by pro-inflammatory cytokines, like interleukin-6 (IL-6). IL-6 plays an important role in synovial inflammation and joint degradation. In this study, a combined in silico, in vitro and in vivo approach was used to identify and preliminarily evaluate valganciclovir hydrochloride as potential modulator of IL-6 receptor mediated inflammatory signalling. Docking studies showed that valganciclovir hydrochloride had favourable binding affinity with IL-6 receptor, and interacted stably with active site. ADMET anal

Utilization of Healthy Volunteers in Oncology Drug Development in Japan: A 10-Year Analysis of Approved Anticancer Agents (2014-2024).

Anticancer agents with favorable safety profiles, such as immunomodulators and molecular-targeted agents, are increasingly used in recent cancer therapy, and clinical trials for these agents increasingly incorporate healthy volunteers as well as cancer patients. Clinical trials in healthy volunteers allow intensive safety monitoring and intensive pharmacokinetic sampling, enabling the acquisition of high-quality, broad-range pharmacokinetic and safety data within a shorter timeframe and at lower cost. Leveraging these advantages by utilizing healthy volunteer trials in place of patient trials

Repurposing FDA-Approved Drugs as Nav1.7 Channel Modulators: An Integrated Structure-Based Virtual Screening and Molecular Dynamics Study.

The voltage-gated sodium channel Nav1.7 is a strongly validated target for the development of novel, non-opioid analgesics due to its genetic link to pain signaling. To accelerate the discovery of safe Nav1.7 modulators, this study outlines an integrated computational pipeline to repurpose FDA-approved drugs. A structurally complete model of the Nav1.7 central pore was generated via homology modeling from a high-resolution cryo-EM structure (PDB: 7W9K) to ensure a physically consistent model suitable for dynamic simulations. We conducted a structure-based virtual screening of 2296 FDA-approved

Clinical Benefit of Multiple Myeloma Drugs at Regulatory Approval in Brazil, Europe, and the USA: A Retrospective Cohort Study (2003-2024).

BACKGROUND AND OBJECTIVES: The value of new therapies depends on the magnitude of their clinical benefit. In multiple myeloma (MM), numerous drugs have been approved in the past two decades, yet the extent of clinical benefit at authorization remains uncertain. This study evaluated MM drugs approved by the European Medicines Agency (EMA), the Food and Drug Administration (FDA), and the Brazilian Health Regulatory Agency (Anvisa). METHODS: This retrospective cohort study assessed MM drugs approved between 2003 and 2024. Data were extracted from publicly available regulatory documents. Clinical

Rational drug design for Alzheimer's disease: from approved therapies to next-generation clinical candidates and AI-guided innovation.

Alzheimer's disease (AD) is a progressive neurodegenerative disorder characterized by multifactorial pathology, including amyloid-β (Aβ) aggregation, tau hyperphosphorylation, oxidative stress, neuroinflammation, and synaptic dysfunction. Despite extensive research, currently approved treatment provides only symptomatic relief, while recently approved disease-modifying monoclonal antibodies have shown limited benefits. Ongoing clinical investigations have shifted toward multi-target directed ligands (MTDLs), RNA-based therapies, immunotherapies, and vaccines. Some approved drugs that have esta

A significant number of pediatric inflammatory bowel disease patients are exposed to a medication not approved by the Food and Drug Administration for pediatric use.

OBJECTIVES: Inflammatory bowel disease (IBD) presents before age 20 years in ~25% of patients. Regulatory approvals of IBD medications for pediatric use are often delayed. Nevertheless, many pediatric patients receive medication not approved for pediatric use. The aim of this study was to summarize the exposure of pediatric patients to IBD medication without regulatory approval for pediatrics. METHODS: A retrospective study of exposure to nonapproved biologic/small molecule medications in patients listed in the ImproveCareNow registry with IBD diagnosed before September 2023 was conducted. Ch

Repurposing FDA-Approved Drugs as Fructosamine-3-Kinase Inhibitors: A Mechanistic and Translational Approach to Redox-Driven Cancer Therapy.

Fructosamine-3-kinase (FN3K), a deglycating enzyme originally studied in the context of diabetes, has recently emerged as a pivotal modulator of redox homeostasis and therapeutic resistance in cancer. FN3K catalyzes the removal of early glycation adducts, thereby stabilizing redox-sensitive proteins such as Nuclear factor erythroid 2-related factor 2 (Nrf2), a key transcriptional regulator of antioxidant defense. This review explores the evolving role of FN3K in tumor metabolism, highlighting its expression patterns across cancer types, structural features amenable to therapeutic targeting, an

Comparative Assessment of Pivotal Trials Supporting the Indication Approvals of Innovative and Modified New Anticancer Drugs in China, 2016-2022.

