Evidence map›Paper›PMID 41850780›Full record

ReviewChinese medical journal2026

Organoid models: Regulations and prospects for the development of investigational new drugs.

Huachao Li, Yin Pan, Zhibao Zheng, Renzhi Lin, Yue Pan, Lizhong Lin, Mingming Quan, Hongsheng Lu, Zhe Hu, Mingbin Zheng and 2 more

Abstract readReview
In one paragraph

Review in Chinese medical journal, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 1 paper.

0numbers the graph read from it
0cells of the map it votes in
1citing 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

1 citing paper in PubMed.

  1. Review
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

12 authors.

Huachao LiSurgical Oncology, Taizhou Central Hospital (Taizhou University Hospital), Taizhou, Zhejiang 318000, China.
Yin PanSurgical Oncology, Taizhou Central Hospital (Taizhou University Hospital), Taizhou, Zhejiang 318000, China.
Zhibao ZhengSurgical Oncology, Taizhou Central Hospital (Taizhou University Hospital), Taizhou, Zhejiang 318000, China.
Renzhi LinSurgical Oncology, Taizhou Central Hospital (Taizhou University Hospital), Taizhou, Zhejiang 318000, China.
Yue PanSurgical Oncology, Taizhou Central Hospital (Taizhou University Hospital), Taizhou, Zhejiang 318000, China.
Lizhong LinSurgical Oncology, Taizhou Central Hospital (Taizhou University Hospital), Taizhou, Zhejiang 318000, China.
Mingming QuanSurgical Oncology, Taizhou Central Hospital (Taizhou University Hospital), Taizhou, Zhejiang 318000, China.
Hongsheng LuSurgical Oncology, Taizhou Central Hospital (Taizhou University Hospital), Taizhou, Zhejiang 318000, China.
Zhe HuSurgical Oncology, Taizhou Central Hospital (Taizhou University Hospital), Taizhou, Zhejiang 318000, China.
Mingbin ZhengNational Clinical Research Center for Infectious Disease, Shenzhen Third People's Hospital, The Second Affiliated Hospital, Southern University of Science and Technology, Shenzhen, Guangdong 518112, China.
Yihua ChenSchool of Pharmaceutical Sciences and Yunnan Key Laboratory of Pharmacology for Natural Products, Kunming Medical University, Kunming, Yunnan 650500, China.
Yuzhu ZhangSurgical Oncology, Taizhou Central Hospital (Taizhou University Hospital), Taizhou, Zhejiang 318000, China.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

abstractOver the past decade, research associated with organoids has entered a golden era, marking a significant shift in the biomedical landscape. Organoids have been widely applied in the industrial sector and have gained recognition from regulatory authorities. However, amid this rapid expansion, a comprehensive and precise overview of the field has been lacking. Our review aims to fill this gap by presenting a comprehensive overview of the regulations and prospects for the development of investigational new drugs (INDs) using organoids. Drawing on our extensive experience in academic research and industrial applications, we meticulously analyzed the organoid field from two distinct perspectives. We explored the synergies between organoids and cutting-edge technologies such as single-cell omics, which highlights their crucial role in customizing personalized medicines, improving high-throughput drug screening, and establishing physiologically relevant disease models. Organoids offer advantages over traditional animal models, including high throughput, rapid results, cost-effectiveness, and strong clinical relevance. Our analysis delves into supportive policies from regulatory bodies such as the European Medicines Agency (EMA), Food and Drug Administration (FDA), and Center for Drug Evaluation (CDE) for the use of organoids. Our comprehensive analysis and reflective discourse provide a deep dive into the current landscape of drugs derived from organoids that have obtained IND status and the subsequent progress in clinical trials. We cautiously anticipate challenges and future directions in organoid research, particularly in terms of its potential impact on personalized patient care, novel avenues for drug discovery, and clinical research. In summary, our review presents a comprehensive exploration of organoid technology and prospects for the development of INDs using organoids, thereby providing reflections, summaries, and projections that can be beneficial for current researchers.

Indexed as

Drug DevelopmentDrugs, InvestigationalMicrophysiological SystemsOrganoidsAnimalsAnimal Testing AlternativesHigh-Throughput Screening AssaysHumansUnited StatesUnited States Food and Drug AdministrationDrugs, InvestigationalClinical trialsDrug developmentInvestigational new drugOrganoidsPersonalized medicineRegulations

Identifiers

PMID41850780
PMCPMC13120518

What Socratic holds

Textmetadata
LicenceCC BY-NC-ND
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.