Evidence map›Paper›PMID 40454890›Full record

ReviewSmall (Weinheim an der Bergstrasse, Germany)2025

Nanoparticle Therapeutics in Clinical Perspective: Classification, Marketed Products, and Regulatory Landscape.

Nimeet Desai, Dhwani Rana, Mitali Patel, Neha Bajwa, Rajendra Prasad, Lalitkumar K Vora

Abstract readReview
In one paragraph

Review in Small (Weinheim an der Bergstrasse, Germany), 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 114 papers.

0numbers the graph read from it
0cells of the map it votes in
114citing papers in PubMed
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

114 citing papers in PubMed.

  1. Review
  2. Toxicity of nanostructures in drug delivery applications.Pharmaceutical science advances · 2026
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54 more citing papers are in PubMed but not listed here.

4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

6 authors.

Nimeet DesaiDepartment of Eye and Vision Science, Institute of Life Course and Medical Sciences, University of Liverpool, Liverpool, L7 8TX, UK.ORCID 0000-0002-3575-6671
Dhwani RanaDepartment of Pharmaceutics, National Institute of Pharmaceutical Education and Research-Ahmedabad (NIPER-A), Gandhinagar, Gujarat, 382355, India.
Mitali PatelMaliba Pharmacy College, Uka Tarsadia University, Surat, Gujarat, 394350, India.
Neha BajwaUniversity Center of Excellence in Research, Baba Farid University of Health Sciences, Faridkot, Punjab, 151203, India.
Rajendra PrasadSchool of Biochemical Engineering, Indian Institute of Technology (BHU), Varanasi, Uttar Pradesh, 221005, India.
Lalitkumar K VoraSchool of Pharmacy, Queen's University Belfast, 97 Lisburn Road, Belfast, BT9 7BL, UK.ORCID 0000-0001-8106-9066

Funding

Anusandhan National Research Foundation ANRF/IRG/2024/000620/LS
6 · The paper itself

Abstract

Nanoparticle-based therapeutics, emerging from advances in nanotechnology, outperform traditional drug therapies by virtue of their distinct biological properties that enhance therapeutic efficacy, reduce toxicity, and enable precise targeting. Since the 1980s, the number of nanoparticle-based pharmaceutical products has expanded considerably, capturing a significant portion of the pharmaceutical market. These systems function as therapeutic agents or as vehicles for delivering active pharmaceutical or diagnostic compounds to targeted areas. However, despite their transformative potential, the development of comprehensive and harmonized regulatory frameworks for nanomedicines remains a critical challenge. This review provides a current overview of market-approved nanoparticle therapeutics, analyzing global regulatory strategies, including pre-clinical testing, safety assessments, manufacturing processes, and quality control standards. By discussing the existing shortcomings, this review highlights the importance of adaptive regulatory pathways in a global context. It aims to support researchers and stakeholders in navigating the regulatory landscape, facilitating the successful commercialization and clinical translation of nanoparticle-based therapeutics.

Indexed as

NanoparticlesHumansNanomedicinemarketed productsnanomedicinesnanoparticlesregulatory approvalregulatory guidelines

Identifiers

PMID40454890
PMCPMC12288819

What Socratic holds

Textmetadata
LicenceCC BY
Read underepoch 390

Registered trials

None linked

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the Socratic graph.