Background: Since the launch of drug regulatory reform in 2015, China has substantially increased the availability of new cancer therapies. However, the efficacy evidence criteria for modified new anticancer drugs have not been evaluated. This cross-sectional study aimed to assess the pivotal trials supporting the indication approvals of innovative and modified new chemical anticancer drugs in China. Methods: The characteristics of indications, regulatory aspects, and pivotal trial designs were extracted and described. The primary efficacy endpoints of the pivotal clinical trials, including ov

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… The majority of these new drugs were intended for the treatment of cancer, and the quantities of new anticancer drug approvals have increased substantially over the past 5 years in China [ 10 , 11 ]. … Finally, further research is necessary to be conducted to analyze the differences between the full range of new drugs approved in China. …

Formoterol, a clinically approved drug, inhibits ferroptosis by suppressing lipid peroxidation and attenuates APAP-induced acute liver injury.

Ferroptosis is an iron-dependent form of regulated cell death characterized by lethal lipid peroxidation and implicated in various human diseases. Despite intensive research, clinically applicable ferroptosis inhibitors remain unavailable. In this study, we identify formoterol, a β2-adrenergic agonist widely used to treat asthma and COPD, as a potent and selective ferroptosis inhibitor through scaffold-based screening of FDA-approved drugs. Formoterol confers robust protection against ferroptotic cell death induced by diverse triggers across multiple human and rodent cell lines, functioning in

Screening Methods to Discover the FDA-Approved Cancer Drug Encorafenib as Optimally Selective for Metallothionein Gene Loss Ovarian Cancer.

BACKGROUND/OBJECTIVES: All 11 metallothionein protein-coding genes are located on human chromosome 16q13. It is unique among human genetics to have an entire pathway's genes clustered in a short chromosomal region. Since solid tumors, particularly high-grade serous ovarian cancer (HGSC), exhibit high rates of monoallelic aneuploidy, this region is commonly lost. Studies have not yet been performed to determine what vulnerability may be created in cancer cells with low metallothionein expression. Here, a screen of FDA-approved cancer small molecule drugs for those best targeting low metallothio

Repurposing FDA-approved drugs to find a novel inhibitor of alpha-ketoglutarate-dependent dioxygenase FTO to treat esophageal cancer.

BACKGROUND AND PURPOSE: The Fat mass and obesity-associated protein (FTO) plays a significant role in esophageal cancer by regulating N6-methyladenosine (m6A) modification. FTO inhibition has shown potential in cancer therapies but remains underexplored. This study aimed to identify a safer, FDA-approved compound for FTO inhibition that can be used in combination with chemotherapy drugs. EXPERIMENTAL APPROACH: FDA-approved drugs were screened from the Zinc 15 database using AutoDock Vina against the 3D structure of FTO (PDB ID: 3LFM). Discovery Studio software was used to determine binding in

Computational approach towards repurposing of FDA approved drug molecules: strategy to combat antibiotic resistance conferred by Pseudomonas aeruginosa.

Antimicrobial resistance is recognized as a major worldwide public health dilemma in the current century. Pseudomonas aeruginosa, a Gram-negative opportunistic pathogen, causes nosocomial infections like respiratory tract infections, urinary tract infections, dermatitis, and cystic fibrosis. It manifests antibiotic resistance via intrinsic, acquired, and adaptive pathways, where efflux pumps function in the extrusion of antibiotics from the cell. MexB protein, part of the tripartite efflux pumps MexAB-OprM present in P.aeruginosa, expels the penems and β-lactam antibiotics, thereby enhancing P

Repurposing FDA-approved drugs to target malaria through inhibition of dihydrofolate reductase in the folate biosynthesis pathway: A prospective approach.

Dihydrofolate reductase (DHFR) is a ubiquitous enzyme that regulates the biosynthesis of tetrahydrofolate among various species of Plasmodium parasite. It is a validated target of the antifolate drug pyrimethamine (Pyr) in Plasmodium falciparum (Pf), but its clinical efficacy has been hampered due to the emergence of drug resistance. This has made the attempt to screen Food & Drug Administration-approved drugs against wild- and mutant PfDHFR by employing an in-silico pipeline to identify potent candidates. The current study has followed a virtual screening approach for identifying potential DH

A Review of FDA-Approved Anti-HIV-1 Drugs, Anti-Gag Compounds, and Potential Strategies for HIV-1 Eradication.

Acquired immunodeficiency syndrome (AIDS) is an enormous global health threat stemming from human immunodeficiency virus (HIV-1) infection. Up to now, the tremendous advances in combination antiretroviral therapy (cART) have shifted HIV-1 infection from a fatal illness into a manageable chronic disorder. However, the presence of latent reservoirs, the multifaceted nature of HIV-1, drug resistance, severe off-target effects, poor adherence, and high cost restrict the efficacy of current cART targeting the distinct stages of the virus life cycle. Therefore, there is an unmet need for the discove

Repurposing FDA approved drugs against Sterol C-24 methyltransferase of Leishmania donovani: A dual in silico and in vitro approach.

Leishmaniasis is a disease caused by the parasite Leishmania donovani affecting populations belonging to developing countries. The present study explores drug repurposing as an innovative strategy to identify new uses for approved clinical drugs, reducing the time and cost required for drug discovery. The three-dimensional structure of Leishmania donovani Sterol C-24 methyltransferase (LdSMT) was modeled and 1615 FDA-approved drugs from the ZINC database were computationally screened to identify the potent leads. Fulvestrant, docetaxel, indocyanine green, and iohexol were shortlisted as potent